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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

26:20

LTR 98: Critical role of medical safety officer in...

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

2025/03/21

Summary“Our true end goal is to be proactive in safety versus reactive. Bring in your medical safety early and often.”How do we figure out why our medical device(s) are failing to perform as intended in the real-world clinical environment? This is where Medical Safety Officers can help us truly understand the root cause(s) during a CAPA investigation. In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Bettina Brant, Senior Director of Medical Safety at Medtronic, to discuss the

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1:24

LTR 97: Surviving chaos and uncertainty at the FDA

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

2025/03/19

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“More importantly than ever, a good product development and risk-based approach is going to be critical.” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Michael Nilo discuss the current state of the FDA amidst significant staff cuts and organizational chaos. They explore the implications for regulatory affairs professionals, t…

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32:06

LTR 96: A patient-centric approach to medical device R&D

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

2025/03/14

Summary“Is it good enough for myself as well as my family and the community at large?”How do we keep the patient front and center when making design decisions for a medical device? How can we balance functionality with safety without over-engineering a device that becomes difficult to use and cost-prohibitive? In this Let’s Talk Risk! conversation, Naveen Agarwal explores these questions with Peter Braido, VP of R&D at MediView XR, about his extensive experience in the medical device industry. They

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31:09

LTR 95: The case for software risk management in...

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

2025/03/07

Summary“If there is a risk in your design for a device used in a hospital setting, you have qualified people there. But at home, there is no more safety net. So (AI) software risk becomes even more important.”In this Let’s Talk Risk! conversation, Erhan Ilhan shares how software is increasingly being used as a medical device in our industry. As a result, we have to pay more attention to software risk management. Software failure will occur, but we need to understand the sequence of events leading to

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0:59

LTR 94: The road ahead for PCCPs and AI/ML amidst...

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

2025/03/05

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Yu Zhao discuss the P…

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32:56

LTR 93: AI use cases in MedTech regulatory applications

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

2025/02/28

Summary“To AI or not to AI is no longer a question.”In this Let’s Talk Risk! conversation, Naveen Agarwal and Michelle Wu discuss the transformative role of AI in the regulatory space, particularly in healthcare and life sciences. They explore key trends observed at the JP Morgan Healthcare Conference, share real-world use cases of AI applications, and address concerns about trust, job security, and privacy in the context of AI adoption. Michelle emphasizes that AI is an enabler rather than a

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1:31

LTR 92: Understanding the notified body perspective...

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

2025/02/26

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.” Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically…

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30:50

LTR 91: International conference on medical device...

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

2025/02/21

Summary“People who were passionate about this subject (safety risk management) and were enthusiastic about it, we got together and said ‘let’s just create a conference for MedTech’, and we did.”In this Let’s Talk Risk! conversation, Naveen Agarwal interviews Bijan Elahi, a leading authority in safety risk management of medical devices. They discuss the upcoming International Safety Risk Management Conference in Amsterdam, focusing on its significance, key speakers, and topics such as AI,

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34:16

LTR 90: Lead with empathy to grow your Quality career

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

2025/02/14

Summary“As a Quality leader, you need to be empathetic to other departments that are impacted by whatever change(s) you are making.”In this Let’s Talk Risk! conversation, Naveen Agarwal and Amit Tyagi explore the intersection of quality management and career growth. Amit shares insights from his extensive experience in quality engineering, emphasizing the importance of innovative thinking, risk management, and effective CAPA processes. They discuss the challenges of navigating change in quality

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1:52

LTR 89: Navigating uncertain times at the FDA

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

2025/02/12

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“For the foreseeable future, core FDA practices such a reviewing submissions and post-market oversight are going to continue. Smart Money says FDA in 6 months or an year from now, as to these core responsibilities, is operating similarly to FDA of mid-2024.” Yes, there is a lot of uncertainty due to the current political environment in the USA, a…

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34:27

LTR 88: Decoding Privacy Laws in Clinical Research

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

2025/02/07

Summary“The root cause of most privacy missteps is a lack of education, training and understanding of what the privacy rule actually is.”In this Let’s Talk Risk! conversation, Naveen Agarwal and Edye Edens delve into the critical intersection of privacy laws and clinical trials. They explore the significance of privacy regulations like HIPAA and GDPR, the implications of proposed changes to HIPAA, and the role of AI in enhancing compliance and efficiency in clinical research. Edye shares real-world

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1:06

LTR 87: A Strategic Approach to Regulatory Success...

