Podcasts about Medtech

In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health.May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility.Before May Health, Colby served as Global Medtech Commercial Lead at Organon, overseeing the worldwide launch of the Jada System following Organon's acquisition of Alydia Health, where she held roles including COO, Interim CEO, and VP of Marketing. She has also held leadership positions at Pelvalon, AccessClosure, Medtronic, and Guidant.In this discussion, Colby shares why early clinical evidence should be built in focused layers rather than oversized, all-at-once trials. She explains how a small, deliberate early launch can reveal the workflow nuances and real-world expectations no study ever captures. And she outlines why founders should define the raise first — and how clarity, preparation, and a deep understanding of strategic partners can dramatically accelerate the fundraising process.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Colby Holtshouse.

Recently I sat down with two true pioneers of the medical device industry — Gregory L. Peel and David “Dino” Harris Jr. — to talk about the book that's already inspiring the next generation of MedTech talent.Greg's new book, The Pivot Point, captures the stories of 16 African-American trailblazers who built careers in an industry almost no one knew existed when they started. Their stories of grit, door-knocking, resilience, and career pivots are pure gold for anyone in (or trying to break into) medical device sales.In this episode we talk about:• How pioneers navigated being the first in a territory• Why most people still don't know this industry exists• The Mayo Stand test — the real scoreboard for reps• The “door-knock theory” and why rejection is a skill• Why you must build multiple income streams• How a single career pivot can change an entire life trajectoryWhether you're a junior rep, a veteran leader, a transitioning athlete or veteran, or someone trying to break into medical sales — this conversation is a roadmap.RESOURCES

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.They discuss:- The hidden costs of regulatory failure and how to avoid them- Why early engagement with regulatory agencies is critical- Global regulatory models, including emerging markets like China and the UAE- A clear explanation of UDI and serialization- How regulatory impacts extend beyond compliance teams- The role of LinkedIn and storytelling in regulatory careers- Steven's experience running for the European Parliament and what it taught him about policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O'RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe to Let's Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.Stephen O'Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of NucleCast, host Adam Lowther engages in a thought-provoking conversation with Rob Kittinger, a seasoned expert from Sandia National Labs. They delve into the critical role of human factors in nuclear safety and explore the intriguing dynamics of the AI race between the US and China. From the potential pitfalls of human error to the strategic implications of AI advancements, this episode offers a deep dive into the challenges and opportunities shaping our nuclear future. "Other examples of color vision affecting job safety can be found here: https://waggonerdiagnostics.com/pages/law-enforcement "Robert Kittinger, Ph.D. is a Senior Fellow at the National Institute for Deterrence Studies (NIDS). He spent nearly 10 years at Sandia National Laboratories, culminating in the Nuclear Threat Science department and working in Nuclear Emergency Support and Counterterrorism & Counter-Proliferation (CTCP). During his time at Sandia, he was also a 2017 graduate of the prestigious Weapon Intern Program (WIP).Before joining Sandia, Dr. Kittinger spent over five years as a civilian in the U.S. Navy and was part of a five-person tech startup, BookLamp, which was acquired by Apple in 2013. Following his tenure at Sandia, he served as a senior researcher at Amazon and currently holds the role of Chief Research Officer at a MedTech company.Socials:Follow on Twitter at @NucleCastFollow on LinkedIn: https://linkedin.com/company/nuclecastpodcastSubscribe RSS Feed: https://rss.com/podcasts/nuclecast-podcast/Rate: https://podcasts.apple.com/us/podcast/nuclecast/id1644921278Email comments and topic/guest suggestions to NucleCast@anwadeter.org

In this episode, Duane Mancini chats with Holly Cotter, a seasoned regulatory quality and clinical consulting expert in MedTech and co-founder of indieMedTech. Holly discusses the inception of indieMedTech, a platform designed to support MedTech professionals, especially independent consultants and startups, with a robust community and marketplace. The conversation delves into Holly's background in biomedical engineering, her hands-on experiences with regulatory submissions, quality management, and clinical trials, and the significance of community and networking within the MedTech space.Holly Cotter LinkedInindieMedTech WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram and the episode's focus[00:05:15] Discussion on the challenges and opportunities of new regulations[00:10:40] Insights into the importance of confidence and adaptability in the regulatory field[00:15:20] Kavetha's journey and advice for emerging professionals[00:25:00] The role of innovation and collaboration in MedTech advancements[00:35:10] Strategies for professionals to stay relevant and proactiveQuotes:"Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram"Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols"Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha RamKey Takeaways:Insights into MedTech Trends:Regulatory changes are both a challenge and an opportunity for innovation.Practical Tips for MedTech Enthusiasts:Stay updated with regulatory changes and understand their implications.Engage in continuous learning and skill development.Foster collaboration across disciplines to enhance innovation.References:Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight GuruQuestions for the Audience:"What advice do you have for budding Regulatory Affairs professionals?"Reach out to us and let us know what you thought of the episode at podcast@greenlight.guruAlso, if you enjoyed this episode, please leave us a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.

Do you know how organs are traditionally transported for transplantation purposes? In a cooler filled with ice. When I learned that this approach was the most widespread method, I admit I was quite shocked... We talk here about "living" organs whose preservation is crucial for the success of their transplant! And as you can imagine, these transplants are often vital. The good news is: some people have racked their brains and rolled up their sleeves to change all that! And one of them is none other than Lisa Anderson, Co-Founder and President of Paragonix Technologies. With her team, she has literally redefined how organs could be transported, wiping the slate clean of an archaic, despite standard method. Last year, their technology was named one of TIME's 200 Best Inventions in the Medical Care category. A technology that allows organs to be preserved and monitored under ideal conditions of temperature, pressure, and perfusion. Since its creation in 2010, the company has enabled the transport of over 10,000 hearts, lungs, kidneys, livers, and pancreases combined to date. A paradigm shift, which not only allows for better preservation of these tissues during transport but is also accompanied by a surprising improvement in transplant outcomes, and helps democratise access to them. We talk about all of this with Lisa, from the complexity of developing such a system to the change management required to lead to its acceptance in the medical field. And everything that this changes for the patients who benefit from it every day. A conversation that dusts off a long-established medical practice and lifts the veil on a unique MedTech success story! Timeline: 00:00:00 - How Lisa got into the transplantation and organ transportation space 00:05:54 - The criticality of organ preservation before a graft 00:08:27 - The parameters to control when transporting organs 00:11:38 - The benefits of improved organ preservation on graft success 00:19:01 - Paragonix Technologies' clients and commercial models 00:21:20 - Sustainability considerations in the organ transportation business 00:25:29 - Paragonix Technologies' plans for geographic expansion 00:28:00 - The journey from A to Z of an organ between its donor and recipient 00:30:56 - Changing practices and mindsets around organ transportation 00:33:20 - The engineering challenges around the creation of Paragonix Technologies' first products 00:40:07 - Matching better the demand and supply of organ transplants What we also talked about with Lisa: Getinge As mentioned by Lisa during the episode, you can have a read at Paragonix Technologies' latest publications here and find out more about their products and technology on their website. You can get in touch with Lisa via LinkedIn, and follow Paragonix Technologies' activities on LinkedIn, X, Facebook, and YouTube. ✉️ If you want to give me feedback on the episode or suggest potential guests, contact me over LinkedIn or via email! ⭐️ And if you liked the episode, please share it, subscribe to the podcast, and leave a 5-star review on streaming platforms!

Send us a textFew people enter the MedTech world because of a personal experience with the technology itself—but for Brent Lavin, that's exactly where it began. At just 23 years old, a CT scan that revealed an urgent medical issue also sparked a lifelong passion for medical technology and its power to save lives. That moment became the foundation of a career devoted to driving innovation in healthcare.Brent's early engineering work revealed an exceptional talent for connecting technical possibility with human need. Over the next two decades, he would lead cross-functional teams through more than 20 successful product launches, three mergers and acquisitions, and hundreds of millions of dollars in portfolio growth. His leadership—marked by curiosity, clarity, and conviction—has earned him accolades such as BD's Director of the Year and the CEO Excellence Award.Today, as Director of Strategic Growth at BD, Brent is responsible for identifying high-impact opportunities for both organic development and targeted acquisitions. Previously, he served as Director of Marketing and Product Management, where he led global teams across multiple disease states to record-breaking revenue growth, even in the face of pandemic-era supply chain challenges.Before joining BD, Brent spent years at GE Healthcare, where he honed his product management and global commercialization expertise, launching next-generation ultrasound systems that achieved over 200% year-over-year growth. His career reflects a rare blend of technical grounding, marketing strategy, and human-centered leadership—built on a mission to deliver meaningful innovation to clinicians and patients worldwide.Beyond the numbers, Brent is known for building high-performing teams and mentoring leaders who thrive in complex environments. Whether he's shaping go-to-market strategies, integrating newly acquired companies, or guiding engineers toward greater clarity and impact, his approach is grounded in purpose: to help people and teams reach their full potential while bringing life-changing technologies to market. LINKS:Guest LinkedIn: https://www.linkedin.com/in/brent-lavin/ Aaron Moncur, hostDownload the Essential Guide to Designing Test Fixtures: https://pipelinemedialab.beehiiv.com/test-fixtureAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

