The Leading Difference

Scott Burwell, PhD | Founder & CEO, Neurotype, Inc. | From Psychology to MedTech & Transforming Substance Use Recovery

Scott Burwell, PhD, is the founder and CEO of Neurotype Inc. Scott shares his journey from a background in experimental psychology to establishing Neurotype, a company developing brain therapeutics to address cravings in substance use disorders. He discusses the innovative use of EEG technology to measure brain responses to stimuli, providing an objective biological assessment and treatment of cravings. Scott emphasizes the importance of integrating science-led approaches in creating medical devices and reflects on the challenges and rewards of leading a MedTech startup.
 
Guest links: https://www.neurotype.io | https://www.linkedin.com/in/scottjburwell/ | https://www.linkedin.com/company/neurotype
Charity supported: Equal Justice Initiative
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 049 - Scott Burwell, PhD
[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, Scott Burwell. Scott is the founder and CEO of Neurotype Inc, developer of new brain therapeutics to make environmental triggers less problematic for people in recovery for substance use disorders and other addictions.
Well, hello, Scott. Thank you so much for joining us today. I'm so excited to speak with you.
[00:01:17] Scott Burwell: Great. Thanks so much for having me, Lindsey. Thanks.
[00:01:19] Lindsey Dinneen: Of course. Well, would you mind by starting off and tell us a little bit about yourself, your background, and maybe what led you to MedTech?
[00:01:28] Scott Burwell: Sure. Yeah. So, I have a background in experimental psychology, a PhD in psychology from the University of Minnesota. And kind of what led me to that was experience: my family had a liquor store growing up and I worked there for many years. And so I saw firsthand from behind the counter people with substance use disorders occasionally, and just knowing from extended family, substance use disorders, and it was an interesting observation to me to see different people, how they get to a substance use disorder. Some through genetic propensity and some through experiences in their life. And that led me to get a PhD in psychology where I really focused on the genetics and physiology underlying substance use disorders.
And during this time of getting my PhD, I was always trying to think of, where does my skill set and my interest align in the future? What kind of job am I going to have after this? So I looked around. I had some experience, thought, "Could I go the academic route? Could I apply for grants, be a professor at a university?" That approach, which is a very good approach for some people, where your main outcome are publications and grants and dissemination of science.
And then I also looked at industry, but a lot of the companies in industry weren't doing exactly what I wanted to do, which was take these biomarkers that we were studying in psychology and transforming that into medical device or medical innovations. And then the third path that I didn't quite see at the time was this sort of like rabbit hole, this unknown path of medical device innovations or startup innovations.
And it was an eye-opener to me through some programs at the National Institute of Health, National Institute on Drug Abuse, that led us to this opportunity that actually, I could start my own startup in this space. And and I'm happy to talk a little bit more about that, that later. But really, this opportunity to make something new, based on the science that we know today, and based on the opportunity and the gap in terms of what people are being treated for with these substance use disorders. So that's kind of what led me down the path, and happy to talk about it today.
[00:03:41] Lindsey Dinneen: Yeah, excellent. Well, thank you for that. And yeah, I'm so excited to delve into so many aspects of your story. So going back just a little bit, you had this childhood where you were observing and you were seeing what was happening to some folks and you thought, "Okay, maybe there's a better way, or at least I'd like to understand more about this." But now, were you always sort of science minded and kind of interested in going into psychology, or did that come about as a result? How did that interest develop?
[00:04:10] Scott Burwell: Yeah, really, I never saw myself getting a PhD, never saw myself going to an academia setting. People with graduate degrees, people with doctoral degrees-- all those people seem to be other people and not something that what we did. But my parents really instilled an appreciation of higher education in myself and my two older sisters. But again, it was never this plan for me to go out and get an higher education, PhD degree.
I think that what really led me to the path was just try to understand myself. I think that's what led me to psychology. It was a psychology class in behavior genetics that I took in undergraduate that, you know, behavior genetics is the field of understanding how your genes and your rearing environment lead to who you are and influence who you are. And it was one of these, this realization that actually it's not just your experiences, it's not all just the soft, mental processing and soft psychological experience. There's really a physical, biophysical basis, to a lot of who you are and who you turn out to be.
And I think that was really eye-opening to me and helpful for me understanding who I was and how I am in the world. And I think, you know, just that little bit of information of understanding, there's this objective information that is programmed in your genes or programmed in your physiology that influences who you are in everyday life, that I found super interesting and eventually led me to work at the Twin Study at the University of Minnesota. And then and then while I was there, I realized there's a lot of people getting PhDs that I'm not that much different from and we're all just curious people. And it's an opportunity for me to, you know, if I apply myself, it was an opportunity for me to pursue a field.
[00:06:06] Lindsey Dinneen: That's very cool. Yeah. Okay. So, so you're pursuing this field and you've already had this background and interest in helping folks who have these substance abuse disorders, and I'm wondering, what were you observing as you have now developed this company? And I'm so excited to dive into that as well, but a little bit before that, what were your observations when you started realizing, "Okay there's a gap in the way that we're treating this or handling this or responding to this." And then what was the outcome for you that you thought, "Okay, let's try something different."
[00:06:42] Scott Burwell: Yeah. So a couple of things. I think the first thing is that, the treatment of substance use disorders and all behavioral addictions and to some degree mental health is been sort of a parallel development. It's been a, it's been a parallel field that's been outside of the rest of the way that medicine is traditionally done. And so, even though we have for some substance use disorders medications for management of the substance use disorder. Or there are social support groups, AA, Narcotics Anonymous also, that help provide social support to people with substance use disorders. These are sort of groups and services that have been built outside of traditional medicine.
And with the exception of these services, there haven't been too many medical innovations, FDA regulated innovations that doctors can prescribe for people with substance use disorders. And this is despite decades of research that are showing there are biological underpinnings of substance use disorders. There are biological interventions that, that can potentially help people with these afflictions.
And so, that was one of the pieces that during my training, I was just constantly looking for companies that were doing this kind of work to treat disorders from a biological or psychobiological perspective. And I just wasn't finding anyone. And also at that same time, the DSM Five, the Diagnostic and Statistical Manual for substance use disorders, the criteria that sort of outline what it takes to get a diagnosis had just included the symptom of craving. It might be surprising to people, but it's only been since about 2013 or so, that craving has been an official symptom of a substance use disorder. And I mean, that's despite again, decades, many years of people reporting cravings being an issue that they deal with day in and day out.
And so I was aware of this addition of a new symptom, but also I'm aware of the fact that the way that substance use disorders are diagnosed, they're assessed, they're monitored, is entirely subjective, meaning that people are reporting these symptoms in an interview in a one on one kind of subjective interview that people can report what they believe, report what they experience, which is valid information. But sometimes what you're aware of, what the clinician is aware of, might not be what's going on an objective biophysical level.
And so I was aware of a certain biomarker that you can measure with brain waves using electroencephalogram or EEG and this biomarker is what leading science says is the biomarker underpinning of craving. And so I felt, well, you know, if there was a way that clinicians had this in their hands as either a diagnostic assistant or as a way to treat people with craving, this could be a valuable medical device that people can use. And so, I can talk more about the specific biomarker, but these were two realizations that I saw that there's a lacking and a need for innovation in this field.
[00:10:03] Lindsey Dinneen: Great. Yeah. Okay. So yeah, could you share a little bit more about the biomarker and then how you have found, how you have discovered to affect this and what this device is and how it works?
[00:10:14] Scott Burwell: Yeah, so Neurotype Inc., we were founded in 2019. We were founded after we were participating in this workshop at Yale University called Innovation to Impact. It's funded by the National Institute on Drug Abuse. And we really pitched this idea to them as kind of a off the cuff, last day of the workshop pitch event and won first prize in that thing. And that's really what gave us the steam to go ahead and apply for these federal grants to support further development of this biomarker.
What the biomarker is, basically we put a headset on you and that headset is kind of like a fitness tracker except other than being like a fitness tracker that's tracking your steps from, you know, a watch or, you know, being a glucose monitor that's on your arm, that senses how much blood sugar you have, this fitness tracker is on your head. It measures the electro physiology that's generated by your brain. And it's entirely passive in that regard. We're not putting any like, you know, electrical stimulations in, but it's just measuring how your brain is acting at all moments.
And what we do is that's different from other companies is we're actually recording how your brain responds on a millisecond scale in response to pictures. So we hand somebody an iPad while they're wearing one of these headsets, and we show them a flip book of pictures. Some of those pictures are like chocolate cake, puppy dogs, you know, cute, emotional pictures. Some of those things are boring things like kitchen supplies, office supplies, whatever they might be. And then some of those things are like opioid pill bottle, right?
And so, for opioid use disorder, if you are liable for craving, and if you're likely to start reusing after being discharged from treatment, your response to that opioid pill bottle, the brain response, the objective brain response, is going to be very similar to how it responds to, for instance, chocolate cake, than a person that's not at risk for returning to opioid use or other kinds of craving. And so this biomarker is really a biomarker of what's called 'motivated attention.'
How interesting you find that stimulus on the screen and how much it grabs your attention. And what we know from psychology is that if something grabs your attention, you're likely to behave in a way that is going to correspond with that. So if it grabs your attention, you're going to act a certain way around that stimulus. And so for people with opioid use disorder, it might be that it stimulates some thought process or some behavioral process in your body that leads you to seek that substance, affiliate yourself with people that have that substance, you know, all sorts of indirect ways that eventually lead you to start using that substance again.
And so, we have done a few different research projects funded by the National Institute on Drug Abuse, and these are different projects over time that have really established the core assessment capabilities of the device. And now we're working towards clinical trial validation through a small business innovation research project from National Institute on Drug Abuse that will be a pivotal clinical trial for us.
[00:13:30] Lindsey Dinneen: That's really exciting. When does that happen?
[00:13:32] Scott Burwell: So, that is part of what's called a fast track project, and we are finishing up our phase one portion of that. And the phase two portion will probably start sometime this coming summer. Yeah.
[00:13:45] Lindsey Dinneen: Great. Okay. That's great. And so what is your dream or ultimate ideal goal for the company and for this device? What are you hoping to affect or where are you hoping this device will be used?
[00:13:58] Scott Burwell: Yeah. So, our main goal or our first sort of beachhead market, if you will, is the intensive outpatient treatment clinics for substance use disorders or other mental health. It's a certain kind of clinic where people are seen on a pretty regular basis during early recovery when they're still in a kind of high risk period. And in this group of patients, they tend to be in a scenario where they are living at home or living in the wild, so to speak, it's no longer a residential treatment setting. But they are living and being challenged day to day with the triggers in their environment that, that can lead to risk for problems.
And the interesting thing about this space though, and this market is that in that space, there really are not many regulated, or any regulated devices, that are being used to manage specifically certain symptoms. And especially none that are applying to brain physiology like ours. And so, it's a pretty big step to bring our device to these spaces because they might be familiar with a blood pressure cuff or people might get blood work done from time to measure other health related risks. But for us, we are bringing an EEG system, and it's a portable EEG with a software device, into a clinic where they've never been before.
And so my grand vision for this is really to be, you know, we're not a fix all. We're not a cure-all solution, but we are solution to help one specific slice of somebody's condition, and be a fix for craving in these settings. But if we can get the device in these clinics settings, it opens the door for a whole lot of other biomarker solutions to take place. And so right now, we're just focused on craving, monitoring the craving, but also treating the craving through what's called closed loop biofeedback.
But the but the long term vision for this is to do-- we can additionally build out with the same brain kind of assessment, we can build out other kinds of biomarkers. So, those that are related to genetic risk. So we don't have to do like a full genetic test, but we could use that same brain data to to study what are called endo phenotypes, but basically a genetic marker of risk for a certain disease type or a certain disease progression.
We could also measure other aspects of distress or you know, other depressive symptomatology or things like this with our measures. So, I think if I were to, at minimum, if we were to be able to make a dent or just get our device into these intensive outpatient clinics, that would be a huge success for me and the company. But, I think much grander speaking, it would open the doors for a lot of more transformative addiction treatment care.
[00:16:56] Lindsey Dinneen: Yeah. Yes. Okay. Well, that's incredible and thank you for sharing your vision, 'cause I always love hearing, all right, what's the longterm heart for this company in this project. So that's great. Yeah. Are there any moments that stand out to you, maybe as you're developing this device or maybe even before as you're studying the biomarker and you're thinking through, you know, how can I make a difference in this particular indication? So are there any moments that stand out to you as really affirming to you, "Yes, I am in the right place at the right time. Doing what I'm supposed to be doing."
[00:17:32] Scott Burwell: Yeah, I think one piece was when we won first place at that at the Yale workshop that we did. I would say another was just getting each of these grants. We've applied for grants over and over again. And you don't get every one of those grants. But when you get certain projects, and when you're awarded these monies, it is incredibly validating because, you know it's gone through scientific review at the NIH. You know that also at the specific institute, so National Institute on Drug Abuse or Alcoholism or Mental Health-- they're different -- that this is an intense area that they see value. And so when you get these projects, and we've gotten over a million dollars now in these projects, that there's some validation behind it from federal and also a scientific level.
So that's one area, but then I would also say that, when talking to clinicians, we talked to clinicians and we talked to some patients about the device, and we demo the device and demo the technology with some clinicians and patients. And, people will come back and be like, "Wow, why is this not out there already? Why don't we have this kind of data?"
And to me that is incredibly rewarding to just see people and their immediate responses to the technology, because I don't think anyone really knows that this science or this technology is readily available. It just needs to be packaged in the correct way. And it also has to go through the correct regulatory and reimbursement pass. I mean, to just say "just," I think that's probably an understatement for sure. But, the science has decades of work behind it. And really it's up to us now to move that, to make it to that next milestone, that next goalpost. And that work isn't really science. It's just hard work.
[00:19:14] Lindsey Dinneen: Yeah. Yeah, indeed. Well, speaking of hard work, you know, forming a company on its own, working in the medtech field on its own, all of those things are difficult challenges to choose. And I'm curious, how has your personal path been in terms of growing into this leadership role where you are directing this company and directing people. How's that journey been for you too?
[00:19:43] Scott Burwell: You know, I think it's been a journey. And when people say that you can't do it on your own, that is 100 percent true. And even if you hear it and you believe it, sometimes I think it takes a lot for me to come to the realization to put that into practice. I tried to do a lot on my own. In the team, I am the CTO, the CEO, the COO, all these different roles that I've assigned myself. We participated and were awarded into the-- NIH has this program called Innovation Core, iCore. And we did this program and one of our mentors there was really harping on the idea of leaning into your what are called core competencies. So what are you actually really good at as a team and as a company? And what are you less good at?
And and I think that the more that I've learned to lean into my core competencies, which are really around the science, the translation of the neuroscience, the translation into a clinical tool that can be used, thinking about the vision of our technology. And tried to offload some of the other things, whether it be regulatory or whether it be some aspects of business strategy or other otherwise to, to other people that can help in a fractional sense or whatever to help us out. That's helped me both maintain my role as a leader and keep on doing the work that I think that I can actually contribute to and be useful contributing to, as well as keeping the company afloat in terms of funding and just hitting our milestones on all the different projects that we've been awarded and need to produce for.
So, so I would say that, you know, I'm no, I'm not a perfect leader. I'm not a perfect CEO by any means. But I, but as I go on, I kind of learned that you can't do it all yourself, and you can't accomplish everything to the same degree as another person possibly could. And so trying to build good teams, trying to lean on team members that can do certain things, finding the strengths in certain team members and asking them to do the right kind of work given their skill set. But I think that's been a crash course for me.
[00:22:00] Lindsey Dinneen: Yes, indeed. Well, that makes complete sense because, you know, like you said at the very beginning, it is a journey, and it is a constant learning and growing process. So yeah, that's, that's fantastic. 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 field. It doesn't have to be. What would you choose to teach and why?
[00:22:29] Scott Burwell: Oh my gosh. Well, You know, I think that-- I'm not sure anyone would offer me a million dollars for this. But if I had the time, I think If I had the time, I would actually really love to teach a masterclass on how to do this sort of neuroscience innovations. There's a lot. This is a really hot area for startups and innovations, the idea of using neuroscience tools as products. There are companies out there like the Muse headband or there's Nurable, which makes these smart sort of headphones that also measure brainwaves. Neurocity is another company that's doing things for productivity. And I know people at these companies. They're all great companies. And these are some very successful examples.
But there's other companies out there too that, that are doing things that I feel are led by engineering first. So, just because you can do something, it doesn't mean that you should do something. And it doesn't mean that there's any validity to what it is that you're doing. So, you know, there's a lot of interest in that. Around developing brain computer interfaces or other kinds of neurological or brain diagnostic or treatment devices. They're doing brain stimulation or brain sensing or biofeedback or all these sorts of buzzwords.
I think we're kind of part of that group, honestly, but the difference between us and the others is that we are science led and a lot of these other companies are engineering or technology led. And when you lead through something, when you start by innovating by technology and innovating by engineering, that's great from a perspective of showing others that you have a tool. But without a use for that tool, and without evidence from science that tool actually does something useful, then it's kind of useless. And so a lot of those companies go broke because they don't have a user for that tool or the tool that they built doesn't actually do what they intended it to do.
So one thing that I think I would do in this course, if I were to do this course, is to really emphasize like, here's how you can approach certain kinds of biomarkers. Here's the types of biomarkers that people actually think is correlate with a disease, major depression, ADHD, substance use disorders, whatever it is, and actually have a scientific grounding versus building a headset that does XYZ first and not really having a scientific basis.
One, one tip I would just offer people is just get a PhD that has the background in that content space first on your team, because they will tell you what the field thinks of it. And a lot of times, the field thinks that a lot of the products that are being developed out there are just snake oil. And so, so really, you know, do your diligence on the science before diving into something.
[00:25:27] Lindsey Dinneen: Cool. Yes. I'm sure that would be a fantastic masterclass and very needed. So, all right. Sounds good. All right. And how do you wish to be remembered after you leave this world?
[00:25:40] Scott Burwell: Great question. You know, I would love, like I mentioned earlier, for Neurotype to play its part in establishing these kinds of brain biomarkers in the treatment for behavioral and mental health disorders. I would love for us to be a building block for what the future looks like. I think we're using the most current science available to build our innovation. And if we can be sort of that first step into the future, I think that would be so great. And the science will change in the future, but I think that if we can be that stepping stone, that would be ideal.
I think on a more personal level, I think I would love for anyone I know, anyone that I come into contact though with, I really want to be remembered as a person that's just been kind to you. If you can remember one moment that that you felt like, "Oh, Scott made me feel good in that scenario" or "Scott was helpful in that scenario." I think that would be a more realistic grab or a closer term grab. So, so, you know, both those things I think would be great. But in the day to day, I really work to at least hope that people remember me and felt that I was kind to them.
[00:26:48] Lindsey Dinneen: Yeah, absolutely. Kindness makes all the difference. Yeah! Okay, and then, final question. What is one thing that makes you smile every time you see or think about it?
[00:27:00] Scott Burwell: Oh, geez. I think, you know, Is it is it okay to say cute animal memes from Twitter or something? But so...
[00:27:08] Lindsey Dinneen: Sure!
[00:27:09] Scott Burwell: I love cute animals. I love any cute animal or cute baby thing on Instagram or wherever. But I will also just say, back to the impact aspect of our company, we do research with people. We do early demo testing with people with substance use disorders. And some people struggle, they're in and out of treatment programs five, six times before something really starts to click. And they put in so much hard work and so much effort to keep on their pathway, unique pathway to recovery.
And so, you know, I think that I'm really encouraged and really puts gas in my tank when I see people that are doing well and that they're happy. And because there's some degree of pride that person carries around and some, and and maybe that pride was not necessarily there beforehand. And so, you know, I think that I will, regardless if they are achieving their goals and living a happier life because of what Neurotype is doing, or something else, really doesn't matter to me.
When I see people that are doing better, it is warming to my heart to see somebody that has made some sort of sustained change in their life that is impacting them in a positive way, because it really does show that people can change. People can do what they want to do and live the life that they want to live in many cases when they. are given the opportunity. And so that's heartwarming to me.
[00:28:38] Lindsey Dinneen: Absolutely, yeah, absolutely. Ah, that's wonderful. Well, yes, and also, awesome little cute memes are the best, especially with animals, oh my gosh.
[00:28:48] Scott Burwell: I know. Yeah.
[00:28:49] Lindsey Dinneen: I spend way too much time looking at baby animals, but I always smile, so, you know, win.
[00:28:54] Scott Burwell: Yes, it is. It's the main, it's the main way I get my little like boosts of dopamine throughout the day for sure.
[00:29:00] Lindsey Dinneen: Yes, absolutely. Well, Scott, this has been a fantastic conversation. I so appreciate you joining me and sharing more about the work that your company is doing and all the innovation. I'm so excited to watch it continue to succeed. So thank you for spending some time with me today. I appreciate it.
[00:29:18] Scott Burwell: Absolutely. Thank you, Lindsey. Thank you.
[00:29:20] 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. 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, and we will catch you next time.
[00:30:02] 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. ​

