In this episode, we sit down with Allison Komiyama, Founder of Bluestocking Health, to discuss medical devices, regulatory strategy, clinical evidence, and the challenges of bringing innovative technologies to market.
Allison brings extensive experience in the medical device industry, having worked on hundreds of FDA pre-submissions and premarket submissions across a wide range of technologies. Her career includes experience as an FDA reviewer in the Center for Devices and Radiological Health, founding AcKnowledge Regulatory Strategies, and now leading Bluestocking Health.
With a background in Molecular & Cell Biology from UC Berkeley and a doctorate in Neuroscience from Stanford, Allison shares her perspective on how science, regulation, and communication can help innovative medical technologies reach patients and remain on the market.
🎙️ Tune in for an insightful conversation about MedTech, FDA regulatory pathways, clinical evidence, and the future of medical devices.
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