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're making are indeed life impacting and make a difference. And that is rewarding because you know that the work you --do all work is important, but it's really fun when you get to know personally the impact that you get to have. [00:09:45] Charu Roy: Right, right. [00:09:46] Lindsey Dinneen: Yeah. Yeah. So, okay, so I'm, I'd love to dive in a little bit more to your current company and role and learn about that, and how you're helping, you're still helping people you know, win through this. [00:10:00] Charu Roy: So, yes, absolutely. Enlil is part of Shifamed, the portfolio. Shifamed invests in med device devices typically, so ophthalmology devices or cardio devices. Enlil came about as an enterprise software company within the portfolio because they realized that they needed some software to throw all their data into, right? So they had early designs, prototype data. They might have had some user requirements, what kind of standards they might have to follow. So all those were floating about, again, in emails and paper. Enlil came in saying that we can store this data more successfully, more cleanly in a structured fashion so that our users can find that data. And this becomes really important as the med device company moves on and tries to apply for regulatory approval at that time, they need all that history and the data behind the device. And they wanna be able to find it easily and present it to auditors. So, Enlil's a structured way of describing all the data that the customer has and being able to find it easily and then run their audits using the data. So it's a very crucial part of their lifecycle, their product lifecycle. And so it's really important for us to be secure, reliable, available, 24/7. All of that applies to us and basically defines how they go about driving their product lifecycle. [00:11:34] Lindsey Dinneen: Yeah. Well, and you know, one thing that stood out to me when you were talking about that was of course the security aspect. And as we all know, we're, we're probably much more so than in the past, hyper aware of the critical need for cybersecurity and the role it plays specifically in medical device technology. And I'm curious if you could speak a little bit more to that particular element. [00:11:55] Charu Roy: Yeah, we have a lot of layers of security, you know, right from the folks who are accessing the software. The software is hosted in a well-known, reputable cloud service environment. So apart from them providing us cybersecurity and access control and everything else, we have another set of layers on top of that. So our users are vetted and they all have a password. People can be invited and not just sort of show up. So, there's a lot of control of what they can see and can do. Every button sort of, you know, has a role behind it or a layer of control. So not everyone can do everything and press any and all buttons. So, security is at many levels. And we also have a lot of audit trails, e-signatures, and so on. So everything is done to protect the data, and audits are run regularly by them and by us to make sure that nobody who's supposed to be, you know, people who are not supposed to see the data, don't see the data. [00:13:01] Lindsey Dinneen: Yeah. Excellent. Yeah, I know that's just something that is, should be at least, on the forefront, especially of startups' minds as they're thinking about this and working towards having a really secure device. So it sounds like you've built in all of that safeguarding really well and really intentionally. So, so, okay, so I know that -- well, there's a few things that really stood out to me on your LinkedIn profile, and I'm just curious if we could dive into a couple things. One was, I love how you said that you're "passionate about teams and people delivering to their full potential," and I was wondering if you could speak a little bit more to that. [00:13:42] Charu Roy: Yeah, so, you know, along the years I've noticed that people in my team, the team members, they're there, they're working hard, but I do like to understand what's making them tick, what might they be wanting to do, which they haven't got gotten to do yet. Can we unlock some potential, some skill, some talent? And I think that comes about by sort of just talking about it , trying to give them openings about, "Hey, look, I've got this cool project or this cool feature. Any thoughts on that?" Just to understand, are they happy doing what they're doing, or is there something more they could do? And so I think that human touch, you know, is -- it was given to me, or at least it was taught to me by some mentors along the way. And I think that's a part that I really like to explore and see how can teams do better, not just in a numbers, not just turnaround features and releases on time, but are they happy doing it? Did they contribute something meaningful along the way? Did they feel they grew in the process? Did they feel they were recognized for some new responsibilities that they may not have stepped up for in some other companies? So that's a feeling I'm trying to always give them and sort of hoping that we contribute to their growth, not just the company and the bottom line. [00:15:02] Lindsey Dinneen: Yeah, that's critical and key,, and really speaks to who you are as a leader. And I'm actually very curious, you know, you mentioned earlier having kind of worked your way up at HP and then, you know, that may be opening some doors for you for of course, your future opportunities, and I'm curious, what has your own leadership journey looked like? Has, does leadership come naturally to you? Have you spent a lot of, you know, time and resources, whatever, developing those skill sets or how did that work for you? [00:15:29] Charu Roy: I think I was thrown into the deep end of the pool several times, you know, like, so I kicked into the pool, so to learn to swim. So similarly I was made to take on responsibility pretty much the very beginning. So I kind of knew that there were certain things expected that I should be doing, can be doing and then this introspection saying that, did I give the right amount of energy to that particular responsibility and did I do well? So just a lot of introspection and being able to understand, did I do well as a leader? But I've been honing it, honing skills. I mean, nothing out of an MBA school, nothing out of, you know, college that helped me. I think it was just about pure interest in psychology, pure interest in humans, you know, just being able to connect and how did I make them feel? How did they make me feel in those interactions? And is that, was that good? Was there something we could do to incorporate more people to get that feeling of ownership or anything? So it wasn't a, you know, by rote or something that I learned in a school. It was more of just sort of. Being thrown into situations where I had to come out of it somewhat gracefully and some somewhat feeling like I had also learned along the way. [00:16:46] Lindsey Dinneen: Yeah. Yeah, that, that's wonderful and incredible. And I think, you know, you mentioned learning along the way, and one thing also that stood out to me was, the recommendations on your profiles are so lovely for you. And two things stood out: they, one thing was somebody mentioned you're always learning, which is a gift in and of itself. And then the other thing was you're always letting others succeed. And that's such a beautiful gift and I'm wondering if you could talk more about both of those as well. [00:17:16] Charu Roy: Yeah, I think it's not about just me being sort of the boss and being able to tell people what to do, though I think success comes from enabling or encouraging the teams to again contribute without any barriers, any levels, or politics. I love the fact that we are in a small company, and I can say safely that, you know, politics --in larger companies there are politics. People are always trying to sort of be showing that they are very valuable. But in a small startup, it's very quickly apparent that there are certain valuable players there and startups, everybody is valuable, right? So I think being able to encourage the team members to do what they think is best for the problem to solve it. And of course, there are reasons why you can't sometimes accept the solution, but the fact that they're thinking about it and the fact they're able to openly express their opinions and say, "No, you're wrong, Charu." I think this is the way to do it. I love that. I think, somebody disagrees with me in a meeting, I just think that's the best thing that could have happened as a style of management. Because I'm not, you know, insecure in that sense. I don't sulk afterwards. I have had bosses and so on who don't like that kind of, you know, disagreements in public. And I think that's a part where I beg to differ, and I want to have people say what they think, what are they feeling, what are the problems, really the truth, and fix it, really. So I think it's less waste of a time when people are honest, and get to the point, and we are able to solve it together rather than hide behind, you know, facades, I guess. [00:19:01] Lindsey Dinneen: Yeah, that's beautiful. And yeah, I've often said for me personally, that, you know, more heads are better than one. I mean, I could have a, an opinion on whatever it is that we're talking about, but really, until we collaborate and start sharing those ideas and those thoughts and opinions , all of a sudden those kinds of sparks happen where, you know, you start with one thing and then it, and then somebody else catches that and they take it even to the next level and it just keeps going. And it's so cool to see the creativity and problem solving and innovation that comes from allowing those conversations. [00:19:36] Charu Roy: Yes, exactly. Creativity and innovation. You've said it so well. That comes with smart people being in the same room, arguing, not agreeing, and then something comes out of that, right? I mean, either your thoughts get clearer because you've seen every side of the coin and you're able to say, "Okay, I know the pros and cons and we can go this way, knowing the full effect of what we are going to do." So I think surrounding myself with smart people who have varied opinions, I think that's a beauty and a blessing really. [00:20:12] Lindsey Dinneen: Yes it is, and you've nailed it with varying opinions. You know, it's easy to get yourself into a situation-- and not necessarily intentionally-- but just it's easy to give into a situation where you've surrounded yourself with people who all kind of have the same opinions on things. And so inviting those conversations to take place that might be difficult, might be challenging, might be frustrating at times, but allowing for that and being open to other points of view and experience. I mean, that's the beauty of a really good collaborative environment is all of those varying opinions that don't necessarily match yours. [00:20:50] Charu Roy: Yes, exactly. Exactly. [00:20:52] Lindsey Dinneen: Yeah. Yeah. So, okay, so looking back, could 10-year-old you have ever imagined where you'd end up today? [00:21:00] Charu Roy: No, absolutely not. I thought I wanted to be a doctor or something vague. 10-year-old me was climbing trees and eating guavas off the trees in Delhi. So it was really crazy childhood. And you know, it wasn't filled with studies and rules and stuff. So I think coming to this, a country when I was young, being able to absorb everything, the culture, the of course the education itself and being able to sort of grow within the companies that I joined, i, I think that was the journey that I was sort of a pointing more towards rather than the childhood me. The childhood me was horrible, I think. [00:21:46] Lindsey Dinneen: Oh man. Honest reflection right there. That's awesome. Yeah, okay. Are there any moments that really stand out to you, perhaps with your current position or, you know, something in your past where you really thought, "Wow, what I'm doing makes a difference. I am in the right industry, at the right time, in the right place." [00:22:07] Charu Roy: I think it's the technology now that, you know, speaking from a technical viewpoint of shipping software, meaning full software, more easily, the time is now. I feel that the culmination of everything I've learned about pain points and users and customers, all of that's culminating in in the product that I'm managing right now, using new technologies, having the right technologies to choose from and being able to propel that software forward to our users. I feel that, "Wow, what a time to be a product officer really, when we have so many choices and being able to be able to apply that to real world problems and real pain points." I had the same pain points 20 years ago, even 30 years ago, but we couldn't do much. We had to, you know, write painful programs. We had to write database queries and, you know, things like that. It was quite painful, I would say. And then now to see all the tools where we can create things overnight and be able to ship it to customers, just hitting the nail on the head. We had to experiment a lot in the old days but I think the time now is is really special. We are on an sort of an industrial revolution or a computer science revolution here with the AI, MML, the LLMs, being able to do so much with probably less resources than before. So. [00:23:39] Lindsey Dinneen: Yeah. So seeing the impact of the work and getting to not have it be so painful. [00:23:45] Charu Roy: Yes. It used be very painful and now I'm thinking, I think we're at the right time, right place now with this product. And it's not just about the products. It's the kind of help we are getting as software professionals to help deliver software and support our users. I think that's really special and I, we are still learning, we're still trying to understand all the technologies that are available to us and how can we make our lives easier and our customers feel that we've solved some problems for them. [00:24:14] Lindsey Dinneen: Yeah, absolutely. And I think that there's just, it is really wonderful again-- just to, to circle back to this kind of been a running theme of getting to be able to experience for the end user or with the end user, that moment of, "Oh wow, I needed this is so helpful and it's gonna make a difference." [00:24:36] Charu Roy: Yeah. I remember in my past, same sort of software tracking wine being made. And that software was pretty cool. It, it used to track where the wine sat and which barrel for how long. And so the pleasure of talking to wine makers, and being able to show them how the software track the progress of the wine and being able to print out a label at the very end for them, saying that "this wine sat in these bottles or these barrels for a while," and that technology application for a simple, naive user, I thought that was it. That was the, you know, the culmination of all the learnings that I had over the years to be able to explain the software so easily to a end user who might be a distiller or a winemaker or somebody, a farmer. I thought that was pretty cool. And that since then, of course, technology has changed, but I think we're beginning to see the effect on a naive user, which we couldn't do, you know, 30 years ago. [00:25:37] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. That is, it is so cool. And I love the work you're doing and just learning all about your history so far and just exciting to see where it's gonna end up too, and as you continue along your career path, but pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be within your area of expertise, it doesn't have to be. What would you choose to teach? [00:26:06] Charu Roy: I would probably think about teaching psychology of the individual. I don't have a PhD or a even basic courses in psychology, but I just love the fact that, you know, you can apply psychology, figure out how a user might or somebody might react to something that you say, do, think so I, if it was a master class and I'd be teaching you know, teaching more about life interactions, you know, ordinary interactions. How can they be made more meaningful, more fruitful, using psychological tricks or phrases? I don't know all of those things, but I would really think that I could teach that based on, you know, facial expressions, body mannerisms, or body-- what do they call it, sort of, you know, criminal stories. They read your mind based on certain mannerisms of flutter viol. So yes, psychology is a masterclass I would teach, but more applied to daily interactions, maybe work situations and being able to use psychology better to improve your own work relationships with people and even just general interactions. Yeah, so that would be my attempt at being a psychologist and eventually be a criminal psychologist. [00:27:28] Lindsey Dinneen: Yes. Oh my goodness. That would be so interesting. Yeah, I love that idea. And the masterclass sounds fabulous, so I'm signing up whenever you do it. [00:27:37] Charu Roy: Okay, I'll go get my degrees for it then. [00:27:40] Lindsey Dinneen: Right, right, right. Yeah. Ah, details. Awesome. How do you wish to be remembered after you leave this world? [00:27:50] Charu Roy: This is something that I've always felt deeply about. It's not what you say or what you do, it's how you make people feel, that Maya Angelo said that this much nicer than what I'm saying, but and I've had a few people say this to me, saying that, "We worked together 30 years ago, but that day you made me feel good." And I don't even remember what I said, what I did, but the fact that they remember me for what I made them feel. The fact that somebody also told me that they "don't avoid me when I'm walking up to them because, because I make them feel like things are okay, things are good, however bad the problem is." So they say that with other people they would duck and, you know, go away in the opposite direction. But with me they're waiting for me to come up to them. I'd like to continue that, that feeling that somebody feels like, "Hey, you are coming up to them and you just make them feel good in some fashion." Nothing else. I think that feeling, if I could evoke in people, they say, "Oh yeah, she made me feel good that day. I don't know what she said, but she made me feel good." That's enough. [00:29:01] Lindsey Dinneen: Yeah, that, yes, that is more than enough. What a beautiful legacy. Yeah, and then final question, what is one thing that makes you smile every time you see or think about it? [00:29:15] Charu Roy: I think my dogs smile. I would say he's got missing teeth and so when he looks at me when I first come, you know, come back home and he is smiling almost, and he is sniffling and, you know, trying to sneeze and smile at the same time. Oh my God, what kind of a character dog this is? So that makes me smile and laugh the whole time, especially the missing teeth. Poor thing. He doesn't understand that his teeth are missing because of me, and yet he's smiling at me, so. [00:29:50] Lindsey Dinneen: That is so sweet and cute. Oh my goodness. I love, I know somebody at one point said, "You know, dogs don't actually smile." I don't believe them. They smile. [00:30:00] Charu Roy: They smile and they choke while they smile because my dog has a small nose, I guess. So he chokes when he smiles, and so he is choking, and he is smiling, and this missing teeth there. I was like, "Oh my God." [00:30:16] Lindsey Dinneen: Oh my goodness. Yes. I mean, that would just I, yes, I can just sort of picture this. I love, love dogs and so I'm just picturing this and I, that would bring me joy every single day, definitely. Excellent. Well, this has been such a wonderful time spent with you today. Thank you for sharing your stories and your journey and your advice, and I really appreciate some of those in particular, your leadership advice, and the impact that you can have as a leader, inviting the collaboration, having conversations that encourage people to have varying opinions and maybe outright disagree with you. I love what you're wanting to, you know, wanting your legacy to be, and so that's how you're intentionally showing up in the world. And so I just wanna thank you so, so very much for being here. We're really grateful to have you. [00:31:10] Charu Roy: Thank you, and thank you so much for your intelligent questions and insightful questions that go above and beyond just you know, a company and it's gold. It's there, there's something so human about your questions-- and I love when I'm like, "Oh my goodness, this is so, so interesting to see in this day and age, somebody taking the time to ask such questions" and I really appreciate you for that. [00:31:36] Lindsey Dinneen: Oh, thank you. Well, I really appreciate that feedback too, because it's, you know, you come up with an idea-- speaking of sometimes echo chambers, you come up with an idea and you think, "Oh, this is how I'd like to go about this, but does it resonate with somebody else?" So that's delightful to hear. [00:31:51] Charu Roy: Fantastic, thank you, thank you for having me. [00:31:54] Lindsey Dinneen: And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support Thank you so much, and gosh, I just wish you the most continued success as you work to change lives for a better world. And to all of our listeners for tuning in, I wanna thank you for being here as well. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time. [00:32:31] Charu Roy: Thank you. [00:32:32] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.Will we need to retest everything?Is this a complete game-changer, or just an evolution?How will Notified Bodies and the FDA react?In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi hosts Marina Daineko, biocompatibility consultant at Intrinsic Medical Group, to unpack what's really coming.This episode covers:The background and current status of the ISO 10993-1 revisionWhy the new version is best seen as an evolution, not a revolutionHow the standard pushes further into a risk-based, scientifically justified approachThe link with ISO 14971 and lifecycle thinkingChanges in contact categorization and cumulative exposureThe industry trend toward reducing animal testing through in vitro methods and data-driven justificationHow to conduct a gap analysis once the new standard is publishedPractical advice on how to prioritize updates without freezing projects or panickingReal-world examples where process chemicals, not base materials, changed the risk pictureHow Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices

