# Let's Talk Risk! Podcast Page: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844 Text version: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844.md RSS feed: https://api.substack.com/feed/podcast/1477050.rss Official site: https://naveenagarwalphd.substack.com/podcast Author: Where MedTech professionals gain clarity and confidence to navigate complex decisions. Episodes: 166 ## Resource Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges. ## Machine-readable JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-risk-podcast-6693844 Markdown: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844.md ## Episodes - [LTR 155: Leverage VIP to Move from Compliance to Capability](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-155-leverage-vip-to-move-from-compliance-to-capability) — 2026-05-15T13:00:00+00:00 - [LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-154-from-procedures-to-judgment-leading-through-qmsr-inspections) — 2026-05-08T12:00:00+00:00 - [LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-153-sherita-black-on-building-a-practical-policy-for-risk-acceptability) — 2026-05-01T12:00:00+00:00 - [LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-152-omar-al-kalaa-on-telesurgery-and-the-future-of-remotely-controlled-medical-systems) — 2026-04-24T12:00:00+00:00 - [LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-151-sarai-pahla-on-managing-supply-chain-disruption-risk-in-life-sciences) — 2026-04-17T12:00:00+00:00 - [Case Study: How Patient Preference Data Rescued a High-Risk Device](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/case-study-how-patient-preference-data-rescued-a-high-risk-device) — 2026-04-10T12:00:00+00:00 - [LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-150-jonathan-kendler-on-rethinking-human-factors-engineering-for-ai-ml-enabled-devices) — 2026-04-03T12:00:00+00:00 - [LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-149-lavanya-ramnath-on-risk-analysis-ide-strategy-and-patient-centered-design) — 2026-03-27T12:00:00+00:00 - [LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-148-chris-daly-on-companion-diagnostics-ai-and-fda-s-evolving-approach) — 2026-03-20T12:00:00+00:00 - [LTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-147-richard-matt-on-bringing-benefit-risk-upstream-in-design-and-development) — 2026-03-13T12:00:00+00:00 - [LTR 146: Ganesh Sabat on Scaling MedTech Through Quality](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-146-ganesh-sabat-on-scaling-medtech-through-quality) — 2026-03-06T13:00:00+00:00 - [LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-145-holly-cotter-on-avoiding-the-qmsr-scramble-with-smart-quality-planning) — 2026-02-27T13:00:00+00:00 - [LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-144-jean-blom-on-how-hazard-first-thinking-improves-risk-management) — 2026-02-20T13:00:00+00:00 - [LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-143-jennifer-mascioli-tudor-on-leading-proactive-quality-in-the-qmsr-era) — 2026-02-13T13:00:00+00:00 - [LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-142-florian-tolkmitt-on-clinical-evaluation-risk-and-the-new-iso-draft-standard) — 2026-02-06T13:00:00+00:00 - [LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-141-ashkon-rasooli-on-applying-an-agile-mindset-to-risk-based-quality-systems-under-qmsr) — 2026-01-30T13:00:00+00:00 - [LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-140-pujitha-gourabathini-on-connecting-risk-management-and-design-controls) — 2026-01-23T13:00:00+00:00 - [LTR 139: Steve Silverman on FDA Readiness for QMSR](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-139-steve-silverman-on-fda-readiness-for-qmsr) — 2026-01-16T13:00:00+00:00 - [LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-138-michelle-lott-on-qmsr-readiness-risk-based-assurance-and-fda-expectations) — 2026-01-09T13:00:00+00:00 - [LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-137-priya-setty-on-qmsr-risk-based-assurance-and-building-a-future-ready-ra-career) — 2025-12-19T13:00:00+00:00 - [LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-136-adam-isaacs-rae-on-what-qmsr-really-changes-and-what-it-doesn-t) — 2025-12-12T13:00:00+00:00 - [LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-135-allison-komiyama-on-rethinking-benefit-risk-in-medtech) — 2025-12-05T13:00:00+00:00 - [LTR 134: James Pink on Responsible AI and Future of MedTech Safety](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-134-james-pink-on-responsible-ai-and-future-of-medtech-safety) — 2025-11-28T13:00:00+00:00 - [LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-133-megan-kane-on-leading-qmsr-readiness-in-medtech-startups) — 2025-11-21T13:00:00+00:00 - [LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-132-bijan-elahi-on-future-of-medtech-safety-and-the-2026-conference-in-boston) — 2025-11-14T13:00:00+00:00 ## Actions Episode pages expose an explicit `request_transcript` action. 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