The Leading Difference

Dr. Silvia Blemker is a distinguished professor of biomedical engineering at the University of Virginia and co-founder and Chief Scientific Officer of Springbok Analytics. Silvia discusses her fascinating journey from a curious child who loved learning about anatomy to now leading groundbreaking research at the Multi-scale Muscle Mechanophysiology Lab. Learn how her innovative AI-driven muscle analytics technology is reshaping fields ranging from sports medicine to neuromuscular diseases. Silvia shares her passion for mentorship, the rewards of pushing scientific boundaries, and the thrill of solving complex challenges.    Guest links: https://www.springbokanalytics.com | http://www.uvam3lab.com Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 044 - Dr. Silvia Blemker [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am very excited to introduce as my guest, Sylvia Blemker. Sylvia is the Robert Thompson Distinguished Professor of biomedical engineering at the University of Virginia. She leads the Multi-scale Muscle Mechanophysiology Lab, which develops multi-skill computational and experimental techniques to study skeletal muscle biomechanics and physiology. The lab explores a range of applications including speech disorders, vision impairments, aging, muscular dystrophies, and human performance. New projects include developing models that incorporate for sex differences in musculoskeletal structure and simulating the effects of estrogen levels on muscle regeneration. Dr. Blemker is also Co-Founder and Chief Scientific Officer of Springbok Analytics, a company commercializing image based muscle analytics AI technology for many applications from muscle diseases to sports medicine. All right. Well, welcome. And thank you so much for being here. I'm so delighted to talk to you today, Sylvia. [00:01:55] Dr. Silvia Blemker: Thank you. I'm excited to be here also. [00:01:58] Lindsey Dinneen: Awesome. Well, would you mind starting off by telling us a little bit about yourself, your background, and maybe what led you to medtech? [00:02:08] Dr. Silvia Blemker: Sure. So I am born and raised in Lawrence, Kansas, a child of two immigrants who are from Argentina. And they're both professors. So from a very early age, I was exposed to the world of academia. My dad was a mathematician. My mom was a math person also. So, math and STEM was always from the get go part of my life and I knew it would be in the future. And when I was trying to decide what to study as an undergraduate student, I learned of this field called biomedical engineering that was somewhat of a new discipline at that point. I started college in 1993. And I just thought it sounded perfect because I was really interested in medicine. I loved anatomy. I was one of those geeks that had anatomy parts, like models. I had an ear and I had an eyeball and a heart, all these different things. I just thought anatomy was really interesting and cool. And I always thought being a doctor of some kind would be really cool because it would mix my interest in biology and anatomy with wanting to help people, but I don't think that was the right path for me, and it also wouldn't really leverage my interest in math and physics and stuff like that. So once I learned about biomedical engineering, I thought, "Wow, that sounds really perfect for me." And so it turned out it was because I did my undergrad in biomedical engineering from Northwestern University. I did my master's degree there, and then I went on to Stanford University. I got my PhD in mechanical engineering. But honestly, I would have been bioengineering, but back then there was no bioengineering department. So I was in mechanical engineering, but focused on biomechanical engineering. And now I'm a professor of biomedical engineering at the University of Virginia. Been that since 2006. And I also, it's been about 10 years now, co founded a company that's in the medtech industry. It's called Springbok Analytics, and it's commercializing software to go from a rapid MRI scan to a fast assessment of muscle health and fitness. [00:04:22] Lindsey Dinneen: Amazing. Well, thank you for providing some background and whatnot. That was so fun to hear about, you know, your interest in biology from even a young age and having all these models and that's just, that makes me smile. I love that. [00:04:35] Dr. Silvia Blemker: like collecting bugs, too. That's weird. [00:04:39] Lindsey Dinneen: Hey, you were interested in it. I love that. So I have so many questions, but the first thing that comes to mind: I love the name of your company and I'm curious why you chose Springbok. [00:04:50] Dr. Silvia Blemker: Yeah, that is a great question. So, it was inspired by the springbok, the animal. It's very fast moving antelope that runs fast. It's very agile, jumps high. And the reason why we went that direction is our first market at Springbok was in human performance and elite athletes. And so we were using this technology to help athletes recover from injury and get to their maximum performance. So that's where that went. And, you know, honestly, when we first started it, we just kind of like dreamt that up and didn't know if it would stick, but now it has. And so here we are. [00:05:32] Lindsey Dinneen: Excellent. So, yeah. So, okay. With the origin of that company, you brought something to market that has previously not existed in the way that you're doing very uniquely. Could you share a little bit more about what makes what you do so unique and how it's helped solve or covered a gap in the market, basically? [00:05:54] Dr. Silvia Blemker: Sure. So I guess maybe while I answer that question, I'll tell you a little bit about where it came from in terms of the initial ideas. So I think that really answers your question too. So, so we're actually, it started as a research project in a combination of my lab and a few other collaborators at UVA. So started pure research funded by an organization that pro wanted to promote translational research. So research that starts on the very academic basic setting, but is translated to the outside world. You know, we do a lot of research that's very impactful, but it stays in the lab. And the idea is that some of it is ready to go out there. So, having said that, the basic idea for the company actually really came out of some conversations I had with a collaborator, an orthopedic surgeon, who treats children that have cerebral palsy, in particular helps in terms of improving specific movement disorders that kids with cerebral palsy have. And so I've had a longstanding interest in understanding what's happening with muscles in these children because though it's an injury to the brain kind of right around birth which leads to these abnormal movement patterns, that ends up influencing their muscles and bones because muscles and bones grow based on the way you use them. And so this happening as a child means their muscles have a fair number of issues. And so I've been interested in that question, obviously, is if we know that, then we can help better improve mobility and treatments for these children. And so, in my research, I've been making use of MRI a lot to study muscle, because that's a great way to do that in humans. If you're studying a mouse, which we do somewhat in my lab also, you can do a lot with a mouse muscle. But if you want to study human muscles, there's only so much you can do unless you're studying a cadaver, which obviously is not relevant. So, we use MRI and develop these fancy imaging techniques or interesting ways to get a bunch of information about the muscle from the MRI machine, MRI pictures, and do lots of different modeling and things like that. So I was pretty young professor and I was developing new research ideas and this clinician said, his name is Dr. Abel said, "You know, all these interesting ideas about what you can learn about muscle from MRI is cool, but you know this is not something we could ever use in the clinic because the way that you're doing these scans is very hard. It's very research oriented. You're only studying one muscle, and really in cerebral palsy and impacts all the muscles of the in the body, but in particular for movement of the leg. And we don't have a way to, to quantify that or understand that. And that's what I really need to have in order to figure out how to treat these kids." 'Cuz ultimately he's has to do surgeries on a bunch of muscles and he has to make the decisions about which muscles to do surgeries on just by looking at the outside of the child and not really having a sense for what's going on at the muscle level. So I was like, "Okay, well, maybe we'll try to solve that problem." Cause it seems like the problem I wanted to solve maybe isn't all that useful to you right now. So, that, that really was the basis for Springbok the initial idea was to develop a way to collect MRI rapidly and then transform that into a assessment of all the muscles of the lower extremity in particular for these kids because there's really no other way to get information at the muscle level. We have ways to kind of assess how strong people are. But that's what we say in biomechanics, we call it at the joint level, you know, but like, for example, if you wanted to see how strong your knee is, you extend your knee for example, to get your quadriceps, but there's four quadriceps muscles. So if there's a weakness, which muscle is the one that is, you would have no idea what that was if from the outside. Same thing for all other joints. So, that's the idea is like to get to that detailed information and in this particular application it's very obvious why you need that because they're going to go in and do surgery on individual muscles. So they want to do the ones that actually need it. And then, you know, the premise of where we went from there is that, the need to have information at the muscle level has a lot of different applications outside of that. And so that's sort of one thing led to another. And again, because we were funded by this grant agency called The Culture Foundation that wanted to promote translational research, one of the early pieces of feedback they gave us was the market that we was associated with the application we were first exploring in cerebral palsy was too small to start with. And there's too many barriers of entry in terms of being able to actually implement in practice. So that's what led us to shift to other areas in particular. And in particular, elite sports because some of those barriers don't exist. The financial aspects are not nearly as challenging to start. And so it's actually a path I've heard of a lot of other healthtech or medtech companies to go start in sports and then veer into once they've gotten a bunch of data and validation, veer into the medical tech, and then that's precisely our path as well. [00:11:12] Lindsey Dinneen: Yeah. Excellent. Well, well, thank you for sharing more about that. That was such a great explanation specifically about the quadriceps. I really latched onto that because what an interesting problem, but then what a great solution that you all have developed. And, you know, I'm wondering, looking back before you started the company and really dove in, could you have anticipated that you were going to become this entrepreneur? And did you expect that this might be part of your path or was this kind of just a happy coincidence after the research developed? [00:11:49] Dr. Silvia Blemker: Definitely did not expect it to be part of my path. [00:11:52] Lindsey Dinneen: Okay. [00:11:53] Dr. Silvia Blemker: Absolutely. By no means, my brother was the one that went, like he was an engineer too, and he worked for IBM and he became more of a business man. That's what I would call him. But, yeah, it was really, you know, a multitude of things, the encouragement. I had some really good, you know, co founders. Craig Meyer and Joe Hart were both colleagues and they were excited. It was sort of like at that point, it was like, "Well, I don't want to be the limiting factor here. We should all do this together, right?" Found some really fantastic people to help it get started because, of course, when you first start something, there is a lot of risk there. And also, the three of us co founders had day jobs. We're still professors. And so we found a great actually grad of our program. To be our first CTO or first official employee. You really need to have that team around you. It's not just one person or two people, there's a lot that goes into this type of effort. And so I think without that, for sure, wouldn't have done it. And then one thing led to the other, I guess. It's definitely has pushed-- I can speak for myself-- out of my comfort zone a lot, you know, and it still does. But I think that's why I keep doing it also is I've learned a lot. [00:13:10] Lindsey Dinneen: I love that. Yeah. Well, and I think that it brings different challenges than you're probably experiencing in the academic side of things, and that's its own challenge too. But I love the fact that, speaking with leaders such as yourself, you're always pushing yourself to the next thing. You're not really just happy being. [00:13:29] Dr. Silvia Blemker: My husband might appreciate it more, but [00:13:31] Lindsey Dinneen: Okay. Yes, this is fair. Yeah. Well, okay. So, so just briefly switching sides to the academic journey that you've taken. So can you speak a little bit more about the program that you are in and helping to continue to develop? And what are you excited about even just with the university as you continue to grow? [00:13:56] Dr. Silvia Blemker: So I am a professor at heart. Right now I'm in a particularly interesting kind of stage of my career where I'm still a professor at UVA, but I'm actually part time professor and I'm also officially employed by Springbok. I'm a co founder, but I'm right now working as Chief Science Officer. So I do have two jobs. [00:14:15] Lindsey Dinneen: Yeah. Nice. [00:14:17] Dr. Silvia Blemker: Yeah. [00:14:18] Lindsey Dinneen: Oh. [00:14:20] Dr. Silvia Blemker: Sons to o, but it's all good. It's, you know, it's nice full life, but so anyways, I have a research lab called, we call ourselves the Multiscale Muscle Mechanophysiology Lab. It's a mouthful. So we just call her, we say M3 Lab or M cubed. And we have PhD students, be it biomedical engineering, PhD students who are doing research and with in my lab going towards their PhD. I have postdoc, so students that have finished their PhD and continuing training for research in my lab, and then a whole bunch of undergraduate students who are getting involved in research for the first time. And the mentorship there that I do is ultimately, I think, honestly, what I love the most. And I joke with them because I now encourage all of my students to do internships while they're in their graduate program. I think it's incredibly valuable for a lot of different reasons that I could chat through. But I tell them, "You know, I never did that. And I did my internship in my late 40s. Fortunately, I realized that I made the right career choice, but I did it a little late. You should do it earlier." [00:15:25] Lindsey Dinneen: Right. Oh, nice. [00:15:28] Dr. Silvia Blemker: So anyways, I love my students all the way from ultimately in the lab, like exploring, you know, I talk a lot about with them, "You know, what we're doing is exploring the boundaries of knowledge together, pushing it and understanding where the boundaries are and figuring out how to push them in ways that can advance the world, really." And doing that with the student together and essentially I find myself like right behind them. I'm like, "Okay, keep going, teach me while you do it." I just find that, I just love doing that. It's very rewarding. And it's a real impact to be able to train other people to do this work. And there's the relationship aspect of it that is very valuable to me. So I just love teaching and hopefully inspiring new students to get involved in the kind of work I do, or help them figure out what they want to do. I think in the industry in the startup setting that mentorship is also a big part of it, but you know, it's just it's different. So one of the big projects we have that is actually the cool thing is, it's empowered by the startup company. So there is a synergy there which I think is really cool. So we are in the lab creating the next generation versions of computer models of the body that account for differences between men and women, between males and females. So in the world of movement biomechanics, in addition to using MRI as a common tool, another way that we study human movement and to try to figure out what's happening on the inside of bodies is to use computer modeling where we have models that sort of help try to describe the person in as much detail as possible from the inside, their bones, joints, muscles, everything, how their muscles move, and combine that with measurements of motion from the outside and physics and use all that to figure out how the person, how their muscles are working. There's a lots of different questions that you can answer once you have a model like that. The problem is that the model that everybody uses is based on data from like a 5'10 man. And then we scale it to fit anybody. So it doesn't even actually probably represent the 5'10 man, honestly. It's kind of an average. We're doing a big study where we collect MRI data of a large number of males and females, and we're doing a whole bunch of other measurements to allow the field to put that model aside and do a much better job at representing the population in particular, and accounting for the differences between male and female, because a lot of clinical problems, conditions, questions, issues that are the answer to them are different between male and females. And as a field, we don't really have ways to handle that. And I think that we need to do better than that. So it's an interesting project because It's a very, it's, there's a lot of interesting technical thing problems that we're solving to do that, to do these modelings, models at scale and stuff like that. But it's also a bit of like a public service model or a project where we're answering these questions, but ultimately going to give these models to the community so that they can do their research better too. [00:18:37] Lindsey Dinneen: Wow. It, you know, it continues to boggle my brain when I hear things like this, where it's like, "Yeah, we forgot to consider half the population." And I, you know, shouldn't make me laugh very much, I'm just very thankful, is really what I'm going to get to, of people like you who are going, "Wait a second, maybe this one thing that we've used all this time could be done more effectively and represent, like you said, just a better understanding of humans." So I... [00:19:07] Dr. Silvia Blemker: Yeah. It's interesting. You know, I've wondered about this myself a lot, how do we come to be? And I think it's this interesting difference between thinking about the impact of what your science is versus how to do the science well, because as scientists were trained, take out all other extra variables so that you can answer the question, you can control for everything that's your questions not to do with so that you can answer your question or test your hypothesis. And so, if you add sex as a variable, that confounds your question. And then, if anything, it just means that you have to double your sample size, you have to account for that. And so to do it well, but maybe with less resources, it would make sense scientifically to go to one sex. So that's why that happens, right? But then, if you're thinking about, "Well, yeah, but then I only answered that question for one sex," then you would do it differently. So I think that's where it comes from. Honestly, I don't think my predecessors were necessarily sexist or anything. I think they were doing things in the way that made sense scientifically by keeping things constant and wanting to have clean results. So that is what it is, but I think in a world where we're thinking more about the impact of what we do, we can't do that anymore. [00:20:30] Lindsey Dinneen: Yeah, well, and I thank you for sharing that. I think that's a really great perspective and realizing that sometimes It's easy to get annoyed by something that when we don't understand maybe where it came from or why somebody chose the route they did and maybe there was a very just practical reason for it. And so I love that you shared that. Thank you for doing that. [00:20:53] Dr. Silvia Blemker: But I will say that I have gotten annoyed though when you ask the question, like, "Why did you just do men?" Sometimes the answer is just, "Well, that's just how it's done." Not reasonable. I don't think that's, I don't think that's an... [00:21:07] Lindsey Dinneen: A lazy answer. [00:21:08] Dr. Silvia Blemker: Absolutely. Yeah. [00:21:10] Lindsey Dinneen: Yeah, that's fair. That's fair. So, you know, either in your academic journey or perhaps in your entrepreneurial journey, are there any moments that stand out that really kind of affirm to you, "I am in the right industry, doing the right thing with my life?" [00:21:29] Dr. Silvia Blemker: Oh, huh. That's an interesting question. I'll tell you when I know that I'm doing the right thing, when I'm excited to get up and do it [00:21:39] Lindsey Dinneen: Yeah. [00:21:40] Dr. Silvia Blemker: Morning, I'm like, "Oh yeah, I'm going to work all this. This is exciting. I want to figure this out." That's usually what gets me up. Like my husband knows when I'm, we call it "locked in" because, you know, we have Gen Z kids, when I'm really trying to figure something out. And that, that really like gets me like figure something out that I know is important and impactful. I just love doing that. I think ultimately that's what I like and being creative and coming up with solutions and questions and stuff like that. That's not, I don't know if that's answering your question though. [00:22:13] Lindsey Dinneen: It actually, well, it does though, because I mean, everyone answers that in different ways, but what I love is the fact that it's your daily life. That's a great answer to that question. It's, " I'm curious. I'm excited. I want to work with these students and solve these problems." And that's a dream. [00:22:32] Dr. Silvia Blemker: That's what I, that's what gets me up in the morning. I mean, obviously not every day can be filled with these super intriguing things. There's a lot about a daily routine of any job that involves other things. And I try to learn to do those. Like one example of that for me was when I first started as a graduate student. As a scientist, a researcher, you have to present your results or give presentations a fair amount, whether it be to your lab group or to your thesis committee or in at a conference or a seminar. And then ultimately as a teacher, you have to do that all the time too. And early on, I really did not like doing that. It was really painful for me. I was really anxious about it. I loved sitting there working stuff out on my computer. That I loved, I knew, but I did not think I could do any-- presenting was scary. The first time I had to go presented a conference, I literally memorized every single word of the presentation to the word, and even my friends, my graduate student friends who I shared a hotel room with, they could give my presentation. They literally could, but now I absolutely love presenting. It's something that I've come to really enjoy all aspects of it. So that's an example of maybe not everything initially seems like that's what I'm going to love doing, but sometimes you can surprise yourself. [00:23:57] Lindsey Dinneen: Yeah. Well, and I actually, to expand on that, I think the idea of you never know what your next sort of joyful surprise is going to be. So try the things and we'll discover that not everything is for you, but that's such great advice also for students, I feel like in particular, or maybe those young in their career is, "Just experiment, try it." You know, use it as this exciting time to just see. And yeah, you might even hate it the first couple of times, but you never know. [00:24:27] Dr. Silvia Blemker: Yeah. Yeah. You never know. You never know. Absolutely. [00:24:30] Lindsey Dinneen: Yeah. Well, this is going to be an interesting one because I'm going to pivot the conversation and ask you something that I ask all my guests, but in your case, you are used to teaching and giving classes. So the question is, if you were to be offered a million dollars to teach a master class on anything you want, what would you choose to teach and why? [00:24:52] Dr. Silvia Blemker: Oh, a million dollars. Oh, but I, like, I love teaching, [00:25:03] Lindsey Dinneen: Yeah, I know. That's why I was like, oh man, this is gonna be interesting. [00:25:07] Dr. Silvia Blemker: I think it was last year I was so proud of the undergraduate students. They give these awards to professors and I got the Lecturer of the Year award. So that was fun. And then I brought it home and my teenage son was like, "Oh yeah, yeah, that tracks. Mom's the lecturer of the year." [00:25:26] Lindsey Dinneen: Oh! [00:25:27] Dr. Silvia Blemker: Momly lectures. So anyways, it's hard to turn it off, but let's see, what would I give it about? I mean, it would probably be something about how muscles work 'cause I love talking about muscles. Honestly, like at the end of the day, that's now I'm kind of all in it. So I, I like talking about that stuff. Randomly about tennis too. I love tennis. I play tennis as a very low level tennis player, but I've become a tennis nerd. So if I had another job, I would love to be like a tennis announcer, but the science tennis announcer to talk about the physics and stuff like that, biomechanics. I would love that. [00:26:05] Lindsey Dinneen: Oh, I would love that. That would make it so much even more interesting to me because I'd go, "Oh my word, I had no idea that this was what's happening here." And yeah, that's cool. Excellent. Okay. Well, I like it. Well, how do you wish to be remembered after you leave this world? [00:26:23] Dr. Silvia Blemker: Ultimately for my children, like Mom to Jack and Daniel Blemker, number one, then wife to Wes and the rest of my family. I think, ultimately, that's the most important, right? And then as a mentor to my students. [00:26:41] Lindsey Dinneen: Yeah. [00:26:42] Dr. Silvia Blemker: And then for like, you know, doing things that help people. Products that we've put out there, I feel like we've had an impact and we continue to see the potential impact. But honestly, that isn't really about me. It's about the impact. So I don't know that I-- I guess it's good to get credit for stuff like that, but ultimately it's just cool to know that it's had an impact and it's really connected to a lot of people not just me, so I think it's cool like sometimes I do reflect on, when I see cool stuff that the company's doing like "Wow, that was my idea. That's cool." But it's like not just that, right? An idea is just an idea. There's so much more. And the people that we have at Springbok doing, it's just a fantastic team of just ridiculously smart people who are also great, work well as a team and really value having a positive environment and they're fun. They're funny. So that's all cool. [00:27:39] Lindsey Dinneen: That's awesome. That is so cool. Yeah. Yeah. I love that. And then final question. What is one thing that makes you smile every time you see or think about it? [00:27:50] Dr. Silvia Blemker: I have a few different things, maybe. Well, the first one that comes to mind, honestly, is every time, and this is one of my favorite things about doing Springbok, is every time we get like an interesting new scan in, and we look at a large range of individuals now from people with muscle disease, neuromuscular disease, and all the way to NBA players and everywhere in between. But whenever I see one that's different, I'm like, "Ooh, that's cool. That makes me smile." So I guess that's muscles. And then also, I guess the other one is just seeing like a mentee or student shine in some way. One of my former student just defended her PhD two weeks ago, and just sitting there watching her do her PhD defense, she's phenomenal. It was just amazing. I mean, who wouldn't smile at that? But [00:28:43] Lindsey Dinneen: Yeah. Oh, that's amazing, and I love how it all ties together, just your answers are consistent, but I, what I love about hearing that is this just thread of appreciation for muscles and anatomy and impact and the students and the lives that you're touching. So I, you know, I definitely, I love that you're doing what you love and that it brings you joy. That's the best. Yeah. [00:29:11] Dr. Silvia Blemker: That's so nice. That makes me smile. [00:29:15] Lindsey Dinneen: Oh, I love that. Well, thank you so much for your time today. This has been such a joy for me actually, to get to talk to you and learn more about your background and what gives you energy, what gets you up in the morning. And so I just really appreciate you sharing about all the great work that you're doing. And I just wish you the most continued success as you work to change lives for a better world. [00:29:38] Dr. Silvia Blemker: Well, thank you. Thank you very much. Thanks for producing such a cool podcast. So very much appreciated. [00:29:45] Lindsey Dinneen: much. Thank you. Well, thanks for bringing a smile to my face. And thank you also to everyone who is tuning in today. And if you're as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:30:01] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Nile Harris, a seasoned leader with two decades of experience in the MedTech industry, is the founder and CEO of HVG Executive Solutions and currently serves as a director in the life sciences practice at Alvarez & Marsal. Nile shares her diverse career journey from financial services to MedTech, including roles at Medtronic and Abbott, and her current work in management consulting. Emphasizing the value of lifelong learning, Nile discusses her philosophy on leadership, blending strategy with tactical execution, and the importance of adapting rapidly. She also reflects on pivotal moments, like nearly quitting due to the emotional challenges in medtech sales, and her passion for closing healthcare disparity gaps.  Guest links: https://gapdemystified.com | https://hvg.llc Charity supported: Opportunity International Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 043 - Nile Harris [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I'm so excited to introduce you to my guest today, Nile Harris. Nile is a highly skilled and versatile leader who has made significant impact in the medtech industry for two decades from the C suite to the operating room and companies such as Medtronic and Abbott. Her agility was forged through a successful cross functional career, spanning corporate strategy and development, product marketing, field sales and marketing, strategic market insights, commercialization, market access, and executive coaching. Nile is an expert advisor and mentor for Life Science Tennessee and the Nashville Entrepreneur Center focused on early stage startups. She is the CEO and Founder of HVG Executive Solutions and currently serves as Director in the life sciences practice at Alvarez and Marsal. All right. Well, thank you so much for being here, Nile. I'm so excited to speak with you today. [00:01:48] Nile Harris: Thank you. I'm happy and excited to be here as well. [00:01:53] Lindsey Dinneen: Awesome. Well, I was wondering if you wouldn't mind starting off by telling us a little bit about yourself and your background and what led you to MedTech. [00:02:03] Nile Harris: Yeah. Interesting story. Happy to share my journey to MedTech. I tripped into it and loved it. I began my career out of undergrad in financial services, actually interned all through undergrad and financial services. And I loved being on a trading floor-- I was actually a licensed broker at one point-- loved working on trading floors. I'm originally from Chicago, worked at the Board of Trade, Chicago Board of Options Exchange, but it wasn't a cultural fit. And I felt like I wanted to give more or put more out into the world other than making more money, essentially. And I went to business school at the University of Michigan and did my internship at Lily in Indianapolis and absolutely loved healthcare. And it had never occurred to me that healthcare was an option. And I spent my summer there as IT Project Manager supporting clinical trials. And I was like, I thought this was just amazing. And so I was recruited to Medtronic coming out of Michigan and they had an IT rotation, leadership rotation program. They're sort of a internal consulting group. And I was in that program for two years. And when I came out of that program, I went to the strategy and corporate development group within Medtronic. And that's when I really saw what we did as a company there. I really have more exposure to the products, the lives that we were saving, and the impact that we were having. And I had really no idea what it took to get a product from bench to bedside. Like, what does it take to get a product designed and into a patient? And I decided to go from corporate strategy and development to field sales and marketing. So I was like, I thought that there was no better way to learn it than just to roll up my sleeves and get into it. And so I went from making PowerPoints and Excel spreadsheets to being out in the field. So I went from being in Minneapolis to Nashville, where I was doing Therapy Development Specialist. So it was a hybrid between sales and marketing. And I spent a lot of time in hospitals. And the part of my job was essentially to grow the pie for thoracic and abdominal aortic aneurysm stent grafts, and then grow our piece of the pie. So I was in surgeries, but I was also doing strategy and sort of marketing and attracting customers and refer referral patterns. And it was great. This was like, this was magical to me. And I had no idea before I got into Medtronic that this was a world that was even open to me. And so I just got deeper into it. I did product management, did value based healthcare and pricing. I did a stop for a couple of years in K 12 education. I'm very passionate about closing the health, wealth, and education disparity gap in America. And so I was a Broad Resident for the system management of school systems. And so I led strategy for a charter school system in Nashville, but went back into working with, with life science companies at a small consulting firm, and then was doing some independent consulting, started doing executive coaching, specifically within medtech for those people who are trying to get to that next level of leadership and trying to figure out how do you run multi generational teams? And then I was at Abbott for a little bit as a Global Director there and built a team there. And now I do management consultant. And so I've been in medtech now for 20 years. And what I love about being a consultant is that I get to take all of those experiences and how companies bring innovations to life. [00:06:20] Lindsey Dinneen: Wow. Yeah. Well, first of all, thank you for sharing about your background. What an amazing breadth of experience you have. And also I love the thread of your lifelong learning and curiosity. And, oh my gosh. I mean, so I looked at your, LinkedIn profile and I was like, okay, so you have a BA, a BS, an MEd, and an MBA. So clearly education. [00:06:50] Nile Harris: I do I believe education is important and so the BS in finance and the BA in communications happened because at the University of Illinois, you can get a BA in Finance or a BS in Finance. And so I went the BS route, but it was very technical. We had these highly technical economic classes, statistical modeling, all these things. There weren't a lot of soft skill classes, and I wanted to incorporate that into my experience. And then I realized, well, if I earned a certain number of hours, I could be a dual degree versus dual major. And my junior year, I had no idea, but my junior year, I got this letter from the university saying that all of my advanced placement classes from high school transferred and I had a semester's worth of additional hours. So I spent an additional summer after I finished one degree and then I was able to finish the second degree. So I did both in four years. [00:07:52] Lindsey Dinneen: Wow. Holy cannoli. Okay. [00:07:54] Nile Harris: I'm a lifelong learner. I believe you need to always be learning. And the curiosity is, I think a lot of times I've gotten the feedback of, "Well, you're kind of all over the place." But not really. I am curious about what people do and how they do their jobs. And I would, when I was in strategy and development, my role was to lead the strategic planning process, and I had access to all of the business leaders, all of the presidents, all of the leaders that they worked with. And that was just awesome. That in itself was just a college education. I had ready access to ask them about their businesses. But I also asked him, "Well, how can I be a better partner for you? If I'm in corporate, how can I be a better partner for you?" And one of the things that came up over and over again was, "Understand my business better. I understand that you have to run the process and you're focused on getting all of the parts and pieces together. But what would help me is if more people in corporate understood my business." And I was like, "Okay, I'm going to go into sales." [00:09:04] Lindsey Dinneen: Yes. Wow, that is so incredible. And, leadership and management, and now with your executive coaching, obviously that's a been a running theme and will continue to be. And I'm really curious what is maybe your top couple pieces of advice for those who are looking to either become better leaders or to even start being a leader? [00:09:32] Nile Harris: That is a great question. I think, first of all, I counsel people to develop your personal leadership philosophy. What type of leader do you want to be? What is the legacy that you want to leave with people? What is it that you want them to remember you for? For me, it was being a servant leader. I see myself as, "People don't work for me. I work for them." My job is to remove obstacles, build them up, set a vision, set the container in which they work and then support them in that. Set the example, model the example and and I always say, you know, the book "Leaders Eat Last." Well, I say, "Leaders eat last and they're the first to the fire." And so you develop that philosophy and talk to people. Like I said, I had access to some amazing leaders and I watched them and I talked to them and I asked them and so, interview people, talk to people who you think are great leaders. The second thing I would say is learn from people who you think are not great leaders. Let them teach you about what you don't want to be as a leader. Right? And the third thing is talk to people. I had one mentor who used to say his version of a quote from Abraham Lincoln, which was, "You can't lead without the consent of the followers. Find out what the followers need and give them that." And leadership is for the people who are following you. Promotions or accolades or rewards are for you as an effective leader, right, for getting results. The leadership is what you are providing to others. [00:11:19] Lindsey Dinneen: Yeah, that's great advice. Thank you for sharing that. I think especially your middle point about learning from leaders that you don't look up to, but that have actually a lot to teach you is such a good point too, because, in general, we look up to the people that we go, "Oh my goodness, I love the way that this person leads. I really admire what they bring to the table." And then, that's great, but it is also such an experience to learn from somebody that doesn't have maybe the leadership qualities that you aspire to have. And so you're able to go, "Okay, so this is what doesn't work. Let me figure out what does." [00:11:58] Nile Harris: Exactly. And even the leadership style, even if it doesn't work for you, even if it doesn't work for 95 percent of the organization that person has been put in charge of, that there's something that they do that you might like. So don't necessarily throw the baby out with the bathwater and just say, "Oh, they're a terrible leader." What they're doing something, they did something to be able to get in that, into that position. Learn from that as well. [00:12:25] Lindsey Dinneen: Yeah. Ooh, taking it a step further. I love it. You know, one thing I really enjoy-- oh, I very much enjoyed reading your LinkedIn profile, by the way-- but one thing that really stood out to me, and I would love if you could talk a little bit about was somebody at some point told you that you have an amazing ability to "seamlessly switch between strategy and tactical execution." Could you speak a little bit to that? That is so cool. [00:12:51] Nile Harris: So this is funny. This is a very funny thing. So that was a manager who I did not get along with. We did not see eye to eye. And we had a facilitator come into our team meeting one day and help us to figure out how do we work together and collaborate as a team. Like, how do we pull out the gifts right in each other? And so the facilitator went person to person and asked, "What's your gift? What's your gift? What's your gift?" And so when he got to me, I said, "Oh, my gift is my organizational skills. I'm very organized and I can connect all these dots." And so my manager, who I did not get along with, says, "Your gift is effortlessly going from strategy to tactical execution. You can be in the clouds and then on the ground. And it is a clear stream and it is effortless." And everybody in the room was like, "Yeah, well, where did you get organization from?" I was like, "Wait, where'd you get that from?" I didn't see that in myself. It didn't, it didn't occur to me that's what I was doing. When they pointed it out, I didn't realize it was a gift. Because I just do it. And then they were like, "Not everybody can do that." And I thought it was so odd that this person who I had sort of like this ongoing strife with was the one to point it out. [00:14:27] Lindsey Dinneen: Yeah, that's irony for you, but what a gift though, because then yeah, to understand, "Oh, this isn't something..." I think that happens a lot where you get to it's really helpful to have somebody who's outside perspective who can say, "Actually, this is your superpower because most people can't do what you think just comes naturally to everyone." If only. [00:14:51] Nile Harris: Yes. And 'cause a lot of times I actually got this question, somebody else was going through my LinkedIn profile and they were like, "Well, how did you develop that skillset?" And I told him, "You know, I didn't do it intentionally. I didn't set out to say,' I'm going to go from strategy to execution effortlessly.'" I think it was the act of doing it. So being able to say, "Well, I don't want to be in financial services, but now I have that financial skill and acumen. I'm going to leverage it to change industries." And then being in this tactical position of putting together models and PowerPoints. And I was putting together PowerPoints for like our executive committee. So I'm this very, I'm doing something very tactical, but at a strategic level. And then to go from that to say, "Well, I want to really understand how these things connect together." All right. And so I go to sales. And so I think it was just the, I followed the trail of the curiosity and I learned something along the way by doing that. And so it ultimately, it just sort of naturally, I think cultivated what I do know that I'm really good at is seeing patterns and connecting dots. And I think it just sort of came from that. [00:16:11] Lindsey Dinneen: Yeah, I think that makes a lot of sense. And I think, to your point of you having demonstrated your willingness to continue to learn and to step into different roles, so that you were able to continue to expand your knowledge and your skill sets, I mean, you know, it's funny. And I know a lot of people talk about the idea of generalist versus specialist. And being a generalist does have a lot of advantages in terms of, when you have this crazy diverse skillset and even experience in multiple industries, then all of a sudden you can draw from, "Oh, you know what? I remember this really random thing back in when I was doing financial services that actually would really apply here. I don't, I wonder if anyone has ever thought about that!" And then you keep connecting those dots, like you said, so. [00:17:03] Nile Harris: Exactly. And that's exactly how it happens in my brain. Right? Like my brain will reach back to, "Remember when you worked on this project and you did this really random thing." And I'm like, "Yeah!" My brain's like, "It applies here." I'm like, "Okay." But I did Strength Finders and one of the strengths, it was described as, I didn't necessarily agree with the word that they use, but when I read the description, in the description, it said, "I am a collector of information." And I'm like, yes! I have every notebook that I used to take notes for work. I have every notebook going back to my first job out of college. And I use Evernote to collect, literally collect articles across the internet. If I'm like, "Oh, this is interesting," I'll clip it into Evernote. And so now I've got sort of this encyclopedia of information. And so if I want to, think about, "Oh, I read this article about this medtech company that was doing this thing," I can search my little encyclopedia and find out. So that also is the whole connecting the dots. And Steve Jobs had a, and I'm going to butcher the quote, but he had a quote about "being innovative and being creative is about having enough experiences that you can connect." [00:18:32] Lindsey Dinneen: Oh, I love that. Oh my goodness. Yes. I cannot agree more, and I think the ability to be creative does often come from being able to draw from lots and lots of different sources and then putting them together in a new way. So, oh my gosh, I love this So, you know another thing that stood out in your profile was, you have a wonderful ability to "plan meticulously and then adapt rapidly," and obviously your career path has really demonstrated that but I'm wondering is that in particular a skill set that you developed over time, or have you always had a tendency towards very careful planning, but at the same time holding those plans loosely enough that you can adapt quickly? [00:19:21] Nile Harris: Yeah, there's a little bit of both. It's inherent in me to want to plan, want to know where things are. That just gives me a sense of comfort. I did not always adapt rapidly. That was working in the strategy and corporate development, working with a bunch of C suite, the CEO, the COO, the presidents of all the businesses, adapting rapidly was a requirement. And things would change super fast. The meeting might start off about one topic and then it ends on a totally different topic. So having to pivot, having to go. But then that also helped me with, "Okay, I'm going to have a plan a and plan B and a plan C," because then I started to learn how to anticipate and I would know, "Okay, if we're going to go through this particular presentation, which is about this piece of the strategic plan, it could go one of three ways. And I want to be prepared for all three ways." And so over time, I became known for my ability to pivot real quick or have something in my back pocket. So people would always then be like, "Oh, Nile, we know that you have a plan B. We know that." And we were doing a sales meeting. I worked under the president of the cardiovascular business, and we were doing a sales meeting and his video or presentation clip, whatever was on this sort of --this was a long time ago. So it wasn't transferred digitally. It had to physically be burned onto a tape or a CD or some medium. And I had to physically transport it with me from Minneapolis to Las Vegas, where the meeting was. And I said, " Could you make another one so I have a backup?" And the guy was like, "Come on." And I was like, "Nope." So I gave the first copy to the person I was supposed to hand it off to. Get to Las Vegas, and they called me over to the hall for rehearsal. And they're like, "Hey, we can't find the first copy." And I was like, "No worries." I pull out the second copy out of my little bag. And the president of the business was like, "Yep, that's Nile." And they were sitting there and they said, "Yeah, the president, he wasn't worried at all. Like we were freaking out and he was like, 'Nah, just call Nile.'" [00:21:36] Lindsey Dinneen: Oh. [00:21:37] Nile Harris: And they were like, "Wow." And he was like, "I told you." And so then being in sales is nothing but adapting rapidly. That is what, that is all day, every day. So that adapting rapidly was, it was taught. But I think being planful was my natural inclination. [00:21:57] Lindsey Dinneen: Yeah. Well, what a great reputation, too, to have. "Just call Nile. It'll be great. It'll be fine." [00:22:03] Nile Harris: "It'll be fine. Nile's got covered." [00:22:05] Lindsey Dinneen: I love that. Yeah. So what are you really looking forward to maybe both personally and professionally in the next couple of years? [00:22:15] Nile Harris: Now that I'm in a bigger management consulting firm not doing the independent piece, but I'm part of this bigger entity, there is so much happening in medtech and medical device and life science in general, with generative AI, health care equities, just so much happening. And I think that we are reaching a really a big pivot point also with like digital health care and collecting data and on patient care, predictive medicine. We are at this next evolution of care, and I'm really excited to help usher that in by working with other, with companies, with innovators in this space. The AI with imaging and streamlining workflows and helping to close healthcare disparity gaps, to be able to contribute to that in a much deeper way that you can't when you are a independent consultant. The other piece is, I really love helping to build those high performing teams. And I, there's like with coaching, I love that aha moment, that moment when somebody is like, "Oh, wow." That moment I had when my manager said my gift is going from strategy to execution. I love helping other people have that moment. So I'm looking to help build that next level of leaders that will be better leaders than I am, better leaders than I had. And then that the next stage for me is how do I again, take everything I've learned and pay that forward. , leave a legacy. That's, and I might be talking about like, it might seem like I feel like I'm old because in two years I'm still going to be working. I'm still going to be doing things, but that's when I feel you start to get into the part of your career where you're leaving that mark, you're leaving that legacy. That's the thing that we want to know Nile for in the medtech space. And then really also outside of work, more personally is, I feel very strongly about the health, wealth and education disparity gap and America and being able to contribute to health and equity where we have two demographics of people who get a disease at the same, same rate, but they don't have the same outcomes, the same treatment outcomes. Like, why is that? So how can I contribute to that? [00:24:57] Lindsey Dinneen: Yeah. Yeah. Yeah. Those are all wonderful things to be thinking about and working towards. So yeah, I really appreciate just-- you talked about how you are a servant leader, but you just have such a beautiful heart of service. And I mean, I could see that throughout even your volunteering and your mentorship and things that you do. So, gosh, yeah. Thank you for sharing about that. [00:25:21] Nile Harris: Yeah. [00:25:21] Lindsey Dinneen: So I'm curious. Along this journey, especially in medtech, have there been any moments that stand out to you as really clarifying to you, "Wow, I am in the right place, at the right time, in the right industry?" [00:25:36] Nile Harris: Oh, oh. There is a moment where I almost quit and it was when I was in sales. And again, it was a hybrid sales marketing role, but I was, it was doing my field training and I'm so excited to be out there. And I, you know, completely committed to the mission and we help people in these devices. They go in people and they restore health and they do all of these things and these things are great. And I was, In the hospital one day with one of my training reps, and we got a call to the E. R. There was a patient in there with a ruptured aneurysm, aortic aneurysm, and he was, I don't know, in his eighties, mid eighties. And we looked at the film to see if the device, the stent graft, it's minimally invasive. The other way you repair an aortic aneurysm is to open somebody all of the way up and take out their aorta and put in a different type of graft. And when we looked at the film, this was a ruptured something like a 10 centimeter aneurysm. And this patient was actively bleeding out. And the rep asked me, " What do you see?" And that's what I said I saw. And she said, "Well, okay, so what are we going to do?" And I'm like going through my training, flipping through my training and everything in my training said, "There's nothing that we can do for this patient." And so I say it to her and she was like, "Correct." And so essentially once you've ruptured to this point, they were just making him comfortable at this point and he was going to expire. And I conceptually understood that people pass away. We can't save everybody, but to have to sit there in that moment and look at looking at this film and you are dealing with a human, is a human being on the table and you are saying it's "Wow. This is the moment where you can't do anything." So we left there and I just went back to my hotel and I was like, " This is stupid. Like, why am I doing this?" And my manager called me and I told him, I was like, "You know what? I don't think I'm cut out for this. I can't do this. I can't not save people. I got into this to save people." And he said, "If you had any other reaction, I would be worried about you." He's like, " Give it 48 hours and call me back." So I gave it 48 hours. I called him back and I was like, " No, I'm supposed to be here. I'm in the right place. I love this work. I love what I do. I would not have been so upset if I didn't. If I didn't love what I do, if I wasn't in the right place, I would not have been so upset. So that was to me was a defining moment of that's why I love this work." [00:28:41] Lindsey Dinneen: Wow. Oh my goodness. What a powerful story. Thank you for sharing that. [00:28:46] Nile Harris: Yeah. You're welcome. [00:28:47] Lindsey Dinneen: You know, I really appreciate-- that's such a human moment to have. And of course we all have them, but we don't always talk about them because it doesn't always feel good, but that is so powerful that you were able to take what, it was such a difficult moment but use it as a little bit of motivation for your why as well. Wow. Yeah, that is amazing. Thank you. [00:29:09] Nile Harris: Yeah. And yeah, you're welcome. And I had two primary trainers in Tennessee. They were like in different parts of Tennessee, and the primary trainer told me when I, first day of training, he said, "If you always do what's right for the patient, everything else will come. [00:29:24] Lindsey Dinneen: Yeah, there you go. That's "great. [00:29:27] Nile Harris: Yep. [00:29:28] Lindsey Dinneen: Yeah, well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:29:44] Nile Harris: Oh, this is such a great question. I don't know how I would do it. But I would teach people how to, how do I put this? I would teach people how to go from like strategy to execution but in a, I think maybe in a broader way, I would teach people like how to connect thoughts or how to be curious or how to always be learning. I don't know exactly how I would do it, but I would teach people to be explorers their life. [00:30:13] Lindsey Dinneen: Yes. Oh, I love that so much. Yes, amazing. Yeah, well, whenever you put that together, let me know because that sounds incredible. [00:30:24] Nile Harris: Yeah. I mean, I just wrote it, like I wrote it down, right? Like, I like, that's what I would do. I would teach people to be explorers, because then if you teach people to be explorers of their own life and curious about their own life, they're going to end up where they're supposed to end up eventually, right? So whether it's medtech or whether it's this or that, like you're going to end up where you should be because you've been curious about your life. And, yeah, that's what I teach. [00:30:52] Lindsey Dinneen: Yeah, I love it. And also, I think the benefit of the explorer mindset is that you are, because you are choosing to view life as an adventure and you're constantly learning and growing, there really isn't such a thing as failure. You're exploring. So if something doesn't go the way that you hoped it would or planned it would or whatever, you go, "Okay, that exploration didn't go as planned. What did I learn from it though?" And then let's move forward. [00:31:21] Nile Harris: Yeah, that's exactly how I look at it. Somebody asked me If I have a fear of failure, and I said, "I don't." And they're like, "That's crazy. Everybody has a fear of failure." And I was like, "No, because I tried something didn't work out. And now I know." Right? Or, "I didn't do it the right way. Now I know the right way, you know?" So I was like, "I don't have a fear of failure. I have a fear of doing things badly, not performing well." But failure? No, it's all exploration, it's all learning." [00:31:46] Lindsey Dinneen: Yeah. Ah, perfect mindset. I love it. So, and then you touched a little bit on this, but just to dive a little bit more into it, how do you wish to be remembered after you leave this world? [00:32:01] Nile Harris: As a servant. Yeah, I, that's a, yeah, I don't think there's more... I want people to remember that I contributed, that I gave more than I got, that I helped others, and I'll be happy with that. [00:32:22] Lindsey Dinneen: Yeah, absolutely. Yeah, and then final question. What is one thing that makes you smile every time you see or think about it? [00:32:32] Nile Harris: Dogs! Dogs! [00:32:36] Lindsey Dinneen: The end. [00:32:37] Nile Harris: The end! See him on the street? Smile. Go to the dog park? Smile. Look at my own dog? Smile. Dogs are our partners in life. They are like four legged dopamine molecules. They are just amazing. And, they're always such a good energy boost, mood boost. Somebody asked me this, " If you quit MedTech tomorrow, what would you go do?" And I'm like, "I would open a doggy daycare." [00:33:06] Lindsey Dinneen: Amazing. I love it. Yeah, they're just little bundles of joy. I mean, how can you not just be so excited to see... Well, I view it that way. How could you just not fall in love? I fall in love all the time with dogs. [00:33:17] Nile Harris: Yeah, the dogs are amazing, I always feel like they make a family complete. I love, and you specifically said "see," so when I see dogs, but I think what gives me energy, I'm kind of, I'm kind of adding a part B to this. I think what personally gives me energy is being around my family. I come from a really big family. And so being able to share that family energy is energizing. But when I see a dog, I'm insta happy. [00:33:46] Lindsey Dinneen: I love it. And I love your part B too. That's a really compelling secondary answer too. So yeah. Thank you for that. So, yeah. Well, Nile, this conversation has been amazing. You are amazing. You're such a powerhouse, and it's, it's such a joy to get to talk with you today and learn from you. So thank you so, so, so much for your time. And we are so honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which works to end global poverty by creating and sustaining jobs while also providing small business loans, savings, insurance, and training to more than 14 million people in the developing world. So thank you so much for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world. [00:34:40] Nile Harris: Thank you so much. I enjoyed our conversation. This was so much fun. Thank you for the invitation. [00:34:46] Lindsey Dinneen: Absolutely. Yes. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:35:01] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Jay Anders, Chief Medical Officer of Medicomp Systems, shares his career transition from an internist to a leader in healthcare IT, emphasizing the importance of usable technology for clinicians. He discusses Medicomp's mission to enhance clinicians' efficiency and patient care through advanced tools. Dr. Anders also explores the challenges of incorporating AI in healthcare, the disparity of healthcare access in rural areas, and the rewarding experience of international medical missions. He highlights the importance of change management in reducing physician burnout and aims to teach coping mechanisms for managing constant healthcare changes.   Guest links: www.medicomp.com | https://www.linkedin.com/in/jayandersmd/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 042 - Dr. Jay Anders [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Dr. Jay Anders. As Chief Medical Officer of Medicomp Systems, Dr. Anders supports product development, serving as a representative and voice for the physician and healthcare community. He is a fervent advocate for finding ways to make technology an enabler for clinicians rather than a hindrance. Dr. Anders spearheads Medicomp's knowledge based team and clinical advisory board, working closely with doctors and nurses to ensure that all Medicomp products are developed based on user needs and preferences to enhance usability. As the host of a popular, award winning Healthcare NOW radio podcast, "Tell Me Where IT Hurts," Dr. Anders has discussed the topics of physician burnout, EHR clinical usability, healthcare data interoperability, and the evolving role of technology in healthcare with a variety of industry experts and pundits. Well, hello, Jay. Thank you so much for joining me today. I'm so excited you're here. [00:01:53] Jay Anders: I'm very glad to be here. [00:01:54] Lindsey Dinneen: Excellent. Well, I would love if you wouldn't mind starting off by telling us just a little bit about who you are and your background and maybe what led you into MedTech. [00:02:06] Jay Anders: Well, I am an internist by training, and after practicing medicine in a large multi specialty group practice for almost 20 years, I decided to have a little career shift, and the reason I shifted careers was I had a little computer science background, so I said, "Let's see if we can put that to work." And about that time is 2004, I'll date myself. We started getting into electronic health records, and when they first started to come out, they were just these read only, do nothings, electronic versions of paper. And I thought, "Well, this is not going to work out really well. Let's see what we can do about that." So my big clinic decided we'd be one of the first to hop in the pool. So we did with a company called Integrate. And when we got that all installed and rolled out and everybody using it, they came to me and said, we really need a physician to really help lead what do physicians want or need in healthcare IT. So I said, "Well, we'll just part time." Well, that lasted about six months. And I said, "I can't be in two places at once. I can't practice full time medicine and do this at the same time." So I switched careers and one of the biggest questions I get asked all the time is "Why in the world you do that?" I mean, I saw, you know, five, six thousand patients a year, big practice. And they said, "Why'd you get out of practice?" And I said, "Well, think about it for a minute. So I can see those five or six thousand patients and affect their lives and help their health get better, or in this industry, I can make the lives of hundreds of thousands of patients better. And not only them, the providers that actually take care of them." So to make a really long pathway short, that company got purchased by another company, which got purchased by a company, probably everybody knows called McKesson. And I worked in the big corporate medicine world for a while. I got kind of tired of that. And I wound up with working with Medicomp. We use some of their products and the Integrate product that we had. So I've known him for quite some time and he always told me, he said, "When you're ready to make a change, let me know." So I was ready to make a change and I joined Medicomp. It's now been 11 years working at that particular organization. Love it. It's great. And it's got the right mission. So I was looking for where can I really make a difference? And this company really makes a difference. [00:04:36] Lindsey Dinneen: That's incredible. Thank you for sharing a little bit about your background. And I'd really love to dive into exactly what you ended with because I think that mission is such a key aspect of maybe a lot of things, and probably opinions vary, but I have found that it is really helpful to have something that drives you so that on the difficult days you go, "Yes, but I am here for this reason." So I'm curious, can you expand a little bit about your current company and how it is so missionally driven? [00:05:08] Jay Anders: Well, Medicomp has a single purpose that has multi facts blended into it. How can I say that a little bit better? It's just, it's got a lot of tentacles, but it does one thing. It was started to actually assist the providers at the point of care to actually take care of their patients. It started out 46 years ago. We're one of the oldest healthcare IT companies out there. We're older than Epic. I love to say that. So we started out to how do you really assist clinicians to, to do what they do. And through multiple iterations and years of development and things like that, we have come up with a set of tools that I think really puts the joy back in the practice of medicine for the providers that have to do it. It also has a mechanism to get the patients involved. So my goal when I first started this is, when I first started looking at electronic health records, I said, "This is not going to work," like I said before. And that's what we're doing now. We're making it work. And it's interesting to see the acceptance or push back, however you want to talk about it. But we have but one mission: is to make the lives of the clinicians that use electronic healthcare work for them. [00:06:29] Lindsey Dinneen: Yeah, absolutely. My mind immediately goes to perhaps some of the challenges that the company faces with these electronic records, things like cybersecurity and HIPAA. And I'm so curious to know how you have been able to navigate that and adapt and evolve because, oh dear, those are hot topics. [00:06:51] Jay Anders: Well, yeah, in healthcare, it's probably one of the most regulated things on the planet at least in the United States. And it just got a little bit more complex because the Office of the National Coordinator keeps rolling out more regulations which we have to comply with. It's interesting how Some of these regulations have morphed throughout the process. I'll take HIPAA as an example. You brought it up. The privacy act had a very simple mission is to protect people's medical records from being shared with the wrong people. It went completely over the falls, meaning you can't share anything. And it's really tough to get permissions and all of that. One of the problems we've had that my company helps solve because we're in the exchange information business is being able to share that medical information when it's needed and where it's needed and in a format that's usable. So when people say, "I don't want my medical record shared," it's interesting because if you really ask patients, they say, "Oh yeah, if my doctor who is in the next town needs what I have, wrong with me, send it. I don't want to have to fill it out again." And one of the biggest bugaboos that I've seen with patients, including myself, is that every time you go to the doctor now, they ask you the same set of questions over and over again. Has that information changed? Probably not all that much. So it spends a lot of time going through machinations of making sure everything is okay and shareable and all of that. I have noticed that lately things are starting to loosen up a little bit along those lines. So people are not so scared that their information is going to get in the right hands or wrong hands, needs to be in the right hands. So I see that kind of fading in, in the United States. And what's interesting is our company is international. So we have installations in Thailand and Indonesia and other places. And over there, there's no problem with sharing information, which is a big plus when it comes to really taking care of patients, and that's why we're in this business as a clinician, either on the healthcare IT side like I am now or on the other side before. It's all about taking care of the patient. [00:09:10] Lindsey Dinneen: Yeah. Yes, absolutely. Yeah, and it's cool to think how you have been one of the first providers of such a service because that must have been, I feel like a barrier of entry would have been challenging. What kind of pain points did you have to solve for, especially clinicians who might have been hesitant to adopt the technology? [00:09:31] Jay Anders: Good question. One of the biggest challenges was the breadth of medicine itself. If you think about all the different conditions that a human can have, you have to have support for all of it. Well, getting to the all of it has taken 46 years. So it's not as if it happened yesterday. So the challenge was actually making it work every time, all the time, for the breadth of medicine. Now, one of the things about physicians especially, nursing not so much, but physicians particularly. We all know that we know everything on the planet and we are the absolute arbiter of everything you have as a patient, and we don't need any help at all. We can handle it. We're trained that way, which is really not true. Even in the old days, I would dismiss myself from a patient's room because I knew I had to go look something up. My knowledge is a little diminished in that area, so I have to go look it up. Well now, medicine's expanded so much that there's no way on the earth you can keep track of it all in your head. So, what can keep track of vast amounts of information, both patient information as well as medical information, pretty easily? A computer! So how can we make that computer act and think like a clinician. And that's what we've done at Medicomp. We've actually done that process. So when you walk in with diabetes or whatever condition, I can give you on a screen everything you need to ask and answer about that particular condition and make it easy for you to take care of that patient and document what you need to document and get all the information you need and sort it out. So computers can do that. It's gotten better through time, and now we have the world of AI we have to deal with in healthcare, which is also a little scary, but it does have a great potential. [00:11:34] Lindsey Dinneen: Well, and to that point, to explore it a little further, what is your opinion of incorporating it? How do you feel that the safety or ethical implications of it, I think there's always a lot of great uses for AI, but I'm curious about how do you feel that maybe it would be best utilized for situations like yours or for companies like yours? [00:11:57] Jay Anders: Well, AI is nothing more than a large program that's trying to predict what the next word will be in any given text. That's what it does, basically, down to the ground. The issues with AI is it's not trained as a clinician. You can read it every medical text on the planet, but it still does not really think like a physician thinks. So, along those lines, it's a great augmentation, easy retrieval of data, easy refreshing your memory about something if it's a little esoteric. It's great at that. It's also great at picking up synonymy, which is picking up every different medical term that you try to use in a particular situation. It can do that very well. The issue is it's not trained medically and it really doesn't have the intuition of a well trained physician So I'll tell you a little bit about myself again. When I started as an intern, I had a white coat with every conceivable little pocket manual I could stuff in it, including my stethoscope and tongue depressors and lights and things like that. I passed all my boards. I knew medical text. I knew all that. But it came down, I have to take care of patients now. A little different. And the experience that I developed over 20 years of doing that is something that you really can't stick into a computer. So, I think AI is going to be great about summarizing different sets of information, filtering it, presenting it, doing things like that. I don't think it's going to be used a whole lot to actually diagnose patients. I've seen people try to do that. It scares me a little bit. The other issue is, who's responsible? If a computer makes a diagnosis, who in the world is responsible? It's not the computer, it didn't care less. It's not the programmer who programmed the computer because they didn't know anything about what you were doing. So who's going to be responsible? So there's that one one step. So it can take you so far. It can really help you to get there, but you have to take the training the intuition, all of the knowledge over time, and apply it. So I think it's going to be a good augmentation, not ever a replacement. I just don't see that happening, at least in my lifetime. [00:14:28] Lindsey Dinneen: Yes, we'll see where it goes, but I, yes, that, that makes a lot of sense, and it's a great tool. I think that's a good way of thinking about it, not as a replacement, but just add it to your arsenal, so to speak, and yeah. Now you are a fellow podcaster and I would love if you would share a little bit about your podcast and how that all came about. [00:14:50] Jay Anders: Well, it's been, oh, it's been three years now. Wow. We were thinking about other ways that we could get the word out about what we do as a company, because my podcast is sponsored by the company I work for. But I also have a little bit of thespian in me. I was in plays in college and high school and all that nonsense. That kind of thing really didn't bother me. He says, "Well, let's give it a shot. What would it be like?" And he said, "Okay." So we had our first guest, second guest, things are kind of coming along. You get into a flow, really enjoy doing it, and the conversations are so stimulating. And then I had my conversation with Mickey Tripathi, who's the National Coordinator of Healthcare IT, and I wound up winning a Power Press Award for that particular interview. [00:15:39] Lindsey Dinneen: Congrats. [00:15:40] Jay Anders: It's been a lot of fun. It's engaging. And the feedback I get from it is that they like the conversation. Everybody likes to talk at you, not with you. And I've really tried to get out of that mode of just talking at somebody, but let's have a conversation about a topic. And I've learned a lot. I hope my listeners have learned a lot and it's been a great deal of fun. [00:16:08] Lindsey Dinneen: Yes, that's great. And I also recognize that you are a featured speaker on healthcare IT. And was that, well, you said you have this background in theater. So was public speaking something that came easily to you? Was it something you developed over time? [00:16:28] Jay Anders: It came pretty easily to me, I think. One of the things I did back three companies ago is I got to introduce a keynote speaker and talk about a keynote speaker in front of an M. G. M. A. Conference, and there had to be 6000 people in that audience. It was huge. But I walked out there and I said, "Okay, they're gonna listen to what I'm gonna have to say, and that's gonna be it. It's not gonna affect me." And it was a lot of fun, too. But so big crowds like that, it really doesn't affect me if I'm well prepped. If I'm passionate about talking about, it kind of rolls out of me naturally. So I don't have any problem with it. It's a lot of fun as well. [00:17:12] Lindsey Dinneen: Good. Yeah. Yeah. Just another opportunity to continue spreading that message. You know, I very much enjoyed looking at your LinkedIn profile and learning a little bit about you. And I wondered if you could share a little bit about, I saw that you do or have done in the past, some medical mission work to various countries. I would love if you would share a little bit about that and your heart for that. [00:17:38] Jay Anders: Well, in the past, I've not done it a lot recently, but I have taken several trips to Asia with a medical team and it had to be one of the most rewarding things I think I've ever done. And we were in the country of Kazakhstan, and we were seeing people who really don't have access to healthcare. And what healthcare they have over there was really not all that good. But we went over with a team of five. Had a physical therapist, a nurse, and probably 15 bags full of medications of which all went through customs without a hitch, which I was very surprised. But I got up in the morning, got there right at daybreak, and I would see 250 people a day and work till the sun went down. And there were still people to see. They were so appreciative of any kind of information, any kind of healthcare, any way you could help them. All done just, it was, like I said, one of the most rewarding things that I think I've ever done. And one of the best parts about that trip is I went and went to an orphanage that had, the kids needed health screenings. And there were about 200 kids. So we started early in the morning and I saw child after child after child after child ' till we finally got through the whole thing. And at the end of the day, it's now hanging in our kitchen. One of the little boys came up and said, "I want to give this to you, doctor." And it was a wooden plaque of an, with an urt on it, a camel and a little star. And in that part of the world, that's how they live is these urts, these very unique, tent like structures. And I just broke down. I couldn't, I, it was one of those things where that is going to me, to the nursing home because of that experience. But I highly recommend if anybody in healthcare and I'm not part of Doctors Without Borders, but I support them. If you have a chance to do that, do it. And you can do it as a non medical person because you always need support people. So if you think you want to do it, get yourself involved. It's great to do. It's massively rewarding and an experience that will last you a lifetime. [00:19:59] Lindsey Dinneen: Yeah, life changing. Yeah. Thank you for sharing about that. I thought that was really neat to see that's something that you've done in the past and you're passionate about. And speaking of passions, I know kind of a similar thing, but I think perhaps even in the US, this is something that you advocate for is, something that seems to bother you is the disparity of access to healthcare in more rural settings. And this is something that I feel like, on occasion, maybe some Americans don't realize that even in the United States, there is this disparity. And I was wondering if you could talk a little bit about that and your passion for that. [00:20:37] Jay Anders: Oh, absolutely. I grew up in a town of 20, 000 in the middle of Illinois. And I'll just give you a little progression. So in the town I grew up in, when I was a little boy at six, seven, we had two hospitals, nice size hospitals in that community. Roll ahead to 2024. One is a derelict building that looks horrifying. It's about to fall down. The other has merged with a larger system, which is about 40 miles away. It's coned down in size. They still do a lot of work there, but it's a lot of the major cases get shipped out to the mothership, which is in an adjacent city. But this plays out across rural areas all over the country. Hospitals are closing, they're under pressure, both cost of care as well as reimbursement for that care. Specialists in certain areas are very hard to come by. And when you look about the delivery of care, this is one of the things that bothers me the most. The people who get better in the hospital the quickest are the people who have support groups around them. They have parents, they have children, somebody to come and visit them and be with them, give them a reason to get better. When you move some of these rural hospitals and put them out of business or reduce them to the point they're just an aid station and you ship that patient to a medical center that's 50, 100 miles away, that support group goes away. It's very hard for that to even exist. So if you take into consideration the lack of real reimbursement at that level, at those types of hospitals, the lack of specialty care, which is still needed, and really the lack of primary care, things are headed downhill with that as well. It really is a disparate way of delivering healthcare in the United States. Not everybody can go to a Cleveland Clinic or a Mayo to get their healthcare. I live here in Western Pennsylvania. We have two massive institutions, both of which are wonderful, but not everybody can come here. People that are out in the Northern Pennsylvania, in the middle of the state, they got to travel because their hospitals are closing. And that I think is a travesty of the system. It's something that needs governmental intervention and it needs intervention in several different modes, meaning increased reimbursement, training physicians that want to practice in that type of environment. There are programs out there that are to start to do that, but it needs attention because people out there are not getting the same healthcare as I can get 15 miles up the road in the city of Pittsburgh. [00:23:28] Lindsey Dinneen: Yeah. Yeah. Thank you for sharing a little bit about that, and even some suggestions for ways that this can be helped. I know it's a long road, but I appreciate that you are bringing light to it and helping to start those conversations that will hopefully lead to change down the road. So. [00:23:49] Jay Anders: And technology does have a place to play in doing that as well. Telehealth, distance, ICUs, things like that. There are ways that technology can augment that medical care, but it's expensive. There has to be some type of support for it, both at the state and federal levels. [00:24:09] Lindsey Dinneen: Absolutely. So I'm curious on your path and your journey so far, and obviously you've had a really interesting career path 'cause you've done a few different things over your career and you continue to, I'm sure, learn and grow. But are there any moments that stand out to you as really affirming that, "You know what, I am in the right industry at the right time, at the right time? I'm doing what I was meant to do." [00:24:36] Jay Anders: Boy, that's a great question. One of the things that really drew me to working at the company I'm working at now at Medicomp was the fact that they truly had the physicians and the providers of healthcare's best interest in mind. Foremost, everything we do, and I mean, everything we do, is geared to make their lives better, more effective, and deliver better care. That's what we do. So in my pathway, which came kind of went around in different ways and different companies, different sizes through acquisition and other things, I really wound up in a place where we're not a large company, but we're all of one mind. And that is an absolutely fabulous place to work when you're all pulling the rope in the same direction. And it's all for a great purpose. And when I have providers come up and tell me, "Well, we installed this or we're using this, and it really did help what I'm doing." I had nurses come up to me and at one of our installations that say, "I've got 50 percent more time to spend with my patients. I'm not spending it in an inefficient electronic health record. That's been fixed." And when people say that it's like, "Okay, I'm in the right place at the right time." [00:26:04] Lindsey Dinneen: Yeah, that's incredible. What great testimonies too. Oh my word. Thank you for sharing that. So pivoting the conversation just for fun. Imagine that you were to be offered the opportunity to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. And you'll get a million dollars for it. What would you choose to teach? [00:26:30] Jay Anders: I would teach physicians and other clinicians change management theory and how to manage change. That's what I would teach. I've had the luxury in my career of having a professional coach for two years, professional training and leadership. It's been a great thing to have, but not everybody has that. I would love to be able to teach clinicians how they can manage all the change that comes at them every day. It's patience, it's technology, it's knowledge base, all of that. It's changing all the time. You got to have a method. You got to have some skills. You got to have some coping mechanisms to go through that. It can't overwhelm you every time you go to work. And I think that's part of our burnout problem is that there's the skill set of managing change just isn't there to the degree it ought to. And physicians throw their hands up. I'm going, "I'm retiring. I'm going somewhere. I can't do this anymore." And I think that's wrong. So, that's what I do. I would teach coping skills around change in healthcare. [00:27:46] Lindsey Dinneen: I love that. Excellent. And then, how do you wish to be remembered after you leave this world? [00:27:53] Jay Anders: I want to be remembered as somebody who made a difference. You know, a lot of people get into the healthcare IT business because they want to revolutionize this or revolutionize that. I don't want to revolutionize anything. I want to make a difference. And if I can make a difference, I've pretty much done what I went into this profession to do was make a difference with patients, make a difference in my colleagues, and in the industry I'm in now. That's what I want to be remembered as. [00:28:23] Lindsey Dinneen: Yeah. Yeah, I love that. And then, final question. What is one thing that makes you smile every time you see or think about it? [00:28:33] Jay Anders: I'm going to go back to my story in Kazakhstan. Every time I think of that little boy coming up, grabbing my coat, jerking on it, to hand me that little plaque, that gives me a smile every time I think about it. It actually gives my wife a smile, too. Because we'll look up at that plaque in the kitchen and go, "I know where that came from. That was a good time." That makes me smile almost every time. [00:28:59] Lindsey Dinneen: Yeah. What a powerful memory and just such great motivation, something to come back to on the difficult days and then you look at that and go, "Yeah. Okay. I can make a difference here. I did make a difference here." [00:29:14] Jay Anders: I did. [00:29:15] Lindsey Dinneen: I love that so much. Well, this has been an amazing conversation. I am so grateful to you for spending some time with me and just telling me about your background and the amazing work that you're doing, that your company is doing. And we are honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support. And we just wish you the best continued success as you work to change lives for a better world. [00:30:00] Jay Anders: Thank you. It's been a pleasure. [00:30:02] Lindsey Dinneen: Absolutely. