{"podcast":{"title":"Let's Talk Risk! Podcast","slug":"let-s-talk-risk-podcast-6693844","podcast_index_feed_id":6693844,"rss_url":"https://api.substack.com/feed/podcast/1477050.rss","website_url":"https://naveenagarwalphd.substack.com/podcast","image_url":"https://substackcdn.com/feed/podcast/1477050/ee2039dcd34796f25b1263b7e1659bef.jpg","author":"Where MedTech professionals gain clarity and confidence to navigate complex decisions.","episode_count":166,"summary":"Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.","last_synced_at":null,"page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844"},"episode":{"title":"LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management","slug":"ltr-144-jean-blom-on-how-hazard-first-thinking-improves-risk-management","published_at":"2026-02-20T13:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-144-jean-blom-on-how-hazard-first-thinking-improves-risk-management","show_page_url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844","url":"https://naveenagarwalphd.substack.com/p/ltr-144-jean-blom-on-how-hazard-first-thinnking-improves-risk-management","audio_url":"https://api.substack.com/feed/podcast/187865396/dbedb96908288ae279c1b5b6cfd8d9a7.mp3","summary":"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 view 20:20 Risk management competence development 21:00 Seek to be understood 23:40 Teaching risk without jargon 26:40 From getting it right to not getting it wrong If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter . Suggested links: LTR: Why FMEA Alone is Not Sufficient for Risk Analysis . LTR: Three Pillars for Defining Your IVD Risk Management Strategy . LTR: Focus on Intended Use for IVD Risk Management . Key Takeaways * When just starting with risk management, begin with hazards: they are tangible and controllable; “risk” is an outcome. * Standards provid…","meta_description":"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…","key_points":[],"chapters":[],"topics":[],"duration_seconds":1697,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-talk-risk-podcast-6693844/episodes/ltr-144-jean-blom-on-how-hazard-first-thinking-improves-risk-management/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-144-jean-blom-on-how-hazard-first-thinking-improves-risk-management.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}