The Leading Difference

Velentium
  • 5.0 (2)
  • MANAGEMENT
  • UPDATED BIWEEKLY

MedTech Leaders Changing Lives for a Better World

  1. 12/12/2025

    Katie Bochnowski | SVP Customer Success & Services, NowSecure | Navigating Mobile Security in MedTech

    Katie Bochnowski is the Senior Vice President of Customer Success & Services at NowSecure. Katie shares her journey from studying cyber forensics at Purdue University to becoming an expert in mobile app security and forensics. She discusses the impactful work her team does in securing mobile apps, especially in the medtech industry. Katie also offers valuable advice on building relationships within organizations, the importance of security best practices, and staying curious as a professional.  Guest links: https://www.linkedin.com/in/katiestrzempka/ | https://www.nowsecure.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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 070 - Katie Bochnowski [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 absolutely delighted to introduce you to my guest, Katie Bochnowski. Katie is Senior Vice President of Customer Success and Services at NowSecure co-author of the book, "iPhone and iOS Forensics," and a recognized expert in mobile forensics and app security testing. Katie holds a master's in Cyber Forensics and Bachelor's of Science and Computer Technology from Purdue University. In her current role, Katie oversees customer support, onboarding and success departments, as well as the mobile AppSec Professional Services Organization that is responsible for pen testing, training, and consulting. All right. Well, welcome. Thank you so much for being here. I'm so delighted to speak with you today. [00:01:37] Katie Bochnowski: Awesome. I'm really happy to be here. [00:01:39] Lindsey Dinneen: Excellent. Well, I would love, if you wouldn't mind just starting off by telling us a little bit about yourself, your background, and what led you to medtech. [00:01:48] Katie Bochnowski: Awesome. Sure. So, I'm Katie Bochnowski. I work for a company called NowSecure. My background, dating back many years to school is in computer technology and more specifically cyber forensics. Where I am now is mobile app security. How I got into that industry is, is really from that forensic background. Our company used to do data recovery and forensic investigations on mobile devices, and we kind of quickly realized that mobile apps are storing a lot of data. So we shifted into proactively working with organizations to secure those apps that reside on devices. And in terms of medtech, obviously you can probably make that connection, but we began working closely with first, companies that really care about the data that's being stored, and transmitted on those apps, which absolutely includes medtech industry. [00:02:43] Lindsey Dinneen: Awesome. Okay, so going back a little bit. So when you were first deciding on college paths and career paths and all those lovely things, what drew you to where you ended up? [00:02:55] Katie Bochnowski: You know, I don't have a great, like "aha" moment for this question. It was just one of those things. I grew up, I had a computer in my house. I did Typing Tutor when I was really young on MS Dos, and I just always en enjoyed that. I had a friend in high school and we both got interested in making our own website with HTML. So, it was just enjoying being around computers and also tinkering to figure out what was wrong with something from a technology perspective. Purdue is where I attended. Purdue had a more generic computer technology degree that I didn't have to know exactly what I wanted to do. You could try different paths, so that's kind of what got me into it. It's not like I knew I wanted to do that my whole life, but I never really went back or questioned it. I always just kind of enjoyed it along the way. [00:03:45] Lindsey Dinneen: Yeah. Excellent. Okay, so the phrase cyber forensics is just exciting. So, can you dive a little bit more into exactly what that means and entails and what it looks like? [00:03:57] Katie Bochnowski: Yeah, absolutely. So, it is exciting- -so much so, in fact, that my senior year of college, the very first time they offered this class, it was called Cyber Forensics, it was an elective and it sounded amazing. And, it was amazing. It was really cool. We went through from start to finish, how you collect evidence from a computer and technology perspective, how you keep it pristine, how you collect the data off of it. We even got to work with local law enforcement as part of an internship to do all that, so I was very lucky in that my very last semester of my four years, they offered this and I just really, really liked it. It always was there in the back of my mind. So yeah, cyber forensics is really the collective of all things digital, which is everything, now. I don't do, necessarily, that work anymore, but I can't even imagine all of the data collection off of Alexas and, and all of those devices. But yeah, that's, that's kind of how I got into that. [00:04:56] Lindsey Dinneen: Wow, that's really cool. Yeah. So, okay, so talking about this data collection and all of these things, I'm curious, what are maybe one or two things that just really surprised you when you started getting into the industry and doing the work? [00:05:11] Katie Bochnowski: I know people always said this, and it shouldn't have been a surprise, but when I first started working for NowSecure-- which was actually called Via Forensics back in the day when I first started-- we worked on a lot of individual cases, so people saying, " Can you recover my deleted text messages, and pictures..." and things like that, and the amount of data that really does reside on those devices still after you delete them, going back months, years. So, I don't know if that's still the case now. I don't know if they do a better job of that, but that was surprising to us. What was also surprising was how much apps are storing and transmitting data on those devices when you don't think about it. So a lot of these cases that we would work on, they would focus so much on voicemails, emails, photos, and text messages, but nobody ever said, "Hey, can you go check the Facebook app or the Messenger app you're using?" That was something we realized pretty quickly, and were shocked to see-- this was 15 years ago-- how many apps were storing incredibly sensitive information on those devices. [00:06:20] Lindsey Dinneen: Yeah. And so now that there's more awareness of this and people are maybe, hopefully taking a little bit more ownership of even their own awareness and education with all of it, what do you see are the changes and shifts towards better protection? [00:06:38] Katie Bochnowski: Yeah. Great question. So there's a couple things: One, people are more aware, so they are leveraging the best practices really for these things. So there's places you should and shouldn't store data on devices, and you should use encryption for sensitive information and encryption that can't easily be broken into. The platforms themselves, too--Android, iOS-- have also made improvements in protecting those sandboxes. But, it's not everything, so you absolutely still have to be mindful of that. A lot of organizations like medtech companies and financial organizations do add a lot of those extra protections. But a lot of people don't, still. They're not either, don't think about it as much or aren't aware of it. And then the other thing that we see is everyone could have, you know, a hundred percent perfect intentions in storing and protecting that data, but you make a mistake, or you accidentally leave a debug flag on or something like that, where this information still can be accessed even though developers and security organizations are following the best practices there. [00:07:51] Lindsey Dinneen: Hmm. Yeah. So as you look toward the future of device security in general and cybersecurity, what are you looking forward to in terms of improvements, and hope for the future? Because I know there's a lot of things to worry about, just in life. But, what are some of the things that you're hopeful about? [00:08:11] Katie Bochnowski: Yeah. I'm hopeful for the--I'm going to call it the camaraderie--we're seeing between security and development groups. Not that there was argument or debate between them before-- there probably was a little bit-- but we are seeing a lot more organizations have what they refer to as a Security Champions Program, which brings those groups together. Security used to be seen, and probably in a lot of cases still, is seen as that blocker. Developers are being rushed and pushed to release features quickly. They have deadlines, timelines, and then if security finds an issue, it has to go back to the drawing board to remediate. But, with these programs, we're seeing either a development group that has a security champion there, or just teams kind of melding together a little bit more to build that testing earlier on. That's a trend we're seeing increase more and more. And

