# 187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-05-07
- Length: 16m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-07-187-why-drug-and-device-development-use-different-playbooks-qbd-vs-design-contro
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/187---Why-Drug-and-Device-Development-Use-Different-Playbooks-QbD-vs--Design-Controls-Explained-e32gc0v

## Summary

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains the distinct regulatory frameworks of Quality by Design (QbD) and Design Controls for drug-device combination products. She contrasts QbD's focus on manufacturing process control (ICH Q8, CQAs, Design Space) with Design Controls' focus on validating the final product against user needs (21 CFR 820.30, DHF, V&V). Saadeh argues that because drugs achieve therapeutic effects chemically while devices solve physical problems through engineering, these frameworks are not interchangeable but both are essential for safe combination products.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-07-187-why-drug-and-device-development-use-different-playbooks-qbd-vs-design-contro#t=0) Introduction: QbD vs. Design Controls Overview

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Let's Combinate (other)
- ICH Q8 (other)
- 21 CFR 820.30 (other)
- ISO 14971 (other)
- ICH Q9 (other)
- ICH Q12 (other)
- Marta New (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)
- [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)
- [#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 Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (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)

## 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/2025-05-07-187-why-drug-and-device-development-use-different-playbooks-qbd-vs-design-contro. 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.