Dans cet épisode sincère et éclairant d'Au-delà de la thèse avec Papa PhD, David Mendes reçoit Marc-André Hachey, ingénieur mécanique et ancien doctorant en micro-fabrication. Marc-André partage avec authenticité son cheminement académique, les réflexions qui l'ont conduit à quitter son doctorat, et comment il a trouvé un nouvel élan professionnel dans le secteur de la MedTech. Ensemble, ils abordent des thèmes essentiels pour la communauté des chercheurs : le syndrome de l'imposteur, la santé mentale aux cycles supérieurs, la quête de sens dans les études, et la transition vers l'industrie. Un épisode riche en conseils pour celles et ceux qui envisagent une réorientation après le doctorat.

This week Liz is joined by Trey Morton, Senior Director, Professional Education and Sales Training, and, as his LinkedIn rightly proclaims, "All-around Awesome Guy." Liz and Trey discuss what companies need to consider about training their sales forces as they add products to their portfolios. They discuss when to pull sales reps out of the field for in-person training, the balance between clinical training and sales training, and the importance of aligning and setting expectations with senior leadership. Listen in and get ready for your next product launch!In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Trey Morton is the Senior Director of Education in the life sciences industry. His passion for training began as a Combat Infantry Officer in the US Army, where he learned a cycle of “learn, do, teach.” Combining that experience with various roles in sales management and marketing led him to an outcomes-focused training philosophy.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Trey Morton⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

This week Liz and Rachel dive into their conversation with Trey Morton on building training programs for your expanding product portfolio. They discuss the benefit of utilizing physicians to teach this new content to both physicians and reps as well as important watchouts to ensure it remains authentic and effective. In addition, they look at when, why, and how to pull reps from the field for training, and creative solutions to meet the needs of already busy reps.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Interview with Trey MortonSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

The UK Investor Magazine was thrilled to welcome Dan Daly, Founder & CEO of Occuity, and CCO Mark Jenkins to delve into Occuity's eye scanning disease detection technology.Find out more about Occuity on Republic here.Occuity is developing handheld, non-contact devices that use the eye as a window to the body's health.The company's patented optical technology already addresses glaucoma and myopia, while future products will target disease screening and, ultimately, a non-invasive glucose meter for diabetes monitoring.Occuity enables screening of glaucoma, myopia and diabetes through optical MedTech backed by 15 patents and £4 million in grant funding. Its first product is selling globally through 19 distributors. The company has established a proven platform with a strategic pipeline of products in development.The company has been busy forging commercial partnerships and is well placed to push forward with its growth strategy on the completion of their current fundraising round. Hosted on Acast. See acast.com/privacy for more information.

In this episode, Duane Mancini interviews Allison Komiyama, a former FDA reviewer turned successful entrepreneur, who shares her journey from her early passion for biology, through her academic achievements in molecular cell biology and neuroscience, to landing a role at the FDA. She recounts the challenges and lessons learned starting her own regulatory consulting business and scaling it to a successful acquisition. The conversation delves into her latest venture, Bluestocking Health, a medtech hype company aimed at educating the public and professionals about medical technology. They discuss the importance of understanding the FDA's role, navigating the complexities of bringing new tech to market, and the significance of promoting and celebrating medtech innovations.Allison Komiyama LinkedInBluestocking Health LinkedInBluestocking Health Website“Your Life Depends on It” Book by Talya Miron-Shatz, PhDDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.Key Timestamps:00:00:15 - Introduction of Perry Parendo and the episode's focus00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles00:12:20 - Agile methodologies vs. traditional project management in MedTech00:22:35 - The importance of risk management and Monte Carlo simulation in project planning00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities00:45:55 - Strategies for efficient and effective product development processesQuotes:"We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo"There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry ParendoTakeawaysInsights on MedTech Trends:The convergence of agile and traditional methodologies tailored to MedTech's unique demands.The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.A call for innovation that transcends regulatory compliance to genuinely benefit patient care.Practical Tips for Listeners:Adopt a flexible approach to project management by integrating various methodologies based on project needs.Prioritize risk management early in the development process to foresee and mitigate potential challenges.Always align product development objectives with the ultimate goal of improving patient outcomes.Questions for Future Developments:How will evolving regulatory standards shape the next generation of medical devices?What role will patient feedback play in the design and development of future MedTech innovations?Can MedTech sustain its pace of innovation while ensuring safety and compliance?References:Perry Parendo on LinkedInEtienne Nichols on LinkedInBehavioral Grooves podcast with Annie Duke - Thinking in BetsBook - Someday is Today, Ron RichardYoutube video - the Heartbeat of New Product DevelopmentQuality Culture for Product Design SuccessDesign News Columns

Chris DuPont, a seasoned MedTech engineer, entrepreneur, and co-founder of Galen Data, which was acquired by Matrix One in late 2024. With a background in aerospace software from NASA and a career dedicated to medical device connectivity, Chris shares a rare behind-the-scenes look at starting a cloud platform with just $600, scaling it into an FDA compliant infrastructure solution and navigating both technical and financial risk.In this episode, we dive into the unexpected similarities between outer space and inner space, how “Twiddler Syndrome” inspired a connected care solution and why the future of SaMD relies on proactive, cybersecure, cloud native design. Chris opens up about managing through the SVB collapse, regulatory war stories from his days at Cyberonics, and what he learned about entrepreneurship that no incubator can teach. From minimal viable features to medical-grade quality systems, this episode is packed with real lessons from a founder who's seen it all.Timestamps[00:01:05] From Space Station Freedom to Inner Space: NASA to MedTech[00:02:56] Launching Galen Data with Just $600[00:06:21] Why They Built Their Own Incubator[00:08:36] Fundraising in a Non-VC Town (Houston)[00:11:33] The Silicon Valley Bank Collapse and Business Risk[00:16:25] Twiddler Syndrome and the Birth of a Connected Platform[00:19:35] Cybersecurity and Compliance in the Cloud[00:22:20] FDA Approval Without Reimbursement: A Regulatory War Story[00:24:32] Why Not Every Feature Deserves to Ship[00:29:13] “You Can't Fake Science”: Betting on Yourself in MedTechConnect with Chris - https://www.linkedin.com/in/chris-dupont-38b5ba15/Learn more about MatrixOne - https://matrixone.health/ Get in touch with Karandeep Badwal - ⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠Follow Karandeep on YouTube - ⁠https://www.youtube.com/@KarandeepBadwal⁠Subscribe to the Podcast

Mit einer Unternehmensbewertung von über 4 Milliarden Euro ging Ottobock im Oktober 2025 erfolgreich an die Börse und erreichte damit einen bedeutenden Meilenstein in der Geschichte des weltweit führenden Unternehmens für Prothetik, Orthetik und Exoskelette. Diese Folge wurde noch vor dem Börsengang aufgenommen, der einen Blick hinter die Unternehmens-Kulissen jetzt aber umso spannender macht: Martin Böhm, Chief Experience Officer bei Ottobock, berichtet, wie sich das traditionelle, familiengeführte Unternehmen zu einem digital getriebenen MedTech-Anbieter transformiert hat. Seit über 100 Jahren ermöglicht Ottobock Menschen mit körperlichen Einschränkungen mehr Lebensqualität und Mobilität und widmet sich heute Zukunftstechnologien wie neuronaler Steuerung, KI-gestützten Prozessen und Virtual Reality in der Prothetik und Orthetik. Wie schafft es das Unternehmen, Patient:innen, Ärzt:innen, Sanitätshäuser und Krankenkassen in einem komplexen Ökosystem zusammenzuführen und dabei den Menschen in den Mittelpunkt zu stellen? Martin Böhm gibt spannende Einblicke in innovative Plattformen, digitale Hightech-Prothesen und -Orthesen und Patient:innen-Engagement. Das Gespräch im Überblick: (1:20) Martin Böhm stellt sich vor (5:00) Einblicke in Hightech-Prothetik & -Orthetik (12:10) Marktdynamiken & Wachstumstreiber (15:03) Entscheidungs- & Kaufprozesse im MedTech-Umfeld (28:26) Digitale Plattform-Ökonomie & KI (42:30) Next Level MedTech: 3-Druck, Patient:innen-Engagement & Mental Health

In this episode, Dr. Paul Beresford, Senior Vice President of Biopharma Partnerships at PathAI, shares perspectives on how artificial intelligence is transforming pathology workflows, enhancing diagnostic accuracy, and supporting precision medicine. Discover practical insights on AI integration, regulatory alignment, and the evolving partnership between technology and clinical expertise in diagnostics.Host: Michaela Miller, Practice Lead, U.S. MedTech Technology & Analytics, IQVIAFeatured Speaker: Paul Beresford, Ph.D., Senior Vice President of Biopharma Partnerships, PathAI

In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kaitlin Maier.