    29 min

  2. 11/28/2025

    Charu Roy | Chief Product Officer, Enlil | MedTech Innovation, Leadership Journey, & Customer-Centric Solutions

    Charu Roy, Chief Product Officer at Enlil, shares her extensive journey in the software industry, which began in the late 1980s and evolved into her leadership role in medtech. Charu discusses her role at Enlil, where she oversees the development of an AI-powered platform to enhance medical device lifecycle management. She emphasizes the importance of understanding customer needs, fostering team potential, and ensuring cybersecurity in medtech software solutions. With profound insights on her career growth, leadership style, and the technological advancements propelling the industry forward, Charu's story is an inspiring tale of innovation and dedication to improving lives.  Guest links: https://enlil.com/ |  https://www.linkedin.com/company/enlil-inc/ Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 069 - Charu Roy [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 absolutely delighted to introduce you to Charu Roy. Charu is the Chief Product Officer at Enlil, where she leads product strategy, vision, and execution for the company's AI powered medtech development platform. With over two decades of experience building and scaling enterprise software products, Charu brings deep industry expertise in product management, user-centered design, and go to market leadership. Before Enlil, she held senior product roles at industry leaders, including Epicor, Oracle, I-2 Technologies slash Aspect Development, HP and Agile Software, where she drove software innovation across enterprise cloud SaaS and data driven solutions. Known for her ability to align customer needs with business strategy, she is passionate about delivering products that transform complex industries and enable measurable impact. Well, welcome, Charu, to the conversation today. I'm so excited to be speaking with you. [00:01:54] Charu Roy: Thank you so much for having me. I'm very really excited about being here on this podcast. [00:02:00] Lindsey Dinneen: Oh, awesome. Yeah. Well, I would love, if you wouldn't mind starting off by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:10] Charu Roy: Sure. As every other sort of person who gets into the software world, I came in a while back in 1987 to 89, where I did Master's in Computer Science at University of Louisiana. That was my first introduction to America, really. And computer science brought me to the Bay Area where I worked at HP, Hewlett Packard. In those days, it was called Scientific Instruments Division in Palo Alto. And there I programmed robotic hands to, to sort of move that, the vial from samples, drug samples from athletes so that they could get tested for drugs. So, I didn't know the importance of all this. It was my first job. I enjoyed myself seven years, you know, software programming, really, and understood how a large company works. And then slowly I started getting a little bored. So I went on to my next startup and was involved in the same kind of principles that drive things today. So I just sort of built my way up. In terms of the software, I joined different groups, ran consulting services, ran engineering, and sort of worked myself up through the ranks and into sort of more decision making capabilities, and you know, continued to join companies and learn new things and leave them for some better opportunities. So I moved from Hewlett Packard to a startup that was called Aspect Development, which got sold to I-2 Technologies for $9.3 billion in those days. So, you know, I went through that acquisition, trying to understand the market, what kind of software triggers buying, you know-- so sort of just the software aspects of how to sell software, how to develop software, how to deploy it. So in general, I was learning all of the ropes until I came to Agile PLM, which is a company which, very popular company which made it very sort of easy to deploy software, especially software called Product Lifecycle Management. So I was -- here, I was in and out of companies, learning and understanding the world of software until I fell into med device companies being my customers. So med device being our customers meant, you know, a lot more strictness, a lot more process, with the software itself. So here I was trying to now go through those kind of features, trying to understand what med device needed when they were building products. So, from Agile, I went to Conformia. Again, it was the same, it was regulatory product for wine, spirits and pharma --very adjacent to med device. But again, it was the same thing about how to be provide, how to provide a traceable platform where our customers can trace there, the make of the wine or make of the spirit, or make of a pharma drug or make off of med device. All the principles underlying it are the same because it's a regulated product at the end of the day, but so that's how I kind of fell into it, and I enjoyed every bit of that until I got acquired by Oracle. And so I continued at Oracle doing the same thing over and over again; rebuilt the same products again at Oracle in the clouds, and I was managing the old Agile products. So it's an interesting journey where I was, you know, started off as a software programmer. And I didn't know anything about, you know, the use cases until the time I sort of joined Oracle and understood my customers better. And that's how I came in there. And of course I was at Epicor and finally I made my way to Enlil, which is a very small company, and I'm doing the same thing again. It's just with a different set of customers, very small to medium sized companies. So that's how my career sort of spanned 30 years. [00:06:11] Lindsey Dinneen: Wow. Oh my goodness. Well, there is so much to dive into all of that. Thank you for sharing. It's so cool to hear about all of the winding paths that lead us to maybe, you know, where we're meant to be in, in any given season. And yeah, I just love learning about it. So, okay. So I'm curious, you know, way back when did you like growing up, did you always have an interest in computers and computer science? Is this something you knew you wanted to get into? [00:06:40] Charu Roy: Not at all, actually it was a suggestion, and in those days, parents kind of suggested that you be a engineer or a doctor or a chartered accountant. The choices were very limited. And so my father said, "you will do computer science." And I said, "okay." And there I was and there was no, no sort of emotional attachment to any of those professions. And, I liked it well enough to continue, and I found it was easy enough to understand the principles and work at it. So yeah, there was no-- you know, in these days I think kids are training themselves like by seven or eight to program. And I'm seeing, you know, machine language I mean AI, ML, LLMs being taught to seven year olds and sort of trying to shape them, but in those days it was just some very simple choices, I guess. So, yeah, not a very romantic story. I was never programming younger in my younger days, but I think you know, compared to all the choices youngsters have these days, but just fell into it. [00:07:44] Lindsey Dinneen: Sure. Oh, how fun. You know, even though, yes, it was somewhat prescribed for you, at least originally, and I'm so glad that you fell in love and it ended up being a happy place for you because... [00:07:57] Charu Roy: Yeah, and I think I fell in love with the customer, how customers reacted to the software. I didn't fall in love with the software delivery process or anything else, but it was just the way customers said, "oh, I like that. It's gonna make it easier for me to do something. I'm having a tough time tracking it on paper. I just hate it what I'm doing right now, and your software will help." So I think that's a part that makes me feel really pleased that okay it's going into some good hands and it's going to be used. [00:08:30] Lindsey Dinneen: Yes, by people who really appreciate and value what you can contribute, what maybe comes --at this point, I guess-- naturally to you. And so it's, you're able to translate somebody's ideas or dreams into a really tangible solution. [00:08:48] Charu Roy: Yeah. And in fact, somebody's pain points, like they're really sort of, trying their best to use little resources they might have, wasting a lot of time on either tracking something on paper or in emails. And I think those are the kind of pain points that I really like to understand and say, "Hey, will the software help really help your day to day life? Will it make it easier to find things?" I think that's where I find my sort of biggest thrill of when a customer says, "Yes, you shaved off three hours of my time by giving me this efficient system." [00:09:26] Lindsey Dinneen: Nice. Yeah. Oh my goodness. Yes , and the products that you'r

