LTR 164: Susan Neadle on Combination Device Risk Management

Summary

“ISO 14971 and ICH Q9 are not competing frameworks. They are asking different questions about risk.”

In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Susan Neadle, Principal Consultant and President of Combination Products Consulting Services, to explore what changes when medical device and pharmaceutical risk-management approaches come together in a combination product.

ISO 14971 places strong emphasis on hazards, hazardous situations, harms, users, and safety. ICH Q9 approaches risk through a different lens, with a strong focus on product quality, process variability, critical quality attributes, and control strategies. Susan explains why neither perspective is sufficient by itself for a combination product—and why the real challenge is understanding the interactions among the drug, device, manufacturing process, user, environment, and lifecycle.

They also discuss the work underway on ISO 24971-3, intended to provide practical guidance on integrating these approaches; how new hazards and hazardous situations can emerge from constituent-part interactions; what combination products mean for supplier controls; and the leadership judgment required when technical, business, and patient considerations converge.

Listen to the full 25-minute podcast or jump to a section of interest listed below.

Chapters

01:19 – What Are Combination Products?02:41 – Difference in Risk Management.05:06 – Why Meeting Specifications Is Not Enough08:40 – ISO 24971-3 and the Need for Practical Integration Guidance10:49 – Bridging Drug and Device Risk Management Mindsets13:17 – ISO 14971 and ICH Q9: Different Questions About Risk14:55 – Combined Use Systems, Interface Risks, and New Hazardous Situations18:01 – Interaction Risks Between Drugs, Devices, and Biologics19:33 – Leadership, Judgment, and Making Risk-Based Decisions22:03 – Supplier Controls and Sponsor Responsibility24:55 – Key Takeaways: Lifecycle Risk Management and Keeping the End User Safe

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Integrating purchasing controls across product lifecycle.

LTR: FDA’s New Risk Lens Under QMSR.