Meeting the right people can completely change the trajectory of one's career. In this episode of Medtech Talk, host Geoff Pardo speaks with Stacy Enxing Seng, independent director and venture partner, about her journey from Harvard Business School to SciMed to ev3 and beyond. She delves into the lessons learned, the challenges, and—most importantly—the people that have impacted her illustrious career. She also shares advice on why soft skills are key to acquisitions and integrations, the importance of transparency, and determining the difference between a CEO who isn't the right fit versus a CEO who has room to grow. Medtech Talk Links:  Cambridge Healthtech Institute   Medtech Talk  Gilde Healthcare  Corza Medical Lightstone Ventures   

Join Liz and Rachel as they debrief the conversation with Becky Lai on the journey to standard of care. They dive into best practices for using training to drive adoption, engage KOLs, and create a respected brand.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:https://open.spotify.com/episode/7DjeuGhXtiKaOM0qRoWC46?si=_wI8T6TkQ--ZsIoG2MgzmgSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Design controls have long been the backbone of safe, compliant medical device development - but artificial intelligence is changing how teams manage them.In this episode of Life Science Solutions, host Chris Adkins sits down with Nick Ciccarelli, Chief Technology Officer at Kymanox, to explore how AI is transforming design controls, the structured processes that ensure medical devices meet regulatory standards. Nick shares practical examples of AI in action today, including analyzing large datasets during design verification and scanning FDA communications for emerging regulatory patterns.Topics Include:What design controls are and why they matter for medical devices and combination products.How AI is evolving from a personal tool to a professional asset in regulated environments.Practical applications: analyzing FDA trends, summarizing post-market data, and streamlining documentation.Specific uses within Design Verification, including sample size determination and data analysis.Managing AI risks: why "hallucinations" happen and the need for expert human oversight.Sustainability considerations: could AI use impact environmental goals in MedTech?Whether you're a MedTech engineer, quality professional, or regulatory strategist, this conversation offers a roadmap for integrating AI safely and effectively into your design control process.

In this episode, Duane Mancini, Tino Chow, and Lindsey Dinneen dive into the intricacies of pitching, focusing on both the technical and emotional aspects. The conversation highlights the importance of authenticity, building relationships, and the critical role a cohesive and credible team plays in attracting investors. They share strategies for maintaining consistency across your brand and various pitching scenarios, whether it's a pitch competition or casual networking. Tino Chow LinkedInGiant Shoulders WebsiteLindsey Dinneen LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

In this episode of the Global Medical Device Podcast, we're joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.Quotes"If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria"Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria"Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena KyriaTakeawaysNetworking is Key: It's not just what you know, but who knows you and what they know you're doing.Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions.Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution.Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team.Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth.Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience.Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career.Adaptability: Be prepared to pivot and adapt to changes within the industry and your career.Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach.Reference Links:Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne Nichols' LinkedInRemember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don't forget to leave a review on iTunes!*Interested in sponsoring an episode? Use this form and let us know!

In this powerful first part of a two-part series, host Sharna Southan sits down with Kirsten Karchmer, health tech pioneer, women's health expert, and founder & CEO of Conceivable Technologies. About Our Guest Kirsten is revolutionising women's health through technology. Conceivable was named one of the most innovative health tech startups by MedTech in 2015 and Best Fertility App by Healthline in 2016. She's been featured in TechCrunch, Fox News, and Huffington Post, and recognized as one of the top female startup founders to watch. What You'll Learn in Part 1 Kirsten's Transformation Story: How being diagnosed with MS led her to discover acupuncture and Chinese medicine Her journey from linguistics professor to becoming a fertility acupuncturist Working with over 10,000 women across three clinics over 20 years Your Period as a Health Diagnostic Tool: Why every symptom of your menstrual cycle tells a story about your health How blood color, consistency, volume, and cycle length reveal fertility potential The connection between period health and ability to conceive and stay pregnant The Three Key Factors for Staying Pregnant: Energy levels - Why you need an 8/10 energy level (without caffeine or exercise) Body temperature - The critical temperature threshold after ovulation that most women don't know about Menstrual flow - What healthy bleeding should look like and why clots matter Why Current Medical Approaches Fall Short: The limitations of jumping straight to fertility treatments without addressing root causes How medications like Clomid and letrozole can impact long-term fertility Why the medical system isn't equipped to provide comprehensive reproductive health support Key Takeaways Your menstrual cycle is a monthly report card on your overall health Getting pregnant isn't enough - your body needs to be prepared to stay pregnant Many fertility issues can be addressed through understanding and optimizing your cycle Technology can democratize access to fertility knowledge previously only available to a few Resources Mentioned Conceivable Technologies app Kirsten's book "Seeing Red" The Institute of Healing Through Pregnancy Loss Pregnancy Loss Practitioner Certification Program Don't miss Part 2 where we dive deeper into practical solutions and how technology is changing the fertility landscape. Connect with our guest: Kirsten Karchmer, Conceivable Technologies: www.conceivable.com TikTok @yourfertilityexpert Stan store: HERE IG: @conciveable.official Connect with Sharna: ** Grab the FREE Loss to Purpose Masterclass if you want to learn how to turn your experience into your expertise: https://www.sharnasouthan.com/loss-to-purpose-masterclass ** Apply for the Certification: HERE IG: @instituteofhealing_pl IG: @pregnancylosscertification IG: Podcast: @pregnancyloss_podcast LinkedIn: @sharnasouthan Share screenshots and tag us to show what resonated DM for conversation and support Check show notes for Pregnancy Loss Practitioner Certification application Important Note: This podcast is for educational purposes only and does not constitute medical advice. Please consult with your healthcare provider for personalized medical guidance. Listen on: Apple Podcasts | Spotify For those seeking guidance and support, this episode is a reminder that you are not alone, and there are resources and communities ready to help you through your healing journey. Thank you for tuning in, and if you found this episode valuable, please leave a review on Apple Podcasts. We look forward to supporting you in the next episode.