    34 min

  3. 11/14/2025

    Garrett Schumacher |  Product Security Director, Velentium Medical & Co-Founder/CTO, GeneInfoSec | Navigating the Future of Medical Device & Genetic Security

    Garrett Schumacher is Business Unit Director of Product Security at Velentium Medical and the co-founder and CTO of GeneInfoSec. Garrett discusses his journey from medical student to cybersecurity expert and educator, dedicating his career to securing medical devices. He shares insights on the intersection of cybersecurity and healthcare, highlighting the challenges of protecting genetic data. Garrett gives honest advice about navigating cybersecurity and data privacy concerns, how to be a good leader, and what medtech startups should consider as they design and develop their devices.    Guest links: https://velentiummedical.com/ | https://www.geneinfosec.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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 068 - Garrett Schumacher [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 excited to introduce you to my guest, Garrett Schumacher. Garrett is the Business Unit Director of Product Security at Velentium Medical, where he has led the cybersecurity efforts on 200 plus medical device products and systems. He is the co-founder and CTO of GeneInfoSec, a startup focused on securing the world's most valuable and private data, our genetic information. In his work, Garrett has trained engineers, developers, manufacturers, healthcare delivery organizations, and laboratories across the globe in cybersecurity, and is an active member of several related industry working groups. He also teaches secure product development and medical device cybersecurity at the graduate level for the University of Colorado Boulder's Department of Computer Science as an adjunct professor in the little bit of time left in his days, Garrett is either rock climbing or spending time with family. Thank you so much for being here, Garrett. I'm so excited to speak with you today. [00:01:48] Garrett Schumacher: Yeah. Thank you for having me. [00:01:49] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind, by starting out and sharing a little bit about yourself and your background and what led you to medtech. [00:01:59] Garrett Schumacher: Yeah. So I guess my background, I mean, it started as I always thought I was gonna be a doctor. I did my undergrad in physiology, thought I was gonna do med school, the whole nine yards. And towards the end of my, let's say junior year, just started being like, "I don't think this is what I want to do." I always had a fascination with tech. I was really involved with a lot of the tech groups on campus at the University of Colorado Boulder, early days of Hack CU, one of the largest collegiate hackathons. And I really regretted not doing a computer science degree, but I was three quarters of the way done. So sometimes you just gotta finish it up, right? Get the degree, find out what's next. After that I went and did a master's in genetics. I wasn't sure exactly what I wanted to do either yet, but hey, a master's degree is not a bad thing to do if you're unsure. And actually I was in a PhD program and dropped out early with a master's. Different story. But yeah. And then I started I helped the University of Colorado Boulder start their cybersecurity programs. So it was getting into the cyber world. I did a, I guess it was a bootcamp, at the University of Denver in cybersecurity. And so that all culminated in me always focusing on healthcare and cybersecurity together. And then COVID happened and that made the world change for a lot of people. And basically I was looking for a new job and I found Velentium, and I think that's where it really spoke to me, where I could do my love of medical and human health with cybersecurity and technology development. And so yeah, I think that's really how I got into it. I had been doing projects related to that before, but Velentium's where it really culminated and I found a place that let me do all the things I love, not just one or the other. [00:03:39] Lindsey Dinneen: That's awesome and such a wonderful gift. So can you share a little bit about what you do now and sort of your growth trajectory even throughout Velentium 'cause I know you've had quite an interesting and exciting career through the company as well. [00:03:56] Garrett Schumacher: Yeah. Yeah. So I started out as a cybersecurity engineer, and just started helping internal projects, external projects with groups that were seeking FDA approval on a medical device and trying to navigate these kind of new cybersecurity requirements. That's where it started. And even since then I've been, so I teach a class at the University of Colorado Boulder on Medical Device Cybersecurity. We're going into our sixth year of that, seventh semester, starting here in the fall. And I also co-founded a startup in the genetic information security space. So, and we can talk about that later. And so I, yeah, talk about what I do. It's all of those things and, it's not, doesn't happen in 40 hours, I promise you that. But after working as a cyber engineer for about a year, I think I got promoted to like Senior Staff Cybersecurity Engineer. Then probably three years ago, I took over more of an operational leadership role within the unit, the team, where I was doing project management and overseeing the other engineers and still doing engineering work. Definitely decided project management is not for the faint of heart and apparently my heart's very faint. It's not for me. So anyways, and then fast forward to just here in like January, February, Velentium made some really awesome changes. They rebranded as Velentium Medical to make sure everyone knew we do medical. And then they created four business units so that they could really say, "Look, we have different core areas of our business. Each of them have their own different operational needs and what have you." So, I was promoted into Business Unit Director of Product Security. And so now we're a business unit. We're a business within a business trying to better serve our clients and implement the processes we need for our small scope of work compared to a large contract development and manufacturing organization. So just that's been my growth goal so far is, come in as an engineer, work my way up to the leadership roles while also still loving to be an educator and and still having my own startup space in the biotech side of the house. [00:05:58] Lindsey Dinneen: Yeah. Excellent. Well, first of all, congratulations on all of that. That is very exciting and it's really fun to see that growth and that development. And I'm also so curious now, can we talk a little bit about your startup? So first of all, let's talk about that and then I wanna talk about the crossover between the two, if that's okay. So. [00:06:16] Garrett Schumacher: Absolutely. Yeah. So, well the name is GeneInfoSec, so it's just short for genetic information security. We're not trying to hide anything there. We focus on protecting the world's most sensitive data. At least that's our opinion is genetic information affects you. And the data you have today is not gonna be any different, for the most part, from the data that you have in, 10, 20, 40 years. But then even beyond that it's partially your children's data, your grandchildren, great-grandchildren, and then even on the, in the inverse, all the way up to your great-great-grandparents, right? You share some, to an extent, some genetic makeup with them. And so it's this really interesting space where networked privacy is-- it's a very different form of networked privacy. It's not just that I upload a photo to LinkedIn and now I could be implicating someone else that's in the photo. It's, I share my info, and I'm also sharing info that belongs to my cousins in, in, in a sense. And so if you think of the Golden State Killer case in California, that was a really interesting one where the federal authorities had genetic information or samples from a cold case in the eighties. And they sequenced that. They uploaded it to a third party, an open public genetic database, and said, "Hey, here's my data. Who am I related to?" And through that they were able to triangulate like, "Okay here it is. This is the guy that did it" many years later. So, there's a case where it's, there could be positives. We want to use it to find that kind of information and protect people. But at the same time, that brings up a lot of privacy implications. And then you can go all the way to the extreme, the sci-fi of designer bio weapons, maybe tailored to certain persons or ethnicities or groups of people. So during grad school, a couple guys and I, we founded this startup, and that's what we focus on through a technology that really our founder, Dr. Sterling Sawaya, he invented, called molecular encryption. It's a way of encrypting molecules before we generate data from them so that the generated genetic data is already