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

2025/02/05

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“You can definitely use (GenAI) as your core algorithm, but you need to enforce that it can only do one specific thing or at least a very clarified labeling. ” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal engages with Dr. Yujan Shrestha to explore the rapid advancements of AI and ML in the medical device industry. They dis…

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1:02

LTR 86: Managing Post-Market Design Changes

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

2025/01/31

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Mismatched design controls can feel like driving through two feet of mud. You will eventually get to your destination, but it will take a lot more time and effort than it really should. ” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Aaron Joseph discuss the ongoing challenges of design controls in medical devices, particula…

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31:31

LTR 85: The problem with CAPA problem statements

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

2025/01/24

“If you frame something in a certain way, you can influence the perception of its cause and the solution. ”In this Let’s Talk Risk! conversation, Jack Garvey cautions against starting a CAPA with a problem statement first. Rather, he recommends the analysis to initially begin from a factual review of both technical and situational context leading up to a CAPA, and then defining a specific problem statement appropriately to guide the subsequent investigation of root cause(s) and identification of

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34:30

LTR 84: Think of human factors for AI as levels of...

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

2025/01/17

“Many of the AI/ML devices are going through De Novo and (in these) human factors considerations are specifically being called out as special controls.”In this Let’s Talk Risk! conversation, Shannon Hoste highlights some of the new concerns emerging for human factor considerations for AI/ML devices in MedTech. She explains how we could consider the level of automation as we think about new hazards related to the user interface. For example, in a clinical decision support system, having appropriate

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1:07

LTR 83: Road to market for AI devices in the EU just...

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

2025/01/15

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Manufacturers that want to go to the European market, thinking about AI devices, it’s really important that you don’t look only at the MDR. You really have to look at the AI Act as well.” In this episode of the Let's Talk Risk Podcast, Florian Tolkmitt discusses the rapidly evolving regulatory landscape for medical devices in Europe, particularl…

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0:39

LTR 82: Tips for Regulatory Success with AI Devices...

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

2025/01/10

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Clinicians need to to trust the (AI) algorithm, and knowing how it works helps them understand where it might fail, or where extra attention might be needed.” In this episode of the Let's Talk Risk Podcast, Dr. Jay Vaishnav discusses the rapid growth of artificial intelligence (AI) in the medical technology (MedTech) field, particularly in Radio…

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29:49

LTR 81: 4 key themes in risk management and an...

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

2025/01/03

Summary“We are all at some point, either patients or loved ones of patients. So, one way or another, we are all touched by the medical technology we create ourselves. In this episode of the Let's Talk Risk Podcast, Bijan Elahi helps us appreciate the most important aspect of our work as risk practitioners, engineers and quality/regulatory affairs professionals in the medical device industry. That our work makes a direct impact on health and wellness of our loved ones and patients across the world

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34:02

LTR 80: Building safety by design into medical devices

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

2024/12/27

“There is a clear case to put the money into the design of the product, and control that, than relying on the human factor.”In this Let’s Talk Risk! conversation, Alex Saegert highlights the importance of focusing on risk reduction through safety by design, rather than relying on information for safety to users. He recommends risk practitioners to apply best practices from systems safety to build a clear understanding of system-level hazards that lead to harm in a hazardous situation through a

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31:32

LTR 79: Tips for SaMD development and success with FDA

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

2024/12/20

“Overconfidence in the performance of AI models in the development phase is a common problem.”In this Let’s Talk Risk! conversation, David Giese highlights the growing need for a rigorous, disciplined development process with the goal of meeting regulatory requirements for marketing authorization. He shares how AI developers are often over-confident in the performance of their models, but disappointed when these models are subjected to rigorous scrutiny during the regulatory review. Software as a

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159 results

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