# #333: Exploring Breakthrough Device Designation

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-08-25
- Length: 35m
- Episode: 333
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-25-333-exploring-breakthrough-device-designation
- Listen: https://podcast.greenlight.guru/episode/333-breakthrough-device-designation

## Summary

Etienne Nichols hosts Ellie Reynolds, Associate Director at Proxima Clinical Research, to discuss the FDA's Breakthrough Device Designation program. They cover the eligibility criteria, such as treating life-threatening conditions, and the benefits like priority review and Sprint Discussions. Reynolds clarifies that CMS reimbursement is no longer automatic and explains how to navigate competitive landscapes where rivals also hold the designation.

## Outline

1. Introduction and Program History
2. Eligibility Criteria and Submission Process
3. Benefits: Priority Review and Sprint Discussions
4. Reimbursement Changes and Marketing Buzz
5. Timing, Q-Subs, and Competitive Landscape

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- FDA (company)
- CMS (company)
- Proxima Clinical Research (company)
- Greenlight Guru (company)
- 510(k) (other)
- De Novo (other)
- PMA (other)

## Related episodes from other shows

- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r) (Let's Combinate)

## Citing this page

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