    32 min

  4. 10/31/2025

    Sarah Ptach | President & CEO, Canyon Labs | Elevating MedTech Standards, Leadership in Innovation, & Patient-Centric Culture

    Sarah Ptach, President and CEO of Canyon Labs, discusses her journey from professional sports and advertising to leading Canyon Labs, a company specializing in medical device and pharmaceutical testing. Inspired by her father's Parkinson's diagnosis, Sarah transitioned to healthcare to make a meaningful impact. She delves into her leadership philosophy, emphasizing the importance of trust, transparency, and collaboration in building a strong company culture. Sarah also highlights Canyon Labs' dedication to elevating industry standards and ensuring patient safety.    Guest links: https://canyonlabs.com/ | https://www.linkedin.com/in/sarahptach/  Charity supported: The Michael J. Fox Foundation for Parkinson's Research Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 067: Sarah Ptach [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 today I am super excited to introduce you to my guest, Sarah Ptach. Sarah is the President and CEO of Canyon Labs, a leading provider of medical device and pharmaceutical testing, consulting, and sterilization services. She joined the company during a critical ownership transition with a clear goal in mind: to raise the standard of service in the industry and build a true end-to-end solutions partner. Drawing on her background in packaging engineering and testing, Sarah focused on expanding beyond packaging alone to create a more integrated, accessible, and expert driven experience for clients. Sarah began her career in professional sports and advertising, but a desire to create more meaningful impact led her to the healthcare space after her father was diagnosed with Parkinson's disease. She went on to help grow and successfully exit a packaging firm before bringing her vision and leadership to Canyon Labs. In addition to her role at Canyon, she co-leads Kilmer Innovations and serves on the board of the Medical Device Packaging Technical Committee of the Institute of Packaging Professionals. She remains deeply committed to advancing healthcare through innovation, expertise, and strong partnerships. All right. Well, thank you so much for being here, Sarah. I'm so excited to welcome you to the show. [00:02:05] Sarah Ptach: Likewise. Thank you, Lindsey. I appreciate you having me. [00:02:08] Lindsey Dinneen: Of course. Well, I'd love if you would start off by telling us just a little bit about yourself, your background, and what led you to MedTech. [00:02:16] Sarah Ptach: Yeah. Thank you. So I'm Sarah Ptach. I'm the president of Canyon Labs. I have kind of an interesting story of getting into to medtech. I originally started my career actually in professional baseball. I was a contract negotiation person mainly for closing pitchers. And I ran track in college. I thought like, "oh, I wanna be in sports." And I like to say that's the most fun I never wanna have again. It was, it was a great start of a career. It teaches you a lot about negotiation, teaches you a lot about high stakes opportunities. But, you know, in the end it, it felt very kind of un unfulfilling in that perspective. And so I had kind of then taken that into to marketing for a pretty big ad agency in Chicago and hit the same thing. I felt like I was-- you know, now I was just selling people stuff that they didn't need instead of promoting people that, you know, that make a ton of money in the sports industry. And at the time my dad was diagnosed with Parkinson's disease and I wanted to feel like I was making a difference. So I, I went back and got my MBA and my whole goal of that was really to, to use my skills to, to do something that makes a difference in people's lives. So, I had reached out to a really small medical device company and it's " I'm willing to make no money as long as we, we have a difference in a change we can make in the world." And at the time that company couldn't hire me but I ended up getting introduced to another company through that that was in medical device packaging validation. And that was the first dip of medical device that I had. And that company's Packaging Compliance Labs. I was one of the first employees there and we grew that company until it sold a couple years ago. And through that, learned a ton about the medical device space. I kind of made it my personal mission beyond just my job to, to go try to participate in the industry as much as possible, push the status quo of things as much as possible, and really kind of learn where the testing realm or validation realm can make a difference in, in medical devices. And so after that, I was given the opportunity to step in and run and grow Canyon Labs. And Canyon is a whole platform. So for me, it was taking the packaging knowledge that, that I love so much and making that a full service offering. You know, I had always dabbled in sterilization or heard about Biocom, but never really gotten my hands on it. And to be able to be that full service solution with Canyon has not only been a awesome offering to, to give to our clients to really be able to go A to Z, everything from your regulatory to your microbiology, chemistry, packaging, bio comp, and toxicology. But also a good learning challenge for me. I thought that I was, you know, a pretty good packaging engineer and now learning chemistry and microbiology and toxicology, I'm like, "oh, wow. I'm definitely not as smart as I maybe thought I was originally," and I luckily have some amazingly intelligent individuals that, that work on our team, but it's, it's an awesome opportunity to, to not only get to help bring some life-changing medical solutions to market but also have a really good technical brain challenge every single day. [00:05:26] Lindsey Dinneen: Wow. Oh my goodness. I love that. And yes, I mean, sometimes I feel like actually, you know, not being the smartest person in the room is such a gift because then you get to talk to all these really cool people with really amazing experiences and learn. And I'm just one of those people who's constantly-- well, I'm curious all the time, so if I don't understand something, I'm like, "can you tell me more?" [00:05:48] Sarah Ptach: Yeah. No I love that. I completely agree. I think that the better that you can be at facilitating conversations, the, you know, the more successful your organization will be. And it, I really think as the leader of a company it's less about being the, you know, smartest person in the room and more about being the facilitator of that collaboration. [00:06:10] Lindsey Dinneen: Yeah. Yeah, absolutely. I love that. So, okay, so going back in time a little bit-- so, so I know you started off with professional sports, which is really cool. Like what a, what an interesting, unique opportunity and experience and you know, you'll maybe never want that particular brand of fun again, but. I still love that you got to do it. And so I'm curious though, was that always the sort of planning goal for you? Or when you were trying to think about career paths and all of that, younger, what were you envisioning? [00:06:39] Sarah Ptach: Yeah. I think I, I always envisioned myself as a leader. The packaging side of things became my kind of technical passion. But I mean, from a young age, I've always been the captain of the track team or the, you know, the head of any school organization I was a part of. So I always knew I, I wanted to be a leader. I think now, you know, being in that role, you, you learn so much about what different styles and brands of leadership is. I think, you know, to go back to your question about being the smartest in the room, I actually think that, you know, the CEO's job isn't to have all the answers. It's to create the culture where the answers emerge. And, you know, I've always wanted to be a leader. I've been passionate on that side, but I really think that the more, you know, more so than just having leadership pieces to you. It's about having that power to bring people together in that way. [00:07:31] Lindsey Dinneen: Yeah. That's a beautiful way to put it. And I actually would love to dive into this more because I know creating a really positive, good company culture is really important to you, and it's frankly, easy to get wrong, unintentionally-- sometimes maybe it just is what it is, but like sometimes it's not a desire to create it, but it happens. So I'm curious, how have you really intentionally cultivated your current company culture, and where did those lessons come from? [00:08:00] Sarah Ptach: Yeah. Deep question. You could answer that in a bunch of different ways and I could talk your ear off about lessons learned on that side. But I, I think the, you know, the most overlooked competitive advantage, both internally and externally is trust. Like the trust in your team to make decisions, the trust in your clients and even the FDA and your labs work. There's trust across it

