Podcast

Let's Talk Risk! Podcast

Author: Where MedTech professionals gain clarity and confidence to navigate complex decisions.
Feed episode count: 173
Official site: https://naveenagarwalphd.substack.com/podcast
RSS: https://api.substack.com/feed/podcast/1477050.rss
JSON: /v1/public/podcasts/let-s-talk-risk-podcast-6693844
Markdown: /podcast/let-s-talk-risk-podcast-6693844.md

Summary

Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.

Episodes

Jul 10, 2026 · not_requested

Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations

Duration seconds: 1049
Source: https://naveenagarwalphd.substack.com/p/case-study-why-fda-cybersecurity-are-qms-expectations

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Jul 3, 2026 · not_requested

LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety

Duration seconds: 2838
Source: https://naveenagarwalphd.substack.com/p/ltr-160-imsc26-highlights-from-compliance-to-proactive-patient-safety

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Jun 26, 2026 · not_requested

LTR 159: The Evolving Regulatory Landscape for AI in MedTech

Duration seconds: 2536
Source: https://naveenagarwalphd.substack.com/p/ltr-159-the-evolving-regulatory-landscape-for-ai-in-medtech

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Jun 19, 2026 · not_requested

Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

Duration seconds: 2486
Source: https://naveenagarwalphd.substack.com/p/case-study-fdas-new-expectation-forfor-use-related-risks

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Jun 12, 2026 · not_requested

LTR 158: Three Questions To Keep Risk Connected to Decisions

Duration seconds: 1691
Source: https://naveenagarwalphd.substack.com/p/ltr-158-three-questions-to-keep-risk-connected-to-decisions

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May 29, 2026 · not_requested

LTR 157: Why Risk Doesn't Get Heard and How to Change That

Duration seconds: 1641
Source: https://naveenagarwalphd.substack.com/p/ltr-157-why-risk-doesnt-get-heard-and-how-to-change-that

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May 22, 2026 · not_requested

LTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control

Duration seconds: 1624
Source: https://naveenagarwalphd.substack.com/p/ltr-156-using-ai-as-a-thinking-partner-in-product-development

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May 15, 2026 · not_requested

LTR 155: Leverage VIP to Move from Compliance to Capability

Duration seconds: 1572
Source: https://naveenagarwalphd.substack.com/p/ltr-155-leverage-vip-to-move-from-compliance-to-capability

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May 8, 2026 · not_requested

LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections

Duration seconds: 2331
Source: https://naveenagarwalphd.substack.com/p/ltr-154-from-procedures-to-judgment-leading-through-qmsr-inspections

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May 1, 2026 · not_requested

LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

Duration seconds: 1764
Source: https://naveenagarwalphd.substack.com/p/ltr-153-sherita-black-on-building-practical-risk-acceptability-policy

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Apr 24, 2026 · not_requested

LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems

Duration seconds: 2181
Source: https://naveenagarwalphd.substack.com/p/ltr-152-omar-al-kalaa-on-telesurgery-and-future-of-remotely-controlled-medical-systems

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Apr 17, 2026 · not_requested

LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences

Duration seconds: 1561
Source: https://naveenagarwalphd.substack.com/p/ltr-151-sarai-pahla-on-managing-supply-chain-disruption-risk

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Apr 10, 2026 · not_requested

Case Study: How Patient Preference Data Rescued a High-Risk Device

Duration seconds: 1237
Source: https://naveenagarwalphd.substack.com/p/case-study-how-patient-preference-rescued-high-risk-device

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Apr 3, 2026 · not_requested

LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices

Duration seconds: 1767
Source: https://naveenagarwalphd.substack.com/p/ltr-150-jonathan-kendler-on-rethinking-human-factors-for-aiml-medical-devices

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Mar 27, 2026 · not_requested

LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design

Duration seconds: 1712
Source: https://naveenagarwalphd.substack.com/p/ltr-149-lavanya-ramnath-on-risk-analysis-ide-strategy-patient-centered-design

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Mar 20, 2026 · not_requested

LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach

Duration seconds: 1742
Source: https://naveenagarwalphd.substack.com/p/ltr-148-chris-daly-on-companion-diagnostics-ai-and-fda-evolving-approach

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Mar 13, 2026 · not_requested

LTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development

Duration seconds: 1616
Source: https://naveenagarwalphd.substack.com/p/ltr-147-richard-matt-on-bringing-benefit-risk-upstream-in-design

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Mar 6, 2026 · not_requested

LTR 146: Ganesh Sabat on Scaling MedTech Through Quality

Duration seconds: 1535
Source: https://naveenagarwalphd.substack.com/p/ltr-146-ganesh-sabat-on-scaling-medtech-through-quality

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Feb 27, 2026 · not_requested

LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning

Duration seconds: 1701
Source: https://naveenagarwalphd.substack.com/p/ltr-145-holly-cotter-on-avoiding-qmsr-scramble-with-smart-quality-panning

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Feb 20, 2026 · not_requested

LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management

Duration seconds: 1697
Source: https://naveenagarwalphd.substack.com/p/ltr-144-jean-blom-on-how-hazard-first-thinnking-improves-risk-management

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Feb 13, 2026 · not_requested

LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era

Duration seconds: 1832
Source: https://naveenagarwalphd.substack.com/p/ltr-143-jennifer-mascioli-tudor-on-leading-proactive-quality-qmsr

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Feb 6, 2026 · not_requested

LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard

Duration seconds: 1671
Source: https://naveenagarwalphd.substack.com/p/ltr-142-florian-tolkmitt-on-clinical-evaluation-risk-and-iso-dis-18969-draft-standard

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Jan 30, 2026 · not_requested

LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR

Duration seconds: 1674
Source: https://naveenagarwalphd.substack.com/p/ltr-141-ashkon-rasooli-on-applying-agile-mindset-to-quality-systems-under-qmsr

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Jan 23, 2026 · not_requested

LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls

Duration seconds: 1572
Source: https://naveenagarwalphd.substack.com/p/ltr-140-pujitha-gourabathini-on-connecting-risk-management-and-design-controls

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Jan 16, 2026 · not_requested

LTR 139: Steve Silverman on FDA Readiness for QMSR

Duration seconds: 1932
Source: https://naveenagarwalphd.substack.com/p/ltr-139-steve-silverman-on-fda-readiness

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Jan 9, 2026 · not_requested

LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations

Duration seconds: 1783
Source: https://naveenagarwalphd.substack.com/p/lltr138-michelle-lott-on-qmsr-readiness-risk-based-assurance-and-fda-expectations

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Dec 19, 2025 · not_requested

LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career

Duration seconds: 1904
Source: https://naveenagarwalphd.substack.com/p/ltr-137-priya-setty-on-qmsr-risk-assurance-and-career-advice-for-qara

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Dec 12, 2025 · not_requested

LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't

Duration seconds: 1647
Source: https://naveenagarwalphd.substack.com/p/ltr-136-adam-isaacs-rae-on-what-qmsr-really-changes-and-what-it-doesnt

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Dec 5, 2025 · not_requested

LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech

Duration seconds: 1925
Source: https://naveenagarwalphd.substack.com/p/ltr-135-allison-komiyama-on-rethinking-benefit-risk

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Nov 28, 2025 · not_requested

LTR 134: James Pink on Responsible AI and Future of MedTech Safety

Duration seconds: 1751
Source: https://naveenagarwalphd.substack.com/p/ltr132-james-pink-on-responsibleai-in-medtech

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Nov 21, 2025 · not_requested

LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups

Duration seconds: 1722
Source: https://naveenagarwalphd.substack.com/p/ltr-133-megan-kane-on-leading-qmsr-readiness-in-medtech-startups

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Nov 14, 2025 · not_requested

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

Duration seconds: 1672
Source: https://naveenagarwalphd.substack.com/p/ltr-132-bijan-elahi-on-future-of-medtech-safety-and-2026-conference

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