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time. [00:30:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Hannah Went, a pioneer in epigenetics, is the co-founder of TruDiagnostic and founder of Everything Epigentics. She shares her journey from the early days of TruDiagnostic to its burgeoning role in healthcare. She reflects on the rapid evolution of epigenetics, the challenges of making groundbreaking science accessible, and the gratifying shift towards mainstream acceptance. Hannah also delves into her personal growth, emphasizing the transformative impact of "The 15 Commitments of Conscious Leadership" and her desire to be remembered as loving and impactful.  Guest links: trudiagnostic.com | everythingepigenetics.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 041 - Hannah Went [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Hannah Went. Hannah has a lifelong passion for longevity and breakthrough disruptive technologies that drive radical improvement to the human condition. She attended the University of Kentucky and graduated with a degree in biology. During that time, she had multiple research internships studying cell signaling and cell biology. After graduation, she worked for the International Peptide Society as their Director of Research and Content. Through work in the integrative medicine industry, Hannah saw an opportunity for a methylation based age diagnostics and started TruDiagnostics in 2020. TruDiagnostic is a company focused on array based methylation diagnostics for life extension and preventative healthcare serving functional medicine providers. TruDiagnostic has a commitment to research with over 30 approved clinical trials investigating the epigenetic methylation changes of longevity and health interventions. Since TruDiagnostics' inception, they have created one of the world's largest private epigenetic health databases with over 75, 000 patients tested to date. Hannah has since created Everything Epigenetics, where she shares insights on how DNA regulation has an impact on your health. All right, well, welcome to the show, Hannah. I'm so excited to talk with you today. Thanks for taking some time. [00:02:14] Hannah Went: Thanks, Lindsey. I'm excited to speak with you. [00:02:17] Lindsey Dinneen: Awesome. Well, would you mind starting off by sharing a little bit about yourself and your background and what led you to MedTech? [00:02:25] Hannah Went: Yes, absolutely. I've known since I was a little girl that I've always been interested in science, how the world works, how the body works. I remember being a little girl and going in our backyard, lifting up rocks, finding roly-polies and worms and getting all down and dirty. I was definitely a tom girl, if you will, growing up. I love sports. I loved connecting with people. So I also loved the social aspect of understanding how the body works as well. And I was very athletic growing up. So I played track soccer, basketball, sports all year round, essentially. I knew I wasn't good enough though, to go to like a D1 or probably even D2 college for sports. So I was like, "All right, well, I'll just go to a larger university, maybe play some club soccer and really focus on my academic route." And I ended up going to University of Kentucky. It wasn't too far from me. I'm just from Ohio, north of Dayton, a small town called Piqua. And I did end up playing soccer, club soccer there, got involved in a lot of other activities. Ended up actually going into veterinary work, animal science. UK has a really good program for that. They have a really good agriculture department. I ended up shadowing a vet one summer and I hated it. It was one veterinarian clinic. So a lot of work, a lot of late hours. And I knew I wanted to have a family growing up. So I was like, "Eh, let me just switch to general biology. Let me just open my doors." And fast forward to senior year. I was really interested in genetics and you know, how do we have these predispositions that are passed on throughout our family? How does that affect our health outcomes essentially? So I applied to genetic counseling school, which is a very new program. It's a master's program. It is where you get your master's essentially in genetics and counseling. So it's like the best of both worlds, exactly what I loved growing up. You have the science aspect, but you're sitting down and helping people actually understand their risk. Applied to school, Lindsey, and didn't end up getting in. So I was like, "Oh, I'm heartbroken. I'm still super young. My life's over!" type of deal, a big eye roll ,and thought it was the end of the world. But really where my career took a huge turning point was at that failure point. I took a job, my best friend got me a position at a compounding pharmacy in Nicholasville, Kentucky, which is just a little bit South of Lexington. And that was when I was opened up into this entire medtech space of healthcare providers and the integrative functional medicine journey who were focusing on healthcare, like true healthcare, not sick care, not taking care of sick people when they're already sick, they're already doomed and just trying to bill them for all of these medications through insurance. So that's really how I've gotten to where I am today. [00:05:23] Lindsey Dinneen: Oh, that is so cool. Well, first of all, thank you for sharing a little bit about your background. It was fun to even hear about your childhood and how that theme of interest in all those different aspects has woven its way through your story. And I would love to hear a little bit more then about, okay, so what does present day look like and how did you end up where you are? [00:05:43] Hannah Went: Yes, so I'll try and keep it short and concise. So this pharmacy was very innovative. It was the fourth fastest growing healthcare company in the nation in 2019. And it's really focused on the unique peptide products. It was again a compounding pharmacy by trade, meaning you can compound anything in all different dosing as long as you have a prescription from a healthcare provider by it. They grew really fast. So, you know, we always had regulatory agencies come check in, make sure we were doing everything correctly, which we absolutely were. But there was always this worry that these products made people feel better, but there wasn't a lot of quantitative data behind it. So we were like, "All right. Well, what can we measure in clinical trials and institution review boards to really prove to people out there, 'Hey, these are having a massive underlying biological effect on people.' They don't just feel better." We used to joke and say, "People can become tan, they can become skinny, they can increase their libido from these products, but they also actually save people's life." They stabilize insulin sensitivity. They can help people lose weight who have metabolic disease. They can mediate a lot of the effects of specific autoimmune diseases. So there are massive impacts that these products had. And we're like, "All right, well, if you had one test, like if you could measure one thing that really relates to all of those items I just mentioned, it's aging," right? These age related diseases. So, "how do you even measure age" is the follow up question and you can do that in all sorts of different ways. But there are actually these DNA regulation markers, like these on and off switches, called your epigenetics that seems to be the best way to measure aging. So we really started measuring and doing clinical trials with these epigenetic aging biomarkers to prove the efficacy of these products. And what we ended up doing is just selling the pharmacy in 2019. It became-- oh-- pretty boring, I guess, for lack of a better word, because there were new rules and regulations in place by regulators on what you can and cannot compound. And then you have built my company now, TruDiagnostic, from the ground up. We have our laboratory in Lexington, Kentucky, and we started out with one goal, which was essentially to offer the best age testing. And now we're doing a lot of different things. So that's what I'm really involved in now on a day to day basis. [00:08:10] Lindsey Dinneen: Wow. Well, thank you for sharing about that. And okay, so, so you embrace this entrepreneurial endeavor, which is a whole second set of-- I mean, obviously you have all the skills from your experience and your education and whatnot, but then to compound that with owning your own business and then setting up a brick and mortar, it's an actual lab and whatnot. How was that transition? Did you feel prepared for it? Did it catch you off guard? What was that like? [00:08:38] Hannah Went: We were kind of creating TruDiagnostic behind the scene when we had the pharmacy. So like end of 2019, we were really creating it. But I do think it caught me off guard looking back where it was like, "Okay, pharmacy sold, full time TruDiagnostic. How the heck do we set up this lab at the beginning of 2020?" It was go mode. So we bought a building in Lexington. It was an old insurance building. We completely knocked out the top floor, which was offices, carpeted, not usable lab space and built the lab again, like I mentioned, from the ground up. So I joke and say, "I'm a construction worker. I was an interior designer." I was doing all of these other things. And of course I had a lot of amazing people helping me all throughout the way, but testing SOPs for standard operating procedures, creating those. I remember the first day we were running samples in like trialing the protocol. I was here till 5am because we were thawing things and freezing things as part of the protocol and didn't even realize that was part of the step once we started to get into it. So yeah, it definitely took me off guard. And I think furthermore, we launched right before COVID 19. So it was the worst timing in history to launch. And you know, we did it anyways. And then the first year and a half, two years, it was a lot of follow up. It was a lot of cold calling. It was chasing or following up with these healthcare providers to use these kits that we sent out because we did a really nice promotion to get the product out there, but it was hard to balance because when COVID 19, this nasty pandemic, came into the U. S., you almost felt guilty asking the healthcare providers to focus on anything else, right? You're like, "That is not what you should be worrying about right now." So it was definitely hard to balance. [00:10:23] Lindsey Dinneen: And yeah, my goodness. And honestly what resonated with me too is, you know, you're talking about, you've worn so many hats, obviously, as a business owner and setting this up. And I used to joke that, when I had a brick and mortar business and I was like, "On any given day, I'm everything from the CEO to the janitor." [00:10:40] Hannah Went: I can relate. I can definitely relate to that. I remember we needed some kind of-- I don't even know what we need this for-- it was like some type of part that had to regulate water temperature or something like that. So a traditional thermometer wouldn't work. I remember I drove across the street to a pet store and I got something that belonged in a fish tank. And I'm like, " I don't even know if this will, will work." But I mean, we are just piecing everything together. It was like you were doing yet literally everything and anything that you could just because you wanted it to work so bad. You had that passion, that, that push. And you realized that the end goal in mind, which for us, it's really just to help our people, you know, people who are working with us, and our clients, whether that's anyone from now a healthcare provider offering our services or a researcher or academic collaboration, it's someone doing third party processing at our lab or even down to the end consumer client patient, whatever you'd like to call them that come directly to our website and do our testing. [00:11:40] Lindsey Dinneen: Yeah. Great. And that actually addresses my next question, which was going to be, so do you only work with healthcare providers? Is it a B2B enterprise? But it sounds like you also do the B2C and you can sell directly to them, to people who are interested. [00:11:55] Hannah Went: Definitely. Yeah. When we opened, we had that one goal in mind, which is what we knew, which were our healthcare providers that we really transitioned from the pharmacy over to TruDiagnostic. So that was like our main customer at the time. And I think we completed that goal of offering the best aging diagnostic tools at the end of last year with a large study we did with Harvard. But now what we've noticed and, of course-- we kind of got lucky in this sense, we would have never imagined where we are now-- is that epigenetics, these DNA markers, these on and off switches are really great for creating new and novel biomarkers. So you can predict almost anything with them. You can predict even how much you've smoked across your entire lifetime, how much alcohol you've consumed, your zip code based on where you live, just because of the environment you're exposed to and your behaviors in that environment. So it's pretty crazy, obviously we, we didn't expect that and I mean it's just being really blown up and everywhere you, you look, I mean it's related to every aspect of life and of course changeable as well. So even, providers who are using this test on a patient once, they'll retest them every 6 to 12 months. And then of course people coming from our website, we just released actually a subscription model a couple days ago so people can start to retest this in more of a hands off fashion. even every three to four months if they wanted to. [00:13:19] Lindsey Dinneen: Wow. So when somebody does your test and they get the results, is this something that you walk them through and say, okay "Here's where things stand now. If you make these tweaks, here's how things could stand?" Or how does it work from that perspective? [00:13:34] Hannah Went: Definitely. So just to walk you through the process, you would get your kit, we'd ship it to you, you would prick your finger. So just a little blood spot card about the size of a quarter, you ship that sample back to our lab in Lexington and we get results back to you in about two to three weeks from the time we receive it. Then you would get all these different age related reports, some of those characteristic and trait based reports I mentioned, like this smoking and alcohol. And we, we do, so we can project you out saying, "Hey, if you still stay on this trend, whether it's aging faster or aging younger, here's where you're, where you'll be in six months, 12 months." So it may be exciting to some, it may be scary to some, depending on where they are. Regardless, it's changeable. So if anyone's listening and they're like, "Oh my gosh, I don't want to know that. I'm so scared." If you've tested your genetics, that's in my opinion, even scarier. That doesn't change, right? You know your risk, you know your predisposition. So, this can all be mitigated through lifestyle factors, through supplements, medications, procedural based therapies as well. So we do give you recommendations on the report on what to do. You can absolutely again take it by yourself, but we can always help you and connect you with a healthcare provider if you're really wanting to go on this journey. But I always say, Lindsey, the first test is really fun. It's sexy. It's really trendy right now. But it doesn't mean much. It's just a baseline. It's telling you where you are, just like your hormones and your CBC panel, your second test is more important than your first third, more than the second fourth, more than the third. And so on and so forth. [00:15:09] Lindsey Dinneen: Okay. Yeah. And you addressed something else that I was going to ask. So when people are interested, they'd like to do it, but they have this like, "Ooh, I don't know if I really want to know," how do you help overcome that? Is it because things are changeable? Like everything can be changed? [00:15:26] Hannah Went: Yeah. Yeah. I'll even give you to an extent, I would say most of it, right. For the purpose of this conversation, yes. There are of course some exceptions, but my grandmother, for example, passed away from Alzheimer's when I was senior in high school. Right after that happened and what started some of my interest in genetics is I went and got my genes tested. I'm like, "Oh my gosh, that was awful to watch her go through. Am I doomed, right? Am I going to have that same risk?" And my results came back. Well, I have this specific snip. It's a single nucleotide polymorphism. So this specific variant on my genes that's APOE 3-4. So this means I'm at a more increased risk to have Alzheimer's, and even at a younger age as well. I would say you have an even further increased risk if you're at APOE 4/4. So I'm not the worst, but I'm the second worst, essentially, and I'm like, "Well, this obviously isn't good. But this can't be it, right? This can't be the end of this story." And you hear a lot of people say that too, people with metabolic disease or diabetes in their family. And, they may shrug and just say, "Oh, well, you know, I can eat whatever I want, right? I don't have to work out, like I'm doomed anyways, type of thing." And we know now that's not true, right? You're no longer really the victim of your genetic predisposition that we may have thought due to these epigenetic changes or the fact that it's changeable. So there are even peer reviewed published papers that come out showing estrogen, so optimizing your hormone levels can actually reduce your risk of Alzheimer's from an epigenetic standpoint along with everything else, exercising, eating very healthy, no artificial foods, flavoring. So you're, of course, always going to have that genetic risk, but you also have all of these other types of risks and you have this epigenetic risk, which should really be the main focus, because you're in the driver's seat again. You're no longer in the passenger seat. And that's really empowering to have all of that knowledge. [00:17:22] Lindsey Dinneen: Yeah. Yeah, absolutely. I know that the test is really important in terms of telling an individual exactly what's going on and how things can change, but in doing all this research and data collection, are there certain lifestyle things that pretty much everybody regardless should pay attention to. Is that a thing? [00:17:45] Hannah Went: Of course, that's the multimillion dollar question and a very frequent one that we get. And the answer is, "Sure, yes and no, kind of, maybe so." And what I mean by that is you can look at all of these general population studies that come out, right? These clinical trials and look at what really moved the needle. But again, those are populational trials, so you really need to find out what works for you. I can tell you what works for me. There is a study on this, which is why I wanted to try it first. So again, you can start to maybe trial some things based on results that are already out there, but I've tested my aging before and what I've noticed that really slows it down is caloric restriction. So it's not necessarily intermittent fasting or time restricted feeding or skipping an entire meal, it's just continual, 10 percent caloric restriction. So if you're on a 2000 caloric based diet, take out about 200 calories, which if you're eating healthier anyways, you may not even be hitting your intake of calories based on your metabolic rate and what your specific goals are. And I've noticed that helps slow down my aging. I've also noticed that I need to do more aerobic based exercises. So things like VO2 max, increasing FEV1, we can actually quantify those on our test. So really VO2 max is your oxygen uptake, so how much oxygen you can get into the body. Your FEV1 is your forced expiratory volume, so how much oxygen you can get out in and out of your lungs. Swimmers have a really good VO2 max and FEV1. So I noticed I was doing maybe too much like weightlifting, too much HIIT type of workouts. So you can get a lot of feedback from those reports. So for me, personally, that's what works. [00:19:30] Lindsey Dinneen: Wow. That's great. That is amazing what you can test and gain knowledge about and then make those changes based off of. So on your LinkedIn profile, something that I was really intrigued by is you are a founding member of an organization, I believe, called Opscotch. Did I get that right? Okay. And one thing that really stood out to me, and I'd love to just hear your take on the organization as a whole, but you said part of your mission is to make biohacking accessible to everyone. And I really appreciated that. And I'm curious if you would share a little bit maybe more about that. [00:20:05] Hannah Went: Yeah. Obscotch is a really cool community. So it is really democratizing the way healthcare I think has been viewed, even healthcare, like the model where we should go towards rather than that sick care. So it's making it a lot less scary. And I know that the founders of Obscotch, Spencer Coppin and Matt Christensen, and they're amazing people. They really set up this community as a way for people to have a support system. I think it can be really scary when you're entering really optimizing your overall health, what do you do? You see all of these ads, what protein should you take? What supplements should you take? They're just everywhere. Whose supplements really match the label? There are a lot of studies that show, that they don't even have promised ingredients on the label included in the supplement itself. So it's really confusing. And then you go down these rabbit holes and after a while, you don't know what you're looking at. So if you're part of this community, you can choose to get a Whoop and to start tracking a lot of these markers. You probably know the quote by Peter Drucker, "You can't manage what you're not measuring," so they measure a lot of things. They do the biological age testing through TruDiagnostic, and then they do some other laboratory based testing as well. So there's different levels of the membership that you can actually get depending on how involved you want to be, but they also do these monthly quarterly type of challenges. So it could be to get your Whoop fitness score above 12 for 15 days of the month. So again, it really encourages people to come together and I love that community aspect of it. They've done a really nice job. And again, are just amazing people there. They're located in Canada too. [00:21:46] Lindsey Dinneen: Oh, nice. Yeah. So taking ownership of your health, but within a community, which makes it a lot, well, more fun, at least. [00:21:54] Hannah Went: Yeah. And the community is awesome. That's probably a really good group for you to even look into, Lindsey. It's a lot of founders and entrepreneurs and people who have like wild backgrounds. And they're from all over the world too. So it's not just like, oh, you have to be in Canada. They do have a lot of like local meetups in Canada, which is really cool for things like cold plunging or running or, you know, scheduling dinners or seeing like Andrew Huberman, he was in town like a couple of months ago or something. So they put together the events and they also send you even like recommended podcast or YouTube videos to watch. So it's really curated health information if you're looking to optimize your own health. [00:22:35] Lindsey Dinneen: Wow. Amazing. Yeah. And then, so another thing that I really enjoyed reading about you and your experience is, you mentioned that you appreciate taking complex scientific ideas and translating them into narratives that resonate with the intended audience. And I love that, and I think that's really important, but I'm wondering if you could tell us a little bit about your process in doing that, translating very technical engineering science speak into maybe what other people who aren't in that world could relate to. [00:23:14] Hannah Went: Yeah, definitely. So I have my personal company too, called Everything Epigenetics. So this is a, something TruDiagnostic wanted to do for a while is just educate others on epigenetics and what that means because there's a lot of education lacking out there. There's not much you can find. With all things that kind of got pushed under the rug in our early days, but I was just, " Screw it. I'll just make it mine." And I set up all of the social, the website domain and didn't do much with it for the first couple of months. And I was like, "Okay, I really want to get into this." And I think I started it at the end of 2022, so almost two years, which is crazy to say. And, I used it as a way to really keep myself honest and involved in the research. So I'm not as involved in our research on a day to day. So I work with a lot of postdocs or PhDs who have created epigenetic algorithms or interpretations. And basically, hopefully break those conversations down for people to easily understand. It's still very high science and not as applicable, so it can be tough sometimes. But my real goal is just educating those on this massive paradigm shift we're seeing with epigenetics in terms of not only taking over traditional lab testing, but just medicine in general. I mean, it's causing a massive wave and really, I think, flipping our understanding of how this field works, how even really the body works. So I don't monetize that at all. It's just something I do on the side. I have a podcast that runs every other week. And then I also am pretty active on Instagram doing these Journal Club Friday kind of spiels. That's where it's usually a video that's anywhere, I think, they're at least 90 seconds, but 90 seconds to four minutes long, just highlighting some type of research paper in the space and trying to do it in really simple terms that way people can understand it. So it's not maybe always going to be applicable to everyday life. I think it's absolutely going to get there where we are able to measure epigenetics, see our exact plan, have everything served us on a silver platter. But we're a little bit far away from that now. And I think that's can be really frustrating to some people, but I think it's also as equally as exciting. And you have to keep in mind that this came out after the iPhone, after the first iPhone. So it only came out about, or I would say only became popularized about 10 years ago, which is very new. So we just have to be a little bit patient. [00:25:51] Lindsey Dinneen: Yeah, that's fair. Well, thank you for helping translate some of these crazy things into more digestible pieces of information for those of us who maybe don't have that same background. So I do appreciate that. [00:26:05] Hannah Went: Yeah, of course. It's really fun to just continue the conversation and start to break these complex ideas down. [00:26:12] Lindsey Dinneen: Yeah, absolutely. Yeah. So, within your journey you know, as a scientist and researcher and entrepreneur and everything else, are there any moments that stand out to you that, that really affirm to you that you were in the right place at the right time in the right industry? [00:26:34] Hannah Went: Ooh, that's a good question. I, I think yeah, I think probably a couple months ago, three months ago. So, we've actually joined with some other clinics on really pushing forward epigenetics. And I think we're starting to see everything coming together. So I think it is hopefully becoming mainstream. And that is just huge, because the vision for epigenetic testing is to be able to use one blood spot card, so really simple, easy collection method at a really cheap cost and getting every single biomarker back that you could possibly imagine: clinical lab values, hormones, inflammatory markers, vitamin levels, minerals, proteins, metabolites. And I think, I remember just a couple months ago, when we really started to get an increased volume and testing, more healthcare providers just saying yes and super open to this idea. So I usually spend my day to day on calls with healthcare providers or our partnerships that we have with, whether it be wholesale or like resellers of these kits. And people are just starting to get it more. Like I remember at the beginning of TruDiagnostic, we always had to set up a call with every single account. It was, Hey, start from the top. What is epigenetics? Even before epigenetics, what is aging? How do you measure this? This is a really weird idea. And now we're starting to see where people set up accounts with us and they don't even set up a call and they just start ordering, right? Or they set up a call and they're like, "Hey, I know what aging is. I know what epigenetics is. Help me market this to my patients. How do I sell this?" So, so we're starting to see that change and that's definitely not been overnight. To answer your question, right time, right room with the right people. But I think probably at the beginning of this year is when we started to really see that change, which has been super exciting. [00:28:35] Lindsey Dinneen: Yeah, that is. It is because it's hard to-- it's great to educate-- but it is hard when that is your entire job day in and day out. And eventually maybe the science will catch up or the understanding of the science will catch up so that you finally get to this, you know, "we're getting there" stage. [00:28:54] Hannah Went: I think it's hard, yeah, because you know, with us we speak with the healthcare providers. We speak with the academics, but we may not actually be seeing the end user, the end patient. So sometimes it can be hard. It's like, "Hey, what difference are we actually making?" And that can be a little bit of a pain point or a struggle. I think not so much anymore because our providers will come back and give us case studies or, you know, talk to us about some of their findings, which is really exciting. And that, continues to expand as we do these clinical trials and dive deeper into the research. But I think we're TruDiagnostics sits right now is just an awesome opportunity because we are in between collaborators in terms of universities and academics and healthcare providers and patients. So we really bridge that gap as new algorithms, as new research is happening. We really do feel like we're at the centerfold and it's our responsibility to push that out to healthcare providers because there's no one really there to merge the two. So we'll start to see our type of healthcare providers we work with are willing to try anything, and willing to want the newest, latest, and greatest information as well to test on their patients. So they make for a really great group. [00:30:04] Lindsey Dinneen: Yeah, that's incredible. And it's so great to hear about the ability to bridge the gap between an individual being able to take ownership of their own health versus-- doctors are amazing. I'm so thankful for every medical person-- but also it's nice to be able to feel a little bit empowered to take ownership as well. So I appreciate that you're able to start bridging the gap and, and help them make be more accessible. So that's great. [00:30:30] Hannah Went: Yeah. Yeah. Definitely. [00:30:32] Lindsey Dinneen: Yeah, so, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach your masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:30:47] Hannah Went: Ooh. What would I choose to teach and why? I think the ,there's a book that's really good that I think everyone should read and it's called "The 15 Commitments of Conscious Leadership." And have you ever heard of it before, Lindsey? [00:31:00] Lindsey Dinneen: Nope, but I'm writing it down. [00:31:02] Hannah Went: Yeah. It's awesome. So there, there are a couple of authors on the book, but yeah, Jim Dethmer, he would previously go to all of these companies and understand how their leadership worked. And it's a super readable book, super short, breaks it down in all of these chunks, depending on what you want to really focus on. He actually came and spoke to our company and it was really cool to learn from him about this. He doesn't do it much anymore. So, we felt very special to, to be able to have him. And It can act in all areas of your life. So it's not necessarily just leadership . It really extrapolates out to relationships, whether it be a romantic one, or not, or kind of a family one. It is really I think changed my outlook on a lot of things in life. So I think I would want to teach something that has to do with that, that book. Jim's wife actually does a lot of the Enneagram work too. So the Enneagram test and understanding really your, kind of, why you're wired the way you are almost. Everyone has this conception of life. And you get to learn more about the way people think and how they work and why they do the things they do. So everyone did that test, the Enneagram test, in our company, and you can start to see these patterns and things. And it's just very useful information and it just makes everyone, I think, work together and flow together a little bit better too, which is awesome. [00:32:25] Lindsey Dinneen: Yeah. It sounds like a great masterclass and I have it written down. I'm going to, I'm going to look it up right after so I can secure my copy. Yeah. So, and then how do you wish to be remembered after you leave this world? . [00:32:39] Hannah Went: Oh, how do I wish to be remembered? Hopefully as someone who is loving and fun and taught the world something. Doesn't necessarily have to be epigenetics related, but I think people probably see me right now as someone who is like very busy running around all of the time, going from place to place, and I don't think I like that. That's just what I think my interpretation of me maybe would be from the outside. But it doesn't feel like I'm busy, right? It feels like I'm doing the things that I want to do right now and I don't think I necessarily even like the word busy, right? What does that mean? Everyone's busy. Everyone's doing something to a degree. So, yeah, I just want to be remembered as fun, loving you know, I think would also be remembered, though, just as hardworking, determined and yeah, willing to work hard to reach specific goals. [00:33:32] Lindsey Dinneen: I love that. Yeah. And then final question. What is one thing that makes you smile every time you see or think about it? [00:33:41] Hannah Went: Just my family, my husband, my sisters, my mom, my stepdad, everyone. So I get to hang out with them next weekend. I'm super, super excited. We'll be with them at their lake house. So I'm excited to be with the family. [00:33:55] Lindsey Dinneen: Nice. Oh yeah. That's going to be wonderful. Well, Hannah, this has been such a great conversation and I so appreciate your spending some time with me today and sharing about your incredible journey and everything that's coming up too. And I'm so excited for you and for this mission and to see the company continue to grow and expand, so I do really appreciate you. being here. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you for choosing that organization to support and we just wish you the most continued success as you work to change lives for a better world. [00:34:49] Hannah Went: Awesome. Thank you, Lindsey. I appreciate your time. [00:34:51] Lindsey Dinneen: Absolutely, you too. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we will catch you next time. [00:35:06] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Ruba Sarris Sawaya is a distinguished medtech executive with over 20 years of experience. Ruba discusses her journey from pre-med research to leading roles in market access strategy and consulting for medical device companies. She emphasizes the importance of curiosity, lifelong learning, and strategic thinking in her career. Ruba shares insights on women's empowerment in a male-dominated industry and the significance of broadening skillsets beyond assigned roles. Guest links: www.MediStrat360.com | www.rizlabhealth.com  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 040 - Ruba Sarris Sawaya [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Ruba Sarris Sawaya. Ruba is a medtech executive who has been passionately committed to the medtech industry over the last 20 years. She is a leader with a reputation for cultivating loyal, engaged, and collaborative teams and who carries a visionary mindset with the ability to conceptualize and execute effective strategies that have contributed to transformative growth and innovation in the medtech space. She is currently leading market access strategy for RizLab Health portable diagnostics devices, enabling access for patients with the greatest healthcare disparities. Concurrently, she is the managing partner for MediStrat360, medical device consulting firm with a mission to accelerate the journey from concept to market for groundbreaking medical devices. Her educational background includes a bachelor of arts from Austin College with a major in biology and a double minor in chemistry and physics, a master's in public health in epidemiology from the University of Texas Health Science Center, in addition to her acceptance and completion of the leadership studies program at the highly competitive Posey Leadership Institute. Ruba brings a wealth of corporate strategy expertise, and a track record enabling successful device commercialization and market access. All right. Welcome to the show, Ruba. I'm so excited to talk with you today. [00:02:16] Ruba Sarris Sawaya: Thank you very much, Lindsey. I'm excited to be here. I appreciated the invite. [00:02:19] Lindsey Dinneen: Sure. Oh, absolutely. I'm so glad we got connected. So I was wondering if you could start by telling us just a little bit about yourself and your background and maybe what led you to medtech. [00:02:32] Ruba Sarris Sawaya: So, I mean, I've spent the last 20 years working explicitly and specifically focused on medtech, dedicated to commercialization of really cool technologies that have a profound impact on patients' lives. And I'm grateful for the opportunity this career gave me to work on some really disruptive technologies and collaborate with some brilliant minds across the industry. I had a front row seat to seeing how the incredible impact to the medtech industry can have on transforming healthcare. So what brought me into it, I initially wanted to go to med school, like a lot of people. I covered all of the basics and then graduated. And then, I was doing preclinical research at UT Southwestern Medical Center. And I completed all the requirements for pre med the summer before, took the MCATs, did all of it. The summer before I was supposed to start, decided I had a soft heart and that may not be the best decision. And so there was a moment there of, I'm going to start with research and kind of see where I go. And ended up working with a lot of reps and connected with a lot of people within the medical device industry. So I started looking for jobs 'cause it felt like the perfect opportunity with the intent that the pre med thing was this sincerely and authentically with a focus on wanting to help patients, right? And the beautiful opportunity med device provided me is that it enabled me to do that without the risks and consequences tied to direct patient care. That soft empathy piece or the super empathy piece on mine wasn't at risk from that standpoint. So I was doing research at UT Southwestern in the physiology department, interacting and engaging from a folks working on trials perspective and then medical devices that were being used at that medical center and then started applying for jobs within medtech. Took one managing preclinical research way back when at Orthofix, transitioned and got promoted to running clinical affairs there, and then got promoted again and managed clinical affairs, government affairs, health economics outcomes, research and reimbursement for that organization. And that was a really long time ago and then moved into different career roles from there. But that's the story on that one. [00:04:52] Lindsey Dinneen: Oh, that's incredible. So, okay. So let's bring it up to present day, and you are doing some fractional work and I know that you have, I'm sure quite a full schedule just in looking at your LinkedIn profile. I could see that you're extremely active in many avenues and I just love to hear some of what you're up to these days. [00:05:13] Ruba Sarris Sawaya: So I'm currently leading market access strategy and advising for a diagnostics company called RizLab Health, and they have a portable hemo analyzer that's really focused on enabling access for patients with the greatest healthcare disparities, which is really cool. I'm the managing partner for MediStrat360, so it's a consulting firm hyper focused on just medical device and accelerating that journey from concept to market for disruptive groundbreaking medical devices. So those are the two things that I'm currently focused on, and then I have some senior advising positions for quality regulatory and clinical for a couple of additional companies, one that's focused on sleep apnea devices. And that one's under an NDA. And then another diagnostics company. So I've got four fractional-- with RizLabs is to focus on device commercialization, go to market strategy. And then the focus for some of the other ones very much centered around regulatory clinical quality. [00:06:13] Lindsey Dinneen: Okay. Yeah. So, so with that you mentioned that you were doing this preclinical research and decided to switch gears a little bit. And now you've got such a, an amazing breadth of skill sets and experience and expertise. And I'm kind of wondering, within medtech, what was the journey like to learning, all these different aspects that now you are such an expert in. For example, say regulatory. [00:06:43] Ruba Sarris Sawaya: I think for me, because you don't see that often, you see a lot of folks that start in one specific area with respect to medtech, and they develop a pretty comprehensive depth in that area over the span of 20 years. I would argue that I've had an extraordinary career and that has not been my journey. And that has not been my journey mainly because I took roles within companies that were either smaller or midsize, and there was always a willingness to proactively volunteer, not even volunteer, but proactively volunteer, raise my hand when people left or when certain gaps existed that needed to be filled, and then proactively choosing to look at issues that were going on within an organization more holistically outside of my department. So just because my roles and responsibilities said I covered clinical didn't change the fact that I paid attention to a dynamic that said, there are reimbursement challenges that are happening. One, we were getting coverage and pushback from an insurance company tied to certain devices, engaging with an industry coalition to try and get some of those policies overturned, and recognizing that the information that I gained as a result of that experience identified certain gaps for the evidence portfolio for clinical affairs. So how did that happen? I think that happened because I had a habit of, I'm choosing to pay attention to what the organization needed and choosing to see the links for the existing roles and responsibilities that I had, and how they bridged across the organization. And then being proactive, quite frankly, about when I was really dedicated to every company I worked for and readily dedicated to the mission that they had and choosing to take roles that I may not have been ready for or may not have had full core competencies for in an effort to support that organization. So in a lot of cases I took it on and I was, I became an obsession and I learned everything I could and I addressed certain gaps by bringing in additional expertise with the intent that we still got the organization's mission accomplished in spite of the deficiencies or gaps or turnover that was going on. [00:08:59] Lindsey Dinneen: Wow. Yeah, that's incredible. I love that. You have been so curious and eager to learn and willing to step outside your roles and responsibilities and seek to understand what the organization needs. I'm sure that really helps now with your consulting work, because you're probably way better able to, and equipped to, find those gaps that you mentioned in a company's strategy or whatnot. And so I, what a strength to be able to bring that breadth of knowledge. [00:09:34] Ruba Sarris Sawaya: It's interesting when clients approach me about a dynamic that says, "We have this challenge." It is a prism where that challenge ties to different additional facets of the organization or facets of their market commercialization strategy. So we end up providing value and feedback that's not only solving the problem they came to us with, but providing recommendations that have an impact across different facets within that organization or within that product commercialization strategy. And I'm telling you it's, it is, that is one, I would argue, differentiating value prop that I bring to the table on the consulting side is offering that feedback where it's not it's not one sided. It's got depth to it and it touches different dimensions because we're not looking at it just within the scope of the problem as it's presented. [00:10:23] Lindsey Dinneen: Yeah, absolutely. That's awesome. That's great. That's something very unique to be able to offer. And so, you know, that curiosity and growth mindset, willingness to fill in the gaps and figure out how to, where did that come from? Have you always been a very sort of curious, eager to learn, lifelong learner type individual, or is that something you developed over time? [00:10:50] Ruba Sarris Sawaya: Both, I'll say both. The lifelong learner piece, definitely a part of my personality my whole life, one. Two, I will also say I was lucky in having some phenomenal mentors and strategic leaders that drove that value and the importance of that value, and enforcing us to see the bigger picture and think more holistically. And so I started out with that as part of who I am. And then on top of that, it was further reinforced by having some fantastic leaders that I was lucky enough to work with and for that emphasized the importance of that. [00:11:24] Lindsey Dinneen: Yeah. Yeah. And, you've mentioned having some amazing leaders that were in positions to really help mentor and guide and lead. And I'm wondering, what are some of the most impactful pieces of advice that you've received from leaders that you look up to and or now as accomplished leader yourself, what do you see as being some of the best pieces of leadership advice? [00:11:54] Ruba Sarris Sawaya: So I'm gonna I'm gonna share with you some of my favorites on what makes a good leader and things to pay attention to as a good leader. So to me, anybody who's trying to explore a leadership role within medtech-- it's to everything we just talked about-- it's unbelievably important to choose to see beyond the expected. So have a deep understanding. If you're a project manager for R&D and you want to get promoted to, you want to move up the ladder, you having a deep understanding of the technical aspects of medical device is important, but it's just as important to cultivate a deep understanding of not only the technical, but the technical and business aspects. So the willingness to learn beyond the scope that you are assigned to, the willingness to recognize the importance of strategic thinking, is really important from a leadership standpoint. Additional aspects that are important with respect to strategic thinking, don't be afraid to voice ideas, but be strategic about how and when you do that. So navigating a leadership role to me really requires developing a good acumen on knowing when to assert your ideas and when to hold back, learning how to read different situations and understand the dynamics at play. I think some of the most important advice I was ever given was that we all, especially when you join a new organization, we all have a proclivity for wanting to prove our value or demonstrate our value as soon as possible. And some of the best advice I've given that I've passed along is to be strategic, is to be really good about proactively recognizing when it's a good opportunity for you to do that. And when you're better off holding back and listening and observing and understanding the dynamics of play and choosing your moments wisely on when you make impactful contributions, right? Doing that, you maximize the effectiveness of the input you provide and the influence that you end up having and sometimes holding back initially, choosing to observe and listen gives you insights that better inform your strategy for what to do or how to do it. Building a network is also really important. That's another really good piece of leadership advice. We tend to keep our head down. Early on in my career, I definitely did that. I treat networking and the relationship management as a mandatory part of the job with roles I've had where I'm within an organization and outside of that. So I think that part is unbelievably important for leadership and success. And it's not just the creating a network offers job opportunities. It's creating a network offers opportunities to seek advice and to learn and to stay plugged in from an industry standpoint. So continuous learning is about being proactive and seeking those opportunities to challenge my current thinking, quite frankly, and expand my horizons from that standpoint. [00:14:57] Lindsey Dinneen: Yeah. Oh my goodness. That was so much great advice. Thank you for sharing all of that. I think even the first thing you said, I really appreciated about, see beyond the expected. And I think that's such, I have never heard it put quite like that before, and I really like that of your willingness to go beyond your scope, so that you keep learning and I like your idea of continuing to even challenge your own beliefs and thoughts and processes. All those things. If you can keep doing that, then you're growing, you're learning, you can't stay stagnant that way. So yeah, I appreciate that advice a lot. [00:15:38] Ruba Sarris Sawaya: One, to be clear, it comes from tons of mistakes made and lessons learned over a couple of decades for starting out in a technical role and a technical career. Those are common mistakes I see made, which is you're presenting to management on a project update, and the tendency for us technical folks, for people that started their careers out in science, is to very much focus on the technical aspects of what are going on without taking into account how that information is being presented, the impact that it's having on the politics and the different players in the room and their intent. So it's choosing to see things in a different light than the way that you're used to processing them is very important. Strategic thinking. It's different. [00:16:27] Lindsey Dinneen: Yeah, absolutely. And being willing, like you said, to look beyond and to approach things in a different way and maybe take a step back sometimes. Say, "Okay, I need to keep observing before I dive in with my solutions." [00:16:43] Ruba Sarris Sawaya: Well, and take stretch rules. I think that's the other thing from a career development. Nobody owns your career. You own that. And If you love medtech, if you love whatever your profession may be, if your goal is advancement and leadership positions within that, but then that profession or that role, it's recognizing that you have to learn other things beyond just R&D if your goal is to manage a division or manage a sector . So I think, it's saying you're going to fulfill your roles and responsibilities and focus on accomplishing those goals, but be selfish about raising your hand for stretch opportunities that provide you exposure to other areas and dimensions of medtech that are outside of your scope, right? With the intent that you're getting that exposure is unbelievably important. [00:17:32] Lindsey Dinneen: Yeah. Yes, I could not agree more. One thing that I noticed from just looking at your LinkedIn profile is you are very passionate about a lot of issues facing our society, our community. And, I saw some speaking opportunities and things where you focus on women's empowerment and whatnot. And I was wondering if you might share a little bit about your passions outside of work that do speak to it. So even with women's empowerment, encouraging women in the medtech field and whatnot, because we have listeners who might really appreciate some of your perspective and advice on that. Would you be willing to share? [00:18:14] Ruba Sarris Sawaya: Yeah, I mean, absolutely. Let's be very frank and transparent. I'm a woman that's been predominantly working in a male industry, and I've had some wonderful experiences, but I've also been granted some wonderful obstacles that tested my resilience and determination. I learned over time to see those challenges as an opportunity to strengthen my resolve and even my commitment. And so to me, a few pieces of advice to empower women as they navigate their own paths in leadership is to embrace your unique perspective. I think as women, we bring diverse experiences and insights to the table. And we should never underestimate the value of that viewpoint that we bring as women, right? Early in my career, and I've run into a lot of women that feel this pressure, to posture, to present themselves with a set of characteristics that are more akin to male dominated characteristics versus owning their executive presence, and recognizing the value they bring in authenticity for presenting who they are authentically and not underestimating the value of their own viewpoint versus others complying with the mass or succumbing to the pressure. So I think it's unbelievably important to honor and respect and embrace that unique perspective that you bring as a woman, trusting your instincts and not being afraid to voice your ideas. But again, unbelievably important to be strategic about when you choose to do that. And that piece of advice applies across both. And I think women have a tendency to coming into, especially high level, higher level management roles, a desire to want to prove our worth and prove we have a seat at the table. You have earned the right to sit at that table by default of the fact that you have been offered the job and you have it. Be smart, strategic about when and how you choose to weigh in, recognizing the politics at that same table, right? Is important. And then advocating for yourself and others to the point that you made about, I do quite a bit of speaking. I am on a mission to drive transformative technologies within healthcare. I'm also on a secondary mission to enable an increase in the number of extraordinary women and their commitment to that mission, right? So advocacy, empowerment, education, training on communications and engagement for women is a focus and how I choose to spend my time with the intent that I sincerely believe the more women that you have, more women and more diversity, quite frankly, that you can have in medtech, the better devices and the higher the impact that you can have with respect to innovation in medtech and an impact that MedTech can have on healthcare. So to me, that is a focus. [00:21:10] Lindsey Dinneen: Yeah. Well, and I very much appreciate your perspective and your willingness to share about it. And the fact that this is a mission for you. So, thank you for continuing to support and elevate women in medtech, 'cause it's a need. And to your point, I appreciate you saying that women bring a unique perspective. And so that can be your superpower and you don't need to shrink. [00:21:37] Ruba Sarris Sawaya: 100 percent and authenticity, Lindsey. I think women bring a unique perspective and value the power of authenticity. Resist the urge to position or posture or present yourself as "A" because you believe that "A" is what they want to see. There is unbelievable power in an executive presence of a woman leader that is authentic in the way she presents herself. [00:22:07] Lindsey Dinneen: Yes, could not agree more. Yeah, so, your career has been so interesting and I love the running theme of you being willing to continue to learn and grow and step out of the current role so that you can fill in the gaps. And I'm wondering if there are any moments that stand out to you where it just made you go, "Wow, I am really in the right place, at the right time, in the right industry." [00:22:36] Ruba Sarris Sawaya: So there's been a few of those, but I think one of the most memorable was when-- I have had a few leadership roles within Medtronic, and there's an annual event that gets held there where patients will are willing to share their stories with company employees. And listening to those stories, you realize what a difference we were making to the daily lives of those individuals. It was unbelievably moving and it gives you a renewed sense of hope. So we all in that office, especially, it's an extraordinary group of people that are working unbelievably hard and all of us were running at 90 and it's a constant hurricane of work, right? You lose sight. of how those hundred little activities we do every day are contributing in a transformational way to the lives of others. And sitting through that two hour testimonial set with those patients was a really emotional experience that kind of puts everything in perspective. That was a good what seven years plus now since I sat through that and it still resonates with me. I still think about it all the time. [00:23:47] Lindsey Dinneen: Yeah. Yeah, I think that's really powerful too, to have those moments of realizing the impact that you're making and it is easy to get caught up in the daily grind. And, and forget that, oh my goodness is actually, this impacts somebody's life. [00:24:05] Ruba Sarris Sawaya: It brings it to focus, Lindsey. I loved that whole experience because, and I'm telling you, on the days when getting up in the morning is a little harder than others, it's a nice reminder to just force myself to recalibrate against that. And that we tolerate the craziness, we tolerate the difficulties, we tolerate the barriers and the more difficult days because we have an impact on the back end of the lives of other human beings. And that's the reason I've stayed in medtech for the last 20. There's something extraordinary about that. The ability to do that for someone else is amazing. [00:24:41] Lindsey Dinneen: Yeah, it's a gift and it's something to come back to when the days are hard and long and frustrating, because you really do know what you're doing matters. Yeah. [00:24:52] Ruba Sarris Sawaya: Exactly right. [00:24:53] Lindsey Dinneen: Yeah. Absolutely. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, but it doesn't have to be related to it. What would you choose to teach and why? [00:25:15] Ruba Sarris Sawaya: Honestly, I would teach exactly what I'm, a lot of the time I'm teaching now, which is device commercialization. And, to your earlier question about give me a couple of things that inspired you and told you were right where you needed to be, I taught a course at University of New Mexico, their innovation center a few weeks ago. And one of the nicest comments I've ever gotten from a career perspective is somebody came up to me afterwards and said, "I've been working with folks for a decade plus, and this is the first time in my life I have gotten such a good training that I walked out having a solid understanding of how these pieces tie together from a regulatory perspective and commercialization perspective." So what would I teach exactly what I'm what a lot of the time I'm teaching now from a consulting perspective, which is device commercialization. I picked a career that, that I'm lit up by and that I'm inspired by. I'd be doing the exact same thing, Lindsey. I wouldn't change a thing. [00:26:13] Lindsey Dinneen: I love that. That's so great. [00:26:16] Ruba Sarris Sawaya: Yeah. [00:26:18] Lindsey Dinneen: That's very special. I love that. Yeah. Okay. And then how do you wish to be remembered after you leave this world? [00:26:26] Ruba Sarris Sawaya: That I do quite a bit of mentoring. That I had an impact, that I inspired a group of people to maintain this mission to transforming healthcare. It's not just putting out and launching additional devices. It's sincerely a focus on looking at the areas across our healthcare system here in the U. S. and otherwise, and looking for opportunities to change the dynamic in a positive way. So after I die, what I want to be remembered for that the folks that I have, and I've taken on quite a bit over 20 years that I've tried to help grow and advance career wise that I inspired them to keep doing this. And I inspired them to do it well, and do it with integrity and do it right. [00:27:16] Lindsey Dinneen: I love that. Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:27] Ruba Sarris Sawaya: I mean, personal, probably my cat. We have a British short hair that has an insanely cute face and it's impossible-- I don't care how stressful of a day I've had-- impossible not to crack a smile thinking about that fluff ball. So yeah, our cat for sure. [00:27:46] Lindsey Dinneen: Oh my word, I love that. Animals are the best. [00:27:49] Ruba Sarris Sawaya: Yes, well, and she's a recent addition. So we've had her a year. And it is definitely the stress buster. [00:27:57] Lindsey Dinneen: That's perfect. [00:27:59] Ruba Sarris Sawaya: For sure. [00:28:00] Lindsey Dinneen: That's perfect. Animals are inherently just happiness. Well, this has been an incredible conversation. I am so thankful for your willingness to share about your background and what you're up to now, but especially all of your advice. It was so packed full of just amazing pieces of advice to take away. And I really appreciate that you're willing to share all of that with us. So, gosh, thank you so much for your time and thank you for being here and and doing that. I really appreciate it. [00:28:33] Ruba Sarris Sawaya: Well, and likewise, thank you for doing this again. I'm a huge advocate for getting more folks and more people and more women and more individuals involved in medtech, and recognizing the phenomenal opportunities that medtech brings from a career standpoint. And so thank you for doing this because you're spreading that message and educating people on other career options besides, you know, firefighter, doctor, lawyer, engineer. So we appreciate what you're doing too, Lindsey, this is great. [00:29:03] Lindsey Dinneen: Thank you. That made my day [00:29:05] Ruba Sarris Sawaya: It's important. We got to spread the message. [00:29:09] Lindsey Dinneen: it's very true. It's very true. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two, and we will catch you next time. [00:29:55] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Harout Markarian, founder and CEO of MARKBOTIX, shares his journey from Lebanon to the US, transitioning from a professional basketball player to a skilled roboticist. He discusses his educational background in mechanical engineering, robotics, and business, leading to the creation of MARKBOTIX. The company develops GRACE, an assistive robot for the elderly and disabled, aiming to reduce falls and improve quality of life. Harout's passion for engineering and helping people drives his mission to enhance independent living and accessibility. Guest links: https://www.linkedin.com/in/haroutmarkarian/ | https://www.markbotix.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 039 - Harout Markarian [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce to you as my guest today, Harout Markarian. Harout is the founder and CEO of MARKBOTIX, an innovative assistive robotics startup focused on transforming care for the elderly and individuals with disabilities. Harout, a skilled roboticist with multiple patents, holds a bachelor's degree in mechanical engineering, a master's in robotics, and an MBA. His professional path has been marked by significant leadership roles in engineering at top firms, including the Boeing company, where he designed the air refueling flight controls algorithm for the Boeing C 17. At MARKBOTIX, Harout's team is developing GRACE, Ground Robotic Assistant for Care Enablement, robot designed to reduce risks of falls, hospital readmission rates, and caregiver burnout, while providing support for everyday tasks. Under his leadership, MARKBOTIX has garnered significant interest, including over a hundred letters of intent from various facilities and is currently involved in beta testing with organizations like the VA Hospital. Harout is also a published author and speaker, advocating for the right use of robotics to improve independent living and accessibility through his book, "Mobility and Inclusion." His work extends beyond business as he actively contributes to the community, particularly through support for organizations aiding the elderly and individuals with mobility challenges. All right. Well, welcome Harout. Thank you so much for being here today. I'm so excited to talk with you. [00:02:23] Harout Markarian: Likewise. [00:02:24] Lindsey Dinneen: Excellent. Well, I wondered if you wouldn't mind starting off by just telling us a little bit about who you are and a little bit about your background and maybe how you got into medtech. [00:02:36] Harout Markarian: Sure. So I, I am an immigrant from Lebanon, a former professional basketball player, danced ballet for a little bit, and at one point ,my parents decided to immigrate to the United States. Needless to say that my academic career was a tremendously suffering when I was busy with the basketballs and the ballet dances of the world. So, so when they decided to immigrate to the United States. States. I was strongly against it, but deep down I knew that my parents always did things for the benefit of me and my sister. So, unwillingly I followed them. I came to the United States in 2008. I was 23, about to be 24 years old. And at that time, basically everything that I knew disappeared from my life. Everything that was normal to me disappeared. So I had to do something. I had no money. My parents didn't come with money. So I had to support, I had to help, so I worked full time as a waiter and I was also going to school full time to continue my undergrad in mechanical engineering. Mind you that I already completed three years of engineering back in Lebanon. When I got here, they said, "Oh the institution that you attended is not accredited." And my luck, I guess the institution got accredited a year after I left. [00:04:02] Lindsey Dinneen: Oh, no. [00:04:05] Harout Markarian: But it was a blessing in disguise. As I said, I wasn't the best student at the time. So the grades were reflective of that too. So, now that everything is no, no more distractions were in my life, I focused on my studies, finished three years of undergrad in mechanical engineering in a year and a half. My GPA went from 1. 8 to 3. 5 by the time I graduated. And during my final year when I was developing the senior design with my team, I experienced a tremendous shift in my life because I was part of this project where we built a six foot tall, fully autonomous robot. And we won the first place internationally in the autonomous unmanned system vehicle international competition. And that was a really a shift in my career in the way I viewed engineering, I viewed education, because up until that point, it was just to satisfy my parents. I'm like, "Here you go. This is the paper you wanted. Get off my back." But ,but right after that, it was like, okay, I want to know more about this robotics world because I really enjoyed it and I'm very curious individual. So robotics has different disciplines, sub disciplines I should say. So there's a mechanical design team, there's the cognition vision team, there's the electrical team, there's a navigation team. So, and I wanted to learn it all and I got involved with everything. And I really enjoyed it. So I ended up pursuing my master's immediately right after I graduated my bachelor's degree. I pursued my master's in robotics, and I was the only one in my cohort or not just cohort, in that year, that opted out of the, the comprehensive exam and wanted to do a thesis dissertation. Because I really enjoyed it. For me, theory alone doesn't mean anything. I need to see it in application. And that's kind of how I pursued it. I was able to build a stair climbing wheelchair. And that's a scale prototype of a stair climbing wheelchair that I presented it to my thesis committee and I learned a lot. I learned a lot and I graduated, but mind you at this time, I'm already working, I'm five years into my, my career in aerospace and defense. So things are going well. Really nothing medtech or healthcare related in my life yet. Except for that stair climbing wheelchair. And, and the reason for that is because I had the opportunity to work with a severely paralyzed person on brain computer interface technology that allowed him to propel his wheelchair through his thoughts. And when I got signed up to this project, I said, "Oh, moving things with your thoughts. That's cool. Let's do it." So, but I was approaching it like so mindlessly, if you will, because I didn't understand the impact that could have on individuals, especially individuals with disabilities, individual with limited mobility and elderly and everything in between. So while we were testing this technology with this individual, it required some training, basically. It's like an electrode that attaches to your skull. So it's a helmet that you wear. And as you think thoughts, it transfers to electrical signals that moves, that propels the wheelchair, moves the motors, right? A very simplistic way of explanation, of course. And, I was trying to test it by myself. So wearing the helmet, trying to move this wheelchair one way or the other. And it was very difficult because it's not second nature to me. I don't, I'm not a wheelchair user. So I, that's not a thing in my mind, but for this individual who was a paraplegic, it was, that was his legs basically. So for him, it was very second nature, right? So, and he got on there and I put the helmet on, set up everything for him and he was driving his wheelchair like I drive my car. That, that, that's how second nature it was for him. And for a moment there, I felt like I was the one with the disability. I couldn't even move a freaking wheelchair with my, so that was a big lesson for me in terms of understanding how limited we can be in, in different aspects of our lives, right? So, at that point I was, that was the first time I realized when I saw how independence and accessibility, what it meant to that individual. That was the first time in my life I said that I want to start a robotics company to help people become more independent. So, so to, to make their environment more accessible for them and to o for the elderly, to have them age with dignity. And that was the purpose. But nothing happened. I just continued with my life, with my job in the aerospace and defense industry. And then sometime later I decided, okay, I think I have a decent background in the technical side of things. I don't know much about business. Let's go get an MBA. So, so, so I went back to school. I did MBA at Pepperdine University. And I loved it because Pepperdine, at least the cohort that I was in and the teacher that I had, everybody was industry professionals and had their PhDs in their respective fields. So it wasn't, I wasn't just learning theory. I was learning how to apply that theory to real world problems. And that's how I learned that. That's where I thrive, right. And once, once I graduated with my my master's degree from Pepperdine, I, next day I went and incorporated the company. Literally the next day I went there and I was like, "Okay, I'm going to incorporate the company." And that's how MARKBOTIX was born. I'm not a hundred percent medtech. I'm approaching medtech from a different angle, if you will. But part of that, when I incorporated the company, I didn't really know what products or service I was really gonna offer. I knew who I wanted to serve, who were the people with disabilities, elderly, people in home cares, assisted living facilities. But I didn't know how to best serve them and with what. So I took a year and a half of going around and talking to people, basically doing customer discovery. And part of that customer discovery session, I stumbled upon the Ground Robotic Assistant for Care Enablement, which we call GRACE now. And all that robot does it initially, at least all that it did, was to pick items up, retrieve items for individuals so they don't risk a fall and then now they're in back in hospital or they injured something. And we're talking about fragile people, right? So when they injure something, the repercussions from it is really could, it could be hefty basically. And as I kept on talking to people, I built this prototype that retrieves items initially, and I tested it with over 300 people, and the more I tested it, the more apparent the need was. People were actually helping me feature up. So, we started with item retrieval, it went to real time video and audio interaction, remote operability, and other stuff that were included in the robot that right now is in development mode. And that's brings me to today where we're raising our first round of funding to bring this to life. We have a bunch of letters of intents from assisted living facilities and somewhere along the way that the DOD got interested in it. We got in contact with the Veterans Hospital. So everybody seems very interested in working with us. So we're, so today we're raising our first round of funding to bring this to life. [00:11:59] Lindsey Dinneen: Oh my goodness. That's incredible. Well, there's so much to your story. I'm so excited to dive in deeper. But first of all, congratulations on your company and its success and the interest, and I'm so excited because I know you're going to be helping so many people and there's such a need for it. So kudos. [00:12:18] Harout Markarian: That's the goal. Yep. Thank you. [00:12:20] Lindsey Dinneen: Yeah. Yeah, absolutely. So, okay. So your story is so interesting and it has so many different twists and turns. And I'm kind of curious, especially knowing, you started off with basketball and ballet and you did your academics of course, but maybe that wasn't quite the focus, could eight year old you have ever pictured you now doing what you're doing? [00:12:44] Harout Markarian: No. So two things. So I knew I wanted to be an engineer, even though I didn't know what that meant at that time. Ever since I was young, I knew I wanted to be an engineer, but I can confidently tell you that I didn't know what that meant. I just, my dad was a mechanic body shop person. He was an entrepreneur. He has his own place. So I thought that was, that's what I was going to be doing if I studied engineering. So that was stupid I was. The other thing is that, no, I mean, my dad was also a professional basketball player. [00:13:15] Lindsey Dinneen: Okay. [00:13:15] Harout Markarian: So, so having those two in mind, eight year old me would never picture me being here today, let alone leaving the country, right? [00:13:23] Lindsey Dinneen: Yeah. So, do you still do anything with either basketball or ballet or has? [00:13:29] Harout Markarian: No, I don't actually want. So once I left both ballet or dancing in general and basketball, I just completely abandoned it. [00:13:40] Lindsey Dinneen: Ah, okay. Fair enough. Do you miss it? [00:13:43] Harout Markarian: No, I don't, because I mean, it was good while I did it and I did it for a long period, I mean, relatively long period of time. So I did dancing for about 10, 12 years. And basketball, I did it from 16 when I went to professional to 23 years, 23 years old. I mean, relatively short career. But for me, my biggest passion was basketball. Just seeing my dad play, and then me being in that world. It was the biggest passion, and when it was taken away from me, or however you want to look at it, or I gave it up. I didn't give it up. I didn't want to give it up. Even long after it was over, I didn't want to accept that was not part of my life anymore. I was passionless for a while. So, finding that robotics world where I'm interested in something again, was a big shift for me. [00:14:36] Lindsey Dinneen: Yeah. Yeah. That's a really big deal. And that is hard, but I feel like it speaks a lot also to your resilience and your willingness to, to change and to pivot, as much as that word is overused. But you know, the thing is you have such a growth mindset, clearly. I mean, you're such a lifelong learner, you've gone and done the things that you wanted to do, but those aren't easy things that you've decided to do and you've had such a robust career so far. I mean, I love the fact that I think you're such a great testament to the ability to keep learning and keep enhancing your skillsets and keep going even when it is frustrating or you feel like you've lost this crucial part of you, but you still are able to keep going and do something amazing with your life. I think that's... [00:15:24] Harout Markarian: Absolutely. [00:15:25] Lindsey Dinneen: ...courage. [00:15:26] Harout Markarian: I mean, I mean, you have to do that because the only constant in your life is change. So you either adapt or you just fall behind and become miserable. And everything bad that goes, that follows that, right? So, if you don't change, time is moving forward, so you're just falling behind. [00:15:43] Lindsey Dinneen: Yeah. Yeah, absolutely. You started off in your career working for others and you had a amazing experiences, it sounds like, with very well known companies and brands, and then you switched to starting your own business and I know you got your MBA and I'm sure that helps you feel more prepared, but I do feel like there's often this-- once you actually do it, how much you have to learn on the job, so to speak. So I would love if you wouldn't mind speaking about your entrepreneurial journey and how that has changed and grown over time. [00:16:15] Harout Markarian: Yeah, so, so I'll tell you that college education doesn't mean that you're going to be able to thrive in the business world, right? Whether it's a technical side of thing or the business side of things. Unless you dive in there and do it yourself, you're just going to be dumber than a bag of rocks. So, I'm sorry for the expression, but that's that's how it is. Basically what engineering taught me is how to figure things out. They didn't teach me to find a job and hit the road running with that job, right. So everywhere I went, every company I worked for, I had to restart from scratch, go into my baggage of tools that college education gave me and depending on these knowledges, just figure out how to do my current job today and how to learn more. Because what you learn in school is just a baseline thing. It's just nothing really. And nowadays you can learn anything and everything online. I would even argue that nowadays, unless you're a doctor or an engineer a lawyer, maybe you don't really have to go to school. Everything else can be learned online. And there's a lot of resources today that back 10, 15 years ago, we didn't have. So on the job learning is the most real thing anyone can ever think of. Pepperdine came really close because I did my actual business plan to the company that I'm building today, I did it at Pepperdine. So it was a benefit for me because I studied, I got my education at the same time I worked on my business, so that's why I liked it a lot. But don't think that you're going to go to college and you're going to take a job. And all employers know, by the way, all employers know that they're going to teach you a lot when they hire you, they're just hiring you based on, I don't know, your enthusiasm, the willingness to learn, willingness to be adaptable, your demeanor, your behavior. That's what they're hiring. And I'm a Director of Engineering right now at different companies. So I hire people all the time. So that I don't hire them. I don't expect them to know things. I expect them to know basic things, but I don't expect them to hit the ground running regardless of where they are in their career. [00:18:30] Lindsey Dinneen: Sure. Sure. So when you stepped into this, this entrepreneurial journey, and you're the owner of a company, you are the leader of this vision-- did you find that to be a relatively easy transition because of the past experiences that you'd had? Or was that element of stepping into this high leadership role, was that, yeah, difficult in any way? [00:18:56] Harout Markarian: In different things that I tried in my life, I felt like I was always adaptable. I was always willing to learn. And I never quit. I failed a lot, but I never quit. Right? So I feel like that definitely contributed to, to how I'm managing myself in this role. Is it easy? It's not easy at all. It's difficult. Whoever tells you starting a company, building a company is easy, it's out of their mind, especially in the beginning stages. Because having other people get on board and see your vision, it's the toughest challenge a founder can embark on. So if you overcome that, then you definitely have what it takes to lead a company. [00:19:44] Lindsey Dinneen: Agreed. Yeah. Yeah. And so are there any moments that stand out to you as you've started this company or even prior to that, where it just kind of confirmed to you, "Yes, I am in the right industry, at the right time for a purpose." Was there like a moment that you thought, "Wow, this is why I'm here." [00:20:05] Harout Markarian: Well, first and foremost, I pray to God every day. I asked God for his guidance. If it's not part of his plans, please give me a sign. So I just go do something else, right? And till now he didn't give me any sign to abandoning it, but or I'm that, I'm just that's too but that i'm not realizing it but no, that's that's my first go to right? I always embark on my day, on my journey, by asking God to guide me through it. Having said that, the countless numbers of interviews and research that I've done-- and this, mind you, this is not leveraged research-- this is me talking to people one on one. So over 1000 interviews over the past year and a half, or almost two years talking to people, it was reassuring to me that, okay, this is needed and I'm going to be helping a lot of people. And that's really what kept me on this journey. Just now I feel responsible for all the people I talked to. I have a responsibility to see this through. If I focus on the competitors, the market, the investment, the investor, then I would give up long time ago. Then that's not the right way because the market, the investor, the Investment, they didn't do the work I did in terms of talking to the end user and how it's going to benefit them. So they don't really know that, they don't understand that. So it's my job to, we talked about vision, it's my job to clarify the vision to the investor, in this case. So it sees that how many people is going to benefit from this. So that was the reassuring factor. Conducting that customer discovery was so important. Because that sets the expectations for myself and everyone I talk to. [00:21:58] Lindsey Dinneen: Yeah, absolutely. Thank you for sharing that. I think it's helpful, so helpful to have those moments, something to hold on to when it does get hard because it's inevitably going to get hard and frustrating and discouraging at times. So being able to go, "Oh, wow. But I know this is impacting people. And if I don't do it, will anybody else?" That's, but that's powerful to motivate you. [00:22:22] Harout Markarian: Yeah, and I mean, I want more people to do what I'm doing because the market supports it, right? Just, we're talking right now, a little left brain, right? Logic. The market supports it, there's gonna be more people older people. The elderly population is increasing, is going to get bigger. So there should be more companies like mine addressing the same need because one or two or three companies are not going to be able to close the gap. [00:22:50] Lindsey Dinneen: Yeah, absolutely. So what are you most looking forward to both perhaps personally and then professionally with your business? What is on the horizon that you're excited about? [00:23:02] Harout Markarian: Personally, I just want to enjoy my family, enjoy my wife, my kids, my parents before they're gone, because of everyone, everyone's going to leave at one point. So I would love to have some quality time with my parents, with my kids, with my wife. That's on the personal side. That's what's really meaningful to me. On the business side, I just want to add value to people. Hopefully this will be the vehicle, how I'd be able to do that. And as I said, I feel like I have the responsibility right now to see this through just because of all the conversations that I've had with people with different disabilities, with different challenges that this technology could help them overcome that. [00:23:45] Lindsey Dinneen: Yeah. Yeah. And it's exciting. You're in a really exciting growth phase too. So there's a lot to, a lot to be joyful about, I suppose. [00:23:54] Harout Markarian: Yeah. [00:23:55] Lindsey Dinneen: Yeah, that's amazing. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:24:12] Harout Markarian: For them to be connected with God more because I feel like, and I don't know if I'm the right person to teach that, right? But because everything else doesn't matter. Everything else is temporary. I think the divine is, is the only thing that is not temporary. Your spirit, your soul is the only thing that is not temporary. Your challenges, your difficulties, your tough times, your good times, your money, your lack of money, all of that is temporary. What's not temporary is your soul and spirit and what happens to it afterwards. So, a lot of people today are behind social media and the fakeness of the world. And that's what I want to separate myself from, and see if I had the opportunity, I would just teach people to be more authentic and more connected to God. [00:24:59] Lindsey Dinneen: Yeah, absolutely. And then how do you wish to be remembered after you leave this world? [00:25:05] Harout Markarian: I don't know if I want to be remembered, but if I do good to people, if I serve people in this world, in my time here hopefully I'll I please my God. And that's what's important to me, because pleasing God is serving others. So that's what it means to me. If I do that, then hopefully I'm pleasing God and helping people in the way. That's my thing. I don't know what being remembered means really who's remembering me, right? That's the question that I always ask and I wasn't always I didn't always think this way. I didn't always think this way. I always said to myself, okay, I want to be remembered like this great athlete, for example, right, when I played basketball. Or I want to be remembered like the person who founded the biggest assisted robotics company in the world. All that doesn't mean anything, because all that is material stuff, in my humble opinion. And I'm not saying I'm right, right? This is how I think. As, as long as I'm serving others, I'm helping others, hopefully doing it in a gracious way, that's what I'm looking for. [00:26:04] Lindsey Dinneen: Yeah. Yeah. Well, I think that's incredible and that's, I frankly wish that more people felt that way. So I think that's a, I [00:26:15] Harout Markarian: Well, I, it's a hard thing to do and I'm not saying I'm doing it perfectly. Sometimes we have a lot of distractions. That's not the norm So if we follow what's around us, then we're not going to think that way and I struggle with it too. So I constantly strive to keep myself true to what I just said right now. [00:26:32] Lindsey Dinneen: Yeah. Yep. There you go. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:26:42] Harout Markarian: Oh, my kids. My son is five, my daughter is two ,and they're hilarious, even when they're a pain in my ass, so. So, sometimes the things they say is, and then, I like to also I'm a light guy. I like to think that I'm a light guy, so everything is a joke to me. I don't take a lot of things seriously. So I'm always giving people hard time kind of in a humorous way. So I like to pick on my wife, pick on my sisters. So these kinds of things make me smile. Sometimes it's stupid. Sometimes it's makes others smile to you, but it's just light stuff. I just enjoy my life, enjoy the time I have with the people I love the most. [00:27:20] Lindsey Dinneen: I love that. That's fantastic. Yeah, well, first of all, again, thank you so much for sharing your story and your insights. And, it's so interesting to me how you have had such resilience and a growth mindset and now discovered this sense of humor as well. I mean, I'm sure that helped exponentially as you had to go through so many different iterations or stages or seasons, whatever you want to call it of your life. And some of them sounds quite difficult. So I just want to say thank you for sharing that story and thank you for talking about it and giving inspiration and hope to somebody else who might also be in maybe a transition period or something like that, where it might be a little harder. So I, anyway, just... thank you. [00:28:05] Harout Markarian: And I, I don't downplay the challenges, right? Of course I recognize them, but I just choose to take it lightly because as I said, nothing is permanent. Everything is temporary, so don't think too much about it. Just, pray and move along. [00:28:23] Lindsey Dinneen: That should be on a t shirt that you sell or something. [00:28:26] Harout Markarian: Yeah, that's a good idea. I might I'm that might be merchandise. I'll say I sell on MARKBOTIX's website. [00:28:32] Lindsey Dinneen: Please do. That's amazing. I love it. Oh my gosh. That's so fun. Well, this has been such a great conversation. I've enjoyed it so much and I'm very appreciative of you spending some time with me today and talking, and we are so honored to be making a donation on your behalf as a thank you for your time today. And that is to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you for choosing that charity to support, and we just wish you continued success as you work to change lives for a better world. [00:29:11] Harout Markarian: Thank you so much. And thank you for your time as well, Lindsey. [00:29:14] Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:29:25] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Ashley Mooneyham and Jennie Lynch are the co-founders of Momease. Ashley, a PhD-trained scientist and melanoma survivor, shares her journey from cancer biology research to developing an innovative breast pump solution inspired by her own motherhood challenges. Jennie, a serial nonprofit entrepreneur, discusses her transition to the MedTech industry and the importance of supporting new mothers. Together, they highlight their mission to create a pumping bra with warmth and massage, aiming to improve the breastfeeding experience for women. Their story is one of passion, innovation, and dedication to advancing women's health.   Guest links: https://www.momeasesolutions.com/ | www.linkedin.com/company/momeasesolutions/ | www.instagram.com/momease_solutions/ | https://www.facebook.com/MomeaseSolutionsInc/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 038 - Ashley Mooneyham & Jennie Lynch [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guests today. They are Ashley Mooneyham and Jennie Lynch. Ashley is the CEO and co founder of Momease with experience as a mother and as a PhD trained scientist to lead research and development. Jennie is the president and co founder of Momease. She is a serial entrepreneur in the nonprofit space with customer base experience leading operations. Well, thank you so much for being here, Ashley and Jennie. I'm so excited to speak with both of you today. [00:01:33] Ashley Mooneyham: Thank you. [00:01:34] Jennie Lynch: Yeah, thank you for having us. [00:01:35] Lindsey Dinneen: Yeah, absolutely. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to MedTech. Ashley, do you want to start us off and we'll go from there?   [00:01:48] Ashley Mooneyham: Yeah, sure. So my background is in kind of your traditional laboratory research science. I did choose to pursue a PhD in cancer biology, and that was motivated both by my own personal experiences as a melanoma survivor, as well as, of course, knowing so many people who suffer from cancer and are impacted by cancer. I really wanted to make a difference there. And I very much intentionally chose a laboratory for my thesis work that focused on ovarian cancer research because I've always been really passionate about how scientific discovery can impact human health. And of course, as we're all aware, women's health kind of lags behind. So we need more women in science to be asking those questions and pursuing those answers when it comes to translating scientific discovery into impacting women clinical outcomes. And I really enjoyed my thesis work, but I felt far from making that clinical impact. I was doing the traditional bench work, working with mice in the basement of my university, and I just wanted to get a bit closer to the action. So after my PhD, I became a medical writer at Superior Medical Experts, which is a Minnesota small business focused on medical writing and research support. And I actually was quickly promoted to their Director of Grants, where I helped small businesses in the medical device industry pursue federal grant funding to de risk their medical innovation. So I got to learn a lot of varieties of discipline within scientific medical device and technology innovation, and got really excited at helping them secure funding to see their idea come to life. And I've actually worked with a few companies that since working with them have made it to clinical use of their innovative technology, which was super rewarding. Then in April 2021, I had my daughter, she's 3 years old now. And I kind of naively thought it would be easy to go back to work after that experience. But a huge pain point in my going back to work was. trying to maintain my breast milk supply for her via the breast pump. So that kind of leads into the origins of Momease solutions, but I'll save that for after Jennie gets a chance to introduce herself as well. [00:04:12] Lindsey Dinneen: Amazing. Thank you. Jennie? [00:04:15] Jennie Lynch: Yeah, so my background is I'm a serial non profit entrepreneur. So I founded two Minnesota based non profits focused on child development and family well being. So mostly doing the business operations and development for those two non profit organizations. The first one is Monarch Montessori School, a traditional children's house Montessori that's really rooted in the literature that supports best pedagogies for optimal child development, as well as Kaleidoscope Learning. That's my second non profit, which is a family community and resource center, just a one stop shop for families to be able to get all the best practices associated with raising their children ages birth to six years old. I frequently work with the population that is going to be Momease solutions' customer base. So I love working with mothers, women who are pregnant or newly postpartum and are going through the very wonderful, but very precarious kind of transition into motherhood. So that's kind of where my background is. I do not have a medtech background. But I'm somebody who's really passionate about looking at the literature when it's related to child development. So what is the optimal strategy in order to really nurture a person's early development related to cognitive, physical, social, emotional development. I originally got connected with Ashley through Mutual Business Connections and I instantly loved the idea. I saw how it would be used by the women who I currently work with and just really recognized that it was a really special product. So I officially joined the team in 2023. [00:06:05] Lindsey Dinneen: Wow. Nice. Well, congrats. How exciting. Yeah. So I love it. So would you mind telling us a little bit more about Momease and just maybe the origin story. [00:06:19] Ashley Mooneyham: So yeah. So like I said, I had my daughter in April of 2021. I was able to nurse her without issue for eight weeks during my maternity leave and I was so excited about that because the American Academy of Pediatrics, the World Health Organization, they all recommend exclusive breast milk nutrition through six months of age. To Jennie's point to try to promote the health of our next generation with cognitive ability and various health indications that research shows are improved with that breast milk nutrition. And I really wanted that for my daughter if I could achieve it. I was grateful to not have issues nursing, but when I went back to work, I thought kind of naively that I would be able to use the breast pump to continue to feed her breast milk, even though I was remote and away. And unfortunately, that was not the case, which is a super common issue with women. I had to pump three or four sessions to get one bottle for my daughter, so I was really working overtime, trying to do enough breast pump sessions to maintain my breast milk supply. And I was sitting at the breast pump for far too long, usually 20 to 30 minutes a session, increasing the suction power to a level that caused discomfort just in my attempt to provide my daughter with the nutrition I felt that she needed. And I was really frustrated by that because I knew, based on my successful nursing journey, that I did provide enough breast milk for her. I simply wasn't able to collect it. So the issue was with the collection mechanism. And with my background in science, I immediately sought answers. How can I improve this experience, just for me personally, on the onset. And I did find academic studies that showed if you apply a warm compress while using a breast pump, you get more milk in less time. If you use a hand massage technique while using a breast pump, you get more milk in less time. And anecdotally, that was true. If I applied a warm compress, if I put pressure on my breasts while using a suction based breast pump, it worked. And that made sense to me because a nursing infant is doing a lot more than sucking breast milk. They're also using the warmth of their mouths and the pressure of their jaw and hands in a combination to efficiently nurse. So adding these elements back in made perfect sense. The issue is it's not convenient. Using a breast pump is already not convenient and having all of these extra tasks while using a breast pump certainly wasn't convenient. So I literally went to Google and looked for a product that could warm and massage the breasts while I was using a breast pump in order to maintain these improved results. And I didn't find one. And I was really shocked by that. I was like, "How could this not exist when there is evidence that it works?" And I'm having personal anecdotal experience that it works. I was so disappointed. And I sat with that disappointment for a couple of months and then realized, "Well, it doesn't exist because people like me just sit disappointed." You kind of have to get up and get going to solve the problems, especially that you see personally. And the whole first year of business before we had a lot of funding in the door, I made sure to broadly collect women's experiences with the breast pump, and I learned really quickly that I was not alone. Our first customer discovery survey received 1, 200 responses in 24 hours, which is incredible and unexpected. I just put it out over my personal Facebook to start and it got picked up and got a lot of responses. And that alone, I think, really speaks to how passionate women are about wanting a solution and how desperate they are for wanting a solution. And every day that keeps Jennie and I going. Every day that we pitch this, every day that we talk about this, more and more women say how much this is needed and how much they're rooting for us. And that, that's our big motivation. [00:10:22] Lindsey Dinneen: Yeah. Wow. That is incredible. Thank you for sharing that story. And even the, I love the personal connection, but then the fact that just within 24 hours, like you said, of your own personal network, you've got this amazing response of all these women saying, "Yes, I am in the same boat or I've experienced this. Please help." I love that. So then Jennie, you're coming into this from your business development, business strategy background. And I'm wondering, how have you been able to to bring Momease along as it continues to grow and opportunities continue to come for it. And then what are you excited about as we go towards the future? [00:11:06] Jennie Lynch: Yeah. So that's a really good question. Momease is pre launch. So, I'm continuously just having conversations with mothers, continue to get that feedback, that customer discovery. Again, being pre launched most of my focus at the moment is long term business development strategies. So just thinking about those things ahead of time, but also just day to day operational things. I'm definitely excited as we move towards launch of the product. I think that I would love to see this product in people's hands. We're currently prototyping. So just seeing women use it, as well as getting their initial feedback is something I'm just very excited about. [00:11:46] Lindsey Dinneen: Amazing. So in this pre launch stage, I know you have a bazillion things going on, I'm sure, and there's lots to think about and a lot of exciting things happening, but what's the next step for you at this point? You have some funding, it sounds like, but now what's coming up, the very next thing? [00:12:08] Ashley Mooneyham: Yeah. So I don't know that we've said explicitly, but just in case anyone isn't aware, we are trying to create a pumping bra with built in warmth and massage. So that's the product that we're seeking to create. And we did receive funding last year from the National Institutes of Health to pursue this, which is really exciting. So the National Institute of Child Health and Human Development awarded us a Phase I grant to do the prototyping that we're currently underway with and achieve our proof of concept ahead of validating it and then launching the product. So right now we're definitely in that proof of concept prototyping phase. We have seen promising early results that we were hoping to see. And now it's a matter of kind of fine tuning the product at this early stage so that when it hits the market it's more than functional, it's convenient to use. We want this to be very clear that it is a product with integrity that was also designed by a mother for mothers, designed by women for women. I think that is something that this market is looking for, and women's products are booming right now. So I feel like this is right place, right time for us to enter and hit that inflection point. [00:13:25] Lindsey Dinneen: Absolutely. Well, congratulations on all of the success so far. I know it's not been an easy road. I'm sure there have been lots of late nights and stressful days, but you're doing it. So that's amazing. And thank you for bringing this to market because it's so needed. And I'm curious, is your goal to be able to provide this directly to consumers? Are you hoping to have an intermediary? What are your thoughts with that? Because I'm sure some people are so excited to go, "When is this going to be real?" [00:13:59] Ashley Mooneyham: That's such a good question. [00:14:00] Jennie Lynch: Yeah, absolutely. So we have two ways we would love to enter the market. The first one is traditional business to consumer channels, so sales directly through our website, maybe at brick and mortar stores, big box stores, boutiques, being listed on online retailer websites. Just the traditional ways you can get a consumer good into your hands. The second channel is more business to business. We would love to sell directly to NICU units. We have heard from NICU units or individuals who work in NICU units that this is something that would be really beneficial, as well as we would love to reach out to breast pump manufacturers who might be interested in bundling our product with their breast pumps to have that kit mothers can buy right away that will have a synergistic effect right from the get go. So those are two go to market strategies. [00:14:56] Lindsey Dinneen: Amazing. Well, that is very exciting. So as you've been going on this journey, and I'm sure you've had amazing days. I'm sure you've had some discouraging days. Are there any moments that stand out to you as really clarifying to you that you are in the right place at the right time doing what you are meant to do? [00:15:18] Ashley Mooneyham: Yeah, absolutely. I think one that I already mentioned was that first customer discovery survey. That's one of the first things I did after formally launching this business. And it's been a through line ever since. It's a touch point that we can constantly go back to that validates why we're doing what we're doing and that it's worth pursuing. And then shortly after that, I did start participating in pitch competitions where I was able to present this idea more widely. And the first competition that we ever entered was the HyVee Opportunity Summit, which was hosted at US Bank Stadium. And we were selected as, I think, a top nine finalist to pitch from over 900 applicants. And during that pitch contest, we took home grand prize. So out of the top nine, we got the number one prize slot. And I distinctly remember getting down from that stage so shocked that we were able to secure the grand prize our first pitch competition, but feeling so proud that what we're trying to do resonated and literally women came up to us with tears in their eyes. And I, it just, it was so buoying. It really felt like, "Oh, this is something that matters. It's something that is beyond a solution for just myself." But 97 percent of our survey responders said that they were dissatisfied with the breast pump. And that's such an incredible dissatisfaction rate for such an essential piece of technology. So those were two big wins for us early on. And then later last year when we were able to receive validation also from this huge federal scientific body that what we're doing is beyond like a feel good mission. It has scientific merit. It has significant potential to impact not only women's health, but human health by nourishing that next generation. That was a big win as well. And we're so excited for all of that collective experience to be really able to dig in this year to the research and development and start to make this idea a reality. [00:17:25] Lindsey Dinneen: Yeah, absolutely. And Jennie? [00:17:30] Jennie Lynch: Yeah, kind of echoing Ashley, she hit some of our big milestones in 2023. This year, I've had a couple friends and family members who've had little ones, and it's just been really interesting seeing a lot of my friends and how they're coming into motherhood. And how this product is something that they're probably not going to be using it for this child, but maybe in the future. And they're just really excited for us to be able to launch our product and for them to use it in the future. So that's something, just that verbal reassurance from our community is something that I think is what keeps us going. [00:18:08] Lindsey Dinneen: Yeah, of course, that makes so much sense, and I'm so glad you have that, so much social proof, the stories of the people who are coming up to you, and then you've also, like you said, have this tangible grant that really did help say, "Yeah, this is very important, this is very needed," and I'm sure those things really help on the difficult days, so I'm so glad you have all of that. But speaking of difficult days, I am wondering, in this journey, I'm sure there have been lots of ups and downs. What are some of the things that you have maybe been surprised about as you have gone about this new journey? And I know, Jennie, there's a lot of entrepreneurial endeavors in your background, but just in general, when you're getting into a new thing, there's always unexpected things that pop up. So just curious as anything come up for you yet? [00:19:02] Jennie Lynch: Something that I have found unexpected and slightly challenging at times, something that Ashley and I constantly are thinking about is, how we're kind of in this in between space where we're kind of known as a consumer good, yet we are a medical device, and it's been really hard to communicate some of the challenges related to being in that in between space with a lot of either investors or cheerleaders or people who are just interested in our product. We're more complicated than that average consumer good, yet we're not going to be put into the body. We're not as technical as maybe other medical devices that are on the market. So we really are in this in between space and there aren't too many players who are as well, at least that we've come across in our own journey. So that is a weird thing that we've run into is how do we effectively communicate where we are on the market and the importance of the product. [00:19:57] Lindsey Dinneen: Yeah. Yeah, absolutely. And Ashley? [00:20:01] Ashley Mooneyham: Yeah. Jennie hit the nail on the head that continues to be a thorn in our side, but we are getting better and better at navigating this middle ground and explaining that's actually our secret sauce in a lot of ways, that we're not a simple consumer good, and we're not a complicated medical device. We exist in this elegant in between to hopefully be that solution. And then I think just what a lot of founders can relate to, the only other major challenge is fundraising for the effort and being really careful with the funds that we have raised to make sure that we can go as far as possible and really time the spends strategically. So that's been something that we're constantly evaluating, making sure that we're using our funds responsibly and constantly have our eye on future fundraise efforts to make sure that there's no major gap in funding that could hinder our progress. And I will just say having a co founder like Jennie through this experience has made every challenge much more bearable. So, I'm so glad that we get to go through it together. The hard days are much easier having a co founder like Jennie by my side and the good days are even more fun to celebrate. [00:21:11] Lindsey Dinneen: Oh, I love that. So you both are absolute powerhouse women. I got to take a look at your LinkedIn profiles and I was just really admiring everything that you have done in your past, your education, your expertise, and then your commitment to community and the fact that you're still actively volunteering and you're doing all of these things. And it really struck me as not only incredibly impressive, but also I just have to ask, do you sleep? [00:21:42] Ashley Mooneyham: I mean, I have a two month old at home, so no. But I will say, that gives me extra waking hours in the day, so that's always good. I don't know how Jennie does it. [00:21:55] Jennie Lynch: Man, I think similar to Ashley, I do have a good support network and I think that makes all the difference. I don't think that I could achieve what I have without the friends and family who continue to uplift me. So that's what keeps me going too. [00:22:10] Lindsey Dinneen: Yeah. Yeah. Good reminder about the importance of community, absolutely. That's phenomenal. What is your top piece of advice you have for other women medtech founders specifically, or women medtech leaders. [00:22:27] Ashley Mooneyham: Yeah. I mean, it's something I constantly think about and learned through this journey is that being a woman founder is a strength. It's not a weakness. You don't need to justify being a woman founder. You don't need to justify pursuing a women's health problem with a women's health solution. I actually think all of that is a strength. And the second I stopped defending myself as a founder and defending my product and instead presented it as the opportunity it is and found like minded, passionate individuals like Jennie to join the journey, the more success we had. So I would just encourage all women founders, women entrepreneurs to remind yourself that you are doing something exceptionally valuable and your perspective is exceptionally valuable. And it's not something that you need to make excuses for or feel like you need to be on the back foot about. [00:23:24] Lindsey Dinneen: Yeah. Yeah. Jennie, do you have anything to add to that as well? [00:23:29] Jennie Lynch: Wow. Yeah, absolutely. The main takeaway that I have since starting entrepreneurship is create a community with people around you who will continue to support you. And mostly what I mean by that is Ashley and I have already established a community, both in Minnesota and nationally, that incorporates women health founders, and the amount of just brainstorming and good ideas that we get bouncing ideas off of one another is really wonderful. And it's great being able to connect with women who are in a similar position. [00:24:06] Lindsey Dinneen: Yeah, that's great advice. Thank you both. Yeah, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be about what you're currently doing, but it doesn't have to be. What would you choose to teach and why? [00:24:27] Ashley Mooneyham: Well, I can give an industry specific answer right away if Jennie wants a couple more minutes to think. This might be the more boring answer, but Jennie leads an exciting life, so she can back end this with something more fun. But like I said, my expertise originally was in helping companies secure that non dilutive grant funding. Honestly, I want to spread that message more to small businesses, because I hear over and over again how much funding ends up being a barrier to small businesses, especially in the earliest stages of ideation and de risking whatever it is that they think matters and should be introduced to the market space. And that ends up stopping so many great ideas from getting a chance even to move forward in the market. So I am constantly working on this now without a million dollars, but if I had a million dollars I'd love to just be able to spread that message more, especially to the businesses that have that mission and heart behind them. So right now there's that White House initiative, as well as the National Institutes of Health Initiative to fund women's health research. Every female entrepreneur I meet in women's health, you can't get me to stop talking about federal grant funding and pursuing grant funding to really maintain ownership over your idea, ownership over that direction, which is going to be important for any founder, but particularly those that are trying to represent disadvantaged populations or underrepresented populations. You get to maintain your ownership and you get to de risk your idea so that you can move it forward. That's just where my mind goes to right away. [00:26:09] Lindsey Dinneen: Yeah, excellent. Very needed too, so. [00:26:13] Jennie Lynch: I guess if I had to teach a master class, I can come in with something a little bit more fun. So a couple years back, I spent a lot of time traveling. I was doing the digital nomad thing, so maybe a master class on all the ins and outs that come with how to work. And live on the road and you know how to organize your life a little bit to make that a little bit more streamlined. There was some trial and error for a couple years and I have this wealth of knowledge that's all living in my head, but it would be really cool to bring that to life in a master class, I think. [00:26:48] Lindsey Dinneen: Absolutely. Yes, as a digital nomad myself, I fully understand what you're talking about and getting, that learning curve can be a little steep sometimes accidentally you think, "Oh yeah, I'm prepared." [00:27:03] Jennie Lynch: Yeah, exactly. You never know what, what's going to come up when you're traveling around. [00:27:09] Lindsey Dinneen: I always say there's never a dull moment. And then, how do you wish to be remembered after you leave this world? [00:27:17] Ashley Mooneyham: Jennie, your turn to go first. [00:27:20] Jennie Lynch: Sure, I can go first. Yeah, well, I guess if there was something that I would love for, I would love to be known as a very loving person, a kind friend, somebody who's always positive, and gives everybody the benefit of the doubt. I guess a distinct characteristic that I would love to be remembered for is maybe what my partner calls "activator energy." I really love just immediately tackling a project, bringing something from zero to one. So if I had one characteristic, it would be that kind of activator energy characteristic. [00:27:56] Lindsey Dinneen: I love that. [00:27:58] Ashley Mooneyham: I do too. And that's a perfect answer. Yeah, I agree with Jennie. What matters most are those interpersonal relationships and connections that you have in close community with. Those are the things that matter most to me. It's way more important to be a good wife, good mother, good friend, good daughter in the time that we have. But also obviously, I'm hoping with Momease to leave a legacy that does make an impact in women's health one way or another. And I try to keep that in perspective with our business goals always that any win that we have is a win for women's health. Anything that we achieve is validation that funding women's health is worth it and that this field is worth pursuing. And I hope that it continues to improve after our journey ends with Momease, wherever that ending point is. And I hope that's a way that we can leave our thumbprint outside of our families with something a bit greater. [00:28:58] Lindsey Dinneen: Yeah. Yeah. Those are beautiful answers. Yeah, and then my final question. What is one thing that makes you smile every time you see or think about it? [00:29:11] Ashley Mooneyham: Well, my answer is easy. I have children, so that's obviously a joy in my life. And another thing that keeps me going every day, I want my kids to know that if they have an idea that you should bet on yourself and pursue it. And I hope that I can model that for them, even in an uncertain, scary landscape like entrepreneurship. So yeah, grateful for my kids. I have a daughter and a son. [00:29:38] Jennie Lynch: For me, it's just a nice cup of coffee, but immediate smile. [00:29:44] Lindsey Dinneen: I can relate to that, especially in the morning first thing when you're just like trying to get recombobulated and here we go. [00:29:52] Jennie Lynch: Absolutely. [00:29:53] Ashley Mooneyham: Yeah, that first cup isn't even a smile. It's just necessity. And then if I get an afternoon cup, that's where then the joy comes in. [00:30:01] Jennie Lynch: Yes. [00:30:02] Lindsey Dinneen: That's fantastic. That's amazing. Well, thank you both so very much for spending some time with me today and sharing your stories and your advice, and I am so excited to see Momease continue to succeed, and I love what you're doing, and this is so needed, and you have this wide open space for it, and that's insane, but I'm so thankful that you guys are taking the time and the effort and the funds and everything to make it come to life because it is so needed. So, gosh, just thank you for what you're doing. [00:30:36] Ashley Mooneyham: Thank you for being a platform. [00:30:39] Lindsey Dinneen: Of course, and we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success. [00:31:11] Ashley Mooneyham: Thank you. [00:31:12] Jennie Lynch: Thank you. [00:31:13] Lindsey Dinneen: Absolutely. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, continue to spread the word about these amazing innovations, and we will catch you next time. [00:31:31] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Shoreh Ershadi is the founder of ANITAGING Institute of California and a renowned expert in clinical biochemistry and pharmacology with over 40 years of experience. Dr. Ershadi shares her compelling journey from Iran to the United States, highlighting her unexpected entry into medical technology and the numerous challenges she faced as a woman in science. From setting up clinical labs and pioneering AIDS testing to founding her own antiaging company, Dr. Ershadi discusses her relentless pursuit of scientific innovation and passion for improving human health. The conversation also touches on her entrepreneurial ventures, the role of art in her life, and her vision for a healthier future driven by natural apoptosis-promoting supplements. Guest links: www.Apoptosis.us | www.facebook.com/apoptosisnutraceuticals | www.instagram.com/apoptosisnutraceuticals | www.threads.com/apoptosisnutraceuticals  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 037 - Dr. Shoreh Ershadi [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm so excited to introduce you to my guest, Dr. Shoreh Ershadi. With over 40 years of expertise in clinical biochemistry and pharmacology, Dr. Ershadi stands at the forefront of scientific innovation in the field of nutraceuticals and supplements. Board certified by the American Academy of Antiaging Medicine and holding dual doctorate degrees, Dr. Ershadi brings a wealth of knowledge and experience to the world. Dr. Ershadi's distinguished credentials, including National Registry in Clinical Chemistry and Toxicology and American Society of Clinical Pathology certifications, underscore her dedication to precision and quality in laboratory practices. Her visionary leadership and unwavering passion for advancing human health has made her a trusted authority in the field. All right. Well, Shoreh, thank you so much for being here today. I'm so excited to speak with you. [00:01:51] Dr. Shoreh Ershadi: Thank you for having me. I'm very excited to talk to you, especially that you're going to talk about medical technology. And that is something that I have been doing or working at for, I would say over 30 years, easy. 1988, I got my license in California. So it's what, 32 years? [00:02:17] Lindsey Dinneen: Yeah. Excellent. Oh my goodness. Well, this leads perfectly into my first question and that is, can you tell us a little bit about yourself and your background and how you got into medtech? [00:02:29] Dr. Shoreh Ershadi: Okay. That is interesting because I was born in Iran and I studied pharmacology. And before I was graduated, the Department of Health in Iran was hiring pharmacists, pharmacologists. So we all went and took the exam and we passed the exam. We were still at the final stages of doing the thesis and going through final stages of graduation. And then they called me and a few other people for an interview. Apparently I had a high mark in the test, which I did not know. So when we went for the interview, and I went to an American school and then later to a British school in Iran, so I was speaking English. At the interview, there was a gentleman who was back in Iran from United States, and he was a PhD in clinical biochemistry, and he asked me to read something in English. And I read it, and he thought that I had it by heart or something, so he flipped the book and found a more difficult page and said, "Okay, read this," and I read that, and he said, "Okay, I'm hiring you for the reference lab." I had absolutely no clue what he was talking about, what was reference lab. I had no intention to even work for Department of Health because I was not even graduated at that time. And then they said, "Okay, start on such and such date." And when I went there the first day, he said he spoke in English and he said, "You're overqualified." Oh my God. What? I mean, it was funny. Without even planning to get into laboratory, I got into the reference lab of Department of Health. And what he was planning to do was to bring College of American Pathologists, the proficiency testing to all the laboratories in Iran. And he wanted someone who would speak English and who could communicate. So first day of my job, I wrote a letter to College of American Pathologists and I said, "Hi, hello, I'm Shoreh Ershadi, I want to buy a thousand proficiency kits." And of course they responded. So just like that, I got into clinical laboratory. And I became the Director of the Quality Control for Department of Health. And that was before the revolution. So, that was my exciting start into laboratory. [00:05:25] Lindsey Dinneen: Yeah, that's an incredible story. Thank you for sharing that. And [00:05:28] Dr. Shoreh Ershadi: Not voluntarily, but serendipitously, yes. [00:05:34] Lindsey Dinneen: There you go. So then at some point, you came to the U. S. and was that transition really difficult? Was it frustrating? Were you excited? Nervous? [00:05:47] Dr. Shoreh Ershadi: There was a part in between before coming to U. S. There was another test by W. H. O., World Health Organization. So I took that test and I passed that test and I got a scholarship to go to medical school in England to do a master's degree. And when I went there, I told them, "I already have a doctorate in pharmacology. I don't want master's. I want to do PhD." And after a few weeks, they said, "Okay, fine, go to PhD. You don't need to do master." So I was in England for about four years. I did my PhD in clinical biochemistry. And I went back to Iran. That was exactly during the revolution. So while I was studying in England, the country in Iran was on fire. It was, things going crazy everywhere. But I went back and I got married. I had my son in Iran, and I was working in a clinical laboratory in one of the best hospitals in Iran, and it got very difficult for women to work. They were saying, " Now you have to wear a scarf. Now, you can't see male patients, you can only talk to female patients." It was not right. So, 1984, I came to United States, I came to California, and with some friends in Iran who had a clinical laboratory, and they were here before me and had started a lab in Orange County, California. I started a branch of the lab in Westwood, in Los Angeles. So that was my first job or position and that was my entrepreneurial side, which now I wouldn't dare to start a life, but then I did. [00:07:51] Lindsey Dinneen: You didn't know the difference then. [00:07:53] Dr. Shoreh Ershadi: Well, yes, I didn't know. I mean, it was a lot easier, I would say. At that point. The lab was not even accepting Medicare or Medi Cal. It was private insurance. I was doing the billing. I was getting the information. I was drawing the patients. I was separating the samples and sending them to the reference lab that was actually running the tests. But I was doing stat CBCs and I was in a medical building and so all the doctors were so nice to send the samples down to me. It worked. So [00:08:33] Lindsey Dinneen: Amazing. Oh my. [00:08:34] Dr. Shoreh Ershadi: Amazing. Yes. Now it sounds really amazing. It's surreal in a way. Yeah. [00:08:42] Lindsey Dinneen: Yeah. Yeah. Well, so, so with that lab and embracing this entrepreneurial journey, and I'm so thankful it worked out so well for you, but were there any moments where you just thought, okay, I've, I, you have such an amazing background. You're so highly educated, you're brilliant. And then you're starting this entrepreneurial journey, which is kind of a different skill set in a way. How was that transition of becoming kind of your own boss and being in charge of everything? [00:09:12] Dr. Shoreh Ershadi: That was pure ignorance. I mean, now I can say then, I thought I knew what I was doing, but it was a fast learning. First that I was in a different country, that I had never been in the United States. Second, that I had a three year old son that I brought with me and my then husband never came, so I got a divorce and I became a single mom. So, and nobody else was from my family was here. So it was very difficult because I had to take him to daycare and then come work and then go pick him up. And then there was a war, the Iraq war had started in Iran and my parents were in Iran and I was going through a divorce, so it was turmoil. And I had to work and learn in a way it was good because it didn't give me time to think about anything else. It was just forward, no looking sideways, no looking backwards. It was just moving forward. But then again, something else happened that made it even more interesting. One of the days that I was at the lab, some guy came and said, "CDL, Central Diagnostic Lab, is looking for a technical director and they've asked me to come and talk to you." I had absolutely no clue if anyone knew me or knew of me or it was the, I mean, a lot of things happened, which, I mean, I'm happy now, but then it changed my life tremendously. And I don't think I've ever talked to anyone about this in this detail. So, Lindsey, I would say you're the first person I'm telling the story of my life. But anyways, I went for an interview and I got hired right away. I had the lab, so I hired someone to do the work that I was doing in the lab. And then I started working at CDL, Central Diagnostic Labs, which was the largest privately owned lab in the United States at that time. There were 1, 200 employees. So that was a very interesting experience on its own because I was introduced to a world that I did not even know what was going on. So, and that was during AIDS testing. Bio-Rad had just come up with Western blot testing and we did the clinical trial, which was very easy in those days. We had AIDS patients and we had a lot of AIDS samples accumulated or saved frozen and we used them to validate the Western blot by Bio-Rad and I went on National TV 1988 and I said, "CDL is the first lab in the world that is doing a confirmation for HIV AIDS testing." So then, that was major. [00:12:40] Lindsey Dinneen: Yes. [00:12:43] Dr. Shoreh Ershadi: But then, then my family came. My father passed away here. It was, again, a lot of complications going on. And one of the other people that I knew asked me to go and partner with them in a lab. Again, my entrepreneurial part took over and I went for the partnership, and I started from scratch. I started Path Labs practically from scratch. There were two pathologists working with Los Alamitos Hospital, and I went there and I started a lab from just buying test tubes, buying, from absolutely nothing. I was there for six years, I think. six or eight years with Path Labs. That was not so successful. After that, I went to Specialty Labs, which is now Quest. Specialty wanted to start a toxicology lab. So, Path Lab was sold. But there was no money made with the partnership and all that. So that was not a very successful six, eight years of my life. Specialty was good. I went to Specialty and I started Department of Toxicology. I don't know if you remember or you were familiar with specialty. Dr. Peters was there and he was the founder, James Peters. He did only immunology testing. They would receive samples and send out everything else to other labs and only do the immunological tests or some specialty tests. When I started the toxicology department, we started getting samples from all over the world. We were running heavy metals and all that. We had an ICP MS and I started running ICP, and the main test that I developed there was measuring iron in the liver biopsy of patients with hemochromatosis. So we would get one spot, in tip of the needle of the liver and then do a measurement and measure the amount of toxicity with iron in hemochromatosis, which was great. I wrote a paper and we were working with Mayo Clinic and they developed the test. So that was very exciting. Then I started the automated lab because all the chemistry. And all the hematology was going out, was sent out. So that brought a lot of money into the lab, but that was not my lab. It was Dr. Peter's lab. It was wonderful. It was nice. But he was the entrepreneur there. So in the year 2000, I started ANTIAGING Institute of California. After passing the specialist chemist license in California, I got National Registry in Certified Chemistry, Certified Toxicology, and then I took the board exam with American Academy of Antiaging Medicine. And that was again entrepreneurial and I started the company, that would be 25 years ago. I've done a lot of consultation. I've been director of lab during COVID. I went back to city health. And I was Director of City Health running 4, 000 COVID patients a night for airports, for schools, for traveling, for a lot of stuff. And then I worked with Siemens Healthineers on regulations for IVDR. So all the kits that Siemens had, over 700 reagent kits that were sold to the laboratories, they need to get the CE mark to be able to be sold in Europe under the new IVDR regulations. And a lot of it had to go through FDA as well because FDA had to approve if there were any changes made to the kits. So I've done a lot of regulation works. I've done a lot of hands on COVID tests, covered it all. Actually, something else that was very interesting. And this, for MedTechs, I would think this would be interesting to know that it's not just one position. And there's so much you can do, if you want to expand your horizon. For about a year, I helped set up extremely high complex laboratory for testing mother's milk, for making milk bank from mother's milk for NICU for children who were born early and the formulas did not work with them. Some of them were so tiny, less than a pound. And so mother's milk bank, it's called Prolacta Bioscience, the company. And I worked there to establish the clinical lab and to get a license for clear and stuff like that. So. [00:18:21] Lindsey Dinneen: Oh! [00:18:21] Dr. Shoreh Ershadi: A lot of good work going into my up and down career, I would say. [00:18:28] Lindsey Dinneen: I love it. Well, first of all, I'm so honored that you were willing to share so much with me. That is. I really appreciate it. And I really appreciate you being willing to talk about some of the amazing moments you've had and the really high, " Yay, we did this," but also some of the moments where it was a little bit tougher and even you being honest and transparent about, the one company didn't do as well as you would have hoped, but you kept going and you are a living testament to resilience and adaptation. [00:18:59] Dr. Shoreh Ershadi: There is no other choice. I would hope that people would have many choices. I mean, you always make choices in life. Even now, this is a choice to talk to you and I appreciate the opportunity because, if I would choose or if I wouldn't know about you, that would be a totally different episode in my life. So I'm open to take chances. You can say that with my experience, living in three different continents and moving and just leaving Iran and coming to us with a three year old, not being here ever before. And then, just jumping in and, but there was no other choice except for moving forward, or we can say, except for success. Because failure was not an option. What would I do? There was nowhere to go back. Sometimes you may have an option to make a U turn and say, "Okay, I don't like this. I want to do something else. I want to stay home." There was no option, no going back. So it was only forward. [00:20:09] Lindsey Dinneen: Yes, absolutely. So, coming here and like you said, having to move forward and I appreciated what you said, you kind of, you couldn't look to the side, you couldn't look back. You had to keep moving forward. How did you go about building a community that could support you, that you could be friends with, and colleagues with, and feel supported coming in from, not having that. [00:20:36] Dr. Shoreh Ershadi: And that was not very difficult. There were many difficult times during that, that I mean, I don't mind talking about it, being a woman, being a young woman, being from a different background there was a lot of resistance. And I see that today as well. I mean, I can't say, "Oh, here I'm in L. A. and Los Angeles is so easy." It's not. I am hoping that women would not maybe experience all the difficulties that I went through. But we're talking about 40 years ago. I came to The States actually July 22nd would be exactly 40 years. I left Iran July 1st, 1984. So this is the 40th anniversary. Being a woman, I thought, when I went to England one of the first things, the professor was my direct supervisor when I worked with him. And I know you can see my face. This is 40 years later. I have no claims, but the professor told me, "You're a beautiful woman. Why do you want to study? Why are you here for PhD?" And I thought that was the greatest insult in my life. So I fought with that professor for four years. [00:22:15] Lindsey Dinneen: No, I'm sorry. [00:22:17] Dr. Shoreh Ershadi: That wasn't easy, but it was so difficult to prove that I am not just a woman or a pretty girl or a young girl or a young woman, or. That was a major fight. I would say that was as difficult as fighting the revolution in Iran, because you wouldn't expect a British professor to say that to you. And I was the only girl, a PhD student, all the others were guys, and this was medical school. And to me, that was very surprising because when I went to University of Tehran, we had probably more girls than guys in the class. Girls were very prone to education in Iran, and they still are. There's still, I think, 60, 65 percent girls in universities, even here. But to hear that was very difficult. That experience repeated itself. in United States over and over till today that I can say I don't feel old. I'm antiaging, but now that I'm an old woman, I still feel that I have to prove myself that I am equal. And sometimes I would say I'm better, but, just to be honest and modest, you want to be treated equal. And that is very difficult. [00:23:53] Lindsey Dinneen: Yeah. Yeah, you're absolutely right. And As much as I would wish things were improving rapidly, I'm not so sure that they are, but what have you found has been helpful in terms of, helping people understand who might come with a bias, but who, helping those people understand, "No I have this education. I am very capable." What are some strategies that you have found that have worked really well for you? [00:24:22] Dr. Shoreh Ershadi: Not many. I have to be honest with you. I mean, if there are a few people, few women, a few even men who are, would be following the conversation, I want them to know that this is not easy. And maybe a part of my success is that I'm a fighter. And I didn't surrender, but I didn't smile my way up. I fought with everyone that went in that direction. And I don't want to get into details, but many of the stronger men would think that if they flirt with you, if they take you out, if they buy dinner for you, then you're going to do what they say. And my story is, just, I have my guards up and I fought. I wouldn't recommend people to fight. Maybe they can find a better solution. I did not find many. Maybe the reason of working separate and starting my own company, maybe one of the major reasons was that I would not have to say yes to power that I did not want to say yes. I worked very hard. I worked hard, long hours. Medtechs, you have to stay there to get the results out. One Christmas. I stayed from December 24th for I would say 72 hours in the lab, maybe two, three hours shower and sleep and go back because we had a lot of toxicology tests that were waiting and results had to go out. And the probe in the I-C-P-M-S was broken. There was no one to replace it during Christmas. It was, we had to borrow from somewhere, FedEx shipping it. Those things happen, you know that, and you have to work hard. It wasn't an easy journey to say, "Oh, I worked four hours a day." And they said, "Thank you. You're so good. Go home." It wasn't like that. [00:26:44] Lindsey Dinneen: Right. Right. Yeah. Well, thank you. I appreciate you sharing that. And so one thing that was really interesting to me, I was looking at your LinkedIn profile and I see that art is a big part of your life in addition to the science and I saw you listed painting and sculpting and I'm wondering how-- well a couple of things-- how did you first get involved in art? And secondly, do you feel that is helpful in terms of having a sort of therapeutic thing to do that kind of maybe helps with some of those harder moments where it's a little frustrating? [00:27:23] Dr. Shoreh Ershadi: Very helpful. But I was as a kid, I started painting at a very young age. And I was always coloring and painting and making things and all that. And my father, a very educated father, he had two master's degree from a University of Texas and came back to Iran. And that's why, we spoke English and we went to English school. So my father was educated and open minded, I can say. But he always said that "You should study art. And don't go to medicine, you'll get old." He passed away in 1988, and I always, when I started Antiaging, I always said "Okay, if you're looking, you will see that I'm antiaging, I didn't age, I went to medical school, I did all the studies." But my logic, first that I love to do this, I mean, it wasn't just you know, forcing myself. I love science. And to this day I do a lot of research. I play with science. You can see the labels are all fancy. I do the paintings. I do all of that. But my logic, more than being scientific, was that this was a career and art would not be a self supporting career, even at younger age. But I always said that if I was a doctor, I could paint, but if I was an artist, I could not do the scientific part or the medical part that I was interested in. But after the divorce, I was in a relationship for 14 years. And I was working hard, raising a son, being a single mother and all that. When that relationship ended after 14 years, the art just popped out. I started painting, sculpting. It was not under control. You can see that, things happen to me, things come out in a certain period. Maybe, I push them down, force them to stay within me, and then they just pop out in different directions. So art came out itself. But there was a period in between that there was no art. Maybe there was too much stress. Maybe there was a lot of, and right now there's no art. Right now it's more entrepreneurial, starting, scientific, all that. But the art pops out every now and then. [00:30:07] Lindsey Dinneen: That's great. Yeah. So speaking of, what you're doing now, I was wondering if you could share a little bit about your company and maybe what you're excited about for its future as you continue along this path. [00:30:19] Dr. Shoreh Ershadi: Okay. That is, this is now where all the passion is. So everything that I have forced inside for all my life is now just coming out into Apoptosis. Apoptosis is a Greek word and it means "falling of the leaves." In science apoptosis, if you Google it, you'll see it means "programmed cell death." So in our bodies in creation or creator or whichever you wanna put it, and I'm sure being a medtech and all the audience, they know there are thousands of reactions inside the body are happening for me just to sit here and breathe and talk. There are thousands and thousands of enzymes and catalysts and metals and oh, whatever is going on. Programmed cell death or apoptosis is a main part of survival. So it's the future of antiaging because we all-- first of all that life expectancy is much longer now. Longevity is longer and younger people do not want to get old. So, at some point I would say my grandmother's generation and my mother is now 95 years old and she's, thank God, healthy and walking and all that, but even she does not want to get old. So, the image of being old and sick is combined together. But we can age without being sick, without getting Alzheimer's, without losing our memory, without getting all these different kinds of diseases. And one major problem is cancer that was much higher with older people and now the statistic is showing that cancer is happening in younger and younger generations. So what apoptosis does is that it's a program in the body. I did not make it. I wish I did, but it's happening all the time. And apoptosis is getting rid of cancer cells, getting rid of damaged cells, getting rid of neurons that cannot connect and synapses with other neurons to take the message over. So if we encourage apoptosis, then all the damaged cells are removed just like falling leaves. They're removed from the body and they're replaced with new energized healthy new cells. Every 10 years, our entire body is regenerated. So why do we get old? We should always stay at a 10 year age. So at 20 years old, we have recycled cells that even though we're growing, growth and youth is defined as between 20 to 25. From 25 to 30, it's sort of stable. There's a plateau. After 30, we start the aging process. So now, as 30 to 60, is still considered not so deep slip going down. It's sort of a plateau up to 60. And then after 60, 70, 80, 90, people are beginning to age. And it shows, I mean, with different diseases, with wrinkles, with memory loss, with all that. So what I'm doing, I'm using nature's product, plant based products, and this has been proven in science that these plants support apoptosis. So, as we get older, just like all the other reactions, apoptosis does not happen at its ultimate way that it should happen. But if we encourage it, for example, we have here, this one is brain beet. This is all beet roots, and it's an organic product. It's all plant based, but it releases nitric oxide. And it works the same way that Viagra works, but it opens all the arteries, it opens the circulation to the brain, to the heart, so why not use it? Why not promote apoptosis the way nature has programmed it in our body, just help it to work better. So that is all my passion right now. [00:35:28] Lindsey Dinneen: Excellent. Excellent. Well, I love that. Thank you for sharing a little bit about it. I'm excited for our listeners to go and learn more about it and, see how they can maybe also take part in the antiaging movement. [00:35:41] Dr. Shoreh Ershadi: Yes, they can partner with us and I would be thrilled. Actually, this is something that maybe I have learned during the long life experience, is that the more partners you have, the more friends you have, the more you share your knowledge, the better it is. Because at some point, it was like people wanted to keep everything to themselves and they didn't want to share or, but right now it's totally different. If they go to Apoptosis.us, they can go to the science section, they can read the papers. And if they would like to partner, I'll be thrilled to work with as many people as possible and take the message out. Yeah, this is a healthy message. This is something that we should all be talking about. [00:36:36] Lindsey Dinneen: Indeed, we should. Yes. Thank you. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach? [00:36:56] Dr. Shoreh Ershadi: Well, the million dollar would be great. [00:36:59] Lindsey Dinneen: Indeed. [00:37:00] Dr. Shoreh Ershadi: Yes. Yeah. Would we all want that. But yes, I think that right now, as I said, I would use the million dollars to talk about apoptosis all over because I see even young children, every time I see St. Jude's children, and thank you for your donation to Save the Children. I admire that. And I'm hoping that all the children in the world would have a good, healthy future. The world is crazy. You can look at it right now and see that, I can say my experience has been crazy. It doesn't get any better. It's always up and down. Things are happening all over everywhere in the world. And I would like to talk about health, talk about antiaging, talk about Apoptosis and educate more and more of the young people to learn and to avoid all the toxins that we are creating and we have created, with what we're doing with industry and go back to a plant based life, go back to nature, enjoy nature, go back to art, if possible, all the good things that we can do with our lives. [00:38:21] Lindsey Dinneen: Yes, absolutely. And then, how do you wish to be remembered after you leave this world? [00:38:29] Dr. Shoreh Ershadi: Oh, wow. That's a very difficult... a fighter? Survivor? Yep. Strong women? I would support women all the way. Now in Iran, they're saying, Woman Life Freedom. I'm sure you've heard about that. And I cannot tolerate, to see women covered all over with a window to see outside. To me, that is very disturbing. So I would like to see equal opportunity for women and I would like to maybe be remembered as a survivor. [00:39:14] Lindsey Dinneen: Yes, absolutely. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:39:24] Dr. Shoreh Ershadi: Oh, my granddaughter and my grandson. Yes, I have a five year old granddaughter. Her name is Julia and she is my sunshine. She is my life. The grandson is three months old. He's still too young, but he's getting there. [00:39:45] Lindsey Dinneen: Aw! [00:39:48] Dr. Shoreh Ershadi: Getting emotional. [00:39:51] Lindsey Dinneen: I'm so glad. It's that's beautiful. That's wonderful. [00:39:56] Dr. Shoreh Ershadi: Yes, that is continuation of the fight. That is when you see that what you've done is worth the fight, worth the hard work. [00:40:08] Lindsey Dinneen: Absolutely. Absolutely. Yes. Well, this has been amazing. I so appreciate you telling your story and sharing some of it that maybe you haven't done before, and that's I feel very honored. [00:40:23] Dr. Shoreh Ershadi: Yes. [00:40:24] Lindsey Dinneen: Thank you. Thank you for trusting me. [00:40:28] Dr. Shoreh Ershadi: Well, thank you for bringing all of this out. This has been sitting there suffocating, maybe. [00:40:36] Lindsey Dinneen: Yeah. [00:40:37] Dr. Shoreh Ershadi: Thank you. [00:40:38] Lindsey Dinneen: Absolutely. And we are so honored, you mentioned this, but to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world. [00:41:06] Dr. Shoreh Ershadi: Thank you so much, and thank you for having me, and thank you for making me tell the story. Thank you, Lindsey. [00:41:15] Lindsey Dinneen: Of course. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we'll catch you next time. [00:41:29] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Tom Salemi, editorial director of DeviceTalks shares his accidental yet fulfilling journey into the medtech industry. Tom reveals his passion for storytelling, building communities, and highlighting the human aspect of medical device innovation. He discusses the evolution of DeviceTalks, its focus on collaboration and education, and the importance of personal connections within the industry.    Guest links: devicetalks.com Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 036 - Tom Salemi Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey and I am so excited to be speaking with my guests today. Tom Salemi. Tom is the editorial director of DeviceTalks. He tells medtech stories with wonder, humor, and great respect. He hosts podcasts, conducts video interviews and organizes events, both virtual and in-person to ensure our innovative medtech ecosystem stays strong and saves lives. All right. Well, thank you so much for being here, Tom. I'm so excited to talk with you this morning. Tom Salemi: Oh, it's my pleasure. Thanks for having me. It's great to be on this other side of the podcast interview experience. Lindsey Dinneen: Yeah, absolutely. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself and your background and how you wandered into medtech. Tom Salemi: Sure. I'm a Massachusetts native, lived here my whole life. Always was aware of the healthcare industry, but I can't say I had a long time love for it or anything like that. My parents were not doctors. I am not an engineer, nor ever could be, but I did go to journalism school. And I wasn't quite sure why, it just always appealed to me. I went to visit a newspaper once, the Boston Herald, and I fell in love with the newsroom. It just seemed like the most fun place to be in the world. So I wanted to work there for a living, but later on, I think I found out it was more, I really enjoy building communities and that's gonna, I think, develop later on. I found my way into medtech quite accidentally. I was at a local paper in Massachusetts and wanted to get a job at the Boston Business Journal 'cause I was tired of covering city council meetings and planning board meetings about the height of fences and things like that. And the only beat that was open was healthcare. And at the time, this was '97, that included all the Boston hospitals, the biotechs, and the medical device companies. So it was a lot, but it was intriguing. And, I'll say my parents at the time were older and starting to see doctors more and more. So I was like, "Well, it wouldn't be the worst thing in the world to understand that industry a bit better." So I took the job at the Business Journal and then that led to an invitation to edit a venture capital newsletter that focused again, broadly on healthcare. So, that was in '98, it's called Venture Capital and Healthcare. Very very descriptive name. And from there, I just really grew to love medtech. I mean, biotech, is of course bigger and fascinating in its own right, but I never quite understood the whole molecule thing, whereas devices, you could see what this thing did and what it looked like. And how the pump worked and why I moved the blood this way or that way. It was just I think an easier and a better story for me to tell. So that's how I wandered my way into healthcare and into medical devices. Lindsey Dinneen: Wonderful. Thank you for sharing. Well, and now with DeviceTalks, can you tell us a little bit about DeviceTalks, and maybe a little bit about what you're excited about for it for the future? Because I know there's just so much in the works and it just keeps growing and it's so exciting to watch. Tom Salemi: Yeah, no, it's been an interesting development. So I joined actually DeviceTalks in 2019. It existed prior to me. It's been around for 10 years or so. It was a sort of the events business related to the Mass Device news site. So, prior to that, I was writing for magazines, wrote for InVivo and Startup. And then decided in 2014, I was I was done with writing. I just wanted to do something different. And at the same time, the company that acquired our magazine decided they wanna lay off the editorial staff. So it was it was quite a good bit of timing for me 'cause I don't think I ever would've got off the branch without a little boot in the butt. So I started doing conferences for a smaller company, medical device conferences, and podcasts. And then the opportunity to join DeviceTalks again happened in 2019 to, to run their three meetings. Of course, 2020 came around. I joined November, 2019, four months later the world shut down and we didn't have our events. So, we pivoted and launched our podcasts and our webinars and went back to events in 2022. DeviceTalks' mission has been really focused on the people who make medical devices, who design them, who manufacture them, who get them through the regulatory process. Anyone who touches a medical device from inception to handling it to a physician to have it implanted in a patient. We try to track that whole process. We do a bit of sort of the venture capital stuff, which was where my interests were lying previously. But DeviceTalks' goal is really again, to focus on the engineers and manufacturing folks, those who were really on the front lines of making medical devices. DeviceTalks has sort of morphed over time from just an events business to our podcast business, which is not only our weekly podcast, but we're working with a lot of the major OEMs to help them tell their stories through podcasts. We're continuing to roll out new series focused on specific OEMs or specific areas. We'll have a neuro one coming out soon. We'll have a structural heart one coming out soon. And we still, the DeviceTalks Tuesdays program that we launched in May 2020, because we couldn't meet the person, we did virtual like everybody else. I thought it would be something that would go away when we went back to in person, but it's only grown. So we'll continue. We continue to do about 35 of those a year. We take a month off in August and then a few days here and there for holidays. But next year we're going to be expanding that to bring some more kind of issues and OEM oriented conversations. So people seem to have responded to the opportunities to talk about medtech all the time and to listen to medtech all the time. So, as the host of a podcast, it's a pretty great time to be producing stories like these. Lindsey Dinneen: Yeah, absolutely. Well, thanks for sharing a little bit about DeviceTalks and its trajectory. It's so exciting to see how it continues to grow and evolve over time. And yeah, it's been interesting to watch how so many companies have changed, obviously because of the pandemic, but then sometimes it's been a really interesting change where, what you thought was going to happen doesn't actually happen the way, but it's exciting. And, you just keep moving with it. So that's great. Tom Salemi: I was listening to the first podcast we did in March 2020,. Chris Newmark and I were talking about, "Well, what does this mean? Like, are we not going to go to meetings? Are we going to have these conversations online? Like digitally? That's crazy. That doesn't make any sense." And we just literally described the world today, but we were both just flabbergasted, "This is nuts. This is just not going to work." So you're right. Things are evolved quickly. Lindsey Dinneen: Yeah. Yeah. And it's great. So, you're coming at the medtech industry from a really unique perspective, and you are telling stories and sharing stories about people's, incredible devices and innovations and the journey from concept to actually producing something. And I'm curious how does that storytelling process work for you? Like how do you go about finding the hidden gems within a founder's story, and then being able to take that and really run with it so that it's not just a matter of, "Hey, this device is incredible. Look at all the shiny, cool, amazing things it does. But here's the purpose and the reason behind that, too." Tom Salemi: That's a good question. I mean, I, like you, start the podcast with the stories about the guests, 'cause I'm really intrigued by their path into medtech. 'Cause I don't think it's, we know the industry itself isn't extraordinarily sexy. It's not on the front page of the Wall Street Journal. We're not talking about, well, these stupid app names that are missing vowels and people seem to get excited about it. We're a very kind of, I don't know, low key industry, but we're the industry, the people who make these devices, are literally saving lives. So I think the guests that we talk to, you know, come to it come to this industry for a purpose. You obviously can build a very successful career for yourself. But I really do enjoy trying to find out what that why is and how it came to be, how it came to lead to a career in medtech. And then I really focused down on, we've all had those moments where we've made life decisions and we could have gone this way or that way. And we chose that way. And it worked out, but what was that? What was the thought process at that fork in the road? And why was that decision made? 'Cause I think really, I think that's something that everyone can connect with. I remember talking with Mike Mahoney, the CEO of Boston Scientific at DeviceTalks Boston last year, talking about his indecision as to whether he was going to take the job at Boston Scientific. He was obviously a senior medtech guy at J& J. Why leave J& J for Boston Scientific, which was struggling at the time? And he just told this great story of how he had hired a consultant to review the situation and to give him a recommendation. The consultant was like, "No way, man, stay at J& J, you're doing great." And he was going to interview at Boston with the intention, I think, of saying no. And then he just took a moment and walked off and just looked in a mirror and said, "Do you want to do this or not?" And he said, "Yeah, I want to do this." And he just went for it and look what happened. So, I think finding those human moments in medtech is important because, more so than tech, in other industries, I think it is a very human industry because, again, people are here for a personal reason. Many people have personal stories as to why they entered medtech. Talk to people who have lost childhood friends, when they were teenagers and that drove them to medtech, obviously the state of our parents, in my case, draws you here. I think very often there's a compassionate thread. I mean, sometimes people just, maybe they go into sales 'cause they see the cars in the parking lot of, and I think there's that and that's fine too, but I think those people also come around to, "Oh wait, this is, I can have my cake and eat it too. I can actually do some good while doing well." So, I do like to focus on the human part of our industry. And I think it's one that needs to be told more because too often it's a conversation focused on FDA approvals or recalls, and we're just talking about the machinery and not the people who make it. Lindsey Dinneen: Yes. Very well said. And I completely agree with you. I think there's, oftentimes a little bit of, because to your point, it's not sort of on the front pages every day. And I will venture to say that sometimes when it is, it's for the reasons we don't want it to be. So, so it's so important to tell these stories. And the thing is, I came in from also from an outside perspective and my background is marketing and business development, business strategy. And so when I came in, it was a whole new world as well. And one thing that I realized is from an outside perspective, sometimes there's this sort of unfair stigma about people are in it solely for the money. And honestly, It's a really hard industry to be in if that's your only goal. So I think, telling these stories about these founders and the why behind it is just so compelling. And I love being able to do that. I'm so glad that you do that all the time as well. Yeah. Tom Salemi: Yeah, no it's just, those are things that need to be reported on and focused on more, so I'm glad we're both shining a light on it. Lindsey Dinneen: Yeah, absolutely. So, okay. So I know that DeviceTalks, it has so many different facets to it. One of the really interesting things that you guys do is put on events. And I was wondering if you could speak a little bit to that process and even just there, there are a number of different industry events available, but DeviceTalks pretty special. So I was wondering if you could talk to a little bit about that element and what makes it unique. Yeah. Tom Salemi: Yeah. No. So when I joined in 2019, I came aboard to help find a direction, a different direction for the meetings to focus it more on the engineering and the device making, which was going to be challenging for me. 