Isabella Schmitt | AI & Regulatory Affairs Leader | Strategic Communication, Navigating Pre-Subs, & the Power of Mentorship

Isabella Schmitt is a prominent life science, AI, and regulatory affairs leader, and was recently named one of the top 100 MedTech Leading Voices Worth Following on LinkedIn in 2025. Isabella shares her diverse career journey—from aspirations of neurosurgery to becoming a regulatory expert in MedTech and biotech. She emphasizes the importance of early regulatory involvement, strategic use of pre-submissions, and understanding the voice of the customer in product development. Isabella also discusses the critical role of communication skills in regulatory affairs and offers invaluable advice for aspiring professionals.
 
Guest links: https://www.linkedin.com/in/isabella-j-schmitt/
Charity supported: Polaris Project
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 048 - Isabella Schmitt
[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 so excited to introduce you to my guest, Isabella Schmitt. Isabella is a life science, artificial intelligence and regulatory affairs leader with expertise in navigating the intersection of science, technology, policy, and innovation.
With a robust background in medtech and biotech regulations, she has contributed to over 200 projects ranging from hardware and software medical devices to AIML products. Isabella holds an MBA from Texas A& M and is pursuing advanced studies in AI management and policy at Purdue University. Known for her engaging communication style, she is a sought after speaker, author, and consultant on AI regulation and innovation.
All right. Well, welcome to the show, Isabella. I'm so excited that you're here.
[00:01:41] Isabella Schmitt: I'm excited to be here. I feel like it's been a long time coming as we just talked about a second ago. We've been needing to connect for a while so I'm glad we're finally getting to do it.
[00:01:50] Lindsey Dinneen: Me too! Well yes. Thank you for taking some time today. And I wonder if you would be willing to start off by sharing a little bit about yourself, your background and actually what led you to medtech.
[00:02:00] Isabella Schmitt: Yeah. So it's an interesting story because I actually have a pretty varied background in general. Like if we start back, back in high school, even so we'll go that far back, I wanted to be a neurosurgeon originally in life, and... well, originally I wanted to be marine biologist, but that was when I was in elementary school. No, I wanted to be a neurosurgeon probably from the time I was like, 14 to like, 21. And then I did a surgical externship and I didn't love it. And so then I had a quarter life crisis where I was just like, "What do I do? This is what I've wanted to do for so long."
And then I found myself going into research, so I did a lot of lab work in primarily healthcare type things. So, with nanomaterials for oncology, you know, specific targeting of tumors and things like that. But then I found with that, I liked the design of the experiments and like the design of new inventions and all of that, but I didn't actually enjoy the lab work. So like the actual part of being a researcher was not fun for me.
And so, I shifted gears, had a little kind of a stray off of the, this normal trajectory, I guess. And I was like, "Oh, well, maybe I want to do veterinary medicine." I love animals, so I did that for a little bit. And then I felt like there was always this drive for me to do something that felt good, aligned with my values, right? But was also intellectually stimulating so that I felt like I was constantly challenged. There was something new. It was very diverse. A little bit of ADHD there, right? So like I need, I need lots of inputs and stimuli. And so I, with veterinary medicine, I felt like I really liked this. It was ticking the sort of values box, but it wasn't really ticking the other boxes for me.
And so then I kind of went back and was like, "Well, maybe I want to go to medical school. I'll revisit that." So I took a job at a pharma company, a midsize biopharma company. And I started off in the clinical research side. I didn't know anything about the industry at this point, 'cause they don't really teach you anything about biopharma or medtech in school. I don't even know what I thought about how products like drugs and devices got to market. I just kind of assumed someone was checking over that, I guess. And so I had no idea and I took the job thinking it was more truly clinical related. Like, I was going to be, I don't know what I thought I was going to be doing, but something clinical, and it was, it was a CRA position.
But what they noticed about me, was that I started trying to analyze the patient data and I unblinded myself in doing that. And so they were like, okay, well, maybe you need to do something that's a little bit, not that there's, you know, that being a CRA is not intellectually stimulating, but not in alignment with exactly where I was. And so they put me towards regulatory affairs. And so I started helping kind of just general regulatory affairs. Then the guy that was running the product side of things, all the manufacturers and getting the product ready, was retiring. And so they promoted me to that position.
And so what was happening at that time was I was getting intellectually stimulated. I was doing well. It had the diversity that I liked where it was ticking the altruistic box and helping people and it's, you know, scientific, it's medical, it's writing, it's reading, it's understanding. And so it was kind of scratching that itch for me, so I didn't go back to school. I well, actually I did, but that's later down the line. But I, I stayed there.
That company got bought by Allergan and I left at that point and I went to a medtech startup company and that was my first foray into medtech. So I moved from biotech to medtech. And, you know, some of those things can translate, right? The cultures between biotech and medtech are very different, but a lot of the foundational knowledge of how you think about things can translate. So at that company, I learned more about medtech, but I could apply the biotech lens to it, which I think ultimately helped me from a strategic standpoint in the medtech world.
And then I left that company and I started at Proxima, which was the company where I first met you. And I was like employee four there, and I ultimately built their regulatory consulting group and that whole kind of department from me to 15 people and over 200 projects. Loved working there. I did a lot of talking, BD, consulting, all kinds of things. I then started running their clinical department as well, and then I left Proxima and now I work at a AIML company as their VP of clinical and regulatory. So I manage all of their suite of products for global submissions and kind of all the clinical collaborations that are ongoing there.
There's a long background, but it's a trajectory and I feel like people feel like they need to know what they're going to do at some point, like early on. And when you go to college, you're like 18, you don't know, and you barely know about what's out there, right? But you feel like 'I should know the answers to all of these things,' and you don't. And sometimes you find yourself in places that you didn't really expect and I know that a lot of people also want to get into regulatory affairs, and it is difficult sometimes to get your foot in the door. It's a competitive type of role largely because it, it is so diverse and stimulating and you have to have a lot of different types of skills to actually be successful in it.
But, you know, what I would suggest people do is look for smaller companies to kind of go towards, because those are the types of companies that'll maybe take a chance on you with leadership that helps and guides you through that transition. So when I was running Proxima, I like to hire people kind of earlier in their career because one reason was selfish. You don't have to reteach or get them out of bad habits, right? And then the other part was I just liked kind of, I liked the, the helping and the molding and the growing of them. And it's really nice to see them be successful there or afterwards as they move on into other places. And we have lifelong relationships now. You know, I've left and I still talk to them and they still come and they ask me for advice about things. And so that's really nice.
[00:08:42] Lindsey Dinneen: Yeah, that's incredible.,Well, first of all, thank you for sharing a little bit about your background. That was really cool to hear about your career trajectory and so many things popped up for, for me right away. But one of the things that really stood out was this idea-- I love how you talked about the fact that you don't have to know at the very beginning of your career or really, I don't know, even in the middle of it, is this what I'm going to do for the rest of my life?
I mean, it's okay to kind of. stumble into a path you didn't expect and see where it leads you. And, I'm curious too, you know, you've had such an interesting, diverse background and you've had all of these different skill sets. So when you first started, I know throughout different places you've been, you've done a lot of business development, but can you share a little bit about the skillsets and the things that you've learned through business development that actually really do translate to... Yeah.
[00:09:35] Isabella Schmitt: So, so business development is... so weirdly I had this sort of side thing where I was doing marketing work kind of just as like a side hustle for a bit. And so at Proxima, I really helped with market. So, business development and marketing, particularly for the consulting side of things reported into me as well. So I did a lot of that work, and I think in those cases, business development and marketing, if you're good at it, is all about communication, right? Like, it is about communicating effectively with other human beings, whether that's through talking to them or through writing. And understanding the audience that you're talking to, whether it's talking to them or through writing.
So, you know, in a conversation, you get good at reading people, right? Like you can kind of hear what they're saying and you start to learn like, okay, this is their pain point. They're saying this one thing, but what I'm getting from it is this other thing that I know a little bit more about that they're not necessarily picking up on. And so you, you start to be able to take on more of an advisory role, I think? There's different approaches to sales and marketing, right? There's the hard sales approach where it's like sell, sell, sell, which is, there's nothing wrong with that. It's just not my approach to business development and marketing. Mine is much more advise, educate, relationship. What is it that you actually need? How can I meet your needs?
And I think that skill set translates really well into regulatory affairs. There's different types of ways you can be involved in regulatory affairs. If you're doing high level strategy type things, you need to have these communication skills. You need to be able to see the forest and the trees and be able to redesign a forest if you need to. But there's also the very by the book administrative side of regulatory affairs where I think these skills probably aren't as necessary and there's nothing wrong with that. Some people really like that sort of structure.
I'm not that way. So I really like the strategy communication talking aspects of it. And I think the business development and marketing, the crux of it all is the communication aspect. And that is incredibly important when you're pulling together regulatory submissions, and you're engaging with regulators, you need to understand your stakeholder there, who you're talking to, the audience, what they're interested in what they're not interested in and be able to read that in that instance as well because you want to give them enough information, but not too much information about what it is that they need to understand in order to clear or approve your product.
For the people that I would bring in, you know, when they were early in their career, I think them being in a more of a consultative environment was probably beneficial to them in the long term because they had to learn those skills in the context of engaging with clients, right? And so we would do different things, you know, as they were training, I would be on the calls with them, but sometimes we'd do sort of like the mic in the ear thing, but through Teams, I would send them messages like, 'say this, ask them that.'
And then I would explain, you know, or if I said something that seemed unexpected, you know, like that was a different direction from the conversation or they expected me to respond to something that I didn't respond to, I would explain it to them afterwards so that they could learn and kind of absorb those skill sets so that they could then take that forward and apply it whether it's with clients or with regulators, or just with teammates, whomever it is moving forward, they would understand the communication aspect is so incredibly important in the strategic side of regulatory affairs.
[00:13:38] Lindsey Dinneen: Yeah. Yeah. Yes. Thank you for, for sharing more about that. I can absolutely see the critical importance of the communication skills, being able to translate, but, but building those skills. And honestly, it's probably just great advice across the board. You know, anyone, especially young in their career. Those are the skills to build.
[00:13:57] Isabella Schmitt: Yeah.
[00:13:58] Lindsey Dinneen: Yeah.
[00:13:59] Isabella Schmitt: Yeah.
[00:14:00] Lindsey Dinneen: So.
[00:14:01] Isabella Schmitt: Nothing, nothing better than relationship building and communicate and clear communication in your personal life, in your professional life, everywhere. So, yeah. And I think, you know, it's interesting too because there are things about my childhood and growing up that also translated into having a skill set associated with communication and understanding people and dynamics that was like a long term training, you know, from being a little kid to now, which maybe not everybody gets and that's okay, but they can learn it. It's something that, it's learned. It's not innate. You can learn it at any point if you're willing.
[00:14:48] Lindsey Dinneen: Yeah, I, I love that. So, you know, okay, so now you've had all this incredible experience. You've helped a lot of companies and, you know, regulatory affairs is your jam. What kinds of things do you see that are kind of common, perhaps stumbling blocks for, especially smaller medtech companies that are trying this for the first time and this is their big hurrah and it's really exciting, but what are some things that you see that, that maybe we could help mitigate?
[00:15:16] Isabella Schmitt: Mm. Yeah, I think the first things that come to mind and it's kind of like two opposing flavors. One, is... and they're both around pre-subs, right? So pre-subs are the big talking point, I think, all the time, and you will often hear people say like 'just do a pre-sub 100 percent of the time.' I think generally, that's true. There are cases where you don't necessarily need to do a pre sub. But as you go into a pre sub, it's again about communication. You want to make sure that you're not saying something that you can't get yourself out of in the future.
So, like, you know, oversharing or oversharing erroneously too. You can share things that maybe are not particularly relevant to what you need to convey but then can cause a flag that sticks in the minds of the reviewers. So you want to go to a pre sub typically with someone who has done them before successfully, and you probably want to find, if you're an innovative company that's doing this for the first time, someone who works with innovative companies a good bit more on the strategy side, even if they're not the one that's writing the pre sub, but that it is overseeing the sort of process with it.
