Inside MedTech Innovation

Shannon Lantzy
  • 5.0 (4)
  • TECHNOLOGY
  • UPDATED BIWEEKLY

Join Shannon Lantzy, as she brings you stories from inside the medtech ecosystem, featuring innovators, commercializers, regulators, and consumers. The show covers a wide array of topics, from patient-driven innovation to cybersecurity. We’ll examine the details that influence individual regulatory decisions and the broader impacts of emerging global issues, ensuring that great technology reaches the people who need it most.

  1. Bridging Diabetes Tech w. Dr. Bob Gabbay

    2D AGO

    Bridging Diabetes Tech w. Dr. Bob Gabbay

    Dr. Bob Gabbay has spent decades at the intersection of diabetes research, clinical care, and technology innovation. From leading the Joslin Diabetes Center to serving as Chief Scientific and Medical Officer at the American Diabetes Association, he witnessed the field transform from sharpening needles on stones to closed-loop insulin systems. Yet despite incredible technological advances, a critical problem persists: the tools that could help people with diabetes simply aren't reaching them or being used effectively. In this conversation, Dr. Bob shares how the DIY diabetes community's "We Are Not Waiting" movement pushed both industry and regulators forward, why A1C and time in range tell complementary stories about glucose management, and how his year of "semi-retirement" turned into mentoring startups and crystallizing decades of knowledge. He discusses the holy grail features still missing from automated insulin delivery, from exercise mode to meal-snap AI, and makes the case for why patient-reported outcomes deserve equal billing with clinical measures. Dr. Bob also reflects on moonshot thinking, the tension between individualizing treatment and population-level safety, and why the last mile problem matters more than the next breakthrough. [00:00:00] Introduction and Dr. Bob's journey from chemistry sets to diabetes care [00:06:00] Creating opportunities through cold calling and community building [00:10:00] Med school without planning to see patients [00:12:00] Leading the American Diabetes Association [00:15:00] Seven turns in diabetes management [00:17:00] A1C versus time in range as outcome measures [00:21:00] Semi-retirement as a digital nomad [00:23:00] Fluid knowledge versus crystallized knowledge [00:26:00] The "We Are Not Waiting" movement's impact [00:30:00] What's still not solved in automated insulin delivery [00:34:00] The mascara metaphor and spoon theory [00:39:00] Sotagliflozin and weighing DKA risk versus benefits [00:46:00] Making emotional outcomes measurable [00:51:00] Moonshots and the Startup Health approach [00:55:00] Non-invasive glucose monitoring lessons [00:58:00] Rapid fire questions Follow Shannon and Dr Bob: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com/ Connect with Dr Bob:  LinkedIn: https://www.linkedin.com/in/drbobgabbay/

    1h 2m
  2. Tech For MedTech: Automated Compliance w. Michael Edenzon

    FEB 26

    Tech For MedTech: Automated Compliance w. Michael Edenzon

    One medical device company cut their software recall response time from 180 days to under 30 by automating compliance evidence collection. In regulated industries like MedTech, shipping software takes weeks not because the code isn't ready, but because proving compliance requires manual evidence gathering. Automated governance captures proof continuously as developers work. When it's time to ship, compliance happens automatically or developers get blocked. The result: 85% faster time to market and developers who become collaborators instead of adversaries. In this episode, Shannon Lantzy talks with Michael Edenzon, CEO of Fianu, about turning cyclical compliance work into continuous automation, why transparency changes developer behavior, and why objective, reproducible evidence should be the new regulatory standard. Timestamps: 00:00 – Why automated governance is the missing piece in DevOps 04:00 – How Michael went from constitutional law student to software governance innovator 06:00 – What automated governance is (and why it's not just another tool) 09:00 – The screenshot problem: When developers game manual compliance systems 12:00 – Do developers hate automated governance or does it free them? 15:00 – What happens when requirements are incomplete or wrong 18:00 – The flywheel effect: How continuous feedback improves control effectiveness 20:00 – Creating a shared language: Pass, fail, in progress, or not found 24:00 – Case study: How a CGM company cut recall response from 180 to 30 days 30:00 – Why you should never automate to a higher standard than you're currently at 33:00 – Simulating the impact of policy changes before enforcing them 37:00 – The power of annotations: Accepting risk while maintaining auditability 40:00 – Why transparency turns developers into your best collaborators 42:00 – Who should (and shouldn't) adopt automated governance 48:00 – What Michael would change about FDA regulation if he could wave a wand 52:00 – Tracking software from Jira story to production runtime and back to adverse events 54:00 – What's next for Fianu: Statistics, reporting, and compliance incentive structures Follow Shannon and Michael: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Michael:  LinkedIn: https://www.linkedin.com/in/michaeledenzon/ Website: https://www.fianu.io/