'Cause my, again, I really focused more on who raised series A, and who raised series B, and who's a late stage investor, and who's an early stage investor. And for me, for a long time prior, medical device coverage was just, you report on the company's financings, your report on their FDA approval. And then, I don't know, all that stuff in between and who knows what happens there. So, COVID in a way presented an opportunity because we were able to focus on the podcasts and really give me an opportunity to learn about the industry, to learn about the engineering and the manufacturing about it, but also to get to know the device companies themselves and the comms teams there. So, by the time we resumed things in 2022, it sort of afforded me the opportunity to really work with the comms teams at the big companies, and the engineers and the folks who had on podcast, and try to get those stories that we told on the podcast on stage and maybe a grander fashion. Maybe there's a PowerPoint vote. Maybe there's two or three people who can talk about pulse field ablation, who can talk about the orthopedic business, who can talk about surgical robotics. So DeviceTalks, although we include some of that in our conversations, partnership and financing, especially in Boston, we've got The Medtech Innovator there and they run a great innovation, sort of forum investment forum. I just love working with Paul Grand and I love The Medtech Innovator crowd. And I still love startups, the folks who start companies are just absolutely insane in a good way. God bless them. I love it. And so, but I really wanted to give an opportunity for the Strykers, for the Boston Scientifics, for the Medtronics to come and sit down in sort of a collegial atmosphere and say, "Look, this is, this is the device we're working on. These were the challenges we had in developing it. This is how we're looking at the patient population." And just go over different challenges that that they had overcome. So it really, I think, is an opportunity for everyone to sit down and talk about the designing, the making, even the selling. We're actually getting more into the selling of medical devices to talk about the business of medical devices in a very, almost. I don't want-- collegiate sounds weird-- but just a very educational, sort of open setting. So we'll do, we have our keynotes, we'll have our big CEO keynotes. We'll have a venture panel from time to time. And like I said, we'd love to have the startups present, especially in Boston with MedTech innovator. We do that a little less of that at DeviceTalks West, but our bread and butter can sit continues to be engineering and manufacturing. And we really want folks to come down and talk about the intricacies behind their very cool and important and lifesaving devices, so people walk away with a better understanding of how to make their life saving device. And hopefully if they've taken the time to get to know this person who's achieved something great, and maybe they connect on LinkedIn, and it leads to a company being started five or six or 10 years down the road or two or three years down the road. Who knows? So we're all about again, open conversations about medical device development and about fostering the opportunity for personal connection as well. Lindsey Dinneen: I love that. Well, and I love your focus on collaboration, and education and that, the knowledge is shareable and it's really important and I think it's really impressive that you've created an atmosphere where people do want to come and share and talk about the good, the bad, and the ugly of their process and being able to share those stories, like you said, could very well inspire the next generation of innovators because it's important to be honest and transparent when you can be. So I think that's really incredible that you've fostered this atmosphere that, that leads to that. So. Tom Salemi: No, thank you. No, and I'm really grateful to those companies that take advantage. Sometimes folks will come and maybe their presentation is a little scripted. But I think just having that person in the room, the Chief Technology Officer or the Director of Engineering for some valve program is important. And it just gives people, I think as much as-- if I were to create a pie chart for the importance of stuff that goes with a bar graph that happens on stage versus like the 10 minutes after someone's on stage, it's probably the bars are probably pretty close. I'm not sure which is more important, but I think just getting everybody together and we've actually, I initially fought this, I'll admit it, but first couple of conferences, we had like five minutes in between sessions 'cause I just wanted to pack so much in. This year, our conference team was like, "Can we do 15 minutes?" And I was like, "No!" If you add it up, you've probably lost like 30 minutes of programming, but the 15 minutes was really great for just to give people some comfortable time to like, "Hey, I heard what you said about X. Here's something I'm working on, what do you think about that?" I think that those kinds of conversations are are very important and you can lead it up. You can leave it up to serendipity that, "Oh, if I'm at the conference and the Chief Technology Officer from major medtech is going to be there, I'll bump into him in the cocktail reception," but it's not always easy to do. So we try to, we really try to foster those connections so people get the insights they need and go home with some really positive insights and feedback. Lindsey Dinneen: I love that. Yeah, I absolutely love what your company does for that. That's incredible. Tom Salemi: Thank you. Lindsey Dinneen: So along your journey, have there been any moments where it stood out to you that you had this realization that "Yes, I am in the right industry at the right time." And just something, like a story that you got to share or something that just made you go, "Oh yes, I'm in the right place here." Tom Salemi: Interesting question. I mean, I have a lot of those moments. Some of those singular moments, I think, some are a just collective moment. Like I've said before, when I was covering the Newburyport City Council, there was literally a moment where they were arguing about the distance-- I was there supposed to be covering this meeting-- and they were talking about the height of fences. And I literally got up and just left. And I was like, "I can't spend, I don't want to dedicate another minute of my life to this." And I've never done anything like that before. I am this Joe Earnest, like I'm gonna stay to the end and make sure it goes. I had the whole journalism thing going on. But I was just like, "I just can't spend my life doing this." I've never, ever had that moment in medtech. I've never come to work and said, "Why am I writing about this? Or why am I talking to this person? Or what, what is this even about? What's the point?" I've never even thought that. And I would have that conversation if I were covering insurance or even, when I was at my newsletter, got a company by Dow Jones. And I thought my only path up was really to like get into news wires and start covering earnings and things like that. And I was like, " I don't want to be covering earnings and being measured by like, did I beat AP or whomever or Bloomberg by 35 seconds?" No, that's not what I want to do. I want to write about cool tech and talk to cool people. So that's when I left Dow Jones and joined EnVivo and Startup, cause I really wanted to focus on medtech. But, there are a lot of those moments where I'm really glad to be doing what I'm doing and there's singular moments too, where, I'm sitting in a plane and I look across the aisle and the woman next to me is just reading an EnVivo Magazine and she's got my article open. And I'm like, ah, I just want to tap her in the shoulder. " What do you think? What do you think about Right Medical, huh? Pretty interesting stuff, huh?" That was very cool. I remember interviewing Kevin Lobo at the early medtech conference I did in Minnesota. It just went super well. He's a really great guy to talk to and very easy to talk to, very open and honest, and will answer any question. But just getting off the stage was like, "Wow, that was a lot of fun. I want to go up and do another one." Which is weird, 'cause I wasn't a big stage guy before, but I don't know, the opportunity to dig and find some cool stories and really see the humanity in these medical device folks is a great challenge and a great privilege for me. I'm really blessed to have the access that I have. So I'm very grateful. Lindsey Dinneen: Amazing. Oh my gosh, I loved that so much. And yeah, I totally, it would be hard not to go, "Hey, what do you think?" Tom Salemi: Exactly, right? Yeah. Then what? Then like, "Oh yeah." Then she's like, "Sure. Sure. You're Tom Salemi." And then it gets really weird. "Oh really?" I let it be, but it's one of those forks in the road moments. What would have happened if I just asked her if she liked the right medical story and maybe who knows? I don't know. Lindsey Dinneen: That's so great. Tom Salemi: I might've had, I might've met a future CEO and then had a great story to tell with her someday. So. Lindsey Dinneen: It's still a possibility. Tom Salemi: it still happen. Lindsey Dinneen: Maybe you'll run into again. Tom Salemi: She's hearing this, maybe. She's like, "Wait a minute, I did read an EnVivo Magazine on the plane once next to some weird guy who was..." Lindsey Dinneen: "...weirdly watching me while I was reading it." Tom Salemi: Exactly, while was reading a magazine. Lindsey Dinneen: That's so funny. I love it. Well, pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach and why? Tom Salemi: Wow. People say "that's a great question" to me all the time. And I always like, "I don't really have that many great questions. Like one or two of them are great!" But that's a good, that's a really great question. Oh, wow. I think For me, learning to speak publicly and enjoy the time on stage, I think has been a real blessing for me. So, and I know a lot of people have that ability as well. I think that would be great thing to, to share with folks. But I think moreover, I mean, it's crazy to me that like people look to me like some sort of storytelling expert where I really just like, it's like, "You're really interesting. I'm not conjuring magic. You have a great story that you just don't know exists. I'm not some wizard who's just waving my wand and saying something in broken Latin and it all happens. It's all in you." And I wish folks could look inside and see their own stories and see the stories of others as well. And they're probably too busy designing that next great device that they don't really have that ability to look inward. But, I think helping people identify their own stories, not necessarily to tell them in a podcast form, but just to have a better sense of, of who they are. I mean, I've talked to a few people who like you, I'll say, "Oh, I'll start the conversation learning about you." And they'll say, "Well, I'm boring. Just talk about the company." And I said, "You're not boring. I've never talked to a boring person." Believe me, like everyone has great stories and everyone has great decisions that they made and, it's just a matter of telling it, or at least knowing those stories are in there. So, because I can't teach on anything of technical value, I guess I'll focus on that. Just helping people identify their own stories and and sharing them in the world in a way that's appropriate for them. Again, they don't have to have a YouTube channel, but they could just say, "Hey, I do important work. I'm interesting. And, I've made a difference in the world." That's pretty awesome. Lindsey Dinneen: Yes. Well, I love that. And I actually think the wizardry component of it comes in with allowing people to feel safe enough to tell their stories, and comfortable, because it can be harder, especially when you're maybe telling a story that is challenging for you, that talks about something where maybe things didn't go the way that you hoped they would, or you failed at something. And so, so giving people, providing that safe space, basically, to allow people to share those stories and encourage it is, I think you've got that wizardry component. Tom Salemi: Oh, I appreciate that. And that's a great point. And I think, like with the keynotes, when you're talking with someone who's willing to trust you a bit and say, "Look, when I do keynotes," I'm like, "Look, these are the things I want to talk about." Just allow me to, if I hear something interesting, I go, "Wait a minute, can I just pull that thread a moment," and just to have someone trust you that you're not going to take it in a really weird way, that you're going to see the positive, I think, is when you really have done your job and have a great keynote. Those are the moments, especially like at a conference where people walk away and say, "That was great." Keynotes should be really great and interesting. They can be informative as well, but if you're just focusing on, why you designed this over that and why that, why it's important to help people with this dreadful disease, all of that's important, but I think the stories that really resonate with people are the ones when they, where the people in the audience can really form a connection with the person on stage. I think that's when you really hit the home run. So, just trying to do that. Lindsey Dinneen: Yes. Yes. Yeah, absolutely. And I think to your point, another component that you do really well and that I think is important in that sort of wizardry aspect, is the respecting and honoring of the person's choosing to tell that story. So it is, like you said, drawing out the positive and honoring the fact that they've decided to share with you. And so therefore they continue to feel safe, and respected in sharing their insights and stories and whatnot. So I think you're absolutely right that it has to have multi layer components. And, and I love your thing. You've never met a boring person. That's so great. That's so true. Tom Salemi: It's true. I mean, just talk to people. My son is going to be an engineer and he's like already 10 times smarter than I am technically. I teach him how to jump a car battery and he's explained to me, "Oh yeah, that's why the red has to be attached to the black." And I'm like, "I don't know that. I just know red and black. Don't tell me why the battery works. I don't really need to know that. I just need to know how not to set my car on fire." That's where my technical knowledge. But there are people in the world who understand how things work. And I just-- that's witchcraft. To understand, why planes fly and why batteries work. That stuff's amazing to me. Lindsey Dinneen: I agree. I agree. All right. And so, on a bit of a more serious note, how would you like to be remembered after you leave this world? Tom Salemi: Oh, wow. I mean, like I said at the start, I got into journalism cause I thought it would be fun. And I was also a shy kid and I didn't want to be in a cubicle all my life, 'cause I think, I don't think I'd ever climb out of it. I wanted to really force myself into the world. But then I came to realize that what I really liked was helping people connect and I think that's becoming harder and harder for people to do, not to get too heavy about it, but I think there are a lot of lonely people in the world who aren't finding connection or the connections they are finding aren't necessarily the most productive. So I hope, I hope I, I ease that somewhat and I'm always --just last week, actually, I got a couple of great messages and I don't get a ton of these. It's just weird timing, but someone who said that they enjoy the podcast, and they're college students, and they went into biomed because of the podcast. They joined a startup competition. It's like, "Wow. I, with my stupid stories, I had an impact on someone in a positive fashion!" And I told this person, " Great. When you invent the lifesaving technology," I said, "I will take total credit because I'm the one who stirred you into medical devices." I'm getting a few of those nice messaging, and it's, I hope that people remember that, we have a lot more in common... I hope people will think that I've reminded people that we have a lot more in common than we do differences, and that we have a lot more positivity to rally around the negativity. And it's the only way we're going to get things done in this world is if we're working together on it. So if I could help that happen a little bit, I think I'd be happy with that as a life lived. Lindsey Dinneen: Yeah. Yeah, absolutely. Wow. And thanks for sharing that story. That's incredible. That is so exciting. Tom Salemi: I'm so grateful. I told him, I'm so grateful that person wrote, "thank you so much," 'cause that, yeah, that people don't do that very frequently. So it's awesome. Lindsey Dinneen: Yeah, and final question. What is one thing that makes you smile every time you see or think about it? Tom Salemi: Huh. My first thought was my, my kids just seeing them find their way through life, seeing them find the things that energize them. It's great when you see that. Dogs, of course would be a good one. Lindsey Dinneen: Yes. Tom Salemi: I love a good dog. I don't know, everything that's coming to mind, it sounds kind of corny. I mean, obviously when you see people take a kindness on somebody else, or be kind to someone else when they don't need to be, I think is extraordinarily uplifting. So my kids, my dogs, my dog, any dog, actually most dogs will do... Lindsey Dinneen: Yes. Tom Salemi: Yeah. But my dog in particular, but no, I think I just, those moments that, unfortunately, we're not shining enough light on where people are overly kind and helpful to each other. I think we need to see more of that at this time. Lindsey Dinneen: Yeah. Agreed. Well, I think that's phenomenal. I, I also am a huge dog lover. So anytime, I mean, really, it's like an instant happiness. Tom Salemi: Yeah. Lindsey Dinneen: Instant. So happy. So. Yeah, they are the best. Well, I just want to say this has been an incredible conversation. It's been so great to get to know you a little bit and also get to know a little bit more about the incredible work that DeviceTalks is doing. So I just want to thank you so much for being here and being willing to share your stories. This has been great. Tom Salemi: Oh, thank you so much. It was an honor to be asked. It doesn't happen frequently and it was-- you've got some great questions. I may steal a couple of them. So. Lindsey Dinneen: Absolutely. Well, thank you again. We are so honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support and thank you for all the work you do to change lives for a better world. Tom Salemi: Okay. Thank you so much. Lindsey Dinneen: Thank you also to our listeners. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time. Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Jennifer L. Horspool, a communication and public relations expert, global brand strategist, and founder of Engagement PR & Marketing, shares her journey from aspiring scientist to a leading figure in MedTech PR, emphasizing the importance of storytelling, branding, and patient persistence in the industry. She highlights how she helps startups and Fortune 100 companies turn their innovative ideas into well-known brands. Jennifer also discusses the transformative role of AI in MedTech and PR, providing valuable insights and practical advice for startups looking to make their mark.   Guest links: https://engagementpr.com/ | https://www.linkedin.com/in/jenniferlhorspool/ | https://www.facebook.com/EngagementPR Charity supported: Paw Prints in the Sand Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 035 - Jennifer L. Horspool Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, [00:01:00] Jennifer L. Hoorspool. Jennifer is a communication and public relations expert, a global brand strategist, international speaker, and founder of Engagement PR and Marketing. As a brand growth and turnaround specialist, Jennifer has been employing her skills in PR, media, marketing, and messaging for more than three decades to grow companies from vision to multimillion dollars and "turn best kept secret brands into the go to experts of their industries." Jennifer works with companies of all sizes from startups to Fortune 100. She's been working with medtech, biotech, and pharmaceutical companies for more than 15 years, and has helped to bring some pretty cool products to market. All right. Well, thank you so much for being here, Jennifer. I'm so excited to speak with you today. Jennifer Hoorspool: Thank you, Lindsey. I'm so honored to be here. I'm excited. Lindsey Dinneen: Wonderful. Well, would you mind starting off by telling us just a little bit about yourself and your background and maybe what led you to MedTech? Jennifer Horspool: [00:02:00] Sure thing, actually. So I've been running Engagement PR and Marketing since 2015. I've actually been in the field of public relations marketing since the nineties, right? I'm 24 years old. I don't know how that mouth works. I don't really have to do numbers. I do words. Healthcare has been my vertical deep for all those 30 years, right? I've worked with some other people outside of health care, but for the most part, health care. I started off doing a lot in patient services and really like direct to consumer about health and wellness and stuff like that. And then got into drug approvals but from a PR perspective, right? So bringing drugs to life. And then that led me into devices, medtech. And then as AI has expanded, it's just been really fascinating in the medtech world. And I've gotten to work with medtech that does need FDA approval and medtech that does not need FDA approval. So there's all different kinds of stuff. And one of the most fascinating things that I've gotten to do is work with a couple of different contract [00:03:00] research organizations. And so those are the companies that hold the hands of the inventors so that they can get their products through the FDA and to market in the United States. It's a fascinating journey. There's all kinds of different avenues to go down. And it's just been really spectacular of the things that I've gotten to learn in the inventors and getting inside the inventor's minds. Lindsey Dinneen: Yeah, I can only imagine. Well, thank you so much for sharing a little bit about your background and whatnot. And so, okay. So I'm curious when you first, maybe as a kid, like would seven year old Jennifer have said, this is what I want to do with my life, or did seven year old Jennifer not know yet? Jennifer Horspool: Well, seven year old Jennifer thought she was going to be a scientist. I was the girl that had all the, like the, I made my own soaps. I made my own potions and lotions. I did not think of myself as a witch. I thought of myself as a science, a scientist. And so I was always inventing this and inventing that and [00:04:00] constantly spilling things on my poor mom's brand new floor. And, you know, "Mom, I cleaned it up as quickly as possible," you know. Lindsey Dinneen: Oh Jennifer Horspool: No, I've always enjoyed science and I've just found it to be fascinating. And then and then I got lost along the way. I forgot about science. Quite honestly, I was taking it, but like those were hard and communication just came so easily to me. And then it became more about storytelling. And so I love to tell stories and one thing after another, I got into branding and brand building. And this is like in the nineties is when that terminology kind of first started maturing outside of your brand mark, which is your logo. Before the, like the early nineties, early to mid nineties, we talked everything about a brand was really just your brand mark was your logo. We thought that was a brand. And then we came down to, no, it's actually-- the brand is the emotional components of who you are and who you are as a company and all the different things. And so I got to get into all of that and I got all into the words and the storytelling and the feelings and emotions of it. And now I got to represent [00:05:00] scientists. And so it's really been a really good match because I think I'm a natural communicator. Lindsey Dinneen: Yeah. That's wonderful. And I think it's so helpful sometimes to bridge the gap because you have that background and that interest in science. And sometimes perhaps not all scientists can communicate as well as they want to maybe those of us who don't have that background and do need to understand what it is you're bringing to market so that we can purchase it. Jennifer Horspool: Right, right, right. And it's uncomplicating the complications that they find simple, right? So it's, how do you take that scientific language and turn it into common language that everyone can get behind? And so, I've always said like really smart people can simplify everything. Lindsey Dinneen: I love that. Yeah. I, there's a saying that something along the lines of "simple isn't easy, but simple is worth it." And I... Jennifer Horspool: I love it. Lindsey Dinneen: ...think a really good thing to, to remind yourself of is, when you can simplify processes or communication or whatnot, it [00:06:00] is worth it in the long run, even though, you know, like that famous, was it Mark Twain, who said something like, "I didn't have time to write a short letter..." Jennifer Horspool: Yeah, "...so I had to write a long one." Exactly. Exactly. Because it's the truth, you know? And that's funny because in marketing all the time, they're like, "I need 11 words to fit right here." And people don't understand that it's much harder to write 11 words about something than it is to write 700. 700 is I get to explain it all. 11, I have to be impactful and those words really matter. And so it's actually much more difficult to write 11 impactful words than it is to write 700. Lindsey Dinneen: Yes, it is. I love that. That's a good analogy too. So now what are you currently doing and excited about and what are you looking forward to as you continue to build the business and move forward? Jennifer Horspool: Yeah. So because we do marketing, PR, branding, brand experience, love to work with brand new startups, love to [00:07:00] help them get their whole-- figure out that whole identity, get their websites going. Everything that's in the beginning, you would be surprised at how many emotions are tied into that first coming out brand. And it, people think it matters so much and it does matter, right? But it's like sometimes, "Get out what you know right now. Let's get something up. And then as your science matures, we can mature your brand. We can mature your website." First thing we want to do is get something out there where we can start getting presence, getting you seen, known, trusted, and found, right? Getting found is the most important thing, and it's not the easiest, right? So, so there's all these different strategies that you do to get found first by your name, you know, by who you are, your company name, the founders' names, and also by what you do or what your promise of your technology is going to do. And so I really enjoy working with people at all stages. I've, I've had the great fortune of [00:08:00] working with startups that are unfunded, startups that are funded, and then all the way through to Fortune 14 companies, right? So the entire gamut, I know who and how to work with. with. And we work with all of them. But our sweet spot really is in just either just launching or have already launched and are just starting getting ready to get known, really building that brand and pulling people to you, to your sites, to your social media, to the studies that you're doing, to all the different things so that we build that rise. And then you're found more easily because at the end of the day, if you're the best kept secret, you could have the best science in the world, but then no one gets to use it. So we take you from the best kept secret to the best known experts in the industry. Lindsey Dinneen: Ooh, I love that. Nice. Jennifer Horspool: Thank you. Lindsey Dinneen: And I think it's so true too, because I think sometimes working with engineers, for instance, who are beyond brilliant and sometimes there's this, [00:09:00] there can be a disconnect of, "Well, it's so great. Like the product is so great and it should just be known." And we're like, "Yes, you're right. It should be, but there actually has to be a process to go through." Cause unfortunately the whole, "if you build it, they will come..." Jennifer Horspool: Yeah, that movie threw everybody for a loop when websites came about because all of a sudden everybody thought, "Oh, if I build it, they will come." And it's like, no, that's a movie. The dream, if you remember, it was the dream field. Lindsey Dinneen: Right. Jennifer Horspool: So if you build it, then you have to market it so that they even know to come. And there's a lot of variety, like it really, it should be. fun. And it needs to be fun first and foremost, right? Like the excitement, you know, there's an acronym that I do about media. How do you get in the media, MEDIA, right? So your message is your magnet. The "M" is your Message. Your message is your magnet and your magnet is your magic that really pulls people to you. And then the "E" is Excitement. You have to deliver it with excitement cause if you're not excited about it, [00:10:00] how is anybody else going to be? But that passion really pulls people to why this is such an exciting breakthrough. What's it going to do that's different than something that's on the market today. Then you have to distinguish yourself. The "D" in media is that: Distinguish. How are you different than what's already on the market? Why is that important? You know, you have to be interesting. The "I" is Interesting. It's like you deliver it with excitement. But how are you differentiating from everyone else? You have to distinguish yourself. You have to describe what's so important. How is it interesting. And then you really do that for your Audience. Who is the main target audience? And it's easy when your audience niche is small, but when people see it as a broad alternative to a lot of things, they get clustered, right? Like, it's like, "Oh my goodness gracious. No, it's all these people. It's everyone." And the sad part is when you serve everyone, then you have to still niche [00:11:00] down into little buckets because everyone is not listening the same way. And when you start talking to everyone, you start talking to no one because it's too generic. People don't know to stop and listen. The whole thing is you're trying to stop that scroll. Everything, it doesn't matter if it's your video, if it's a meme, if it's a white paper, if it's your blog, whatever it is, we're all in the same scrolls right now, right? It doesn't matter if it's social media or on email or you're trying to stop that scroll. How do you get them to open your thing? And really, so the MEDIA: the message, the excitement, you know, all of that just really comes into play. Lindsey Dinneen: That was amazing. Thank you so much for sharing that. You're obviously brilliant at all of this and I really appreciate that summary. I could not stop nodding my head because I was just like " yes." So thank you. And I love your acronym. That's perfect. Oh my goodness. Easy to remember. So what are some of the challenges or roadblocks that you see, [00:12:00] maybe especially with some of these startups, because a lot of startups are listening to this podcast. And so speaking of niching down, speaking to your people, but so, so what advice would you have? What kinds of challenges and roadblocks do you see? And what kind of advice would you have for somebody who is in this situation of, "Okay, I'm ready to start being known. I don't want this to be a secret anymore." What do you see and how can they overcome some of those issues? Thanks. Jennifer Horspool: Yeah, that's an excellent question because patience is a virtue still today and we have less and less of it. Right? We think like, "We've been working on this for a year and a half and here we are, ta da!" And everybody's gonna be like, "Oh my god, they're here!" Right? You know what I mean? But that's not really how it is. We all, we have trust issues. issues. And in today's world, because there's so much online and because we have so much accessibility and because there's always new things being invented all the time, where's the credibility, right? So, and even if you're [00:13:00] the most credible person in the world, where's the credibility in the product? Where's the credibility in your launch? Where's the credibility? And sometimes it's much slower to ramp up than you want it to be than, you think it's going to be. So the first initial, sometimes even press releases or outreach to media introductions to media, and you might get interviews, you might get like all different kinds of things where you're seeing a lot of groundswell, but it hasn't turned into stories yet. It hasn't turned into articles on the web. And it's very frustrating because you're like, "I gave them my time. I gave them all my expertise. I was as transparent and authentic as possible. I shared all this, like, where's our story?" But they might still be just accumulating information on you and watching and waiting. They're seeing how your science matures because if they come out with it, it's an endorsement by their publication that this is authentic, that this is a real thing. And so, especially in credible publications, which is what you're trying to get into, right? And so [00:14:00] they're waiting and watching for the right time to release your story. They might interview you three, four, five times, collecting the data, building up the story before they actually cover you, before they actually release the interview notes, before they actually do something that you can really use on your site and to build out your stuff. So in the meantime, you do the media interviews. You build the relationship with your key media who are writing about your topics. And you really, that's what you're doing is building the relationship. You're making them feel comfortable enough with you, your science, the results, your white papers, like everything that you're putting out, all of your studies, especially if you're presenting, by all means, share that with your media without necessarily expectation. You want the expectation, right? You want the story to come out of it, of course. But they might still be just collecting information and building up your [00:15:00] file and then what, once it happens, it could be something grandiose. It could be something really great that then you can really use. And then don't be afraid to repurpose these when you get stories. Don't be a one and done. "Oh my God, we were the Wall Street Journal. Here it is." You're done. I think it's 8%, you know of LinkedIn followers even see your posts or even if they're exposed to your post, whether or not they're on social media that day. And it goes through down and through your feed. It's still in your social media, but repurpose it all the time. Pull out quotes from it, pull out interesting tidbits, share your infographics, like share that thing. Don't be afraid like 20, 30, 40 times throughout the year, you can take one study and really dissect it and share different pieces to it. Different people are going to see it. They're going to absorb the, and the same people are going to absorb it differently each time. It's like watching your favorite movie over and over again, and you grab new tidbits every time you're like, "I never even noticed that before." It's the same kind of concept with your [00:16:00] science. Lindsey Dinneen: Oh, brilliant. Thank you. That was great. I really appreciate you sharing that advice with us too. Yeah, and I think to your point, it is hard to be patient because you're so excited about whatever it is that you're building and working on. And patience is such a wonderful thing to keep in mind. Like it's okay, you know, it will come just, you know, one step at a time. Jennifer Horspool: When you get started on your marketing, it can take like three, four months before you really are starting to see real results because it's like AB testing all the time, right? What are people responding to? What are they not responding to? It's kind of the same thing with traditional media when you're trying to get in with a media. Lindsey Dinneen: Yeah. Excellent. Thank you. Well, so I'm curious, are there any moments or a series of moments that stand out to you because they clearly reminded you why you chose this field and why you're specifically doing it for healthcare, medtech and whatnot. Jennifer Horspool: So I think I feel like we're at kind of a pivotal point in health care right now. It's been [00:17:00] very much like one specific way. We've been a pill popping society for lack of a better way of putting it. We all wanted a pill to solve all of our problems. In fact, there was some show in the nineties and it was like all about the year 2025. And we were such a pill popping society that by the year 2025, you pressed a button and this pill came out and that was your entire meal. And you took your pill and that was your meal. And you just went on, you had all the proper nutrition. Like we thought, "Oh, we're not even gonna have to bother to eat anymore." Well, foodies hadn't really come about yet. So foodies came about and they're like, "No we want to eat. Eating is the great part. Like, why would you take that away? Nobody wants to eat a pill." So I think with medtech, where it, is we're able now, especially combining it with AI, is that we're able to create new things that, that test the body in new ways. We're able to create new things that show us like even where your body's misaligned. And the part that's so important about the way your body is aligned is that has to do with nutrient delivery. [00:18:00] It has to do with injuries. Most injuries we think, "Oh, it's because I was playing soccer and I twisted my knee this way." But it was actually because, well, your hip and your ankle were out of joint to begin with. You went and you played soccer and your body was already misaligned. You slept wrong or you had poor posture while you were watching television. You got all cranked up the wrong way. And then you went out and you played basketball, cause you always play basketball on Saturdays, cause you're a weekend warrior. Weekend warriors are the ones that get the most injuries. And that's because we don't do the training all the way along. And then you go out and you play and then you have injuries. So it's like getting ahead of all those things. Medtech today has such an opportunity to change the entire trajectory of the way we look and analyze the body, that I think there's no more fascinating industry than medtech right now. Lindsey Dinneen: Yeah. Oh, I love that. And Thank you for sharing a little bit about some of the, even the technology that you get exposed to too, because that is [00:19:00] just so cool. And I am curious, you mentioned at the beginning how, and this is a hot topic because it's on everyone's mind, of how is AI impacting medtech? And I'd be curious to know how AI is impacting even the work that you do for medtech and healthcare. Jennifer Horspool: Right. So two totally different things, right? Like when you say AI, to anybody today, they just go, "Oh, ChatGPT, right?" Lindsey Dinneen: Right, right. Jennifer Horspool: There's so much more than ChatGPT, right? I've been fortunate, I've actually been working with AI for 15 plus years because we didn't call it AI back then. We called it different things. We just talked about what it did. We didn't say, well, "the artificial intelligence is putting it together." Like we didn't do that. It's a term now, right? What we talked about was the application of it and taking all this data and getting the analysis out in an intelligent analysis that's going to help people. Or now [00:20:00] you can use AI processes that were developed for something else. You can plug and play it into your application and it can vascularize things that never were vascularized before. I mean, that's one of the things in certain types of medtech that people are working on galore is really in creating 3D printing organs, for example, 3D printing life saving aspects. I'm working with one company and they're developing a, it's a 3D printed bio biopolymer wrap that actually, it's got bio absorbable materials. There's just, there's new materials, there's new stuff, there's new technologies. And AI is really the ability to speed up data analysis, the ability to combine mass amounts of data or mass amounts of processes and simplify it into something that humans can do, but nowhere near at the speed. So we're taking things that might have taken three months or three years, and we're able to get it down to three seconds or even [00:21:00] less. We're able to take things like military applications or there's the God awful bombings that are going on, how are we getting medical care to areas where they're so remote that there's no medical care? So AI is actually able to connect things up where there is no technology. There's no wifi, there's no this, there's no that, but then you can do x rays and you can actually get your x rays and upload them and get them, get a diagnosis. get like intelligent insight back when you don't have access to the internet and to other things. And so it's really, AI is the ability to dream bigger and make those dreams actually truly happen. And then in my field, It's a really great way to never have to start with a blank piece of paper. The blank piece of paper is the hardest thing in the world to start with AI right now, especially if you're going like ChatGPT, it's great for content. It's not so great for context yet. You still have to personalize [00:22:00] everything. Never take what AI does and just use it straight out. Everyone knows, first of all, everyone knows the way it writes. So then you just look lazy. And you look like you didn't really share your own stuff. No one cares what AI had to say. They care what you, the expert, had to say. So, we do a lot of ghostwriting. We write a lot in other people's words. We might take it to AI to get that started or maybe get some ideas. It's fabulous for ideas for blog posts. It's fabulous for ideas for social media. It's fabulous for ideas, you know, then take those ideas. It's fabulous to get started, but not to finish. You need to take it and spend a good hour with it and really make it yours. Lindsey Dinneen: absolutely, wonderful, thank you for sharing a little bit about that too, I, it's just always such an interesting, it will be a discussion point for years and years, probably forever, I don't know, but it is so exciting, I love the way that you described it too, of being able to not approach it out of a fear [00:23:00] or concern, but approach it out of, "Oh my goodness, I can actually make these dreams come true. And I can have a bigger, even more positive..." Jennifer Horspool: ...impact, right? We, every, we're looking for impact and it's really, don't be afraid of it. I talked to some people and they're like, "Well, everything we do is just so personalized." Everyone wants to think that everything is so different, what we do is so unique. I know everybody's is so unique. It's so unique. We're all the same uniquely, but... Lindsey Dinneen: Yeah. Jennifer Horspool: ...we're all uniquely the same. I don't know, you know, whichever way you want to put it. But it's really about amplifying who you are. You can take it and create avatars to let it think in a certain person's tone. And then you can feed it that avatar. And you're saying like, you're telling it, "I want you to be this avatar, in this way of thinking with this tone and these personas, these personality traits" that you're giving it, "I want you to create now. something spectacular" and it can give you something that could might, it might even be 70, 80 percent done, right? But just never take it [00:24:00] straight out and just plain old use it. But what it's also really good for is in finding gaps, right? Where you're like, "Here's everything I know about this and here's everything I know about this. Why aren't they, why aren't they working together? Find the gaps in this for me." Excellent at doing that, especially in medtech, where you can really then find out like what's happening today. What are the problems that we have with the medtech that's out there today. If you want a product, but you want it to go even bigger, maybe you want to change standard of care somehow by making something, taking what we have now and amplifying it to a whole another realm where you're taking the aspects of maybe three other products and you're marrying it with standard of care today. And you're saying, "this is how it's going to go that much better." It will find all those gaps for you, right? You can create programs. There are AI program writers that you tell them, "I need this as my end result and they can design a program that's intelligent, that continues to [00:25:00] learn." There's a, another gentleman that I've been working with and he developed, it basically helps you make decisions and it helps you weigh all the decisions. And it's not like it's so profound that you couldn't have done it on your own, but you don't do it on your own, right? You plug the things in and now you get the answers back. And that's AI. Lindsey Dinneen: Ooh, fascinating too. That is so cool. Yeah. I mean, the possibilities are endless and it's just the beginning, so it's going to be exciting to, to stay on it. Yeah. Well, pivoting the conversation just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want, could be in your industry, but doesn't have to be. What would you choose to teach? Jennifer Horspool: That is a fascinating question. I would talk about-- I, I would talk about the power of being you. You know, we are, we're born uniquely us. That is the one thing where you really do get to own the unique. You are [00:26:00] uniquely you for a reason. I grew up in the seventies and eighties. Like I said, I'm 24 years old. I'm sure you know that math. But it wasn't the time for girl power. It really was not the time for girl power. And then girl power came about and it was so great because watching the transition of girls into sports and really owning sports, right? And girls into science and STEM, like now females are owning STEM and there's femtech. Femtech is a real, true industry, not just a word, but an entire industry. And that is how are we serving women? So we've been marketing to women for years because women are the caretakers of the family, but we haven't been taking care of those women. We've been empowering those women to take care of their families. So it's, we've been shamed, " Oh, you can't be conceited. If you love yourself, you're conceited." That's what growing up in the seventies and eighties was like, it was very much about, you're not allowed to love yourself and loving yourself in today's world, as we know, is the key to everything. [00:27:00] And so the more uniquely and fantastically you are you, the better innovations you're going to bring to your life, to the people who know you, to the scientific world, if that's where you belong. You didn't get into science by accident. You didn't get into inventing by accident. That is part of what is uniquely you. You have a curious mind. And one of the things that we forget to do, we do it in science all the time. The hypothesis is designed to be proven incorrect. Incorrect. We think, "Oh, I'm trying to prove my science." No, you're trying to prove it incorrect. And if you can't prove it incorrect, the assumption is that it must be true until we can find something else or something better. The same thing applies to your life. The same thing applies to yourself. And in fact, I'm going to challenge, but the same thing applies into the way that you're researching your politics. The same thing applies to the research and you're applying to your beliefs about everything in life. And if you can start to say that, "This is my [00:28:00] current hypothesis. This is what I believe based on all these things. And I haven't been able to prove myself wrong. Therefore, I believe these to be true." And if you start researching everything like that, you're going to find so many more discoveries in life and you're going to find so much more of your sweet spot and where, what makes you really happy and find your people who are going to go on this journey with you. And so I think that's what I would like to do. And thank you for the million dollars. Lindsey Dinneen: Yeah! Well, that's a brilliant sounding masterclass, and I totally want to sign up, so let me know when you offer it, because I'll be there. Jennifer Horspool: You got it. Lindsey Dinneen: And then, how do you wish to be remembered after you leave this world? Jennifer Horspool: Gosh, that's another nice question. I think as an empowering person who helps people to see the value in being truly and authentically themselves. I think the more we really embrace who we [00:29:00] are and all of our flaws and all of our own cuckoo, cause everybody gets some. We love to point the finger, right? And one of the, one of the greatest things I learned, and I don't even remember which coach I learned it from, but you know, when you're pointing the finger at everyone else, you've got three more pointing back at you. And so the most empowering thing about that is it puts you in charge. And that means it puts you in charge of being able to fix anything. And so, yeah, that. Lindsey Dinneen: I love that. Yeah. Excellent. And then final question. What is one thing that makes you smile every time you see or think about it? Jennifer Horspool: My dog, Bruno. Lindsey Dinneen: Yay. Jennifer Horspool: My dog, Bruno. He's the greatest thing that ever happened to me. He was homeless. He was sleeping under my friend's truck for about three weeks. She posted, "Hey, I have to find this guy his forever home." And and we met and it's just been a fabulous engagement ever since. He's the greatest thing ever. Lindsey Dinneen: So sweet. I love that. Dogs are the best. [00:30:00] They're perfect companions. Jennifer Horspool: Yeah. Lindsey Dinneen: Excellent. Well. Jennifer Horspool: He's spoiled now. He went from outside to a couch and a bed and all these other beds and he's a happy guy. Lindsey Dinneen: Yeah, I love it. I love it. That deserves some love and attention and, yeah, pampering. Jennifer Horspool: Right. Lindsey Dinneen: That's phenomenal. Well, Jennifer, thank you so much for being here today. Seriously, it was value after value. It was nonstop amazing advice, amazing insight. We are so honored to be making a donation on your behalf as a thank you for your time today to Paw Prints in the Sand. Paw Prints in the Sand Animal Rescue is an all animal foster based animal welfare organization with a mission to give at risk animals a second chance at life by providing medical care behavior training and loving forever homes. Thank you for choosing that organization to support! Thank you for joining us and thank you for everything that you do to change lives for a better world. Jennifer Horspool: Thank you. [00:31:00] And thank you for doing this. This was fantastic. I really appreciate the opportunity to come and speak with you and talk medtech to all the scientists out there. It's one of my favorites. It's always fascinating. And thank you for doing the podcast. It's fantastic. Lindsey Dinneen: Yeah, excellent. And for those startups and founders that might need some assistance, where could they find you? Jennifer Horspool: Email me at jennifer at engagementpr. com or or just go to engagementpr. com, fill out the form or you can go to LinkedIn, Jennifer L. Hoorspool, everywhere I am, get my L in the middle. It's I say, whether it's my middle initial or my last name, please put the L, it's really important. Lindsey Dinneen: Okay. Excellent. Sounds good. Well, again, thank you for being here. And thank you also to our listeners. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time. Jennifer Horspool: You're the best.   Ben Trombold: The Leading Difference is brought to you by [00:32:00] Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dasha Tyshlek, founder of StratCraft and strategic advisor to life science and healthcare tech companies, shares her inspiring journey from a dance teacher to a leading entrepreneur in MedTech. She discusses her passion for technology and problem-solving, and how she helps companies innovate and commercialize groundbreaking products. Dasha also highlights her podcast, "Biomedical Frontiers," which showcases transformative technologies and offers hope for the future of healthcare. Tune in for a compelling conversation on entrepreneurship, innovation, and making a difference in the world.    Guest links: http://stratcraftpartners.com | https://rss.com/podcasts/biomedicalfrontiers/ | https://www.engineering.virginia.edu/centers-institutes/coulter-center-translational-research/podcast  Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 034 - Dasha Tyshlek Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to be speaking with my guest today, Dasha Tyshlek. [00:01:00] Growing up, Dasha knew she wanted to become an entrepreneur, leading people to change the world through innovative products and services. Her love for technology and problem solving led her to study engineering science, focusing on biomedical engineering and product development at the University of Virginia. Today, Dasha is the founder, president, and chief strategic advisor of StratCraft, and is a strategic partner for growing life science and healthcare technology companies. Dasha has developed a strategy for advanced manufacturing spinouts such as Core Composites and MicroAnt GPS. She has led company wide strategy development and unique growth initiatives across multiple high tech industries, including biomedical device, pharmaceutical, translational research, automotive, financial, satellite, and defense. Dasha is the director and host of "Biomedical Frontiers: Stories with Innovators in Healthcare," a life sciences and biotechnology commercialization podcast hosted by the Wallace H. Coulter Translational Research Foundation at University of Virginia, and she is a lecturer [00:02:00] at University of Virginia's Biomedical Engineering Department. Due to her deep technical understanding and ability to forge complex, multi company partnerships and agreements, she is a sought after advisor to innovative companies working to commercialize their new technologies. All right, Dasha. Thank you so much for being here. Dasha Tyshlek: Lindsey, it's such a pleasure. Lindsey Dinneen: Awesome. Well, I was wondering if you would be willing to start off by just telling us a little bit about yourself and how you got started in the medical device field and what led you to what you're doing today. Dasha Tyshlek: Yeah, absolutely. I think one of the things that's been a defining trajectory in my life is, is entrepreneurial pursuit. And I actually started out, I think you and I connected on this earlier, as a dance teacher early on in my life and decided even in high school since I was learning dance to, to try coming up with my own dance aerobics programs and try to pitch that to local Golds [00:03:00] Gyms. And so that, that's been something I've, I've endorsed and participated in and tested out various forms of entrepreneurship over my life. But I'm also an engineer and I love interesting new technologies and the scientific approach to problem solving, kind of methodical, process driven, deeply curious ways of creating solutions. And so, when I started my engineering degree, I met some people who were entrepreneurial engineers. And that really excited me that you could be a technologist who is working on solving a problem and you're not doing it just to then maybe write a paper and hope somebody notices, but then you do the steps necessary, bring the team together, find the customer, and, and then do it, do that transition, that bridging. And so that really put me on a path even when I was studying to start exploring that. And I got to [00:04:00] participate with an organization called Venture Well, which is really famous for supporting STEM entrepreneurship even at undergraduate level. And at my university, I worked to create an organization that would help sprout kind of entrepreneurial innovation roots into the student community. So we created a Maker Space. We hosted a Medical Hackathon took people to startup trips to visit companies that were doing new technology developments. And, and also did some expos and speakers and things like that to expose students. And that had some really great success. A lot of people got very involved. A lot of the people that went through that with me are now entrepreneurs themselves-- not all medical device entrepreneurs, although most of them were biomedical engineers-- but all of them, very entrepreneurial, and working on some really interesting technologies now, so I think that's that's kind of the defining piece of where my career began. And then today I'm [00:05:00] consulting and helping companies, particularly companies with large portfolios of new technologies, who are trying to come up with ways to commercialize products, come up with that strategy for commercialization, taking one product, one technology at a time. Lindsey Dinneen: Wow, that is an amazing backstory. Thank you for sharing all of that with me. And it is so cool to see how, first of all the synergy, the fact that you did have a dance background as well. And you were so entrepreneurial, even back then in creating this program. So I do have to ask, did that program ever get sold to a gym or to anyone. Have you developed it? Did you fully do that? Dasha Tyshlek: Yeah, I actually had two Golds Gyms that I taught on a regular basis two different types of programs. And then since I was already a teacher with Golds Gym, they wanted to introduce some other dance programs from kind of well known brands. So they picked me as their [00:06:00] flagship dance instructor. So I actually ended up picking up some new classes and certifications through that. I also had a private class, just my dentist and her friends wanted to do dance, but they didn't want to enroll in a gym. So I was like, "Here, I'll come over, you know, everybody pitch in, here's the price and I'll just bring the gear and everybody dances at someone's living room." So we even had and they were all really busy women. So. So I think it worked well for them to just, you know, be in the neighborhood and use a living room rather than have to kind of travel. So you know, and, and we did, did some, there was two Golds Gyms, but there was also I was a substitute teacher and actually partnered with another dance trainer who was testing out ballroom dancing for people with disabilities. And so I was his like dance partner demo. So I just got to explore so many different opportunities through that and kind of see how you do business development and relationship management and new product rollouts and have to get, you know, prove that my class will bring in new [00:07:00] customers. So it was very fun. Lindsey Dinneen: Oh, that is incredible. I absolutely love that. Oh my goodness. So, so you have always had this entrepreneurial bent, but then of course, like you said you've also-- you're so curious. You like exploring you like learning new things and you're clearly not afraid to go out and pitch those ideas to whoever will listen. So I'm curious, how did you come to the pathway of "I want to be an engineer. I want to go to school for this and develop that skill set as well." Because it's not that they're not compatible. They obviously are. But a lot of times people don't necessarily put the two together. So I'm curious how that worked for you. Dasha Tyshlek: Yeah, when, when I was-- so, deciding to be an engineer was a little bit tough. I, I really like chemistry and I thought maybe to go into the chemistry side of things. But a lot of the people in my family are engineers. My grandmother is an engineer. Both my parents have kind of a practical math backgrounds. So, there was a lot of engineering in the [00:08:00] background of my family. And it seemed to me that the engineering focused a little bit more on kind of what's here and now, what you can build now. Science may be focused more on fundamental discovery. And so that that seemed to be kind of the difference for me is is I thought, "I'm probably like a little bit more like practical here and now rather than thinking in these like 20 year timelines." And so I think it was just a better personality fit. And then once I got into engineering school, that turned out to be really a great fit because I loved learning about the technology. I loved working with other engineers who were very building, creating, designing oriented. And the way that you look at problems and investigate in engineering is very similar to scientific approach, but also tends to be then, you have to then think through, "Okay, great, we found out how this spring works or something like that, but how do you use this spring to do something now in the world?" And so I, I love that [00:09:00] translation from kind of, "We have a technology, we have an approach to, it has to work for people in the world in reality." Lindsey Dinneen: It's so interesting because I love talking to people who are multi passionate and have a lot of different avenues that they have pursued over the years because I do think, overall, the more generalist you can be-- not that you shouldn't really hone in on some specifics-- but the more that you can have a lot of general experience and knowledge and skill sets, it seems to all end up working really well together in the end. And it helps you be a little more creative maybe when you're solving problems or approaching a new idea or a difficult conundrum and you're going, "Okay, well, you know what's interesting is, I have this background in science and engineering, and I have this background in dance and entrepreneurship and then blending it all together." I just love the stories of how it comes together. Dasha Tyshlek: One of the things I learned when I was [00:10:00] in engineering school is, for a lot of the projects-- so I took some project types of courses, and the first one I did that was like a year long course-- what I learned is, first semester, there was somebody to train me how to do the thing, but then everybody left the class, and I was the only one left. And so, the second semester on the project, I was basically spearheading, like, this kind of modeling project, and I had only been doing it for a few months. And I noticed right in that project that I was able to keep a team really organized, really clearly articulate goals, and at the end of the project, aside from the technical work that I was doing on it, I was actually the person synthesizing the results and communicating. And it led me to think, "Is there something there that's a real strength for me? And should I be doubling down on that?" And that, that's an area I've pursued a lot in my career is technology communication: clearly articulating what we're trying to achieve at the onset, developing requirements, [00:11:00] understanding the use case, et cetera. And then on the back side of it, once we've developed something, there's an entire kind of art and science to it, to talking about technology because there's a lot of detail. A lot of the people who work in the detail of the technology want to share that science and process. But a lot of the people who then make decisions want to hear other information about the technology that might not relate to how it works or how it was built. And so by, by actually having some of those experiences in engineering school, I was able to see that this technology communication and crafting of project goals was something that was really needed for engineering teams, and it really benefited when there was an engineer who was doing that, but you had to be in a different mindset and develop a different set of skills in addition to the design work. Lindsey Dinneen: Yeah, absolutely. Now, when you, and thank you for sharing that. I love that, that bringing it all together and again, how things work [00:12:00] together to help you. I, and I'm curious. So you are, you were so well prepared, from an outside perspective at least, to go out on your own and become this high level, amazing consultant for these companies. Did you also feel ready, or was it still this sort of leap of faith when you said, "Okay, I'm going to go in, full time for myself." Dasha Tyshlek: No, I was, I was very ready. I think, like any entrepreneur, I'm going through a process of discovery by learning exactly what it is my customer really needs help with, what industries and specific technologies I'm able to bring my skills to the best. And also what types of companies are looking for help I provide. So I can't say that I knew all of that information when I started out, but I had a good experience in, in the role I left. When, when I started my business, having had walked into an engineering company that had great innovative products, but was sort of [00:13:00] underperforming in the market relative to their potential and the quality of the technology they provided and going through the process systematically of creating a company strategy with them helping them understand what pieces were missing from their business development side, and working through the marketing and the business side of things to help them better articulate their technologies. But also taking a look at the portfolio of technologies and recognizing that some of the technologies there didn't quite fit their main business model, but were really valuable, helping them figure out a path to get those out to market separate of their company, but in a way that still contributed to the overall value of the business. And after I did that, I had several years of success and meaningful impact to look back on. And I said, "I've done it, I've proven it in one place." But in my experience doing this, I just kept meeting more and more companies [00:14:00] that struggled with a similar kind of problem. They had all the innovation. They had an amazing, talented engineering team, but they either lacked focus on which products had the most potential, or they would develop a lot of stuff that they didn't know how to move forward into the market. And so I could see the problem all around me. I was solving it. And so, after I've done enough at one company. I said, "Okay, I see the need and I know that I have the skills to solve it. Now I just need to kind of open that up and create a firm around this concept that helps other companies succeed in the same way." Lindsey Dinneen: Wonderful. Wonderful. Thank you for sharing. And so since starting your own consultancy, what has been maybe one of the most impactful, or things that really stand out to you as one of the most exciting things that you've gotten a chance to work [00:15:00] on? What kind of goes, "Oh, this is why I'm doing it this way in this industry." Dasha Tyshlek: Yeah. So, just generally, I get to meet so many interesting innovators who are changing, particularly healthcare. There are very interesting transformative technologies coming to the market that utilize virtual reality, that utilize AI technologies, to do things we weren't previously able to do in medicine to make me visualize your body in a way that no amount of human brain power could have done because of the way these models can work with data. But the project or the specific thing that I think I am most excited about in terms of its general impact is, it's called Biomedical Frontiers: Stories with Innovators in Healthcare. And it's a podcast i'm producing on behalf of University of Virginia's Coulter Center for [00:16:00] Translational Research. It's a center that focuses specifically on biomedical research that has potential for commercialization, or you could say translation, into the clinic, and they fund that research. They help with the business development efforts to bring that research into the world. And the podcast supports that mission by both highlighting the technologies that are a part of that portfolio, as well as that are connected to that portfolio, but also by educating people not only on the process of invention and the process of innovation in the medical and life sciences industry, but I think, very importantly, about what is coming: the hope and the good news about some of the incredible things that are coming to the market and to the world to help solve some of our intractable problems. So, I think in terms of human impact, that's probably the, something that I'm working on with, with a tremendous [00:17:00] vision that is available to all to participate in, to listen or, to be interviewed on. Lindsey Dinneen: Excellent, excellent. And can you just share a little bit too about your experience becoming a podcast host because you have kind of an interesting, unique story with that. And then how can people listen to this podcast? Where is it available? Dasha Tyshlek: Yes, of course. So public speaking and presenting technology, something that I've been interested in for a long time. And even before I started my business, in the Director of Marketing kind of roles that I've done, I've realized that video and audio communication, kind of deep diving in technology, helping create content that educates people because in a lot of engineering, even deep engineering technology areas-- you're working with other engineers who are deep in some technology area that you don't necessarily understand. There's a lot of miscommunication that happens because of that and podcasts are just such a [00:18:00] powerful way to bring more education and deep conversations about various topics, including very niche topics into the world. So I've kind of experimented with interviewing video interviews for some time now. But when I started my business, I was working alongside another business, Sales Chasers, and the founder of that business, Michelle Page, she and I were just kind of throwing around ideas. How do you grow your business? How do you find customers? What things we were interested in? We started kind of collaborating because you know, when you're starting a business, it's just you and headphones and your computer and it you know, you kind of miss-- especially if you're in a business development communicator role-- you're like, "Ah, I need people." I'm, I, I need some, some sort of co working to go on because it's, it's too lonely. So she and I were each other's co workers in that way, kind of similar stages in our, in our different consulting firms. So she and I decided to do a project called Go Go Grow, focusing [00:19:00] on business to business scaling with each of us coming up with some lesson plans on kind of key frameworks, tools, or ideas that are really important to business to business type of business growth. And so she and I developed that Go Go Grow together and put out a season focusing on kind of the fundamentals that we think are the most important, with some interviews of experts as well as some content that she and I kind of lesson planned together. And she's continuing on with that into other kinds of topics, but I was already working on this podcast, and I was teaching at University of Virginia, a class in the biomedical engineering department focused on engineers' professional development skills. And so when I was talking to my co lecturer who is the professor at the University and the head of the Culture Translational Research Center, he had this idea of "We should do a podcast." And I said, "Let [00:20:00] me help you. Can I please do this?" So I created a vision for what we could do, tying his foundations' mission and the goals that we were both pursuing in the class in terms of professional development for biomedical engineers. And then presented it to the engineering department, to the biomedical engineering department, and that's how we got started. Lindsey Dinneen: Amazing. Well, thank you for sharing that. And yes, please go check out her podcast. It's going to be just really informative. You'll learn a lot and you'll also get a lot of inspiration, like she said, about the fact that there's so many new amazing technologies emerging, there's a lot of reason for hope and optimism, and that's a good reminder, especially nowadays. So absolutely. Well, I'm curious, are there any moments or any one moment that stands out to you as just this [00:21:00] realization that you chose the right industry, you chose medtech for a reason, that it just kind of clicked into place, "Yes, this is why I'm here." Dasha Tyshlek: I think there's been a couple small moments, but each meaningful. I think when I got my first client that was really outside of my existing network. It was somebody I met through the work I was doing of developing my business, and not somebody who I'd previously known or worked with or anything like that. I think that was a real key moment. That's like a line that you cross. You're like, "Okay, this is not about my network or the people who sort of know me. My value and the skills are clear. I can clearly articulate them to somebody else, and somebody else can put the trust in me to help them deliver something." So I think that was one is that first client that's sort of outside of of anybody you knew at the moment you started your business. [00:22:00] I think the second one was really landing my first kind of big client, a company that really does a lot of technologies and they're not necessarily like a startup. They're mature. They have a lot of technology. They have a lot of process. That was, that was something that was like, "Okay, now I know that I'm starting to get into the kinds of companies that I'm envisioning helping and they are seeing the value that I can provide them back. So we're in agreement and it's starting to make sense." I think the third moment was when, so I have an analyst on my team. I also have some different suppliers and people, other consultants that I work with, so kind of distributed network plus starting to build my internal team. And the first time a client approached me to actually hire somebody, my junior consultant, from my team on a project based on something that this person did for a project that I was primarily working on. And so really starting to [00:23:00] see that some of the processes and systems and ideas I'm putting in place, that it's no longer just because of me, but now it's starting to say, it's because of the company and, and their skills that other people on my team have that, you know, knowing that I manage them and knowing their skills, they, they want to hire them and me because of them. Now I know that I'm moving beyond sort of sole openership and into-- there's a company here and we're developing a shared capability. So that sort of reinforces the vision and opens up a lot of possibilities. Lindsey Dinneen: Yeah. That is incredible. First of all, you know, congratulations because it's hard enough when you venture out on your own, but then to go ahead and have so much success and I'm sure-- you know, you have that daily grind so it's not always all sunshine and rainbows-- but to be able to grow your team and to have that moment of, "Oh my goodness, this is a company. It's not just me now, it's a company and there's other team members and we're all providing such [00:24:00] value to our clients." That is amazing. Congratulations. That is just the first step. So I'm really excited for you. Dasha Tyshlek: Thank you. Yes, me too. Lindsey Dinneen: Yeah, absolutely. Well, pivoting the conversation just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything that you want. It can be in your industry. It doesn't have to be. What would you choose to teach and why? Dasha Tyshlek: Oh, that's a tough one. I actually have a competing hobby that I would probably choose from, and that is how to set up a wonderful backyard garden that produces food and flowers for the season. I think we I think we need more backyard gardens and more gardeners. But I think I would have to spend that entire million dollars on getting people to attend. So maybe not the best choice of a million dollars, but professionally speaking, I think I would love to teach about setting up frameworks [00:25:00] for thinking about-- any kind of problem really-- but business development related problems. I think there's, there's a lot of really great frameworks out there teaching people how to use them in order to anchor your thinking and your decision making in kind of a shared understanding of priorities that requires a framework. So we could start with the frameworks that exist, but teaching people how to think outside the box and create their own framework for the situation, how to be basically their own strategy consultant in PowerPoint or on paper and help them think through problems that are complex and chaotic by creating frameworks would be, I think, really valuable to many people. I don't think it's taught very often. And certainly it's it's such a huge leg up on any kind of problem solving that you have to do to be able to kind of anchor yourself in a structure before you go and start making [00:26:00] decisions. Lindsey Dinneen: Yeah, I love that. I love that idea too, because especially something that you said really struck a chord with me about solving the idea of chaotic and overwhelming problems and creating a framework for that. There's so much of life is, I mean, life is a learning curve, right? So there's so many times where it might be very helpful to approach even a personal problem or a personal challenge that comes up with the idea of a framework where you can say, "Okay. Yes, this feels overwhelming and anxiety inducing, and whatever other big feelings you have about it that make it feel so overwhelming you can't even get started." But what if you think about it in terms of a framework and how could that help you take it out of all of the emotion, maybe, and help you transform it into, okay, this can be resolved is some creative problem solving strategy. I think that'd be amazing. Dasha Tyshlek: Yeah, and sometimes [00:27:00] when you put things in a framework, you discover that either pieces of information that you need to actually make a decision or a path forward are just missing. You put it in a framework, you're like, "Oh, of course, it makes sense, I'm missing this whole thing of information." Or, alternatively, so it can actually stimulate that aspect of creative thinking, but also it can prompt more idea generation. And, and I do find sometimes-- it's like the problem diagnosis-- sometimes if I come into a scenario where there's a lot of confusion about, "What do we do? How do we move forward? What product should we choose? What business model should we choose?" The first thing to do is to create a framework for decision making because, you go and you do the research and you get the information, you still don't know which one to do because the information by itself, you know-- unless the information's like there's zero opportunity here, but there's never information like that. The information's always that there's some pros over here, and some [00:28:00] pros over here, and some cons, and some cons. So without the framework you just drown in the amount of knowledge. Facts without a framework don't lead to a decision, they just lead to a lot of facts. So learning how to step back, when do you actually go back to a framework, and how do you create a framework for this situation, because sometimes it feels like you don't have a framework for this situation, the situation's unique. But you can then come up with your own framework, merging ideas from other frameworks, or utilizing your own creative skills to kind of draw up a structure within which you can make decisions. So. I think that would be, that would be a very fun master class. Lindsey Dinneen: It would be fun and super valuable So I'll sign up for that when you give that Well, how do you wish to be remembered after you leave this world? Dasha Tyshlek: I always focus on three areas of growth for myself. When people ask me what I want to be, I think "kinder, wiser, and more courageous" is what I want to be over time. And [00:29:00] so I would hope that, I don't know that those things have a definite end, but if I can be remembered as having worked towards that in a way that people felt in their lives, then that will be good. Lindsey Dinneen: Yeah, that's a beautiful answer and finally, what is one thing that makes you smile every time you see or think about it? Dasha Tyshlek: Flowers. I love, especially on the side of the road, when you're driving somewhere, and sometimes you see that nowadays on highways, there's been some wildflower planting. That's just so good. It's good for the environment, it's beautiful on the eyes, it's good for the bees. So, so always happy to see more flowers being planted for a more beautiful world. Lindsey Dinneen: Yeah. Oh, I love that so much. Great answer. Well, thank you so very much for joining me today, Dasha. This has been such a pleasure, and I'm just so impressed with you and [00:30:00] everything that you're bringing to the world to help these amazing companies become even more effective, and this creative problem solving that you bring to it with your frameworks and whatnot. So, I just want to say, you know, a huge kudos to you for everything that you're doing: the podcast, I hope that all of my listeners go and check hers out as well. And yeah, just thanks for being here. Dasha Tyshlek: Thank you for having me. Lindsey Dinneen: Of course. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. And we wish you continued success as you work to change lives for a better world. Dasha Tyshlek: Thank you very much, and thank you for that donation on my behalf. Lindsey Dinneen: Oh, yeah. And thank you also to our listeners for tuning [00:31:00] in. And if you're feeling as inspired as I am right now, we would love if you would share this episode with a colleague or two, and we will catch you next time. Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit [00:32:00] velentium.com to explore your next step in medical device development.

