# 217 - 5 Fixable Problems Holding Back Drug–Device Programs

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-12-10
- Length: 17m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/217---5-Fixable-Problems-Holding-Back-DrugDevice-Programs-e3c50q2

## Summary

Subhi Saadeh, founder of Let’s Combinate BioWorks, outlines five critical quality issues in drug-device combination products, drawing on his experience at Pfizer, Gilead, and Baxter. He addresses documentation misalignment in design transfer, late manufacturing input, arbitrary sampling plans, unclear method transfer ownership, and supplier qualification gaps. Saadeh proposes solutions such as integrating pharma change controls with device design plans, embedding DFM/DFA reviews, and adopting PPAP frameworks for component qualification. The episode emphasizes harmonizing drug and device development processes to ensure scalable, compliant, and patient-ready solutions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs#t=0) Introduction: Subhi Saadeh and Let's Combinate BioWorks

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Let's Combinate BioWorks (company)
- Pfizer (company)
- Gilead (company)
- Baxter (company)
- ICH Q8 (other)
- ISO 13485 (other)
- PPAP (other)
- DFM (other)
- DFA (other)
- Boothroyd Dewhurst (other)
- ISO 2859 (other)
- Z1 (other)
- AQL (other)
- CPV (other)
- FDA (company)

## Related episodes from other shows

- [#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)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (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)
- [Most Common Problems Found During FDA Inspections in 2022](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022) (Global Medical Device 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/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs. 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.