EPISODE · Aug 4, 2026 · 47 MIN
Cleared by the FDA, Ignored by Everyone Else: The Real Medtech Journey w/ Allison Komiyama
from Unstable Vitals · host Dr. Adam Brown and Dr. Lara Zibners
Dr. Adam Brown and Dr. Lara Zibners sit down with Allison Komiyama, PhD, RAC, former FDA reviewer, founder of Bluestocking Health, and self-proclaimed "med tech hype woman", to demystify what actually happens when a medical device tries to reach patients.Allison breaks down PMA pathways, why "the FDA is the big bad hurdle" is only half the story, and why getting cleared is often just the starting line: insurers won't pay, hospitals won't adopt, and promising life-saving tech can quietly shut down within a year.They dig into AI's real (and overhyped) role in medical devices, why 8 of the last 10 drugs pulled from FDA clearance failed women specifically, and how the same inequality showing up in clinical trials shows up in art museums too.Plus: summer camp chaos, killer houseplants, and why everyone needs a "food distribution engineer."
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Dr. Adam Brown and Dr. Lara Zibners sit down with Allison Komiyama, PhD, RAC, former FDA reviewer, founder of Bluestocking Health, and self-proclaimed "med tech hype woman", to demystify what actually happens when a medical device tries to reach patients. Allison breaks down PMA pathways, why "the FDA is the big bad hurdle" is only half the story, and why getting cleared is often just the starting line: insurers won't pay, hospitals won't adopt, and promising life-saving tech can quietly shut...
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Cleared by the FDA, Ignored by Everyone Else: The Real Medtech Journey w/ Allison Komiyama
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