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, quote unquote encrypted, or at least protected in some manner. So, so that's what we do. And yeah, I guess why we do it a bit. [00:08:27] Lindsey Dinneen: Yeah. Wow. So, okay, so that brings up a really interesting question. I can guess the answer to this, but is there any safe way to-- this is a funny way to put it-- but recreationally to test your genetic data in the sense of the way that a lot of us would think about it in terms of, "Oh, I'd really love to learn more about my ancestors and things like that." But there are so many security concerns, like you've pointed out. So is there any quote unquote, safe way to do so at this time? [00:08:58] Garrett Schumacher: You know that-- it's a great question. There's been a lot of things going on in the news recently, like with, I'm sure people have heard of 23 & Me, and how they went bankrupt and now a company called Regeneron is buying them and all their assets for a lot of money, but not that much compared to what 23 & Me was worth a few years ago. So that brings up a lot of issues, right? 23 & Me still owns a lot of samples, like maybe around 10 million samples. And the sequencing they've been doing is very small. So if your genome's a whole book, they've been kind of flipping through the pages and picking specific letters, and that's the data they have. So that's not the most sensitive, it's not the full story. But if you have the samples, you can always generate the full book someday. And as that cost of full human genome sequencing decreases rapidly, someone's probably gonna want to do that someday. So, okay, so back to your question though, is there a safe way? What I would say is that I, I don't tell people not to do it. I would say if you have health reasons, concerns, and your doctor suggests a genetic test, a lot of those tests are also that similar, picking a few letters, a few known letters and trying to just read that for a very specific purpose. If your doctor and you come to the agreement that you should do that, you should just do that. However, I do not promote, and even to my family members, I highly don't recommend, using these services. I used to really love who's that group out of Utah? Ancestry.com. They used to be a great group. They were trying to sequence the world's DNA for understanding basically the family tree of everyone. Because anyways, they have interest in understanding who's related to who and how that relates to their religion. So they used to do it for internal purposes, keep it on pretty tight, secure. Well then, they sold to a venture capital group. So, it's really tough to say that there's these groups that there's a good place out there to do it. There are some companies that have security or privacy focused DNA sequencing services. But it's really odd, like you have to set up a cryptocurrency account, pay with cryptocurrency, set up a PO box so that you're not like actually shipping to and from your home. And then ultimately the price of it and how they're getting it to be cost effective is China's doing the sequencing. So you do all those privacy measures and your sample gets sent off to another country. And the FBI has disclosed that they know that when certain countries like that are doing the sequencing, whether you want them to do a little tiny test, like a COVID test or whatever it is, they're sequencing the whole thing. They're keeping the data. This is known, disclosed, not conjecture. So, yeah, so sorry-- long-winded answer of saying, I'm interested too, I wanna learn about this. I've got family members that have done it. But right now I recommend just thinking very carefully and critically about whether the immediate fun of it is worth the potential long-term impacts, and maybe if you're someone that's security or privacy conscious, maybe wait a few years because there are some things on the horizon that will make this a lot better. [00:12:02] Lindsey Dinneen: All right! Thank you for the honest answer. I really appreciate it. So, okay, I wanna go back to your work with Velentium specifically and talk about-- you've gotten to work with so many different clients over the years and you've seen so many different variations on a theme. And I'm curious, what are some of the common mistakes or pitfalls you might see a younger startup make when they are perhaps first designing their device, and cybersecurity is maybe not quite top of mind. So what are some of the things that you see that are challenges we can overcome? [00:12:41] Garrett Schumacher: Yeah I think one of the biggest challenges is that a lot of people aren't maybe aware yet of the scrutiny and the requirements that the FDA-- and not just FDA, but the European union's medical device regulations and the bodies over there that review submissions. And any, if you look across the board, pretty much almost every regulatory market has, very much in the last couple years, placed a lot of scrutiny on cybersecurity. So a lot of companies, especially smaller ones starting out in the space, may not be aware of this. And so then oftentimes they'll find out too late, they'll submit. They'll get feedback back, "Oh no, we have 90 days to respond and we didn't do cyber. We gotta do cyber now." And they don't know how to spell it yet, which is a joke. But there's that. And then there's also, or they'll get in just late at the game, "Hey, we're submitting in a month or three" and "Oh, we gotta do this thing retroactively." And so then therefore, we haven't been able to support someone through the full process, at the proper time, doing the right design things to inform the design during the design, not after. So I think that's probably the biggest mistake is not seeking that external support early and often. And if you're getting that, it shouldn't just be someone that can help you navigate the regulatory space. It shouldn't be someone that can just do the pen testing for you at the end. Really I think in that context, you need a partner that can do everything end to end. So that's what we've really tried to make our processes and our services geared towards is being that partner. And whether you have the bandwidth and you will do a lot of the documentation and work, but you just need someone to guide you, consult you, give you the materials to do so, or if you are truly looking for, no, we need to augment our own team and have you do a lot more of the work for us. That's great. We can do that. So, so that's, I think, the biggest challenge. And I think that the answer is just getting the right partner early and working with them often throughout that entire development, not at the end. [00:14:37] Lindsey Dinneen: Yeah, absolutely. And I really appreciate that perspective. I think that there's a lot more awareness, it seems like even in the industry that, "Oh, cybersecurity is a thing now." But as you said, getting to partner with somebody who does know the ins and outs from the start and can really help guide you through is really critical. Now you do quite a bit of speaking and presenting. You're obviously still teaching a college class and all of those wonderful things. I'm curious how that has played into your career as well, and is that something that you will always want to do? You've got this educator side of you as well. [00:15:13] Garrett Schumacher: Yeah, I mean, I love it. I actually taught at a high school for one year between my master's program and my undergraduate, decided that that's not for me, but that teaching at those higher levels where people are really wanting to be in the room. So now I teach at the graduate level, half of the students will be older than me. And now everybody wants to be there and we can have very mature conversations and they even can challenge me with some really great questions that I'm not ready for, right? And I think the best way to learn is to teach. Absolutely. That's, yeah. I think a lot of people have said that. I completely agree. So I plan to always do that. I mean, I love, even with our internal engineers and external clients, like the idea of helping people understand something and humanizing it for 'em. That's really my big flag I'm waving right now is humanizing it. We don't have to use alphabet soups and crazy language. We can make it easy to understand and we can humanize it for the masses. So that's really what I'm trying to do, one of my big pushes. And so I don't foresee myself ever going away from that, I even do a lot of international training on the cyber biosecurity space where I go to all these countries and these biosafety laboratories and help biologists understand cybersecurity as a fundamental practice and how they can improve their personal security, their professional security. And to me that's the most rewarding thing. [00:16:36] Lindsey Dinneen: Yeah. Oh my goodness. That's so cool. Thank you for sharing about that. So, as you are looking towards the future in the industry itself, but also I suppose your own career, what are some things that you're excited about? What are some trends that you see as being positive? I know that, recently, it's been a little bit challenging-- as a nice word-- for a lot of medical device companies and they're a little worried about funding and those kinds of things, and so, that's maybe a trend that's a little not as fun, but what are the things that are empowering and exciting to you as we move forward? [00:17:13] Garrett Schumacher: So not to make it about artificial intelligence or machine learning, 'cause everybody does. It's definitely, its hype curve. But that is actually one of the things that I think I'm most excited about, but also most scared about. We've seen a lot of companies with layoffs because they believe this artificial intelligence enables them to be more efficient and therefore they can do more with fewer people. And that saves money. And I understand that. I think that one of my big pushes right now is trying to help people understand that AI, at least right now, it's not taking over human jobs-- that it can instead augment, improve how we do those jobs. But people have to be ready for it. So even in, in my own space, like, making sure that our team and our people are ready for that. Because if you aren't getting into that space, if you aren't with the curve, then you're gonna fall behind. And yes, you could be replaced in that sense that someone has done it and so now they're doing it better than you. And so if you're not using these tools, these resources to, to improve your efficiency and to just maximize your capability-- like for example, my team, maybe I don't need to hire a person. Maybe we can build out things that enable us to, with the same amount of people, to better serve more clientele. So that's what I'm really trying to navigate. But it is scary thinking about that future and am I even gonna be ready and technically savvy enough to navigate that new future in the next year, in the next five, 10 years. And especially as someone who I've always had this, this goal of maybe someday, and I'm getting talked out of it very quickly, but maybe like being a Chief Information Security Officer at a large company or a Chief Product Security Officer, something like that. And yeah, quickly, I'm-- "Eh, we'll see." But it's those kind of things that, if we can navigate them correctly, may maybe that is something in my future. So that's, I think, one of my big fears and also passion projects right now. And then also, same on that funding vein-- with my startup, we're experiencing that as well. And we actually, we had a lot of funding potential pre COVID. And then even though our technology-- like in some ways COVID brought the need for our technology to the forefront of people's minds-- it also killed a lot of funding opportunity. And so yeah, I mean, navigating that space of how do you get funding and then does it come from venture capital backed or equity, private equity, and I've seen those worlds. I even advise startups. So I mean, that is also probably one of the biggest challenges I'm facing currently as well. [00:19:41] Lindsey Dinneen: Yeah. Yeah. It's gonna be really interesting to see how things evolve, and it's been fascinating to read the news and see even the headlines where it's like, the FDA is using AI to review submissions and all sorts of things, and you really do wonder how we'll move forward and time will tell, I suppose. [00:20:01] Garrett Schumacher: Yeah. [00:20:02] Lindsey Dinneen: So you have stepped into quite a number of leadership roles fairly young in your career, if you don't mind me just saying so, and so I'm curious how you have navigated that growth for yourself. First of all, do you feel like you were a natural leader or were those skills things you developed along the way? And secondly, what advice might you have for younger leaders? [00:20:27] Garrett Schumacher: Great questions. Yeah, definitely nothing is natural about it. I think for anyone, I mean, it's nothing that you just do and you're just like, "Yep, I'm a leader. That's easy." So it definitely something, just like all aspects of work and maturity, is you have to work on it. But I think how I got there was-- and someone told me a couple tips early in my career, I suppose-- and it was a couple are: find a mentor, and as the mentee you have to put in the effort. If you set up meetings and they're not there, whatever, like they're busy, and you are asking them to give their time for you. So, find mentors and then be a good mentee, meet up with them. I had several people that were critical in my early career. One was Bunky Davis and she was amazing. She was no longer with us, but her and I grabbed coffee every single month. She had navigated biotech startups for like 50 years, was also just a phenomenal cyclist, Olympian, like just amazing. And we'd meet up every month for coffee without missing. And we did that for several years. And, and I had another mentor from the University of Colorado Boulder, Lloyd Thrall, who came from the Department of Defense, and just a spectacular, stellar guy, and we would go meet up all the time. And so learning from these people I think I saw-- well, there's that. And then everybody has their bosses and their horror stories from work, whether that's a high school job or professional later on. And so you see the ways that people can be, you don't want to be. And so that, that makes it easy. But without having those mentors, yeah, I don't know if I would've exposed myself to the good ways, right, and the better ways, and be challenged. So that was really critical was finding a good mentor and then being a good mentee. And then I think the other thing is interacting with people and just listening, active listening. So going to the professional shows and meeting people, listening to them, reading a lot of great books out there on how to be a leader, and you don't take all that exactly word for word, but there are golden little nuggets that you can just pick up out of all those things. So, no, definitely something that I have actively worked on and still am trying to work on. And then I'm constantly trying to listen and being that, have that open door policy for my people too. Because if I hire really smart people, I want them to do the thinking and therefore I need to listen. [00:22:44] Lindsey Dinneen: There you go. I love it. All right, so. You've had a really interesting and exciting career so far, and you're obviously very passionate about medtech and cybersecurity and biotech and all those things, and I'm wondering if along the way there are any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time." [00:23:09] Garrett Schumacher: Yeah. Yeah. One was we had a really special project where and I won't give any names away, but basically my stepmother has an implant inside of her and it's it's not life sustaining, but it's one that you want working just so that your body's working normally, and so that you're not, not embarrassed. You can go into public spaces and be a normal person, right? And whether it's pain management, incontinence, those kind of things. So she had this implant and it was, she had one that came from the leading provider of that at the time. And it, the battery life, right, is supposed to last like 10 or 15 years, and it seemed like pretty much seven or eight was all she was getting out of it. And after decades of having far more surgeries than she needed, all the way up to the very last device she got in her-- it failed within the first year, I think-- so it was like, okay, time to pivot. And we found this new company and they've become a huge leader in the space, recently acquired by another one of the big leaders in medtech in general. And we were hired to do the security work for that project. And the only reason that I actually found out-- because my stepmother was literally like in the process of getting this new device inside of her-- I was at that client's facility doing a pen testing and security testing engagement and some consulting and just visiting them. And I FaceTimed my family in the break room and there was a sign behind me and they're like, "Oh my gosh. We're literally, we just got that implanted in your stepmother like, a couple weeks ago. It's working great. She's so happy with it. It's smaller, it works better, all these things." And it's like, "Wow." So I got to lead the security effort and what they're actually doing is adding remote programming capabilities so a doctor can, over the phone, be improving that therapy for you. But that leads to a lot of cybersecurity implications, right? That kind of connectivity. And so I gotta lead the security work on that for something that is in a near and dear, your family member. And it's those kind of things where it's not, you're not just helping patients. It's, I'm helping someone that I care very deeply about. And it hits home differently when it's not just, "Oh, I want this device to be secure. I want them to get FDA clearance. I want whatever." It's, "No, I need now, I need for my own family member for it to be the best." And it's not that project got special scrutiny from us-- we bring that to every project-- but it helps to have the actual experience of one of those projects. [00:25:33] Lindsey Dinneen: Yeah. And to have that real-- well, you were mentioning it-- not just patients that I kept thinking, "Yeah. Not just patients, people," and the idea of it's sometimes probably necessary honestly, to have a little bit of separation from a clinical point of, "I'm helping all of these patients, and that's a really good thing." But then if you could take a step back and go, "And these patients are human beings that rely on what I'm doing for safety and for security and for this lifesaving, life enhancing device." That's-- what a gift to get to experience something like that. [00:26:04] Garrett Schumacher: It is, it's especially like, if you work in the diabetes-- we've had several projects with insulin pumps-- and insulin's a drug that is, highly toxic if given in the wrong dosage. 99% of the world population would die if it's in the wrong dosage if it's too high. And the only reason the other 1% exist is 'cause they're insulin intolerant. They just, they don't respond to insulin and that's why they have their own type of diabetic issues. And I've got several cousins, a brother-in-law, that also use that stuff every day, rely on those kind of technologies. So, yeah, just it's a little bit more special when it's when you get to do that. But we try to do that for everyone. We try to think of everyone's that person that we're trying to help. [00:26:42] Lindsey Dinneen: Yeah, absolutely. All right. Well, this has been so great, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. What would you choose to teach and why? [00:26:59] Garrett Schumacher: Ooh. Well, yeah, first of all, a million dollars for-- I feel like I, I'd have to go with something like that I know deeply, very deeply on. But okay, if I wanna have some fun here, I would say rock climbing, because rock climbing is my other big passion. It's the one thing that takes me away from a computer screen typically. And so if you're paying me a million dollars to teach rock climbing, A, these people really wanna learn how to be good rock climbers, so they're gonna be very engaged. And B, that's going to mean that I can go now actually make money on something that has only ever been a passion for me. So, that would be fun. That would be awesome. [00:27:33] Lindsey Dinneen: Awesome. [00:27:33] Garrett Schumacher: If you're offering, Lindsey, I'll accept. [00:27:35] Lindsey Dinneen: Okay, deal, right? Yeah. I'm gonna have to earn my first million first, and then I'll let you know. [00:27:40] Garrett Schumacher: I'll wait. [00:27:41] Lindsey Dinneen: Okay, fair? Fair enough. What got you into rock climbing? [00:27:45] Garrett Schumacher: Oh man. Well, so my mother was, I grew up in like a small farming town in the northeast corner of Colorado. There's not a mountain for, until you get to Denver area, right? In the summers, she worked at the local college, and in the summers she ran the ropes course and they had a giant rock wall. So, I mean, as a 10-year-old, I'm just hanging out there. I didn't know that there was routes or certain ways or techniques. I just, who can get up the fastest, right? But that was always fun. That was my summers. I always, and I was, shoot, I was always told I was a monkey. I was always on stuff climbing something. I've had my share of injuries from it, trust me. And then in college, it just was natural. I went to CU Boulder, as I've probably already said, and a lot of outdoor climbing opportunities. A lot of, they, they built a new gym there inside the school. And so that then it became this thing where, oh, I can actually-- as you move away from high school sports, basketball and American football and those things, you miss that. You can miss some competitiveness and some team-based things. So now I had another active thing that I could-- and I, again, I wasn't so formal in technique or things like that-- so now I could work with people, socialize and work on that technique in something that I was able to do at that level, instead of, I'm not gonna go beat myself up playing football again. So, yeah, I think that's where it came from. And then it's just been my big hobby ever since. And I mean, now I have a bunch of friends down in Austin, Texas, and we go on a big climbing trip once a year, and I see them once a year. It's fun. So it's like expanded my friend group and it keeps me sane. [00:29:14] Lindsey Dinneen: Huh. Excellent. Yes. That's wonderful. All right. How do you wish to be remembered after you leave this world? [00:29:22] Garrett Schumacher: Oh, that's a good one. How do you humbly answer that? When part of the answer I would wanna say is humble, but that's something I always try to work on, is I just wanna be a good guy. I want people to remember that, he was kind, considerate-- would do something at the drop of a hat for you without expecting anything in return-- just kind, generous. And I think a family guy would be a big one. My, my friends and family first and foremost. And maybe second to that, hardworking. Yeah. [00:29:46] Lindsey Dinneen: Yeah. I love that. All right. And final question. What is one thing that makes you smile every time you see or think about it? [00:29:55] Garrett Schumacher: Oh, my wife. I wake up to her every day and that's she's the best part about everything. So yeah, she's my favorite person, and I'm lucky enough to, when I'm not traveling, wake up next to her and see her at night, and that's the best part. [00:30:08] Lindsey Dinneen: Yeah, absolutely. What a wonderful thing. Well, this has been a fantastic conversation, Garrett. I'm so thankful for your time today. Thank you for sharing some of your stories, some of your advice. And I just honestly wish you the most continued success as you work to change lives for a better world. [00:30:26] Garrett Schumacher: Thank you. Thank you, Lindsey, for having me. This was my first podcast ever. So it went great. Yeah, it was fine. [00:30:32] Lindsey Dinneen: Awesome. You rocked it. Good job. That's wonderful. All right, well, celebrating that and celebrating all your future successes to come. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do. [00:31:05] Garrett Schumacher: Thank you. [00:31:07] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:31:19] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Esta semana os traigo un monográfico sobre la inversión en el sector salud a través de este fondo que invierte en tecnología médica. Variopartner SICAV - MIV Global Medtech ISIN: LU0329630130 Este fondo tiene la característica especial que invierte del sector salud en el subsector Medtech, uno de los sectores con mayor crecimiento a mas largo plazo y con retornos bastante estables. Una buena opción de inversión a largo plazo. Uno de los motores de crecimiento a largo plazo del sector será el envejecimeinto de la población mundial. Es estima que a largo plazo los costes sanitarios van a crecer mucho mas rápido que el PIB mundial. Si te ha gustado el programa te agradezco le des un like en la aplicación donde lo estés esuchando para que de esta manera este contenido informativo y divulgativo pueda llegar a mas gente. Para cualquier duda o consulta sobre este Podcast mi dirección de email es: eusgomez@gmail.com