Meet Holly Rockweiler, CEO of Madorra. This episode explores the transformative journey of Madorra from a Stanford Biodesign fellowship project to a pioneering force in women's health aiming to revolutionize the treatment of vaginal atrophy and dryness without hormones. Holly's story is not just about groundbreaking medical devices, but also about the passion and determination that drive the quest for better healthcare solutions. Through engaging storytelling, this episode unveils the challenges and triumphs of bringing novel technologies to market, the power of female leadership in STEM, and the broader impact of MedTech on improving lives.  Guest links: www.madorra.com | https://www.linkedin.com/company/madorra-inc-/ | https://www.facebook.com/MadorraMedical | https://twitter.com/MadorraMedical Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 033 - Holly Rockweiler [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:51] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Holly Rockweiler. Holly is co-founder and CEO of Madorra, a woman's health company dedicated to changing the treatment paradigm for vaginal atrophy and dryness. She co-founded Madorra as a spin out of the Stanford Biodesign fellowship, where she implemented ethnographic research to identify unmet clinical needs and define user market and product requirements for solutions and women's health, urology, and infectious disease. Prior to Biodesign, she worked as a Senior Research Scientist at Boston Scientific, where she developed therapies to enable more efficient care for patients living with heart failure. Her preclinical and clinical research has led to more than 20 pending and issued patents. Holly holds an MS and a BS in Biomedical Engineering from Washington University in St. Louis. Welcome, Holly. It's so wonderful to have you here today. Thanks so much for joining us. [00:01:49] Holly Rockweiler: Thanks for having me. [00:01:51] Lindsey Dinneen: Yeah, absolutely. Well, I was wondering if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry. [00:02:02] Holly Rockweiler: Sure. So let's see. So my background is in biomedical engineering. I majored in biomedical engineering. Maybe I can say why, like I, I knew that I wanted to be an engineer. I felt like, well, first of all, as a woman in math and science growing up, when I did every teacher told me to be an engineer, but I didn't really know what that meant until I got to college, but I liked it. Pursued engineering and I started undecided, but very quickly found that I was, most just excited about the problems in the biomedical engineering field. I remember one of my classes was like "calculate the torque of a drill on a tooth," I was like, "Wow, that's amazing. I think I found it." [00:02:41] So majored in biomedical engineering, got my master's and bachelor's at Wash U in St. Louis, and then I went to work for Boston Scientific. And so they are a medical device company. And so that's obviously how I got into it, but I did seek that out. When I was thinking about what did I want to do, I thought about... chemistry was never an area I felt very strongly about. I liked stuff I could hold in my hands and really conceptualize. And so I think that's what led me more in the device road and then had a incredible opportunity to work at Boston Scientific. [00:03:15] And so I worked there for several years in their implantable cardiac division. So that's pacemakers and ICDs, working in the research department. So that was also really cool because we were on the front end helping to define the next generation products and was able to also work very cross functionally. So just because research conceived of an idea didn't mean it was going to be in the product development had to help it go forward, and obviously we were keyed in very closely with the marketing team to understand. What were the needs that we were solving. [00:03:45] So it was an incredible introduction to our industry. And then I decided that I wanted to try a smaller company. There was just some broader themes of working in a large company that didn't totally jive for me. And so I was like, "Well, I don't know the first thing about startups." So I had heard about the Stanford Biodesign program, which is where I went next. And the company that I started, Madorra, is a spin out of that program. [00:04:14] Lindsey Dinneen: Wow. Okay, so your path is really cool, and I love that you are an engineer, and I love your passion behind it too, just hearing you talk about that one random problem and your excitement about it. I adore that. I do. Because that is not my leaning. So whenever I hear somebody just get really excited about that kind of thing, I'm like, "Yes, tell me more." [00:04:40] Holly Rockweiler: Well, then you're in the right field too, I would say. [00:04:42] Lindsey Dinneen: Indeed. Indeed. Indeed. So, yeah. I'm just curious. Okay. So, so going back just a little bit, you started off at Boston Scientific and kind of developed this appreciation for the medical device space and innovation. And then with Stanford Biodesign, can you tell me a little bit about being a part of that and then how you were able to spin off into your own company? I mean, that's not, that's like a one sentence thing that you put in there, but I know that it took a lot of work, and I'd just love to hear about that process, and your experience. [00:05:17] Holly Rockweiler: So, absolutely. So, the Stanford Biodesign program has many different facets. I was part of the fellowship, but they also have classes they teach and books and online resources. And then other universities have kind of sister programs around the world, frankly. So I was very interested in joining the program, like I said, to kind of-- what I was telling myself was like a way to dip my toe in the water of what a smaller company would be like. Now that's not at all what Stanford pitches the biodesign program as. Really what it is a an academic training program for an innovation process. And that's what they teach you. Now there are a lot of companies that end up spinning out of it. [00:05:56] And so I thought, "Well, maybe, like I said, this is a way to dip my toe in the water, but also if I decided to come back to a larger company setting, this skill set still would be highly useful given what I want to do in my career. So that's what I set out to do. And so the program I love, I think is fantastic. It's as described initially, it's this innovation process and they teach you that in a very hands on way. So first you start with really understanding and building a list of unmet needs, and so that starts by looking for problems in Stanford Hospital. You kind of have this unfettered access as an engineer. It was the 1st time I had that, you know, observe and ask questions and talk to physicians and patients and other health care professionals and then. you end up with, obviously, a long list of problems that you can find, just like any, anywhere in the world, right? This could happen. But also this, in healthcare, it happens. [00:06:55] And then you translate those problems into what the program calls need statements, to really-- there's a lot packed into that, but once you have those, then you spend the bulk of the program actually learning how to filter that long list of problems down into a couple key top unmet needs that you're working on. And so again, this is their goal is academic. They want to teach them their product is the people. They want to teach people this process and have them go out and share this process and use it to be successful in whatever, you know, vein they end up going down. [00:07:32] And so I was like, I was just having a conversation with my husband this weekend. I was like, we were talking about something interpersonal and I said, "Well, the unmet need here really is..." So it certainly has, you know, I've drank the Kool Aid completely and love to share it. So, but anyways, so, but what happens because you're working hands on these projects you very often, which was the case for myself and my co founders, by the end of the year, you may have something that you're pretty passionate about. [00:08:00] And so what has now become my about me description is working in women's health. I had no idea how passionate I would be about. I feel like I kind of backed my way into it, but now kind of reviewing that history, it's like, "Oh, maybe I was always kind of destined for this given my interest in, in, you know, activism." So kind of combining all of this together is what led us here. So, spinning it out was a consequence of having a lot of hard work with my team throughout the year. And we had other projects too, but this became the one that kind of survived every stage gate. And we ended up spinning out. into the company, Madorra. [00:08:42] Lindsey Dinneen: Wonderful. Well, thank you for sharing a little bit about that. And also, I love the crossover into real life, not that's not real life, but I do your daily life as well. Oh my gosh. That's great. I'm going to start doing that. Okay, so can we talk now a little bit about your company and the product that you've developed and where you're kind of looking to take it in the future? [00:09:05] Holly Rockweiler: Certainly. So, again, being born out of Stanford, we started with an unmet need around creating a treatment for vaginal dryness and atrophy for postmenopausal women that didn't rely on hormones. So this is a problem that I had never heard of before we literally met patients with this problem and talk to providers about this problem. And as we started researching, "Wow, up to 75 percent of all postmenopausal women are dealing with some, you know, degree of this. How have we not heard of this before?" That is a striking number of people. [00:09:39] And so as we continued to do our research, very quickly learned the gold standard treatment here is hormone therapy, but even though this market is huge, only 7 percent of the market is using hormones today. And so that... there's a lot of reasons why, but that's really what motivated us to say, "Wow. There needs to be another option." Because if you don't want hormones right now, the only other FDA cleared product or category for treating this are over the counter lubricants and moisturizers. And those are like, both of the products that exist today are really, those categories are really great, but they're not enough. [00:10:16] And again, with 43 million women in the United States with this problem, like we need more than just those two categories. And it really felt like no one had really looked at this. I mean, hormones, again, are a good solution for the patients who want to or can use them. But for patients who can't, for example, breast cancer survivors, they're stuck with, you know, just kind of subsisting off these over the counter products that really are not enough when your case is more moderate or severe. [00:10:43] And so we said, "Well, let's look at this and see if there's a better way or, you know, something we could combine," and ended up developing the idea for what is now the main product that we're developing at Madorra, which is a home use device that uses ultrasound to really rekindle the body's natural lubricating process. And so our whole goal has been to be very supportive of the other products in this category. We think hormones should be used more often than they are, frankly, but that women shouldn't have to make a compromise. If they don't want to use hormones, then they should have other options, and that's where we come in. [00:11:21] So our product, we will, it's not on the market yet. We're working towards that, but when it's out there, what we envision is a prescription happens from the gynecologist, and then the patient uses the product at home on a regular basis to, like I said, kind of revitalize that natural process. And what patients have told us they like about this is that It is restarting their own natural lubrication rather than some exogenous hormone or chemical. And there's less of a kind of a goop ick factor, you know, than having to use these over the counter things, which again, they like say that not to say that those don't have their place because they absolutely do, but it's not enough. [00:12:01] And so, we're pre FDA clearance, but we have a breakthrough designation from FDA. So that's feather in our cap and will help us get through the agency more expeditiously. And we have done several clinical trials and look forward. We've published one of those trials in our first manuscript, and we look forward to putting more of our data out there to help really lay the foundation to say, "Yeah, ultrasound is an appropriate approach to treating this and has virtually no side effects." So this should be a great option to be available to as many people as possible. [00:12:36] Lindsey Dinneen: Oh, that is incredible. Oh my goodness. Well, yeah, first of all, again, you know, it boggles my mind and it probably shouldn't anymore, but it continues to when you tell me statistics like this, that 75 percent of women who've are in this situation or have this concern or whatnot. And you're just think, you're addressing it in a way that's so innovative. And yet that hasn't really been addressed yet and it happens again and again with healthcare for women. And I'm wondering, you know, you mentioned earlier being very passionate about this. So I'm wondering if you can speak a little bit to fem tech and women's health and how you're involved in helping to push the conversation forward 'cause I know that can be a little challenging at times. [00:13:23] Holly Rockweiler: Absolutely. Yeah. And well, it's super fascinating too, because we spun out of Stanford in 2014. So we're coming up on 10 years here and the conversation is so different today than it was just, well, just 10 years. I mean, it was a decade, but it feels like yesterday. Like a lot has changed. When we first were starting Femtech wasn't a hashtag, like that was not a conversation. And people would say like, "Ooh, that's a niche." Yeah. And that doesn't happen anymore, which is really great. So while that's, that's certainly progress, so we should acknowledge that and be proud of everyone who's worked towards creating that progress. So I think what's been interesting, though, it's like the pace of progress, maybe? [00:14:09] So it's very exciting to know that there are, for instance, obviously I spend a lot of my time fundraising, there are women's health focused venture groups now. They, that's fantastic. That we just need bigger and bigger funds to be focused on that. We just need more and more We need more of everything, right? I mean, one of many things I've been very surprised to learn is how little training physicians get on menopause specifically. And so that has to change. And so there's just like a lot. [00:14:40] And so to the point of activism, like there's a lot to say, and so I think, it's... being raised by parents who are feminists, that helps, I think, me just start by saying, "Well, no, this shouldn't be . We can do better, and we will do better." So that's helpful, and I think that's also what really keeps me going-- obviously, every job is hard, and in our startup world, this is certainly a lot emotional rollercoaster. And so when I think about when I have harder days, it's like, "Wow." We've had patients tell us, for example, "I can't believe you're even paying attention to this. I can't believe you're listening to what I have to say." And so one, that's disturbing that's, as little as it's needed to make someone feel better. Secondly, it's "Wow, we can have such an impact by just being out there." So like the fact that we exists, I always think is helpful and that we do things like this and have open conversations about vaginal health for an aging population. [00:15:39] I will also say that, a year ago at the Super Bowl last year, there was an ad for a hot flash drug. And so that's like, you know, the world stage, menopause is being discussed. That was not happening 10 years ago. There is real progress being made. The last thing I want to say is that one thing I, I have also really appreciate about working in women's health and how supportive everyone is of everyone else. Every, anytime, even like our closest competitor, when I met their CEO, she was wonderful to me and, you know, shook my hand and said, "How can I help you?" And it's like, "Where else does that happen?" That's incredible. I think 'cause we all see there's a lot of work to be done. We can't do it alone. We want to support each other. [00:16:19] Lindsey Dinneen: Oh, I love that. Yeah, that is something that I have really admired and appreciated about the medtech industry. I think because people are curious, and their mindset is very innovation problem solving, "how can I help?" It seems like even with competitors. Yes, we're maybe vying for similar people to sell to. However, there's this idea of camaraderie, which I don't find in a lot of industries. So yeah, to your point, I think it's really helpful to have those allies in the space because that's, it's a little different. [00:16:53] Holly Rockweiler: Totally. [00:16:54] Lindsey Dinneen: Yeah. So yeah. And I, I love what you were saying about these conversations are happening more and they're becoming more mainstream and less embarrassing or taboo, which sounds hilarious because it's 50 percent of the population or whatever. But anyway, the point being, it is exciting to see this continue to move forward. And I'm wondering, even as a company, obviously your next big hurdle is getting that FDA approval, going to market and whatnot. But as you continue down the road, what other kinds of problems are you looking to solve? Or are you not even there yet? This is just like, "Let's start here. We'll get into that later." [00:17:38] Holly Rockweiler: Yeah. No, it's a great question. I think like what kind of harkening back to the just the prior question about the community of women's health. It's like you can't go a day without finding five other problems that you want to solve. So absolutely. I think that yeah, I mean, like with Madorra, we are very focused obviously on this technology and developing it, but we certainly have a roadmap of where this technology could go and other ideas of where to take it. And then what I find fascinating is that there is no menopause "brand." Like no one owns menopause, which I, if I worked at Procter and Gamble or Kimberly Clark, I would be like, hopefully 15 years ago, I would have said, "Guys, let's do it." So it's very surprising to me. So I think there's a lot of opportunities. [00:18:23] So would Madorra be that brand? I would love that. We would need a lot of other products that come together with us. So what I really see is a roll up in the future of multiple women's health products together. So I think that's exciting. In terms of, also a little bit maybe more broadly speaking, and this is no surprise to you, I'm sure, or your listeners, that reimbursement is an area that needs massive... I don't know, I was gonna say like overhauling, but that sounds pretty drastic. [00:18:53] It just needs to be clearer and cleaner and simpler. In terms of a process. I'm not saying that we should be handing out reimbursement left and right, but any investor conversation I have is, we go there immediately. And it's like, "Okay, what's the path? Well, why do you think that's going to happen?" And when, you know, X, Y, Z, other company had this happen and I can, we have a good strategy. I think I have a good pitch, but, oh, just... it just is an area that is really murky, and given that's a really critical piece in any business is how are you going to get paid? That's an area that I think there's a lot of good work being done. It just moves at a pace that is painfully slow. I don't have anything insightful to say about it except that, thank you to the people who are working on it, and I support you. I think the TCEP program is a step in the right direction, but even that has been very slow, and not without its own issues, so. [00:19:53] Lindsey Dinneen: Yeah. Still work to be done, but thankful for the work that is being done. [00:19:58] Holly Rockweiler: Well said. Yes. [00:20:00] Lindsey Dinneen: So, yeah, so, okay. So obviously, listening to you speak about your background and about the industry, it's really clear how passionate you are about this. And I, I wonder if there are any moments or series of moments that stand out to you as kind of confirming that, "Yes, I am in the right place at the right time. I'm here for a reason." [00:20:23] Holly Rockweiler: Oh, good question. Yeah. I'm trying to think like, there are plenty. There's plenty of times in the moment where it's like, "Of course, yes." And then there's like quickly like, "Oh, what's the next fire I'm trying to put out?" So it's hard to really think. I wish I had a super answer right away. I'm thinking, I guess I always come back to the patient and so like hearing-- so we've done some clinical trials in Australia and various team members of ours have gone over and been able to support the trials and be a part of them. And just hearing the stories that they bring back, it's just like, "Yes, we have to keep doing this." [00:21:01] One of our employees was there and came back with a couple stories of one of them was just like after the study visit, the patient was speaking to her and was saying, "It's a conspiracy of silence. This is a huge problem. So many of us are suffering. We're so glad you're here." And then it's other things like we did, for instance, a human factors study that was really helpful to us. And we learned a lot from, and in that study, it was like patients came in to do mock use of the device so we could improve our training materials and also, you know, all parts of the user experience. And it was amazing to me. [00:21:38] So patients, you know, participants, I should say, got zero benefit theoretically about being in that study. It was all for us to learn how to do this better. I mean, we did compensate them, but marginally, right? And so many people wanted to be in that study. And even if it was the early on patient who had-- I'm going to make it up. I had like, "Oh, the user manual didn't make sense to them" or something. They were still like, "I'm so glad to be here to help you because this product needs to be out there." And so it's like, " This is incredible. Yes!" And that part is really rewarding to me. [00:22:09] For me, it's the patients and their feedback and just their enthusiasm. And then, I was gonna say also for the healthcare providers too, we have a lot of wonderful physicians that we work with and their support has been helpful. Like for instance, as I mentioned, we put a paper out there and one of our clinical advisors was highlight, or I think a couple of them highlighted to us that like, "We need to do a second paper on a specific subset of that data because it's super valuable and hasn't been out there before," which may be the clinicians do that for everything they do 'cause they, they know the scene and they know what needs to be published, but it just felt like we have a lot of people who really are rowing in the same direction and really want to make an impact like we do. [00:22:49] Lindsey Dinneen: Oh, wow. Yeah, that's incredible. Thank you for sharing those stories. I think, you know, as you alluded to earlier, because your role has so many components, because that's the space you're in and you've got so much going on, I think it's really compelling to have something to hold onto when it gets hard and go, "You know what? I remember that patient who was so thankful just to have the opportunity to be a part of it and just wait until this gets into the hands of so many more." [00:23:15] Holly Rockweiler: Totally. [00:23:17] Lindsey Dinneen: Yeah. Yeah. Yeah. And so for you, you know, you obviously have a very strong background in engineering and innovation. How was it for you going from that to also now being an entrepreneur, and having a business, and having to also learn all of those skills as well. How was that transition? [00:23:42] Holly Rockweiler: Fun. I think that-- there's a lot of personal growth, and I've learned a lot about myself and what where I find passion. So I think there's definitely a lot of hard parts too, but what, well, one thing is that I think there's also a heavy dose of naivete that was important. I didn't know what I didn't know. And so here I am 10 years later I think, you know, in the beginning too, I was not... what do I say? I wasn't convinced, yeah, I wasn't convinced that I could be a CEO, that I should be or could be. And so I think that was, and is maybe still a definitely a continuous journey to it. So why is, why did I think that? What does that mean to me? And where am I now? That's been certainly a learning process. [00:24:31] But that's also like why I said fun, because I, I get to do such a variety of, like, I get to have this opportunity to speak to you on this podcast. I get to work with our clinical advisors on a paper. And I also get to apply for grants. And there's a lot of hard things that come with all those things, but I feel like it's been a really, I don't know, just an incredible opportunity to have a job that It requires so many different things. It also requires me to do financial modeling, which I'm terrible-- well, was terrible at-- have learned and much better at, but also don't really love doing. [00:25:04] So it teaches you what, what you might look for in a future chapter of your life as well. But I'm someone who really thrives on, I have a very curious mind. So trying new things and figuring out new things. And that, I think that curiosity is well satiated by an entrepreneur's life. The managing your own psychology is really difficult, but that's why you have a great community of people around you, both within the entrepreneur community and outside of it. [00:25:36] Lindsey Dinneen: Oh my word. I think I just need to take what you just said those last couple of sentences and just make it into a quote because that was so well articulated. [00:25:45] Holly Rockweiler: Oh, thank you. [00:25:47] Lindsey Dinneen: I cannot think of a better way to describe that journey. So thank you for, but also thank you for being vulnerable and willing to share that, because it is such a journey and it is a learning curve, but kudos to you for embracing it with an attitude of fun, like, "Let's just learn something new and it might not go great the first time, but that's okay. I'll try again." [00:26:10] Holly Rockweiler: Yeah, I was thinking, I was like, "Well, if any of my investors are listening, I have gotten really good at a lot of these things, so y'all don't need to worry." But I do think that's maybe the blessing and the curse of being a first time entrepreneur. So I think, you know, there's certainly a lot of benefits for having done it before and knowing exactly what to expect. But I think with anything in maybe any regulated industry, or maybe any startup, really, there's always going to be curveballs. So that keeps you excited. [00:26:41] Lindsey Dinneen: it's never boring. It keeps you on your toes. There's at least that. [00:26:45] Holly Rockweiler: Yes, absolutely. [00:26:47] Lindsey Dinneen: Excellent. Pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach and why? [00:27:04] Holly Rockweiler: Oh, that's interesting too. And that's a nice paycheck. [00:27:08] Lindsey Dinneen: Right? I [00:27:10] Holly Rockweiler: Let's see. It's getting right to what do I think I'm good enough at to teach a class about. So, I mean, I think one thing that I've been thinking about a lot recently is scientific communication and how, how different voices get amplified and how the kind of stereotypical scientific persona is, it's not the one that wants to be necessarily on social media with a gazillion followers and all these TikTok videos. So I think that I would like to teach the class in concert with, I have a lot of ideas of like, who would be a great way, who would be great people to collaborate with in order to teach or really to help promote more scientific discourse in a conversation that's appropriate and approachable for anyone. [00:28:04] I think that obviously our country has faced a lot of division and I don't think that's really true. I think that a lot of that is-- well, there certainly is a lot of division. I don't mean that. I just mean that I think there's a path to human connection via communication and that, wouldn't it be cool if we could help bridge conversations. And obviously I'm, I am a scientist. I think of myself as a scientist, so I want to think about ways to provide other voices out there to be amplified as well, or perhaps amplify the right voices to help promote just a more enriched dialogue than what is often presented as the country's dialogue today. [00:28:48] Lindsey Dinneen: I love that. [00:28:50] Holly Rockweiler: It's kind of rambling. I can get back to you with my course description, but that's probably where I would go. [00:28:56] Lindsey Dinneen: Syllabi due Tuesday. No, I think that is absolutely incredible. And I love that because I think that is something that's missing and there's some translation error that occurs. And one of the things that I'm passionate about is helping to bridge that gap between-- so I'm right on board with you-- but to bridge that gap between maybe taking some what are traditionally considered complex ideas, concepts, whatever, and distilling it down to a more accessible format. And because everyone learns differently, it's just helpful to have a wider range of options. [00:29:35] Holly Rockweiler: Totally. [00:29:36] Lindsey Dinneen: So I love what you would be passionate about sharing. I mean, I would sign up for that masterclass. [00:29:41] Holly Rockweiler: You can help me teach it, I think. [00:29:43] Lindsey Dinneen: Okay. Deal. We'll get back on that. [00:29:45] Holly Rockweiler: Okay. [00:29:47] Lindsey Dinneen: Excellent. Yeah. How would you wish to be remembered after you leave this world? [00:29:53] Holly Rockweiler: You have some great questions. Yeah, let's see. You know, I've honestly never thought about that. I think that I would, what would I want people... well, I think about like what I would want my friends to think. That, like, they were loved and that they hopefully shared that love broadly. But then, well, let's see, that's not really, like, remembering. Yeah, I guess, maybe it is. So, yeah. That I'm a lover, a curious person, and that I, there is a lot of beauty in the everyday, and so there's a lot to be excited about even on the hard days, [00:30:32] Lindsey Dinneen: Yeah. I love that. And then, final question. What is one thing that makes you smile every time you see or think about it? [00:30:41] Holly Rockweiler: Certainly my family. I have a four year old son and he is, keeps me very present and cracks me up continuously. And so, my husband and I are very lucky to have him. And obviously my husband makes me laugh. A lot. And so I really appreciate them. And so even when, you know, the work day is hard, I feel really fortunate to have a very rich personal life outside of that. So my family and then my friends also. [00:31:09] Lindsey Dinneen: Oh, yes. Of course. That's wonderful. And I'm so glad you have that amazing support system to bring that smile to your face, especially on the tough days. [00:31:19] Holly Rockweiler: Absolutely. [00:31:20] Lindsey Dinneen: Well, Holly, this has been a wonderful conversation. I'm so thankful for you and what you're doing in this space and the fact that you're tackling an issue that affects so many people, and that you're just bringing all this innovation to, and you're so passionate about sharing that in a way that resonates with people. So I just want to first say, you know, thank you so much for the work that you're doing. I know it's not easy and there are probably days where you, you just kind of want to, you know, toss something in the trash, but honestly, thank you for continuing to do the work you're doing. It's not nothing. And I want to appreciate that. [00:31:59] Holly Rockweiler: Well, that is very kind. Thank you. And that means a lot. And thank you for doing what you're doing, too, to give people like me a chance to share, and also us to listen to others sharing their stories. And for asking, I will say, asking questions that are more about me as a whole person too. I think that when I've been in other conversations sometimes are really-- and there's nothing wrong with those, but it's fun to have, we can ask these questions. I'm like, "Wow, I would do some thinking this weekend about how I want to be remembered" because I've never thought about that. [00:32:30] Lindsey Dinneen: Yeah. There you go. I love it. Well, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you for choosing that organization to support, and we just wish you continued success as you work to change lives for a better world. [00:32:59] Holly Rockweiler: Well, thank you. It's been a pleasure. Thank you. [00:33:03] Lindsey Dinneen: Me too. And thank you so much for our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:33:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Mark Oreschnick, a MedTech industry leader and the founder of Evolve Engineering, shares his journey of nearly 30 years in engineering and leadership, starting in aerospace before landing in the medical device industry. With a passion for mentoring and helping startups, Mark discusses the importance of right-sizing staff and systems for success. This conversation not only showcases the human side of technology, but also highlights the power of networking and building relationships for personal and professional growth. Guest links: https://www.linkedin.com/in/mark-oreschnick-82367a8/ | marko@evolve-engr.com | www.evolve-engr.com | https://www.linkedin.com/groups/14248328/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 032 - Mark Oreschnick [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey and I am so excited to introduce you to my guest today, Mark Oreschnick. Mark is the founder, owner, and president of Evolve Engineering, LLC. With over 25 years working in and leading engineering and operations in small, such as four employees, to large, such as 15,000 plus employees, companies, he has gained valuable experience he will use to complete your project as efficiently as possible. Mark's career has focused on developing products, processes, people, and businesses. Mark, thank you so much for being here. I cannot wait to talk with you all about what you're doing and your background. So thanks for joining today. [00:01:36] Mark Oreschnick: Thank you. I'm happy to be here. [00:01:39] Lindsey Dinneen: Wonderful. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself and your background and maybe what led you to MedTech. [00:01:47] Mark Oreschnick: Okay. I've been an engineer and leader for nearly 30 years. I started in the aerospace industry in college, and while I was an intern, I was offered a full time position to work as an engineer for my last year of college. So I did full time school and work, which I think very much set me up for my life in startups because I was sleeping about two and a half hours a night. [00:02:15] Lindsey Dinneen: Oh my word. [00:02:16] Mark Oreschnick: So, after that, I just kept having bosses challenge me with a variety of different projects. I've designed and built buildings for two different companies, automated. Equipment doing 16 million packages in four months, shipping out of a company, totally different industry and 20 years ago, coming this Valentine's day, I started the medical device industry. So, I'm coming out of my 20th anniversary right now. And within the medical device industry, I've been in really large and really small companies, both on the operations and manufacturing side and the R&D side. And I'm currently working with my seventh startup. So that's, like I said, the world of startups I've really enjoyed. [00:03:02] And now I've moved into consulting full time, and I'm working with startups as a fractional CTO. So I'll put together their technology roadmap, help build their R&D team, work with the founder on what I've learned from my experience. What are the good things to do? What are the bad things to do? And how to right size your staff and your systems to be successful. [00:03:26] Lindsey Dinneen: Oh, that's incredible. Well, thank you for sharing about that. It's so much fun to see how little bits of threads throughout your career kind of interweave, and then all of a sudden they've produced this really cool thing. And that's now you doing this on your own and consulting. And I just love hearing about that. Several things just stood out to me and I'm curious. Okay. So, so you said you sort of set yourself up for success by being like full time college student, full time working at the same time. And then yes-- so can you start by: where did this drive in this passion come from, because clearly your work ethic is astronomical and wonderful, so maybe start there. [00:04:11] Mark Oreschnick: I would say it comes from my parents. Definitely did not grow up on the rich side. So everything that we had in our lives, we worked hard for. And I learned that if I wanted something, I needed to go out and get it. So, I think that was a good attitude that my parents put into me. And then they also, I won't say over expected things from us, but it was more, if you say you're going to do it, you're going to do it, figure out how to get it done. Just live up to what you say you're going to do. And that I think automatically put a drive behind me to just, all right, and you offered me a full time job. I'll be successful at it, but I'm graduating. So I got to be successful there and I'll just figure out how to make it happen. [00:04:59] Lindsey Dinneen: Yeah. Yeah. And then you alluded to the two and a half hours of sleep a night. I hope that's still not the case moving forward. [00:05:08] Mark Oreschnick: No, it's better than that now, but I've had 24 hour days as things come up throughout a career, and it's, you do what you need to at that point for your company and to get things done or you're having a team work extra hard. You get in there, you work with them, make sure that they're getting the support they need and they know you're there for them. So, sometimes it's insane. Other times you get to relax a little bit, but that's also, like I said, the life of a startup, you have your big pushes and then you get to relax for a little while and then you hit your next push. [00:05:47] Lindsey Dinneen: Yeah, so true. It seems like you have quite a passion for helping startups in particular, and you obviously also have your own entrepreneurial bent and endeavors. And so where did the interest in helping startups in particular come about? Because I know that's a, can be a different skillset in terms of you often wear a lot of different hats and you end up pitching in so many different ways. So, so tell me about your heart with startups and entrepreneurship. [00:06:17] Mark Oreschnick: Someone who has now become one of my best friends, we, my very first medical device job, I worked with him and when I left to go to another company, we looked for a position for him to join me. There wasn't a good fit, but a couple of years later, he went to a startup, which he had already been in startups previously, and asked me to come over and work with him there. And I came in, I saw that I could do a lot of things to help people. And that's kind of been my career also is how can I help people do things easier, better, just make their life easier. So if I saw a gap where there wasn't someone to jump in, I just jumped in and filled it. And that's what you do in a startup and it just really worked with my attitude of, I get to help a lot of people because, today I'll work on documentation with the quality side, next week I'll go build a fixture for production and whatever was needed at that moment. It let me get that joy of helping people. [00:07:23] Lindsey Dinneen: Oh [00:07:23] Mark Oreschnick: And that's ... If you get joy out of everything you do in work, it makes going to work really nice. [00:07:29] Lindsey Dinneen: That is so true. I love that. That is so true. And so, you know, then you also have the skill sets to be able to help in lots and lots of different ways. And one common theme as I've been doing some of these interviews is that it seems like having that generalist background-- I mean, obviously you're highly specialized as an engineer. You're incredibly incredibly gifted and talented in that way. And you've built that skillset, but then you also have the opportunity to draw from multiple different industries that you've been a part of. So how has those various other kinds of influences in your life maybe contributed to your success now? [00:08:13] Mark Oreschnick: I would say one of the ways that definitely benefited me a lot was getting into a non technical industry. The industry where I did the packaging automation and built my first building is called Consumer Fulfillment. Literally at that time, you were getting in buckets of mail, manually sorting it, data entering information into a computer, typing in UPC codes, like not technical, not anything like that. But it made me look at that world in a big picture format. And how could I help the process and make things flow from department to department much easier. And I just had to step back and kind of, all right. By making this process easier, I'm helping on the finance side. By making this less labor intensive, we have less workman comp. [00:09:14] And it was just, what affects each piece of it? And as you kept digging deeper and deeper, you got to learn what the IT group did and how they could change the software to make it better. You'd figure out what the shipping companies are doing. We actually figured out how to load semis and make sure that the addresses were in the order of the post offices that they were going to. So the last bag onto the mail truck was the first bag that they took off. And we built that into our computer system so the trucks could drive direct and never have to backtrack or unload extra things. So it's just, you have to start looking at that big picture and you got to learn about every department to see how they all work together and make sure everyone's efficient, not just your little group. [00:10:05] Lindsey Dinneen: Yeah. Well, and I love that approach. Being able to look beyond maybe what you feel like is the daily task or the task most important at hand and have that zoomed out view of, okay, this isn't just important for the success of this one department. It affects everybody else. And I love that. So now in your current role and in your current business with Evolve Engineering, you get to have that more eagle eye perspective again. Is that true? So when you're coming in, you're able to help? [00:10:36] Mark Oreschnick: At the beginning, yes, if it's a new founder, and there tend to be two new founders that I've met lots of. They've, almost all of them have never been in a startup before. So that's a common theme. And they either come from not within the medical device industry or from a very large company within the medical device industry. So changing the mindset and getting real expectations and real realistic goals and budgets is where you kind of start with that. So I work with them to talk about, here's how much you can expect to spend on this project. Here's how long it's really going to take. [00:11:21] If you're from a big company and you're still having five different computer systems that are managing your inventory and your sales and everything else, we're going to be running on QuickBooks and Excel, and that's what we're going to live by. Because if you want to put those systems in, you're going to hire 20 people to manage those systems rather than 10 people to get the product out the door. And get this design finished. So it's teaching them to just have a total different mindset about everything. And still knowing how all those systems have to work together. But trying to get it down onto the micro, basic scale, rather than going on to buying a great enterprise system, but we're not actually going to sell anything for five years, so we don't really need it. [00:12:15] Lindsey Dinneen: Yes. Yeah. Yeah. Thank you for sharing a little bit about the two different types of these startup leaders that you're encountering. And I'm wondering, so part of your role, it sounds like, is not just getting into the very specific nitty gritty details of the actual company operations and technology and whatnot, but it's also having a little bit of this even broader range of, how do I help you as the leader develop the skills and priorities that you need to. So it sounds like you're in a, you're in a very Diverse mentorship kind of role in addition to like, let's get down to the nitty gritties, but you're also helping them develop those skill sets. Yeah? [00:13:00] Mark Oreschnick: Yep. That's my goal is to help them become a good leader of a startup and understand what it takes. And I met with a doctor who had found me on LinkedIn about his company. And I wasn't sure exactly what he wanted, but as we were talking through things, I told him, "if you plan on being the CEO, we are going to figure out what day you fire yourself from that position." I said, we will do it to save money in the beginning, but you're a doctor. Be a doctor. Let's bring in a professional CEO when we get to the point where you stop saving the company money and possibly cost us money." And, he didn't want to be the CEO. [00:13:43] So it wasn't a conversation that had to be had, but trying to put the mindset of, you're a great inventor, kick me out of my job, become the company CTO, drive development once we get to that point. I'm totally fine with that because it's the best for the company and it'll get us to the sale of the company or commercialization spending the least amount of money and getting there as quickly as we can. So being part of it's, be open, have those conversations with people and do that type of mentorship in the beginning. And if somebody said, "no, I'm going to run this thing until the end, I'm going to be the greatest CEO." I probably know from the beginning, I'm not the one to work with them. [00:14:29] Lindsey Dinneen: Sure. Yeah. [00:14:33] Mark Oreschnick: We probably won't gel in the end. [00:14:36] Lindsey Dinneen: Yeah. And do you find that it's partly because perhaps the idea of, the things that got you to where you are not the same skill sets that are going to get you to the next level? Is it partially just because usually that somebody who comes up with this great idea and has the passion and the vision for the company can really get it off the ground and maybe get those first rounds of investment, but then they might not possess the skill sets to get them to continue growing and scaling. Is that part of it? [00:15:10] Mark Oreschnick: That's 100%. [00:15:11] Lindsey Dinneen: Okay. [00:15:12] Mark Oreschnick: What normally it is and truly that passion in the beginning as the CEO gets your team driven. You get a lot done. It is a wonderful thing. But once you start to look at the commercialization and how do you grow a business, that creativity and passion don't directly translate. Now it's getting into nuts and bolts, black and white, a little more ruthless and you have to do what's right to make the company commercial. [00:15:43] And the, I think it's lots of times not even ego of the founder. It's the passion. It's their baby, and they don't want to give up control and worry that somebody is going to ruin it. But that's why if you move yourself out, but stay within the leadership role in a different way, you're hand in hand with the CEO and you can move the company forward together rather than having a board kick you out because you're not doing your job and then you've lost all connection to your company. [00:16:20] Lindsey Dinneen: Right. [00:16:21] Mark Oreschnick: So I look at it as a, here's a way you can grow and you can learn from that CEO so the next time you do this, maybe you are the person who can take it another step, bring in the new CEO, one step farther down and finally you'll get to be that person who runs the company from start to finish, but you got to learn it. You got to live through it and protect your baby by moving into a different seat. [00:16:46] Lindsey Dinneen: Oh my goodness. Yeah. What a challenging thing to overcome. So it's helpful that's your perspective from the start so you can help people prepare for that and that this is actually a wonderful thing. It's a growth thing. It's not a demotion. It is not a, you are any less important. You aren't. You're as still as important, but you're just moving into a role that suits you and suits what the company needs. Yeah. That's really interesting. [00:17:13] Mark Oreschnick: And there are some investors who, if they hear that day one, that you know you're the one to bring it up to a certain point and then you will transfer it that will give them more faith in you because they know that you understand where your skills are and that you need the commercialization person to move the company to sale and they're going to appreciate that. [00:17:37] Lindsey Dinneen: Yeah. Yeah. And so with your consultancy now, can you tell me a little bit about how that came about? And then I'd also love to hear, because I know that you've started, or co-founded, a very successful networking group in Medical Alley. And I would love, if you wouldn't mind sharing just a little bit about that, because that's a really cool opportunity for people in the area. But I would just love to hear a little bit about your origin story as well. [00:18:04] Mark Oreschnick: So my origin actually started about eight years ago. [00:18:07] Lindsey Dinneen: Aha. [00:18:09] Mark Oreschnick: And the gentleman that I talked about who brought me into my first startup, we were at two different startups and he asked me if I could do a side project for him for his company to help it out. So I started Evolve Engineering. [00:18:24] Lindsey Dinneen: Okay. [00:18:25] Mark Oreschnick: And they brought me into interview to see if I was the right guy to do this project for them. And they liked my overall skill set and offered me a permanent position. So I wound up not consulting. [00:18:39] Lindsey Dinneen: Sure. [00:18:40] Mark Oreschnick: But it was something that I'd always thought, yeah, someday I'll get into this because one of the things great about startups is doing lots of short term projects. Even if your company lasts for seven years that you're there, you've jumped around a lot in it because that's what the company needed. So the idea of consulting and knowing that I'm going to be jumping around is exciting because you're always doing something new. So that got me hooked. [00:19:07] Lindsey Dinneen: Yeah. Yeah. [00:19:09] Mark Oreschnick: And then I was with a startup and I was looking for, what do I want to do next. I knew it was time to be moving out of that startup. And I started researching consulting and got myself connected with a bunch of people. And then another company offered me a permanent position. [00:19:27] Lindsey Dinneen: Okay. [00:19:29] Mark Oreschnick: So that postponed me for about another 16 months. And then in late 2022, I made the decision that "No, it's really my passion. I want to get back helping as many startups as I can." And I just dove into it. One of my former employees became my first client. And then another group called me up of a bunch of employees that I used to work with at a different startup, and I started working with them. And then, like I'd mentioned, a doctor called me up, so I have a deal going with that company. And it's all these little pieces just coming together. And right now, I have two different companies that are submitting me for projects that they're just waiting on funding for. And someone that I connected with through this networking group. He called me up and said, "Hey Mark, in, in February, I'm going to need your help on one of my projects." So he used to be the founder of a startup. Now he's doing the exact same thing I'm doing and he's my competitor. And he called me up and said, "I want you to work with me." [00:20:37] Lindsey Dinneen: Phenomenal. [00:20:39] Mark Oreschnick: Yeah, it's good competition and those are the people that I still have around me are people I've worked with in the past or met in the past. We don't look at each other as competitors. It's, "You're going to be better at this one than me. So you take it and you'll tell me about one that I'm better at than you." So, so that's got me kind of up to today. And you had mentioned my networking group, which is called The Twin Cities Medical Device Networking Group. I was in a group pre COVID that actually died before COVID. So COVID wasn't the killer, but it made starting a new networking group a real challenge during COVID. I tried bringing the old group back. We had one event and then a new spike, and it died again. [00:21:32] Lindsey Dinneen: Yeah. [00:21:33] Mark Oreschnick: So working with one of the startup accelerators that I'm involved with, I went to a medical presentation that they were having a showcase about all of their startups that they were working with, and met a gentleman named Kris Bauerschmidt. And he and I actually already had a call scheduled for the next day through a different networking group and we just happened to run into each other in person. So we started off, we did the call the next day, and I toured his company a couple weeks later. And I brought up, "Hey, I'm thinking about starting a networking group." And he said, "Oh, I'd love to be a part of that, can I help you?" And that was on Thursday, so April 29th, which was a Saturday, I started the group. And it took about 16 days to get up to 100 people. [00:22:24] Lindsey Dinneen: Wow. [00:22:26] Mark Oreschnick: About another month to get to 200. And then it started slowing down a little bit. So now we're at eight and a half months since we started it, and we have almost 850 people. [00:22:38] Lindsey Dinneen: Wow. [00:22:39] Mark Oreschnick: So it's growing basically a hundred a month. [00:22:42] Lindsey Dinneen: That's amazing. Congrats. [00:22:45] Mark Oreschnick: So each month we just post on LinkedIn, "Hey, we're doing a happy hour at this brewery." People come out, get together. We normally have around 70 people show up to each of our events and people sit around and you talk a little bit of business, you know, "Hey, what do you do for a living? What cool projects are you working on?" that type of stuff. And many of these people have now got to the point of, "So how's your son's basketball game last night?" And we've become friends and we're building relationships. Business is going to come out of that naturally because now we've actually built trust in 70 other people that we meet, and really it's probably about 150 people rotate through our events, but there's always around 70 that show up. So this 150 out of 850 is getting to be a tighter network every month. [00:23:40] Lindsey Dinneen: That's incredible. [00:23:42] Mark Oreschnick: And out of that, we wound up doing a presentation at startup week, Kris and I, for other people, we did a panel discussion on Networking 101. [00:23:50] Lindsey Dinneen: Nice. [00:23:52] Mark Oreschnick: A college brought out their entrepreneur program and we had 20 plus students from that, and it was a total of, like, 80 people showed up to hear us talking about networking. [00:24:03] Lindsey Dinneen: Nice. [00:24:04] Mark Oreschnick: And that's one of the keys in the med device industry, or actually in any industry, network, know the people you're working with. If you ever get laid off, fired, you're in transition, you instantly have a group of people to go talk to. But the big thing that we've seen in our group, lots of the people are there really just to help. [00:24:26] Lindsey Dinneen: Yeah. [00:24:27] Mark Oreschnick: Much less about, "What can I get out of this," and it's, "What can I do for you?" So, it's really nice that, you know, people are saying, "Hey, let me introduce you to this recruiter. Hey, let me introduce you to this person. They might be able to help with your project." And it's much more of the giving side of things. And it gets kind of funny when you have two people who are both givers, who have are meeting for the first time and trying to talk about something, and both of them are trying to give and neither wants to receive. [00:24:59] Lindsey Dinneen: Yes. [00:24:59] Mark Oreschnick: So eventually somebody has to just step out of the zone that they're in and say, "This person's honest and trying to be helpful. I need to accept that." [00:25:10] Lindsey Dinneen: Yeah. [00:25:11] Mark Oreschnick: It's quite funny when you start to see these interactions of people who really network on a regular basis and are out there just to meet and help people. [00:25:21] Lindsey Dinneen: Yeah, that's incredible. And I love that. I love that that's the spirit of the group because I think a lot of times where networking groups can get challenging is it seems to be kind of the opposite. And it's sort of "what can I get from this group" versus "how can I give and contribute," but that's, that's such a part of who you are. In fact, you've recommended a couple of books to me that I have thoroughly enjoyed. And I wonder if you wouldn't mind telling a little bit about maybe how that philosophy has impacted even your own life and the way that you've approached your entrepreneurial endeavors and your networking endeavors. Would you like to share about that? [00:26:02] Mark Oreschnick: Sure. So, similar to the words that I was just saying. [00:26:06] Lindsey Dinneen: Yup. [00:26:07] Mark Oreschnick: I know the book she's talking about right off the bat and that is " The Go Giver" and it's tells the story of how somebody is out there trying to get sales and bugging everyone trying to get leads, trying to just close the deal, worrying about the end of the quarter. And eventually he meets a series of people who talk about being in things for the right reason, and you can't sell something to someone, someone has to want to buy from you. So you have to give them value, and then they will choose to purchase from you, because you cannot force a sale. You can't make somebody sign on that dotted line. [00:26:54] Lindsey Dinneen: Yeah. [00:26:56] Mark Oreschnick: So it's all about: connect with people, meet them, figure out how you can help them. Karma's going to come back, help you in the end. And I have definitely seen that in my career, you know, like I'd mentioned earlier, somebody who is a direct competitor of me calling me up and saying, "I want you to work on my project." I was trying to help him find investors at his last company. And I didn't have any stake in the game in that, but he seemed like a really good person doing a good thing. So I wanted to help him. [00:27:30] Lindsey Dinneen: Yeah! [00:27:30] Mark Oreschnick: The thing that for me about "The Go-Giver," I read it and I went, "Okay, this reinforces what I've been doing. And here's a few ways I can do it a little bit better and a little more intentionally." So I highly recommend, read the book. The guy who I founded the networking group with, I gave him a copy. He absolutely loved it. He now recommends it out on LinkedIn. The author wound up seeing that we had been recommending it to people and connected with us and commented. So, and I'm actually in another group that has about 230 people, and the first time you meet with the founders of that group, they're going to say, "You need to go by "The Go Giver" and read it." So right off the bat, that's just their first conversation. It's kind of, "If you go forward with this attitude, your business will be successful." [00:28:22] Lindsey Dinneen: Yeah. [00:28:22] Mark Oreschnick: And then the other book, it's from the same authors and it's called, I believe, it's "The Go Giver Guide to Marriage." [00:28:28] Lindsey Dinneen: Huh. [00:28:29] Mark Oreschnick: And I actually read it while I was on my 10th anniversary with my wife in Napa. And it was again about intention. You can tell your spouse that you love them, you can tell them they're beautiful, all these things, but why are you doing that and making sure you do it with reason and not just because I should say I love you every time I walk out the door. [00:28:53] Lindsey Dinneen: Yeah. Right. [00:28:55] Mark Oreschnick: And there are lots of really good tips in it that is just kind of, okay, I'm doing things good, but I can do it better. Here's a way to do it better. And it's the reminder of why you're in your relationship, why you love the other person. And it was a fun book to read. And the fact that I chose to do it on our anniversary weekend was a really good thing. [00:29:15] Lindsey Dinneen: Nice. [00:29:17] Mark Oreschnick: It was the right time to reinforce everything. [00:29:19] Lindsey Dinneen: There you go, folks. Life and business advice all wrapped up into one. It is a great series of books. I recently finished "The Go Giver Leader" too and that's another brilliant book. I was listening to it on audio book and I kept having to rewind so that I could take notes because I was like, there are too many amazing quotable quotes in this book. It's, [00:29:43] Mark Oreschnick: Yes. [00:29:43] Lindsey Dinneen: Highly recommend. Yeah. So just out of curiosity, looking back over your life, do you think six year old Mark could have ever imagined being where you are now? Or is this engineering and business and creativity? Has this always been a thread of your life or has this evolved over time? [00:30:07] Mark Oreschnick: So engineering and creativity, yes. The business side, no. If you would have asked six year old Mark, what he was going to be doing, I actually know the answer from my parents and I was going to be a garbage man. [00:30:20] Lindsey Dinneen: Yes! Coolest job ever! You get to hang on! [00:30:25] Mark Oreschnick: I love trucks. I loved big equipment and that part of me has never changed. I am a mechanic. I have two cars in my garage, one up on the lift, one underneath it. I'm always working on something mechanical. And that mechanical side of me, along with the creative side of me has helped me design different devices and keep that vision. And I know how things work on the inside, and now I can design something because I know the different pieces, and I can put them to use for a different reason. So one of my products was an upper arm orthotic that helped people eat and drink and do activities of daily living when they had upper limb weakness from muscular dystrophy. So I was able to watch a lady who couldn't put her, push her glasses up. She put our device on and held a bottle of water for three minutes. [00:31:19] Lindsey Dinneen: Oh. [00:31:19] Mark Oreschnick: Another lady went back to painting. [00:31:22] Lindsey Dinneen: Oh. [00:31:24] Mark Oreschnick: And she hadn't painted in five years since her injury. So, but it was a completely mechanical nut and bolt type system, my side of it that I worked on, and my brain just knew how to make that stuff work. [00:31:38] Lindsey Dinneen: Yeah. I love it! [00:31:41] Mark Oreschnick: That's from when I was a little kid building with Legos and working on lawn mowers and mini bikes, and it's never stopped. [00:31:49] Lindsey Dinneen: Yeah. Sure. [00:31:52] Mark Oreschnick: The business side of things, I think it still fits with my analytical brain and, you know, you can have things in columns, things have a right way of doing it. There's a process to everything that just, so that aspect of it fits me, but no, I would have never thought of that when I was a kid. [00:32:10] Lindsey Dinneen: Sure. [00:32:10] Mark Oreschnick: It doesn't sound like fun to a six year old. [00:32:13] Lindsey Dinneen: Okay. Well, I have to nerd out for just a minute because as a, I think I was maybe a little older than six years old, but for one of my early birthdays, it would have had to have been like seven or eight, or actually for Christmas, I asked for a bunch of office supplies, because I am that nerd and so I was like setting myself up to play office ever since I was six or seven. And I would have, I had my little fake phone and my little fake receipt thing. I, it was a blast. So yeah, I, I... [00:32:48] Mark Oreschnick: And your organization skills have led through to this day. [00:32:52] Lindsey Dinneen: I know. Yeah. Yeah. All the hard play worked out in the end. It's really paid off. So anyway, you've actually shared a couple of very touching moments, even those last two stories that you shared were really sweet. And I'm wondering if there are any moments like those that kind of stand out to you as reinforcing the idea that, "Hey, you're in the right industry doing the right thing at the right time." [00:33:18] Mark Oreschnick: Yeah, they're definitely, I remember the first time that I had that moment. I had always thought once I got into medical device that I was in the right field. It fit me really well. It worked with how my brain worked. We have to do all these steps to prove everything because it's a human. We need to do the right stuff because we're dealing with people and we want to save lives, not hurt lives. But the first startup that I was in, we had a whole bunch of patient videos of interviews of patients that had used our, had our device used on them and how it affected their life. [00:33:54] And the one that I always remember, there was an older gentleman who had bad circulation in his leg and a doctor told him he needed to have a below knee amputation. And he was going to be in a wheelchair for the rest of his life. Luckily he didn't like his diagnosis and he got referred to a doctor who is using our product, and the doctor was able to go in and clear out the blockages in this gentleman's leg and get blood flowing to his foot again. So all of his sores healed, all of the swelling went away. His foot became normal again. And in a very short period of time, he went out, and golfed nine holes, pulling his bag. He walked for nine holes. [00:34:44] Lindsey Dinneen: Oh. [00:34:44] Mark Oreschnick: So he went from, "I'm going to have my leg chopped off and be in a wheelchair" to going back to the sport that he loved. And being able to actually walk, not even have to ride a cart. [00:34:56] Lindsey Dinneen: Wow. [00:34:57] Mark Oreschnick: That was that moment that's kind of, "Yep, I'm where I belong." [00:35:02] Lindsey Dinneen: Yeah. Oh my goodness. Thank you so much for sharing that. That's a powerful story and what an amazing testament to the power of medtech and being able to be a part, even play a small part, in those developments and realize that you're impacting lives. Like there's, you hear these incredible stories of, you know, even if it's just one person, which it never just is, but even if it's just one person, you change their life. That's incredible. Yeah, nothing more rewarding. [00:35:36] Mark Oreschnick: Yeah, I said, that story, I'm never going to forget. I can still picture the guy and this is 14, 15 years ago. So. [00:35:46] Lindsey Dinneen: I love that. Well, so, so amazing and pivoting completely for fun. Very different. Okay. Imagine you were to be offered the opportunity to teach a masterclass on any subject you want. It can be in your industry. It doesn't have to be, but you're going to get paid a million dollars to do so. What would you choose to teach and why? [00:36:11] Mark Oreschnick: So it's actually what we've already talked about and it would be networking. My experience with networking is it can have a huge effect on your career from day one. And luckily I've always liked talking to people. So I've been networking as long as I can remember, but people always say, "it's not what, you know, it's who you know." There is a, I'm going to say that should not be a truth. And if you actually live that way, there's a little problem there, because you should get the job because of what you know, and you should not take a job because it's just who you know and you're not qualified. But as long as you are qualified for that position, the who you know is going to introduce you to so many more opportunities, and if you go into all of those relationships trying to figure out how you can help others, people are naturally going to help you. [00:37:10] But as a student, you know, one of the things from our networking one on one class, we had the student saying, "what do I have to give to people when I'm networking? I'm still in school. I just, I'm about to graduate." During the conversation, ask them the type of people they want to meet at that event. And when you're walking around talking to others, if you meet that person, bring them over and introduce them. You can be their ears and talk to more people for them. You always have something to give no matter what. [00:37:46] Maybe they have a kid who's thinking about going to school and you could talk to their kid about what school you went to. You always have something. So going out, having that attitude, but every job I have gotten throughout my career, someone has introduced me to that position. My first internship was one of my lab partners in college. " I'm doing an internship. Would you like to meet my boss?" So yeah, I wasn't networking to do that, but we were friends from a class, so it was the who I knew. [00:38:24] Lindsey Dinneen: Yeah. [00:38:25] Mark Oreschnick: And every, like I said, every job has been that way. The doctors that found me on LinkedIn, they found me because of my posts about networking. [00:38:37] Lindsey Dinneen: Nice. [00:38:38] Mark Oreschnick: So direct indirect, my networking had me meet those doctors and turned into a client. [00:38:46] Lindsey Dinneen: Yeah. [00:38:47] Mark Oreschnick: So it's just, it always happens. Go out, meet people, talk to them, learn how to do things out of the goodness of your heart, and it will take you a very long way in your career. And when I think of people you and I both know that we've worked with, how many relationships have those people made throughout their lives that have now become business? It's just always happening. And so, yeah, that would be my

