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PODCAST

Let"s Talk Risk! with Dr. Naveen Agarwal

Casual and informal conversations about practical aspects of medical device risk management.

Every Friday, Dr. Naveen Agarwal leads a Let"s Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a

technology how to

All Episodes

16:05

FDA CSA Debate: Streamlined Assurance or Audit...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/10/06

In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer Software Assurance (CSA), issued September 2025.The debate highlights two perspectives:* Quality professional’s view: CSA cuts unnecessary documentation, aligns validation with patient safety risk, and supports agile manufacturing.* Auditor’s view: CSA’s reliance on qualitative judgment, binary risk classification, and vendor dependence creates new challenges for audits, SOPs, and Part 11 compliance.Key

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26:48

LTR 126: Adam Foresman on Proactive Compliance and...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/10/03

Summary“Compliance can’t just be a once-per-year audit anymore. It has to be continuous, proactive, and built into the way we work every day.”In this Let’s Talk Risk! conversation, Naveen Agarwal speaks with Adam Foresman, Co-Founder and CEO of Ryden Solutions, about building the first platform for continuous compliance gap analysis in the life sciences industry. Adam shares his journey from leading quality and regulatory affairs at a diagnostic AI startup, where he managed hundreds of requirements

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27:30

LTR 125: Kevin Schawinski on Building Trustworthy AI...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/09/26

Summary“EU MDR is the spiritual ancestor of the EU AI Act”.In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying black holes to building AI governance solutions, and explains how the EU AI Act is modeled after the EU Medical Device Regulation (MDR). He highlights the parallels between product safety regimes in MedTech and emerging AI regulation, offering practical

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16:22

Case Study: Comparing EU and FDA Cybersecurity...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/09/22

In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especially in areas like authentication, secure coding, network security, and resilience.Key points in this audio brief:* The biggest risks of connected medical devices and why cybersecurity is now inseparable from patient safety.* Where the EU and FDA

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28:12

LTR 124: Omar Al Kalaa on Wireless Coexistence and...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/09/19

Summary“Wireless coexistence is not a checkbox. It’s a risk management approach”.In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless scientist, to explore the challenges and opportunities of integrating wireless technology into medical devices. Omar shares his journey from academic research on wireless coexistence to leading FDA initiatives on 5G-enabled medical devices, offering a unique perspective at the

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25:48

LTR 123: Richard Matt on Effective Risk Communication

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/09/12

Summary“Management listens when you connect patient risk to product requirements and business goals.”.In this Let’s Talk Risk! conversation, host Naveen Agarwal and Richard Matt delve into the complexities of communicating risk to senior executives. They explore the common challenges faced by risk practitioners in effectively conveying risks and the importance of framing these discussions in terms of both risks and benefits. Richard shares his experiences and insights on building trust, engaging

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16:10

Case Study: What AI/ML Device Recalls Reveal About...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/09/08

In this audio brief, we unpack recalls data on AI/ML enabled medical devices to gain insights on emerging vulnerabilities from a risk management point of view. Here are a few key highlights* The Landscape: 12,247 FDA cleared AI/ML devices across 155 product codes; 38 recall events identified for a deep dive.* Recall Severity: Mostly Class II recalls, no Class I recalls.* Leading Causes: * Software and algorithm errors (e.g., incorrect dose calculations).* Data integrity issues (e.g., misfiled or

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32:48

LTR 122: Tibor Zechmeister on PSUR Best Practices

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/09/05

Summary“The PSUR should be a snapshot showing if your medical device is really safe, not just a 200-page report for auditors”.In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Tibor Zechmeister, Head of Quality and Regulatory at Flinn.ai, to unpack the complexities of the Periodic Safety Update Report (PSUR) under EU MDR. They discuss key takeaways from the RAPS Euroconvergence Conference, the real-world challenges of estimating device usage, and why PSUR must be treated as a

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1:09

LTR 121: Michelle Lott on Risk, CAPA and FDA...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/29

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System Regulation (QMSR) for medical devices, emphasizi…

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12:58

Case Study: Contrasting U.S. and EU Approaches to AI...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/25

In this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framework.Here are a few key highlights* U.S. AI Action Plan (July 2025): Prioritizes speed, innovation, and global leadership; promotes a “try first” culture; frames AI as a national security imperative.* FDA Guidance: Good Machine Learning Practices, predetermined change control plans,

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27:56

LTR 120: Atty Chakraborty on India's Rising MedTech...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/22

Summary“The opportunities in India’s MedTech sector are tremendous. Start networking, join incubators and get involved!”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Attrayee (Atty) Chakraborty, a quality systems engineer specializing in regulatory affairs. They discuss the rapidly evolving medical device landscape in India, the importance of networking for young professionals, and the comparison of Indian medical regulations with global standards. Atty shares insights on

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0:54

LTR 119: AI, Risk and Regulatory Strategy with Dr....

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/15

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“In this world that is changing really fast, your greatest superpower is your ability to learn new things.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and guest Dr. Jay Vaishnav discuss the dynamic regulatory landscape in the MedTech industry, particularly focusing on AI-powered medical devices. They explore the concept o…

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15:57

Case Study: When Clues to a Future Recall Hide in...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/11

In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on life support.But the story doesn't stop there.We take you inside the analytical process, examining over 2,000 adverse event reports from the FDA’s MAUDE database, and revealing early warning signals going back five years. Through deep narrative review, we uncover overlooked patterns

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25:53

LTR 118: Off-Label Use with Kristen Petersen

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/08

Summary“When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.”In this Let’s Talk Risk! conversation, host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples, and regulatory considerations surrounding off-label use, as well as the importance of documentation and

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29:53

LTR 117: Queenita Fernandes on Smart Use of AI for...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/01

Summary“You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.”In this Let’s Talk Risk! conversation, Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing clinical literature reviews and signal detection in adverse events. The discussion also highlights the need

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16:31

A Quick Primer on FDA's Final Guidance for...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/28

FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025:With the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information and other information, the need for robust cybersecurity controls to ensure medical device safety and

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26:38

LTR 116: Priyanka Murawala on ISO 10993 Update,...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/25

Summary“A major change proposed in the draft of ISO 10993-1 revision is the focus on foreseeable misuse and effect of cumulative device use for biological safety. ”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Priyanka Murawala, an expert in biological evaluation of medical devices. They discuss the latest updates on ISO 10993-1, the differences in regulatory approaches between the EU and the US, challenges faced in biological evaluation, significant recalls related to

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1:19

LTR 115: Startup Lessons from EU MedTech Shark Tank

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/18

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opportunities in bringing innovative medical devices…

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31:12

LTR 114: What QA/RA Professionals Need to Know About...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/11

Summary“MedTech in India is poised to generate $50 billion in revenues by 2030.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges

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14:04

Case Study: When Underestimating Risk Leads to a...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/07

The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments, Severity Rating has been incorrectly selected for many assays’ false result failure modes. Additionally, FDA found issues with procedures for CAPA,

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