# 160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-10-30
- Length: 19m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-30-160-drug-tech-transfer-vs-device-design-transfer-explained
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/160---Drug-Tech-Transfer-vs--Device-Design-Transfer-EXPLAINED-e2qamjs

## Summary

Host Subhi Saadeh explains the critical distinctions between drug tech transfer and device design transfer in combination products. He details how drug transfer relies on ICH Q10 for process validation and analytical method transfer, while device design transfer is governed by ISO 13485 and the Device History File (DHF). Saadeh highlights differences in regulatory submissions, such as CMC for drugs versus 510(k) or PMA for devices, and discusses the complexities of synchronizing timelines and supply chains for commercializing combination products.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-30-160-drug-tech-transfer-vs-device-design-transfer-explained#t=0) Introduction to Combination Products
- [0:55](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-30-160-drug-tech-transfer-vs-device-design-transfer-explained#t=55) Drug Tech Transfer and ICH Q10

## Topics

- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- ICH Q10 (other)
- ISO 13485 (other)
- FDA (other)
- EMA (other)
- 510(k) (other)
- PMA (other)
- PPAP (other)
- Larry Mager (other)
- Ben Lockwin (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)
- [#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)
- [Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices) (Global Medical Device Podcast)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)
- [DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact) (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/2024-10-30-160-drug-tech-transfer-vs-device-design-transfer-explained. 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.