The Leading Difference

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MedTech Leaders Changing Lives for a Better World

  1. -2 ДН.

    Stuart Grant | Founder, Archetype Medtech | Engineering Innovations, Medtech Advancements, & Global Impact

    Dr. Stuart Grant, founder of Archetype Medtech, shares his journey designing and delivering breakthrough orthopedic and surgical innovations across the UK, US, and China. Stuart recounts how an early internship led him into medtech, what kept him there, and how building the ASPAC Innovation Center in China helped accelerate a total knee instrument system that dramatically reduced time to market. He explains the leap from corporate leader to entrepreneur: planning for years, earning a PhD in Medtech Product Innovation, and building a consultancy that helps startups and scale-ups turn early clinical unmet needs into market-ready, regulator-approved devices through a network of experts and an “expertise for equity” model.    Guest links: https://archetype-medtech.com/  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 074 - Stuart Grant [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 Dr. Stuart Grant. Dr. Grant is a chartered engineer and the founder of Archetype Medtech, a consultancy and innovation studio helping medical device startups and scale ups transform early clinical, unmet needs into market ready products. With nearly 25 years of experience, Stuart has led global teams across the UK, US, China, and emerging markets delivering breakthrough innovations in hip, knee, shoulder, and trauma surgery. A highlight of his career was establishing the ASPAC Innovation Center in China, where he built R&D capability from the ground up and launched a pioneering total knee instrument system that dramatically reduced time to market. Passionate about advancing medical technology and mentoring future engineers, he bridges creativity, engineering, and regulation to accelerate safer, smarter medtech innovation worldwide. All right. Welcome to the show. It's so great to have you here today. Thanks for joining me. [00:01:57] Stuart Grant: It's lovely to be here, Lindsey. [00:01:58] Lindsey Dinneen: Yeah. Excellent. Well, I was wondering if you could start by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:08] Stuart Grant: Yeah. So, I was actually, I'm obviously, as you can tell from my accent, I'm British, but I was born in Germany because my, my dad was in the military in the 1970s when I was born. So I was born actually in Berlin, which is quite interesting to be a place to be, grew up in. So I traveled around a lot here in the UK, in Germany with my dad getting posted everywhere. My mom's a nurse. So I was in medtech, not really knowing I was in medtech as a kid, but I, my family was, so yeah. And then obviously went to school, all the places I was at university. I went to university to do product design, and my goal was to be a product designer, a cool product designer, designing fancy products like Johnny Ive. And when I was looking for a job as a co-op, or an intern as you call them in the US, I was just really unsuccessful finding a job. I was doing a lot of interviews, getting turned down, sending my CV out a lot, and j happened just to advertise on the Board of University, and it said Johnson Orthopedics and no one really knew what that was in. And none of my fellow students at applied because they thought it would be designing baby bottles for putting talcum powder in and shampoo in and stuff like that. So they're like, "I'm not doing that job." So I desperately applied for it and luckily found out about all this medtech, and I've been here doing medtech for 25 years. So they gave me a job. I had to work hard to keep the job and get reemployed over and over again. But yeah, joining originally Johnson Orthopedics a long time ago is how I found out about medtech. I never knew when I was 18 that really it was a thing that existed. [00:03:47] Lindsey Dinneen: Yeah. So, okay. So you thought product design, and then when you got into medtech, what were some of the things that attracted you and that actually compelled you to stay and make a career out of it? [00:04:00] Stuart Grant: Ha. So I was a young guy with the student debts. What compelled me, I was getting paid to stay, but not to be too flippant about it, but, you know, when I was doing this engineering and design work in my early days in the CAD system, it was just so interesting. I was designing these