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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-09-14
- Length: 42m
- Episode: 336
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-14-336-from-academia-to-fda-clearance-true-quality-roadshow-boston
- Listen: https://podcast.greenlight.guru/episode/true-quality-roadshow-boston

## Summary

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.

## Outline

1. Introduction: Christy Sheehy-Bensinger and C-Light Technologies
2. From Academia to Startup: Navigating the Mindset Shift
3. Validation Strategy: NIH Grants and Customer Discovery
4. Fundraising Lessons: Good Money vs. Bad Money and Digital Health
5. Building Quality Culture and Selecting CMOs
6. FDA Clearance Journey: Predicate Selection and 510(k) Strategy
7. Post-Clearance Priorities: Commercialization and Team Scaling

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

early-stage companies

## Mentioned

- C-Light Technologies (company)
- RediTrack (product)
- Greenlight Guru (tool)
- Corning (company)
- UC Berkeley (company)
- NIH (company)
- Yamaha Motor Ventures (company)
- Creative Ventures (company)
- Medtech Innovator (company)
- FDA (company)

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## Citing this page

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