Tim Balz, a former SpaceX engineer turned CEO of Kalogon, shares that his passion for MedTech began in high school when he founded a wheelchair refurbishment charity, Freedom Chairs. From creating the Intel connected wheelchair, endorsed by Stephen Hawking, to running a company developing innovative seating technologies, Tim's story is one of relentless innovation and profound impact. His mission? To enhance the quality of life for people with disabilities and beyond. This episode is a testament to the power of engineering and empathy in creating a better world. Guest link: https://www.kalogon.com/   Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 031 - Tim Balz [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Tim Balz. Tim is a former SpaceX engineer with over a decade in the wheelchair seating space. He has 12 years of firsthand wheelchair experience. He founded a wheelchair refurbishment charity at the age of 15 and has donated over 150 wheelchairs, including orchestrating an international expansion into Moldova. He created the Intel connected wheelchair endorsed by Stephen Hawking, and has been invited to design a custom wheelchair for Hawking himself, which has been named the number one IoT device of the year by Intel. Currently Tim serves as the CEO of Kalogon. [00:01:37] Well, Tim, thank you so much for being here today. I'm so excited to talk to you and hear more of your story. [00:01:44] Tim Balz: Yeah, I'm excited to be here. Thanks so much for having me. [00:01:46] Lindsey Dinneen: Of course. Well, I would love if you don't mind starting off by sharing a little bit about yourself and your background and maybe what led you to MedTech. [00:01:56] Tim Balz: Yeah, absolutely. So, so I'm Tim Balz. I'm founder and CEO of Kalogon. So I've been working in and around the wheelchair space specifically for well over a decade now, starting with a nonprofit in high school now leading up to Kalogon where we make the world's most innovative seating for people, such as people use wheelchairs and really anyone who has to sit for long periods. [00:02:17] Lindsey Dinneen: Yeah, that's incredible. Would you mind starting a little bit at the beginning and sharing, how did you even come up with the idea to start the nonprofit, and you were so young and that's such a wonderful thing. How was that even received? Just what led to that whole part of your journey so far. [00:02:33] [00:02:33] Tim Balz: That's, yeah, it's actually kind of an interesting story, 'cause I was a part of a robotics team in high school, and so I kind of started learning to, to build things with my hands. I didn't really have any plans to go to college or anything like that, and my grades weren't the highest, but I had a neighbor that actually found a wheelchair in a dumpster, and he gave it to me to mess around with the robotics team, but I noticed there was this student in the school, Steven, and he would pull the recycling behind his manual wheelchair, and he'd go from classroom to classroom, and they would dump the recycling in it. [00:03:01] But after a while it would get so full that he would just be stuck there waiting for someone to come wheel him back. And so I asked his teacher, why didn't he have an electric wheelchair? And he actually his teacher actually said that the insurance company denied it, because he could move something like a hundred yards under his own strength. And apparently there's this, like, in the home rule and because of some unnecessary red tape he wasn't given the equipment that he very clearly needed. [00:03:24] So that first wheelchair was unfixable. So I traded my moped for a wheelchair on Craigslist. I tricked it out. I added like a sound system to it, added leg rest, added a hitch so he could pull his recycling, put his name on it, and really made it custom for him. And it totally changed his life. And then from there, I just had a bunch of people start coming to me in need. And, I was always raised to not necessarily have to wait for someone to ask for help in order to offer it. And I was raised that if there's something you can do to solve a problem for someone else, you should do that. And that's how I started out my nonprofit Freedom Chairs. [00:03:58] Lindsey Dinneen: That's incredible. What an amazing story too. Thank you for just sharing about that. And being willing, like you said, I love your emphasis on, you don't necessarily even have to be asked. You saw a need, you saw a way that you could help, and then you just took it and ran. And I love that. Yeah. So since then, you know, since that was sort of the inspiration, but then since then you have done so much with this organization. Do you mind sharing a little bit more about the work that you all do now, even with that? [00:04:28] Tim Balz: Yeah. Yeah, so Freedom Chairs would refurbish and we give away primarily power wheelchairs, but also some like manual wheelchairs and scooters. So we still run that. It's not at the same scale, you know back when I was in high school and college I a lot more free time than I did now, so we still probably give away five six seven chairs a year. But we actually took Freedom Chairs all the way to going international. We actually took a bunch of wheelchairs into Moldova, and that was a really cool project went over there a few times and then so still run that. [00:04:59] And then actually off of that, I realized I learned a lot about how these chairs work from repairing them and actually got hired by a design firm that was designing an all terrain wheelchair because of that experience. And so working with them, I got my name on the patent and actually helped design a wheelchair that's on the market today. I'm not associated with the company in any way. I was employed by the design firm, but that was where I started figuring out that, oh, I could give away these wheelchairs, but if I can actually improve the products that are available, I can help a lot more people than what I ever could hope to with a small nonprofit. [00:05:31] Lindsey Dinneen: Wow. Yeah, that makes a lot of sense. And so you then from starting this nonprofit, then from there, you've obviously had quite a bit of really amazing experience. You've been a SpaceX engineer and whatnot. Can you share about how those past experiences and your desire to help people have merged with all of your technical expertise over the years to create your company and what that has looked like? [00:05:58] Tim Balz: Yeah, absolutely. So, you know, I became an engineer because of what I learned with Freedom Chairs. I learned that with engineering, you can change a lot of people's lives. And so, the first thing I did was I knew that technology for people with disabilities was way behind the rest of the world. So that's where I did the the proposal for the world's first smart wheelchair and actually got that funded by Intel. They sponsored the project,, and then Stephen Hawking endorsed it, and it was named the number one smart device of the year by Intel. So that was really cool. That was where I was able to take technology and really advance the state of technology and in the space, but from there I knew that I still had a lot to learn before I could go start a company or something like that in the space. [00:06:36] And so I knew SpaceX was the place where my friends would go and they would learn so much more working there than other places, partially because you work such crazy hours. When you're doing 80 to 100 hour weeks, you're learning twice as much as someone that's working 40 hours. And that's what I wanted. I wanted to learn as quickly as possible, and I wanted to be at the forefront of technology so that I could take those learnings back to the back to people with disabilities so that they didn't need to have technology that was a decade plus behind what the rest of us get in our day to day life. [00:07:03] And so I stayed at SpaceX and actually moved to multiple different teams that were different phases in the product development and commercialization cycle so that I could learn how is it that SpaceX, this scrappy startup, was able to completely disrupt a space that was dominated by multi billion dollar companies. And with those learnings, that's where we started Kalogon and we actually structured a lot of our processes based on the learnings I had from working there. [00:07:30] Lindsey Dinneen: Yeah. Yeah. That's incredible. And so now can you share a little bit about what your company does and the products that you're really excited about and... yeah, I'll stop there, 'cause I, I'll ask too many questions all at once. [00:07:46] Tim Balz: Oh, no worries. I'm so, I love geeking out on the technical side. [00:07:49] Lindsey Dinneen: Excellent. [00:07:50] Tim Balz: So, you know, Kalogon, when we started Kalogon, what was really important is focusing on the need first and then building the technology for it. So many people just love technology and they're like, "We just want to shove technology into the end user's face. And we'll try to find a need based on the technology we want to build." And we didn't want to do that. So, we first went out and just started interviewing as many people as possible and said, " What are the big challenges that you have in your day to day life because of your disability?" [00:08:16] And we talked to everyone from the clinicians to the end users to even the family members to try to understand what are the largest unmet needs for people with disabilities. From there, we discovered pressure injuries. And we did this actually while I was still working at SpaceX full time, I even bought a house and all the co founders with me, they all moved in the house and we made it where their rent was able to pay for the mortgage on it. And we started using that to prototype and really start building the team. So we start with the team and the need. And when we found out that this need, these pressure injuries killed more people than any cancer in the US other than lung cancer, we were like, "That's crazy. Someone else has got to be solving this problem. We're probably way behind on this because of how big this is." [00:08:59] And then we looked and we're like, "Oh my gosh, there hasn't really been any innovation in like 50 years." And it just was mind blowing this something at the scale of cancer And the, still the leading technology that was being used to try to prevent these sores for people in wheelchairs was like twice my age at that point. And that was just crazy. So, so we said, "All right, there's the problem we're going to solve. Now let's go dive into that, become experts in that, and try to figure out how we can start iterating a solution to solve that problem." And that's how we created Kalogon Smart Seating technology. [00:09:30] Lindsey Dinneen: Wow. That's incredible. Was there ever a time as you're creating this technology and you're talking to the people who are going to be using it and so deeply affected by it, was there ever a time when you just kind of had this moment of realization where you went, "Yes, this is why we're doing what we're doing." This is a moment that really kind of enforced that. [00:09:53] Tim Balz: It's almost like a weekly basis. Like some of the early ones, we had early prototypes that we, we didn't expect them to succeed, because they were so early. And we had a, an individual where their, their wound care doctor came to us and was like, "Hey, I've tried every cushion on the market, their wound's not healing. It's probably going to take them out. And so I heard about what you were doing from, you know, some of the people that you were asking questions in the community to try to understand this problem. I was wondering, do you have anything?" [00:10:21] And we're like, "We have this prototype. It's completely unproven, but if you want to try something, if you're at the point of, almost, it felt like giving up, let's give it a shot." And being able to see that progression and finally hear from-- actually, what my favorite part with that one was-- a couple of months after we provided that, that cushion I was out at at a lunch with a prospective investor. And all of a sudden I had someone like call over to me. I turned around and it was the individual that we given this cushion. I'm like, "What are you doing out?" And she was saying that the cushion was so successful, that they let her go out for lunch with her friends and then come back to the rehab facility, and that she thought she wasn't ever going to get to do that again. [00:10:58] And that, that along with the fact we get multiple Christmas cards every year from people that say we changed their life and that they thought they wouldn't be able to go visit their grandkids again, or that they're able to now, instead of sitting in a chair for two to three hours a day, and that's all they get to go live their life, because of the pain reduction from the technology, they're able to be out for eight to 12 hours. Those instances always really fuel the passion because start ups a rollercoaster. [00:11:23] Lindsey Dinneen: Yeah. [00:11:23] Tim Balz: There's ups, but there's typically a lot more downs than ups in a startup. You're trying to solve problems that have never been solved before. And that's hard. That's really hard. And that's the startup kind of journey. It's lonely. You've got your co founders, but it's tough. And those moments are always the ones that make it all worth it. Every, any one of them is enough. [00:11:38] Lindsey Dinneen: Oh, I love that. Yeah. And I love your perspective on that too, where you said all of it matters. And it's just one, you realize how many times that one person has made a difference, and that one person matters so much. And I love that perspective because like you said, it is such a roller coaster and that's a lot of challenge that you're dealing with on a daily basis. It would be easy to get discouraged or feel like, "Oh my goodness, is it worth it?" So being able to talk to a human being who goes, "Yeah, it is worth it." You know, that's, there's nothing quite like that. That's very rewarding. Wow. [00:12:15] Tim Balz: It's true. And then at the end of the day, the people that change the world are the optimist. And so knowing that, I'm not going to give up, the team's not going to give up, until we succeed. That's that along with the positive reinforcement from hearing these stories, people's lives were changing, it really does make it all worth it. 'Cause at the end of the day, if we were in it for the money, I should have stayed at SpaceX. I walked away from a lot of SpaceX stock that was still left unvested, and I regret nothing because at the end of the day, I'm doing what I need to be doing in the world. My goal is, let's say, when I die, I want to know that I put in more than I took out. And so I want to create the largest net positive on the world possible. And I think Kalogon is my way to be able to do that. I'm solving problems that wouldn't likely get solved if Kalogon wasn't doing it. [00:13:04] Lindsey Dinneen: Yeah. That's incredible. And so what are you looking forward to as you continue to grow the company and even for yourself, you are continuing to grow in this role too. But, for yourself and then for the company, what excites you coming up? [00:13:22] Tim Balz: Yeah, we've got a, we've got a Series A coming up in 2024. So we're really excited about that. One of my favorite things about the job is, in a startup, especially when you're a first time founder, you've got to make sure you grow personally at a rate faster than what the company is growing otherwise it's going to outgrow your competence.And so I'm always looking for and getting feedback from our board, for example, and then the team is, "What are the things that I'm going to need to do six months from now? What are the skills I'm going to need to have to be able to successfully run this company?" [00:13:53] And then that means I get to do tons of learning. And with that learning, I know I'm growing as an individual. It's going to make it where someday, post Kalogon, I'm going to want to start something else and solve more problems. And the learning I'm getting is one that's, it means having a new challenge every day where I don't already know what the answer is when the challenge pops up. That keeps me motivated. [00:14:15] Like this morning I woke up at 3am and I was like, that's what we need to do for our CNC machining on that part. And even though I'm the CEO of the company, I literally was like texting one of our engineers. I'm like, "Oh yeah, here's what, like check this out," like moment of clarity. "This is going to totally improve the efficiency and solve that challenge that we have in the organization." [00:14:34] And while typically I'm not solving challenges at that level anymore, I'm more equipping people and putting the right people in the places, and they're truly the ones doing the innovation now, I still like to try to make sure I understand what are the challenges that are limiting Kalogon's ability to impact more people's lives. And and that's like my personal litmus test. I've always said, even when I was at SpaceX and one of the reasons I left was, if I'm not doing something that's so interesting and challenging me so much that I, that it doesn't keep me awake at night thinking about it, then it's probably not, it's probably not the right thing for me to be doing. [00:15:09] Lindsey Dinneen: Yeah. And so how was that transition for you? Did you enjoy going from sort of more of a doer role to a leader role? Was that an enjoyable thing or was it really challenging at times to sort of, you know, you have the heart of the company. So was it a little hard to go from being so hands on to being at a little bit of a higher, eagle eye view? [00:15:32] Tim Balz: Yeah. I'd say the process was a bittersweet one. At the end of the day, if my goal is to have the largest net positive impact, this is what I need to be doing. So from a, from being a rewarding side, it's so rewarding. I would say like, it was something where, of course, there were times when I had a hard time letting go of specific tasks that really I'd outgrown that as being something that I should have been doing in my role. There were times where I had a hard time emotionally giving it up, but I never had a time where I like wanted to jealously guard something just because I enjoyed doing it. [00:16:04] At the end of the day, I look at my job as, I wear a lot of hats, and if I'm doing my job effectively, I'm setting other people up so I can take that hat off, give it to them, so that I can be putting on a new hat for what the company needs next. And so if I'm not doing that, then I'm not doing my job. And so being able to take a job that I love doing and equip someone else and see them be successful in it, that's where I get my rewards now. [00:16:30] Lindsey Dinneen: Yeah. Oh, I love that. I love that perspective too, and I think it's very telling about your leadership that you are so willing to learn and grow at a pace that will enable you to continue leading at such a high level, because it is, that is challenging and, I'm sure that there will, like you've mentioned, every day you have a new opportunity to solve a problem that might have been a little just out of left field, but if you're continuing to help grow your own skills and you're able to continue to lead the company well. So out of pure curiosity, what kinds of learning tools have you found to be particularly effective? [00:17:10] Tim Balz: Yeah. So one, I'm a big reader, but like audio books. So I'll look at what are the skills I need. And I'll go, so one, mentorship is huge for me. I have a ton of mentors, and often I'm working directly with those. I have a technique I call verbal iteration, where I just like, will throw ideas at people who have good insights. And I'll have them tear it apart, throw it back. And I have no ego about things needing to be my ideas, so I steal the best of their ideas. And now I change my new idea, and then I'll throw it at someone else. And that way I can get a lot of diverse opinions and diverse perspectives. And so that's one way where I'll kind of change my mental models for how I look at the world. [00:17:47] And then another thing I do is, so lots of audio books, I listen to very specific podcasts. I'm a big fan of podcasts. When I'm driving, I often you use audio books and if I'm doing like tasks around the house, I'm always listening to podcasts. And I go on runs in the morning, always got a podcast on, but besides that mentorship is the big one. And then I do have a strategy coach 'cause strategy is one of those things that, it's so abstract, it's hard to truly absorb it from just a one way transfer of information from audiobooks. And so I do have a strategy coach that, we look at like case studies and, and he'll help me apply those to our business and make sure that I'm truly leading the company in the right direction. [00:18:26] Lindsey Dinneen: Yeah. Yeah. That makes a lot of sense. Thanks for sharing that. I'm always just intrigued because it's fun to keep learning and growing and everyone has different methods of doing so, and I'm always just fascinated to hear how someone wants to do that, enjoys doing that. So you know, looking back over your life so far, could your six year old self have possibly imagined what you'd be doing now, or is this completely out of left field? [00:18:53] Tim Balz: I love that you use that analogy there because one of my favorite things, whenever things are going rough, like I have to do a ridiculous amount of travel. And I think a lot of people romanticize work and business travel. We're a startup. I'm sharing hotel rooms. I'm trying to get the cheapest I can get. I'm flying Spirit, back row, middle seat, red eye to save money. [00:19:16] Lindsey Dinneen: Yeah. [00:19:16] Tim Balz: Because at the end of the day, we're a startup and any dollar I can put back into the business is, it's more innovation. And so for me, when I'm in those moments, I'll always think back, would younger me be proud? And I'm like, man, younger me would have been so jealous of being able to fly on an airplane. I got to fly on one or two airplanes when I was a kid. And I'd be like, okay, younger me would be pretty proud of and pretty, pretty jealous that the older me gets to go fly around the world to have business meetings and go try to solve engineering problems. So I really do think that six year old me would never believe that I would be so fortunate to be in the position I am to be able to build and innovate and change people's lives. [00:19:58] Lindsey Dinneen: Yeah. Yeah. That's incredible. And it's helpful to have those perspectives too. We talked about earlier a little bit about knowing because you can, and because people send you cards and they talk with you, it's like being able to know that your younger self and the people that you're currently affecting are grateful and proud and whatnot. It just, it really does help, like you said, because those red eyes are not always super fun, I'm sure. And there are days where it's a little more demotivating than others. So [00:20:30] Tim Balz: Absolutely. [00:20:31] Lindsey Dinneen: So what kinds of other big engineering challenges would you be thrilled to help solve? [00:20:40] Tim Balz: I mean, one thing we've kind of realized is, our initial goal was to take technology for people with disabilities and try to at least bring it up to the level of what's provided to people without disabilities. And one thing that ended up happening was, we truly went to solve this need and did such a good job of it, that we realized our technology can solve problems for a lot of other areas in the world where people have to sit for extended periods. And that was something that wasn't the initial intent. We just went to go build what was right, not what was easy. [00:21:12] And what's exciting for me is we've now got contracts outside of the wheelchair space where we're able to keep funding and putting more money and effort into R&D to just understand and become the world experts in seating. And so the way I look at it is, there's no one in the world that knows more about dynamic seating and seating that actually changes based on the user, no one can do anything like what we're able to do. And so I'm excited for things like. airplanes, automobiles, long haul truckers, construction equipment. [00:21:41] There's so many different areas where people have such a negative impact on their health and wellbeing because they have to sit for long periods. I mean, look, office chairs. And so I am really excited to, to make Kalogon's technology available to those people so that they can, at the end of the day, go home and play ball with their kid, or pick up their kid without, without back pain, or without one of the many other medical issues that can arise from sitting so much in our days. [00:22:09] Lindsey Dinneen: Yeah. Yeah. Oh, I love that. And I'm very thankful for what you're doing. I love that the work that you all do and that you are so passionate about becoming experts to help solve some problems that have-- like you said it's kind of wild when you think about it-- that the technology hasn't evolved, or maybe emphasis hasn't been placed on this kind of technology, and lots of people are affected by it. [00:22:35] Tim Balz: The average person sits more than they sleep, which is crazy to think about, yet the research in the space on sitting is so narrow, and it's still in its infancy. Like the fact that a company our size can become leading experts so quickly, it's post a testament to the team we have, but it's also, it just shows that there's so much runway here because this is a problem that it's just going to keep getting bigger as the world ages and as more people are sitting as part of their job. [00:23:06] Lindsey Dinneen: Yeah, of course. Well, I just think it's really amazing what you guys are doing. And it's cool to hear all about it. So I'm, I just, I want to pivot just for fun. Imagine you were to be asked to give a masterclass on any subject that you want to. It can be in your field. It doesn't have to be, but you're going to get a million dollars to do it. What would you choose to teach and why? [00:23:31] Tim Balz: I believe. So I think I would start with, what is the criteria that would help me decide what area to teach? And I would say, what is a skill that I've had to build where I was not able to find a lot of resources to help me learn how to do that. And so, there's a lot of things out there. There's 20 masterclasses in leadership and project management and those things. So no one needs another, no one needs another masterclass in that. And there's a lot of people, a lot smarter than me at that stuff. [00:24:00] I would say, how to innovate as a hardware company, and how do you do that in a cost effective manner? I think one of the things I learned at SpaceX, I have a very different approach to product development, especially with hardware products. We at Kalogon, we treat hardware like software in a way that very few companies do. And I think sharing that so that other startup founders who are afraid to go do a hardware starter, 'cause typically people think you need a huge amount of capital, and people build products without properly iterating with customers in the loop. So like empathy driven design and early product manufacturing, test, and iteration, I think is something that there's not a lot of great resources out there. And I think a lot of people could learn from it. [00:24:49] Lindsey Dinneen: Yeah. Yeah, I think that would be an incredible masterclass, exactly for all the reasons that you mentioned. And it is a difficult subject area, so that would be phenomenal. [00:25:02] Tim Balz: Where a lot of companies die too, is they don't get the product market fit right. They don't create a system to be able to validate and do a bunch of tiny pivots to make sure that they truly build a product that solves a problem, and solves a problem that's worth solving. So, so I think there's a lot of companies that have to fall into those traps. [00:25:22] Lindsey Dinneen: Yes. "Solving a problem worth solving." I really like that. So, how do you wish to be remembered after you leave this world? [00:25:32] Tim Balz: For me, I don't care super much about what people think about me. I care about my reputation, and I think that's really important. But for me, I more care about building lasting businesses that, when I'm gone, continue to drive value, and specifically drive value for their customers above all else. That would be a pretty cool way to be remembered. The teams I've been a part of if, if they're continuing to be successful, I'd love to have people in that business remember me because a lot of people I work with are like family. You spend more time with their coworkers a lot of times than your significant others during a week, especially in a startup. [00:26:09] And so, so definitely would like to be remembered as someone that always put the customer first and made sure that. That I was providing value for others above all else. And then, of course, I want to make sure my family remembers me fondly. I want to make sure that one day I can actually throttle back and, have kids and be a good dad. And hopefully they can feel that I did a good job raising them one day. But right now I have no kids. So. [00:26:30] Lindsey Dinneen: Yes. Okay. Perfect. And then, final question. What is one thing that makes you smile every time you see or think about it? [00:26:40] Tim Balz: I mean, it's going to be my wife. She's pretty amazing. Totally out of my league, way smarter than me. And, and having a startup founder as a husband is-- it's, I don't know what it's like. I can assume I have, I know I can be pretty difficult sometimes not knowing if I'm gonna have to stay super late to help with a product launch or the stress of doing an investment round is, it's a lot. So I would say anytime I actually get to see her and spend time with her, that's, that's my favorite activity in life. [00:27:09] Lindsey Dinneen: That's special and it is worth holding on to. I love that. Amazing answer. Well, I just want to say, this has been so much fun to get to know you, get to know your company, and get to know the heart behind everything that you're doing. I love hearing the story of what first sparked your interest in this particular thing that you couldn't have necessarily predicted would end up being something that you really chose to focus on. But I love the synergy that has occurred throughout your life so far and that you've been able to take all these little pieces and put them together, and it's just really cool to see that. And so I just wanna, again, just say, thank you for the work you're doing. I know being in a startup, , running a startup, is a lot of work, is really hard. But, thank you for being here. [00:27:59] Tim Balz: And thank you for sharing the stories. There's a lot of founders out there that, they're out there solving problems that are, they're really important. And I love the perspective you're trying to bring so that people, understand that a lot of people, especially in the medical space, they're out here not just in it for the money. We're in it because we want to change the world. If we're in it for the money, it's so much easier to just go work for Johnson and Johnson or GE Health or something like that. And it's it's a tough road. So I appreciate you putting the spotlight on on founders. [00:28:25] Lindsey Dinneen: Yeah, sure. Absolutely. My, it's my pleasure. I get to meet amazing people like you and I love that. So, I'm happy. Well, again, thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. And we just wish you continued success as you work to change lives for a better world. [00:28:59] Tim Balz: Absolutely. Thanks so much. [00:29:01] Lindsey Dinneen: Thank you. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I'd love it for you to share this episode with a colleague or two, and we will catch you next time. [00:29:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Roy Morgan, CEO of Eagle Medical, shares his unique journey in the MedTech industry, starting from a pivotal one-question interview in 1997 that set the trajectory of his career. He reflects on his experiences in leading groundbreaking projects, emphasizing his deep-seated desire to improve and save lives. Roy's approach to leadership is both inspiring and intellectual, demonstrating a commitment to excellence and a profound understanding of the impact of his work.  Guest link: www.eaglemed.com Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 030 - Roy Morgan [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:51] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to be speaking with my guest today, Roy Morgan. Roy has had a distinguished career at multiple medtech corporations. His experience includes team building, platform strategy, intellectual property filings, project management, budgeting, and scheduling. His project design and engineering skills are highly sought after in the medical device field, and Roy has a BS in Mechanical Engineering, a BA in Semiotics from Brown University, as well as a degree in project management from the University of California at Berkeley. Roy currently serves as the CEO of EagleMedical. [00:01:32] Roy, thank you so much for being here. [00:01:34] Roy Morgan: Well, it's wonderful to be here, and thanks for having me. [00:01:36] Lindsey Dinneen: Course. Well, I would love if you don't mind starting off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:45] Roy Morgan: Sure. So, my journey into medtech started in 1997 with a one question interview phone call. And it was an amazing moment in my career. I'll never forget it because it was only one question, and the question was, "Can you invent?" And I'll never forget it because I'd never heard that question asked before. You know, looking back now on a 30 plus year history in med device, I think I answered the question right. But some days I'm still not sure. [00:02:15] I started out after that working for the Stryker endoscopy division of the Stryker corporation, was the lead innovator commercializer of their, I guess it's currently called the Crossfire Electrosurgical System. So I drove, you know, those things into market. I worked on their sports med team for a while, went on from there to work for some small startups doing other RF innovations in you know, tissue excision spaces, treatment spaces, then did some interesting work for Abbott diabetes care that launched I think people can see that now on television, it's called Freestyle Libre, it was originally known as Navigator. I was part of that development team in the early 2000s that got that off the ground and into the market [00:03:07] Subsequent to that, went to do additional in vitro diagnostics and diabetes work for some startups in florida And then came back to the Bay Area, and found myself kind of wanting to do something a little bit different, and chose to work with a company called Eagle Medical to drive sterilization, packaging, and innovations in assembly technique and you know, speed to market from the last operations process standpoint. And that's where I find myself today. [00:03:42] Lindsey Dinneen: Very nice. Well, thank you for sharing a little bit about your background. Did you always think that you might be an inventor or was this something that kind of came about over time? [00:03:53] Roy Morgan: Well, you know, it's interesting. That question, if you can imagine yourself taking a phone call and thinking like the recruiter building this up as like, "Wow, this is the next greatest company since, you know, I don't know, Johnson and Johnson" or something like that. And you feel all this pressure. And then it's one question. And I can't tell you exactly how I answered it. It was something to the effect of, "Well, I can't be 100 percent certain, but I believe with every cell of my being that I can do it." And I guess it was good enough to get the next round of interviews. It worked out. [00:04:29] And today I'm blessed to have been part of just an amazing industry. The things that I have been able to participate in, that I've seen done that are going on today, and that we continually, through Eagle, help produce for the greater global community, just amaze me. It's remarkable what we are able to do. It's even more remarkable the things that we're targeting to do in the coming years. [00:04:56] And so all of that just kind of makes me think: I hope I can continue to invent and do things. I've been blessed and fortunate to have more than a few patents to my name at this point. So I think there's some truth to the answer I gave, or at least I, you know, I kidded myself into believing it and it worked out. [00:05:15] Lindsey Dinneen: Well, yeah, you believe it and then you do it, right? So hey, you're just... [00:05:19] Roy Morgan: There's lots of phrases for that. I won't use them here, but you know, it worked out is what I'll say. [00:05:25] Lindsey Dinneen: Fantastic. Well, if you wouldn't mind sharing just a little bit about your work today with Eagle and just share a little bit about your heart behind it. I know you're very missions and values driven, and I would love to hear more about that too. [00:05:39] Roy Morgan: Sure. I'll start with our why, because I think that's the biggest and most important thing to understand. Our mission here at Eagle is to provide just the absolute best quality of service to our customer base, and our customer base comes in layers. But I always try diligently to remind our staff at every level in the company that the most important layer of customer that we have is the end recipient of the products that we package here. [00:06:15] They, as I like to tell them, they don't get a say. They're under anesthesia. They're unconscious. They can't see the quality of our work. They don't know, perhaps, even that it's part of the surgical process that there'll be receiving on any given day, of course, there's an implicit faith in our system that these products will be delivered in sterile conditions, that they are able to provide all of the benefit that surgeons, clinicians and support staff say that they can, and because our patients don't get a say, we have to do it right every time, all the time, without exception. [00:06:56] And that's something that we really try to drive home here to, to everyone that works at Eagle. It's part of what we do, and the other thing that I remind people about is that everything that comes through our facility has UDIs and part numbers on them, but that's really a misnomer. Each and every product that comes through here really has a name on it. And that name could be a sister, a brother, father, mother, could be your own name. And so remembering that, I think, really brings home the importance of what we have to get right every day. [00:07:33] Lindsey Dinneen: Yeah. Yeah. And have you had any particular moments where it just really stood out to you as confirmation that you were in the right place at the right time in the right industry? This awareness of, "Oh, wow, yes, this is why I do what I do here." [00:07:51] Roy Morgan: Wow, that's a great question. It's I don't know that there's like one moment. There are strings of moments that, that I can piece together in my mind. Most of it I think comes down to something that's deep seated in myself that has to do with desire for spreading good health to everyone around me, and I think it's... how do I say this? It's really something that's almost unconscious for me. There's a desire to see healing in people. [00:08:28] Without going into it really in my own background, there's healing that's had to go on for me and others in my family that are important things to support, to encourage, and to help along in the world. And those I think are, they're just very powerful beliefs for me. And so the moments in my career that kind of lend themselves to that, have been moments in operating theater with patients that are conscious. [00:08:58] Without getting too much into it, some very high profile athletes that have thanked me for the innovations that we brought into that operating theater that would enable them to continue their championship level sports endeavors. So it's about giving people a continued opportunity in life to do what they love to do to restore the life that they want and to have second chances when injury or misfortune might befall us, as it does all of us. [00:09:30] So I think those moments really stand out in my mind as, "wow moments" where, you know, you may not be expecting it, you, it catches you off guard and it gives you a little bit of introspection about your own why. Why am I doing this? What's my mission? So, yeah, those are the kinds of things that, that count. [00:09:51] Lindsey Dinneen: Yeah, and I love the way that you put it earlier where you were saying how-- and I think it's very human nature-- we get into the nitty gritty of the details and, and sometimes it does feel like, well, it's just, it's a component, it's a part number, it's whatever. And I love the way you put it about how actually those are, they get assigned to people. Those are humans who are affected by each and every one of the things you produce. And I love your emphasis in general, just listening to you speak, your care for human life and bettering it and helping the next generation. [00:10:26] So I just want to say thank you for your perspective, because it's easy to lose sight of that when you're having to do such detailed work, I think, and I love that you continue to remind the folks that work with you and yourself, I assume, too, about how important this is, and it's, it's not just another day for somebody who's affected directly by what you're doing. And I think that's pretty cool. [00:10:49] Roy Morgan: Yeah. Yes. Thank you. It's really my honor to serve in this role. [00:10:54] Lindsey Dinneen: Yeah. Well, what are you excited about next as your company continues to grow, you continue to invent and innovate. What's exciting for you? [00:11:03] Roy Morgan: Well, so, you know in our industry, the past couple of years with the pandemic and other industry related challenges have made it a difficult time for a lot of med device manufacturing . Just to, to name a few, you've had supply chains that have gone upside down and sideways and every other way you can imagine. You've seen sterilization modalities come under intense environmental pressure, forcing closures throughout the industry of certain types of modalities, and putting pressure on the balance of the system to rise to the occasion and meet the excess demands, which of course, something like a pandemic raises to an entirely new level. I don't know if we understood it, prior to 2020, in the visceral manner that I think we do now that a strong healthcare supply chain, a strong healthcare technology sector is really a matter of national security. It's really a matter of being able to sustain our population and sustain our society at a level that is functional. [00:12:14] I think the events of the past two years have highlighted for everyone that importance. So, I speak about those things in terms of how it's raised awareness. The excitement that it creates within me for the coming years is that I see tremendous innovation in how we're going to make things more resilient, how we're going to make them more capable, more scalable. And here at Eagle, what we're doing specifically, is implementing new digital transformations of this last operations process workflow so that we are able to spool up to demand levels that might seem insane. But to do it without breaking the machine, if you will. [00:13:02] And I think a lot of a lot of companies out there, a lot of my compatriots that I speak to, CEOs across the industry, I hear the same echoes that, wow, there was just so much that had to be done that it was very difficult and nearly broke us to try and reach those levels of production. So I think building those systems now and putting those in place for us, really is exciting to look at the future to say, "Okay, we'll be much more ready next time around." [00:13:32] Lindsey Dinneen: Yeah, I mean, fingers crossed and all, there won't be that same. But I love that you are actively working towards it because I think you're absolutely right. It took so many people completely off guard and without having come up with a way to handle it ahead of time, it was very difficult for many people. So I love that you're going ahead and putting those systems in place to be prepared and, tackle it head on in the future. [00:14:00] Roy Morgan: One, you know, one of the things that we're doing just as part of evolutionary innovation in the packaging space, we've developed a new system that's called the "PATH System." It's our Packaging Accelerated Timeline Help. And what it is, it really represents the first step of digital transformation of packaging validation. Traditionally packaging validations have been thought of as the rigor that terminally sterilized device has to be subjected to, to get all the way through distribution to actual operating theater, and it is and has been so for many decades. But, we have continually been testing the same types of packaging for decades. [00:14:43] We, Eagle, just ourselves within our own production database, we've got millions of test data points that we can mine and use to our advantage. And in fact, we've done that. And what we've created is our own engineered proxy device that we validated inside of a packaging solution. So, PATH is really, I call it a time machine because what you're buying is not a pre validated sealed package that contains nothing but air. You're getting a full digital data package of a validated proxy device. [00:15:21] It can be adopted as a worst case for any product family that's out there. The short story is, you're buying time, which helps a lot of companies out there that are trying to bring life altering technologies to market. They can save that time and that money, of course, because they both go hand in hand, getting to market sooner and being able to deliver that life altering technology to potential patients so they can benefit from it. [00:15:47] We saw this as a natural innovation in the space of time compression, of the utilization of massive amounts of data in the historical canon that we have, and that other companies also have. So really, it just kind of made sense for us to move forward with it. It's now available. And we're seeing lots of interest and we expect to see a few companies take advantage of it in 2024 to get to market much more rapidly. [00:16:12] Lindsey Dinneen: So exciting. Oh my goodness. Yeah. Thank you for sharing about that. I'm excited to look into it a little bit more too, but it's great to see all the innovation coming out of this space and keeps the hope very much alive that there continues to be passion and innovation moving forward. So, you know, throughout your career, you've held multiple leadership roles, of course, and I'm wondering how you view leadership. What is your own leadership style or philosophy and what's your advice for someone who might be looking to get into a more of a leadership role in the medtech industry for themselves? [00:16:50] Roy Morgan: Sure. I'd say my leadership style is, I lead with inspiration and I follow with intellect. So it's pretty straightforward, but not easy to do. The inspiration is, I think, been popularized lately by Simon Sinek, who talks about start with "why." Well, that's what it is. Inspiration is the why. The intellect, that's what I call the mechanics of how to get it done. And that's really how I've gone throughout my career in tackling the various leadership roles that I have had the privilege of being a part of. [00:17:30] I guess what I would say is to anyone looking and thinking about how to be an effective leader, it's a, it's as much an exercise in vulnerability as it is an exercise in your commitment to your own mission. You've got to know what that is. If you're going to be a leader, you want to be a leader in some particular endeavor, it's going to require a personal commitment to believe in that, to move toward it, and to live up to it. You're going to lead by example, which is generally the best way. But you're going to put your own success in the hands of others. [00:18:16] I can't say that as a leader, the success is all mine, it's not. I've worked with some of the most amazing teams, the most talented engineers, the most amazing people who help make things happen in a way that leads to that success. And so that's the exercise in vulnerability. I often tell people being a leader means that you're willing to underwrite failure after failure without loss of enthusiasm. [00:18:43] Lindsey Dinneen: Yes. [00:18:45] Roy Morgan: And if you're, you know, if you're able to do that you'll get there. So. [00:18:49] Lindsey Dinneen: Yeah. Thank you so much for that advice. I really appreciate your perspective too. Yeah. And so how do you see that play out especially nowadays where, you're in this obviously top leadership role, and one of the things that you are so passionate about is this sense of mission and core values and why we're doing what we're doing. And so I'm wondering, what are some ways that you have found to be effective in shaping culture to reflect the core values and help ensure that alignment, because I know sometimes, it's lovely to write those statements and we believe in them and we want them to be true, but it can be hard in the day to day operations when things get tough and difficult decisions have to be made to really adhere to them. So I'm wondering, how do you go about that particular component of leadership? [00:19:43] Roy Morgan: You've caught me at an opportune juncture in my career. Let me give you the setup and then I'll tell you what's going on. For the past 20 plus, 30, almost 30 years now, I guess, yeah, 30 years, I have used a performance management system, a goal system, which most people are familiar with, that I'll work with individual team members, my direct reports and their sub teams, et cetera, to establish a set of goals. That's worked very well. It's been successful and has provided a great amount of accomplishment over that time period. [00:20:17] But recently I felt like I was getting stuck in a rut, that the goal system as effective as it is has become-- I'm not sure what the best way to put it-- other leaders out there who go through this sort of self check in or appraisal, if you will, will understand what I'm getting at. You're just wondering if, "Gosh, I haven't innovated myself in a long time." And I would say that this is the other challenging thing about being a leader: if you let yourself get stuck in a rut, you develop complacency. Just like teams, just like company, it all happens, but it can happen to you. And I think in 2023, I took a look in the mirror and I said, "You know what? I'm feeling a little complacent. I'm feeling a little bit like this goal system is just my go to thing. I've done it for 30 years." [00:21:09] And so this year, I am trying something very different. We're trying the Four Disciplines of Execution, the 4DX approach, to how we're going to run our team goals. So, people out there who are familiar with it will know what it is. I'm not going to go, it's not going to go into the details of it here. But Lindsey, what I'll tell you is, for me, it's terrifying at the outset because it feels like I'm taking my hand off the wheel. I'm entrusting my teams to develop their goal set, to set their timing, to set their commitments. [00:21:50] Sure, I took part in setting the what they call the "WIG," the wildly important goal for the year, right? But I didn't set it by myself. I had to call the team in and say, "Look, guys, this is where we are. This is the struggles we're going through. This is what we want to achieve going forward. Is this the right goal for us to focus on?" I created a proto goal, but it was modified and I was okay with that. So, it's basically a starting line, a finish line and a deadline, right? [00:22:21] And so we did that. They changed it. It's now created and I'm uncomfortable. I'm in that, I'm in that gray space of uncomfortableness where I'm trusting that the system, which has many successful reports is going to work for us in the same way. It's knocking me out of my comfort zone. And I did that to myself on purpose. I'm doing this because, for me, I know that's a growth zone. I'm going to have to stretch. I'm going to have to grow. I'm going to have to think differently moving forward. It's terrifying. [00:23:00] And I would say to other leaders out there, this is what you have to do. This is what you have to do to achieve growth, having mentors, having other inputs, those are valuable, and they work for me too. But really this is a question of courage. It's a question of courage. You have to step up to the plate. I'm taking a swing. I'm hoping I hit the ball and if I do, I hope it goes over the fence. [00:23:28] Lindsey Dinneen: I love it. Thank you. Thank you for sharing that. I I really appreciate first of all, you being willing to talk about that because it is uncomfortable when you're going through a growth season maybe whether it's your choice or not, but even more so, when it's your choice and you're going, "I'm doing this because it's like you know taking your daily vitamins or whatever, maybe something you don't love, but you know it's for your benefit in the long run," and, but I understand that curve of, "Oh boy, this is, there's a lot of change and we're gonna, we're gonna see how it goes." But I commend you for that. I really do. And I'm excited. I hope we get to check back in a year and all things, "Say, hey, how's it going?" [00:24:08] Roy Morgan: Great. Yes. I hope to have great reports for you. [00:24:11] Lindsey Dinneen: I love it. Well, that was great. I really appreciate that. Pivoting just a little bit for fun. Imagine someone were to offer you a million dollars to teach your masterclass on anything you want. What would you choose to teach and why? And also, it doesn't have to be in your industry. It can be, doesn't have to be. [00:24:31] Roy Morgan: Sure. I think for me it would be it would be about creativity. It would be about, it would be about how to organize your life to have creative moments at as many turns as you possibly can, because creativity in itself, people ascribe for whatever reason, I guess in Western culture, we talk about it as a, an element of productivity or an element that's woven into capitalism, if you will, in a way that I don't think it's necessarily-- no, in fact, I know this-- it's absolutely not meant to be that. [00:25:11] Creativity is a source of fun by and large at its core, at its absolute core. It's like being... How do I say this? Well, this happened to me the other day. I was out on my, my, on my bicycle and I came over this hilltop after a long, hard climb and I began this descent and it was it was so overpoweringly filled with joy, that for a moment, you forget what you're doing. You have to get back on task quick 'cause it's a mountain road and you don't wanna make mistakes. But in that moment, it's, it's just about the joy and the fun. [00:25:45] I think I would teach about that because there are so many, I guess, so many challenging moments in human life for so many people, that to have a structure to help themselves to bring themselves joy, well, that would be really rewarding. Yeah, so I think that would be what I would talk about: how those elements in, in my own life got me through some difficult periods and, saw me through to the other side. [00:26:26] Lindsey Dinneen: Yeah. I love that. [00:26:28] Roy Morgan: That would be it. [00:26:30] Lindsey Dinneen: I would totally take that masterclass. I'm all about creativity and joy, so, yeah. That sounds like a fabulous class to teach. How do you wish to be remembered after you leave this world? [00:26:41] Roy Morgan: Ooh, wow. That's, that's a question that combines both austerity and optimism in the same note. How would I like to be remembered? I guess if I had to put it in one sentence, as a song. I don't know, I don't know that, yeah, I don't know that song is fully written yet. [00:27:04] Lindsey Dinneen: Yeah. [00:27:06] Roy Morgan: Yeah, I think that's how. [00:27:07] Lindsey Dinneen: Okay. Now, would it be instrumental or would it be a lyric-ed song? [00:27:15] Roy Morgan: It would probably have few lyrics and it would be mostly music. [00:27:21] Lindsey Dinneen: Okay. I'm digging it. That's by far the most creative answer I've ever gotten for this question. So I I'm loving it. [00:27:29] Roy Morgan: Well, it's, there you go, creativity, right? [00:27:32] Lindsey Dinneen: There you go. [00:27:33] Roy Morgan: That's what it's all about. [00:27:34] Lindsey Dinneen: Reoccurring theme. I love it. Yeah. And, and final question, what is one thing that makes you smile every time you see or think about it? [00:27:45] Roy Morgan: Oh, wow. One thing, there's so many things I'm lucky like that, that do that for me. I, well, the one thing that pops into my head right now is the sunrise. And I guess that, that kind of ties it in for me. I have this saying that I tell people, in fact, I was just doing a whole bunch of it here on New Year's Day. I say this all the time to myself and to others, "Well, here is another 365 chances to be great." [00:28:15] Lindsey Dinneen: Yeah. [00:28:16] Roy Morgan: So with each sunrise, a new chance to be great. [00:28:21] Lindsey Dinneen: Yes, and that's definitely a reason to smile. There's new hope every day. I love it. [00:28:28] Roy Morgan: May sound a little corny, but it works for me. [00:28:29] Lindsey Dinneen: I'm all about the corny when it works. Sometimes even just the corny for corny's sake. Let's be real. Yeah, well this has been an amazing conversation. I really appreciate you. I love the work that you're doing, but I especially resonate with and so value the emphasis that you put on remembering that what you're doing and the work that you're producing matters so much and it matters to humans and it's not just another part coming out. And so I just want to reiterate again how much I appreciate the way that you talk about that and the way that your company actively works to change lives for a better world. [00:29:09] So thank you for what you're doing and what you're bringing to the world. And I just really appreciate it. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation. [00:29:36] Roy Morgan: It's been my pleasure, Lindsey, and I wish you and all your team there a wonderful 2024. [00:29:42] Lindsey Dinneen: Thank you. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:29:55] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Annmarie Ison, Vice President and Head of Service at Elekta, share her remarkable career focusing on life-saving medical technology. Annmarie reflects on her initial aspiration to be a doctor, her pivot to physics, and the serendipitous turn that led her to a startup revolutionizing radiation oncology. With a personal touch, she shares insights from her childhood fascination with science, her transition from aerospace to the dynamic world of Silicon Valley startups, and her commitment to improving patient care through technology. The conversation not only showcases Annmarie's technical expertise but also her deep passion for making a tangible difference in people's lives. Guest links: https://www.elekta.com/ | https://www.elekta.com/products/oncology-informatics/elekta-one/ Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 029 - Annmarie Ison [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Annmarie Ison. Annmarie serves as the Vice President and Head of Service at Elekta. With over 25 years of experience as a software development professional, Annmarie specializes in product development and software architecture for information management systems and radiation therapy delivery devices, specializing in software, inter connectivity, machine functionality, and clinical workflow. She is highly effective and directing all aspects of the software development life cycle. And is passionate about new technology, customer relations, and products that have the potential to enhance the standard of care in oncology. [00:01:37] Welcome to the show, and thank you so much for being here. [00:01:41] Annmarie Ison: Oh, thanks for having me, Lindsey. I'm really excited to be here and chat with you and see where this goes. [00:01:49] Lindsey Dinneen: Absolutely. Well, I would love, if you wouldn't mind starting by telling us just a little bit about yourself and maybe your current role. [00:01:58] Annmarie Ison: So my current role is Head of Service for the software products at Elekta. And these products support radiation therapy and medical oncology and for clinics to deliver therapy, both chemo and radiation therapy, in a more efficient, safe, and effective manner. I actually for many years was in engineering and this role in service is fairly new to me. It's only been about a year that I've been in this role. I sometimes wonder how I got here, but I think it really comes from the fact that I love interacting with customers. [00:02:42] I started with the company as a startup, and there were only about 20, 25 people when I joined. And so you did a little bit of everything. And one of the things that got me really excited was working with our customers, talking to them, finding out what they need, why they need it, what they're doing. And also occasionally having those uncomfortable conversations on why things aren't working and how we can make 'em better and how we can fix stuff. And so I think over the years I've done different, as I said, different roles. [00:03:22] I did some product management and went back to engineering again, and then recently took on this challenge of service because, yeah, I just love interacting with the customer for good and for bad, and I really want to help them be better, help us be better by helping them be better and do their jobs in a easier way so that they can focus more time on the patients and less time on the stuff that they have to do. The computer systems are everywhere. We all have to use 'em, right? We have email and we have everything. And I don't want our software products to be burdensome to them. I want them to be easy and streamlined and make their life easier, and again, so that they can make the patient's lives easier. [00:04:19] Lindsey Dinneen: I love that. Oh, thank you so much for sharing a little bit about yeah, your story and how you ended up in this new role. This sounds like a wonderful blend because you have this, I can already tell, this heart for other people making a difference. And then you have that combined with your love of people and your enjoyment with working with them and that's not always easy. So I love the fact that you're able to combine some of those passions. And I'm curious, how did you start getting involved with the company at the beginning, when it was first a startup? How did that all come out? [00:04:58] Annmarie Ison: That was really just by happenstance. I'm gonna go back even further and say, as a child, as a kid, nine, 10 years old, I loved science. I was always into science. I had experiments. I had a chemistry set in my bedroom. But I always just assumed that I would be a doctor. And I, it wasn't, this is gonna sound really weird. It wasn't that I wanted to be a doctor. I just assumed that's what one did. If you were good in science, you became a doctor. That's, that was the only path, and I really never gave my career choice-- it wasn't a choice, actually. It was the only path. [00:05:40] I never really gave it much thought until I got to college and of course I was pre-med and I started meeting my new classmates and talking with them about what, why they wanted to be a doctor, why they were drawn to the practice of medicine. And I realized really quickly that I wasn't, that wasn't me. That isn't what I wanted to do. I didn't have that-- I didn't aspire to practice medicine. And so I kind of pivoted and I went away from that completely and I studied physics. And I focused on physics. And to me, I picked physics because to me it's foundational. And plus, physicists have the best toys. We get to play with all sorts of cool things. [00:06:26] But to me it was foundational and it really helps you understand a lot of other disciplines, and at the same time I was into mathematics and other staff and-- this was many years ago, for those younger folks listening-- computer science as a degree, as we know it today, didn't actually exist back then, or at least not at a lot of universities, and certainly not the small liberal arts college that I went to. And the, but the courses around computer science were taught outta both the physics and mathematics departments, and so I was really fortunate to have these great professors who were, I consider on the forefront, at least to me, they were on the forefront of figuring out how to use computers, and I'll really say PCs, as a tool to connect the physical world and the digital world, and use it to do the things that computers are really good at and let humans do what humans are good at. [00:07:35] And, you could focus on the physical situation and the data collection and data analysis was all done by the tools that we take advantage of or take for granted today. Excel and things like that didn't exist back then. It's a long time ago. So anyway, it, kind of pivoted away from that, from healthcare and being a doctor altogether and focused on physics, went to graduate school. And when I left graduate school, I really wanted to do exciting things like pay rent and eat. [00:08:09] So I found myself in aerospace and it was really interesting. I, I also found myself in Silicon Valley. I met my husband who grew up there, so that's where we wound up, and in aerospace I had, like I said, it was a cool job. I liked it. I was working on satellites. I, GPS was kind of a new thing then. It was really just coming into its own. And I even got to work bit on the space shuttle, so I, I was very excited. I was happy to stay in that role, but unfortunately the job moved out of the Bay Area and I had found myself going what do I wanna do with my life now? [00:08:58] But there were so many exciting things happening in Silicon Valley at the time that I I mean, it looked, it felt like there was a startup on every corner or really in every garage, right? And I just really, by happenstance, found this startup. And during my discussions with 'em, I met the principals and they shared their vision with me and it just resonated. They were working to change the face and the trajectory of radiation oncology, and when they explained their vision, I saw it, and I also saw a path to get to that vision. [00:09:48] Even more so, I felt like I saw how I could bring everything that I had done up to this point-- my physics background because there's a lot of physics in radiation oncology, my safety background for man's space flight, and my desire to do good and help people from when I was a little girl thinking about being a doctor-- I was able to bring all of that together into this one job. And I'm gonna say I was hooked and I haven't looked back. I've been doing, I've been with the company aiming for that vision really for the last 29 years. And I'm still striving for that vision because it really was a visionary that we're not quite there yet. There were paradigm shifts along the way, and we hit those and helped change how things are done and really form a market, but we're still striving. We're still striving to do better. [00:10:48] Lindsey Dinneen: Yeah. Yeah. Thank you. Thank you for sharing about that background. I love how, I just love when a pathway isn't, isn't as straight as we necessarily think it's gonna be. It's kind of funny how, you said looking back, it was almost like this expectation of, I'll be a doctor. And then you were able to, yeah, to take your interest in science, but your interest in lots of other things as well, and then form this career path that's probably looked unexpected, but seems to have wound you up in a place that you feel at home? [00:11:23] Annmarie Ison: Yeah totally. I do feel at home and sometimes I wanna go back to that nine, 10 year old self and go, "see, see, there isn't one path, there are options." There are so many different people and disciplines and viewpoints and technologies that are all needed to change healthcare, to advance the standard of care and the standard of practice. And you can make that difference by bringing your own set of skills, your own viewpoints, your own passion, and by just being you. And I hope that people hear that and realize that there isn't one path. [00:12:06] Lindsey Dinneen: Yes. . Thank you. I am completely in agreement with you, but I also just appreciate that, that you shared that particular advice because I think you're absolutely right. There are always multiple avenues to a dream and what might work for one person might be a different path for someone else. Well, so are there any moments that stand out in particular as just having this moment of realization that you are where you're supposed to be, like you're in this field, you're at this company, you're doing this particular work. Just any, anything that stands out in particular as, "Yes I am, I am in the right place at the right time." [00:12:51] Annmarie Ison: Oh goodness. I mean there, it's been a long career. So there are so many things that I'm proud of, but there's a moment that sticks in my head from many years ago. Maybe about two or three years after I joined the company, there was a new forum, a new technique in radiation therapy that was trying to become --I'm gonna just call it mainstream or standard clinical practice-- but there was a challenge there that the amount of data that was involved in preparing the patients for the treatment was huge. Hundreds, thousands of pieces of data that the medical physics team had to check and recheck and do measurements on. And it took a lot of effort and we were working with some of our customers to tried to streamline that process and provide them the confidence. Some of these checks, again, people can do those checks, but computers can do those checks really fast. And so we were working with a number of customers and there was one night, and like I said, it sticks in my head. I was in a, can I say I was in a bar in Saddlebrook, New Jersey of all places? [00:14:06] Lindsey Dinneen: Of course. [00:14:07] Annmarie Ison: You're up in New Jersey, so maybe that's why it sticks out. But where I was talking with a colleague, a customer, and we were gonna give a seminar the next day, and he had just, he was putting his slides together and going over them with me, and he had told us that he was able to get this effort that took him like 30 to 40 hours down to about an hour, and we were like, "Wow, that's awesome. That's fantastic." And we were really excited about that. But it was the thing that he said next that really stuck with me. And there's two points on it. The first is he said, "And now we don't have to choose. If the clinical indication requires this kind of treatment, we can offer it." [00:14:54] And that just hit me and I was like, "Wow, we moved the needle. Right? We really moved the needle." And I just, I was really excited about that statement, but it also hit me in a slightly different way. It reminded me that in all the rush to, in the day-to-day responsibilities of getting these features to the market, and who has to sign what paper, and what form has to be done, and what project plan has to be completed, and all those things that I actually didn't think about the patient. I'd forgotten about the patient. [00:15:35] And really since that day-- I actually felt bad about myself when he said it. I was frustrated and angry at myself for not thinking, not keeping that patient and that set of patients in mind-- that really since then, every day I think about the millions of patients that are impacted by the products that we work on. And I also think about each individual patient. When I'm never sure about, "Is this the right thing we should do? Are we working on the right thing? Is it good enough?" I think about the patient, the individual who could be anyone. It could be your brother, your sister, your spouse, your next door neighbor, child as well as I think about that vast set of patients that can be impacted. [00:16:24] And it helps recenter me and refocus me to make sure that I know I'm doing the right thing. And it's just stuck with me all those years. I'm a little bit of a broken record at work when I say, "Two and a half million patients, two and a half million patients," , or I say, "What about the patient? What about the patient?" But, I think in the end, it serves us well to do that, to always keep that in mind. [00:16:52] Lindsey Dinneen: Yes, absolutely. And, thank you so much for sharing that story. That's powerful. And so I know that women's health and advocacy for femtech, whatnot, that's something that you are interested in and passionate about. And I was wondering if you could share just a little bit about maybe your experience. [00:17:13] [00:17:14] Annmarie Ison: Yeah, so I think that access to care is really the key thing. And, whether it's women's health-- which I think is a huge issue of getting access to care-- but it can be anyone really. As I mentioned in the previous discussion about bringing these advanced techniques to the clinical setting, there are areas of the world that, that don't have the resources. And the resources could be basics like electricity and access to power and things like that. But also, the resources of skills. Right? [00:17:56] As I mentioned, medical physics is a big part of radiation therapy and if you don't have really skilled medical physicists around, it can be difficult to use these really advanced techniques that can, provide better care, fewer side effects, shorter treatment times. Again, when if you're looking at someone who has to travel a long way to get to care, you don't want them to have to come back every day for 25 or so days. If you can shorten that down into a week or so, which we can with some of these really advanced techniques. [00:18:35] But again, you need those resources, you need those expertise, and I think that's where I. The digital world comes into play again. And if anything, the pandemic taught us that we can do so much remotely. I can be, and we have this already today, can have medical physicists from some of the leading clinics in the world, here in the United States as well as in Europe, looking at and supporting countries that don't have that same baseline of resources and technical expertise. [00:19:10] And I think, women's health comes into play there a lot in that there are many indications in that are managed by radiation therapy. So I think, again, being able to offer these advanced techniques, shorter timelines, hopefully higher cure rates, or at least control rates, to these emerging markets, and expand access to care is really important to me. And I feel that's the direction that we have to go with in the, in healthcare in general. Access to care is the key. [00:19:47] Lindsey Dinneen: Yeah. Yeah. Thank you for speaking to that and elaborating a little bit on, on that, and I, I, I appreciate the fact that that you and your company in particular are aware of those issues and are thinking through them and talking about them and, that's how change is gonna happen. So, it's always exciting to see that. [00:20:08] Annmarie Ison: Yes. [00:20:09] Lindsey Dinneen: Yeah, absolutely. So, pivoting the conversation, just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach about and why? [00:20:30] Annmarie Ison: Oh my goodness. I think fundamentally I have a hard time with this question because I don't consider myself a master of anything. I always consider myself an intermediate, because as I learn, I realize how much more I don't understand about them. But for the million dollars, and I'll take it, I think it would have to be something around cooking. I love to cook, but I wouldn't want to talk about technique, mastering a specific chopping technique or sauteing technique or whatever. But I think I'd call it "collaborative cooking." I have so many friends who are intimidated by cooking and, "Oh, I don't know how to cook. I don't have a recipe." But I just can't think of anything more fun than to work as a team, bring everyone's different perspectives and skillsets and passions, if you wanna use that word, together, to bring a nice meal on the table and if things go wrong, well, that's part of the experience. [00:21:38] I also think that if you don't cook and you can still be a part of the team. My, my family does this, my family and friends, we do this all the time. Someone, we have three or four people in the kitchen, all cooking together. Someone made the menu, someone else has picked the wine, someone setting the table. Hopefully someone's pouring the wine too, but we all come together and it makes everything less, like I said, intimidating. You don't, you shouldn't be intimidated by cooking. It's fun and there's nothing better than enjoying a nice meal prepared by all of us together. [00:22:16] And that's my feeling about a team also is when you have a team working with food, like I said, dinner, it's no one's thing. It's everybody's thing. We all came together to make it so it's no longer, "I cooked this." It's, " We cooked this, we did this, and we made this wonderful evening or afternoon or whenever it is." You're enjoying it. So that would be my theme of the masterclass, if I could. [00:22:50] Lindsey Dinneen: I love that. Oh, I love that. [00:22:52] Annmarie Ison: Yeah, just, cooking with my nieces and nephews is always fun, and everyone coming together to enjoy and celebrate. [00:23:01] Lindsey Dinneen: Yes. . Yes, that is very exciting. And hopefully, like you said, the, the teamwork component of it will be joyful as all the families get together . [00:23:11] Annmarie Ison: It can also be, I call it, "passionate." It can be . It can also be passionate at times, like... [00:23:19] Lindsey Dinneen: I love it. [00:23:20] Annmarie Ison: ...someone can feel strongly about the temperature that cookie should be cooked at. I don't know. [00:23:25] Lindsey Dinneen: Yeah, that's right. And we're all working together towards a common goal, so gotta figure it out. . Amazing. Amazing. How do you wish to be remembered after you leave this world? [00:23:38] Annmarie Ison: This question, I'm gonna have a hard time with answering without getting very emotional. My husband passed away a few years ago, and he was in medical devices as well. We actually have a very similar background, he was a physicist, went into medical devices and we actually talked about this when we knew the end was nearing. And his answer was, "I want to be remembered that I helped." And I can't think of a better answer. I would love to be remembered that way, that I helped in some way, in all sorts of ways, that I helped my family and friends in times when they needed help, whatever that was, might be cooking something for them. But also that I helped forward this vision that the founders of the company had that I helped clinicians help their patients, and that I had some small impact on the standard of care and the direction of oncology. Yeah, that's the way I would like to be remembered, that there was some help. I can't think of anything better than that. [00:24:51] Lindsey Dinneen: Yeah. That's beautiful. That's a wonderful thing to aspire to. Thank you for sharing those stories, really appreciate it. And last but not least, what is one thing that makes you smile every time you see or think about it? [00:25:07] Annmarie Ison: Oh man. I feel like I should say something honorable like my family and friends and things like that, but they would all know that I was lying if I said that. They know the answer. The answer is pandas. [00:25:25] Lindsey Dinneen: Yes. [00:25:27] Annmarie Ison: I love pandas. As a little girl, I had a stuffed panda instead of a teddy bear, and I became a bit obsessed, and I consider myself now a recovering panda- holic. I had a rough week when the pandas left The National Zoo. It was very emotional for me, but I still lean towards pandas. I can't help but smile and laugh when I see them, and if you were to look under my desk on my early morning teams calls, chances are that I'm wearing my big fuzzy panda slippers while I'm taking those morning meetings. [00:26:09] Lindsey Dinneen: Oh. [00:26:09] Annmarie Ison: You dunno that, but I've got my big fuzzy panda slippers on most days. [00:26:15] Lindsey Dinneen: I love it! Thank you so much for sharing that. That just makes me smile. I love pandas, oh my word, and I just, every time I see those videos of those care takers trying wrangle the babies, oh my goodness. I love it. [00:26:34] Annmarie Ison: I, I, if I wasn't doing what I was doing and helping people this way, I, that's my dream job. [00:26:40] Lindsey Dinneen: Yeah. I have often said my retirement gig is gonna be a animal caretaking in some way. Oh my word. Well, this has been such a pleasure to speak with you today, Annmarie. I really appreciate you sharing a little bit about yourself and your background, how you came into this industry, and just your heart and passion for people, and making a difference. I really commend you and I just I thank you. Thank you for everything that you're doing to change lives for a better world. [00:27:10] Annmarie Ison: Oh, thank you. Thank you for having me. And I've actually listened to a number of your podcasts, so I feel honored to be a part of the group that you've talked to. And thanks. Thanks for inviting me here. I really enjoyed it. [00:27:24] Lindsey Dinneen: Thank you so much and thank you so much also to all of our listeners, and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time. [00:27:39] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. ​