products that were going into people or the instrumentation to make help the surgeon and going to these ORs and watching the surgeon do their job and trying to figure out how how I can make it better from their input was really interesting. I could apply it straight away, basically. In the early two thousands, there wasn't all these regulations and standards that slowed you down. So you could go and design an instrument, get it machined in the machine shop, get it clean, take it to the surgeon, he can use it, you know, probably be frowned upon 25 years later. But that's what we used to do and really adapt. And probably more interesting than going into product design and fast moving consumer goods where you're designing a, a kettle or a toaster or something, a plastic casing. It was actually much more interesting to do that. And I stayed because I spent four years here in Leeds, in the UK, was getting a bit bored and wanted to find something else to do, and then an opportunity came up in the US. So I moved over to Warsaw, Indiana, the orthopedics capital of the world, as you might know it. Worked there for, stayed there for seven years. Really enjoyed it.. People sort of bemoan Warsaw for being in the sticks in just a bunch of cornfields around it. But I enjoyed it. It's got, we had a good bunch of young friends there. I was in late twenties, early thirties at the time. There was Noah and Spikes. You'd go for a drink and some nice food. It was all right. I enjoyed my time and after that I was, after seven years, I was like, "Okay, what do I do next?" And I was looking around for jobs in medtech. Then another opportunity came up in and we were looking for people to go over and help set it up, train the staff on what MedTech product development was. And so I jumped to the chance and spent five years living in China, in Shanghai. After five years is your limit, so I had to come home. I couldn't stay. I wanted to stay, but they wouldn't allow me to. So, so I came back to the UK. And then started MDR for five years as leading the Joints MDR program, which was lots of fun, as you could probably tell, wasn't really R&D, was a lot of leadership and project management and dealing with a lot of people and a lot of problems on a day-to-day basis. And so, yeah, after that I I left J&J about three years ago and started my own product development agency. And we can talk about a little bit about that later. So that's where I am and where I got to. [00:06:50] Lindsey Dinneen: Excellent. Yeah, I definitely wanna talk about that as well. But going back a little bit-- and perhaps this is actually something that's occurred since you started your own company as well-- but are there any moments that really stand out to you along your journey of affirming that, "Hey, yeah, I actually am in the right place, in the right industry?" [00:07:12] Stuart Grant: That's a really hard one is sort of the, is the grass always greener somewhere else, type of question. Right? I guess compare, you shouldn't compare, but comparing to my friends at my university, my product design and what they've done and what I've done they've moved into the car industry a lot. Went to the car development and car industries always had its ups and downs and its problems. And you know, they've had some really cracking jobs working for McLaren and Ferrari and you know, but I think just the interesting things that medtech do that nobody really knows about is really what keeps me moving along and having conversations with people when they, you tell them like, "I used to design hips and knees and shoulders and things like that," and they're like, "Oh, my mother's got a hip and knee" and blah, blah, and you really talk about it. Actually, my mother does have a hip now and she's going in a couple months time to get the other hip done. I do know what brand she's got, so. [00:08:10] Lindsey Dinneen: See, that's really cool. Yeah. Okay. So, so, on your LinkedIn I noticed that you describe yourself as a fixer, a challenger, and a change maker, which I love. But I'd love to hear from you exactly what you mean by all those things as you have developed in your career, and now as you're doing, of course, your own consulting. [00:08:34] Stuart Grant: Yeah, so in Johnson and my colleagues are probably, I agree with this, I had a bit of a reputation of getting the more difficult projects. The, that's probably why I got MDR in the end 'cause I would always get the projects that had problems and I e

