Hardware Podcasts

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

Let's Combinate · 12 Oct 2026 · 34m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Reliant Life Sciences
Also
ISO 14971, ICH Q9, ISO 13485, QMSR, IMDRF, FDA, 510 K, CDMO

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