Essa Abdool-Karim, an emerging companies lawyer specializing in medical technology, shares his intriguing journey from sports and entertainment law to finance law, before finding his passion in MedTech legal affairs. He discusses the vital role of contracts, liability considerations, and the complexities of navigating regulatory landscapes, especially when expanding into international markets. Essa offers invaluable insights into the importance of strategic investor relationships and the distinction between "smart money" and "dumb money." His optimistic outlook and dedication to facilitating breakthroughs in MedTech make this a must-listen for aspiring and established entrepreneurs. Guest links: https://www.linkedin.com/in/essa-abdool-karim/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 028 - Essa Abdool-Karim [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey and I am so excited to introduce my guest today, Essa Abdool-Karim. Essa is an emerging companies lawyer who helps his clients build their businesses. This can be through raising capital, producing the correct contracts or structures, navigating regulatory hurdles, or purchasing new businesses that will either expand or open a new market for their current businesses. [00:01:17] Essa, welcome to the show and thank you so much for being here. [00:01:21] Essa Abdool-Karim: Thank you for having me. [00:01:23] Lindsey Dinneen: Absolutely. I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background. [00:01:30] Essa Abdool-Karim: Yeah. So a little bit about myself. I am an emerging company's lawyer, some would say a venture capital lawyer as well. I, I have sort of like a general practice, but my emphasis are in several technology companies, but I have a special interest in medical technology companies, representing them from their early sort of incubation stages all the way up into hopefully one day, some IPO or other form of exit. And a lot of my practice is helping sort of build that out and almost acting as fractional general counsel to a lot of the activities that they do. [00:02:03] Lindsey Dinneen: Excellent. And then would you mind telling us a little bit about your background, maybe how you got into this field and specialty in the first place? [00:02:11] Essa Abdool-Karim: Yeah, my journey is quite interesting actually. It is not, it's not a straight line by any means, right? So, I actually started as a, so after I finished law school, I went and worked for sports and entertainment law firm where I was representing athletes, entertainers, at sort of international tribunals and contracts sort of negotiations, mediations. There was contract drafting as well. So it was really cool. It was a lot of fun and I don't know what possessed me to say, "Hey, I want to go leave this and go to the exciting world of finance." [00:02:41] So I ended up in the the finance industry. I worked for an broker dealer in Montreal. So I did sort of a quasi-legal role there. But at some point I just missed private practice. So I left, ended up starting my own shop and then joining up with the firm I'm currently with. And yeah, so as I was developing my practice, I realized that I loved working with startup companies and growth companies or companies in a growth stage. I found it to be very exciting. [00:03:11] How the medical technology thing sort of happened. It sort of lined up with my interest and I had one client that sort of reached out to me that was sort of a larger, they had a more established medical technology company than they all also had an early stage medical technology company. They had a couple. And it sort of through that, I really sort of delved into the world of medical technology and all of the legal issues that these companies typically face, both in local markets and international markets. Prior to that, however, I've always been interested in the space. I just didn't know exactly what the space was or meant. Right? So yeah, that's that's a bit of background about me and sort of how I ended up where I'm now. [00:03:51] Lindsey Dinneen: Yeah. And so out of curiosity, did you growing up think, "oh my goodness. One day I'm gonna be a lawyer?" Like, was this always a goal and interest of yours or has that evolved over time? [00:04:03] Essa Abdool-Karim: Yeah, weird. It's kind of weird how that happened. Law has always been sort of something of interest to me and from a very young age. And it is something that I've often entertained. I did wanna do something a little bit different, but it was like, "oh, it would be nice to be like a marine biologist. What do they do? It'd be nice to be an astronomer, but I do just look at the stars all day?" I'm not sure, right, what that sort of entails. So I was like, "okay, I understand what lawyers do, I think for the most part. So I'll just do that". So, yeah, how that happened. [00:04:32] Lindsey Dinneen: Okay, . Okay. So, so first was just sort of, okay, I have an idea of what you do, but then, I mean, that's a huge commitment in terms of education and time and all sorts of things. So, how has becoming a lawyer and then going from sort of industry to industry, how has that been a compelling thing in your life in terms of career trajectory as you've gone from one industry to another? [00:05:00] Essa Abdool-Karim: Yeah, Yeah, Yeah it's been interesting. I kind of like it personally just because when I first started, and even a little bit right now, I'm sort of industry agnostic. I wouldn't have been where I am today, if not for the journey that I've had. I kind of done everything that I wanted to do. Like prior to law school, I taught, I was a teacher because it was always like, maybe I should become a teacher. Then I went to law school, wanted to work in sports entertainment. I think every entry class has about 30% of the students want to enter into that. I was very fortunate that I ended up in there. So, and then I went, I've always wanted to try the world of finance. I tried that, got to see what that was about. It was interesting. Not interesting enough for me to stay, but interesting, so. [00:05:43] Lindsey Dinneen: Sure. [00:05:43] Essa Abdool-Karim: So it was, it's good. It's been a very good journey in that regard. And I'm just happy that I ended up dealing with medical technology as one of my major verticals. So that's been, it's been really cool and I've been very fortuitous to have that experience, and it's exciting. I enjoy the pace of it. [00:06:01] Lindsey Dinneen: Yeah, for sure. So with medical device companies in particular, I imagine that each industry, and of course each company has different focus points in terms of legal considerations, but MedTech is a very heavily regulated industry, so what are some of the top considerations that you help-- especially very young startups, maybe it's their very first invention or product-- what are some of the considerations that you always help them to think through from a legal perspective? [00:06:35] Essa Abdool-Karim: It's a loaded question and I don't wanna, don't wanna. No, it's a very loaded question. It's a good question though. I don't wanna give you the lawyerly answer and say it depends but in, in a way it does, but I think the essentials are, there's, there's a few. [00:06:50] So, you know, contracts are very important. Obviously having the right contracts in place is, there's a very good starting point, especially with your founders. You, everyone sort of starts your relationship thinking, oh, this is sort of like a "kumbaya kind a moment. We're all gonna be fine. Everything's gonna work out." But the reality is, you know, I'm not paid to think about the kumbaya moments. I'm paid to think about, you know, what's the worst that can possibly happen and how do we account for that, unfortunately, right? So that's one thing that's very important. Understanding where everyone's responsibilities are, outlining that in a document is a very good starting point. [00:07:22] The other critical starting point I would say is liability, particularly in the medical technology industry. It's a highly regulated industry. There's a lot of money flowing around, and with that, there's a ton of risk. So, as an example for Canadian companies they will be receiving any sort of regulatory approvals that you need to receive from the relevant Canadian authorities. And once you obtain that, you have it, you're in the market, but more often than not, you're looking to expand to the United States, as an example. [00:07:54] Now there are a number of considerations when you're having to do that. There's obviously FDA regulations that you have to worry about, certain sort of disclosures that are required to be made. And this isn't even going into the intellectual property element of patents and other sort of important intellectual property issues. But just both focusing right now on the corporate side. When, and I'll speak from a Canadian perspective and I'll transition into the US, but when a Canadian looks at the US the, they're, the biggest thing they're afraid of is getting sued and understandably so. The United States is the most litigious society on earth in the entire world. I think I saw a statistic where it said there's a lawsuit literally every second. And. [00:08:38] Lindsey Dinneen: Oh my word. [00:08:39] Essa Abdool-Karim: Yeah, so it's understandable. There's a high risk, high reward because the United States is such a large market, and there's so much promise here, people want to enter into it, but they wanna be very careful when entering into it. And I typically advise them the relevant corporate structure to enter in to this market for it. Now there's a distinction, right? There's the early stage elements where we're dealing with startups, making sure the contract correct contracts are in place. There is a basic corporate structure in place. And you're working towards some sort of intellectual property ownership because that's critically important, particularly in this field, although I'm not an intellectual property lawyer. [00:09:17] I do, I shouldn't say-- I'm not a patent lawyer. I do some intellectual property work. I'm not a patent lawyer specifically. You know, I'm familiarized with trademarks, copyrights, but patents that are very sort of technical area of law. But it's critically important to have your eye on the prize and want to work towards that. So I do liaise with patent agents, patent attorneys and other relevant legal minds. So that's all part of the process. [00:09:45] I think building your vision very early, understanding how you want to get there and where you want to go is all critical and part of the process. In my experience, patents take a very long time relatively to secure, but I think that's the end goal. And even with that, there's time limit after you obtain it to, to file for it in other countries. So it becomes a global thing as well. But yeah, so at the early stage you wanna work primarily on the structuring, get the right team together, make sure that everyone has the right documents in place. Could be employment agreements, could be independent contractor agreements. [00:10:15] It depends on how you wanna structure your company, how much appetite you have for it, what's your relationship with the employees or independent contracts ought to be. anD even the boring stuff like share classes, understanding how those work. And then there's raising money, and that's a big one because everybody needs money to operate their company, and to get it off the ground. So those are some of the early stage considerations. When you're sort of like at a growth stage, what you're looking at is market entry, how to enter into foreign markets, which obviously I help my clients with as well. [00:10:48] Lindsey Dinneen: Yeah, so lots of considerations. So we can just barely scratch the surface, and folks should hire you if they need additional supports. [00:10:56] Essa Abdool-Karim: For sure. [00:10:58] Lindsey Dinneen: You know, it's so interesting. Thank you for sharing some of those considerations and bringing to light some things that you might not think of initially, especially like you mentioned, it, it does feel very exciting when you start a company and you have all of these like celebratory moments, 'cause everything is exciting and a big deal. And then like you said, but you have to think it is your job to think about what could go wrong though, and then prepare for that. So I am curious though, that sparked a question for you personally in your own life, how are you able to separate or negotiate the fact that a lot of what you need to do is look for worst case scenario, when probably you wouldn't wanna do that in your personal life all of the time. So I'm curious how that works where it's like your work is so heavily focused on being proactive in a preventive way, however, at the same time, for you personally, how do you balance that? [00:12:00] Essa Abdool-Karim: Yeah. Yeah, it's interesting. It's a good question too because we have... listen, I'll be honest with you, lawyers are pessimistic by nature, right? I think generally speaking, we just think of the worst case scenario. I'm not like that personally. I'm an optimist. I'm a cautious optimist, a realistic optimist, whatever you wanna call it, right? My philosophy is always hope for the best, but prepare for the worst. I think it's critically important to do that. I do that in my personal life. I do it in my professional life. And just because you're thinking of the worst case scenario, it doesn't mean it's gonna happen, right? You just have to calculate for it. My job is to make sure we don't get to that point, right? But you have to account for it nonetheless. [00:12:39] Lindsey Dinneen: Yeah. So, so you are able to keep the perspective of we're doing this as a, as something to be prepared for as a preventative and not get to that point, so therefore it can be a little bit more optimistic and a little less... [00:12:54] Essa Abdool-Karim: Yeah, and it's so difficult. It's so difficult too, to be honest with you, just because so much of my job is, you know, thinking about that stuff, [00:13:04] Lindsey Dinneen: Yeah. [00:13:04] Essa Abdool-Karim: It's very easy to get down on yourself outside of work. So you need to be really good at sort of detaching. And I have a good support system in place. I think that's very important. I didn't marry a lawyer. I know a lot of people that do, like lawyers marry other lawyers. So I think the fact that I'm not married to one probably helps. [00:13:21] Lindsey Dinneen: Yeah. [00:13:23] Essa Abdool-Karim: I know me if I was married to one, we just bought talk shop when I got home. So, and I know a lot of lawyers that are married to other lawyers and it works for them. I think they probably make it a point to probably detach and they probably understand each other in, in that sort of capacity. But I'm married to an accountant, so very different world and I think is beneficial for me. [00:13:45] Lindsey Dinneen: Yeah, that makes a lot of sense. . Yeah. So with the medtech industry specifically-- when you do get to work with those clients, what are some of the things that stand out to you as being particularly noteworthy or enjoyable? What in particular do you like about this industry? [00:14:04] Essa Abdool-Karim: Oh, I love how brilliant everyone is. Everyone is so smart, so much smarter than I am. Like it's It's amazing. [00:14:11] Lindsey Dinneen: Yeah, [00:14:12] Essa Abdool-Karim: It's [00:14:12] Lindsey Dinneen: I get that. [00:14:13] Essa Abdool-Karim: It's really cool. It, there's so many smart people in this industry. Watching, not only watching, but also being in that room with people who are trying to solve a problem makes such a massive difference because I feel it pulls myself up as well. I really have to be on my A game. And because of that, it's just so enjoyable working with them. So yeah, definitely. It's definitely the intelligence. That's one thing. [00:14:37] Another sort of element is-- and I went to law school with this intention-- I always wanted to be able to provide for my family, but I always wanted to do good. I wanted to be able to sleep at night and knowing that I was doing good. And, when I'm servicing medical technology companies, I know, yeah, obviously you have to care about the bottom line. That's, that's part of the business side of it. But a lot of the founders I met their intentions aren't just the bottom line. [00:14:59] Their intentions are, we wanna change the world for better and we want to make the world a better place. We want to make it easier for, for everyone who's going through this particular difficulty and we want to make their life easier. And I think that's remarkable. So one of the greatest pleasures I have is I'm trying to help 'em achieve that goal and I'm trying to help them realize that success and that is really cool for me. [00:15:22] Lindsey Dinneen: Yeah. Yeah, absolutely. Yeah. Thank you for sharing that. I think those two things are-- I agree with both of them. I really enjoy both those elements. I also really like-- I don't know what your experience has been-- but one thing that I very much enjoy about the industry is how friendly people tend to be, and they tend to be just very welcoming. And us about you, tell us, you know, it is, it's just a very inclusive place for the most part. And I hope it will continue down that pathway because [00:15:47] Essa Abdool-Karim: I think, yeah, I for sure. I think the people I've met are very receptive, and that's, and I think that's really cool. Typically, and I'll be honest with you, in some industries there's almost, I wanna call it a fraternity, where they try to keep people out. But I haven't found that in the medical technology industry. I found that people are very receptive, very open, and I think the worldview actually is a little bit different from other industries in that sense. There's very human side to this that I think everyone appreciates. And I think that's really cool. [00:16:18] Lindsey Dinneen: Yeah. Yeah, absolutely. And so, are there any moments along your lawyerly journey where you had this realization, maybe you were helping a client, or it could really could be anything, where you just had this thought of, wow, this is why I do what I do. [00:16:38] Essa Abdool-Karim: Yeah, that's a very good question. There's a really basic one I had recently a couple of months ago. So I drafted up an independent contractor agreement for a client and things didn't work out. Independent contractor got upset. They parted ways. Independent contractor comes back threatening to sue. Client goes, "Hey, look at the contracts. You can't do that." And I was like, "yeah I drafted that. So this is what I do. Okay, cool. So there's purpose to my job and the work I do." So that was, so that was good. That was a full circle moment. That was really cool. [00:17:16] Lindsey Dinneen: Yeah, exactly. Seeing it in real time, the protections that you've put in place, actually helping your clients, which of course you want them to, but if they're not tested... there you go. [00:17:27] Essa Abdool-Karim: For sure. And when, and one of the other, one of the other things I think that was really cool recently was one of my clients launched in in another jurisdiction. And I helped set that up and knowing that, and I've seen testimonies about the product and the treatments that the clients were receiving, and to be a part of that is really something special. [00:17:44] Lindsey Dinneen: Yes. Yes. Absolutely agree. Absolutely. Yeah. And so, coming down the line, what are some of your things that you're looking forward to with with your firm, with your clients, or, you know, continuing to expand? What are some things to look forward to? [00:18:00] Essa Abdool-Karim: Yeah, it's it's an exciting time for me just because I'm expanding my, my practice a little bit in the sense that I'm really digging into sort of medical technology community, even to an extent the health tech community. So it's exciting for me because I'm moving in that direction. And I'm really doubling down on helping my clients open up their companies into international markets. So that's been really exciting. We do quite a bit of work in the Middle East, for example. But I. The United States for a lot of people is a big, a big market. So expansion here is very important, and even for US clients, expanding outwards is still really good for simply diversifying your portfolio. And there's many companies that do this. [00:18:40] The Canadian market is really good for that as well because we do have a robust economy. We do have a good set of regulations in place. Market entry is a little bit difficult because of the regulations, but we have a very sophisticated consumer market and a very good infrastructure, which is the appeal of Canada, which is something I didn't realize until earlier this year, I, in my mind it was, why come to Canada when you can go to the US, right? And it still very much is the case. And if you just look at the consumer market, ours is smaller naturally. The US has, I think, the second largest consumer market in the world behind China. So, makes sense why companies would wanna open up in the US over Canada. But for us, companies that are already established here, I think it's a very good move for them to establish themselves in Canada, just because there is a very sophisticated user base and consumer base for the products that you would launch there. [00:19:30] Lindsey Dinneen: Yeah, so continuing to expand even more into helping those clients as they look towards more global reach essentially. And yeah, continuing to build up that medtech portfolio. That sounds good. [00:19:44] Essa Abdool-Karim: Yeah. Yeah. And it's a lot of fun, again, just because of the people you meet. Super, super exciting. I mean, there's been. There's been there's so many anecdotal stories. There's a saying amongst lawyers, we'll do everything for you. Just give us the book rights, right? Waive-- your story is so phenomenal-- just waive your book rights, so when, you know, at the end of my career, I can put it in my book and tell people about it, sort of thing, right? Because we do a lot of that and... [00:20:08] Lindsey Dinneen: Right. [00:20:09] Essa Abdool-Karim: Some of the stories we see are truly sort of remarkable. And a lot what we do, it's kind of sad, but funny at the same time because like my, one of my mentors says, and one of the principal lawyers in my firm, he says, "Listen, they're either gonna get us on the way in or the way out. You know, one way or another, you're gonna need us. Either when you're starting the company, you're gonna hire us or you're gonna make a mistake down the line and you're gonna need us down the line." And unfortunately, I've seen the latter situation where down the line things have gotten really bad. And have you had just spent a little money upfront, this wouldn't have cost you a million dollars later on. And that has, and it has happened. I've seen it happen firsthand and it's super unfortunate. [00:20:47] Lindsey Dinneen: Yeah, so in general, I it, I'm not putting words into your mouth, but it sounds like one of the first things if you establish your own company is to consult with a lawyer. [00:20:57] Essa Abdool-Karim: I think so. I think I, I think as far as... and obviously I have my bias here, but you know... [00:21:03] Lindsey Dinneen: Sure. [00:21:03] Essa Abdool-Karim: Again, I've seen, I've, I've seen companies, that started barely anything, right? And they built into this thing that they never thought they'd be, like this massive company. And not to say that they never wanted to reach that point, or they never wanted to get to that point, but it grew into something that they never thought, even dreamed possible, right, in a very good way. The problems, the foundational documents and the relationships they had with maybe vendors or licensees, weren't the best in nature. And then I have to come in and I'm doing crisis management at this point. I'm either managing their litigation or if I'm not managing their litigation, I'm trying to diffuse the situation so it doesn't get worse, could be through mediations and out of court discussions, right? Even though I'm not a litigator, I do this sort of litigation management. All that to say in long-winded way of answering your question is, yes, please consult a lawyer as early as you possibly can, as early as you can afford it. [00:22:00] You want to be able to resolve issues before they get to court, generally, right? When you're not the offensive side, but even when you are suing, right? Because obviously if you have a patent interest in something or someone's infringing on your patents or you know, maybe there's a commercial disagreement. Even if you are the party suing, you have to be very careful when going to court. And the reason for that is you cannot tell who the judge is gonna be and how they're gonna view things. It's always, you always throw the ball up in the air. [00:22:29] You know, even we as lawyers, we can do as much case law research as we want. We can look at the legislation as hard as we want. We can really scrutinize it. We can go into the wording, we can make our arguments, but we cannot guarantee that things will end up in your favor even if you have a really strong case. Because when you go into court, anything can happen. From witnesses to, to, to the judge's opinion, maybe their own personal experience in something, you don't know. So even in that situation, it often is better to settle outside of court or have some sort of discussion. But yeah, it's it's an important sort of strategy to note that dispute resolution is a critical part of any legitimate litigation strategy, in my view, at least. [00:23:14] Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. I absolutely see the value, of course, in that. And then, and like you said if you end up sort of inviting in non-controllable human elements into the mix, if you do end up.... yeah. Yeah. Okay. Yeah. All right. [00:23:32] Essa Abdool-Karim: it's not I think. I think if a lawyer tells you, "This is a slam dunk," you should be very cautious. Yes. I think that's a big, I don't like, maybe it's a red flag. It's definitely like an orange flag. Not even a yellow. It's like an orange flag, right? So you definitely wanna watch out for that because a lawyer's telling you, "oh, this is a slam dunk. This is not a problem." I like, okay, are like, "are you a psychic? Do you know the judge person?" Like, you know what-- there's a lot of things that can go wrong. [00:24:01] And by the way, it's all very expensive to go to court. It is very expensive. And this bothers me 'cause even lawyers are expensive, right? I know this. It's unfortunate because access justice is something very important to me. But the problem is there's a big paywall behind it. So, and it's one of the things a lot of early stage companies struggle with. So how can you get legitimate and valid legal advice when you can't afford it? [00:24:23] So there's actually two ways I have in my mind and I guess I share with you right now. And perhaps your listeners will find value in it. One of them is obviously to join some sort of incubator or accelerator. Those are always good, because the network you can build in them. Even, so one of the other thing is, and perhaps if you'd like, we can talk about investing right after this, you'd be able to connect with, you know, could be venture capitalists, could be angels, but what's important, you open up sort of a new network for yourself in a myriad of different ways. So that's the first element. [00:24:55] The second element, and I posted on this on LinkedIn a couple months ago. It's, you can have an advisor committee where you give maybe one or 2% of your equity or whatever the advisor wants. But you can bring a lawyer onto that advisor committee for equity. That way you're not actually paying liquidable cash for that advice, but you're actually bringing them in to advise you on how to set things up while giving maybe one or 2% of your company away, which maybe a lot, maybe a little, depending on how valuable the lawyer is, but it's a good way to save upfront cost. [00:25:28] Lindsey Dinneen: Those are great suggestions. Thank you for that. That's great advice. And then you mentioned the investing side. Do you wanna talk a little bit more about that too? [00:25:35] Essa Abdool-Karim: Yeah, absolutely. So financing is a difficult thing, right? Because you're very sort of, subservient to the markets in a sense, right? And we're in a little bit of a down market right now, but people are still raising capital. I know people are, that completed about a $50, $60 million raise like about four or five months ago. So, I mean, money is still being moved. [00:25:53] But the sort of important thing here is, and I cannot emphasize this enough, there is an important distinction between smart money and dumb money. And what I mean by that is, it's sounds crazy, but anyone can go out and get money. I, you know, you can go and you get in front of the right person and they'll just give you, they'll write a check for a 300,000, $400,000, whatever, right? The problem is you don't want to just take cash. I mean, you can. But it's not gonna open up a network if that person doesn't have the network that you need. [00:26:24] The smarter way to go about it is to make sure to get it, bring in an investor that can actually open up a network for you, because at some point they might want a board seat and those shouldn't be given away just to anyone. It has to be very strategic. And one of the important things I find is that if you have a very good investor, someone who actually has a market behind them. And since we're talking about the medical technology space, we want someone in that invests into medical technology companies that understands the vertical. Because when they come in they likely already have an ecosystem that you can use. [00:26:57] They might, I don't wanna say have a relationship with the regulators, but they might be familiar with the regulators and maybe familiar with certain professionals that they can introduce you to. They may have in their own portfolio connections to distributors. That could be huge, that could be more valuable than the million dollars they just gave you because it might open up a $10 million market for you, just by virtue of the fact that you got introduced to distributor because of this person's reputation. So you have to scrutinize your investors as much as they scrutinize you. [00:27:24] And I know that's difficult sometimes because obviously there's a huge power dynamic between early stage companies, even growth companies, growth stage companies, and an investor when you're literally might be on fumes and your runway is at its the very end, maybe like a month or two away from giving out. So it's very difficult to sort of stand there and tell them like, "look, you need to open this and this door for me, you to bring me in." Very difficult to put yourself in that position, but that's the position you ideally wanna be in. Connect with someone who can open, open market for you. And I think that's one of the most important things about bringing investors in, [00:28:01] Lindsey Dinneen: Yes. Thank you. That's really great advice and that's the first time I've heard that particular advice, so I really appreciate you sharing that. [00:28:08] Essa Abdool-Karim: You are welcome. [00:28:10] Lindsey Dinneen: Yeah, I think I, that brings a lot of value to when people are looking for those resources. And like you said, maybe the million dollars, I mean, it is cash, it's gonna be useful, but might not be, as you said in the long term, as impactful to your business as those relationships in this context can be. So something to really think about, and take seriously. [00:28:31] Essa Abdool-Karim: It can be very difficult sometimes to remove those investors that have invested into the company that you don't want anymore. And they're just taking up a spot in your cap table... [00:28:42] Lindsey Dinneen: Yeah. [00:28:42] Essa Abdool-Karim: ...with not one really bringing anything. And that's very difficult. And this is one of those other issues, is if you don't have something in writing that allows for you to both parties to sort of set the step away amicably, they'll be stuck on there. [00:28:57] Lindsey Dinneen: Yeah. [00:28:58] Essa Abdool-Karim: And that's happened and I've had sort of like these business divorces that I deal with, which is not fun, but it is sort of part of the game as well. But there are strategies you can employ at a high level without breaking any laws that will help remedy that. But again, situation by situation [00:29:17] Lindsey Dinneen: Absolutely. So you have shared lots of great advice, but I would just say when I summarize it in my mind, one of the biggest things is talk to a lawyer early and often. [00:29:28] Essa Abdool-Karim: Yeah. [00:29:28] Lindsey Dinneen: Yeah, there you go. There you go. Amazing. [00:29:34] Essa Abdool-Karim: Play the long game. You know, make a friend, be like, "Hey listen, you'd make a great lawyer one day" and just kind of push them to law school. Yeah, just push them into law school. [00:29:43] Lindsey Dinneen: And maybe, maybe offer to contribute to the law school tuition a little, just you know. [00:29:48] Essa Abdool-Karim: I just believe in you so much [00:29:53] Lindsey Dinneen: That's amazing. I love it. Pivoting a little bit, just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your field, but it doesn't have to be at all. What would you choose to teach and why? [00:30:10] Essa Abdool-Karim: I think I'd want to teach people how to motivate themselves. I have a background in coaching, coaching sports. So I've always found it and no matter what sort of industry I've been in, what position I've been in I find great value, in, in being able to motivate others. I think it's very important and I find great satisfaction in it. And it's really, it feels really good when you, when you see people becoming successful, perhaps not, I don't wanna say as a result of it, your advice, but partly as a result of your advice or your encouragement. So I would probably put together some sort of masterclass on how to get out of bed in the morning, how to set your goals, how to set your visions, and how to execute on those visions. [00:30:54] Lindsey Dinneen: Yeah, that's a great masterclass and one that I'm sure a lot of people would sign up for, because it's so important. I recently actually listened to just a snippet-- I need to go back and listen to the whole thing-- but of a TED talk where the woman was talking about how we often treat confidence as a" nice to have" instead of a "must have." And what a difference it makes when you do treat it as a must have. And anyway, that I thought of that immediately when you were talking about the motivation and sometimes you need a coach to kind of come alongside you and help with that and say, "Yeah, no, you can do this. Let's figure out how we're gonna do this together." [00:31:31] Essa Abdool-Karim: Yeah, Lindsey, it takes, honestly, it's, it can just be one person, just one person that says, I" believe you can do this." It makes an entire, huge difference. And I don't think some people maybe do realize this, others don't realize how big that can be. [00:31:46] Lindsey Dinneen: Yeah. Yep. Absolutely. And I just kept thinking though, , is a very, that was a very good point and a serious one, but the first thought that popped into my mind was like, "Okay, who do I know that I can tell, ' Yes, I think you'd make an excellent lawyer.'" Oh man. [00:32:03] Essa Abdool-Karim: You're always giving, Lindsey. It's really good. I like the way you.... [00:32:05] Lindsey Dinneen: Yeah. So giving. [00:32:07] Essa Abdool-Karim: Helping propel everyone forward. It's really good. [00:32:11] Lindsey Dinneen: Yeah, exactly. Exactly. Oh my word. Oh my goodness. Okay. Yeah. So how do you wish to be remembered after you leave this world? [00:32:21] Essa Abdool-Karim: Yeah, it's a good question. You know, I deal with some incredible entrepreneurs that at this point in their careers, they're not even thinking about, you know, exits or companies. They're thinking about legacy and they want to be sort of remembered as luminaries and experts, not just experts in the field, but people who sort of change the world. So for myself, I do eventually want to get to the point where I can change the world. I don't know what that's gonna look like or how it's gonna happen, but I want some sort of positive lasting influence in the world that I played a part doing. Now interestingly mentioned like how do I want to be remembered? I don't necessarily have to be remembered for doing it. But I want to know to myself that I was a part of it. [00:33:02] Lindsey Dinneen: Yeah. Absolutely. Yeah. And then final question, what is something that makes you smile every time you see or think about it? [00:33:15] Essa Abdool-Karim: My life. Just... [00:33:19] Lindsey Dinneen: Yes! [00:33:20] Essa Abdool-Karim: You know, retrospect really is 2020. And it's this crazy, life is just crazy thing, right? You know, we go through so many difficulties and everybody does. You just can't see it, right? We all go through these difficulties, these ups and downs, these mountains and valleys, these peaks and valleys, and no, not everybody sort

Meet Alexander Ballatori and Shane Shahrestani, two innovative minds revolutionizing the medtech industry with their groundbreaking company, StrokeDX. Their story is not just about technological innovation; it's a tale of resilience, determination, and a deep-rooted desire to enhance stroke care. Amidst financial hurdles and skepticism, their commitment to transforming stroke diagnosis and treatment shines through. Their episode is a must-listen for anyone intrigued by the confluence of medical technology, entrepreneurial spirit, and the profound impact of personal experiences in shaping healthcare solutions.   Guest links: https://www.linkedin.com/in/shane-shahrestani/ | https://www.linkedin.com/in/alex-ballatori/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 027 - Alexander Ballatori & Shane Shahrestani [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guests today, Alex Ballatori and Shane Sharasani. They are the creators and innovators extraordinaire behind StrokeDX, and I'm so excited just to talk with them, find out more about the innovation and see where they're going from here. So thank you all so much for being here. [00:01:11] Alexander Ballatori: Yeah. Thank you so much for having us. We're really excited to be here. [00:01:15] Lindsey Dinneen: Excellent. Excellent. I'd love if you two wouldn't mind starting off by just sharing a little bit about yourself, your background and, well, let's stop there. Let's do that first. [00:01:26] Alexander Ballatori: Great. I'll go ahead. So, I'm Alex. I'm originally from upstate New York, from Rochester, so very grateful to be in sunny California at the moment. Now that we're entering the winter period. But I went to the University of Rochester to study biology and chemistry. I was really interested in medtech and medicine in general. And I want to take some time before deciding what type of graduate degree I was going to pursue as well as learn a bit more about the startup ecosystem. So I ended up living in San Francisco for a few years. I really got to see a lot with respect to medtech in general, predominantly in the orthopedic in the pediatric health space, and then I ended up choosing to go to medical school where I met Shane is my first roommate in medical school and we hit it off right away started. [00:02:07] This is our 2nd business together and yeah very passionate about stroke. Stroke has impacted my family numerous times and when I saw this creative solution that Shane developed during his PhD and also just given my long lasting interest in medtech, it was a no brainer to start this company with him, but I'll let him kind of take over from there, give him some background, and then we can dive into more about our story as a company. [00:02:32] Shane Shahrestani: Thanks, Alex. Yeah, so my name is Shane Sharasani. I grew up in sunny Southern California, very different from Rochester. And I was at UCLA for undergrad. I studied neuroscience and then I did my MD PhD, my MD at USC and my PhD at Caltech. And the way they designed that is you do 2 years of med school, you do the full PhD and you come back and you finish med school. So in the first 2 years, I saw the effect that stroke had on patients. And when I went into my PhD, I wanted to develop technology that can solve that problem. Namely, having timely access to stroke care diagnosis that you receive faster treatment because time is brain. So that's where this idea came about. [00:03:13] We pivoted this tech from the aerospace industry and developed this tech for stroke detection. And when it came time to spinning out of Caltech, there was no other partner that I wanted on this other than Alex. He's my best friend and also my first roommate, as he said. So it made sense to work together and we work very well together. So since then, it's been a exciting journey since the end of 2020 when we spun out and filled with highs and lows. And we're happy to be here today on this podcast. Thank you. [00:03:46] Lindsey Dinneen: Yes, of course. Again, thank you all so much for being here. And it's just fun to hear how you guys got connected in the first place, and the fact that, you know, this roommate, which could be so hit or miss, let's be honest. And it just turned into this fantastic friendship and now business partnership. So I love hearing those kinds of background stories. So, you know, Alex, you mentioned having a personal connection to stroke, and perhaps Shane, you do as well, but I would love if you would share a little bit about your, your own experience and kind of what really motivated you all to tackle this issue and to try to make a difference in this arena. [00:04:26] Alexander Ballatori: Yeah, so, I mean, it started really close to home with my grandfather, actually, as well as a couple other uncles and great uncles, unfortunately. And, you know, my, so both my family, both my parents are clinicians by training. And so, when I saw them, and I saw the care that they received, my, my family was always, my, both my parents were very strong advocates for anyone in my family that became ill. And when I saw my family members go through stroke care, I saw that even if you have the best advocate at one of the best hospitals, there's still so many inefficiencies in the care that we can deliver. [00:05:00] And then going to medical school and seeing it firsthand when we are now. I was functioning as the provider at that point, there's just so, it's just so many issues. And despite all the advancements we've made from surgical technique and therapeutics, we haven't put a dent in stroke outcomes in multiple decades. So, you know, when we, when I first saw what this technology could do, the chain had developed at the price point that it can, also at the safety level and in the amount of time that it can deliver this information, I saw all of those problems from at my, within my family and within my medical training. That could be solved just with this simple, elegant, low cost solution. [00:05:42] Lindsey Dinneen: Yeah, that's incredible. And Shane, do you have anything to add to your own experience with stroke and what motivated you to develop this? [00:05:51] Shane Shahrestani: Yeah, of course. So I briefly touched upon the fact that I went to the PhD, I already had some experience with stroke in terms of dealing with patients in medical school and really looking at the inefficiencies there. Why are we ordering so many CTs? There has to be a better way to monitor at the bedside. And why do we not have that? Right? And now I work as a neurosurgery resident and those problems still exist. So many patients every day have to be sent back to the scanner just because something changed about their exam, and we have no idea what happened until we send them down to this big, bulky, expensive machine that requires transport. It uses radiation and there have to be better ways to solve these problems and provide the information at a point of care at a efficient cost to the patient in the hospital system. [00:06:41] Lindsey Dinneen: Yeah. And so I would love if you both or one would share a little bit about the technology itself, kind of where you are in process with approvals and all that fun regulatory excitement and just, you know, what do you envision for your company as it grows? [00:07:01] Shane Shahrestani: So from a tech perspective, there are sensors that they use in aerospace to look for cracks in airplane wings. And we have methods for non destructive detection. That's what they call it: "non destructive testing and detection" that we use every day in other fields. So what we did is, we took this technology and we optimized it for the human body, specifically for the brain and by doing so you can create a non invasive handheld, small, cheap, portable, non radiating technology that you can use anywhere to quickly assess objectively how the brain is doing in terms of its cerebrovascular health, right? [00:07:52] And the idea is it works a lot like a metal detector, right? And in stroke, you can either have too much blood in the hemorrhage or too little. And in ischemic stroke, where you're literally stopping blood flow. And if you have a metal detector that's tuned for the human body and for blood, then you can quickly assess how is the blood flow changing and what are we going to do about it? So that's the technology, and I'll pass it over to Alex to talk about the rest. [00:08:17] Alexander Ballatori: Yeah, so absolutely. So given that this technology can differentiate, localize, as well as produce an image of where the lesion is, and in stroke, again, there's two types of stroke. You need to know what type of stroke they're having. And then once they have the stroke can progress over time. So back in 2020 and 2021, when Shane was first validating this technology with an NIH funded grant awarded to Caltech and USC, we saw that it could provide all of that critical information in a very compact form and in a very low cost form. [00:08:48] So once we published that information in Nature Scientific Reports, we went out and started the company. We went out and started to raise money. And one of the, one of the things that we knew is that our basis, the basic form of our technology the common baseline principle, how it works could impact the entire stroke continuum. Right? So the stroke space has a lot of problems. So, for example, 1 out of 6 stroke patients in an ambulance goes to the wrong hospital because we can't evaluate their brain. Often stroke patients are just found down. Right? [00:09:20] So as an EMS personnel, all you want to do is get them to the closest hospital. But unfortunately, not all hospitals can manage stroke patients. So, one out of six times they're wrong, and that leads to hours in their delays in care. And like Shane said, time is brain. Every minute that passes, you lose a million neurons irreversibly. So, that's the first problem. It's kind of like the EMS. [00:09:38] Then in the emergency department, it still takes quite a while to rule in stroke, because we rely on CT scans. And there's also just a whole slew of things that have to happen for a patient in that process of getting admitted to the hospital. So stroke on average takes over two hours to diagnose from the initial symptom onset. So that's kind of the pre hospital, early hospital problem within stroke care. [00:10:01] The other big problem in stroke care is we don't have any way of monitoring patients at the bedside with a disease that's rapidly progressing. And so currently we just send patients back down to CT, on average four times for admission. And so 80%, unfortunately, these repeat scans are negative. Nothing had changed in the brain, but we require objective information to manage these patients appropriately. So we keep sending them back. [00:10:26] The other problem not to get too into the weeds with this is that most stroke patients are above the age of 65. They are enrolled in Medicare and the Medicare bundled payment system. Ever since it came out, hospitals have been losing money across the board route on stroke care, and a big contributing factors are inability to monitor and image the brain in a timely manner. So that problem also goes into the neuro rehab setting where hospitals are now pressured to push patients into neurorehab where they're getting paid, you know, per diem. And also can kind of close the DRG. [00:10:56] So you can kind of look at the stroke continuum as two problems. The early hospital, pre hospital, and then the inpatient inability to monitor this rapidly progressing disease. We have built an automated device for that second space, the inpatient and neurorehab space. Which is an automated, lightweight device that takes our sensor and has two mechanical arms that move it around the patient's head in a completely automated fashion, removing the human element to the path and the scanning path. [00:11:23] And so what that enables us to do is it enables us to put this device-- it sits right at the head of the bed-- all you have to do as a user is set them up in it, which takes less than a minute. You press go on a tablet and it scans everything and tells you all the information that's happening right at the point of care. It also enables us to leave it on and monitor patients over time, which is going to be a game changer in inpatient stroke care, where currently it takes quite a while to get patients to CT. [00:11:48] And again, 80 percent of the time it was a negative scan. So it's a completely inefficient process. That's actually we estimate to be over a 6 billion in efficiency in the U. S. alone. So we're first pursuing that, but not to say that we're not interested in the pre hospital space. We still are very interested in prehospital stroke ruling and so a lot of our diluted first round of our first round of funding, which was just about a year ago, we came to our 1 year mark, like 4 or 5 days ago, is spending a lot of time on improving our sensors capabilities, which we've improved about 3 X from what it was back in 2021. [00:12:21] So ultimately we are pursuing the inpatient space first, because there's a very clear problem for us to solve that we can solve, but it's not to say that we're not going to go for the outpatient space at a later date. We are still very actively pursuing it because our technology will be the one to solve that problem as well. [00:12:39] Lindsey Dinneen: I love it. And I love how bold and confident y'all are in your ability to do this because it's exciting to see that there are such amazing innovations and there's progress in this space. So thank you for doing the work to make that happen. I know that's going to impact so many people's lives. And also, I want to say congratulations because y'all are winning so many awards. I was looking at your LinkedIn pages and it was so fun to see, you know, post after post. So tell me a little bit about some of your recent wins, if you'd love to share that. You've been part of the MedTech Innovator Accelerator cohort for a year ish now. So yeah, just tell me about your experience and what you're celebrating. [00:13:25] Alexander Ballatori: Yeah. I mean, it's been an incredible process. MedTech Innovator is by far the most significant thing we have participated in since forming our company. The doors that were completely shut and locked and sealed that we could never potentially even knock on are now wide open because of MedTech Innovator. So yes, we've been participating for the past year and it's been a wonderful experience. First, starting off at the the pitch events at UCLA, where we pitched to the judges, where they narrowed it down. They had about 1200 early stage companies. I think a total of 1900 applications in total. And they, after those pitch events, which there were five, they narrowed it down to 61 companies total and about, I think it was 40 early stage companies. [00:14:06] So we enrolled in that program and got assigned to some incredible mentors, got to meet all of these amazing alumni that were either first time founders or seasoned, seasoned founders that have been through a lot. And we just had this complete access to this amazing network of people that we could talk to. And so, you know, it started off with Wilson Sonsini, the Innovator Summit, and the Wilson Sonsini medical device conference where we were picked to be in the top five for the vision award, which is based on the criteria, "would you invest in this company? And would you want to work for them? And do you find them inspirational?" [00:14:38] So we made it into the top five, which we're pretty surprised about, honestly, because it was a cohort wide boat. And then we had 7 minutes to pitch very similar to the finals, which I'll get to in a second. And we won that, and that was the first kind of wave of, you know, just increased interest in us, a lot more visibility for us, and a lot of validation. Our 2022 was a very very trying time for us, which we can talk about later. But anyways, that was the first big win for us. [00:15:05] And then we participated in the cohort and got to know the MTI team and our mentors and go through the value proposition program. It was so helpful for us in so many ways, and it culminated in us making it to the finals at the AdvaMed medtech conference, whereas a similar setup, we had about 7 minutes to pitch, try to explain all of the wonderful things about our technology in just a couple of minutes. After a crowd vote, we ended up winning. And so, it was really special for us because in 2022, as young innovators, you get a lot of doubt, you get a lot of no's, you get a lot of people saying you're crazy. And so to win that was really special. And I want to give Shane a moment to say anything else with respect to that too, but it was just a really sweet moment for us after what we've been through. [00:15:48] Shane Shahrestani: Yeah, a hundred percent. You know, we were two young guys in medical school, no previous business experience, trying to spin out a medtech company while also being in medical school. And the number of times we got said no to, we completely lost track. So to be able to build back up and to make it to a point where we're actually the top startup in medtech in the world was, you know, we didn't even believe it. And also, you know, a couple other things it was, Alex and I just went so much. It was awesome working together as a team over the last year and figuring out all these other problems that came up. And at the same time, at MedTech Innovator, we met so many other people going through similar problems as us. And there are so many amazing cohort companies that we got to meet who are going to change how medicine is provided in the U. S. and globally. So it was an absolute pleasure to work with all of them and to work together to solve so many problems in MedTech Innovator. It's cool. [00:16:47] Lindsey Dinneen: Yeah, that's incredible. I'm so glad that you guys had such a great experience with the cohort. And again, yeah, congratulations for winning the whole thing. That's fabulous. And I think it does speak to the innovation that y'all are bringing to the world and how important it is. And obviously you're getting some really good external validation. I mean you know the value that you're bringing, but it's always nice to have an outside person saying, "yes, we agree," you know, and to that point, I'm really curious about your 2022, because you kind of mentioned that that was a little bit more trying. So if you'd be willing to speak to that, I'd love to hear a little bit about that. [00:17:28] Alexander Ballatori: Yeah, absolutely. So like Shane mentioned, we were both full time in medical school. We were in the hospital for, I don't even want to admit how many hours. I don't think I'm allowed to say how many hours. And you know, trying to form a pitch deck. And, we're both heavy in science and research and we know how to build the presentation typically for the scientific community, right? And so, and again, we're clinicians, like, one of the reasons why I mentioned before, I think, before the recording, one of the reasons why we're so excited to come to this podcast is that this podcast is really about increasing and bringing technology to increase human health and improve human health. [00:18:05] And, you know, one of the things that we were passionate about, and still are very passionate about, is that we want to bring this product to market because we know it's going to help a lot of people. But one of the things that we had to learn is that we needed to pitch a company, right? We needed to pitch a vision and a mission, which we had the vision and the mission. It's gotten much more refined. But we had, that was our, I think our first learning curve, which we give a lot of, we have got to give a shout out to Helen McBride and Julie Schoenfeld from Caltech, as well as our lead investors at Freeflow for helping us with that one. [00:18:33] But it was tough. We were pitching during our lunch breaks and we were pitching on the weekends and we had investors lined up and then unfortunately, the day before the round of funding was supposed to come through, the markets went south and they said, "Hey, we're not investing right now. So sorry." And we were in a good amount of debt. And so, it speaks to one of the value or one of the most important things when starting a company is kind of faith in your mission and faith in your founder. [00:18:57] We were sitting and just looking at each other like, "man, what are we gonna do right now?" Like, we were still fully deep in school studying for our board exams, and we were in debt and we couldn't even build anything. And so, you know, we kept going at it and we really believed in what we could do. And we ended up finding Freeflow Ventures with David Fleck and Kevin Barrett who believed in us and, and saw our vision as well as the individuals at Caltech, and then we ended up finding quite a few other angel investors who are all directors of stroke centers, neuroradiologists, triple board certified neurologists, and you know, experts in clinical trial neuro design. [00:19:34] And they all believed in us. And so we got the money that we needed. And we've been sprinting ever since, which is why we've been able to accomplish so much in the last year. And, you know, now looking back, Shane and I were just talking about this, after we'd won MedTech Innovator finals and we were like, you know, 2022 was really tough, but it put us in a really good position because it forced us to study everything about the market, learn everything about our competitors. And really hone in on where are we going to bring this thing first? Right? Because like I said before, there's an entire continuum of stroke care where the sensor could be applied and we will apply it to all of those areas. [00:20:12] But what did we want to do first? Right? And so I think us having to go through that tough time is one of the reasons why we're so successful in such a short amount of time. So it was a tough time, but we're obviously, I think we're doing much, much better out of it. Now we can, you know, when you look back at it, we're grateful more than anything else. It's taught us a lot and definitely earned our stripes. [00:20:35] Lindsey Dinneen: It sounds like it. Shane, do you have anything to add to that? [00:20:39] Shane Shahrestani: Pressure makes diamonds. I mean, we felt the pressure. We definitely felt the pressure. It's an understatement, but you know, we learned a lot and we were able to thoughtfully revise our pitch decks, our business plans, our engineering plans with all the no's that we were getting and the feedback that we were getting underlying those no's and that's how we were just able to learn and grow. And I think there's something to be said about being young and trying to run a business. I think a lot of people don't necessarily believe in you, especially when you're asking for millions of dollars. So, we learned that we, as Alex said, earned our stripes and proved ourselves and that we were serious and we knew what we were doing. [00:21:27] Lindsey Dinneen: Yeah. And you know, what's so interesting is, when I was looking at both of your LinkedIn profiles and just seeing, I kept thinking, do you guys sleep? Do you have time to sleep? [00:21:40] Alexander Ballatori: We're sponsored by caffeine. That's actually, so Shane and I, before we even started this. We, I don't know, Shane, how many papers we published together and like 30 at least and so many conferences. And it was honestly like that, that the number of nights where we consumed hundreds of milligrams of caffeine, just working together is how we knew we were going to be great business partners. And so, you know, again, we're StrokeDX is sponsored by caffeine. [00:22:06] Lindsey Dinneen: Amazing. Can we get that official so that you actually don't have to pay for your coffee or whatever? Your caffeine of choices. Incredible. So this journey from, and obviously you probably wouldn't consider it a complete pivot or anything, but this journey from clinician to entrepreneur, and everything that entails, you know, obviously, like you said, 2022 was this huge learning curve. What would be some advice that you might have now looking back and being able to say to somebody who might be in a similar situation, maybe what's a one or two pieces of advice that you would say would be beneficial? [00:22:49] Shane Shahrestani: All right. A couple of things. One, find a co founder that you trust with your life, who is your best friend, that you'd rather be awake drinking Monsters at 3am than being asleep. That's very important. Two, every time someone says, no, that's an opportunity to learn and grow. And if you have the resilience and grit to keep your head up when you're being told no and to learn from it and to keep going forward, it will always work out. [00:23:20] Alexander Ballatori: Yeah, that's exactly, literally exactly what I was going to say. You know, someone gave us a good piece of advice. They said, expect to receive 200 no's. And so when you get your 113th, you know, you're barely, you've just barely crossed the halfway mark. Just keep going, because you should expect 200, right? And that was something that, you have to be a little crazy to do this. But also, I think, in addition, like what Shane was saying, you need to have someone that when you hit a low, you know that you can trust the person next to you and you just say, "okay, let's learn from this. Let's refine our approach. Let's , amend our deck and our plan. And let's keep going." Right? [00:23:58] And also, I think really taking the time to understand the market is really-- what you have, first of all, this is before you even get to this point-- you need to understand what you have, how it will be applied. And I think that was actually one of the one of our biggest benefits is that we work in medicine and we understand clinical utility, clinical need and as well as what we've learned that was very easy for us to learn because of we are clinicians is the whole pay/ payer system, right? [00:24:25] And, you know, price points and pricing strategies, it's all kind of coming from a clinical side. And seeing these products that I know how people use them. I've seen them use. I've used them. It just made it a lot easier for us. But yeah, ultimately boils down to having a strong partner. And and not taking things too to heart when people tell you that you're crazy. [00:24:51] Lindsey Dinneen: Yes, indeed. You know, that reminds me, I remember one time somebody saying, " when you hear no it's very rarely no forever. Never going to consider it, the end, close the door, slam it, and lock it." It's usually, "no, not right now." So if you can take that with a grain of salt, if you can take those no's with a grain of salt, eventually, you'll get to either them changing their mind or somebody else saying, no, I agree with you, you're absolutely right. [00:25:22] Alexander Ballatori: Yeah, we got a lot of "not nows." And I think it really boiled down to the fact that our first prototype was handheld. And so we were confident in our decision to go into the inpatient setting. And so now the pendulum has swung the other way. And now that we've validated that our automated device has worked in this translation, translational project of automating this technology has been successful, all of those people that were the not nows are the, "are you raising money now?" questions, which is obviously a great feeling. But yeah, no, definitely. We learned a lot. There were-- also be frank. There are many times where they ask us questions that we studied for weeks afterwards and learned so much from so all those not now is really they shaped us in such a positive way. [00:26:07] Lindsey Dinneen: Yeah, yes, I can imagine. Anything to add to that, Shane? [00:26:13] Shane Shahrestani: No, I totally agree. As Alex was saying, a lot of the previous no's are now reaching out to us. So table turn for sure, but it just takes hard work, great resilience. Got to keep your head up, keep fighting and it works out. [00:26:30] Lindsey Dinneen: Yeah. Yeah. Excellent. Out of curiosity, going back to your childhoods, could you have possibly imagined where you are now, back in the day? I mean, did you always have an interest in medicine? Is this something that sort of developed over time? Did you think you were going to be a business owner? [00:26:50] Shane Shahrestani: So ever since I was in fifth grade, I always loved the brain. I knew I wanted to do something related to the brain and now I am working in neurosurgery, but my deep passion is medtech. That's what I wake up for every day. I look forward to working with Alex and our team and solving complex problems and creating new devices that can save brain. Right? So I knew I'd be somewhere in this field, but I had no idea that I'd be able to work on a product so amazing that can really just change the paradigm and stroke care, which affects so many people every year. So, so, I never thought I'd be a business owner. I knew I'd be in the brain somewhere, but this is super exciting. [00:27:35] Alexander Ballatori: Yeah, and for me, I, so I grew up with two rockstar parents. Both came from nothing from, you know, farms in Italy, but both were very naturally gifted when it came to science and medicine. And so my parents actually met while my dad was completing his PhD at the University of Rochester. My mom was finishing up her MD. And they both saw that they had Italian last names, and then the rest is history. And then I grew up in Rochester, New York, and clouds and snow for the first 22 years of my life. But, I was very, whether it's nature or nurture, I was always very drawn to science and medicine, and both my parents actually were both entrepreneurs as well in the medical space. [00:28:13] So my dad was a pioneer in lipid and bile metabolism in the liver and developed a lot of enzymatic targets and a lot did a lot of the early work in understanding bio reabsorption. And my mom is a surgeon with multiple devices under her belt and actually is pursuing, it just gotten one of her products just got FDA cleared at the moment. They're launching right now. So I grew up in a very unique household where this is kind of dinner conversation, but I didn't know what I wanted to do. I knew I wanted to be in medtech. I knew I wanted to some sort of degree in medicine. [00:28:44] And so I took time off after I graduated and I got a degree in biology and chemistry. And so I kind of went into my time off just trying to explore as much as possible. I got my hands on so many different startups. I also got to learn from kind of the bigger medtech corporate world is getting more in respect to the orthopedic world. And so I knew it was for me, but then I was deciding PhD or MD. And for me, I liked kind of the wide breadth of knowledge that you get from the MD because there's so many problems in medicine that need to be solved. [00:29:16] And one of the things that really sticks with me is that this whole definition of "gold standard" or "standard of care," or "this is the best that we got" that I just don't, I don't like accept fully, maybe that's just kind of how I was raised or what, but I knew that I was going to, I wanted to go to medical school because I knew that there were so, there's so much more I could learn with respect to how we take care of patients that is so behind with respect to where it should be and can be, especially when you look at what's happening at some of these top universities, like a Caltech and USC and at the lab or at the benchtop. [00:29:52] So, of course, the PhD would have kind of pigeonholed me into one very specific area that I couldn't decide what I was super interested in. So to tell to go back to your question, if I, if you ask me 5 years ago, if I would be doing exactly what I'm doing right now. No, there's no way. But given my background, given my experience with stroke and then, you know, working with Shane, it just really harmoniously kind of just worked out very well. [00:30:17] And I'm really looking forward to the next few years and seeing where we can take this and then the next one as well. And the next one after that. Shane and I have a very common, one of, one of the we're I keep saying we're crazy. We kind of are in many ways where when a finish something a little bit, when we finish a task and we like finish our to-do list, the next thing we say is not like, "let's go grab lunch or grab dinner or something." It's "alright, what's next? What do we do next?" Right? And so I know the day... [00:30:40] Shane Shahrestani: I'll call Alex at like 6, 7 p. m. and be like, "Alex, I'm itching to do something. Like, just tell me something to do. What needs to be done?" He's like, "dude, you just worked a 14, 16 hour day. Why do you want more work?" I don't know. I just, it feels wrong. [00:30:56] Alexander Ballatori: I was like, Shane, go to sleep. [00:30:57] Lindsey Dinneen: It's all that caffeine. You've got your system wired, ready to go. Oh my word. Oh, that's incredible. Oh, my goodness. So out of curiosity, are there any moments or maybe one moment or whatnot that kind of stand out to you? It could be through medical school, it doesn't necessarily have to be with StrokeDX, but just a moment that stands out to you as saying, "yes, I know exactly why I'm here. This is it." It's reinforced for you: "I am in the right place at the right time doing the work that I really feel passionate about." [00:31:37] Alexander Ballatori: Yeah, you know, I think there wasn't one specific moment, but more so a process over 2022. And being told no, so so many times. And then finally battling through debt, and thank you so much to our lawyers for being very flexible with us on that. But when we finally got the amount of investors that we needed and the amount of money that we needed, everything, just we were on fire. We were so ready and we had such a strong plan. The moment the money came in, it was we were already starting to send it out the door to our engineers to start paying. And we started working that the same day that the money came in, we had a meeting with our engineers to start working. And I think just that transition point from going from trying to sell the mission to actually executing it was definitely a highlight for us. So I don't think there's one specific moment. But I think it was that kind of transition and seeing all of our incremental improvements in our sensor and seeing this device come to life. It's just been, it's, I think it's almost the whole process is really just validated that this is where I'm supposed to be. [00:32:45] Shane Shahrestani: Yeah, I think to the families of people who had a stroke and explaining to them what a stroke is and the prognosis and what's going to happen to their loved one, and then seeing people unfortunately pass because of stroke, and maybe they live too far from a hospital and their life could have been saved if they came in a little bit sooner, or they didn't know that they were having a stroke and they tried to sleep it off and woke up and couldn't move half their body. Right? And the stories go on and on. You see it in every permutation and every variation. But then, at the end of the day, these are people and their loved ones are in the hospital with them and you're trying to keep them alive and all our odds are against you and it's a function of losing brain cells and that is a function of time and efficiency, right? [00:33:41] So a big why is just so much suffering, sadness, loss can be prevented by creating new technologies that can just make healthcare more efficient for people, right? Faster, cheaper, better diagnostics, better assessment tools, better ways to monitor. And you know, that's another reason why I think Alex and I, you know, share that in common and we just work tirelessly just to create new things to just change the paradigm, change the standard of care, make things better for people. 