In this episode of Medsider Radio, we sat down with Somer Baburek, CEO and co-founder of Hera Biotech. Hera is developing AI-driven tissue diagnostics for conditions that disproportionately affect women, including endometriosis and cervical cancer.Before launching Hera, Somer spent nearly a decade in venture capital, where she evaluated early-stage medtech startups and learned what separates the survivors from the rest.In this conversation, Somer explains how Hera designed global clinical pathways that balance cost and credibility, why boutique CROs can outperform big names, and how a pre-commercial startup completed three strategic acquisitions using equity and brand trust rather than cash.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Somer Baburek.

This week, Isabel is joined by Giuseppe Savoja, Western Europe Senior Business Director, Cardiac Surgery Business at Medtronic, for a deep-dive into the evolution and future of ECMO, innovation in critical care and the realities of leading in the MedTech space. In Part 1 of the interview, Giuseppe talks about what attracted him to the medical device industry, what his day-to-day role involves and what advice he would give to anyone considering joining the MedTech sector. Guest bio Giuseppe Savoja is Senior Business Director for Cardiac Surgery in Western Europe at Medtronic, where he leads the business with a focus on transformation, growth, and patient impact. With 20+ years in the medical device industry and leadership roles across Europe and Asia, he brings a blend of engineering expertise, commercial experience and a passion for developing high-performing teams. Born in Rome and having lived around the world, he's now back in the Italian capital with his family. Outside work, Giuseppe enjoys windsurfing, snowboarding, sailing and motorbiking. Follow us on Instagram: @emj.gold

What does it take to pivot from military service to medical technology leadership? In this episode of Inside the GMAT, GMAC Zach talks with Alec Burris, a former U.S. Marine turned MBA graduate from the UC Irvine Paul Merage School of Business, and Burt Slusher, Assistant Dean for MBA and Specialty Masters Programs. Alec shares how he translated his military discipline into business school success—and ultimately into a purpose-driven career at Edwards Lifesciences, where innovations save lives every day. Burt explains how Merage helps veterans and career changers discover their leadership strengths, connect with mission-driven employers, and find personal ROI that goes far beyond rankings. Whether you're a veteran, a career pivoter, or someone seeking a greater sense of purpose through business education, this conversation is packed with practical wisdom and inspiration for your next chapter. Learn more about the Merage School of Business: https://merage.uci.edu/ About Our Guests: Alec Burris is part of the Strategic Leadership Development Program at Edwards Lifesciences, a global leader in the structural heart space. He holds an MBA and is pursuing an MS in Business Analytics from the University of California, Irvine, after earning his BS in Biochemistry from Arizona State University. Originally from Alaska, Alec served in the United States Marine Corps from 2018 to 2023, concluding his service as a Platoon Sergeant with 3rd Light Armored Reconnaissance Battalion. Burt Alvaro Slusher is the Assistant Dean of MBA and Specialty Masters Programs at the University of California, Irvine's Paul Merage School of Business and has been a member of the UC Irvine community for 23-years. In this role, Burt oversees the School's current portfolio of graduate programs consisting of three MBA Programs (State-supported Full-Time MBA, and self-supporting Flex MBA and Executive MBA) and six self-supporting Specialty Masters Programs (Master of Finance, Master of Innovation and Entrepreneurship, Master of Professional Accountancy, Master of Science in Business Analytics, Master in Management, and Online Master of Science in Business Analytics). In addition, this role also oversees the Master of Science in Biotech Management program in tandem with leaders from the School of Biological Sciences. Burt also serves as part of the School's senior leadership team. Prior to his current role, Burt served as the Senior Director of Recruitment and Admissions for the Specialty Masters Programs and served as chair of the Admissions Committee. With two decades of higher education and business school experience, Burt has worked closely with Merage students, alumni, corporate outreach, marketing, and has provided career management to students while maintaining a high level of engagement with the business community. He was part of a team that helped launch the Merage School's Business Administration major in Fall of 2008 and also managed the admissions process for the Merage School's Accounting minor launched in Fall of 2004. Chapters: 00:00 Introduction 01:31 Meet Alec 03:34 Transitioning from Military to MBA 05:50 Burt on Veterans in Business School 08:53 How Alec Chose UC Irvine 14:59 The UC Irvine Advantage 23:37 Leadership Skills From Class to Career 25:26 What Veterans Bring to the MBA 27:07 The ROI of an MBA 31:56 Final Advice  

In this episode of The Lebanese Physicians Podcast, co-hosts Dr. Khalil Diab and Dr. Hamad Ali sit down with Dr. Firas Mahdi, Partner at LEK Consulting in Singapore, to explore the intersection of strategy, technology, and innovation in healthcare across Asia and the Middle East. From his beginnings in clinical medicine at AUBMC to leadership roles at GE Healthcare, Medtronic, and now LEK, Dr. Mahdi shares a remarkable global journey spanning Lebanon, the Gulf, and Southeast Asia. We discuss: How Singapore's hybrid public–private healthcare model achieves world-class outcomes Lessons for Middle Eastern health systems in value-based care and operational excellence The evolving role of MedTech and AI in shaping the future of healthcare Building purpose-driven careers and navigating non-clinical paths in medicine A rich conversation about healthcare transformation, professional reinvention, and the future of global health strategy — where East truly meets Middle East.  

Fixation on Histology: From Professional to Patient, A Med Tech's Organ Donation Journey Written based on the NSH Laboratory Webinar- When Worlds Collide Through Organ Donation To Read the Blog, Click Here. 

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation's stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.Key Timestamps[02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show's focus on the China market.[05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.[08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."[11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.[14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.[16:20] Leveraging the Hainan Free Trade Zone (Bo'ao region) for pre-market clinical data collection and urgent needs product access.[18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).[20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.[23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).[25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.[29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.[30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China...

Trailer del prossimo episodio:La Sanità del Futuro è già qui: dentro l'Innovazione di Nuvyta e la rivoluzione MedTech di Alice Magni

Il nuovo episodio della serie: “Game Changer” con ospite Alice Magni Ceo di Nuvyta. Qui non si fanno PR.Qui si parla di scelte vere, di tensioni strategiche, di futuro industriale — con il coraggio di dire le cose come stanno. Quando accendiamo il microfono, lo facciamo per una ragione precisa:le persone che invitiamo non sono ospiti, ma protagonisti.Founder, CEO, innovatori — scelti perché stanno facendo, hanno fatto, o faranno la differenza. In questa puntata, parliamo di un'impresa italiana che ha cambiato le regole del gioco nel settore IT Clinico. Questa è la storia di Nuvyta. Fondata a Cologno Monzese, nel cuore dell'hinterland milanese, Nuvyta è una software company nata con l'obiettivo di rivoluzionare il settore dell'IT clinico-ospedaliero in Italia e oltre i suoi confini. È stata la prima azienda italiana a investire in un modello di interoperabilità a standard internazionale, promuovendo l'integrazione dei dati e valorizzando il loro potenziale nel supportare le migliori cure per i pazienti.È stata anche la prima azienda in Italia ad entrare nel mercato del software clinico con una strategia vendor-based, esternalizzando totalmente o parzialmente la personalizzazione del proprio software investendo in un'architettura solida ed in strumenti no/low code, e aumentando così la capacità di collaborazione e interazione con i clienti. Nata nel 2018, dopo aver affrontato con resilienza le difficoltà legate al periodo del Covid-19, oggi Nuvyta collabora con numerose cliniche, ospedali e regioni italiane. Ha registrato una crescita del 18% nel 2024 e prevede un incremento superiore all'80% nel 2025. Con la sua visione innovativa e un approccio aperto e dinamico, Nuvyta mira a rinnovare il mercato dell'IT clinico, migliorando l'esperienza degli operatori sanitari attraverso la tecnologia.In questa conversazione Alice Magni condivide la sua esperienza nel trasformare il settore sanitario in Italia attraverso l'innovazione tecnologica. Parla della nascita della sua azienda, delle sfide affrontate durante la pandemia di COVID-19 e dell'importanza di investire in interoperabilità e personalizzazione. Alice discute anche del ruolo dell'imprenditore, dell'eredità familiare e della necessità di avere una visione a lungo termine per il successo. Infine, esplora le opportunità nel settore MedTech e l'impatto dell'intelligenza artificiale sulla sanità. A guidare l'intervista di oggi è Marco Mizzau — già CEO di aziende complesse, oggi Senior Advisor per fondi di Private Equity e banche d'affari.Un investitore con il fiuto per le imprese che cambiano le regole del gioco. Marco ha visto cosa succede quando visione e capitale si incontrano… o si scontrano. E come sempre, lo farà senza filtri.TakeawaysNuvita è un'azienda innovativa nel settore sanitario.La tecnologia deve essere prioritaria nello sviluppo di prodotti.Investire in interoperabilità è fondamentale per il successo.Il supporto del PNRR ha facilitato l'innovazione.La personalizzazione dei servizi è essenziale per i clienti.L'eredità familiare può influenzare la mentalità imprenditoriale.Il private equity può essere un partner strategico.L'AI ha il potenziale di rivoluzionare il settore sanitario.La visione a lungo termine è cruciale per la crescita.La digitalizzazione è una necessità per il futuro della sanità.Sound bites"La tecnologia viene per prima.""Siamo dei sopravvissuti nel vero senso della parola.""L'AI sta rivoluzionando tutti i mercati."ChaptersIntroduzione a Nuvita e Alice MagniLa nascita di Nuvita e la sua visioneStrategie di crescita e innovazione durante il COVIDInteroperabilità e personalizzazione nel settore sanitarioIl ruolo dell'imprenditore e l'eredità familiareEvoluzione verso una piattaforma sanitariaPiani industriali e visione a lungo termineInvestimenti e opportunità nel settore MedTechL'impatto dell'AI sulla sanità e il futuro di Nuvita