Like I said, there's, there's a very administrative side to regulatory affairs too, and there are people who can turn, turn, turn submissions out and that's great. But when you're dealing with an innovative type product, that sort of administrative part of it== it's still important, but it becomes less important-- because you're basically navigating a new landscape and you need someone who has done it before, who can kind of understand how the regulators, whether it's FDA or notified body might think about it so that you can convey the information adequately or answer their questions adequately too.
The flip side of it is... so do a pre sub, but do it smartly. The flip side of that is don't do too many pre subs. So one of my friends in the industry and I were just talking recently about ' death by pre sub,' where you do so many pre subs that you've kind of painted yourself into this corner and you maybe don't want to be in that corner and you have to figure out a way to kind of claw yourself out of it. It, it can become very restrictive. So if you go, you know, if you're on pre sub eight, you're probably too far, too far or too deep in at that point. So you want to be smart about the pre-subs and generally speaking, I think that was the first comment, death by pre-subs is usually if you're not being smart about the pre-subs.
And then I think people go in maybe without a pre-subs at all thinking that, "Oh, I have a 510 K. It's straightforward." Maybe they're using a predicate. If your predicate's really old, they may have changed their thinking on it, so you probably still want to do a pre-sub even if it seems straightforward. Those are the things that I think are are probably major pitfalls.
I'd also say companies not involving someone with regulatory expertise early enough on, so even if you're not engaging with FDA, companies can get kind of stuck in a perpetual loop of product changing and advancement to the point that is detrimental and that a lot of that doesn't actually help in the long run, from a regulatory standpoint, understand your minimal viable product. And then from there, once you understand what that is, right, then you should really start engaging someone who has regulatory expertise. Or maybe you need someone to help you figure out what the minimal viable product is through, you know, some sort of regulatory lens as well. But I wouldn't spend 10 years going through design iterations and all of that before you get someone in to level set with where you are from a regulatory standpoint,
[00:19:31] Lindsey Dinneen: Mm hmm.
[00:19:32] Isabella Schmitt: And then I think shifting a little bit from regulatory, also involving regulatory and clinical, is understanding the voice of the customer. You design a product, you kind of want to design a product that people want and will use, because you can get through regulatory right? But if nobody wants that product, you've wasted years developing it, and a lot of money, and so getting with whoever the, the end user is going to be and understanding what their actual needs are and having them kind of look and touch and feel the product is, I think, incredibly important, even in the earliest stages, because you don't want to spin your wheels, designing something that nobody ultimately wants or can use.
[00:20:19] Lindsey Dinneen: Yeah, absolutely. So design with the end user in mind, talk to the end user in mind, and then talk to an expert such as yourself to really help guide you through that regulatory process. And it sounds like the earlier the better just to start that process going so you have an idea of where you need to head.
[00:20:39] Isabella Schmitt: Exactly, yeah. That's exactly right. Yeah.
[00:20:41] Lindsey Dinneen: Yeah, excellent. So, you know, you have had such a very cool diverse background and, you know, you've been honored a lot. You're, you know, a Houston Woman to Watch. You have gotten a business award, multiple ones. You just recently got named to MedTech Leading Voices, you know, 100 MedTech Leading Voices. That was really cool. So congratulations.
[00:21:02] Isabella Schmitt: LinkedIn's been blowing up from that. I was like, yeah,
[00:21:06] Lindsey Dinneen: That's awesome. Yeah.
[00:21:07] Isabella Schmitt: I haven't looked at it on my own LinkedIn yet. And it's, I opened it today. I wasn't on it all weekend and I had like 50...
[00:21:14] Lindsey Dinneen: Oh!
[00:21:14] Isabella Schmitt: ...requests. I was like, what? So yeah.
[00:21:17] Lindsey Dinneen: Amazing. Well, congratulations! That's really exciting!
[00:21:21] Isabella Schmitt: Yeah.
[00:21:21] Lindsey Dinneen: You know, like, just looking back, could 10 year old Isabella have ever anticipated this is where you would be right now?
[00:21:29] Isabella Schmitt: No. Well, you know, not exactly, but I was Student of the Year when I was 10, so maybe that was an early hint, I guess.
[00:21:42] Lindsey Dinneen: I love it.
[00:21:43] Isabella Schmitt: Yeah.
[00:21:44] Lindsey Dinneen: Yeah.
[00:21:45] Isabella Schmitt: Yeah, 10 year old Isabella I don't know. 10 was a weird age.
[00:21:51] Lindsey Dinneen: Yeah. Fair enough. Fair enough.
[00:21:54] Isabella Schmitt: I definitely wouldn't have seen myself in this industry and even, you know, 18 year old Isabella wouldn't have seen myself, because I didn't know it existed,
[00:22:03] Lindsey Dinneen: Right.
[00:22:04] Isabella Schmitt: But, you know, being highly on the business side of things too, because regulatory is very deeply integrated with all should be with all aspects of a product, right? And so I have to understand the voice of customer and I have to understand if there's a market for this and I have to understand the engineering and be able to translate all that information and, you know, and then on the other side of it with Proxima, I built the actual business. So, you know, I had to design pricing strategy and marketing stuff.
And so I never really saw myself being so heavily involved in the business world and that may have like honestly come from, not to get all political or whatever, but like a lens of sort of my vision of business person was male, you know, and so I just didn't have a lot of exposure to women in, in business roles and I don't, I don't think I ever had imposter syndrome because I always felt pretty confident in my abilities. I felt more like the world of business was male dominated, which it largely probably still is. But, but I think that kind of maybe held me from having that vision. And I mean, surgeons are male dominated too, but I was thinking I was going to be a surgeon. So, so, but I also had a vision of the business world as being more like Wall Street kind of world.
And you grow up, you know, and you learn new things and get exposed to new people. I'm very thankful for the people that I have met who have given me opportunities to, to shine, I guess who have trusted me, like Kevin with Proxima trusted me to build the department. The company that I work for now basically trusts me to do all the regulatory stuff. Obviously, hundreds of clients have trusted me with their regulatory, with their babies.
So it's one of those things where it's a combination of your own aptitude, but also other people. And, and I think for me, and that's why I wanted to also bring in, you know, green people who are coming new into the industry, to give those people opportunities to live up to their potential too, because a lot of it is having the opportunity and having someone trust you in order to, to show what you can do or can't do, I guess, but you learn either way, right? Failures are learning opportunities too. So.
[00:24:40] Lindsey Dinneen: Yeah. Well, I love that because you, you saw people, you know, 'cause sometimes it feels, especially as a job seeker, if you're young, or you don't have the industry experience, it just feels so invisible. So I love the fact that you were willing to do that. And then mentorship sounds like a really strong pull for you. Like, you very much care about that and helping the next generation of folks...
[00:25:02] Isabella Schmitt: Yeah, yeah.
[00:25:02] Lindsey Dinneen: ...find their footing too. So I love that.
[00:25:05] Isabella Schmitt: I, I love doing that. And I was teaching at Rice. I would teach a lecture a semester at Rice when I was at Proxima, maybe I'm going to do it now, I don't know. And then A&M a little bit too, and so even just kind of meeting students, I just, I like to give people opportunities, so if people are listening to this and they want to understand how to get into regulatory affairs or really anything, I am happy to have a conversation. Lindsey will tell you that I might reschedule it, but I will have the conversation.
[00:25:40] Lindsey Dinneen: I can attest to this. She will, she will. Absolutely.
[00:25:43] Isabella Schmitt: I do want to do it. It's just, yeah.
[00:25:49] Lindsey Dinneen: MedTech has become sort of, at least it sounds like your calling, for lack of a better word. And so I'm curious, you know, you are obviously very passionate. You are one of the leading voices in the industry. You are a thought leader. Along the way have there been moments where you just thought, "Wow, this really cinches it for me. I am in the right place at the right time doing the right thing."
[00:26:11] Isabella Schmitt: I mean, I think, in general, I feel that way. I, I'm the type of person who, though, is kind of always looking to grow and advance and more and more and more. And so I think it's, it's always kind of a learning experience. I think I will stay in this industry till I die, but for for a long time and it kind of just like, it clicks in my brain. Like, it just, it sort of makes sense with how my brain works.
But, you know, I have also expanded a little bit into AI kind of generally speaking as well. So, I work at an AI company now and I've worked with many AI products before. But I also am in a master's for AI, and I've been doing some policy work with it. So I, I try to, I try to go deep and broad at the same time, which I think is hard and maybe tends towards workaholism, workaholicism? But, but it keeps me stimulated and feeling like I'm productive and moving forward. And so, you know, I, I guess, to answer your question succinctly, I do think I've found a place that I really love.
I think that I will continuously look to expand and grow, just how I am, whether that's in specific with regulatory affairs or whether it's spinning off another consulting company or whatever, you know, my own product company one day, whatever it might be. I think this space is what I like. And I, I like growth personally, and I like growing people and I like growing businesses.
So I think all of that, I guess if there was a moment, honestly, Proxima. My experience at Proxima with growing, growing there, myself, the company, clients, employees, marketing, whatever it was that, that probably sealed the deal for me staying and not kind of looking to do something else. There was a short stint where I was very confused again before I started at Proxima. I was like, "I don't know if this is right for me."
I was thinking about leaving the industry and going and doing psychology and all of that. And, I got the job at Proxima, it just kind of checked everything for me. And so I think that, that, you know, if you're a person that likes a lot of diversity, I think getting into a strategic regulatory affairs role, particularly if you're able to work with multiple companies is, is the sweet spot. But yeah, that was one of the best places I've ever worked, one of the best experiences I've ever had.
[00:29:02] Lindsey Dinneen: That's incredible. Well, great. I'm so glad and thank you for sharing about that experience. Yeah, that's wonderful. So, okay, pivoting the conversation a little bit 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, doesn't have to be at all. What would you teach?
[00:29:21] Isabella Schmitt: would I would probably teach AI policy with specific towards regulated industries. So meaning, obviously, medtech, biotech to o, aviation, aerospace defense. So I kind of want to take it, sort of a broad approach, of how we think about regulatory with regards to AI, and the differences in regulating that type of product versus more standard types of products. So, that would probably be what I would would like to do if I were teaching a master course.
[00:30:06] Lindsey Dinneen: That sounds incredible and very needed, very timely.
[00:30:10] Isabella Schmitt: Yeah,
[00:30:11] Lindsey Dinneen: Yeah. Excellent. How do you wish to be remembered after you leave this world?
[00:30:18] Isabella Schmitt: That's a big question. So, and it's a tough question. I want to have made an impact on the industry, on people's lives, on an industry because, you know, with AI, it could be multiple industries, I guess, too. Probably sticking closely with medtech. It's what I like, and it feels like the best again, like value kind of.
I think if I were to like make up this dream scenario of where I ended up, eventually I would have my own product company. I would sell that off. I would probably start another consulting company that I helped people with still. And then I would do like philanthropic things with money. And largely focused probably on pediatric type devices, rare diseases and conditions, and probably veterinary medicine, which those areas I don't think get enough attention.
I have a lot of experience with with pediatrics in particular and I think I would like to be able to work closely with getting more of those products to market. They're, you know, difficult funding opportunities there because such a small, still large burden, but such a small group of patients that the ROI is not typical of what you would see, you know, a lot of VCs investing in. So something like that, I think, and being remembered for those, those things, I think, would be great to me.
[00:31:50] Lindsey Dinneen: Yeah.
[00:31:51] Isabella Schmitt: Also, if I influenced policy in some kind of way that was fundamental, I think that would be pretty cool too.
[00:31:57] Lindsey Dinneen: Absolutely. Yeah. Very cool. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:32:06] Isabella Schmitt: Oh, that's a good question. Not work related or work related?
[00:32:10] Lindsey Dinneen: Oh, both, either.
[00:32:12] Isabella Schmitt: I, probably my dogs would be, that's an easy not work related answer, although sometimes they drive me nuts too. So there's a spectrum of emotion with them, but generally dogs. Dogs are just the best. I'm, I'm a dog person. They're just so loving and understanding.
Work wise, obviously, anytime I have a successful submission, or there's an exit, any success, it always makes me smile. So, and then, you know, I also really like-- I haven't been to many over the last year, just with the change and the dynamics of my world-- I love networking events. So, like, thinking about networking events, I just, I really enjoy those types of interactions. They've always been really fun. I've been thinking about going to them just for fun, just to see people again because it's been a while.
And I used to love, like, my favorite thing was Medtech Innovator. So I'm answering this question, and I'm thinking of the answers I'm talking about. So MedTech Innovator, I love MedTech Innovator. It was almost like when you're a kid, and you go, and you have the summer off, and you don't see anybody or any of your friends, and then you go back to school, and you're sort of excited to see them again. That's what that community felt like, really to know the people there so well. So MedTech Innovator, that's my answer.
[00:33:35] Lindsey Dinneen: I love it. Great answer. Great answer. Fantastic. Well, oh my word, this has been so much fun. Thank you so much for taking some time today just to share with me about your life and your experience and all the wonderful things that you're bringing to the world. I just really appreciate it. And, just thank you for your time.
[00:33:56] Isabella Schmitt: 'Course, thanks for having me.
[00:33:58] Lindsey Dinneen: Yeah, 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 I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks to our listeners for tuning in. And if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.
[00:34:36] 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.

