# 244 - 5 Critical Quality Differences Between Drugs and Devices

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-07-01
- Length: 8m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/244---5-Critical-Quality-Differences-Between-Drugs-and-Devices-e3lg88e

## Summary

Subhi Saadeh, a consultant specializing in drug-device combination products, explains five critical quality differences between pharmaceuticals and medical devices. He contrasts the drug industry's focus on consistent manufacturing of clinically proven products (ICH Q8/Q9) with the device industry's emphasis on design robustness and user needs (ISO 13485/14971). The discussion covers divergent approaches to risk management, regulatory submission evidence, and lifecycle change control, urging teams to intentionally integrate these systems rather than forcing one onto the other.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices#t=0) Introduction and Quality Philosophy

## Topics

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

## Most relevant to

established companies

## Mentioned

- ICH Q8 (other)
- ISO 13485 (other)
- ICH Q9 (other)
- ISO 14971 (other)
- ICH Q12 (other)

## Related episodes from other shows

- [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)
- [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)
- [#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)
- [#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)

## Citing this page

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