    36 мин.

  2. 6 ФЕВР.

    Rachel Knutton | Founder & CEO, Alluvia Studio | MedTech Storytelling, Brand Consistency, & Joy-Driven Leadership

    Rachel Knutton, founder and CEO of Alluvia Studio, shares how a 30-year healthcare journey—from hospital marketing and public relations (PR) at HCA Healthcare to medical device commercialization, product launches, and sales—shaped her belief that everything in MedTech ultimately comes down to storytelling. Rachel explains how her “been there” experience in hospitals, cases, and value analysis environments helps her create messaging that’s compelling, compliant, and built to endure. She also opens up about becoming an “accidental entrepreneur,” discovering unexpected fulfillment in leading people, and building an agency culture grounded in authenticity, humor, and joy.    Guest links: www.alluviastudio.com | www.linkedin.com/rachelknutton | www.linkedin.com/alluviastudio  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 073 - Rachel Knutton [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 Rachel Knutton. Rachel is founder and CEO of Alluvia Studio, a strategic medtech marketing agency based in Tennessee that supports some of the largest medtech brands in the world. Her experience in healthcare spans 30 years, including hospital marketing and PR for HCA Healthcare, as well as various roles in medical device commercialization, sales and marketing. Right. Well, welcome to the show, Rachel. It's so nice to you for having me. Of course. I would love if you would start off by just, uh, telling us a little bit about yourself, your background and what led you to medtech. [00:01:36] Rachel Knutton: Yeah, so I actually have a pretty interesting background and I bet I'll cover a little bit more of it as we go through the discussion, but currently I have an MedTech marketing agency. We have 16 employees. been in business technically since 2011, so 14 years. And just really focused on this industry. My path to getting into MedTech actually came through HCA Healthcare. I started working in hospital world back in 1996. And actually it was accidental. I, you know, I was pretty new outta school, a couple years outta school and I'd answered an ad and I dove right into a really exciting world. It's, you know, of course headquartered here in Nashville. Learned all about hospitals. I supported I think eight different hospitals at that time that were in region, the Nashville region, doing marketing and public relations, walked into my first open heart surgery case, helped feed employees at midnight, handled all kinds of interesting PR events because we're hearing Nashville, a lot of country music stars might get hospitalized. And I did that for about 10 years. And then I ended up moving into devices a recruiter, and it's when Kimberly Clark Healthcare had gone into the medical devices arena through the purchase of Ballard. so honestly I really didn't know much about it. But I had, you know, I did have my MBA, I had been working in healthcare, which sort of met the qualifications at that time. And I got a early start in marcom. Learned so much, got back into the hospital through that role from the other side of the coin and I had the chance to do product management, launch a product, and then I moved into sales and sold the product a whole bag and then got back into the hospital, you know, working through the whole value EIS ecosystem and working with physicians and being in cases. So it's been a very interesting path for sure. [00:03:37] Lindsey Dinneen: Yeah. Yeah. Thank you for sharing that. And so I'm curious about a lot of things, but I'll start with this. So what do you find are some of the differences and similarities between marketing and PR for the hospital side of things versus the device side of things? [00:03:55] Rachel Knutton: I mean, certainly I think PR piece is a much bigger aspect, the community aspect. Um. Every hospital is such an important part of the community. So there's a heavy weight there on that. And then of course, the regional aspect of it. So whereas in the device world, you know, all targeting like very large geographies, maybe either the US or outside of the US. And so in the hospital world, that tends to be more regionalized. I would say. That's like one of the big differences for sure. And then honestly, hospital world, it's more business to consumer. is a lot of physician related marketing as you're trying to drive preference to, you know, using your hospital for surgeries or trying to recruit physicians, but it's a lot more B2C in the, medtech world. world. [00:04:44] Lindsey Dinneen: Yeah. Yeah. So, okay, so you mentioned know, you responded to an an ad and that led you to was sort of like, well, a say, um, synergy, whatever you wanna say. that was was marketing and communications something that you always had a passion for or what led you to kind of pursue that? [00:05:05] Rachel Knutton: Yeah. Well actually I was a little bit more of a writer. would say telling stories is origin story. So I wanted to work in magazines. This is back when we still did print and newspapers and things like that. And always wanted to work in the magazine um, industry and I, and it started out writing for a business magazine. Started working for an agency for Ford, doing writing for a sales focused magazine. And so it just sort of morphed into that. I would say in the marketing and PR world, we were telling stories about patient stories, pitching those to newspapers. We were telling stories about physicians doing new types of procedures employees, you know, trying to promote them within the hospital world. That's also important to that ecosystem. And so I think that's kind of where that transition happened. And I would say that's still what I do today. So it's taken a lot of different forms and product management and working in Excel files and figuring out demand forecast isn't really about telling stories what it is, right? Everything is about telling a story in the end. [00:06:06] Lindsey Dinneen: Yeah. Yeah. So it sounds like you have the strategist side, the analytical side, and the creative side, which doesn't always, you know, align. And so tell us a little bit about your approach maybe to, say, there's a client of yours that is interested in bringing a product to market, and story tell to help them achieve their goals, and within compliance, because obviously that's a component. [00:06:35] Rachel Knutton: yeah, I mean, that's certainly in our industry, you know, figuring out are the guardrails. course in marketing, I always think, you know, we, know the rules. But we're also going to make sure that we're not self-limiting within those rules. So I let the regulatory people and the legal people push back. But I know what not to risk, right? So I think one of the things that's very helpful is having sold devices, having launched devices myself, having worked in the hospital system, I spent a lot of time on the floors watching how devices are used. I spent time in ICU collecting data. I think really having been part of that environment helps feed the story building process. It's almost like a natural part of what goes into building that story. So because of that experience, because I've walked those halls, I've been in those shoes, I kind of know what some of those limitations are and that just automatically configures into the storytelling process. I know what the product managers are up against when they're trying to launch a product. And theoretically, I should know the right questions to ask and how they got to the product that they have today and how they've, you know, customer feedback has fed into that. And then how do we take that and make sure that the messaging meets the same requirements? Like you have a, you know, you have design requirements, well, your messaging should have the same requirements and achieve a goal. So I think that's the analytical side is making sure, does the message achieve the goal? Are we being very committed to what's the business objective? How is the marketing objective supporting that? And then is the, how is the messaging fitting into that? I think that's a very important part of the discipline. We also are very familiar with, you know, claims matrices and the importance of having, you know, data and research to support claims. And so kind of knowing that framework, I think is helpful when you're building messaging because helps you think through like, okay, here's how the client is going to need to organize the messaging. Here's how they're gonna have to reuse the messaging. You know, how can we be very consistent in how we roll that out so they're not having to go back through and through their approval process every time. It's really important part of the discipline in the medtech world that we have to deal with that industries as well, of course, but it's certain