Steven Collens | CEO, MATTER | Accelerating Medtech Innovation with Collaboration & Entrepreneur Ecosystems

Steven Collens, CEO of MATTER, an incubator & innovation hub, discusses his journey and the impactful work MATTER does in healthcare innovation. Steven shares his transition from Abbott Labs and Capitol Hill to leading MATTER, emphasizing the importance of collaboration in accelerating healthcare advancements. He provides insights on how MATTER supports both startups and large companies and also reflects on personal moments that confirm his career path and the strengths that help him lead in the industry.
Guest links: https://matter.health  
Charity supported: Innovation Development Institute
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 047 - Steven Collens
[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 delighted to introduce you to my guest, Steven Collens. Steven is the CEO of MATTER, the premier healthcare incubator and innovation hub. MATTER opened in February 2015 and nurtures entrepreneurs and innovators building next generation health IT, medical device, diagnostic, and biopharma technologies. MATTER has worked with more than a thousand healthcare technology ventures and the company partners with dozens of industry leading companies, health systems, and universities.
Steven holds an MBA from Northwestern University's Kellogg School of Management and a BA from Washington University in St. Louis. He chairs the board of Hubbard Street Dance Chicago and serves on the boards of 1871 and the Chicago High School for the Arts. He is a member of Chicago Next, the Chicago Mayor's Council of Technology and Innovation, a Leadership Greater Chicago Fellow, and a member of the Economic Club of Chicago and the Commercial Club of Chicago.
Well, thank you so much for joining us, Steven. I'm so excited to be here talking with you today.
[00:01:57] Steven Collens: It's a pleasure to be here. Thanks for having me.
[00:01:59] Lindsey Dinneen: Of course! Well, I would love if you would start off by sharing a little bit about yourself, your background, and maybe what led you to MedTech.
[00:02:09] Steven Collens: So myself, I guess it's all intertwined together, so after business school, I went to work at Abbott and I was at Abbott labs for about 10 years. That was my introduction into healthcare and medical technologies of any sort. And after that, I went to work at an investment firm. On behalf of them, started an incubator that was not focused on healthcare, and then had the opportunity to do what ultimately became MATTER, which was starting something that could really help accelerate the pace of change of healthcare and figuring out how to combine elements and do that.
And our basic thesis at MATTER is that collaboration is the way to accelerate the pace of change of health care. And so MATTER is structured as a not for profit entity. We functionally incubate startup companies. They are different types of technology. It's primarily software and devices. They're all over the world. It's a membership model and we've got a suite of resources to help them at different stages of growth.
And then on the other side of it, we work with big companies, so big life sciences companies, health systems, insurance companies, and we help them innovate more effectively. We help them collaborate with entrepreneurs. We help them harness innovation in ways that they're otherwise not necessarily wired to do. And by putting all of that together you know, almost 10 years in, we like to think and certainly hope that we're helping make a change in healthcare.
[00:03:40] Lindsey Dinneen: Yeah, I know you are and I know that by your mission and the way that you go about your organization, and it's very exciting to see how the companies that have come through the program have continued to thrive. And I was wondering if any of those, particularly companies that you've worked with, really stand out to you in terms of making a huge difference in the way that you could come alongside them and work with them to make that difference.
[00:04:09] Steven Collens: Yes, for sure. There are companies where people come in and they come from the healthcare industry and they know a lot, and the ways that we help them are different than companies where the entrepreneurs come in and they're not necessarily from the industry. And we love working with all of them. We will work with entrepreneurs, but we don't have anywhere near the level of screening that a venture capital firm would do, where it's a more of a democratized approach. We look for companies that are trying to solve something that's meaningful in healthcare. So if they are successful, they will help advance healthcare in a direction that's meaningful.
We look for entrepreneurs and teams that give us some reason to believe they can be successful. Could be prior success, it could be that we're just so impressed by how smart they are. It could be their passion. It could be some combination of a variety of things. It could be somebody else has invested in them already. And like, "Well, we know they did a lot of diligence." And then the only other criteria is like people we want to work with and be around and that are going to increase the general level of joy and happiness in our environment.
And so, there's one guy who met his co founder at MATTER. He's more of the business guy. The co founder was more of the inventor, scientist guy and, you know, it's an example of a company that's solving one of these problems that if you're not in healthcare, you just sort of scratch your head as to, which in healthcare, there's like an endless number of these problems where if you look at it with a more rational lens or from an outside perspective, you're like, "Huh, that's how healthcare works? I don't, that's so strange."
It's a device for when a surgeon is putting screws into a bone, the way that they need like a, some sort of a depth gauge to determine what size screw to use. And it's like a reusable thing that they all use. It's totally analog. It's not a sophisticated piece of technology. They learn how to use it when they're doing their training and they just keep using it. And obviously they wash it and sterilize it, but you know, it's not ideal for a lot of reasons.
And so this company developed a digital and disposable version that is more accurate, more sanitary, obviously, you know, we don't always want to advocate for things that are disposable versus reusable, but in this case, having this combination of accuracy and not dealing with any issues around sterilization and cleanliness, is a big improvement.
And, it's a medical device, took a couple of years to develop. Again, he met his co founder at MATTER. He met a lot of other people who provided different guidance and advice and support and financing through MATTER. And so now the products in market and doing great, and they're working on other other products. So that's one of the companies that, that pops to mind. I mean, I, we could use up the entire time talking about different companies, but I'll pause there.
[00:07:27] Lindsey Dinneen: Yeah, I'm sure that we could. So, at the beginning, you talked about collaboration and how that can be the key to success for these companies that you're working with. And I'm wondering, I feel very strongly that collaboration is the key in so many ways to amplify success, and even to get to a point of success, because we don't know everything ourselves, but how do you get past-- and or help up maybe some of the companies that you work with-- get past sometimes a more competitive mindset where it's hard because you're very protective of your IP, you're very protective of your process and your business. So how do you help companies understand the value of collaboration and what we can do together to rise together?
[00:08:11] Steven Collens: I think it's such an interesting question, and I'll take you all the way back to when we first were creating MATTER. And so I had just recently built this other incubator, not focused on healthcare, more like web mobile tech stuff at the time. And I was working with the same architecture firm and real estate people. And one of the things that we were trying to figure out, because we knew it needed to be different, for that because healthcare is different. It's a different set of people. It's different archetypes. In some cases, it's even different motivations. It's just, it's a different milieu.
And one of the things that we spent a lot of time trying to figure out was, IP is so much more important when you're dealing with medtech as compared to your average software company, which is more about speed of execution. And I mean, it's about a lot of things, but it's, in the early days of most software companies, IP isn't top of mind. Whereas in the early days of most medtech companies, IP is top of mind. And how is that going to work? Are people going to be collaborative?
And so we spent a lot of time, we talked to lots of people, tried to figure out how to deal, it turns out it like doesn't even matter. For 95 percent of the entrepreneurs out there, obviously they care about their IP, but there's collaboration in two veins. One is, other entrepreneurs are not doing the exact same thing. They're almost never directly competitive. Knock on wood, we've supported a thousand companies who've been around for 10 years, and we have not had one entrepreneur steal another entrepreneur's technology and try to run with it. God forbid that we land in that stage.
The more complicated question is in dealing with the large players in the industry. And so on that dimension, some of the entrepreneurs are reasonably a little bit careful. Our basic thesis is that if you are building a new technology that you're trying to put into the healthcare system, you need to know more than you probably think that you need to know about how that system works, how things get paid for workflow solutions, decision making processes. It's just, there's so many areas of healthcare. Even if you've been in healthcare, unless you're just exactly in the space that you know inside out and backwards and forwards, there are so many areas and aspects of healthcare that are not intuitive, that frankly, if you were coming up with a design system, you'd never design something that way, because this doesn't make a lot of sense. But that's how it works. And you need to understand all of that if you're an entrepreneur in order to be successful.
And so, one of the ways that we help with that, we've got lots of mentors and executives and residents and folks, but we also have lots of relationships across the industry with payers and with providers and with medtech companies and pharma companies and software companies, big ones. And they are immense sources of knowledge and resources and understanding. We have actually had one case where a large company met with one of our startups that was not really a medtech company. It was not a regulated device and they didn't have any IP. Just had an idea, they had a prototype of it, and the company basically went and did it on their own and it was really quite disappointing. And so we did not bring them back for anything. And, that was disappointing. So far, it's a one in 1000 events and that still more than we want to have, and hopefully we won't have that again.
And we spend a lot of time with these large companies, and for the most part, they understand what the dynamic is, and they come and work with us for multiple reasons. One of those reasons is that generally large companies cannot innovate as fast as technology is evolving. And so if they want to capitalize on new and emerging developments, new and emerging technologies, one of the best ways to do that is find entrepreneurs to work with, maybe eventually by the company, it depends on the dynamics could be, you make an investment, could be you just collaborate, could be you buy it. I mean, there's all sorts of different structures, but that is a tried and true way of accelerating innovation within a large company to advance goals.
The challenge is that large companies don't necessarily know how to find the right entrepreneurs. Once they find them, they don't necessarily know which ones to work with. It's not as straightforward as picking Deloitte or Accenture or something with a massive track record. And so it's more complicated than that. And then once they do decide to work with one, working with an early stage startup is a very different experience than working with a very large company. And a lot of large companies just aren't very good at that. And so that's, we help them. And again, 99. 9 percent of the time so far, it's been successful.
[00:13:39] Lindsey Dinneen: Yeah. Well, thank you for sharing about that and your philosophy behind it. And also, I appreciate you being willing to share that one story because it's, you know, even though of course we wish that would not happen and never did happen, but the idea that you can still be successful in collaboration and there's still so much opportunity for mutual growth and learning. And yeah, you might have the bad actor every once in a while, but for the most part, to your point, 99. 9 percent of people really have that spirit of collaboration, which is great. So now you come into MedTech from a different background than some other folks. And so I was wondering if you might share a little bit about your early career and how that actually helps you now, because those skills I'm sure translate a little bit, but I would just be curious to know a little bit more about how that has played into your career.
[00:14:35] Steven Collens: Yeah, well, my early career, so I in college, I studied political science and French literature, like the farthest thing from, I walk by the engineering building and be like, "I don't, I have no idea what's going on in there. I'm going to go back to my French literature class where I feel comfortable." And then I went to work on Capitol Hill. So I, I was an aide to a Senator for almost six years. Spent most of that time working on education policy and transportation policy, loved it, but sort of looked around at a certain point and there weren't a lot of people where I, I looked and I said, " In 20 years, I want to be like that."
And it wasn't obvious to me what my longer term trajectory is. I didn't have the faintest idea what I wanted my longer term trajectory to be. So, you know, I sort of, tried and true strategy went to grad school. So that's when I went to business school and I ended up at Abbott because, when I came out of business school Abbott at the time had a kidney business, a renal business, and they made a drug for dialysis patients. At the time it was a 300 million or so product and Medicare, and this was a long time ago, the structure of how dialysis treatments get paid, get are paid for as different now than it was then. But at the time, this drug had was in the process of replacing a generic version, which Abbott also sold and it had been engineered and tweaked in a way that ultimately some researchers at Harvard that we had nothing to do with showed that it had a survival benefit compared to the old one.
But before we, before they showed up on our doorstep with this New England Journal of Medicine study that they were, it hadn't been published yet, but they said, "Hey, just FYI. We're, we've done this massive analysis and the New England Journal of Medicine is going to be publishing it and your drug prolongs life and there's a survival benefit based on all these." And we're like, "We thought that, but thank you for proving it."
Before that, Medicare looked at these two drugs and they said, "These are basically the same thing. One of them is way more expensive than the generic one. And we want doctors to stop prescribing that because we don't see the evidence." And, you know, obviously we believed in our own data and we showed it, but they did whatever analysis they did and they came to a different conclusion. And so they were trying out these different tools that they've never used before, because Medicare doesn't have the right, the ability today, and certainly not back then even less, but not today, to dictate what doctors can use and what they can't use. And they were trying out these new tools to effectively get around that and force doctors to use the generic. And so the business unit within Abbott was looking for a couple of people who had a mix of business and an understanding of politics and policy and how Washington works, and so I joined that team and focused for the first year and a half or two years on trying to solve this problem that Medicare was trying to essentially put this business out of business.
And then after we've solved that, I had a more traditional marketing job and then I kind of moved around within the company. Some of those jobs I had within the company are directly tied back to the experience I had in Washington. So I wouldn't have gotten that job, first of all, had I not had that Washington experience. After my sort of stint as a normal product marketer I went and wrote speeches for the CEO, which I was only qualified to do because I'd written a thousand speeches when I was in Washington. And so that moved me then into sort of a role around messaging and communications for the company, which I was in for a while in different roles.
Fast forward, when I left Abbott, I went and I joined this investment firm. I was effectively the chief of staff to the to the guy who was running or one of the two guys who was running the firm. I certainly wouldn't have, without that foundation from what I learned in DC, which was partly about messaging and communications and policy and things like that, but also it was a really strong foundation in two other things. One of just understanding how the world works and how people and groups interact with each other to advance their goals and how that happens. And also how to mobilize other people and organizations to help accomplish one's goals.
And so that was part of what fed into me getting that job at the investment firm. Building MATTER, and even the incubator before, I approached as very much a listening exercise to the community. Now I would say it was very much following a design thinking or a lean startup or those sorts of things where it's, we'd come up with some ideas and then go bounce it off the market and see what entrepreneurs or other stakeholders wanted. And they don't call it that in politics, but I certainly learned how to do that on Capitol Hill, because in order to get anything done, you need a lot of different stakeholders to both be bought into what you're doing. In some cases, you need them to think it's their idea. And so, so certainly that was very helpful and continues to be really helpful in building and then operating and running MATTER.
[00:20:33] Lindsey Dinneen: Yeah. Yeah. Well, thank you for sharing a little bit more about your background and how it has actually aided you getting a few different of the roles that you've had. I think there's always, if you look back, maybe some purpose to the meandering that sometimes happens where you go, "Oh, okay, here I am in MedTech!" And maybe didn't expect it, but I love how it worked out. So are there any moments that stand out to you as confirming along your career, maybe especially with MATTER, but even beforehand, as confirming that "I am in the right place at the right time in the right industry?"
[00:21:13] Steven Collens: Yes. I mean, there's so many. When I left the firm to, and then was starting MATTER, I assumed I would do this for two or three years. I kind of get it up and running and everything. And then I go do something different. I'm still here, just about 10 years later, which sounds to me like a really long time. And I, so I think about, and I have for probably the last five or six years, regularly think about, "Is this really what I want to be doing?" I've been doing this for a long time and, is this really the direction I want to go? And so there's a lot of things that, that keep me engaged and enthusiastic about what I'm doing.
So one of those is, it's probably hyperbolic to say every day, but every week, the kinds of people I get to work with and the kinds of things that they are thinking about and trying to solve, I find very energizing. I love working with entrepreneurs. They, for the most part, are people where their passions are aligned very closely with what it is that they're doing and building. If you want to build a successful startup, you have to be all in. You have to just be passionate about it and committed to it and dedicated to it. And you're giving a part of your life to building this thing and this company. I find that archetype just really energizing to be around, and to be able to help folks like that, I find endlessly enjoyable and and satisfying.
And on the other side of what we do, the people within these large companies that we work with are, almost by definition, trying to push the company in ways that it's not already going. They're trying to push boundaries. They're trying to change things because they are driven by this mission. It's much easier if you're in a big company to just go with the flow. And a lot of people do that. And you need a lot of people to do that in a large company. The things that large companies do really well, they don't do really well because every single person in the company is trying to constantly push the boundaries and innovate and change things. The company couldn't work like that. But there's a subset of people who are trying to do that and they're trying to push harder. And they're trying to go in different directions and experiment and try things, and we get to help them. And I also find that endlessly engaging and interesting and rewarding.
A couple of years ago I did a-- I love personality tests and all these different kinds of things. And so I did one, it wasn't really a personality test, but it was a fairly detailed exercise of, "Are you in the right role in the right industry and are you doing the thing you should be doing?" And I went through this whole thing and what came back was a resounding "yes" that when you just, when you look at it in a whole bunch of different dimensions, this really fits. Is it the only thing that I could be doing that? Of course not. Would I be just as happy and in other roles? For sure. But I get a lot of satisfaction and joy from the work that we're able to do, from the team that I'm able to do it with, and the people that we're able to help.
[00:24:43] Lindsey Dinneen: Yeah. Yeah. That's incredible. Thank you for sharing about that. So 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?
[00:25:03] Steven Collens: Wow. A million dollars to teach a class on anything I want. There's some interesting triangulation of of what I'm actually capable of doing, but I guess if I had a million dollars to do it, I could become a lot better at something. It's an interesting way of asking about passions and things like that. It would probably be something around hiking and outdoors and camping and functioning in nature, which is how I spend a lot of my free time.
But I'd also would love to teach a masterclass on healthcare innovation and healthcare technology. I think more people would probably benefit from that than a class on hiking. But I like to think that I've learned a lot over the last 10 years about what makes healthcare innovations go farther, go faster and be successful, even if they're coming from different lenses. They're coming from large companies, if they're coming from entrepreneurs, if they're coming... and our healthcare system just needs an endless amount of innovation and technological advancement and, you name it, it needs everything. And so if I could impart some of what I hope I've learned over the last 10 years doing this, plus 10 years at Abbott labs and other things, but I would love to do that. And it would probably be more useful than a class on the outdoors.
[00:26:36] Lindsey Dinneen: Okay, well I think both sound like good classes, so we can do both. It can be a yes and!
[00:26:42] Steven Collens: Excellent.
[00:26:43] Lindsey Dinneen: Alright, and how do you wish to be remembered after you leave this world?
[00:26:48] Steven Collens: You know, I'm not a religious person, but one of the 613 rules in the Old Testament is basically like a catch all for other things, but if you take aside from all of the prescriptive, very specific ones, there's one that is just, "be holy." And the point of it is that, in this case, God, writes all of these rules about how people are supposed to act in order to create a functioning society. But the people will always get around that if given the opportunity. It doesn't matter how many rules you have. It doesn't matter how prescriptive they are. People have the innate ability, and a lot of people will, figure out work arounds and ways to get around it.
And so this one is supposed to be the catch all for that. Again, I'm not a religious scholar. I'm not even religious, but this is my understanding, and I love this as a concept. And so by being holy, you're supposed to think about what is the intention of all of the different rules or the rules that are tangential or this, what am I trying to accomplish? And is my behavior and action going to contribute to the kind of world that I think that I want to live in. And so, I would love to be remembered for somebody who is acting that way. And that's hopefully people see that or look back, the kinds of decisions I've made, the kinds of things I've done, the kinds of actions I've taken, and see it as a form of being holy in that sense.
[00:28:44] Lindsey Dinneen: I love that. That's a very thoughtful answer. Thank you for expounding on that too. I really appreciate that. And final question, what is one thing that makes you smile every time you see or think about it?
[00:28:58] Steven Collens: I mean, every time is a challenge. Most of the time, our six year old kid. Probably dog, most of the time, maybe even... the dog's a lot less complicated than the six year old. And so the level of feelings are not as quite as depth, but also it's a more of a pure, she's just a sweet, lovable dog. So maybe it's the dog.
[00:29:25] Lindsey Dinneen: I love it. Dogs are wonderful.
[00:29:28] Steven Collens: I don't mean to say that I love the dog more than the kid. It's just very specifically your question about.
[00:29:35] Lindsey Dinneen: it is specific.
[00:29:37] Steven Collens: Yeah.
[00:29:38] Lindsey Dinneen: I love that. I love that. Great answer. Well, I just really appreciate your time today. Thank you so much for joining me. Thank you for sharing about your background, your career, MATTER and how you are encouraging people to do things that matter. I really appreciate the way that you have this collaborative spirit and are helping to propel these companies to success. So thank you for all of the work you're doing. Thank you for joining me. And we just wish you the most continued success as you work to change lives for a better world.
[00:30:10] Steven Collens: Well, and thank you so much for having me. It's been a pleasure.
[00:30:13] Lindsey Dinneen: Excellent. 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 it if you would share this episode with a colleague or two, and we will catch you next time.
[00:30:28] 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.