    58 min
  3. Marketing MedTech w. Joy Duemke

    FEB 12

    Marketing MedTech w. Joy Duemke

    Only 2% of sickle cell patients who could benefit from blood therapy actually receive it, despite it being first-line treatment. Marketing in medical devices isn't about jingles or promotions. It's about looking at data, drawing hypotheses, testing them, and ensuring every claim you make is scientifically relevant. It's closer to research than advertising, requiring the ability to translate between what physicians know, what devices do, and what patients need. In this episode, Shannon Lantzy talks with Joy Duemke, Director of Marketing at Terumo Blood and Cell Technologies, about her 15-year journey across six different roles at one company. They discuss why learning agility matters more than subject matter expertise, how to navigate the overlap between clinical knowledge and product understanding, and what it takes to launch the Bet on Blood program, a partnership addressing systemic gaps in sickle cell care. Timestamps: 00:00 – Why marketing in medical devices is closer to science 03:00 – Joy's path from software to MedTech and the art of cat herding 06:00 – Learning agility: Getting B-pluses in everything from jazz to business law 08:00 – What Terumo does: Unlocking the potential of blood 11:00 – Blood supply chain resilience and the Blood Emergency Readiness Corps 14:00 – The Bet on Blood campaign for sickle cell patients 17:00 – Strategic vs. clinical vs. tactical marketing 20:00 – Getting humble pie from physicians and learning not to guess 23:00 – Creating business cases for new device applications 26:00 – Why marketing is a translator for science 28:00 – Managing claims with precision across legal, regulatory, and clinical teams 32:00 – The art of translation: Making apheresis "an oil change" 35:00 – When you want to make claims but can't support them yet 37:00 – Patient stories and the importance of peripheral vascular access 40:00 – Navigating tariffs and AI in MedTech today 44:00 – Rapid fire: Bet on Blood, heroes, and listening to patients Follow Shannon and Joy: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com/ Connect with Joy:  LinkedIn: https://www.linkedin.com/in/joy-duemke-339a922/ Website: https://www.terumobct.com

    47 min
  4. Diagnostic Innovations w. Resa Lewiss MD

    JAN 29

    Diagnostic Innovations w. Resa Lewiss MD

    What if you could see inside a patient's body instantly, without moving them from their bed in the emergency department? Dr. Resa Lewiss spent 25 years in emergency medicine, pioneering the integration of point-of-care ultrasound into clinical practice. As the founding head of ultrasound at Mount Sinai St. Luke's Roosevelt, she built education curricula, established quality improvement processes, and trained the next generation of emergency physicians to use this life-saving technology at the bedside. Her work helped transform ultrasound from a specialty radiologist's tool into a standard part of emergency medicine training—so much so that no emergency medicine resident can now graduate without being deemed competent in bedside ultrasound. In this conversation, Resa reveals how ultrasound changed emergency procedures from blind needle sticks to guided visualization, why she thinks emergency doctors are like assembly line cooks, and how she's democratizing medical education through free, open-access platforms. Plus, she shares a decades-later validation of a life-saving diagnosis that she thought no one had witnessed. TIME STAMPS:  00:00 Introduction to Emergency Medicine and Guest Speaker 00:40 Meet Dr. Risa Lewiss: Career Highlights and Achievements 02:05 Dr. Lewiss' Journey into Medicine 05:16 Choosing Emergency Medicine 08:10 The Reality of Emergency Medicine 10:41 Founding an Ultrasound Program 13:33 The Importance of Point of Care Ultrasound 17:06 Challenges and Future of Ultrasound in Emergency Medicine 22:39 Balancing Administrative and Clinical Roles 23:43 The Role of Ultrasound in Trauma Care 27:14 Challenges and Misuses of Ultrasound 30:07 Med Tech Innovations and Middleware 36:10 The Future of Medical Education 39:44 Rapid Fire Questions and Personal Insights 42:09 Concluding Thoughts and Reflections Follow Shannon and Resa: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com/ Connect with Resa:  LinkedIn: linkedin.com/in/resa-Lewisss-md Website: https://www.resaLewiss.com/