    34 мин.

  3. 23 ЯНВ.

    Shaun Bagai | CEO, RenovoRx | Revolutionary Cancer Treatment, Startup Success, & Medtech Mentorship

    Shaun Bagai is the CEO and Director of RenovoRx, and a seasoned MedTech leader whose path began with a Silicon Valley startup internship that ultimately pulled him away from medical school and into building life-changing technologies. Shaun shares how early experiences in clinical research, physician training, and commercialization—from Medtronic to multiple high-growth startups—shaped his leadership philosophy around mentorship, hiring for “fit,” and balancing empowerment with accountability. Shaun reflects on legacy, values-driven leadership, and why networking rooted in genuine curiosity can become one of the most powerful tools in a MedTech career. Guest links: https://renovorx.com/contact-us/ | https://www.linkedin.com/in/shaun-r-bagai/   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 072 - Shaun Bagai [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 delighted to introduce you to my guest, Sean Bagai. Sean has served as Chief Executive Officer and Director since 2014 of RenovoRx. Prior to joining, he led global market development for HeartFlow, Inc from 2011 to 2014, which included directing Japanese market research, regulatory payer collaboration, and key opinion leader development to create value, resulting in a company investment to form HeartFlow Japan. During his tenure at HeartFlow, he successfully orchestrated their largest clinical trial to date and contracted HeartFlow's first global customers. In addition, Sean has launched innovative technologies into regional and global marketplaces in both large corporations and growth phase novel technology companies. Sean is a graduate from the University of California Santa Barbara with a Bachelor of Science in Biology / Pre-med. All right. Well, thank you so much for being here, Sean. I'm so delighted to speak with you today. [00:01:54] Shaun Bagai: Thanks for the opportunity. I really appreciate it. [00:01:55] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind starting off by just telling us a little bit about who you are, what your background has been like, and what led you to MedTech? [00:02:07] Shaun Bagai: I really appreciate the question 'cause it's really my background and kinda the early part of my journey that landed me where I am today. I actually did an internship at a medical device startup company in Silicon Valley between what would've been college and med school. And while I was applying to med school, my goal was to get some experience in the industry, in a medical technology space, and then go out to med school. And the founder of my company and CEO really advised me not to go to med school once I got in to become, someday an entrepreneur like his own self. And I ended up following his footsteps with the goal of, just like he, did build companies that really make a major impact on medicine. [00:02:44] Lindsey Dinneen: Wow. [00:02:45] Shaun Bagai: So from, yeah, so from that early kind of intro to medical technology and learning what an entrepreneur could do in building new therapies and technologies, I ended up running clinical research at that company once I declined med school. We exited to Medtronic where I learned the sales side of things. So, this physician founder CEO along with my mentor, said, look, if you want to build and run companies, you have to really understand what the market's like and how you get a product into the hands of physicians to treat patients and what it takes to really sell the product. So I spent a couple years flying around the country training physicians on the technology that I learned as a proctor-- which I've done in every company that I've worked with and for-- then went on to sales for about five years and launched Medtronic's first drug coated coronary stent as a sales representative. And then transitioned out of Medtronic after several years, cutting my teeth on the big company dynamics and the sales revenue aspect of it to a startup company called Ardian, which developed a new way to treat high blood pressure using a device. There I led physician training, transitioned them from clinical research into commercial in Europe. We exited to Medtronic for about a billion dollars and went on to another startup company to help develop their market. And really that was a disruptive technology in how to assess coronary artery disease in leading