LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
From Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.
February 20, 2026 · 28 min
About this episode
The episode discusses how hazard-first thinking can enhance risk management practices in medical device development.
Summary “Risks occur. They happen but they don’t exist … hazards do.” In this Let’s Talk Risk! conversation , host Naveen Agarwal sits with Jean Blom , a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing, ISO 14971 risk management (including usability), and certification/accreditation perspectives. Our conversation is deliberately informal and highly practical. We explore why many teams get stuck in the mechanics of risk tools (especially large, bottom-up FMEAs), and how a shift toward hazard-first thinking can make risk management more tangible, especially for startups, early-career professionals, and teams working on diagnostic and software-driven devices. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:01 Introduction to Jean’s start in risk management 02:45 Linear standards vs. real-world complexity 05:20 Indirect harm in diagnostic and AI devices 07:10 Risk management for start up and early career professionals 10:30 Risks don’t exist , hazards do 13:20 Role of examples in risk management 16:45 Risk information outside of risk management team 18:00 Why FMEAs fail at the executive…
People in this episode
Host: Naveen Agarwal
Guest: Jean Blom
Topics covered
- risk management
- hazard-first thinking
- medical devices
- ISO standards
- FMEA
- startups
- diagnostic devices
Keywords
- risk management
- hazard-first thinking
- ISO 13485
- ISO 14971
- FMEA
- diagnostic devices
- startups
- risk tools
Mentioned in this episode
Organizations: ISO 13485, ISO 14971
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