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Latest episodes
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#475: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy
October 13, 2026 · 34 minIn this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current…
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#470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova
September 22, 2026 · 40 minBuilding a medical device rarely follows the smooth, predictable trajectory presented in investor pitch decks. While regulatory consultants often default to "it depends," medical device teams require concrete figures regarding engineering…
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#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
September 21, 2026 · 34 minIn this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Nikhil Mangale, Vice President of Quality at Kapstone Medical, to discuss the real-world impact of the FDA's Quality Management System Regulation…
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#473: The MedTech Odyssey: Bridging Academic Science to Series A Success
September 21, 2026 · 43 minThe transition from academic research to commercial MedTech entrepreneurship requires a strategic mindset shift, particularly when navigating high-risk vascular innovations. Jordi Martorell, CEO and co-founder of Aortyx, shares his journey…
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#472: Cost Containment: Right-Sizing Medical Device Cybersecurity with Chris Gates
September 21, 2026 · 40 minMedical device cybersecurity is no longer an optional feature or a last-minute checkbox prior to market entry. Hosted by Etienne Nichols, this episode features Chris Gates, founder and CEO of arsMedSecurity, who delivers a practical…
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#471: From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap
September 21, 2026 · 39 minMany MedTech startups and innovators focus heavily on core technology development, often assuming physical product design is simple polishing once a working concept exists. Michael Sprauve explains that this approach frequently creates a…
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#469: Why Market Strategy Comes First in MedTech Development
September 21, 2026 · 39 minMedical device startups frequently fall into the trap of developing complex technology first, only to struggle downstream with clinical adoption, regulatory hurdles, and reimbursement. In this episode, host Etienne Nichols sits down with…
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#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey
August 10, 2026 · 44 minMost discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves…
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#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment
August 3, 2026 · 36 minNavigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory…
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#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth
July 27, 2026 · 32 minMany early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle…
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#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian
July 20, 2026 · 39 minIn this episode, host Etienne Nichols sits down with Ali Samiian, founder and managing principal of Popular Access Advisors, to demystify the critical and often misunderstood world of MedTech reimbursement. Far too many early-stage medical…
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#464: Why LLM Unpredictability is a Liability in MedTech
July 13, 2026 · 53 minArtificial intelligence has officially entered the mainstream cultural zeitgeist, creating a wave of excitement—and a fair share of fatigue—across the medical device industry. In this episode, host Etienne Nichols sits down with Tyler…
About the show
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.