    34 min

  5. 10/17/2025

    Tyler O'Malley | VP of Clinical Affairs, Exagen | Pioneering Autoimmune Diagnostics & Building Communication Bridges

    Tyler O'Malley is the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen, Inc. Tyler shares his journey in the MedTech industry and discusses Exagen's innovative approaches to autoimmune testing solutions, including cutting-edge diagnostics for lupus and other diseases. With over a decade of experience, Tyler provides insights into the challenges and breakthroughs in the field, highlighting the significance of early diagnosis and personalized treatment, while also discussing the challenges and opportunities in effective leadership during different stages of company growth.   Guest links: https://exagen.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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 066 - Tyler O'Malley [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, Tyler O'Malley. Tyler serves as Associate VP of Clinical Affairs and Market Access at Exagen, Inc., a leader in autoimmune testing solutions. In his role, he oversees clinical trials, bioinformatics, and medical policy development for Exagen's current diagnostic portfolio and pipeline of proprietary solutions. With more than a decade of experience, O'Malley has contributed to more than a dozen clinical trials focusing on clinical validity and utility evidence for autoimmune diagnostics. His expertise is widely recognized with numerous publications in esteemed peer reviewed journals, and notably, he's the first author of one of the largest clinical utility studies in lupus diagnostics. O'Malley graduated from Georgia Gwinnett College with a Bachelor of Science in biology, concentrating in biochemistry. His 11 year career in research and development and medical affairs encompass medical science, education, assay development, and clinical research coordination. Well, welcome to the show, Tyler. I'm so excited to have you here today. [00:02:01] Tyler O'Malley: Thanks, glad to be here. [00:02:02] Lindsey Dinneen: Yeah, absolutely. Well, I would love just starting off by telling us a little bit about yourself, your background, and what led you to MedTech. [00:02:11] Tyler O'Malley: Sure. So, I'm the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen. We're a specialty diagnostics company focused on autoimmune rheumatic diseases. So we develop proprietary testing technology for conditions like lupus, rheumatoid arthritis, Sjogren's disease, as well as many others. And yeah, our focus is trying to find solutions for patients who are dealing with what are many times challenging chronic diseases that can present themselves in very mysterious ways oftentimes. And so, these are challenges that patients have that have, for the most part, gone unsolved for many decades, and so there's a lot of opportunity out there. In terms of, myself, my background, I've been with Exagen for the past 11 and a half years. So I've been doing this for a while now, and I've worked in a couple of different areas within the organization, doing work within the lab assay development, as well as outside the lab doing clinical research, statistical analysis, which led to the bioinformatics role. And then as well as doing some work trying to align our clinical evidence with medical policy for our tests which is the market access role. So, a little bit of everything, but there are some through lines that I assure you do make some sense if you really think about it. [00:03:33] Lindsey Dinneen: Excellent. Excellent. Well, thank you for sharing a little bit about that. There's so much to dive into, but going back a little bit in your story, when you were thinking about careers-- you're a eager high school student ready to embrace college, and you're ready for the next step --is this something that you could have imagined yourself doing or has this always been a passion of yours? Or is this something you kind of found yourself in? [00:03:57] Tyler O'Malley: Not at all. So, no I, so I will say I've always been interested in autoimmunity. So that's always been something that has always piqued my interest, whether I was in high school or college. And so I guess in that sense, it's not a surprise. But the laboratory diagnostics component of it was not something that was on my radar when I was in high school or college. And I guess the journey to Exagen was, after graduating from high school, went and got a bachelor's degree in biology with a biochemistry focus. So, that's sort of my background there. And while I was getting the degree and focusing on biochemistry, I had the opportunity through a resource scholarship at Georgia Tech to work in a graduate lab, which was a really interesting experience where, you know, for a little over a year I had the opportunity to work alongside PhD candidates, postdocs, on a research project that was partially funded and get the experience and understand what it's like to work towards a PhD and what it would look like to kind of go down that path of graduate level research. And I think it had the opposite effect that it was intended to have in that it kind of showed me I didn't want to do that. So, I think in a lot of ways I was happy I had that experience 'cause it showed me before I went down that path that it was something I didn't wanna do. Nothing against it, I guess I wanted to do something that maybe had more of a translational impact, a little bit closer to the patient. And so, finished my degree, and at the time I was living in Georgia, so I finished my degree in Georgia, left and moved out to California, and ended up at Exagen by pure chance through a recruiter. And that was back in 2014, and basically just joined Exagen at the time when it was a smaller company, and grew with the company, and was fortunate enough to have the ability to learn a lot of different functions within the company as it grew, and there were a lot of different things that needed to be done a as the company was growing. And so it, it's been kind of a, an interesting ride since then. [00:06:08] Lindsey Dinneen: Yeah, absolutely. And of course all of those different experiences, I'm sure, have woven their way in, like you said. Sometimes you have to kind of look for that line, but there is one that's, apparent when you look back. So, can you talk a little bit more about the company, what it does, especially in regards to its testing technology, and I'd love to hear about some of the innovation that's just coming out of this incredible organization you're a part of. [00:06:35] Tyler O'Malley: Sure. So our our testing, again, primarily focuses on addressing unmet needs in patients who have autoimmune connective tissue diseases. And specifically we have some proprietary technology around biomarkers that help diagnose systemic lupus. And lupus is kind of the prototypical autoimmune disease in that it can manifest in just about any different way. It can show up in your skin, your heart, your lungs, your kidneys, just about any way you can imagine, and sometimes in multiple different ways. And so in that way, it can be challenging to diagnose 'cause it can look like so many different things. And much of the testing that is used for lupus or has been used traditionally is very antiquated. Antibody tests that were developed many decades ago that have been refined to some extent over the years, but for the most part are not overly sophisticated. So, what Exagen has done over the past 15 or so years is brought forward some technology, that was originally licensed from University of Pittsburgh, looking at measuring a form of the complement system, which is a part of our immune system. It's a very ancient form of our immune system. It's a collection of proteins that come together to help fight off pathogens and help clear debris to keep our our immune system healthy. And what we're able to do is measure essentially the buildup of a complement fragment that builds up on your red blood cells and on your B lymphocytes. And what this does is it gives us a unique ability to detect lupus that's much more sensitive than the conventional means. And what that means, when I say sensitivity, is that it's able to pick up more lupus patients than the conventional testing. So, one way of thinking about this is like, if you have a hundred patients in a room that all have lupus, right? Because they've been assessed by a doctor, they've been clinically diagnosed, and you were to test them, and say your conventional test is 50% sensitive, meaning half of the room would test positive on this test and the other half would test negative. This test that we're talking about here, it would pick up two thirds of the room, right, as opposed to conventional testing, which would pick up fewer patients. So, that's the kind of technology that we're trying to develop here, which is trying to be more

    26 min

  6. 10/03/2025

    Sara Aswegan | Strategic Advisor | Rare Disease Advocacy, Patient-Centric Solutions, & Global Collaboration

