Medical Device Startups: What Founders Get Wrong About the FDA | E204

Why do promising healthcare startups struggle to bring their innovations to patients? And what separates founders who make real progress from those who get stuck? On this episode of the Advancing Healthcare Innovation Show, Michael Stamatinos sits down with Megan Kane, Executive Director of Rellia Health, to explore what it really takes to build and grow a medical device or digital health company. Megan has spent much of her career navigating FDA regulations, quality management, and the complexities of bringing healthcare technology to market. Today, she's helping entrepreneurs overcome those same challenges through a growing network of 81 founders and more than 250 advisors. Her journey into entrepreneurship wasn't exactly planned. What started with an invitation to judge a healthcare hackathon eventually led her to build an organization focused on helping founders turn promising ideas into measurable progress. In this conversation, we explore: Why FDA regulation doesn't have to be the enemy of healthcare innovation Common mistakes medical device and digital health startups make How founders can approach regulatory strategy and clinical validation The importance of mentorship, relationships, and access to the right people Why startup accelerators need to focus on outcomes, not just advice How Rellia Health is helping founders navigate the path from concept to commercialization Rellia Health: https://www.relliahealth.com/about What great healthcare founders and leaders have in common One of the most interesting stories Megan shares involves a simple introduction between a telehealth founder and a rural healthcare network. That connection helped launch a pilot program and eventually inspired something much bigger. It's a reminder that sometimes the right relationship can move an idea forward faster than months of planning. Whether you're building a healthcare startup, investing in medical technology, working in digital health, or helping bring innovation into health systems, there's plenty to take away from this conversation. Chapters: 00:00 Why Great Healthcare Innovations Struggle 03:23 Megan Kane's Journey Into Healthcare 05:34 From Microbiology to FDA Regulatory Strategy 07:02 Understanding Medical Device Regulations 08:08 Common Misconceptions About the FDA 09:37 Discovering the Healthcare Startup Ecosystem 12:04 How One Introduction Launched a Telehealth Pilot 13:52 The Unexpected Journey to Founding Relia Health 15:38 Helping 81 Healthcare Founders Make Progress 17:32 What Makes Relia Health Different 19:28 Lessons Learned Building a Healthcare Startup 21:58 The Future of Relia Health 23:38 What Great Healthcare Founders Do Differently 25:14 The Leadership Lesson Every Founder Needs 26:56 Advice for the Next Generation of Healthcare Innovators 28:00 Final Thoughts and Closing 📣 LIKE, COMMENT & SUBSCRIBE About the Show The Advancing Healthcare Innovation Show is hosted by Michael Stamatinos, a nationally recognized connector, strategist, and advocate for innovation with purpose. Each week, Michael interviews healthcare leaders who are driving meaningful change—highlighting stories of access, resilience, equity, and transformation. The AHI Show started with the idea of wanting to highlight stories of what healthcare innovation truly looks like in action. Our mission, highlight real people who are really innovating within healthcare. Guests include healthcare entrepreneurs, providers, payers, and professionals from the investment community. We showcase little wins as well as valuable lessons learned from setbacks through these interviews. The real innovators in healthcare are often the ones in the trenches doing the work with razor-sharp focus. We find these innovators and bring their stories to light. 🔗 Michael’s LinkedIn:   / michaelstamo   🎧 Subscribe for more episodes that move beyond theory and into the heart of what’s really possible in healthcare. Join our group, Advancing Healthcare Innovation Forum on LinkedIn:   / 7056196