# 258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-10-12
- Length: 34m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/258---Combination-Product-Quality-Human-Factors--CDMO-Scorecards--ISO-14971-vs--ICH-Q9--with-Ben-Locwin-e3qabd5

## Summary

Ben Locwin, Vice President at Reliant Life Sciences, and Subhi Saadeh, Founder of Let's Combinate, discuss the divergent quality philosophies of pharmaceutical and medical device industries, focusing on combination products. They explain how human factors studies must account for different user types (HCP vs. lay) even with platform devices, and how CDMO scorecards often fail to reflect operational reality due to subjective weighting. The conversation details the differences between ISO 14971 and ICH Q9 risk management, emphasizing the need for FMEA as a living document updated with real-world data.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q#t=0) Introduction: Ben Locwin and Subhi Saadeh on Combination Product Quality
- [0:51](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q#t=51) Pharma vs. Medical Device Philosophies: Clinical vs. Design Controls
- [9:03](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q#t=543) Platform Technology and Human Factors Studies for Combination Products
- [15:40](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q#t=940) CGMP Harmonization: QMSR, ISO 13485, and ICH
- [25:07](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q#t=1507) CDMO Oversight: When Scorecards Mask Poor Performance
- [31:13](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q#t=1873) ISO 14971 vs. ICH Q9 Risk Management and FMEA

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- Reliant Life Sciences (company)
- ISO 14971 (other)
- ICH Q9 (other)
- ISO 13485 (other)
- QMSR (other)
- IMDRF (other)
- FDA (other)
- 510 K (other)
- CDMO (other)

## Related episodes from other shows

- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (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)
- [#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)
- [#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling) (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/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q. 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.