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Global Medical Device Podcast in 2026

37 episodes, newest first.

  1. 15 Oct#476Part 2: FDA Guidance: What We Should Expect in 202752m
  2. 13 Oct#475Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy34m
  3. 22 Sept#470The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova39m
  4. 21 Sept#469Why Market Strategy Comes First in MedTech Development39m
  5. 21 Sept#471From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap38m
  6. 21 Sept#472Cost Containment: Right-Sizing Medical Device Cybersecurity with Chris Gates40m
  7. 21 Sept#473The MedTech Odyssey: Bridging Academic Science to Series A Success42m
  8. 21 Sept#474Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls33m
  9. 10 Aug#468SaMD Issues, Defects & DetectionShawnnah Monterrey44m
  10. 3 Aug#467Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment35m
  11. 27 Jul#466Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth31m
  12. 20 Jul#465Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian39m
  13. 13 Jul#464Why LLM Unpredictability is a Liability in MedTech53m
  14. 6 Jul#463Finding MedTechs Leading Voices with Sean Smith45m
  15. 29 Jun#462Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders38m
  16. 22 Jun#461Why Manufacturing is Part of Product Development with Mike Dolphin47m
  17. 18 May#460FDA AI Regulations: Master the QA/RA Skills to Stay Ahead15m
  18. 11 May#459The Purolea Warning Letter & Validating AI in Medical Devices - What FDA Actually Requires24m
  19. 4 May#458What the FDA Actually Says About AI in Medical Devices18m
  20. 27 Apr#457Exploring the MedTech Commercial Valley of Death with Ryan O'Mahoney35m
  21. 20 Apr#456What You Don’t Know Can Hurt You: 483 Pitfalls and Regulatory Accountability53m
  22. 13 Apr#455MedTech Founder 101: Shifting from Corporate to Startup with John Schindler39m
  23. 6 Apr#454Bridging the Gap: Avoiding the MedTech Valley of Death with Dr. Adam Saltman39m
  24. 30 Mar#453Sustainable Material Selection in MedTech with Lucas Pianegonda44m
  25. 23 Mar#452Switching Careers to MedTech: A Practical Guide for Engineers and Professionals26m
  26. 16 Mar#451Building a MedTech Powerhouse: The 5 Stages of Founder Success30m
  27. 9 Mar#450Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling53m
  28. 2 Mar#4497 Pitfalls of International MedTech Expansion48m
  29. 23 Feb#448MedTech Investment: Outcomes, Regulations, and the Shift to At-Home Care1h 00m
  30. 16 Feb#447Solving the Pediatric MedTech Gap with Edwin Lindsay43m
  31. 9 Feb#446The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss45m
  32. 2 Feb#445ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech37m
  33. 30 Jan#444Scaling Your QMS: What the FDA Really Expects for MedTech Startups57m
  34. 26 Jan#443Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli44m
  35. 19 Jan#442MedTech Leadership: Vulnerability & The CEC Framework with Dr. Jenny Hoffmann45m
  36. 12 Jan#441ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech Industry45m
  37. 5 Jan#440ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory50m