Justin Bantuelle & Michael Roberts | COO & CMO, Health Connective | Improving Patient Outcomes & Streamlining Processes

Justin Bantuelle (COO) and Michael Roberts (CMO) of Health Connective discuss the company's role in supporting medtech firms by developing custom web applications for surgical planning, post-operative reviews, and other solutions. Justin and Michael share their personal journeys into medtech, highlighting the rewarding experience of contributing to life-saving technologies. The conversation touches on common challenges in medtech like security and user experience, emphasizing the importance of empathy, active listening, and adaptability in solving complex problems. 
 
Guest links: https://www.healthconnectivetech.com/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPTEpisode 046 - Justin Bantuelle & Michael Roberts
[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'm so excited to introduce you to my guests today. Justin Bantuelle and Michael Roberts. Justin is the Chief Operations Officer and Michael is the Chief Marketing Officer for Health Connective. Both have been working with the company for more than 10 years. Health Connective supports web application development for medtech companies, including online interfaces for pre surgical planning and post operative review, streamlined systems for customer orders, and training portals. They understand that every company's needs are unique, and your solution should be too.
Well, welcome, Justin and Michael. I am so excited to have you guys today. Thanks for joining me.
[00:01:35] Justin Bantuelle: Yeah. Thank you for having us.
[00:01:36] Michael Roberts: Very excited to be here. Thank you.
[00:01:38] Lindsey Dinneen: Awesome. Awesome. Well, I would love if you wouldn't mind starting off by just sharing a little bit about your background, maybe what led you to medtech and your heart for it. So I'll start with you, Justin.
[00:01:51] Justin Bantuelle: Sure. It was, I kind of fell into it, I guess, initially, which I think on the tech side, probably a lot of people end up doing that. I had a computer science background. I got my bachelor's degree and I started at the company we're at now, Health Connective, out of college. And I've been there for 16, 17 years or something, but we were healthcare focused. And so they needed web development skills. I was a programmer, and that's how I started, but I've learned a tremendous amount since then. So I think coming from that technical angle, this is like where I fell into it. And I've moved up to the company. I manage a lot of people. I manage a lot of client interactions, help build systems that support medical devices, robots, things like that. So I've gathered a tremendous amount of information about this field as a result of that.
And I've stuck with it cause it has been very rewarding. It's something that matters so much to so many people. You see the real Impact that it makes when you help get these products to market. And you see all the research studies that show how much this is transforming these different fields of care. And then just, I think we all have personal experiences with these healthcare systems and the challenges people face, the uncertainties about it. Just talking to like my parents or to friends who know less about the sector and just that I have any kind of insight into it helps assuage fears. And yeah, it just, it matters. And that's very rewarding.
[00:03:18] Lindsey Dinneen: Yeah, absolutely. Thank you.
[00:03:20] Michael Roberts: Yeah. I did not set out necessarily to be in medtech as well. Like Justin, long story short, when I got into marketing, I was working more in the hospitality industry, hotels, restaurants, all that kind of stuff. Decided I didn't want to do that anymore and thought, "Where can I get as far away from the hospitality industry as possible?" And so, the funny thing there was some non compete things that I had to deal with from my previous employer. And so I was literally looking for a place that had no overlap with the previous company that I'd worked with as a marketer.
And so I found the company, found Health Connective, and jumped into it and try to bring in the same skill sets. I'll just do some of the SEO and I'll do some digital advertising and some of that kind of stuff. And some of that worked and some of it was just so drastically different, right? Like this is such a different experience for people.
So my first thing that I worked on here at the company was working with orthopedic physicians, helping them out with their marketing. And it was very similar in small business marketing in a lot of ways, but again, drastically different in so many ways. And then one of the first things that I ended up working on within the first few years was working with Olympus on a campaign that they were doing about raising awareness around gastroenterology around going to get your colon checked and all of that fun kind of stuff.
 I have a family member that has a Crohn's disease. And so this was something that very quickly became like, "Oh, this is a part of what we're all experiencing." I was able to go and ask people questions at Olympus. We went to Digestive Disease Week, which I had no idea was a thing, went there and I got to meet with the Crohn's and Colitis Foundation, just purely as a dad. Being there and just going like, "Can you just tell me how to help my daughter, how to help understand it?"
So that was kind of the thing that really clicked, "This is where I need to be. This is what I need to be doing." Because so many of us are experiencing something like this somewhere in our family, whether it's us as patients, family members, whomever. So that was kind of the big click moment for me.
[00:05:20] Lindsey Dinneen: Awesome. Wow. Yeah, that's powerful. Thank you for sharing that. So could you tell us a little bit about the company and maybe also a little bit about your goals as it continues to grow.?
[00:05:33] Michael Roberts: Yeah, so, you know, we, as a company, we're out there to help MedTech companies with a couple of different kinds of things. So we end up helping the product and sort of R&D side of things. And that may be with robotic devices, if there's different types of data coming off of the device that they want to be able to show back to the different physicians, the different people that are involved with the procedure, that's the type of work that we do.
And I'm super glossing that over and saying that very quickly, but there's a lot of different people that we share this information with that comes off the robot, everybody from physicians to engineers, to field service teams, all those different kinds of folks. And the goal there is just, "Hey, you're obtaining an immense amount of data out of every single procedure. What can you do with that data? How can we help you better utilize that information and improve outcomes and do all those kinds of things?" so that kind of product development and like I said, R&D side of things that's kind of where we fit.
And then on the marketing side I, I kind of refer to it as like the, "Wouldn't it be cool if?" kind of group. It's like, "Wouldn't it be cool if this process that we had didn't suck? That would be awesome. How could we get somebody to help us with that?" So anything from ordering online kinds of processes where, because it's not as simple as just setting up an e commerce solution and just letting it run, you have to have different pricing for every sector and you have to have different contracts with everybody and all of those kinds of things. We can marry a lot of that messy data and make it a seamless experience for people so it doesn't suck.
And so that's what we're hoping for. And then also like, "Wouldn't it be cool if these things could be that much better?" So a lot of efficiencies, a lot of things where again, these systems don't natively talk to one another. How can I get my CRM and all of these other unique data sources that I have to actually cooperate with one another. So, that's the kind of stuff that we set out to do. Again, I'm saying it super simply as opposed to how Justin would be able to define it. But, but those are the things that we're setting out to do for people is improve that customer experience and then get better data coming back from their procedures, that sort of thing.
[00:07:41] Lindsey Dinneen: Yeah. Well, I would love to dive a little bit more into what does it look like when somebody starts working with you? How do you go from, you know, taking them through lead all the way to your day to day? What does that look like?
[00:07:57] Michael Roberts: Yeah, I'll start the conversation. And then Justin, 'cause Justin takes over at a certain point and I just go, "Hey, let me know if you need anything." But a lot of it is, these kinds of things are very trust driven, right? So we have a lot of messaging out there. We have a podcast, we have advertising that we're doing, we're going to be at a few different trade shows through the rest of 2024, figuring out which ones to be at for next year, but a lot of it does come down to relationships. So somebody has introduced us.
We've started having those kinds of conversations because any of these kinds of things that you're talking about there, there's kind of big, messy problems that aren't easy to fix. They aren't something that you just sign off on quickly that's a 5, 000 a month subscription and off you go. It's a bigger, more thought out process. So a lot of it is that sort of process of, "Hey, let's get to know one another. And then really digging into what problem are you trying to solve?" Everything that we do is a custom solution. So it's not, you don't have to use XYZ systems in order for us to work with you. We can be very flexible on that, but then, so we really get into that kind of problem definition stage, and then Justin, I'll let you kind of take it from there once we get into the problem itself.
[00:09:05] Justin Bantuelle: Sure. Yeah. I mean, the initial touch point with it is really just listening and reassuring that, "I've heard your problem before something similar to it. Okay, you have these different technologies. These are the things that are unique about what you're trying to do in this space. And here's how I can craft a solution for you." So it's a lot of listening, helping them along the process of requirements gathering, usually this part of it, this front end data visualization after the fact for a lot of medical device, I find that's not their core competency. Their core competency is the device itself. They've built the device. The device works very well. It achieves something and it solves a problem in the medical space, but then there's all this stuff you have to do after the fact. And so it's like, "Great, this work, the procedure is amazing. And now there's all these things that we need to take action with," and that's where we kind of step in and provide that end of it.
And we augment their teams that they already have. They have several very technical people. They've got brilliant engineers, they probably got brilliant developers involved in a lot of the software written around the device itself. And that's where we understand what their needs are, solutions are, their implementations where there's gaps. And then we help shape that for them and make sure it matches what they need. Yeah, like Michael said, never any one size fits all. It's always very customized. And that's where we shine is helping just lead them through that. They don't need to micromanage it. They're not just hiring a handful of developers and needing to tell them what to do. It's like, we take it kind of from, "You articulated the problem. We'll fully craft and implement a solution for you and then work alongside you for assessing how that works, how much it's solving your problems, what emergent needs are there, what maybe needs iteration."
So we also view this as long term engagements typically, and we find that's what works well for our customers as well. Usually you're not just building something and then just abandoning it. Hopefully this goes for years and years as a successful product that you continue to iterate on, improve in the field, and then you necessarily need these other systems to work alongside it. So, I find that a lot of people have a bit of a fear that. We'll build something for you and then kick it over the wall, and then now your team has to manage it. Good luck. And I don't like operating that way. I enjoy continuing to see the success of something I build. I like standing by what we have built. And so that's kind of our outlook on it, I guess, and how we try to assist people a little bit on the side, I guess, maybe, but hopefully that made sense.
[00:11:37] Lindsey Dinneen: Yes. No, that's incredible. Thank you so much. So, you know, I know you said that one of the strengths that your company brings is having this flexibility, being able to, like you said, be very customized with your approach to different companies and really help them because no problem is exactly the same. But I am curious, have you come across some themes that are a little bit common, especially in the medtech industry, that perhaps folks who are in the process of developing something could be aware of. What are some of the things that you commonly see that your company could help or they should be thinking through.
[00:12:15] Justin Bantuelle: I think that security is a big one that tends to get overlooked until the project is finished. And then you're going through some final regulatory steps and the security team comes in and assesses it and goes, "You didn't think about any of this." And now you're re architecting like half of what you built. I think that's probably the biggest pain point I see. There's like a major gap in looking at that. And it's important everywhere, but a lot of fields aren't as highly regulated, so they get away with not sweating it as much until it bites them. Whereas you can't really do that here. You're not launching if you didn't put these considerations in place.
And that's something that I think it's more unique to a handful of sectors where, and medtech is one of them, where you're really hurting yourself if that's not at the forefront of your mind. And so somebody who's not used to those considerations is probably not going to build you the right thing up front. And you're maybe not knowing how to articulate for this part of what's being built as a client that "No, you really need to think about this. We're going to be doing this as part of the process afterwards." Usually it's a completely separate team and it's all part of the documentation, filing it, getting it all in right at the end. And that's a terrible time to find out that you should've thought about something. So that's the biggest one that comes to mind up front.
[00:13:37] Michael Roberts: Yeah, I can jump in as well. I think one of the big things that we don't see a lot of medtech companies do that, that we ended up helping, right? If they had this right, they probably wouldn't need our help as much with it. But one of the things is that I think that, because this is such a complicated industry, everybody kind of gets used to sort of a cruddy experience. You know, it's like, "Well, man, this system is really slow, but you know, it's okay. It's just an internal tool." Or, you know, "Just the physicians are using this one so it's not as bad. We can make it too complex, too messy to whatever." And everybody just seems to say like, "Ah, well, that's good enough."
And I think that, one of the things I've been surprised by that people aren't considering more, is just how much we are all acclimating to an Amazon experience, to all of these kinds of things where we just expect it to work. And then as more and more of these AI systems catch on and we get used to being able to just talk to the systems and they just do what we want them to do, I think that that frustration is going to get more and more apparent even on systems that have nothing to do with AI, even if they never touch it. We're just getting used to faster and faster systems that intuitively work. And there are so, so many in medtech that don't across the board. And it's not just the stuff that we work with, but I think that there's a lot of pain points in that area.
[00:15:00] Justin Bantuelle: That's a really good point as well. Yeah. Yeah. I think most people are familiar at this point with Amazon being able to measure exactly how much money they lose per a 10th of a second longer the page loads, right. And you're right, Michael, that this platform isn't the, like what we're building, these visualizations, these like post procedural dashboards, things like that. Those aren't the product. Those are supplementing it. Those are where you're getting augmented value after the product has done a very good job performing a procedure.
And, so yeah, it's much more-- pretty much every system that physicians use in hospitals, like when you're on a computer in there, if you're a physician, if you're working the desk, whatever you're doing in there, those systems are often ancient, very slow, bad interfaces. And so I think Michael's right that a lot of companies sort of overlook that because they sort of assume this is the norm in this space. It's like, "No, we can do a lot better than that." And that's sort of baseline for us. And that's easy for me to forget that a lot of people are trying to cut corners on that front or not prioritizing that aspect of it. And you do see fall off in usage as a result of it. And yeah it's not something to be neglected.
[00:16:19] Lindsey Dinneen: Yeah. So just in general user experience and being able to help companies navigate that. And you know, actually, that goes back to what you were saying earlier, Michael, the idea of "wouldn't it be cool if," you know, so "wouldn't it be cool if this worked really well"...
[00:16:37] Michael Roberts: Right.
[00:16:38] Justin Bantuelle: Right.
[00:16:38] Lindsey Dinneen: ...instead of settling for, like you said, a cruddy experience. Maybe there's something else we could do. And I love that sort of "what if" idea, because it just opens you up to all these possibilities.
[00:16:50] Michael Roberts: Absolutely.
[00:16:50] Justin Bantuelle: There's some things that are sort of corollaries to that, where a lot of groups don't consider. A lot of developers, I find as part of the user experience, so much of that is there's accessibility considerations and how severe a look it is if you're borderline non compliant with ADA, when you're in the medical field, like that's embarrassing, right? And potentially outright illegal.
[00:17:16] Lindsey Dinneen: Right.
[00:17:17] Justin Bantuelle: And these things often also can get overlooked if you don't have somebody who's used to doing this in the space with the interfaces that they're building.
