# 190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-05-28
- Length: 15m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-28-190-harmony-not-sameness-what-drug-device-teams-keep-getting-wrong
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/190---Harmony--Not-Sameness-What-Drug-Device-Teams-Keep-Getting-Wrong-e33b298

## Summary

Subhi Saadeh, Quality Professional and host of Let's Combinate, explains that drug-device combination products fail due to a lack of harmony across three levels: global regulatory alignment, sponsor-CXO collaboration, and internal cross-functional teamwork. He argues that while the market for products like autoinjectors and inhalers is projected to reach $181 billion by 2030, fragmented regulations and siloed teams delay patient access. Saadeh advocates for shifting from a 'license to operate' compliance mindset to a 'license to collaborate' culture, emphasizing that drug and device teams must align on shared blueprints and incentives rather than trying to make the distinct entities identical.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-28-190-harmony-not-sameness-what-drug-device-teams-keep-getting-wrong#t=0) Introduction: The Reality of Drug-Device Combination Products

## 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)

## Most relevant to

early-stage companies

## Mentioned

- CPHI (other)
- FDA (other)
- EMA (other)
- Amgen (company)
- Combination Products Coalition (other)
- ASTM Committee E55 (other)
- AAMI (other)
- IMDRF (other)
- ICH (other)
- ISO 13485 (other)
- ICHQ10 (other)
- 21 CFR part 4 (other)
- ICHQ 12 (other)
- ICHQ6 (other)
- QBD (other)

## Related episodes from other shows

- [#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)
- [#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)
- [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)
- [Closing the gap between Regulatory and Development with Milton Yarberry](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry) (The Pragmatic Embedded Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-28-190-harmony-not-sameness-what-drug-device-teams-keep-getting-wrong. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.