    Sarah Aswegan, a seasoned biopharma leader and strategic advisor for global rare disease solutions, shares her journey from sales in pharma to her consulting work today. She discusses her experience in transitioning biopharma companies from clinical to commercial success, the evolution of medtech in diagnosing and managing rare diseases, and the collaborative efforts required to bring innovative treatments to market. She also shares insights on current trends in gene therapy, the dynamics of funding, and the importance of data in advancing care for rare disease patients. Guest links: www.saraaswegan.com  Charity supported:  Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 065 - Sara Aswegan [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 welcome to the show, Sarah Aswegan. Sarah is a seasoned biopharma leader helping organizations transition and grow from clinical to commercial success. She prides herself on the success of leading multiple global cross-functional teams and contributing to the success of the franchise areas she oversaw and served. Until recently, she's applied these experiences while serving in a consultancy capacity for many small to midsize biotechs entering or expanding in rare disease. She has also successfully helped organizations to start and scale adjacent spaces to biopharma, and most recently has been serving as a Global Head of Commercial Assets, Brands, and Care Solutions, and has led transformational change at UCP, having been part of the design and scale of the business unit for rare disease. She maintains a strong network among clinicians, access, bioethicists, and patient advocacy globally. Well, thank you so much for joining us today. I'm so excited to speak with you. [00:01:52] Sara Aswegan: Thanks, Lindsey. It's nice to be here. [00:01:54] Lindsey Dinneen: Wonderful. Well, I'd love, if you wouldn't mind, sharing a little bit about yourself and your background and what led you to medtech. [00:02:02] Sara Aswegan: Yeah, thanks Lindsey. You know, I, I started my career ages ago in the pharma side of things, and as my career has grown, so has the exposure across pharmaceuticals, into biotech and including aspects of medtech. As we look at some of the areas I've spent the last 18 years in rare disease, the medtech component is coming in largely around if we think about the diagnosis component and then the management of the different conditions over the lifespan of a child or adult affected by a rare condition. You can see things really evolving. I started my career on the sales side of things. My education is in business and communication, so anyone can learn the science if you have good mentors and people to help you along the way. And I was really, really fortunate to work amongst a team of amazing individuals, both in the US and then now having lived away for about 15 years outside of the US that have helped open my eyes to what can be possible and the differences by markets. And as I mentioned, I spent the last 18 years in the rare disease space really helping companies of all sizes build out and scale their teams, bringing in new assets and bringing solutions to the field of rare disease. And it's something I'm very passionate about. [00:03:06] Lindsey Dinneen: Yeah. Well, thank you for sharing a little bit about that. So I'm curious, that's a very specific niche and I would love to understand how you arrived at that and how you realized, "Oh, this is what I'm meant to be doing." [00:03:19] Sara Aswegan: Yeah. So I made a move geographically and company-wise to a small firm at the time. We were just a very small team. We called it the bootstrapping team at Shire Human Genetic Therapies, and I moved from the Chicago area to Boston, and that was my first really exposure to rare diseases. And, it's a completely different field and it continues to evolve even to this day. But the closeness and proximity you have to patients and their families and those with unmet need. And I have, you know, a couple of close friends as well as a family member that's been affected by a rare disease. So as you're seeking care and support for them, it's not always about the medications. It's about that total person and thinking really holistically about the individual and their care teams that are impacted by those conditions. So the external community we were serving really drove me and introduced me to something that I've stayed with, and it brings great passion to try to find ways to support individuals in our western society, but also looking at low middle income countries and helping facilitate diagnosis to treatment to, again, that whole supportive care and largely from the internal teams within the organizations I've worked with has just is been tremendously rewarding and also equally challenging. It's beautiful to see progress. I mentioned diagnosis and. One of the areas I worked in initially was in the lysosomal storage disease area. And it's the age-old question on diagnosis. Do you facilitate newborn screening, for example, so when your child is born, you have a heel prick done and you can do a series of tests depending on the state you live in, and in some countries in Europe it's also provided. But if there's not a therapy, is it okay to do that type of diagnosis support. And so that challenge, you know, in seeing the policy evolve on a state by state basis. When I began in the rare disease space and MPS Type Two Hunter Syndrome, it's a condition that affects mostly boys and a very small part of our population. We knew we could do newborn screening and there was a therapy available, but it wasn't only realized until a few years ago to introduce newborn screening to help those families at the point of birth to know if their child was affected, and therefore start a different trajectory on how they planned for care for them and plan for if there was a medication or other supportive tools and resources available for them. So it's been extremely dynamic to see how things have evolved. And then now as you see medical and pharma medical technology advance as well into gene therapies. You're seeing news about gene therapy and it's a one time treatment and then the individual hopefully will not have be re redos in their lifetime. Along with that come challenges on that diagnosis piece to make sure they're eligible for the gene therapy. So again, through the device and technology sector, it plays a key role. In addition to the supportive care that goes on for some of these really severe conditions, people have some pretty dynamic needs and it's great to see how things are progressing, but it's still as equally as frustrating, whether you're on the manufacturer side or the family side, to see things be kind of slow sometimes. [00:06:15] Lindsey Dinneen: Yeah, of course. And you're dealing with a specific situation where many times-- please correct me if I'm wrong-- but it seems like many times there's these kinds of studies and conditions are not funded very well in terms of finding solutions to the problem. So how is that something that you, well, first of all, of course we're in a very interesting season of life right now. So how are you seeing funding evolve over the years for these different diseases that are a little bit more rare, and what can we all do in terms of even just awareness and understanding? [00:06:51] Sara Aswegan: Yeah, so that's a huge question. We could probably have about five conversations on this just to scratch the surface, Lindsey. I think if I reflect on the question on what we've seen around funding, I mean there are some wonderful, supportive grants available for the brilliant scientists we have around the world that have a curiosity. So making sure we can facilitate that ongoing academic environment to explore and test the hypothesis. And one of the things that you see coming along, and it's not really around-- I won't think about funding as just pure financial-- but it's the funding of the smarts that go around the table. You see a lot more collaboration amongst academia, industry governments coming together to help build and scale so that there's an awareness and understanding of a condition. I mean, a pediatrician could go through their entire career and never see a boy with Hunter Syndrome. It's just that rare. At the same time, and on the converse of that, if you're working in an industry where you do have access to more funds, the introduction of AI and looking at how we look at drug targeting, drug target selection, genetics and precision medicine have come along quite leaps and bounds in the last several years, but we're still not quite there. But you're seeing advancements with the different cell and gene therapies, having that precision medicine as an option. It's coming forward. The challenge is the size of stud

    30 min

  7. 09/19/2025

    Dr. Adam Power | Co-Founder & CMO, Front Line Medical Technologies | Innovating Trauma Care, Aortic Occlusion, & Global Impact

