Office Hours: Former FDA Reviewer on the Mistakes Founders Keep Making

A single FDA class at Stanford changed Allison Komiyama's life. She was a neuroscience PhD student who thought she'd end up in academia. Then she discovered regulatory science and never looked back. Allison spent time as an FDA device reviewer before moving to industry, where she built and sold her own regulatory consulting firm over seven years. Now, with her new venture Blue Stocking Health, she's tackling a problem she watched play out for over a decade: founders who treat FDA clearance as the finish line, only to stall when the real challenge of getting their device to actual patients begins. In this conversation, Allison pulls back the curtain on how FDA actually thinks about risk, what reviewers want to hear in pre-submission meetings, how early design decisions can quietly lock you into a regulatory pathway, and why the best FDA interactions feel like collaboration, not confrontation. She also shares the career philosophy her father gave her as a kid that still drives everything she builds. Whether you're sketching a back-of-the-napkin illustration of your first device or preparing a 510(k), this is the regulatory conversation you'll wish you'd had years ago.Subscribe to First in Human: - Apple Podcasts: https://podcasts.apple.com/us/podcast/first-in-human/id1842644737 - Spotify: https://open.spotify.com/show/3C1xG5SxPei8m2lI63WSkd Connect with Allison on LinkedIn:  https://www.linkedin.com/in/allisonkomiyama/