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Let's Talk Risk! Podcast Let's Talk Risk! Podcast Where MedTech professionals gain clarity and confidence to navigate complex decisions. Happy Work - Management & bien-être au travail Happy Work - Management & bien-être au travail Gaël Chatelain-Berry Ca$hMire de Pierre Couture Ca$hMire de Pierre Couture Pierre Couture Alfa Tu Camino (Ingeniería cuántica de seducción) Alfa Tu Camino (Ingeniería cuántica de seducción) Hugo Cervantes Vision Vitals Vision Vitals e-con Systems Real Talk with Zuby Real Talk with Zuby Zuby PMP Exam Success in 40 Days! - Project Management 101 PMP Exam Success in 40 Days! - Project Management 101 40 Days to PMP Exam Success Alpha Casts - AI Market Intelligence Alpha Casts - AI Market Intelligence StockAlpha.ai Get On With It Get On With It Tom Elliott - Focused Creative The Classy Career Girl Podcast The Classy Career Girl Podcast Classy Career Girl International, LLC The Vox Markets Podcast The Vox Markets Podcast Vox Markets Podcast 財經一路發 財經一路發 News98 Unearthed Unearthed World Gold Council Digital Finance Analytics (DFA) Blog Digital Finance Analytics (DFA) Blog Martin North Rebel Capitalist News Rebel Capitalist News George Gammon Affaires de business Affaires de business Choses à Savoir The Bridge by iCapital The Bridge by iCapital iCapital Mon argent Mon argent Choses à Savoir The Modern Market Show The Modern Market Show The Modern Market Show What’s Up Dunwoody What’s Up Dunwoody Matthew Weber Macro met Boot en Mujagić  | BNR Macro met Boot en Mujagić | BNR BNR Nieuwsradio Contracting Officer Podcast 2.0 (samples) Contracting Officer Podcast 2.0 (samples) Kevin Jans, Paul Schauer, Contracting Officer, government Contracting, proposal management, proposal writing, targeting, contract administration, contract management, subcontracting EverydaySpy Podcast EverydaySpy Podcast Andrew Bustamante Ecommerce Conversations Ecommerce Conversations Practical Ecommerce Money Making Conversations Master Class Money Making Conversations Master Class Rushion McDonald The Progress Report Podcast The Progress Report Podcast REVOLT The Sage Sayers The Sage Sayers Debbi Gardiner McCullough Quality Insights Podcast Quality Insights Podcast Quality Insights Breaking Free from the Grind Breaking Free from the Grind Amelia Noël The Macro Trading Floor The Macro Trading Floor Alfonso Peccatiello & Brent Donnelly 1715 Treasure Coast Financial Wellness with Thomas Davies 1715 Treasure Coast Financial Wellness with Thomas Davies Davies Wealth Management The Jered Williams Show The Jered Williams Show Jered Williams The Breakthru Podcast The Breakthru Podcast J.Paul Fridenmaker Everyday AI Podcast – An AI and ChatGPT Podcast Everyday AI Podcast – An AI and ChatGPT Podcast Everyday AI WTR Small-Cap Spotlight WTR Small-Cap Spotlight Water Tower Research The Breakthru Podcast The Breakthru Podcast J.Paul Fridenmaker Onramp Bitcoin Media Onramp Bitcoin Media Onramp Bitcoin
Let's Talk Risk! Podcast

Business

Let's Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations

July 10, 2026 7:00am 17 min

You cannot bolt cybersecurity onto a medical device at the end of development.FDA’s cybersecurity guidance makes a clear shift: cyber risk is now a quality system issue, a patient safety issue, and a lifecycle management...

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

July 03, 2026 7:00am 47 min

Summary“The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.”In this special episode of the Let’s Talk Risk! c...

LTR 159: The Evolving Regulatory Landscape for AI in MedTech

June 26, 2026 7:00am 42 min

Summary“Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop”Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices,...

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

June 19, 2026 7:00am 41 min

You cannot reverse engineer your human factors regulatory strategy at the 11th hour.FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about u...

LTR 158: Three Questions To Keep Risk Connected to Decisions

June 12, 2026 7:00am 28 min

Summary“Tools do not remove uncertainty”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Vilma Nasteckiene, PhD, founder of Holistic Business Risk, about a broader and more human view of risk manage...

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

May 29, 2026 7:00am 27 min

Summary“Quality and risk people need to translate safety into business terms.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eric Sugalski about how MedTech professionals can communicate safety, r...

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

May 22, 2026 7:00am 27 min

Summary“AI can be a powerful helper, but it should not be the decision-maker.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with David Grilli about how MedTech teams can use AI responsibly in product ...

LTR 155: Leverage VIP to Move from Compliance to Capability

May 15, 2026 8:00am 26 min

Summary“Compliance alone does not drive quality”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Mike Cook about the the Voluntary Improvement Program (VIP), and how it can help MedTech leaders go b...

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

May 08, 2026 7:00am 38 min

Summary“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about wh...

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

May 01, 2026 7:00am 29 min

Summary“Just having a policy in place is one thing. Having a QMS that aligns to it is the next.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and o...

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

April 24, 2026 7:00am 36 min

Summary“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits do...

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

April 17, 2026 7:00am 26 min

Summary“Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.”What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep...

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

April 10, 2026 7:00am 20 min

Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.If you ar...

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

April 03, 2026 7:00am 29 min

Summary“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned me...

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

March 27, 2026 7:00am 28 min

Summary“The clinical study is actually where your risk analysis is going to meet reality.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory Affairs Specialist at In...

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

March 20, 2026 7:00am 29 min

Summary“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”Companion diagnostics (CDx) are inherently high-consequence because they can directly shape...

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

March 13, 2026 7:00am 26 min

Summary“Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.”In this Let’s Talk Risk! conversation, Richard Matt shares ...

LTR 146: Ganesh Sabat on Scaling MedTech Through Quality

March 06, 2026 7:00am 25 min

Summary“A company can become world class the day the quality team decides.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT)...

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

February 27, 2026 7:00am 28 min

Summary“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion pers...

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

February 20, 2026 7:00am 28 min

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...

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