[00:17:25] Lindsey Dinneen: Yeah. That makes a lot of sense. Yeah. So I'm curious as you've worked with all these different companies and you've had very cool experiences, are there any moments that stand out to you as really confirming to you? Yes, I'm in the right place in the right industry at the right time.
[00:17:45] Michael Roberts: This is a big question. You know, it's interesting. We've been involved in a variety of different types of projects. And as we've talked about stuff going into COVID, you know, when we were prepping for that there was work that we were doing with physicians directly, the stuff that I was, that I started off doing at the company, we still do work with physicians directly. And then we do work with some of the companies that were involved at various stages of vaccine creation process and all that kind of stuff. And so as we were sitting home during COVID and everything's going down and everything's happening all around the world, it's like, "Well, hey, we're at least helping some of these groups navigate this process." We're at least helping out some of these institutions continue running, or helping them get their messaging out or helping them in one way or another.
We actually had a podcast previous to the one that we have now, and it was called The Paradigm Shift of Healthcare. And we named it that before COVID hit. We had no idea that was coming. It was just like, hey, consumers are more of a part of the healthcare process. People are making decisions more on their own and then everything changed about healthcare. And so, definitely made for some interesting conversations about, "Yeah, we had no idea that this is what was coming."
But I do think that going through that process, seeing the provider side of it, what they were dealing with, we dealt with a lot of orthopedic surgeons who had to close their practice during the worst of it, right, when everybody had no clue what was happening. So there was that process. It was a lot of getting communication out on their websites, getting information out that way as they were trying to figure out any kind of remote appointments that they might be able to do. Figuring out that for short term, helping them just get some of that information on their sites and everything. And then, yeah, like with working with the companies as they were going through all this mess and trying to figure out how to allocate resources and all that. So that was probably one of the big times I think of like, "Okay, again, we're in the right space, beyond just this is how it's impacting my family, but it's impacting all of our families right now."
[00:19:43] Lindsey Dinneen: Yeah. Thank you for sharing. Yeah. How about you, Justin?
[00:19:47] Justin Bantuelle: Yeah, I think I touched on this a little bit in the intro, but something that really stands out to me is working on supporting this robot. I didn't work on the robot itself, but obviously we're working on these systems that are ancillary and critical to the overall business operation of it. And it wasn't at market yet when we were coming in and assisting, and so seeing that process where it went through to market and seeing all of the studies that are continually coming out as they're performing this to submit to the FDA, and the actual tangible data showing the massive improvement in patient outcome and realizing that like, "Yeah, we're working on things that really are transformative for care."
I had no idea how bad the space was in terms of outcomes before this robot was coming in and how much it was going to make things better for patients. Seeing the actual, tangible impact that it was going to have and that it has have since coming to market was really remarkable and something that it was like really proud to be involved in some capacity. And it just made me that much more excited about continuing to support these groups as they're doing this.
[00:20:55] Lindsey Dinneen: Yeah.
[00:20:56] Justin Bantuelle: It matters. And seeing the numbers on it really drive it home for me.
[00:21:00] Lindsey Dinneen: Yeah. Yeah, absolutely. Both of you have said at various points, things like "it matters," like "matters" has been like a big theme so far. And I think there is so much to that. But I am curious to dial a little bit more into it because, obviously, work in general matters. There's ways that you can make an impact in any field, but what drives you when it's a particularly difficult problem, or frankly, or a difficult client where it's a little bit challenging to maybe see eye to eye. So what continues to motivate and drive you to this work that you know matters so much?
[00:21:41] Justin Bantuelle: I think, for me, it's wild to see that some of this is actually life and death. I never worked on something where like, and even some of what I'd done within medical device was just quality of life, which matters a lot too. But then some of this is about like diagnostics where a delayed outcome, a delayed assessment of the diagnostic and a misdiagnosis due to challenges with diagnostics, these things could be the difference if somebody survives or not, or like how quickly it gets them into treatment. So that's a weightiness that I never dealt with before prior to this. And so that was different than any jobs I had before where, I mean, I cared about things in like retail, but it's still, hopefully nobody's dying as a result of anything if they don't get the right thing.
So there was a weightiness to that, that I guess carries a commensurate responsibility on the same side, is there anything to talk about what keeps me going with it. For me, I don't find myself necessarily pushing through. I don't find client engagement to be that challenging. I find that everybody does care, but miscommunication can happen, but I try not to center myself in any of that. And I find that giving others the benefit of the doubt as well on that usually leads to a pretty comfortable resolution. I'm there to help solve their problem. I'm not there to win an argument or be right on the direction we take, and I've definitely recommended pathways before from a technical standpoint and they just disagree or overrule and I don't think that's necessarily the best pathway, but I defer to their judgment on what they want in this field. And we're still working towards an end goal. If I ever feel like what we're doing is not helpful, then I don't want to take their money and build something that's they're going to be unhappy with.
So, yeah, that, that part of it, I don't really necessarily personally experienced or feel that much, but it does help me just for from a personal motivation standpoint to see the outcomes on this. I don't think you always necessarily get to see that information. Some of our prior retail jobs, I don't know how happy somebody is with something once they go home with it, like unless they're coming in to return it, right? But here, it's not so much about the customer satisfaction the same way. There's very measurable. Improvements to treatment, diagnostic outcome. These things are very measurable, so you can see the results of it. And it's nice to see that you're achieving something with this, that you can
[00:24:16] Lindsey Dinneen: Yeah.
[00:24:17] Justin Bantuelle: estimate and keep with you as opposed to just hoping that it it's impacting somebody positively.
[00:24:22] Lindsey Dinneen: Oh, yeah. Excellent. Do you have anything to add to that, Michael?
[00:24:26] Michael Roberts: Yeah, I'll just quickly touch on-- so I actually came from a ministry background, from a faith background. And so part of, I guess my heritage in that field is this idea of service and this idea of trying to better people's lives in some way. And the concept of, when I started working with the physicians directly and still kind of applies with medtech companies same way is like, in my mind, I frame it as helping the people who help people. You know, really helping equip them so that they don't have to worry about that. They can go do their job. They can focus on the serving that they're doing.
I don't enjoy being the frontline person. So, when I was working for churches and stuff like that, I did some stuff where, you know, I did a mission trip and we built a house in Mexico and you see that like, "Man, this makes such an impact." But it's exhausting and it's hot and it's really tough to do. And, "Wow, what if I could help equip people that are going to be in those kinds of areas?" I could never work in a hospital. I could never be that person. I don't have that mental fortitude. I don't have that emotional fortitude to do that every day. But if we can help make that process easier, I can deal with a lot of stuff in the meantime to help that part, you know, and let them do their job well. So that's the framework that I kind of bring to it.
[00:25:45] Lindsey Dinneen: Oh, I love that. Yeah. Thank you both. 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-- could be in your industry, doesn't have to be. What would you choose to teach and why?
[00:26:03] Justin Bantuelle: Yeah, okay. It's kind of similar to what or it's related to what we just talked about those frustrations of the customer. I'd really want probably to teach something along the lines of empathy and listening, like active listening. I feel like so many of the problems that I see in the workspaces and personal exchanges boils down to a form of miscommunication and boils down largely to making bad assumptions about what the other person is thinking or feeling. And I find that you can alleviate a lot of that. And I think it's just being able to really put yourself in their shoes, understand their motivations, understand what their pain points are, what they're trying to achieve. I've seen people butt heads just so many times and often felt it was unnecessary. They're not, neither of them's wrong about anything, but I think they kind of lose sight of the common goal that they share.
And I've often helped my own employees who maybe feel like they're getting antagonized and help them reframe like what's going on and why it's not about them. It's not a personal attack kind of thing. I've seen Issues with clients where two different departments are having an issue. And I have less control over helping ameliorate that, but maybe sometimes helping to talk through it and just bring an outside perspective on it. Just with friends, family that struggle, often I find that advice to try to take a step back and reframe what's going on and think about that. I think there's a lot of techniques that, and it makes your life better, right?
You're not getting the outcome you want if you're in conflict with somebody else and that's something that I think is one of the most unnecessary friction points often in a work environment or in a personal environment that I really try to put at the forefront of my mind when I see something kind of going wrong or when I'm experiencing something where I feel like I'm not getting my point across or somebody is not really understanding. And there's probably something going on their side where I'm not communicating well myself and taking that step back and understanding what's happening. Just, I feel it makes a big difference in the outcomes for everybody.
[00:28:25] Lindsey Dinneen: I, and I really appreciate that perspective. It goes back to something you said earlier too. It's kind of, you know, you're on your client's team. It is you all against the problem. It's not you against each other. And it should never be. So trying to always remember that, or even in a work situation where it's maybe colleague to colleague, again, you're on the same team. So how do we go us against the problem rather than us against each other? So I really appreciate that perspective.
[00:28:54] Justin Bantuelle: Yeah, I think, yeah, I find that it's not that frequent that somebody's actually acting in bad faith. It's not that it doesn't happen, but I think it happens a lot less than we may be assumed. I do think that how much of our communications now are via text instead of verbally where you can hear tone a little bit more, I think it becomes a little easier to misread something and that can help contribute to the miscommunication that can then boil over into something. So yeah, it's a challenge probably we all face. I certainly like for all that I care about this and I'm talking about it, it's a challenge I face as well, but I think that awareness kind of helps to check yourself and reevaluate and maybe change how you're communicating that.
[00:29:42] Lindsey Dinneen: Yeah. Amen to that. Michael, what would you teach?
[00:29:46] Michael Roberts: I should have gone first. That was, that's like sets the bar so high. I think that the thing that I would try to teach is focusing on learning different types of skillsets that you've had before. I think that the next 10 years, we're just going to consistently see that need for everybody to keep reshaping how we interact with our work world with just the world in general. There's just so much that's changing and happening right now. And so I see this some for just basic literacy of the world that we're going to need this.
But also, you know, I had to transition from one job to another. I started out in ministry and it was not for me and I needed to do something else. And it was hard. It was a good long while before I found the right fit and skilled up enough in that area for it to work. And so bought myself a book on HTML, code your first site in 30 days kind of thing. And did that and figured out how to put together a very crude website. It was just not great, but it worked. And but that kind of stuff, you know, what's possible today for people to keep on learning, to be able to shift from career path to career path.
And then knowing how much you actually do bring with you because you very much feel out of your depth in so many ways. And I felt out of my depth at Health Connected for a good long while. But finding these experiences, these things that I'm bringing to the table, helped shape me and helped me deserve to be here in a way. And I think that everybody has that. It's just unpacking all that stuff, you know, and so getting the skills we need and then being able to figure out how like to actually like match up with where we're trying to go.
[00:31:22] Lindsey Dinneen: Absolutely. Well, and you know, that's such a good point too, because sometimes I think it can feel, especially when you do transition jobs or even broader industries and you do feel a little bit out of your element. And I think the thing that you can also remember is, though, it is a strength to draw from all of these different sources of information and experiences that you've had over the years and maybe actually it is a really positive thing for you because you can go, " I don't know if MedTech has ever considered X, Y, and Z, but we did this in hospitality and let's just try it, you know?" And so I love that idea of bringing all the things together and allowing it to help shape you.
[00:32:04] Michael Roberts: Yeah. Watching customer experiences be bad in healthcare just kills me. It just, 'cause you'd automatically lose in hospitality. You're automatically out if you don't have your customer experiences solid. That's the benchmark you have to start there. So
[00:32:19] Lindsey Dinneen: Excellent. Yeah. Well, how do you wish to be remembered after you leave this world?
[00:32:25] Justin Bantuelle: I, I think more than anything, I would just want to be thought of as somebody who was kind. It really matters a lot to me. I care about how people feel. I care about helping people. I'd like people to think that I always did right by them and helped where I could. So, that's at the forefront a lot of what I try to make decisions on in my personal life. So hopefully I live up to that.
[00:32:56] Lindsey Dinneen: I love that.
[00:32:57] Michael Roberts: I would add something similar to that, I guess, would be willing to invest in the people that I cared about, that I was willing to disrupt my day, ' cause I can get so focused on a thing. When I was a kid, I wanted to be an artist of some sort, and that you think about the artists that have kind of stood through time and it's like, "Oh, well that's the pinnacle of what it means to be a person is you're remembered through time for some major achievement." And it's like, well, yes, there are a handful of people that do that, but I think being able to be remembered that you valued other people as being more valuable, as being more worthy than whatever project you had at the moment, 'cause so many projects come and go. It's something that we all need to do, is something we all need to work on, but yeah, investing in those relationships
[00:33:45] Lindsey Dinneen: Absolutely. And I think that's a good reminder. Both of your points are very good reminders, especially for entrepreneurs who, I'm sure that most of them feel that everything kind of weighs on them. And so it is easy to get deep into project mode and maybe forget sometimes that they are human. So being kind and investing and willing to disrupt your day. But yeah that's really powerful. Thank you both. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:34:16] Justin Bantuelle: Sure. I think for me it's, I like animals a lot. I have my pets that I'm very fond of. I spent a lot of time looking at animal photos and videos online as I'm sure everybody does. I'm particularly fond of ones where it's two completely different species of animal that seem to be best friends. That is what really helped shape a positive day for me in the morning, if I come across some of those and that is just the cutest thing in the world.
[00:34:40] Lindsey Dinneen: Absolutely. How about you, Michael?
[00:34:44] Michael Roberts: For me, it's just being out, out somewhere where I'm just surrounded by nature and just getting that moment. And it's not, it doesn't make me smile in the same way, I guess, Justin, but it does kind of bring that peace every time I'm there of, no matter what else is going on, it's like, "Okay." Grounded, in a way and it's like, "Okay I'm here. I'm ready. And I can go face the day."
[00:35:04] Lindsey Dinneen: Yeah. Yeah. Excellent. Well, thank you so much, both of you, for sharing your stories, your insights, your experiences, and even some advice. I really appreciate you taking the time today. This has been such a great conversation. 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 I just wish you both the most continued success as you work to change lives for a better world.
[00:35:46] Justin Bantuelle: Thank you so much.
[00:35:48] Lindsey Dinneen: All right. 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 if you'd share this episode with a colleague or two and we'll catch you next time.
[00:36:01] 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.