Medtech is a $900 billion industry transforming how we treat, diagnose, and prevent disease—but its innovation engine is slowing. Vikram Aggarwal, global leader of BCG's medical technology work, explains what's behind the slowdown and how leaders can rethink regulation, software, and talent to re-accelerate breakthroughs. Learn More: Vikram Aggarwal: https://on.bcg.com/4osjpc6 BCG on Medtech: https://on.bcg.com/3LlJ6MC How Medtech Leaders Are Revving Up Their Innovation Engines: https://on.bcg.com/4op2Rl8 Chapters 00:00-01:25 Introduction/Vikram's ‘So What' 01:26-02:10 What is medtech? 02:11-03:46 Where are some of the most exciting innovations happening in medtech? 03:47-05:36 What areas get the most attention? 05:37-07:33 What are the barriers to innovation? 07:34-08:36 How do software and hardware innovation compare? 08:37-09:58 Software in a medical device vs software as a medical device 09:59-11:40 Is there a lag between innovation in software vs hardware? 11:41-13:41 What is the ideal innovation environment for medtech? 13:42-15:13 How do we fix the STEM skills shortage? 15:14-17:46 What will bring the most value over the next decade? 17:47-19:04 What is happening at startups vs established companies? 19:05 – 20:01 Vikram's ‘Now What' 20:02-20:15 Outro This podcast uses the following third-party services for analysis: Podtrac - https://analytics.podtrac.com/privacy-policy-gdrp

Liz is joined on the podcast by Becky Lai, Chief Strategist and VP of Marketing, to talk about the true North Star of commercialization: standard of care. Their discussion reframes success as more than building a product—it's about building a market where the product is trusted, adopted, and indispensable. Together, they explore how purposeful training, meaningful KOL engagement, and a clear strategic vision accelerate adoption and move technologies from launch to lasting impact.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Rebecca Lai is the Chief Strategist and Marketing Executive at Rebecca Lai Consulting. She is a strategy and commercial executive with over 20 years of experience in medical and health technology companies, ranging from venture-backed startups to Fortune 200 corporations. As a dynamic strategic operator specializing in go-to-market, commercialization, and innovative business strategies, she has consistently driven double-digit growth and scaled new businesses with global impact. With a strong background in devices, diagnostics, and the digital transformation of healthcare, Rebecca has a proven track record of pioneering disruptive solutions across the continuum of care. Most recently, she was VP of Corporate Development and Strategy at iRhythm Technologies (NASDAQ:IRTC), a digital healthcare provider of cardiac monitoring services. She began her career at Medtronic (NYSE:MDT), where she held progressive global leadership roles in sales and marketing. Rebecca is recognized for her ability to navigate complexity and her data-driven, customer-centric approach to creating value and delivering cutting-edge products and services to patients worldwide. She holds a BSE and MSE in Bioengineering from the University of Pennsylvania and serves on the advisory board for Diversity by Doing Healthtech.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Rebecca Lai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠.Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.We cover practical implications of recent and emerging regulations, including:Batteries Regulation (EU) 2023/1542AI Act (EU) 2024/1689Packaging and Packaging Waste Regulation (EU) 2025/40European Health Data Space Regulation (EU) 2025/327You'll learn:About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.How to identify all applicable legislation for your product and verify coverage.What notified bodies expect to see and the typical level of scrutiny.How to structure your compliance register, QMS updates, and regulatory reporting.Transition timelines and planning tactics to avoid last-minute surprises.Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.Panelists and moderator:Greg Griffin, PhD, MRSE – Technical Specialist, BSIClaire Burrows – Regulatory Partner, BrabnersChris Parr, PMP – Principal, RQM+Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)--

This panel was recorded October 2, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠⁠RQMplus.com⁠⁠.PMCF surveys can strengthen your CER and PSUR or create rework. In this 60-minute panel with live audience Q&A, RQM+ leaders from regulatory, clinical, and scientific writing share what MDR reviewers look for and how to design surveys that generate decision-grade evidence. The session is intended for regulatory affairs, post-market surveillance, clinical evidence, and medical writing leaders at MedTech manufacturers.Listen to learn how to: Define clear objectives, endpoints, and target population so the survey maps to your PMCF plan and CER. Improve response rates without bias and capture higher-quality data, including adverse events and usability feedback. Learn how to position your physician level survey as a chart review. Document methods, rationales, and traceability so notified bodies can follow the logic. Avoid the top reasons reviewers push back on PMCF surveys and how to correct them. Walk away with a practical checklist to pressure test your next PMCF survey and reduce review risk. Who should attend: Regulatory affairs leaders and PMS managers. Clinical evidence and clinical operations leads. Scientific and medical writing leaders, including CER and PSUR authors. Quality leaders responsible for post market surveillance programs. Panelists and moderator: Torrie DeGennaro – Vice President, Scientific & Medical Writing Bethany Chung, Ph.D., RAC – Director, Technical Solutions & Innovation Garrett Jeffries, Ph.D. – Principal Jon Gimbel, Ph.D. – Vice President, Regulatory Affairs--

This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality management system (QMS) pathways.Alex and host Etienne Nichols discuss the immense value of having a diverse internal team of consultants to draw from—a collective knowledge base that helps solve complex problems for clients. They emphasize that quality professionals don't need to know "everything" but rather must have the right resources and a "beginner's mindset" to guide companies effectively. The conversation also explores how modern software, like Greenlight Guru's QMS and EDC solutions, eliminates common industry pain points, such as fragmented, error-prone spreadsheet-based design controls by building true, linked traceability directly into the eQMS.Finally, the discussion touches on the philosophical "why" of the medical device industry: the patient. Alex shares a personal story about how orthopedics improved his grandfather's quality of life, underscoring the importance of maintaining a patient-first ethos. They conclude by discussing the upcoming QMSR transition, reassuring listeners that compliance is manageable, especially for those already adhering to ISO 13485.Key Timestamps[01:50] Alex Naber's MedTech Career Path: From Bioengineering to Design Quality and Post-Market Management.[04:30] The Power of Pooled Expertise: Why Greenlight Guru's Consultant Team is a "Sherpa up the mountain."[07:35] The Problem with Spreadsheets: Comparing traditional Design Control methods to modern eQMS traceability.[11:00] Accelerating Compliance: How Greenlight Guru's QMS Templates dramatically cut implementation time.[13:30] The Bloated QMS: Why adopting procedures from large corporations may hinder small-to-midsize companies.[16:00] Design Quality Explained: Marrying R&D/Product Development with QMS compliance.[21:30] The MedTech Ethos: Focusing on the patient and improving quality of life.[27:00] CAPA Management Insights: The critical distinction between Correction and Corrective Action.[30:25] Navigating the QMSR Transition: Reassurance that compliance isn't "that deep" if you are already ISO 13485 compliant.Quotes"It's a rewarding thing to just understand that you don't need to know everything. I think that's a thing that... people should realize and they should reach out to other people that are smarter or more experienced in realms that they don't understand." - Alex Naber"I think what got me into MedTech was more of the ethos behind it... We're creating products to make patients' lives better, to impact our world, our society in a positive manner, to give a better quality of life to individuals." - Alex NaberTakeawaysSeek a Unified Quality Solution: Fragmented quality processes (e.g., design controls in spreadsheets separate from the QMS) introduce significant regulatory risk. Adopting an eQMS, like the Greenlight Guru QMS solution, creates true traceability and dramatically streamlines compliance.Design Quality as a Partner, Not Police: Design Quality Engineers should actively partner with R&D, not...

Audacity is defined as the willingness to take bold risks. It's also a mantra for Lishan Aklog, MD, a co-founder and CEO PavMed, the parent company of Lucid Diagnostics. Aklog makes his second appearance on Let's Talk Medtech to give updates on both companies and to discuss his philosophy on why audacity breeds innovation.

In this episode of Tank Talks, host Matt Cohen sits down with Sameer Dhar, Co-Founder and CEO of NiaHealth, to explore how proactive healthcare is reshaping the future of medicine.Sameer shares his remarkable journey from living in nursing homes for a year while building his first startup (Sensassure) to launching NiaHealth, a Canadian health-tech company empowering people to take ownership of their longevity through AI-driven diagnostics and personalized insights.With over $8 million in funding and a 12,000-person waitlist, NiaHealth is building a clinician-first model that complements Canada's public system, helping users prevent disease decades before it develops. Sameer also discusses why prevention, not treatment, must drive the next wave of healthcare innovation, how AI will augment rather than replace clinicians, and what it takes to build a mission-driven company in a regulated industry.Whether you're a founder, investor, or health enthusiast, this conversation reveals how the next generation of health tech startups can blend AI, clinical integrity, and human empathy to create lasting impact.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.The Entrepreneurial Spark (05:52)* How the Next 36 program transformed Sameer from a finance student into a founder* The power of founder-focused education in shaping Canada's startup ecosystem* Lessons from learning to “think like a builder” instead of an employeeFrom Customer Discovery to Conviction (10:46)* How customer discovery can turn into “analysis paralysis” if you never act* Why true innovation means taking bold bets, not just collecting insights* The importance of timing when moving from research to executionBuilding NiaHealth (13:26)* The personal mission to keep people healthy long before disease develops* How the pandemic revealed gaps in personal healthcare ownership* The evolution of NiaHealth into a platform offering advanced diagnostics, clinician reviews, and personalized longevity plansIntegrating with the System (17:12)* Why NiaHealth chose a “clinician-first” model rather than going fully digital* How nurse practitioners bridge the gap between data and diagnosis* The importance of integrating with Canada's public system to maintain trustTrust and Transparency (22:51)* Addressing criticism about private healthcare models in Canada* Why NiaHealth avoids affiliate sales to maintain clinical integrity* The company's research-led approach to responsible, evidence-based testingFilling the System's Blind Spots (26:13)* Canada's biggest blind spot: a reactive healthcare model built around disease* How prevention and early diagnostics reduce system strain and save lives* The mission to empower users to act on health risks decades in advanceAI as an Enhancer, Not a Replacement (29:16)* Why Sameer believes AI should support, not replace, clinicians* How AI enhances diagnostic accuracy and clinician productivity* The role of empathy and human connection in patient outcomesScaling Impact (33:11)* NiaHealth's vision to reach 100,000 Canadians by the end of next year* Partnering with insurers and governments to expand preventative care* Why a “built in Canada, for Canada” strategy is key to long-term successAbout Sameer DharSameer Dhar is the Co-Founder and CEO of Nia Health, a serial entrepreneur and health-tech innovator recognized among Canada's Top 20 Under 20 and Edmonton's Top 40 Under 40. He previously founded Sensassure, an elder-care technology startup acquired by global health leader Essity.Connect with Sameer Dhar on LinkedIn: https://www.linkedin.com/in/sameerdhar/Visit the NiaHealth website: https://www.niahealth.co/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech's Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.Need to knowFetal surgeries carry risks — In addition to uterine damage complicating future pregnancies, 40% of surgeries have a risk of preterm birth.Few specialized tools are used — In the field's forty-year history, the FDA has only approved the Karl Storz Fetoscope for use in fetal surgeries.Off-label device use is widespread — Equipment borrowed from adjacent fields like laparoscopy and neurosurgery weren't indicated for use in the uterus.The nitty-grittyShirkin and Chief Technology Officer Eric McAlexander founded Fetal Therapy Technologies as students in Johns Hopkins University's biomedical engineering graduate program. While shadowing surgeons, they saw how off-label instruments complicated procedures.“I watched a surgeon using a grasper and suture,” Shirkin recalled. “The suture was falling out of the grasper because they didn't fit. It took time in the surgery to make sure that didn't occur.”Observations like these led the team to wonder why the field lacked optimized tools. “As biomedical engineers,” Shirkin says, “we asked ourselves what if we created those purpose-built instruments that actually make these procedures safer?”They quickly ran into the commercial limits of a market as small as fetal surgery. With only one device FDA-approved for in-uterine procedures, surgeons have no choice but to use devices off-label. So Fetal Therapy Technologies is flipping the script by leveraging the broader applications of an instrument designed for fetal surgeries.“In a way, our company solves two problems at once,” Shirkin says. “A company that creates a fetal innovation [that] also raises a much broader market of general microsurgery.”Their first product is a uterine port. “Similar to laparoscopic surgeries,” Shirkin explains, “that involves inserting a port through the abdomen into the uterus. [The new] port is designed to leverage the elastic properties of the uterine environment to make entry safer than the current clinical standard.”For broader commercialization, they aim to demonstrate equivalence to predicate devices and qualify as a 510(k) Class II device following benchtop and animal studies. Approval for fetal surgeries is a longer journey, but the company can build on its data before entering human trials.Data that made the difference:Shirkin offered insights for other students considering an entrepreneurial future in MedTech.Leverage university resources. “We work incredibly closely with the Johns Hopkins Center for Fetal Therapy,” Shirkin says. We've also gotten opportunities from Johns Hopkins Technology Ventures.”Build a network of advisors. “We are supported by a very broad variety of clinical, technical, and business mentors across the Johns Hopkins ecosystem and beyond.”Tap into local funding sources. “There's a lot of collegiate business plan competitions that we've been very successful [raising] non-dilutive funds that way. There are also state-level grants. We just received a Baltimore Innovation Initiative grant.”

