Episode

LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston

Podcast
Let's Talk Risk! Podcast
Published
Nov 14, 2025
Duration seconds
1672
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not_requested
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https://naveenagarwalphd.substack.com/p/ltr-132-bijan-elahi-on-future-of-medtech-safety-and-2026-conference
Audio
https://api.substack.com/feed/podcast/177900830/f0df073f9c1874af5e0fcbf5633e16f0.mp3
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Markdown
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Summary

Summary “This conference is really by the community and for the community - a place where people passionate about MedTech safety can come together to share ideas, learn, and make a difference.” In this Let’s Talk Risk! conversation , host Dr. Naveen Agarwal welcomes back renowned safety risk management expert Bijan Elahi to discuss the upcoming International MedTech Safety Conference 2026 in Boston. Bijan shares the inspiring story of how a grassroots effort among passionate professionals has grown into a global movement for advancing safety risk management in medical devices. From its beginnings at Medtronic headquarters to a sold-out conference in Amsterdam, this event has become a central hub for knowledge exchange between industry, academia, and regulators, including keynote participation from FDA CDRH Director Dr. Michelle Tarver . Together, Naveen and Bijan explore emerging themes shaping MedTech risk management today - AI and machine learning, combination products, and proactive safety by design - and highlight the many ways professionals can get involved in shaping the future of safety science. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Introduction and welcome 01:40 Emerging themes in MedTech risk: AI and combination products 03:30 Why Bijan created the MedTech Safety Conference 05:00 From Medtronic to Amsterdam: a 400% growth story 06:45 The 2026 theme: Proactive Safety by Design 08:30 Academic and regulatory collaboration (Northeastern, MIT, FDA) 10:00 QMSR and the growing role of risk-based assurance 12:00 Conference structure: workshops, keynotes, collaboration day 15:00 How to participate: speak, teach, or lead a discussion 18:00 Abstract selection and deadlines 21:00 New ISO documents on AI/ML and c…