Chad Bareither | Principal Consultant, Bareither Group Consulting | Process Improvement, Systems & People, & "Improve LESS"

Chad Bareither is the owner and principal consultant of Bareither Group Consulting. Chad shares his journey from working as a civilian engineer in the U.S. Army to becoming a Lean Six Sigma Master Black Belt and consultant for medtech and pharma companies. Chad discusses his process improvement framework, the importance of understanding both systems and people, and insights from his recently published book "Improve LESS." He also covers the transition from being an employee to an entrepreneur and the qualities essential for leadership in the industry. 
 
Guest links: https://www.linkedin.com/in/chadbareither/ | https://www.bareithergroup.com/ | https://www.youtube.com/channel/UCTjC2ZBL3mqnriCeAIkmSlQ
Charity supported: Polaris Project
Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 045 - Chad Bareither
[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 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, Chad Bareither. Chad is the owner and principal consultant of Bareither Group Consulting. He partners with med device and pharma company leaders to boost productivity. This is delivered through the Focus and Align Framework, the subject of his book, "Improve LESS.". Chad is a Certified Lean Six Sigma Master Black Belt and holds a Bachelor's degree in Mechanical Engineering from Michigan Technological University, as well as Master's degrees in both Industrial and Systems Engineering and Applied Statistics from Rutgers University. He has over 10 years of experience in the med device and pharma industries and almost 20 years of professional experience.
All right. Well, welcome to the show, Chad. I'm so excited to talk to you today.
[00:01:42] Chad Bareither: Yeah, thanks for having me on.
[00:01:45] Lindsey Dinneen: Of course! I'd love if you wouldn't mind by starting off telling us a little bit about yourself, your background, and maybe what led you to what you're doing now.
[00:01:54] Chad Bareither: Sure. So I started my career in the US Army as a civilian engineer. So my background's in engineering, mechanical, I have a degree in mechanical engineering and also industrial engineering. So I started out in the U. S. Army as a civilian doing acquisition projects. So we would design and then purchase componentry for our warfighters from various defense contractors.
And so my role in that was quality. So understanding are we designing all of the elements correctly. Then when they're being produced, are they meeting our specifications? And then once they're in stockpile, do they continue to work before we hand them to the brave men and women that are defending our freedom. And so I worked there for a while and pretty early found my niche that I was really into process improvement. So I would visit defense contractors, and if we had an issue, what I was really seem to have a knack for was helping to understand the process and make it better. So we could either expand capacity or have better quality.
And so that kind of bridged right into a unique program they were introducing at the time, which was called Lean Six Sigma, which is a corporate program for reducing variation and improving efficiency of processes and the corporation at large. So I was pretty lucky that these two things coincide at the same time is that I was finding my niche and they were rolling out a program that really focused in that. So I was able to get into one of those programs, get trained and certified.
And then I followed that path on to several other industries, including med device, pharma, and then was also a corporate employee in some utility, electric, natural gas. After my last corporate engagement, I went off on my own and I began consulting. So delivering the same services I had internally to those larger organizations. But now I have the ability to target smaller or growing organizations. In my consulting engagements, if you combine corporate experience and consulting engagement, it's somewhere around eight industries that I worked in.
But I really enjoy the work and the challenges in med device and pharma a lot more. There's the purpose behind it of serving patients, and there's also some really significant technical challenges that I just find are fascinating to learn about. So for the last-- oh, it's six years now-- I've been consulting delivering those services in various industries, but really trying to focus my space into the medtech arena.
[00:04:46] Lindsey Dinneen: Nice. Well, first of all, thank you for sharing a little bit about your background. I appreciate it. And it's fascinating to hear how you started off with one focus and then it just continued to evolve and twist and turn into this amazing consulting career that you have now. So many questions, but the first is could seven year old Chad have possibly anticipated what you're doing now, since it's different than what you started off with.
[00:05:15] Chad Bareither: Yeah, no, I think seven year old Chad probably wanted to be a professional baseball player. But if I zoom forward a little bit from that, once middle school and high school, I always. naturally gravitated to our math and science was thinking it was going to be engineering. And I did, I studied engineering and most of my day is not engineering. It's really understanding people.
But what's fascinating is if I look back, I think what all of my engineering education taught me was really a system for solving problems, right? So the problems that we solved happen to be mechanical design or industrial design. Got it. But taking that mindset of problem solving and now saying, well, the systems that I work with on a daily basis with my customers are a little bit more complex because you have mechanical systems, but you also have people systems that are intertwined with that, right?
So, whether I've worked across the spectrum and still do of research and development, clinical trials, manufacturing and post market surveillance and across that. You can have systems set up, but people still operate it. So, it's difficult to just analyze your way into the perfect solution. Even if I can show on paper that it works, like you still need to understand the people elements of it. So I think that's been the biggest evolution through my career is early on, it was like, "I don't understand why we're doing this. It makes sense on paper." And it's like the change management component of that has been really something I've been able to develop personally, I'd say, over the last 6 to 10 years.
[00:06:51] Lindsey Dinneen: Yeah. And I'm curious, so bridging that gap between systems and people and understanding that what looks good on paper might not translate as perfectly into real life as one would hope, because we're people and people are complex. So were there certain learning opportunities that you had that helped bridge that gap of gaining your expertise and knowledge in that way? Or what led you to be able to do that so efficiently now?
[00:07:23] Chad Bareither: Oof, well, you're assuming I do it efficiently now, so but I'd say I still believe we learn more from failures than we do from success, right? So, there are specific projects or engagements I can look back to. So I'll talk about one specifically. This was a medical device assembly plant. And the particular production line that we were working on, we were trying to increase capacity on, and we even had the team engaged, right? So we were doing everything right in terms of the engagement project, had the teams involved, understood their pain points. We were trying to make it easier for them. And then like on paper again, showed we could do the production line, with the main assembly line, with three operators instead of four.
And so we were really pushing for that because being just transparent, looking back now, it's like the productivity gain would have looked really sweet to management. But we had the operators telling us like, "I don't think it's going to work. I don't think it's going to work that way." And we're like, " No, it's going to work," right and pushing for it. And I don't know, you, you get a little focused on your own goals or whatever you, however you want to phrase that. And yeah it was a struggle to launch. And they ended up having to cover some of that with overtime. They made some adjustments long term, but that was a big learning for me of, I mean, if the people actually doing that work eight to 10 hours a day are telling you it's not going to work, like you should probably pull back and either, you've got more explaining to do, more improvements to do, or you should just maybe listen to them a little bit more. But you know, there's other scenarios I can look at that were.
You know, when I say failure, right? Not everything means it's a flaming dumpster fire, but sometimes you don't get exactly what you expect out of it. And a lot of it can, I can point back to and say, " Ooh, you know, I could have done a better job. It's not that the analysis was wrong. It's not that the tool we put in place or the management technique or the visualization, it's that we didn't have the right level of buy in or the right people buying in."
[00:09:35] Lindsey Dinneen: Okay. Well, I, thank you. I appreciate your honesty and transparency. But I do think to your point, failure or whatever we perceive to be as failure because it didn't work out quite the way we hoped for, is such a powerful learning tool if you can take it and go, "Okay, here's what worked. Here's what didn't. Here's what I can do better next time." And you don't have to go, "Okay, that was a waste." It's never a waste if you can learn from it.
[00:10:01] Chad Bareither: A hundred percent. And I think only in recent years, I'd say the last four to five years, that I've really gotten into that of more of a bias for action of, " What's the worst that's gonna happen?" And honestly, I'm not talking about changes that are gonna bankrupt a company, right? It's if you're changing the direction, but " Well, let's try it." So having a bias for action and thinking, just like you pointed out, that it's going to be a learning experience, right? So if you treat it more of an experiment, success isn't necessarily binary-- it was a success or it wasn't-- we learned something. Maybe we got better. Maybe we didn't.
But that means the next round, the engagement that we talked about before we started recording, I'm just coming back from-- we had two weeks of not going so well. And then the last week there was finally a breakthrough. And it was like, but I'm comfortable with it. The team was getting disengaged and I'm like, "We're going to get there! You guys stay positive, 'cause I know we're going to get there." And the failures we learned, we know so much more about that process now than we did three weeks ago.
[00:10:59] Lindsey Dinneen: Yeah. Yeah. And that brought up an interesting point. So persistence and the willingness or the bias to action, which I really liked the way you put that, the willingness to experiment is something that does take a level of comfort that maybe not everyone is so excited about. But I'm wondering what you have seen over the years as being some of the top qualities of a leader that contribute to that success and that willingness to experiment.
[00:11:33] Chad Bareither: Yeah. So, it helps me to think about specific leaders when I, that are like embodying that rather than just speak generically about it. And there was an R&D manager that I work with, his first name was John, but really took the stigma of failure, and I think not even using that word as much, out of it, and just saying, " Let's try and see what happens." And kind of building that learning mindset of, I'd rather move fast and learn something than move slow and get it perfect.
And in industries, especially like a bunch of the medtech fields, I know in some of the pharma clients I've worked with, they're looking at things like new technologies, new modality of disease and I'm not a scientist, but these are things that we've never done before. And so the mindset of trying to get it perfect-- like this leader I work with previously, John is like, "Why are we wanting to get it perfect? We won't get it perfect the first time. And if we try to, we're going to be moving too slowly." so that's kind of the first thing that I think of is taking the stigma out of failure and turning it more into trying, learning mindset, things like that.
I think the other thing is keeping open communication. And what I mean by that is there's another leader I'm thinking of and his first name was Mickey. And trying to have more open conversations. Information can be used for power, in some cases, or if you're harboring information or knowledge, like, " I'm the conduit, right? So then I become what puts it all together." And he was big on breaking down some of those and having more open conversations about what we're learning and what works and what doesn't work. And I mean, you see teams grow together faster.
And so then when you take those two qualities, if I take the stigma of failure off of the organization as a whole, and I work to build more open lines of communication and you build trust, right? So then I'm more, I don't want to say confident-- that's not maybe the right word to go after-- but there's less hesitancy, less fear, maybe. So not being confident doesn't mean I'm not fearful, but if I can take a little bit of that fear, a little bit of the stigma of failure out, I'm willing to try. I'm willing to go off on something new. And as we look at this industry of new advances in technology, new challenges of diseases, we're going to have to keep moving fast and do it in areas that are pretty uncertain. So those are some things that I think help, of saying that we're not going to get it right every time, opening up lines of communication to build trust in the team. And then we can really move faster to a shared goal.
[00:14:08] Lindsey Dinneen: Yeah. I really like that. Thank you for that advice and insight. That's really helpful. So now with your own company, consulting, well, a couple of questions, but the first is what stage of business do you usually typically come in on? Or is there not necessarily a stage that's your sweet spot?
[00:14:28] Chad Bareither: There's, I wouldn't say right now there's a stage where I could say I have a, a litany of business cases for one stage, so multiple stages. I work with some organizations that are still in-- I mean, so if you think about the business, the corporate stage, established businesses, so they're past what would that be? Series two funding. So commercialized product. So I'm either working with the R&D pipeline on next generation products, next innovation, or in the operation space of improving manufacturing operations are typically the two areas that I'm working in the most.
[00:15:09] Lindsey Dinneen: Yeah. Was there an interesting learning curve going from being an employee to being an entrepreneur?
[00:15:18] Chad Bareither: Yeah, so let me answer that two ways. The first is moving from being an internal employee to being a consultant, right? Because it's just a different, you're of a different role in the company, right? And then there's also to your point is great moving from being an employee to an entrepreneur. So if you don't mind, I'll kind of tackle both of those.
The first is moving from employee to consultant is interesting. Because I was on the employee side when you would have consultants come in. And so leaving the bad taste in my mouth from some consultants we had worked in, they're there to make an impact so that they can either upsell their services or whatever. And I can remember being on engagement. So it's like pushing so hard and just, " I have to work with these people when you leave. So you're kind of creating a mess for us." And just trying to meet people more where they're at.
But you know, there's an adage of "a prophet isn't recognized in their hometown." It's sometimes they just need someone from the outside to point out what everyone has showing. And I know that sounds simple, but sometimes you just need to come in and say, "Independent third party here. And yes, that is the problem." So it's nice that you have that sense of authority, but I am personally, I am very cautious about the fact of, look, these people need to live with the solution when I walk away. The worst thing in my mind could be helping a client solve a problem, and then it returned for them.
So even if they did want to call me back, that would be seen as not ideal in my mind. I want to help them get to a solution that then they can buy in and sustain. So that, that first change is going from internal employee to consultant where, you do have to make an impact, a splash, a return on investment, whatever you say. But, I'm cautious to also say, but they need to adopt the change. They need to own it. It can't just be my great idea.
