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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

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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30:38

LTR 78: New challenges in managing risks of software...

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

2024/12/13

“Software more than any other type of device, has integrations with other systems and devices. You have to consider a complex network of dependencies and infrastructure when analyzing risks.”In this Let’s Talk Risk! conversation, Megan Kane highlights the growing role of software, including artificial intelligence, in in-vitro diagnostic devices, including in next generation sequencing applications. We are now living at at time where technology is rapidly enabling precision medicine solutions for an

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22:09

PCCP: Opportunity for risk practitioners to shine

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

2024/12/11

Risk practitioners in MedTech now have a unique opportunity to help accelerate development and post-market improvement of AI/ML enabled medical devices while also reducing the regulatory burden.PCCP, or Pre-Determined Change Control Plan, is a novel regulatory approach that allows device manufacturers to include planned changes in their initial submission and avoid additional submissions in the post-market phase when these changes are implemented.This is even more important for AI/ML enabled medical

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0:58

LTR 77: How GenAI is transforming Quality in MedTech

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

2024/12/06

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“You are not gong to lose your job to AI, but you may lose your job to someone who knows how to use AI better than you do”. In this episode of the Let's Talk Risk Podcast, we explore the benefits of applying Generative AI to improve consistency of quality system documentation in MedTech with Garth Conrad, VP of Quality at Flex Health Solutions. G…

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18:33

EU vs. FDA: Aligned but different in their approach...

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

2024/12/04

Applications of AI in medical devices are growing rapidly. The regulatory environment in both the US and the EU is also changing fast. In this dynamic environment, it is important to stay updated and practice a flexible approach to both risk management and your regulatory strategy. Listen to a brief audio summary above, about the emerging regulatory environment in these two major jurisdictions, and key takeaways for risk practitioners and regulatory professionals.Regulatory environment is changing

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36:46

LTR 76: Challenges and opportunities of AI/ML in MedTech

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

2024/11/29

“The classic thing with AI is that the hard stuff is easy and the easy stuff is hard. It can do math I cannot do, but it cannot do the reasoning I find easy.”In this Let’s Talk Risk! conversation, we discuss key challenges and opportunities for applying Artificial Intelligence/Machine Learning (AI/ML) in MedTech. This was an open conversation with a live audience as part of the weekly Let’s Talk Risk! conversation on LinkedIn.AI/ML applications in MedTech are growing rapidly. FDA has authorized

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33:10

LTR 74: AR/VR devices in MedTech

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

2024/11/15

In this Let’s Talk Risk! conversation, Ritam Priya advises device manufacturers to engage early with the FDA through the Q-sub program. Applications of AR/VR in MedTech are growing rapidly, but the regulatory science is still evolving. There are many specific safety and performance concerns unique to AR/VR technologies used for medical purposes. Early engagement with the FDA can help in developing adequate plans for verification and validation of these devices. Image quality, cyber-sickness, rapidly

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1:12

LTR 73: It's time to up our game on medical device...

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

2024/11/08

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Medical devices are now increasingly connected in a hospital network. Or even if they are not, they are vulnerable to cyber attacks”. In this episode of the Let's Talk Risk Podcast, Eric Henry highlights the growing concern about security and cybersecurity of medical devices. As technology evolves and medical devices increasingly operate in an i…

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33:37

LTR 72: A clinician's insights on risk and...

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

2024/11/01

“It comes down to collaboration. It comes down to intentional communication and ensuring there is trust and familiarity on both sides.”In this Let’s Talk Risk! conversation, Dr. Olaf Hedrich emphasizes the need for collaboration, building trust and familiarity between clinicians and engineers. We all have a mutual desire to do the right things for our patients, but sometimes our lens is a bit narrow. It is important to understand some of the technical side of our individual functions so we can learn

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31:20

LTR 71: Medical device cybersecurity now more...

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

2024/10/18

“It is not just about protecting your data. It is also about protecting safety of a medical device.”In this Let’s Talk Risk! conversation, Nidhi Gani highlights the important difference between data security and cybersecurity, especially for a life-saving medical device such as a pacemaker. As medical devices become more inter-connected, they are also increasingly vulnerable to cyberattacks. Managing the risk of these vulnerabilities is a key party of cybersecurity risk management of medical devices

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1:06

LTR 70: Best practices for applying usability...

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

2024/10/11

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Apply the usability engineering process diligently, and with the spirit of inquiry. You will learn things that you never thought. And these are the things that make your device possible”. Human factors engineering, or usability engineering, is often thought of as a check-the-box activity for the purpose of regulatory compliance. But it is a lot …

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35:29

LTR 69: A quick update on the 4th edition of IEC 60601

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

2024/10/04

“Technology has changed, we need to move with the technology change.”In this Let’s Talk Risk! conversation, Leo Eisner shares a brief history of IEC 60601, the comprehensive global safety standard for active medical devices, and the work currently ongoing on the 4th edition. He is leading the group currently working on the user-interface aspects, which includes information provided by the manufacturer, usability, alarm system and also user interfaces aspects. There are a total of 12 working groups

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33:08

LTR 68: Tips for making customer-focused decisions

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

2024/09/27

“Before making a decision, we have to look at the issues end-to-end. We have to consider how our actions will impact the customer.”In this Let’s Talk Risk! conversation, Rajesh Kathuria emphasizes the need to consider the full impact of our actions on safety of customers and users and quality of performance. As an example, when working at the component level, we should consider the impact of any changes at the system level and how it could affect the safety of end user or the patient. Rajesh advises

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147 results

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