    Dr. Adam Power, co-founder and Chief Medical Officer at Front Line Medical Technologies, shares his fascinating journey from a background in vascular surgery to developing COBRA-OS, a groundbreaking device for hemorrhage control. He discusses the challenges and milestones in bringing this life-saving technology to market, the impact of the device in trauma and emergency care, and innovative future applications, including its unexpected use in non-traumatic cardiac arrest.    Guest links: https://frontlinemedtech.com/ Charity supported: Canadian Cancer Society Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 064 - Dr. Adam Power [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 excited to introduce you to my guest, Dr. Adam Power. Dr. Power is a leader in innovative medical devices for trauma and emergency care that is committed to lowering the barriers and bleeding control and resuscitation. Dr. Power was instrumental in the development of COBRA-OS, drawing on his unique clinical viewpoint and expertise to ensure utmost patient safety and assist with the company's global expansion. In addition to his current role as co-founder and Chief Medical Officer at Front Line Medical Technologies Incorporated, Dr. Adam Power is a vascular surgeon in the division of vascular surgery at Western University, which he joined in the fall of 2012, and he is involved in all aspects of academics and clinical care. Also, Front Line was just named the 2025 Medical Device Technology Company of the Year, so I definitely wanted to highlight that too. All right. Well, thank you so much for being here today, Adam. I'm so delighted to speak with you. [00:01:55] Dr. Adam Power: Yes, it's a pleasure to be here. Thank you. [00:01:57] Lindsey Dinneen: Of course. Well, I'd love if you would start by sharing a little bit about yourself, your background, and what led you to what you're doing today. [00:02:05] Dr. Adam Power: Sure, I'd love to. So I'm a Canadian. I grew up on the east coast of Canada and was always interested in science and math and those types of things. I think, importantly, I grew up with an identical twin brother as well. So we really didn't know what we wanted to do with our lives, and ultimately we're good in science and math and ended up in medicine. And then both of us, when we got into medicine, we weren't sure exactly what we wanted to do in medicine, and ultimately both of us became surgeons. He became a urology surgeon, and I became a vascular surgeon, where we joke that we're both plumbers. I deal with the red stuff and he's the yellow stuff. But I did my initial medical school out on the east coast of Canada and then I did my general surgery training, which also involved trauma training, and then did a Master's of Bioscience Enterprise, which was basically biotech business from the University of Cambridge in the UK. When I finished my general surgery training, I continued on and did vascular surgery training at Mayo Clinic down in the US, and since that time after graduating from there, I've been at Western University in London, Ontario, Canada, for the past 13 years practicing as a vascular surgeon and an academic vascular surgeon. But when I was here at Western, I was always interested in innovation. I filed my first patent as a resident way back when, and have filed many over the years. But ultimately, if I was ever gonna see anything that came outta my head and was actually used in a patient or I could actually use in a patient, I figured I'd have to do it. I knew that I couldn't do it by myself. And so, I was very fortunate to meet my co-founder Dr. Asha Parekh. She's a PhD, biomedical engineer, extremely smart jack of all trades, and we teamed up now about eight years ago. We met here at Western, teamed up and really took an idea right out of our heads and patented it and raised money for it, prototyped it, brought it all through the regulatory steps to approvals, built a quality system and ultimately got it out onto the market in Canada, US, Europe, now Australia, and more to come. So the commercialization piece is what we've been focusing on over the past three years. And it's been really fun, but very exhausting but very rewarding as well. I think I'll stop there because I've been blathering on, but... [00:04:39] Lindsey Dinneen: No, it's fantastic. I really appreciate it. Plus, it's really fun to hear about your trajectory and so, okay, so you've teased us a little bit about this company of yours and this innovation of yours. Can you now share a little bit more about that and the development of it over time? [00:04:55] Dr. Adam Power: Yes, of course. Well, I mean, thing that we recognized early on is, and I'll just explain how I normally explain it, is if you have bleeding, it's a hemorrhage control device. And so if you have bleeding in your extremities, then you can often either put pressure on it or you can put a tourniquet on it. The problem when you have internal bleeding in the torso is that you can't actually put direct pressure on it, and there's no tourniquet that necessarily works for intraabdominal, intrathoracic bleeding. And when people bleed to death before coming to hospital, I mean, they're bleeding in these areas. You can empty almost your entire blood volume into your chest or into your abdomen. And this does account for a significant number of fatalities in all environments, basically in the trauma environment. That's military, that's pre-hospital, that's any time that that people are bleeding from internal organs. And so, because this is such a problem, the old fashioned way to fix it is to open up someone's chest and put a clamp on the aorta. So what does that do? Is it basically above the clamp, keeps blood flowing. The remaining blood in the body keeps blood flowing to the brain and the heart, keep you alive. And then below the clamp, it stops sort of the hemorrhaging from the spleen or the liver or whatever. So there's two things going on. One above the clamp and two below the clamp. But opening up somebody's chest in, you know, side of the road or in the emergency department really is impossible. You need highly skilled people like vascular surgeons like myself to be able to do this. And even if we were at the side of the road, we don't have the resources available to keep a patient alive. So there is this idea that we could do this minimally invasively, sort of accomplish this through minimally invasive means. And this, the idea of doing REBOA, which is an acronym-- Resuscitative Endovascular Balloon Occlusion of the Aorta-- came into being. This was probably 15, 20 years ago now. It wasn't necessarily a new idea. It had been done since the Korean War. There was somebody actually put a balloon up into someone's aorta to stop bleeding, but it came back again and was starting to be used a little bit more because. And so really the idea is to, through the femoral artery in your groin where you can feel a pulse, you introduce initially a sheath, which is your access point, and then you place the device up through the sheath, up into the aorta and inflate a balloon in the aorta. So instead of an external clamp, it's an internal balloon clamp that keeps blood flowing above the balloon and stops the blood flowing from below the balloon. Initially these devices were as big as my baby finger, like they were massive. And so if you put them in and you took it out, there was a big hole in the artery, had to cut down on the artery and repair the artery. But as it got more and more advanced and technology advanced, they become smaller and smaller. So that's really where we came in. The initial devices were 12 French, about the size of my baby finger. And then it advanced to Seven French and all of a sudden Seven French-- and these are diameter, French sizes are basically diameter-- and so when it went from 12 to seven French, now we could start doing it through the skin without actually cutting down on the artery. But that Seven French size was still very large and you're putting this in the hands of people that don't do this all the time. And so, we had the idea to bring it down even further now to Four French. And so this is essentially the size of an IV. And so you put a tiny little IV in somebody's femoral artery. And lots of different people can do that. And then you advance the device up in, inflate the balloon and you can magically occlude the aorta. In our first study that we did, the first inhuman study, we averaged about just over a minute to occlude someone's aorta, which was really fast to be able to get that amount of control that quickly. So that, that was really been the advancement is to decrease the access size, make this whole procedure simpler so that so that we can essentially save more lives. [00:09:08] Lindsey Dinneen: Okay, so thank you

    29 min

  8. 09/05/2025

    Morgan Evans | CEO, Agitated Solutions & Founder, Avio Medtech Consulting | Supporting & Accelerating MedTech Startups & Entrepreneurs