'Cause that's just where our heart and our passion lies. [00:34:20] Lindsey Dinneen: Yeah. Yeah, absolutely. I'm very glad that you both did not let all the no's deter you. I'm glad you were willing to come back to your why and just keep at it. Yeah, that's, that takes a lot of grit and determination, but glad y'all are doing what you're doing. So, pivoting just for fun, imagine that you were asked to teach a masterclass on anything that you want. You're going to be given a million dollars for this. What would you choose to teach and why? It also doesn't have to be related to your industry at all, although it could be. [00:34:58] Alexander Ballatori: I, so my family and my my, just family events and cooking is, and my Italian heritage, is very important to me. And so I, it's, when I'm not working, I'm cooking or I'm spending, I make wine for fun. It's just it's all the traditions from my family. So I think if I had to teach a class, it would probably be sharing some of my family recipes, and also I love to cook and host all the time. So I like have had cooking classes at my house with friends and every year I make wine. It's always a big event and always have people over it. It's a really simple process. It seems so daunting, but it's quite simple, especially when you do it the old world way. And so, yeah, I guess I guess that would probably be mine. [00:35:45] Shane Shahrestani: First of all, I would go to Alex's masterclass. I'd pay however much he charged. I'd be there. His wine is like the only wine I drink now. If I had to teach a masterclass, so there's two things about me that I don't even know if Alex knows. I can identify the

Laura Yecies, CEO of Bone Health Technologies, shares her journey from a tech and marketing background to leading a company that's revolutionizing the treatment of osteoporosis with Osteoboost, a wearable device using NASA-proven vibration technology. Laura's diverse professional experiences highlights her personal motivation to improve people's lives. Her story illustrates a passionate commitment to developing non-pharmacological treatments and fostering better patient support, emphasizing the significance of technology in advancing healthcare. Guest links: www.bonehealthtech.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 026 - Laura Yecies [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guests today, Laura Yecies. Laura is the CEO of Bone Health Technologies, makers of Osteoboost, which is the first clinically proven, safe and effective non-pharmacological treatment for low bone density. Osteoboost puts NASA proven vibration in a wearable, comfortable, convenient belt form factor. Laura, thank you so much for being here today. I'm so excited to chat with you. [00:01:23] Laura Yecies: Me too. Really happy to be here. [00:01:25] Lindsey Dinneen: Wonderful. I would love, if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry. [00:01:35] Laura Yecies: Sure. My background's in business and tech primarily. I went to college on the east coast and after business school, in 1988, I came to California. I grew up in New York, but my husband was from California and so we decided to give it a shot out here for a little bit. And I started working in tech doing marketing, first in enterprise software, relational databases, and developer tools. And then I moved into consumer softwares, started off at Netscape. And when I was at Netscape, I took on larger roles and responsibilities. I was Vice President of the browser division, managing a group of over 200 engineers, and we were responsible for Netscape 6.1 and 7.0 and the Mozilla spin out. I then led the mail team at Yahoo, when we were sort of the number one email provider. [00:02:30] And then I also worked at a tech startup and spent some time at Checkpoint, which is a large internet security company heading up marketing there as well. And then I was CEO of two different tech startups, Sugar Sink, which is a sink and share company, and that's now owned by J2 Global. And then I became CEO of a small company called Catch. We had a note taking app and we were able to sell that company to Apple and the Catch team became the core part of the Apple Watch team. So that was very exciting. [00:03:03] And after that when I was thinking about what I wanted to do next, I worked on some ideas for my own startup with some colleagues and, some things that happened in my life that really drew my attention to healthcare. And also I grew up in a family of doctors, both my parents, two of my siblings. And then at that point, my two older sons were in medicine, and I'd always been interested in that and had a bit of flexibility because of this exit and decided that, I'm gonna, I'm gonna make a pivot. And so I switched and started looking for roles in the healthcare area. [00:03:40] And everyone sort of wanted me to work in more of the pure software side of healthcare more of the billing and receiving and revenue cycle management and staffing and logistics. And that's interesting and important. But I found that I really wanted to work on something that had directly a health or therapeutic or diagnostic benefit for patients. And so I started consulting. I consulted with companies in the genomics field, MS. And then I was lucky to get my first CEO role at a concussion diagnostic company. And that company, now called NeuroSync had great science. I think they went on to get an FDA clearance for diagnosing concussions. But after a couple years, the board and I had different ideas of what to do. It sometimes happens. [00:04:26] And so I left, I spent a year consulting at Achille Interactive and at Fabric Genomics and a couple of other companies while I was looking for my next CEO role, and I was really excited to have the opportunity, just over three years ago, to join Bone Health Technologies. I knew a marketing consultant that had been there and was connected to the company, and as soon as I saw what they were trying to work on and solve and have, frankly really make a dent in this issue of osteoporosis, I was interested. [00:05:01] I mentioned that my parents were doctors. My dad had been Medical Director of a nursing home, and I worked a couple of summers during college as a nurse's assistant. And people seemed, my recollection was that they were in the nursing home typically for one of two reasons: Alzheimer's, or they broke their hip. And, my grandmother had osteoporosis. I'm a small person. It certainly runs in my family. And so I recognized that it was an important problem, a big problem, an unsolved problem. [00:05:30] And so my really, my only question for the company was, does it work? We had this innovative treatment for osteoporosis and the founders shared the data with me. It was not a sure thing, but I found the data to be very compelling and so I joined and we're three years down the line from that point in time. And one of the most important things that's happened is we finished our pivotal trial and we got the results. Now it takes a while to do a trial for osteoporosis, but we had excellent results from the treatment. [00:06:03] Lindsey Dinneen: Yeah. First of all, thank you so much for telling us a little bit about your background. You have such an incredibly diverse background. So many questions just emerge from that, but I would love to hear about your current device and the way that it works and whatnot. [00:06:18] Laura Yecies: Sure. So it's a wearable treatment. It's a belt that has a vibration pack that you wear over your lumbar spine, specifically at the sacrum. And so we're applying vibration to the hips and lower back, and those are to the key areas that experience fractures from osteoporosis. So hip fractures are very life impacting, deadly for almost 30% of people. Spine fractures, you can imagine, are very painful and debilitating. And so we're focusing vibration, which has been proven to improve bone density on the vulnerable anatomy. And, there's a body of evidence from NASA where they did whole body vibration to try to reduce bone loss for astronauts. [00:07:05] So when astronauts spend time in space, they lose bone. And what they proved was that standing on a whole body vibration platform can improve bone density. But those companies that make these platforms, they have very good products. I'm a believer in the science, but those products haven't gone mainstream. They're people that tend to not comply very well with them, and the good ones are expensive. And so we're aiming to take this proven science-- and by the way, before NASA did the whole body vibration studies, there's a lot of studies in animals and cellular research showing the same thing. There's really a lot of science to support this. [00:07:45] But our device, we aim to solve the ease of use challenge by making it something wearable. And then most importantly, the vibration is applied locally to the vulnerable anatomy. So that's what we do. And what we showed in our pivotal trial is that we reduced bone loss by over 80%. So we measured the lumbar vertebra with a CT scan at baseline in one year. And the patients who were on the active treatment lost about a half a percent of their bone strength. And those on the placebo or sham treatment lost just under 3%. Our patients, we kept them clinically, essentially stable and slow this bone loss so you don't outlive your bones. [00:08:29] Lindsey Dinneen: Wow. That's incredible. I am. . I . I say this a lot and I know it's used as sort of a more tongue in cheek manner, but for real, what a time to be alive. That is so cool how so much innovation is just constantly coming through and the, there's this, people like you are doing this incredible work to bring new devices that are really impacting patients' lives. So that sounds like incredible results. You guys must have been thrilled with those numbers [00:09:03] Laura Yecies: Yes. And this was really our first attempt. We had done a pilot study, but this was our first one year study and we just applied for a grant to do another study with in basically a longer treatment duration, essentially a higher dose of vibration. So from my point of view, this is a great result, but this is like the beginning. [00:09:26] Lindsey Dinneen: Yeah. Yes, which is so exciting too, because it just leaves room for so much more as you continue to go down this path. So that is exciting. And so that's your next step. I'm imagining, is this, next level of treatment and what do you envision the company to, to do or be doing in say, three, five years from now? [00:09:50] Laura Yecies: So in three to five years, my goal is first of all, that we have this device very widely used in the market or with patients. So there's 52 million patients with osteopenia and other 12 million with osteoporosis. Our trial was for patients with osteopenia, and so there are a lot of patients out there who I think would benefit from this device. We also want to start to develop a relationship with those patients. Not just sell them a device, but support them in their overall bone health optimization. So we today have created an OsteoBoost application. So we help patients remember and comply and we remind them and give them encouragement to use the device. We help them get the optimum amount of calcium by tracking that exercise. [00:10:41] And then, our vision is to add community and other elements of optimizing bone health and potentially to have other services. We never wanna get in the way of a patient's relationship with their doctor. So if their personal physician is supporting their treatment of their bone density issues, that's great. But in many cases they're not. And so we wanna have services available for that as well. And it's interesting if you look in the app store or look at a lot of startup activity, there's many companies doing these kinds of solutions for diabetes or cardiovascular disease or asthma or depression, but there's really not much out there for bone health. And yet it's really a key part of staying well and independent and living, living healthily, and it's such a common problem. So we're excited, that we have something unique, yet very much needed and not in a, in a small group it's not a rare thing. It's very common. [00:11:46] Lindsey Dinneen: Yes. Yes, absolutely. And is your plan to sell directly to the consumers or will you be going through, insurance companies, doctors, whatnot, or do have you gotten that far yet? [00:12:00] Laura Yecies: We haven't finalized the details of that. So we're not ready to share them. But but what I will say that I think we are quite certain about is first of all, it is a prescription device, so there will be a doctor involved to write prescription and some of the details, and we will certainly have a way where the personal physician can write that prescription. We may have some other options for patients, but a doctor's involved, which is appropriate because they have a condition that puts them at risk of fractures and other health issues. [00:12:34] But the other thing that I am confident about is that we are going to want to appeal to patients to generate interest. We have seen tremendous inbound interest into the company with not a lot of marketing. I mean, I've done things like this podcast and I speak at conferences, but we have not spent money on advertising or things like that because the product's not on the market yet. And I hear from patients all the time, they are searching for an innovative treatment. They're searching for ways safely to slow their bone loss. I, I'm a member of a number of Facebook groups for osteoporosis and hear how patients talk about this, and so I believe there's tremendous interest by patients and that we wanna tap into that to build the business. [00:13:24] Lindsey Dinneen: Yeah. Yes. And part of the reason I brought it up, the question in the first place was exactly for that reason. I was thinking there's gotta be so many people who are searching for a solution and yours is so innovative and accessible. I'm so excited to see where it leads. Yeah, that's gonna be incredible. And it really struck me, you talked about your background being heavily in marketing back in the day and so obviously those skills are still very present today. So it's fun to see how, elements of things that you've done throughout your life will lead to this success, in this next endeavor. [00:14:01] And I'm actually very curious also. yoU talked about some really amazing positions that you had, and then those led you to have these CEO roles. So I'm curious, how was that transition for you stepping into your first CEO opportunity? Was that exciting, daunting, energizing? How are you feeling in those moments? [00:14:25] Laura Yecies: Those, you captured many of the feelings. So you know, a bit of context. So it was the very end of 2008. And so the world from a financial markets point of view was kind of falling apart. I had led large groups. I had been a general manager, but I'd not been CEO. I had never raised money before, and so I stepped into a company that had been through some trauma. They were supposed to be acquired. The acquisition, the plug got pulled out because of the markets collapsing. The founder had left before I got there. So it was, the company was really in a crisis, I would say. The employees were very afraid for their jobs. We didn't have money and, the financial markets were terrible. It was really challenging to go in and stabilize things and kind of pull the team together and then, build the business in a challenging environment. [00:15:23] Existing investors gave us some runway, but it was limited. They had already kind of been in investing quite a while, and so I had to find outside money, which in 2009 was challenging. But it was exciting. I loved the product that I was working on. I had been a user of it. It was something that was in my wheelhouse of, I had worked quite a bit on productivity tools for workers and business people and consumers. And, and I, we had great technology. So it was exciting. But it was It was intense. But we built that business. When I joined we had essentially zero revenue and we got to essentially in the 20 million run rate in four years. [00:16:07] Lindsey Dinneen: Wow. [00:16:08] Laura Yecies: That was great. [00:16:09] Lindsey Dinneen: Yes. That is great. That is kudos to you and your leadership for being able to step into such a challenging situation and it around. Yeah. [00:16:19] Laura Yecies: You know, one thing I learned then, because we did have all these challenges, but we also had a market where the latent demand and need was growing. It was a rising tide. Just to be specific a bit-- and then I'm gonna give an analogy to bone health technologies. So at that time we had a sink and share solution. We were a little bit more niche, but you could think of it as it was quite similar to a Dropbox or a box.box, what was then box.net, and that was also the time that iPhone sales, laptop, Netbook sales were growing very quickly, and so the need to get your data into the cloud was I mean, you could argue that it was always useful to be able to access your data remotely. And there, there were always kind of some niche solutions like, Go To My PC. [00:17:12] But suddenly, because the environment was changing where people were having these devices the market demand and the market opportunity was growing. Okay, so fast forward, oh, 14 years, 13 years, and osteoporosis and osteopenia is growing. But the other thing that's growing is awareness. And our target demographic, postmenopausal women, I'd say our typical patients are in their sixties. I don't know, what's the joke? Sixties is the new fifties or the new forties. Like these are women who wanna stay active, right? They may be still working if they're not working. They're very involved in the community, they're very involved with their family. They may have, they may be at a point where they've educated their children, they've saved some money, so they have disposable income that they want to take care of their health. And so it's a demographic that spends money on their health. They also are very social and community minded. [00:18:16] Let's imagine a six year old woman with osteopenia and she's going on a hike or a walk with her girlfriends. What are the chances that her female friends also have osteopenia That's probably 80%, right? If similar in age, and so I see this set of patients and who we're going after as being very interested in safe non-pharmacological solutions that are easy to access. You can call it the Amazon effect. They're used to things being convenient and seamless. And they, they want this type of solution to help them stay kind of active and healthy and be in a way preventative of the need for medication. So I see this as in a very different way than Sugar Sink, still a rising tide market. [00:19:08] And oh, by the way, at the same time talking about health concerns related to menopause is suddenly, and as it should be not just socially acceptable. It's a hot topic, right? Oprah, Michelle Obama, Gwyneth Paltrow, they're all talking about menopause symptoms. And by the way, osteopenia is very much a result of menopause. You're losing bone density slowly typically starting your thirties, but in the five years after menopause, there's rapid bone loss, and that's typically when women get into that osteopenia stage. [00:19:44] Lindsey Dinneen: Yeah, absolutely. [00:19:46] Laura Yecies: Oh, by the way the women who are in their sixties today, when they were going through menopause 10 years ago, or 12 years ago, or 15 years ago, they were told no. Hormone replacement therapy unless you're completely miserable because of findings in the Women's Health Initiative. And that pendulum has now swung back to a more moderate position. But today's 60 somethings are less likely to be on HRT or to have even been on HRT, so they're more likely to have bone loss. [00:20:21] Lindsey Dinneen: . Yeah. And. Speaking of this, and you were talking about thankfully, there's much more awareness, there's much more conversation happening about women and menopause and going through symptoms and whatnot. I've just been reading lately how much it is still a struggle despite that for women founders, especially of medtech companies to get the funding that they need. And I'm curious, what was your experience when you were fundraising, what were your challenges? What were your triumphs and maybe even suggestions for other women founders who are gonna be going through this soon too? [00:21:01] Laura Yecies: There's no controlled experiments on these questions, right? So if my fundraise on a difficulty from zero to 10 was a seven. Right? Would it have been easier or harder if I were a man? I really don't know. I know that women, there's less funding going to women, but I have felt that, at least for this company, I don't have any reason to assume that to be the case. If anything. I believe that investors, many of them, they even talk about this, they're looking for founder product or founder market fit. And I'm not the founder of the company. I was brought in as CEO after it started, but I feel like a founder. I operate that way. This is my adopted child. And I love it no less than if... [00:21:56] Lindsey Dinneen: Yeah, of course. [00:21:58] Laura Yecies: ...if I gave birth to it. [00:21:59] Lindsey Dinneen: Right, right. [00:22:00] Laura Yecies: I am a user of our product, right? And I empathize with very deeply and connect with our patients. And I think if a, a 25 year old man were sitting in my shoes trying to raise money, maybe he would've even had a harder time. So I, I know. I don't know. Women's health has been under invested in, I believe it still is under invested in. And why is that? It's very hard to tell. I will also say that devices are a harder field to raise money for, independent of gender. There's more investors investing in digital solutions or pharma than devices for a variety of reasons. The size of the device investor market has shrunk. [00:22:51] And I think that's unfortunate and because I think there are a lot of solutions that are less invasive, less systemically invasive. Osteoporosis or osteopenia is one example. But we see devices for other women's health areas like pelvic prolapse or stress urinary incontinence, or a number of things that are of concern to women, but also things that affect everyone like migraine and these device solutions are very safe. They don't completely replace pharmacological solutions, but I think it's really important to have other options and so I do think it has been challenging, especially in the early stages in that field. [00:23:37] Lindsey Dinneen: Yes, exactly. Yeah. But I thank you for your perspective too. It is, I think quite refreshing to hear from somebody who was a woman who went through this raising capital and actually did have a really good experience, 'cause you hear so many of the opposite, so sometimes it's easy to go, "oh gosh, it's not changing fast enough." But it is so encouraging to hear from somebody who has had a really good experience, so I appreciate your telling me about that. [00:24:03] Laura Yecies: Yeah. And for women's health if most of the investors are men, a good investor should be able to appreciate concerns outside of their personal experience. But I think human nature is such that we tend to connect with problems that we've had. And so the fact that most of the VCs and investors are men makes the whole women's health field, I think, more challenging for fundraising. But we'll see. That's changing too. [00:24:35] Lindsey Dinneen: Yeah. Absolutely. Yeah. . So what are some things that you are excited about, either personally or professionally in the coming, coming couple of years? What are, what's gonna, what's gonna get you up and ready to just tackle the day? [00:24:52] Laura Yecies: Yeah. It kind of goes back to what we were talking about before that most of my career I've spent more on the commercial and marketing and sales side. And since I've been at BHT, we've been very much in sort of science and research mode, which has been very interesting, fascinating. I've enjoyed it, but I'm really looking forward to this next phase where we can get the product on the market. I mean, I hear from patients multiple times per week. "When is this gonna be available?" And I don't like saying "it's not available today." [00:25:27] Lindsey Dinneen: Yeah. . Yeah. [00:25:29] Laura Yecies: I wanna say today, and that feels tantalizingly close. I'm very much looking forward to that. And, first doing it at a small scale, we have a waiting list of patients. And I wanna, kind of put a shout out on that. We will first go to the waiting list. To make the product available and people can sign up at bonehealthtech.com and the front of the line are the patients who, the citizen scientists who participated in our pivotal trial, and they're, we have another trial going on. They're first in line. They have contributed so much and did it really out of a total generosity of spirit. They had minimal compensation. And then of course to get to the next level of, hitting the gas and growing the availability and distribution of the product. I'm imagining, I talked about hiking before and that's because I love to hike and I'm imagining, osteo boosting hiking groups or something like that. I know that sounded corny, but. [00:26:27] Lindsey Dinneen: Oh, I love it. . No, it's fun. And that is so exciting. I am really cheering you on as this next phase comes to reality. That's, yeah. That's incredible. Pivoting just for fun, imagine you were to be offered an opportunity to teach a masterclass on any subject you want. It doesn't have to be in your industry, but it can be, and you'd get a million dollars for doing so. What would you choose to teach and why? [00:27:00] Laura Yecies: I think I would want to teach around marketing and commercialization, sort of product management, and then really the full life cycle of bringing products to market. I've been doing it for 35 years. I hate to say that. Sounds like a long time in various formats. I mean, I've, some of it has leaned heavily on the digital marketing. Some of it has been more B2B sales, business development. So I feel like I've spent a lot of time in that area and I have lessons learned to share. I actually enjoy teaching. I spent some time, when I first came out to the Bay Area, I taught marketing at Santa Clara Business School. I enjoyed it, but I enjoyed working in the marketing field more, and I had young kids, and so between a full-time job and kids, there wasn't also time for teaching. But I would love to get back and do more teaching. And I do executive coaching and I informally coach and that's a very rewarding part of my job. [00:28:07] Lindsey Dinneen: Yeah, absolutely. That sounds like a great masterclass and very needed. So we would sign up for that one. [00:28:13] Laura Yecies: Thank you. [00:28:15] Lindsey Dinneen: And how do you wish to be remembered after you leave this world? [00:28:22] Laura Yecies: Oh I mean, I'm a family first person and I am lucky to have great husband, four kids and today's six grandchildren. And the first thing that goes through my mind when you ask that question is, to have had just a really positive impact on them and the other family members and friends in my life. And then, work-wise if this device or our solution is effective it provoke small changes, but in our field, small changes over time can have big results. And, if we've prevented fractures and help people, I would be really honored to be able to be known for that. [00:29:00] Lindsey Dinneen: Yeah, of course. And final question. What is one thing that makes you smile every time you see or think about it? [00:29:10] Laura Yecies: My grandchildren getting to play with 'em when they want, when they come through the door every Friday. [00:29:16] Lindsey Dinneen: Aw. [00:29:17] Laura Yecies: We have a family dinner almost every Friday night. And I look forward to it all week and when they walk through the door. So that's my mental image and I for sure smile with that one. [00:29:29] Lindsey Dinneen: Oh, I love that . What a great tradition. And I, it's so lovely that all your families, or at least some of your family, is close enough to be able to do that. How fun. [00:29:40] Laura Yecies: Yes, it's really fun. It's fun. And I grew up with that so I'm trying to continue, with the next generation. [00:29:47] Lindsey Dinneen: Yeah. Yes. That's fantastic. Laura, thank you so much for joining us and sharing about yourself, your background, and the incredible work that you and your company are doing. I'm so excited to see it come to market and just really impact lives. Thank you for the work you're doing. [00:30:06] Laura Yecies: Oh, my pleasure. And thanks for the chance to share it with people and for inviting me onto your show. [00:30:11] Lindsey Dinneen: Of course, and we're so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world. [00:30:40] Laura Yecies: Thank you very much. [00:30:41] Lindsey Dinneen: Thank you, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:30:55] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Richard "RJ" Kedziora, co-founder of Estenda Solutions, dives into the inspiring world of digital health solutions, where innovative minds are not just developing technology, but also saving and improving lives. RJ shares his journey from early software development days to creating impactful healthcare technologies, highlighting the importance of understanding patient and provider needs. With a focus on people and process management, RJ's story is a testament to the power of technology in making a tangible difference in healthcare through human compassion and the drive to better lives. Guest links: https://www.linkedin.com/in/rjkedziora/ | https://estenda.com/  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 025 - Richard "RJ" Kedziora [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to welcome as my guest today, Richard "RJ" Kedziora, co-founder of Estenda Solutions, focusing on people and process management which also provides strategic technical direction, guidance, and innovative insights, creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient provider satisfaction. RJ received an MBA from Westchester University and a BS in Computer Science from Duquesne University, where he received the excellence in computer science award. RJ is a frequent podcast guest, has spoken at numerous technology and healthcare conferences, and has coauthored articles in technology and peer reviewed clinical journals. [00:01:37] Welcome to the Leading Difference, RJ. And RJ, I would love if you would start by telling us just a little bit about yourself and your background. [00:01:46] RJ Kedziora: Yeah, Lindsey, thanks for having me. It's a pleasure. I look forward to our conversation. My background is through software development. Graduated with a computer science degree back in, in the early nineties before web and mobile and internet. So crazy days. And came up through those software development racks. Started out programming, got into requirements analysis, understanding what a solution is about, project management, general management. And then in 2003, with a good friend, we were working with together at a large consulting company in the pharmaceutical space, we went off and started our own company called as Estenda Solutions and remain there today. We just hit our 20th anniversary, which is always crazy when I can talk about decades, but it has definitely been an interesting journey. So my day to day is, I think of it as a digital solution architect. So helping a mix of large companies and small companies, startups develop tools, technologies, algorithms, better ways of looking and dealing, handling data, to make a difference in the lives of people. [00:02:56] Lindsey Dinneen: Wonderful. That's incredible. So 20 years. Congratulations. That's no small task. . So I commend you for that. That's really exciting. I. Yeah. So how did the idea to start your own company come into being? Did you identify a gap basically in the market? [00:03:15] RJ Kedziora: It's something probably even early on as I was graduating from college, always in, in the back of my mind to make a difference, to go off and try something new and really drive what I wanted to do. Even before starting my own company, as I worked in various different roles, I'd be hired by a company, I'd come in with a defined role, and then I'd always just find a niche. They'd be like, "okay, where does this company need help? Where can I make the biggest impact?" [00:03:40] And that's how I went from software development into like more of the analysis and project management , 'cause I quickly realized software development, developing a digital product, it, you know, technology is important and you have to understand how to program and how to test, but it's very much about the people, the process, understanding what they're going through, and realizing those things. It was sort of a natural evolution of like, "okay, I need to strike off on my own and really drive projects and things like that with my talents and capabilities and now our team's talents and capabilities." [00:04:17] We were fortunate in those early stages to have a Congressional grant for the development of a diabetes disease management application for military healthcare. That's how we got our start. So we worked with people like Walter Reed Army Medical Center, the Boston VA, the Indian Health Services, which is responsible for the Native American population here in the United States. Still working with 'em 20 years later, which is crazy that we have 20 year clients-- bunch of other clients that we've been working with, 10, 11, 12 years a across the board. So, it's been enjoyable from that perspective. [00:04:53] And I always talk about, I've developed accounting systems, I've developed inventory management systems. And even a railroad car scheduling system, it's like, "Hey, great. We need to get that railroad from here to here. It's important!" You know, it's essential and the economy's important. But healthcare, there's that sense of giving back, of making a difference. [00:05:16] Lindsey Dinneen: Yes. Absolutely. Yeah, I, that is one of the things that I really enjoy about being in this industry is you're right all of those things matter that you could do with your skills, because obviously you have those skills and can use them in all sorts of capacities but in healthcare and med tech, it's this really great extra layer of feeling like you really are able to impact people's lives directly. And it, it just, it has a different sort of feel to it. [00:05:46] RJ Kedziora: Yeah. And our projects are typically on the R&D side, work, working with the R&Ds, working with academic medical centers, work with PhDs, with doctors, where they'll have an idea. It's like, okay, here's a different way of treating a patient with diabetes. A different way of looking at the data that you can collect around diabetes or other chronic conditions. I, I wear the Aura ring. It's there's a lot of data that's available there now. And so as we develop those solutions, it's one thing for us and the doctors, the PhDs, the corporations we work with to say, "okay, yes, this really works." But they, you know, they have to go to clinical trial. They have to go and do, they work in the real world. So we also have a couple PhDs on staff to help drive those discussions and do the planning around those clinical trials. [00:06:34] And ultimately, in certain situations, things then have to go to the FDA to be approved and validated. These days, there's a new terminology called digital therapeutics that we're getting heavily involved with. It's a relatively new term, probably 2017, 2018 that came around. And if there's probably 300,000 digital health applications out there. Systems, you know, some of which we've helped create over the years. But there isn't extensive clinical evidence that they work. There's some, but not extensive, and I think of it as the difference between, supplements and prescribed medications. And so there's lots of supplements out there. You can go to your CVS, your Rite Aid and pick them off the shelf, and there's some evidence they might work, but the evidence isn't exactly clear. [00:07:25] But then you go to prescribed medications, go through a very extensive, rigorous process of development of clinical trials, and then the FDA or other global regulatory bodies look at these and say, "okay, yes, this does make a difference." And that's the idea of digital therapeutics today is there are lots of digital health applications out there, but now people are taking these digital therapeutic applications: evidence-based, clinically validated, approved by regulatory bodies that can be prescribed by your doctor, by your provider. And more importantly than reimbursed by the insurance company. So making a difference. [00:08:05] You know, and we talk about health, healthcare, and being able to make a difference. There's not enough healthcare professionals out there, particularly in mental health. There's a mental health crisis in the United States. We just can't train enough people fast enough. Digital health is a way to approach that, to scale, to increase access and equity to these systems, to the care and treatment people deserve, and so that's the idea of digital therapeutics. They can get out there, provide this treatment, share the information with your provider, and make a difference. [00:08:38] Lindsey Dinneen: Yeah, absolutely. So what does it look like when somebody comes to you and says, "Hey, I have this idea for this app, for this software, whatever." And then how does it work when they start approaching you, and this is a brand new, never before , you know, project and you step alongside them. How does that work? [00:09:00] RJ Kedziora: Yeah, it is. It is a great question. And we work with a mix of Fortune 50 clients, so big customers, global customers, lots of people, processes, technology. We do happen to be ISO 1345 certified, which quite simply means we have a, well-developed quality management process of how we do software development, very template driven, process driven. It's like, here's how we're going to do it, and then we demonstrate that we do it. We get audited regularly by external third parties, by our clients. [00:09:32] But then we also work with startups who, in some cases don't really understand software and don't understand regulations and what's required to create one of those digital therapeutic applications. So when a customer does come to us in the, in those early stages, it's very exploratory. It starts out with prototyping understanding the problem in the domain space. One of the things that differentiates Estenda from a lot of other companies is we are going to provide the entire development team, software developers, QA from the ground up, educational training, medication training. So if you're working in diabetes or congestive heart failure or lupus, multiple sclerosis, the better the entire team can understand the condition, have empathy for the patient, can understand the provider, the care professional's journey about what they're dealing with and how they can care and treat that patient, the better off they're gonna be. [00:10:27] So it's those early stages of experimenting and playing and we start with, you know, black and white wire frame diagrams and really get those going and gradually build them up. And I think about it as you, you have a problem and you want to get across town as fast as you can from one end to the other, and you can walk. Great. Okay. But it's not very fast. Okay? I have this idea for a car. I can get across town really fast, but it's gonna take a long time to build that car and realize value. So, let's first build a skateboard. Very simple, can do it very quickly, provide value, get feedback, from the stakeholders, from the customers, from the patients, from the doctors, the nurses, whoever we're developing that application for. [00:11:15] And so you figure out the unknowns, you know, so what, aren't we sure? What areas are showing promise? So we build that skateboard and then it becomes a scooter with a handlebar, you know, okay, I'm getting across town faster. It's not the ultimate goal. But I can get there. And then you can build a simple motor on it,, and then you build a body around it and you progress gradually until you get to that car. But along the way, you're adding value very quickly, which is important. [00:11:47] Lindsey Dinneen: Absolutely. Yeah, that sounds like a really good process to work through. And I love your illustration. That's such a great way of capturing the essence of the process and the way that you go through all of that. So, I'm curious, have you always had an interest in and passion for computers, technology, software development, or is this something that evolved over time? [00:12:08] RJ Kedziora: Yeah, I was very fortunate. My parents were able to buy an IBM PC Junior when I was in probably seventh grade in the mid eighties. I went to a local parochial school. They had a computer lab, you know, as one computer in the classroom. But, for the eighties, that was phenomenal. And so I knew going into college that I wanted to do software development. A good friend had a Commodore 64, which is typically a gaming, and so I'd be over there and it's like, "okay, games are fun, but what can we make the computer do?" You know? So I was very early driven by what can I do and the possibilities of digital everything. [00:12:49] College, I really thought I was gonna go and get the PhD in artificial intelligence. Very much enamored with that idea. Ultimately as I got ready to graduate, I got offered a job and was like, huh, money and so that, that turned my, you know, immediate trajectory there. You know, I did start working in programming kind of thing, but always followed AI and things and applied those ideas and principles and what AI is, has evolved a lot over the years. We've developed some AI systems in the past, but you know, now when you look at them, they're really like rules engines, and think things of that nature. And they were considered AI at the time, but nowadays it's like, "okay, that really wasn't AI." [00:13:36] But you know, the idea is, and the principals were there, and one of my senior thesis projects was genetic algorithms and how do you apply the idea of genetic algorithms to solving computer problems? And that was at the early stages of the internet kind of thing, just as a browser were coming out. So that made research interesting 'cause you could even at that early stage reach out globally to people and seek ideas and thoughts and stuff like that which led me down that road. But fast forward 30 years now and AI is everywhere. It's all that, that the media can talk about these days. Rightfully so. [00:14:15] Lindsey Dinneen: Yeah, and actually that brings up a great question that I had for you, because I did notice on your LinkedIn, you do share a lot of articles about AI, and you're obviously very involved in that. How have those tools helped your work or how has it changed your work or whatnot? How do you feel about all of that? [00:14:33] [00:14:33] RJ Kedziora: It really comes down to data. That's the core of AI. In the past and today, you need data to be able to train the AI systems to do what they're capable of. And it's interesting, our journey as Estenda is, as I've been reflecting on it was one of data scarcity. You know, 20 years ago, getting data was the difficult challenge. In diabetes, it was typically finger sticks, and people would, you know, do it a couple times a day and EMRs were there. They existed. We were lucky working with government organizations that had them, the military, the VA had them. Now it's, you know, fast forward 20 years later, there's an overwhelming amount of data. So early on it was like, how do you make decisions with limited data? Now it's like, okay, how do you use all of this data and pick out the important, salient things to be able to make decisions on and drive recommendations, [00:15:29] And the same thing is true with AI today. As you're developing a system, you need a robust set of data to train the AI systems. The broader data that you have, the better off you're gonna be. Day-to-day. I think today, generative AI, you know, the Chat GPTs, the Bards, what everybody's really, the media is talking about are amazing. You need to know and understand how to use these tools today. And it's not so much where they are today because there are challenges, there are problems, you know, they make up stuff. It's called hallucinations. And so you do have to fact check what they do. It was interesting is I was sharing, we do a monthly all staff meeting kind of thing, and I was sharing my experience with chat GBT and one of the people on the call sort of googled, like, tell me about Estenda. And it made him the president of the organization kind of thing. It was like, he's a great guy, does amazing work us, he's not the person. And it was just one of the odds of that, in that moment, kind thing. It was like, yeah, that's not true. [00:16:34] Lindsey Dinneen: Right. [00:16:34] RJ Kedziora: So you do have to fact check it. But that's today and where we are. And so imagine where we're gonna be 10 years down the road. And Bill Gates said a long time ago, "Humanity overestimate what technology will be capable of in, in the 18 months, two years, underestimate where it's gonna be in 10 years." And I think about Estenda, if the iPhone didn't exist, Facebook didn't, Instagram, Twitter, X, none of these things existed when we started, and here we are a short 20 years later and the world's changing. In terms of AI now it's really an efficiency thing. And it's like, "okay, I need to do some blog posts." And yeah, I can sit there and come up with the blog, post ideas, but it's like "Hey, ChatGPT, gimme 10 ideas for blog posts," you know, and I might not like four of 'em. Okay, "gimme four more." I don't like this. "Gimme four more." [00:17:29] You know, and it's just, it's an efficiency thing. Even in healthcare, that's what we're seeing. So there are, a lot of, I think it's over 400 now, approved, FDA approved AI algorithms very much in the idea in the area of radiology and looking at images. That's by far the biggest use of . Today, if you have those images, you can train systems to recognize certain things, you know, whether it's breast cancer or diabetic retinopathy. You can train systems to recognize what you need to see in those images instead of a person looking at them all the time. So, again, you can scale much more effectively, which is nice. But in, in healthcare it's very much, it's that efficiency question. [00:18:09] Lindsey Dinneen: Yeah. [00:18:10] RJ Kedziora: It's like, okay, I know how to write a prior off letter for this patient, but that takes time. So have ChatGPT write the prior off letter. And then you as the physician, the trained professional, have to look at that and evaluate. And you can't just send it off. You do have to look at it, but you know, EMRs, there's a plethora of data in the EMR. Let the AI systems... [00:18:35] Lindsey Dinneen: Yeah. [00:18:35] RJ Kedziora: ...you know, surface what is important, is a challenge. EMRs is a general idea, are very much around capturing data for billing, not the best, usable experience. If you can use AI that's just listening in the room to then document that encounter, that provider's now not heads down on the computer typing, trying to make sure they get everything in and not looking at the patient and not paying attention to the patient. [00:19:02] Lindsey Dinneen: Right. [00:19:03] RJ Kedziora: It can reverse this kind of thing. It's like, okay, the doctor can now pay attention to the patient and look at that person and really understand their situation better and pick up on those cues of just their body language kind of thing, and not have to worry about typing away at the computer. And then there's a lot of duplication in clinical records. So it's like, let the AI systems get rid of that duplication, make it better. And then just, you know, enhance. And I saw an article, I think I posted about it, the idea of collaborative intelligence, but a lot of people are asking is, AI going to replace Doctors, software programmers, software developers, insert profession X, is AI gonna replace it? And then people are like, "AI is not quite there. AI makes mistakes. It has biases. AI Hallucinates." [00:19:50] I love my doctor, but my father has said over the years, " the doctor that graduates last in his medical school, what do they call him? Doctor!" You know, they're human. That, and that's what it amounts to. It's, they provide a great service, but they're human too. And they might not recognize everything. And so if we work collaboratively with the AI to balance that out we can improve overall care and treatment. So. [00:20:18] Lindsey Dinneen: Yeah, so a lot of potential for it, and I love your idea of using it for some of those more tedious, time consuming tasks and just giving you your first draft because it's not, like you said, it's not gonna replace the human. Let's look through this. But it can help. And if you're using it appropriately, there's a lot of good uses for it too. So, yeah. So, you know, there's a couple of things that I noticed from your LinkedIn profile I'd love to chat with you about. One of the things that stood out to me was in your headline, you mentioned Chief People Officer as being most important. So I would love if you would speak a little bit to that and why you feel that way. [00:21:00] RJ Kedziora: I can do a lot, but I can't do everything. So I, the people that work for us are very important. I can make an impact. A team can make a much bigger impact. A company can make an even a bigger impact. So that is, that's why they are important. I talk about family first a lot. And, we provide fully paid healthcare benefits for you and your family. You want to have that sense of safety, want people to feel that they can take risks, and do their best work kind of thing. And the better they feel, that emotional safety, that the better off we're gonna be as an organization. They'll be able to provide more value to that customer, be more productive, 'cause ultimately that's what it amounts to is we need to get software out the door. We have customers and clients that have needs and demands and we have to meet those, but you know, you have to balance that with life. So. [00:22:02] Lindsey Dinneen: Yeah, absolutely. And I love the emphasis on people first, and I'm, I'm wondering if that's something that, is that an ethos that developed over time for you as well as how did your leadership skills evolve? Because going from starting a business to then and then growing it, I mean, it's a whole thing. So, yeah, I'd love to hear a little bit about that. [00:22:24] RJ Kedziora: Yeah, it definitely has grown and evolved o, over the years. It there, there's this concept of being a 10x software developer, one person making the impact of 10 people. And that's somewhat of a myth, but there are people that are more productive than others. And the idea of empathy and understanding that other person's perspective and experience is what's driving to that next level to become that 10x developer. You're not developing for yourself. You're developing for the end user, but we embody it in, we have a professional development process, and the idea of helping others is embedded in that. [00:23:01] You'll see that we do one-on-ones, not as great, as frequently, as I would like. But we try and do those. But as part of our structured plan, we do a self-assessment and we ask everybody that question, "how have you helped other people?" as part of the goal process, "how are you helping others?" But even as you're developing in that day to day when you're writing code, "how is it helping you in the future understand what you're doing? How does it help the tester better test that software? How does it help the support person provide better support?" [00:23:37] So it's really thinking about how you're helping others along the way. And ultimately the whole company is driven by that of working in healthcare. But it starts at that bottom of every person. It's like, "how, what you're doing, helping the next thing?" So we try and constantly reemphasize that when we can. [00:23:54] Lindsey Dinneen: Yeah, that's a great approach. And so, and because that is so much the heart of your company and your people, I'm curious if there's any particular moment that stands out to you as you've gone along this journey, that kind of really reinforced, yes, this is why I am here doing this work. Is there anything that, or a series of moments, just things that really stand out as being a very sure "yes, this is correct" for you? [00:24:20] I [00:24:21] RJ Kedziora: Yeah. It, I would say it's more a series of moments, because as we've developed software and then it's used by the care providers or patients, we've constantly over the years, hear those anecdotal stories of "Hey, I was using your software, what you developed for us, and found this and helped this patient." There's a series of those, but then it even goes up, it bubbles up that we do those clinical trials and we've done five year NIH funded National Institutes of Health funded RO one study. So it's like a five year study to then demonstrate that the software we produced does make an impact kind of thing. [00:25:00] But even more importantly, as we're part of that process, we've had several customers put our names, our developers' names on patents, or as those articles have gone to clinical journals, peer review journals that our software developers and QA, other staff have been authors on those. That, that's just rewarding where, okay, yes, we are helping people, but then our customers are also recognizing how much of a part of this journey we are. You know, if you really know what you wanna do and have it, here's my 10 requirements kind of thing. We're probably not the company for you. Let's explore and create something together. [00:25:38] Lindsey Dinneen: That's really cool. So it's always a collaboration it sounds like with your clients. It's not just a one way or the other, them dictating to you or you dictating to them. It's this, let's figure out the best way for us to work together. [00:25:50] RJ Kedziora: Yeah, it says how do we add value? How are we, you know, we want to contribute. [00:25:56] Lindsey Dinneen: Yeah. That's amazing. Yeah. So, one other kind of random question. Based on your LinkedIn profile, when's your next triathlon? [00:26:04] RJ Kedziora: How much time do you have? [00:26:06] Lindsey Dinneen: Yeah. [00:26:06] RJ Kedziora: I, yeah, that's a whole 'nother podcast. [00:26:08] Lindsey Dinneen: Yeah, sure. [00:26:09] RJ Kedziora: I think I'm, I think I'm, I think I'm done for this year. I live in the Philadelphia area, the temperature's getting, yeah, temperature's getting a little colder and that type of thing. But, you know, take a little rest for a month or two before I get back into training. And, but there are definitely ones I do every year. There's one escape from Cape May, Cape May, New Jersey. You jump off the back of a boat, the ferry, into the ocean and swim to shore. I did escape from Alcatraz two years ago, which is interesting because they take you out in a boat, in, into the. And jump off the boat from Alcatraz and swim to shore. Always interesting kind of thing to, to do those, but it's very much-- it's interesting because my day-to-day at Estenda, my own company, and how I get involved in projects is 'cause I enjoy the challenge of it. [00:27:00] And in triathlon, yes, there, there's a definitely a physical aspect of training and, but it is also very mental to, and that's really what I think drives me in the sport of triathlon. It's like, "okay, I need to get up at 4:30 and go jump on the pool and swim for 45 minutes and then hop on a bike" time and time again. And I thoroughly enjoy it. But yeah, it is that mental challenge. I've done just pure marathons in the past and it's like, "okay, get to the next telephone pole. Get to that next half pot." It's that mental, keep pushing kind of thing is drives me. [00:27:34] Lindsey Dinneen: That's incredible. It just reminds me-- tangent very quickly-- it reminds me, I remember I was running a 10k with my husband and I'm not a runner, I don't claim to be, but I was doing this challenge for myself, and I just remember we, we were getting close and I was so exhausted and, you know, kind of miserable at that point. And he was like, "it's all downhill from here. It's all downhill." And I was like, "it's literally sloping up!" [00:28:00] RJ Kedziora: Yeah, but it's, you know, it's like, yes, for me, try, it's hard. It's difficult kind of thing. but I'm also good enough that I'm not out there it's like, for a a marathon, I can-- in the past it was like 3:20 for a marathon. [00:28:16] Lindsey Dinneen: Wow. [00:28:17] RJ Kedziora: But there are people out there that are five hours, six hours. I think that is so much harder, so much dedication for that individual to be out there for five hours. It's kudos to you for being out there for, you know, it's like, yeah. I'm not saying I, I have an easy time of it by any means, but I'm not out there for five hours and they did it. So I just, I'm astounded by those people and they're not on the couch. And I know I, I look to have a long lifespan and a long healthspan. I want to hit a hundred years, but with a good quality of life. And I have a couple friends that are in, still out doing that 5k at 70 years old, and they're like, "I won my age group! I was the only one in my age group..." but you weren't on the couch! Like you did it! And that's motivation to, to keep going out there as well. So hopefully I'll be that person. [00:29:10] Lindsey Dinneen: I love it. That's brilliant. Excellent. So, pivoting just for fun, but imagine you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:29:29] RJ Kedziora: Oh wow. It would probably be about health. [00:29:34] Lindsey Dinneen: Okay. [00:29:35] RJ Kedziora: Which, which combines sort of everything I do. The triathlon, the training, the fact that I'm in software development in the health field. It brings all of those things together. And just a lot of people don't know what they don't know. And so if I could impart that knowledge on more and more people, I think that would make an impact that would make a difference. So yes, I could teach a software development course on cybersecurity. Interesting.. I could teach one on AI. Yes, interesting. But if it, if you really just focused around the idea of eating better, moving. You don't have to do a triathlon, you don't have to do a 5k. And it's like park a little further away from the supermarket and walk. You're gonna be better off, have that longer lifespan, longer health span. So yeah, it's, if I have that million dollars and it is probably health in in general, which encompasses a lot. But yeah, it would be health. [00:30:37] Lindsey Dinneen: Yeah, absolutely. Yeah. And then, how would you like to be remembered after you leave this world? [00:30:44] RJ Kedziora: Huh. Wow. Then I've made an impact and I've made a difference in, in some small way. I don't have to win the lottery, I don't have to be the billionaire kind of thing, but that, that I've made a small impact and, the lives of the people around me and hopefully a bigger audience through the work that I've done, that our company's done. And yeah, I've made a small difference and made a few people laugh. [00:31:12] Lindsey Dinneen: Yeah. Yeah. I mean, I've already laughed today. So , you're succeeding. Excellent. And then final question, what is one thing that makes you smile every time you see or think about it. [00:31:26] RJ Kedziora: Family, I, that's, you know, wife. I have two daughters, 24 and 21, doing very well. Yeah, any chance I get to see them? Family. [00:31:36] Lindsey Dinneen: Yeah. [00:31:36] RJ Kedziora: And oldest of six. So you get to see them and their family kind of thing. Family's important, yeah. Yeah. [00:31:43] Lindsey Dinneen: Yeah. And you've mentioned that several times: family first and people first. So it's a running theme. . That's great. RJ, this has been so much fun. I really appreciate your time today and just thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. So, thank you so much for picking that, that organization to support and we just wish you continued success as you work to change lives for a better world. [00:32:24] RJ Kedziora: Thank you very much. This was a great interview. Thank you. [00:32:27] Lindsey Dinneen: Excellent, excellent, and thank you so much to our listeners for tuning in and if your feeling is inspired as I am right now, I'd love if you'd share this with a friend or two and we will catch you next time. [00:32:38] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. 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