# 135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-05-08
- Length: 41m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/135---Combination-Products-Mindset--MDUFA-and-Combination-Products--FDA-Hierarchy--Supplier-Management--Surprises-in-Industry--and-Culture-with-Tony-Watson-e2jcn92

## Summary

Tony Watson, Vice President of Regulatory and Quality at Windgap Medical, discusses the evolution of combination product regulation, tracing the creation of the Office of Combination Products (OCP) and the impact of MDUFA on FDA structure and resources. He details his transition from FDA reviewer to industry roles at Biogen and Sanofi, highlighting the challenges of establishing device competency within large pharmaceutical organizations and the unique supply chain dynamics of startups like Windgap. Watson emphasizes the critical importance of a 'combination product mindset' that balances drug and device perspectives, fostering a culture where dissenting opinions are heard to ensure quality and safety.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=0) Introduction: Tony Watson and Windgap Medical
- [2:50](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=170) FDA History: Ombudsmen, CDRH, and Early Combination Products
- [6:02](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=362) MDUFA, Office of Combination Products, and Resource Challenges
- [11:30](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=690) FDA Hierarchy: Branch Chiefs, Division Directors, and Reorganization
- [14:08](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=848) Transition to Industry: Biogen, Sanofi, and the Part 812 Shock
- [23:18](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=1398) Combination Product Mindset: Large Pharma vs. Startup Dynamics
- [28:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=1736) Global Regulatory Landscape and Digital Health Maturity
- [33:21](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=2001) Quality Culture, Dissenting Opinions, and AI Risk
- [38:39](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su#t=2319) Handling Hostility and Personal Resilience in Regulatory Affairs

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [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)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies, large enterprises

## Mentioned

- Windgap Medical (company)
- FDA (company)
- Biogen (company)
- Sanofi (company)
- Eli Lilly (company)
- Novo Nordisk (company)
- AbbVie (company)
- CDER (company)
- CDRH (company)
- MDUFA (other)
- Part 812 (other)
- GHTF (other)
- IMDC (other)

## Related episodes from other shows

- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [#352: Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)

## Citing this page

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