    46 min
  5. The Next Generation of MedTech w. Sasha Keck

    JAN 15

    The Next Generation of MedTech w. Sasha Keck

    Sasha Keck was the only girl in her high school engineering class of 26 students. By her senior year of college, she and her team had patented a surgical device that could cut spinal surgery exposure time in half. As a Technical Development Program Engineer at Edwards Lifesciences, Sasha bridges the gap between R&D innovation and manufacturing reality. She's part of a generation that grew up during a pandemic, learned to code with ChatGPT, and shares their location with friends as naturally as older generations exchange phone numbers. In this conversation, Sasha shares her journey from building mobility devices for paralyzed dogs named Harold and Fred in high school, to developing VacuTrac—a combined retractor and suction device for spinal surgery at Rice University. She reveals what it's like to be a young woman in mechanical engineering, how she and her team iterated through hundreds of 3D-printed prototypes, and why this generation's adaptability might be exactly what MedTech needs. Timestamps: 00:00 Introduction and Guest Welcome 01:03 Choosing an Undergraduate Program During COVID-19 03:36 High School Engineering Projects 05:56 Freshman Year at Rice University 09:48 Senior Design Project: VacuTrac 20:58 Current Work and Future Aspirations 25:36 Ensuring Accurate Testing and Identifying Failure Points 26:17 Utilizing AI and Automated Tools in Engineering 28:24 Challenges and Opportunities in Medical Device Development 31:09 The Importance of Pediatric and Rare Disease Research 33:47 Navigating Career Paths and Future Aspirations 43:36 Addressing Gender Disparities in Engineering 49:09 Reflections and Advice for Young Professionals 52:45 Conclusion and Final Thoughts Follow Shannon and Sasha: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Sasha:  LinkedIn: https://www.linkedin.com/in/sasha-keck/

    53 min
  6. Innovating Patient Access w. Paxos Health

    JAN 1

    Innovating Patient Access w. Paxos Health

    In this episode of Inside MedTech Innovation, Haley King, co-founder and CEO of Paxos Health, joins host Shannon Lantzy to explore how technology can level the playing field when patients face insurance denials. Haley shares her journey from designing cardiovascular implants at Medtronic to founding a company that helps patients overturn insurance denials with a 90% success rate. The conversation examines why reimbursement strategy matters as much as FDA approval, how AI can help patients navigate complex coverage systems, and what happens when innovation meets the reality of payment barriers. For med tech founders, innovators, and anyone who has faced an insurance denial, this discussion offers insight into the gap between regulatory approval and patient access, and how one startup is working to close it. Timestamps: 00:00 Welcome to Inside Med Tech Innovation 00:04 The Invisible Barrier: Insurance Denials 01:01 Personal Story: Navigating Insurance Denials 02:50 Introducing Haley King and Paxos Health 04:19 Haley King's Journey: From Engineering to Entrepreneurship 14:23 The Birth of Paxos Health 20:30 From Service to Product: Building AI Tools 25:43 Navigating the Healthcare Ecosystem 34:28 Challenges in Pediatric Drug Testing 35:35 Software as a Medical Device 36:37 Navigating CMS and Private Insurers 37:53 The Importance of Reimbursement Strategy 44:31 Balancing Speed and Accuracy in Startups 48:51 Marketing and Sales Strategies 56:24 AI in Healthcare Access 01:01:04 Patient Success Stories 01:03:15 Rapid Fire Questions and Closing Remarks Follow Shannon and Haley: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/  Website: https://www.shannonlantzy.com/  Connect with Haley:  LinkedIn: linkedin.com/in/haleymking/ Website: paxoshealth.com/about