Sydney Mrowczynski didn't plan to end up under a welding hood. As a teenager she dreamed of fashion design — until a boyfriend told her she couldn't weld. Challenge accepted. A few years later, she's worked across multiple shops, learned how things really get built, and is now studying industrial management and applied engineering at Southern Illinois University to bridge the gap between the floor and the front office.This episode of the Manufacturing Culture Podcast is a crash course in what real culture looks like from someone living it. Sydney's take is simple: great culture means communication, teamwork, and quality. Most shops have one or two of those — rarely all three. She shares what it's like being the only woman on the floor, the extra proof she's had to carry into every new job, and why too many people get comfortable doing things “almost right” for 20 years.We get into failure as a teacher — how welding forces you to face mistakes and learn faster than any classroom. Sydney talks about integrity, leadership, and the shops that cover bad welds instead of fixing them. She lays out the difference between a leader who checks in, listens, and teaches versus one who just points and barks orders.If you run a team, hire apprentices, or manage training programs, you'll want to hear her take on trade schools too — how they teach to plate instead of teaching to reality. She argues that students should weld on rusted, greasy, and painted metal, not perfect coupons, if they're expected to survive their first week on the job.Sydney is now balancing school with work at Tenco Hydro in Sugar Grove, Illinois, helping bring metal fabrication in house and ship their first stainless wastewater tank. She's seen the gaps firsthand — and she's building the bridge from within.It's an honest, sharp conversation about what manufacturing culture really needs: leaders who communicate clearly, care about quality, and build environments where new talent wants to stay.SponsorMed Device Boston is your go-to Med Tech sourcing and education expo, September 30 through October 1 at Boston's BCEC. With 200+ suppliers, 1,500+ attending professionals, and expert-led workshops on 3D printing, AI, materials, regulatory tech, and contract manufacturing, it's built to advance the next generation of medical device innovation. Visit meddeviceboston.com to register.ConnectFind Sydney Mrowczynski on LinkedInSubscribe to the Manufacturing Culture Podcast on YouTube and your favorite platform.

In this episode of Medsider Radio, we sat down with Tim Gleeson, CEO of BRIJ Medical, a company rethinking one of the oldest procedures in medicine — surgical wound closure.BRIJ's Brijjit Force Modulating Tissue Bridge is a small, non-invasive clip designed to redistribute tension across incisions, helping wounds heal with fewer complications and smaller scars.An accomplished entrepreneur and investor, Tim also founded and led Novasyte Health through its acquisition by IQVIA and later launched VIDANT Capital. A former Medtronic executive, Tim brings global experience and a lifelong passion for building impactful medtech ventures.In this interview, Tim shares why the biggest opportunities often hide in “boring” markets, how focusing on physician champions and patient psychology drives commercial traction, and why the best fundraisers plan for twice the time and four times the cost.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Tim Gleeson.

In this episode, host Etienne Nichols and guest Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, dive into a fascinating dialogue about the language used in healthcare and MedTech, particularly the terms patient, customer, and user. They explore how these words influence the perception of care, service, and the entire medical device development process. The conversation touches on the friction and inefficiencies that arise when the relationship dynamic is unclear, highlighting the different nuances between passively receiving treatment and being an active consumer of health services.The discussion delves into the historical context of the word "patient," which is rooted in the Latin patior, meaning 'to suffer.' Dr. Komiyama shares insights from industry conferences, noting that many individuals prefer to be called a "person" or an "empowered patient" rather than a passive sufferer. This ties directly into the growing movement of individuals seeking to own their health and be active participants in their care, fueled by readily available information and a focus on health span over just disease treatment.Ultimately, the key takeaway for MedTech innovators is the importance of understanding their end-user and tailoring their language—in labeling, clinical studies, and human factors testing—to align with the user's preferred terminology. The shift from "caregiver" to "care partner" is highlighted as a prime example of evolving language that acknowledges a collaborative, mutual relationship, moving away from a hierarchical structure to one of shared purpose.Key Timestamps[0:01:25] - Introduction to Dr. Allison Komiyama and Blue Stocking Health's mission to amplify the good of MedTech.[0:04:14] - Discussion begins: Patient vs. Customer vs. User in MedTech.[0:06:05] - The etymology of "patient" (patior, to suffer) and the push for "person" or "empowered patient."[0:08:22] - Historical context: Passivity of the patient role and the doctor's assumed knowledge.[0:09:50] - The impact of consumerism, AI, and the "health span" movement on patient empowerment.[0:12:35] - The value of seeking multiple opinions and the role of patient priorities in customizing care.[0:15:30] - Shifting terminology: Why "caregiver" is moving toward "care partner."[0:18:22] - How language diversity enriches the conversation and enhances communication.[0:21:00] - Tying diverse language use to MedTech innovation and product development.[0:22:15] - The importance of understanding end-user biases and assumptions in MedTech.[0:24:25] - Impactful personal stories: How specific interactions define a positive care experience.[0:29:10] - Concluding thoughts: Why plurality and qualifiers (e.g., "empowered patient") may be the ideal goal.Quotes"I think there's a lot of folks at FDA even that we're like, we don't want to use the word patient. We want to use the word person. And patient actually comes from the term patior, which means to suffer." - Dr. Allison KomiyamaTakeawaysRegulatory & Clinical Strategy: When defining the target population for your device—in 510k, IDE, or PMA submissions—be mindful of the terminology. Consider using terms like "end-user," "person living with [condition]," or "care partner" alongside "patient" to reflect a modern, inclusive understanding of...

In this episode of Tank Talks, host Matt Cohen and John Ruffolo break down the most important stories shaping Canada's innovation economy, from the upcoming federal budget and its impact on founders and investors, to Canada's fintech shake-up as open banking finally gains momentum.The duo dives into AI's growing legal minefield, including the mounting lawsuits against Perplexity and Sora, and discusses what this means for startups training models on licensed versus unlicensed data. They also unpack Cohere's rumored IPO, Canada's AI partnership with the UAE, and what it reveals about the country's global strategy for data centers and sovereign capital.From Blue Jays playoff economics to AI data sovereignty, this Rundown is packed with sharp insights, timely analysis, and the kind of candid commentary you won't hear anywhere else.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.Canada's Make-or-Break Federal Budget (08:46)With the federal budget weeks away, John calls this the Liberal government's credibility test, a defining moment for innovation, R&D reform, and fiscal discipline.* The state of Canada's finances and investor sentiment* Expectations for R&D tax credit and AI policy reform* Why “good ideas” might not matter if the fiscal hole is too deepOpen Banking Finally Gets Real (12:55)The Bank of Canada registers 300 new payment service providers, marking a major milestone for Canada's fintech ecosystem.* How this could shake up the Big 5 banks' oligopoly* Why Wealthsimple, Shopify, and Koho stand to gain* John's take on trust, liquidity, and the future of financial competitionCanada-UAE AI Investment Deal (15:34)AI Minister Evan Solomon signs a non-binding MOU with the UAE on data center investment. Is this a real opportunity or political theater?* What “non-binding” really means for Canada's capital strategy* Mark Carney's push to diversify trade away from the U.S.* Why every major country is chasing sovereign data capitalCohere's IPO Tease and the AI Hype Cycle (18:11)Cohere's CEO Aidan Gomez hints at “going public soon.” Matt and John weigh the risks and timing of an AI IPO in a frothy market.* Lessons from the Faire America IPO and $16B valuations with no assets* The pressure of capital requirements in AI infrastructure* Why timing the public markets almost never worksAI Lawsuits, IP Infringement, and Data Licensing Wars (20:48)From Reddit vs Perplexity to Hollywood vs. Sora, Matt and John break down the growing AI legal battles over content rights.* The global IP divide: what happens when China ignores licensing rules* Why only the biggest players can afford compliance* The coming “Rule of Three” in the AI data economyConnect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

The Transformation Ground Control podcast covers a number of topics important to digital and business transformation. This episode covers the following topics and interviews:   A MedTech Firm Warns of Their Impact from Their Software Switch, Q&A (Darian Chwialkowski, Third Stage Consulting) What do the EU's Antitrust Allegations against SAP Really Mean? (Scott Hays – Vice President at Rimini Street, Marcus Harris – Partner at Taft Law) The #1 Software Proposal Mistake That's Costing Companies Millions   We also cover a number of other relevant topics related to digital and business transformation throughout the show.  

What if a discreet sensor could quietly prevent one of healthcare's most common—and dangerous—IV injuries? In this episode of Med Tech Gurus, Jaclyn Lautz Ph.D., COO of IV Watch, takes us inside the journey of building a global standard of care. Jaclyn shares how her team navigated the EU MDR maze, achieved regulatory approvals across 16 countries, and proved their technology's impact through powerful clinical studies. From mentoring moments that shaped her career to the operational discipline driving IV Watch's innovation, this conversation delivers invaluable insights for MedTech leaders aiming to scale globally while keeping patient safety at the core.