Podcast

Trying to Keep Up

The FDA moves fast. Guidance changes. Policies evolve. Submissions get weird. Former-FDA reviewers Michael Nilo and Allison Komiyama started Trying To Keep Up for a simple reason: they were already…

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Latest episodes

  1. From FDA Reviewer to MedTech CEO: The 12-Year Overnight Success (ft. Shreya Mehta) - 10/15/2615 Oct 2026
  2. A Heart Valve That Grows with Kids, a Cuffless BP Ring & AI That Learns – 10/8/268 Oct 2026
  3. FDA’s 2027 Priorities, Human Factors & Breakthroughs (ft. Tim Marjenin) – 10/1/261 Oct 2026
  4. eSTAR 7.1, Patient Voice, and Robotic Devices (ft. Laura Gilmour) – 9/24/2624 Sep 2026
  5. Biocompatibility, Global Harmonization, and ISO 10993 (ft. Rob Allen) – 9/17/2617 Sep 2026
  6. AI That Spots Heart Attacks + Robots Helping Kids Walk (ft. David Pudwill) – 9/10/2610 Sep 2026
  7. When Does AI Become a Medical Device? (ft. Aubrey Shick) – 3/19/267 Sep 2026
  8. When FDA Sees Risk, Who Makes the Case for Benefit? (ft. Laura Rose) - 9/3/263 Sep 2026
  9. Poop Tech, Migraine Glasses, and Neural Ice (ft. Keith Christopher) - 8/27/2627 Aug 2026
  10. Robotic Blood Draws, Generative AI & Device Reclassifications – 8/20/2620 Aug 2026