The other side that you talked about is going from employee to entrepreneur, which is also an interesting transition. As an employee, there's some perceived safety and stability, and I say that just perceived, because depending upon the industry that you're in, as markets change and things like that, layoffs come, things of that nature. So job security is never a hundred percent, but there is some perceived job security and stability there.
But as you get past the startup stage, you start to specialize, which means your job responsibility narrows, right? So in a larger organization, typically you become a specialist, but not very broad in thinking, and, and so that can be comfortable as well. You develop some technical expertise. Moving into the entrepreneurial space, which you probably have dabbled in a little bit as an, as a business owner yourself is, you are simultaneously the chief marketing officer and IT support and delivery services, and fill in the blank.
So you're wearing a lot of hats. And it can be difficult to gravitate towards the stuff you're really good at. So, I am best at the delivery, the actual client engagements. But I recognize if I'm not doing sales and marketing, and building new connections like that, eventually that work goes away. So it's trying to manage yourself and not stay where you're comfortable, if that makes sense. And not just deep dive all the way down to specialty in one area and have to learn some of these things. Or, you know, find the right people to do it for you.
[00:18:49] Lindsey Dinneen: Yeah. Yeah. Yeah. That's very insightful. So you are also a published author and I was wondering if you could share a little bit about your book.
[00:18:57] Chad Bareither: Yeah. So the name of the book I wrote in the fall of 2023, it was released, is called "Improve LESS" and intentionally thought provoking title that I got to it in a very roundabout way. The whole concept of the book started behind that, when I launched my consulting firm, I was still working full time as a corporate employee. So a friend of a friend asked if I can help. And I said, "Sure!" And that was a side gig. And then had another one come up and another one come up and then one of those clients wanted something more. And eventually I didn't have time to do a full time corporate job anymore.
But then I had three clients that were all kind of different phases and asking for different things. And so I had one client that was really focused on strategy. And, " We need to align our strategy. We need a better way to cascade that in the organization." Another client that was really focused on process improvement. "We want to build our problem solving and process improvement skills for the organization." And I had a third client that really wanted to have better eyes on the business, so we would call it a daily management system, visualization of metrics and understanding the business so we can diagnose problems.
Well, once you get good at strategy, then you actually have to go improve the processes. Once I'm pretty good at process improvement, I should probably align those strategically. Once I can see the problems in my business, I need to-- so essentially all of those three clients needed the three parts that were together. So I sat back and I said, "Well, this is starting to become a little bit of a mess. What would I do if I had a new client? What, where would I start?"
So I started writing down the process really for my own benefit. And then working with a business coach, I was like, "I'm going to give this away as like a PDF or whatever." They're like, "No, you should turn this into a book." And I'm like, "Like a book?" And they're like, "Yeah." And I had no idea how to do that. So, you know, back to our conversation about entrepreneurs is, so I found someone who did. And I'm work with someone else, a publishing strategist helped me go through everything, which I thought it was pretty good, in terms of editing, that was not the case.
So, went through some content editing and professional editing, and then, hired a professional illustrator from my hand drawn drawings. So, yeah, it was a journey, but that's how it started was me saying, " Well, what's my process?" And so really the purpose of the book is it is a framework. Anyone can pick it up and follow it. And I also tried to keep it short. I don't like to be very verbose in the communications to my clients because they need to understand it. So it's literally something that you could read in a weekend and start on Monday.
[00:21:39] Lindsey Dinneen: I love that. Okay. So yeah. Yeah. So you've written this book, and you have your consulting firm, and what are you excited about coming up? Maybe both personally and professionally.
[00:21:53] Chad Bareither: Yeah. Oh, I think it's easier for me to answer personally. So I'll start there. So my wife and I have three children and they're all pretty active in different competitive endeavors, gymnastics. We talked before, my middle daughter is a dancer, the two girls, the gymnast and the dancer, also play volleyball. And then my youngest son is on a baseball and a soccer team. And so, I mean, I just love supporting them in those. Now I say all that academics are also important. They're doing well academically. That's kind of the condition for doing the sports and stuff like that, but really pouring into them right now.
It's It's going to sound so cliche, but our oldest is 13 right now. And some pictures came up, memories on my phone, and it's goes by quick. So personally, I'm just excited about in them right now. And they're turning-- I use this term and my coworker laughs at me-- but they're turning into real people, with their own personalities and their own likes, and it's frustrating at times because they have their own thoughts. Yeah. But it's fascinating right now. And just being able to spend more time investing in them is, is great.
Professionally is exciting to really I'm niching back down into this medtech area, right? So I'm carrying a pharma client. I came off a pharma engagement. That was just at the beginning of this year and I've worked in other industries, but I'm just really fired up about the work, the technical challenges in these areas. So getting back into some client engagements that are med device and pharmaceuticals, and then, pharmaceuticals has stuff going on that I don't, I can't begin to understand. Bio therapeutic proteins and cell therapy stuff, which is-- it's fascinating technology, but it's still process, right? And so I might not understand the science, but I do understand process. And I've been able to help in those areas. And it's just, it's humbling to be contributing to the field. So I'm really excited to niche back down in that area and do some more work in this medtech field.
[00:23:56] Lindsey Dinneen: Yeah. And when it comes to medtech, are there any moments working with clients that stand out to you as just confirmation that you are in the right place in the right industry at the right time?
[00:24:10] Chad Bareither: Yeah. So, I know very little about cell therapy, but basically, you grow stem cells and you make them into other type of cells that would be beneficial. If there's people in cell therapy listening to this, you can correct me if I'm wrong. But I mean, it's just, it's mind boggling the science, but I was working with that group and so they were building up their pilot capabilities. And I'm looking at for more like an industrial engineering, manufacturing point of view, developing standard work. And so they're like, "Oh, this is so helpful." And I'm just thinking, I'm like, "I don't even understand what you guys do. So the fact that I can be of any contribution here is..."
But I think, pulling back on that is, you need to invest in your strength. So here's, very skilled multi year experience, PhD scientists. And sometimes they just need someone to help them with structuring up the process flow and the capacities and the standard work that they need to do this consistently. And I'm good at that. And so this kind of harkens back to our conversations about entrepreneurship, right, of knowing what you're good at and knowing what you need help with. And I just, I know what I'm good at. And if I find clients that need help in that area, I'm thrilled to support it. But that was one engagement where it was like, "I understand about zero of what you just explained to me, but I think I can help you."
[00:25:36] Lindsey Dinneen: I love that. That's fantastic. One of the things I've noticed and really appreciated about the medtech industry is everybody is really good about celebrating and acknowledging how we all fit into the efforts to make it successful. So even if you are not the scientist, or you are also an engineer, but say in my case, I'm not a scientist, I'm not an engineer, but I do have a marketing ability. And the respect mutually that occurs for everybody's contributions, I think is really special in the medtech industry. I'm wondering if you experienced that too.
[00:26:17] Chad Bareither: Yeah. You know, I think there's definitely times it's kind of like a family, right? Families fight, the families get along together. There's definitely times where it's like people are like, "Ah, sales department doesn't know what they're doing," or and you're like, but at the end of the day, you recognize you do need all those parts. Unfortunately, these technologies and this research is expensive. So you do need to sell, right? I mean, that's a reality. So you're right. They do all need to get to, and if people slow down, I think you're right. Eventually everyone's, " Yes, we need all these parts to work."
I think there's definitely times where people are having a bad time and they get a little grumpy and they're like, "That department doesn't know what they're doing." But it's, but no, I think all the departments are actually really good at what they're doing. So, you just look at the growth that you're seeing in the industry and the valuation of some of these companies and it's, they know what they're doing and they're serving a need that, that we have supporting our health and wellness. And so it's cool. It's really cool to see that all come together.
I think you get a very interesting view of that at some of the smaller organizations 'cause there is a lot more of that trust and that team camaraderie, but even, you know, I worked for a fortune 500 company when I was in in med device, as a corporate employee. And you still have that, within the product teams, within the production teams, that they're there to support each other, they're there for the win. There's also a healthy dose of competition in the industry, I think, that makes it a really driven. So it's, it's fun to be a part of it's fast paced because of the personalities. It's fast paced because of the science. It's fast paced because of the competitiveness with other competitors in the industry. So yeah, it's a fun space to be in.
[00:28:00] Lindsey Dinneen: Yeah, absolutely. Yeah, so 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 could be in your industry, but it doesn't have to be. What would you choose to teach?
[00:28:17] Chad Bareither: Yeah. So this is maybe, I'm hopefully not being risk averse here, because I would teach something that I'm already good at teaching. So some of my favorite things to teach are structured problem solving. So most people that are in any type of leadership position got there because they were probably good at solving problems. And I think where we have challenges in, as organizations grow, is that not everyone solves a problem the same way. So how do you develop the new talent coming up to be like those next leaders? And you can't, you shouldn't just rely on individual people to be like, "We'll just find the good problem solvers and they'll go up."
I've seen in organizations where you can really multiply, even exponentially grow, the pace of improvement by having structured problem solving in. So that's what I would do. Personally, that's DMAIC formatted problem solving. It's a five phase problem solving approach: Define, Measure, Analyze, Improve and Control. So that's something that I love teaching because I love the lightbulb moment that goes off in people's heads and we teach them that. There is a portion of that is statistics and I love teaching statistics because most people think this is going to be the worst thing ever and I tried to make it a little bit fun and they're like, "Oh, that was fun. And I learned something." And that's what fires me up. So yeah, it would be structured problem solving. That's what I would teach a masterclass on.
[00:29:43] Lindsey Dinneen: Okay, I like it. And how do you wish to be remembered after you leave this world?
[00:29:49] Chad Bareither: Oh, my. So my love language that I express as in service. Helpful, that's, I think that's the main thing. Whether it's in a client engagement or in the neighborhood or the family, I enjoy helping people. And so whether that's consulting on the launch of a new diagnostic device or helping someone repair their tractor, right? I enjoy engaging and learning with people and solving problems together. So I really like helping people. So I think I'd like to be remembered in that way. Helpful.
[00:30:27] Lindsey Dinneen: Yeah, I like it. Absolutely. And then final question. What is one thing that makes you smile every time you see or think about it?
[00:30:38] Chad Bareither: One thing. Well, I don't know. I've smiled a lot this week, seeing pictures of my kids when they were younger, because I don't know, maybe my iPhone's just paying tricks on me. It keeps showing pictures of my kids when they were little. So that's it. I think right now, just the point of life that I'm at right now as kids, two of my brothers just had babies as well. So little kids and just me realizing like my kids are never going to be that age again. I've been on travel and seen a lot of little kids in different cities, and it's sweet because it's so simple. Their world is so simple at that age. So I think it makes me smile just because the innocence is there. Yeah. I'm gonna stick with that.
[00:31:17] Lindsey Dinneen: Yeah, great answer. It's, it's special to witness and it always brings a smile too. Especially little kids at airports that are dragging their tiny little backpacks or rollie bags behind them and they've got their best stuffed friend. Oh my gosh, it's so cute.
[00:31:35] Chad Bareither: So one thing that's been interesting to see is when people have younger kids, and maybe they're misbehaving or maybe they're just excited, right? And the parents are kind of flustered. It's just it's, it brings a smile to my face. Not because the parents are flustered. It's just because I can remember being a parent and you make a big deal out of it, and it's man, but I just appreciate the innocence and the genuine joy that this small human is trying to have right now. And it's, I think, that's the thing right now in my life. That's bringing a smile every time I see it or think about it.
[00:32:05] Lindsey Dinneen: I love it. I love it. Well, Chad, this has been an incredible conversation. I really appreciate your insights and advice and everything that you're doing. If anyone's listening and needs some outside support, please definitely get in touch with Chad. 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 just wish you the most continued success as you work to change lives for a better world.
[00:32:42] Chad Bareither: Thanks a lot. And you got a lot going on. So I wish you continued success in all your endeavors as well.
[00:32:49] Lindsey Dinneen: Awesome. Well, thank you so much. 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.
[00:33:04] 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. Silvia Blemker | Co-Founder & CSO, Sprinkbok Analytics | Teaching & Advancing Biomedical Engineering & Muscle Analytics

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 CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: 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 | CEO, HVG Executive Solutions | Balancing Strategy & Execution, Building High-Performing Teams, & MedTech Advancements

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 CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: 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, Medicomp Systems | Enhancing Healthcare IT, EHR Usability, & Being Mission Driven

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 CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: 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 | Co-Founder, TruDiagnostic | Pioneering Epigenetics, Transforming Healthcare, & Making Science Accessible

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 CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: 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 | Managing Partner, MediStrat360 | Commercialization, Advocacy for Women in MedTech, & Industry Leadership

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 CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: 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.