Hardware Podcasts

#336: From Academia to FDA Clearance (True Quality Roadshow - Boston)

Global Medical Device Podcast · 14 Sept 2023 · 42m · Episode 336

What this episode covers

Christy Sheehy-Bensinger, CEO and Founder of C-Light Technologies, discusses her journey from optical engineering at Corning and a PhD at UC Berkeley to securing FDA clearance for the RediTrack eye movement monitor. She details the strategic pivot from seeking digital health investors to focusing on medical device investors, the critical role of NIH grants in validating the technology, and the importance of building a quality culture early using Greenlight Guru. She also shares insights on selecting predicate devices for 510(k) clearance and the ongoing challenges of post-clearance commercialization and team scaling.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
C-Light Technologies, Corning, UC Berkeley, NIH, Yamaha Motor Ventures, Creative Ventures, Medtech Innovator, FDA
Products
RediTrack
Tools
Greenlight Guru

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