# 166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-12-11
- Length: 20m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-11-166-sync-or-sink-3-levels-of-harmonization-for-combination-product-success
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/166---Sync-or-Sink-3-Levels-of-Harmonization-for-Combination-Product-Success-e2s6813

## Summary

Subhi Saadeh, who chairs the international working group of the Combination Products Coalition (CPC) and works in the CXO space, presents on three levels of harmonization for combination products: regulatory, sponsor-CXO, and internal drug-device alignment. He argues that while regulatory harmonization is critical, it is slow to implement, so companies should focus on operational harmony through standardized quality agreements and cross-functional collaboration. Saadeh highlights specific pain points such as misaligned definitions of combination products, inconsistent change notification processes between sponsors and contract manufacturers, and cultural silos between drug and device teams. He advocates for leveraging forums like RX360 and the CPC to drive standardization and trust.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-11-166-sync-or-sink-3-levels-of-harmonization-for-combination-product-success#t=0) Introduction and Broadening Harmonization

## Topics

- [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)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- Combination Products Coalition (company)
- MDSAP (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)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (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)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)

## Citing this page

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