international market development. They hired me about 15 years prematurely to commercialize them, so I helped them with physician training, market development in Japan, clinical research and left to join RenovoRx where I took over 11 and a half years ago. That company actually went public for about 2.5 billion this last year. So, and all three of these technologies have really already made a major impact on patients, and I feel that RenovoRx, this has probably my biggest one yet in terms of major impact. [00:04:26] Lindsey Dinneen: Yeah. Okay. So I can't wait to dive into that, but there's a lot before that too to talk about. So, when you were growing up, was medicine and science always a huge interest to you or did that develop later on? [00:04:41] Shaun Bagai: You know, it's funny you asked 'cause I've done a lot of interviews and that question has never come up. So I've gotta, I've gotta pause for a second. It's interesting. My, my background was really business oriented growing up. I loved business. I loved the idea of how you get something marketable. As a very young child, I had very embarrassing stories of trying to sell things as a kid that I used to bring back from India, for example, like bouncy balls or crocheted place mats or whatnot. But then sustaining a football injury in high school, I found that physicians couldn't treat me. And I learned that there's gotta be a different way to treat patients. And I arrogantly thought, "Well, I could be a better doctor than you guys and someday treat young athletes like myself." So, my passion went immediately and complete a hundred percent into become a physician to help patients. So that kind of transitioned me to being med school bound from the age of about 15, and didn't look back until I got into med school and got pushed back to business. And now I get the best of both worlds. [00:05:37] Lindsey Dinneen: Yeah, no, absolutely. So you have so many diverse experiences with a bunch of different companies and you know, everything from it sounds like a quite the small team to obviously these huge enterprise type companies. What are some of the key lessons you learned along the way that help you in your current role? [00:05:58] Shaun Bagai: I think the biggest aspect I've learned along the way, and what I'd definitely tell the younger entrepreneurs, is to be very open and receptive to different ideas. Also look for mentorship and leadership examples. And I've been lucky throughout my career, I've been able to identify leaders who are not perfect because no one is, but I found skill sets and activities and thought processes that I wanted to emulate, and I feel like I've been successful because I've been able to take the best of those and also look for mistakes and weaknesses and to see how I could either surround myself with people to fulfill my lack of strengths in areas and or improve on myself to help be a better leader by emulating them. [00:06:37] Lindsey Dinneen: Yeah. And speaking of leadership, as you kind of grew into all of these, you know, more and more responsibility laden roles, were there any moments along the way where you kind of just had these learning curves of, you know, either witnessing something that you were like, "Oof, I don't wanna do that." Or the opposite of it sounds like you had maybe some really great mentors in your life that showed you perhaps a better way of doing things. But in terms of your overall leadership strategy, how did the various good, bad, and ugly shape how you show up as a leader? [00:07:16] Shaun Bagai: You know, that's a four hour discussion probably, but, but to, to tackle some of the high notes that I learned, it's --and I continue to always learn-- the biggest challenge we face as leaders is trying to find out what makes people work in the right fit for your organization. And as, as you mentioned aptly, I've worked for very large and small teams, big companies, small companies, and not everyone's fit for those positions. You have very talented, enthusiastic, passionate people that could really flourish in a big company structured environment and would die in a startup company. And vice versa. You have very structured people that cannot understand the idea of progress ahead of process in small companies as well, and finding that balance of trying to get the best out of what someone likes to do and what their fit is. And further really identifying if you can align their passions and their

    27 мин.