    1h 7m
  7. Breakthrough MedTech Founders: Steve Brown’s CureWise

    12/18/2025

    Breakthrough MedTech Founders: Steve Brown’s CureWise

    What happens when a digital health pioneer becomes a cancer patient and discovers his own doctors missed a life-threatening diagnosis? Steve Brown, founder and CEO of CureWise, shares his remarkable journey from building one of the first remote patient monitoring companies to nearly losing his life to a rare blood cancer that went undetected until the Palisades Fire displaced him to new doctors with fresh eyes. In this episode of Inside MedTech Innovation, Steve joins Shannon Lantzy to discuss how he built AI agents that diagnosed his own cancer using the same data his original doctors had reviewed, then used those same tools to advocate for off-label precision treatments that saved his life. Now, he's building CureWise to give every patient access to the same level of personalized treatment insights. Steve and Shannon explore: Why the standard of care often represents what we knew years ago, not what's possible today How AI can synthesize all of medical knowledge to enable truly personalized medicine The critical difference between building healthcare solutions for others versus being patient zero Why precision oncology requires new regulatory paradigms beyond randomized controlled trials How patient advocacy powered by AI can level the playing field in cancer treatment The role of FDA innovation in accelerating life-saving treatments without compromising safety Timestamps 00:00 The Promise and Perils of AI in Healthcare 00:08 Introducing Steve Brown: A Digital Health Pioneer 01:30 Steve's Journey from Video Games to Healthcare Innovation 03:52 The Impact of Remote Patient Monitoring 06:15 A Personal Health Crisis: Steve's Cancer Diagnosis 14:10 The Role of AI in Steve's Diagnosis and Treatment 23:00 The Vision for Cure Wise: Precision Medicine for All 25:04 The Future of Personalized Medicine 27:21 Navigating Medical Scenarios and Doctor Conversations 28:54 The Role of AI in Personalized Medicine 29:20 Business Model and Future Vision 30:36 Challenges and Opportunities in AI and Healthcare 32:20 Focus on Cancer and Personalized Medicine 35:22 Patient Education and Advocacy 37:54 Regulatory Innovation and AI 47:02 The Paradigm Shift in Medical Knowledge 49:30 Rapid Fire Questions and Final Thoughts Follow Shannon and Steve: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Steve:  LinkedIn: https://www.linkedin.com/in/brown2020/ Website: curewise.com

    56 min
  8. Securing Life Critical Technology w. Jacob Combs

    12/04/2025

    Securing Life Critical Technology w. Jacob Combs

    When your insulin pump connects to your phone or your glucose monitor shares data with the cloud, is it secure? And what does "secure" even mean? In this episode of Inside MedTech Innovation, Shannon Lantzy sits down with Jacob Combs, Chief Information Security Officer and VP of Cybersecurity at Tandem Diabetes Care. Jacob brings deep expertise from across telecom, defense, financial services, and healthcare—and now protects connected devices that deliver life-sustaining insulin therapy to people with diabetes. This conversation explores the unique challenges of medical device cybersecurity: the tension between usability and security, the reality of legacy systems and security debt, how to scale security by design across engineering teams, and why regulatory requirements can actually be a competitive advantage. Jacob and Shannon discuss: Why medical device security is fundamentally different from enterprise IT security The critical balance between safety risk and security risk in insulin delivery systems How threat modeling becomes a verb that transforms engineering culture The challenge of maintaining security across interoperable diabetes management ecosystems Why "secure enough" requires sophisticated risk management, not just risk assessment How compensating controls and lifecycle management address security debt in fielded devices The role of FDA guidance in driving security programs forward What it takes to push software updates quickly while maintaining quality and regulatory compliance Timestamps 00:00 Introduction to Medical Device Cybersecurity 01:03 Meet Jacob Combs: Expert in Medical Device Cybersecurity 02:12 The Mission-Driven Approach to Cybersecurity 03:16 Balancing Safety and Security in Medical Devices 05:18 Challenges in Medical Device Cybersecurity 09:57 The Role of a CISO in Medical Device Companies 13:55 Risk Management and Cybersecurity in Medical Devices 17:17 Interoperability and Complexity in Medical Devices 26:55 Future of Cybersecurity in Medical Devices 36:08 Cybersecurity in Med Tech: A Non-Competitive Necessity 36:30 The Ethical Dilemma of Charging for Security 37:25 Product Security as a Growth Engine 38:50 Marketing Security: A Competitive Edge 39:32 Quality and Security: A Symbiotic Relationship 41:08 Regulatory Challenges and Operational Efficiency 42:36 Measuring Cybersecurity Quality 43:57 Navigating Regulatory Requirements 51:23 Innovating with AI in Security Documentation 55:25 Threat Modeling: A Cultural Shift 59:23 Legacy Devices and Security Debt 01:06:03 Balancing Security and Innovation 01:09:08 Rapid Fire Questions and Closing Thoughts Follow Shannon and Jacob: Connect with Shannon :  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Jacob:  LinkedIn: https://www.linkedin.com/in/jacobcombs/ Website: Left to Our Own Devices Podcast

    1h 13m
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About

Join Shannon Lantzy, as she brings you stories from inside the medtech ecosystem, featuring innovators, commercializers, regulators, and consumers. The show covers a wide array of topics, from patient-driven innovation to cybersecurity. We’ll examine the details that influence individual regulatory decisions and the broader impacts of emerging global issues, ensuring that great technology reaches the people who need it most.

Information

  • Creator
    Shannon Lantzy
  • Years Active
    2024 - 2026
  • Episodes
    40
  • Rating
    Clean
  • Copyright
    © Shannon Lantzy
  • Show Website
    Inside MedTech Innovation