    Morgan Evans is a biomechanical engineer, serial medtech entrepreneur, and angel investor. She shares her journey from aspirations of becoming a doctor, to working in mergers and acquisitions at Medtronic, to co-founding/founding six companies, including Agitated Solutions and Avio Medtech Consulting. Morgan discusses the importance of supporting startups in accelerating market entry, the challenges and opportunities with innovative medtech development, and the value of servant leadership.   Guest links: www.aviomedtech.com Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium   EPISODE TRANSCRIPT Episode 063 - Morgan Evans [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 excited to introduce you to my guest, Morgan Evans. Morgan is a serial medtech entrepreneur and investor, which means her passion is launching new businesses. She's a biomechanical engineer by training, went to business school and worked for Medtronic in corporate development before jumping fully into the world of startups. Over the past 10 years, she has founded or co-founded six companies: two medical device companies, two medtech accelerators, and two venture investing vehicles. She spends most of her time with Agitated Solutions, which is developing several innovations related to contrast and ultrasound, and Avio Medtech Consulting, which helps lower the barriers to entry for new ideas and new medtech companies. All right. Well thank you so much for joining us today, Morgan. I'm so excited to speak with you. [00:01:42] Morgan Evans: Thank you again for having me. Pleasure to be here. [00:01:45] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to medtech. [00:01:53] Morgan Evans: Sure, of course. Originally from Houston, I went to school in the Bay Area and studied to be a biomechanical engineer. I originally thought that I was gonna be a doctor, and wanted to start in heart lung transplant of all things. Did an internship between my freshman and sophomore year and quickly learned two things. One is that I love people a bit too much to distance myself emotionally, so it would've really been a hard career for me, I think being on the front lines with that. But the second important thing I learned as well was there was a lot of technologies that existed in the medtech side of the world, just trying to buy people time and give options. And so I fell in love with medtech as a career relatively early. Started working for my first startup in the neuromodulation space before I even graduated undergrad, and loved that. Wore a ton of hats ranging from engineering, clinical commercial. I did some vertical line integrations in there and I started before we were even at 10 employees, left at 55. Thought it was massive 'cause we had middle management. Then toward the tail end of that, started studying to go to business school 'cause I realized I was getting further and further away from my engineering degree. And then I went to Kellogg at Northwestern and when I was there, co-founded my first startup with a clinician that had a great idea, didn't really know how to navigate the regulatory side of the world, and we co-founded that company together. And toward the tail end of that, was recruiting for formal kind of post-business school. Where am I gonna land? What am I gonna do? And decided to go to Medtronic and do mergers and acquisitions within the corporate development team. Did that for about two years. Loved it, learned a lot. The team was great. But big company was a huge change, especially as I just mentioned, you know, I thought 55 was large with middle management. And then you go to 90,000 at the time and deal teams of that. And kind of felt like my calling was going back to startups, so left in 2016 and have been innovating and building companies ever since. [00:03:53] Lindsey Dinneen: Wow. Okay. Well, thank you for sharing a little bit about your background and everything that's led you to where you are today. I really appreciate it, and so I am so intrigued. Okay, so you were on track in, in theory, initially to be a doctor and to go that route and then decided, "Okay, well, maybe this isn't for me," which is so great that you learned earlier rather than later, of course. But so as you were processing through making this transition into medtech and going, "Oh my goodness, there's actually a whole lot here." Were there any particular things that really stood out as being the most intriguing? Were you just kind of interested in the industry as a whole, or were there specific things where you thought, "Oh gosh, I really wanna learn about X, Y, and Z." [00:04:37] Morgan Evans: Yeah. Two things happened in relatively short order that I think landed me in my love, right? The first is, when I was doing this internship, they actually had some preclinical research going on in the basement of the hospital. And I, it's a long story, but I randomly ended up wandering into this place and figuring out it existed, and saw some of the early preclinical research happening live where they actually had a pig that they were trying to induce a heart attack in to then do a treatment for. And this pig actually coded in the middle of the procedure and they literally come out with paddles. And I'm just like, "This is the coolest thing in the world, this is actually how innovation is done and people learn." So that kind of, "Oh, cardiovascular sounds really interesting," was where I originally started. And then, at the time when I was at Stanford, I was playing on the basketball team as well, and I went to a event with some supporters of the program. And the person at my table was Chairman of the Board of a neuromodulation startup, autonomic technologies. And the one thing I at least love that I'm not afraid to ask questions. And so I just was like peppering him with like, "What is this? How does that work?" And that actually led to my first job. And it's kind of fortuitous that you're in the right place at the right time, but then just get exposure, and that was in pain and pain's a hard space. The type of treatment we were doing was treating condition that was known as a suicide headache. And so I think that was helpful to see the impact of the work we can do so early on. And then I, like I said, I've been hooked ever since. [00:06:05] Lindsey Dinneen: Yeah. Yeah, that's great. And those are great stories. I love the synchronicity and how those moments sometimes just play out perfectly and lead you to your next right step. So now you are in a position where you are advising startups, but you have lots of things going on. I feel like when I was looking at your LinkedIn, there were multiple different organizations you're a part of and participating in. So could you share just a little bit about all the wonderful things you're up to these days? [00:06:31] Morgan Evans: Yeah, for sure. So my day job, as I call it, but where I spend by far majority of my time is I am co-founder and CEO of a company called Agitated Solutions. And we say that we're unlocking the potential of diagnostic ultrasound. So we have multiple products that include a contrast agent that's revolutionary and that it has a temporary micro bubble, looking for holes or flaps known as a patent foramen ovale in the heart that's highly associated with cryptogenic stroke. So we have contrast side, and then we also have some software as a way to have better prediction of what our high risk shunts and what could cause stroke. That had a company spin out of it called Moonshot Medical that is more of a traditional incubator where we put all of the IP and ideas that weren't quite ready to be full-blown companies, but we knew there were some things there that I also technically lead. So those are the two that I'm CEO of. I founded a company called Avio, that I'm very passionate about, that is really focused on trying to help get these medical technologies to market faster. The work we do is on the backend of medtech, so quality systems, regulatory, R&D project management. But just in the theory that there's so much paperwork that is behind any innovation, like how do we get better at that paperwork so that we can keep innovators doing what they do best. And then we're just really that helping hand alongside. I joke, all of the things I'm involved in, this was my happy accident. I felt like I was building what I needed for my own startups. Literally no intent of anyone else ever seeing this or offering that as a service. And I just remember distinctly, I woke up one day shortly before my son was born and I was like, "Oh, I think there's actually a business here. Maybe I should run it like one." So that's another one. And then passionate about angel investing in early stage as wel

    30 min
See All (70)

Trailer

Ratings & Reviews

5
out of 5
2 Ratings

About

MedTech Leaders Changing Lives for a Better World

Information

  • Creator
    Velentium
  • Years Active
    2023 - 2025
  • Episodes
    70
  • Rating
    Clean
  • Copyright
    © Copyright 2024 All rights reserved.
  • Show Website
    The Leading Difference