  4. 9 ЯНВ.

    Hyedi Nelson | Director of Health Strategy, Bellmont Partners | Navigating MedTech PR, Strategic Communication, and Industry Innovation

    Hyedi Nelson, the Director of Health Strategy at Bellmont Partners and an award-winning strategic health communications leader, shares her journey from studying mass communication to becoming an expert in medtech communications. She discusses the importance of storytelling, building trust, and collaborating with various stakeholders, including engineers and regulatory bodies. Hyedi also touches on the evolution of social media in the medtech space and offers insights on fostering creativity while staying compliant.    Guest links: https://www.linkedin.com/in/hyedinelson/ | https://bellmontpartners.com/health-and-medical-public-relations/  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 CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 071 - Hyedi Nelson Lindsey Dinneen: [00:00:00] Hi, I'm Lindsey, and I'm talking with medtech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating, and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives, and it is incredibly motivating to work with people who are in that same business, saving or improving lives, Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is the Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to introduce you to my guest, Hyedi Nelson. Hyedi is an [00:01:00] award-winning strategic health communications leader with deep experience partnering with MedTech companies of all sizes and stages, with a special affinity for working with entrepreneurial startup companies. She has dedicated her career to leveraging her strategic communication skills and expertise to help improve health outcomes. Hyedi is the Director of Health Strategy at Bellmont Partners, a full service PR and communications agency where she helps medtech organizations navigate and communicate around complex crisis situations and mergers and acquisitions, launch breakthrough technologies, raise capital, drive clinical study patient enrollment, and ultimately position themselves effectively with key partners and interested parties, including investors, healthcare providers, current and prospective employees, media, and patients and caregivers. All right, Hyedi, welcome to the show. Thank you so much for being here today. Hyedi Nelson: Thank you for having me. Lindsey Dinneen: Of course. I would love, if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and what led you to medtech.[00:02:00] Hyedi Nelson: Sure. Absolutely. So my name is Hyedi Nelson. I'm currently the Director of Health Strategy at Bellmont Partners. We're a full service communications and PR agency located in the Twin Cities of Minnesota, which I'm sure you're well aware, that's considered Medical Alley. My whole background, my whole career has been spent in health and medtech communications. So, I kind of gotten to that area and just really fell in love with it. I guess the backstory on that, I was graduating undergrad from the University of Minnesota in mass communication and still kind of didn't really know what I wanted to do and timing-- I'll date myself here-- but that was around 2008 and so if you recall, it's kind of a tough time, you know, in the economy and a lot of my friends who were graduating were having a hard time finding a job. And around the same time I ended up just kind of looking for a class to take to fill some re remaining requirements for graduation. And I took a health [00:03:00] theory class and I just like became obsessed with health and I started to think, well, maybe there's something there. And the professor of that class actually shared with me that they had a two year master's MA program that was like a joint program between the School of Journalism and the School of Public Health. And so you've got this really nice combination of you know, communication theory and how to create, you know, more communication strategies and influence public health, but you also got a really good overview of the healthcare field as well as some basic knowledge in like epidemiology and biostats to like really give you the tools you need to do a good job as a healthcare communicator. So I ended up applying for that and finishing out that program and kind of positioning myself in a better place a couple years later to graduate and look for employment. So during that time, I was asked to participate on a Social Media for Healthcare panel. [00:04:00] So at the time it was like social media was super new to healthcare. They were really far behind, you know exactly what I'm talking about. And I met someone who was PR professional and I was not super familiar with the world of prPR but we started talking and she shared that they were really looking to expand their health and MedTech practice within the, within their agency. And kind of one thing led to another and I applied and started working there, and the rest is history there. That's kind of what I've been doing ever since. Lindsey