Podcast Index

Podcasts

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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. Cork Today Cork Today C103 The Top Line The Top Line Fierce Life Sciences Imagen Empresarial Imagen Empresarial Imagen Empresarial The Dales Report | Trade to Black The Dales Report | Trade to Black Dales Media Group Marketing Talks Marketing Talks Catherine and Tom Afternoons with Helen Farmer Afternoons with Helen Farmer Dubai Eye 103.8 The Dentalpreneur Podcast w/ Dr. Mark Costes The Dentalpreneur Podcast w/ Dr. Mark Costes Dental Consulting Recruiting Future with Matt Alder - What's Next For Talent Acquisition, HR & Hiring? Recruiting Future with Matt Alder - What's Next For Talent Acquisition, HR & Hiring? Matt Alder This One Time in Real Estate... This One Time in Real Estate... Mark Gellman Productive Therapist Podcast Productive Therapist Podcast Uriah Guilford, MFT Next Biz Thing: Unveiling Tomorrow's Business Next Biz Thing: Unveiling Tomorrow's Business Markus J. Diplama Marketer of the Day with Robert Plank: Business Growth & Entrepreneur Stories Marketer of the Day with Robert Plank: Business Growth & Entrepreneur Stories Robert Plank PreMarket Prep PreMarket Prep Dennis Dick, Joel Elconin Inteligencia Artificial para Emprender Inteligencia Artificial para Emprender Borja Girón PZ Briefing – Die wichtigsten Nachrichten des Tages PZ Briefing – Die wichtigsten Nachrichten des Tages Pharmazeutische Zeitung Fence Guy Podcast Fence Guy Podcast Craig Eubanks Overcoming Distractions-Thriving with ADHD, ADD Overcoming Distractions-Thriving with ADHD, ADD David A Greenwood Billianon Billianon Billianon Pivot: SHIFT Ahead Mastermind Pivot: SHIFT Ahead Mastermind James Shaw Rich Young & Powerful Rich Young & Powerful Andrew McNair 鞠强教授:管理心理学 鞠强教授:管理心理学 管理心理学教授鞠强 Cenário Econômico com Leandro Resende Cenário Econômico com Leandro Resende Rádio CBN UBC News World UBC News World David Steward Beurs | BNR Beurs | BNR BNR Nieuwsradio The Happy Hustle Podcast The Happy Hustle Podcast Cary Jack NY Executive Podcast The Next Million Streams Could Be Yours NY Executive Podcast The Next Million Streams Could Be Yours NY Executive Podcast Network 伊藤洋一のRound Up World Now! 伊藤洋一のRound Up World Now! ラジオNIKKEI Wall Street mit Markus Koch - featured by Handelsblatt Wall Street mit Markus Koch - featured by Handelsblatt Markus Koch Computer America Computer America Ben Crossman Get Ready: Before Life Happens Podcast Get Ready: Before Life Happens Podcast Tony Steuer Artificial Intelligence Growth Architect | Connor with Honor | Real Estate Consultant Artificial Intelligence Growth Architect | Connor with Honor | Real Estate Consultant Connor T. MacIvor | Connor with Honor Leaders In Payments Leaders In Payments Greg Myers The Norris Group Real Estate Radio Show and Podcast The Norris Group Real Estate Radio Show and Podcast The Norris Group, Bruce Norris & Aaron Norris The Porn Reboot Podcast The Porn Reboot Podcast J.K Emezi The Reverse Selling Podcast with Brandon Mulrenin The Reverse Selling Podcast with Brandon Mulrenin Brandon Mulrenin FELIX PREHN DAILY MARKET NEWS By Goat Academy FELIX PREHN DAILY MARKET NEWS By Goat Academy Felix Prehn
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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