Dinneen: Wow. That's amazing. Yeah. So first of all, thank you for sharing a little bit about that. There's so much I kind of wanna dive into. But I'm curious, was journalism and marketing and those kinds of interests were, did you have those, you know, growing up? Or was this something that developed in college, or how did that all come about? Hyedi Nelson: I think for me, just the love of writing, first and foremost, was what really did it for me. I read a lot, so I was always just [00:05:00] like really amazed that people could, like, use words to, you know, make you transport yourself into this other place, or get you to take some sort of action. It seemed like kind of a magical thing. And then you know, just going through school and everything, I realized that like my skillset definitely wasn't like math or that side of things and was really drawn more to the the writing piece of it all. So, I thought about, "Do I wanna be an English major?" Do I, I actually went into college wanting to go into the music industry and did an internship for a record label-- I suppose that's another story for another day-- but ended up deciding an English major, wasn't sure I what I wanted to do with that. And so, trial and error kind of decided that communications more broadly, you know, whether it's journalism or strategic communications felt like it would be a really good fit for kind of where my interests lied. Lindsey Dinneen: Nice. Yeah. And so-- okay, well what's funny is I actually did wanna dive a little bit. So we're gonna, if we can take a [00:06:00] very quick detour into the music aspect, because I did notice on your LinkedIn that's something you still do, is you actually help musicians-- is that correct-- with some of their PR and marketing? Hyedi Nelson: Yeah. I, a couple years ago started my own consulting side hustle thing where I really use, you know, my skills that I do like in my full-time job and a communication strategy and promotion and publicity and project management to help independent artists, just because I have a lot of friends and my partners a musician. And I see kind of the struggles that they go through with how the industry is, is really like how it exists and how the payment structures aren't there and it's really hard for them to make a living as well as the fact that they're expected to like not only be a super creative person who's putting like this music out into the world, but also like a business person and a marketer and, you know, all those things. [00:07:00] So, kind of doing that to like merge all of my passions together and do something kind of fun and different than what I do, you know, during the day. Lindsey Dinneen: Yeah. No, I love that. I love that. Especially because I don't know if we've talked about this before-- it's, I know we've had a few different conversations before this-- but yeah, i'm also a professional ballerina and so I understand. Stand having the two sides of, you know, the art, the artist and the medtech enthusiast and sort of the both worlds. So I just I love that you do both too. Hyedi Nelson: There's gotta be some sort of like where that helps us in our job somehow, like having that too. I don't know, but I think so, yeah. Lindsey Dinneen: Yeah. I think part of it is, you know, creative problem solving and, you know, sort of the skill sets that are learned. Are you a music musician yourself? Hyedi Nelson: I mean, I am not very good at it, Okay. I do play, yes. Lindsey Dinneen: Yeah. And so I think a lot of the, of it comes from the [00:08:00] discipline of having, you know, grown up learning some kind of an artistic endeavor because it's, there's so much discipline that goes into it. There's so much you have all of these skill sets that you're learning. And anyway, I don't wanna get too far off on the tangent, but that is one thing that I do think it helps honestly. But yeah. So, okay. So back to your career. So now you are working with Bellmont Partners, and can you just share a little bit about what your day-to-day kind of looks like helping these medtech, health, tech life science companies succeed? Hyedi Nelson: Sure. Yeah. I mean, every day can be wildly different than the last. But in my role, I really, I've been with the agency now for about 12 years and we've really grown tremendously our busines

    37 мин.

  5. 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 мин.

  6. 28.11.2025

    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 мин.

  7. 14.11.2025

    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 мин.

  8. 31.10.2025

    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 мин.
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MedTech Leaders Changing Lives for a Better World

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  • Автор
    Velentium
  • Годы выхода
    2023 - 2026
  • Выпуски
    74
  • Ограничения
    Без ненормативной лексики
  • Авторские права
    © Copyright 2024 All rights reserved.
  • Сайт подкаста
    The Leading Difference