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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

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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38:09

LTR 67: 3 pillars for defining your IVD risk...

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

2024/09/20

“There are 3 pillars I consider essential to defining a strategy for IVD risk management. What is the system definition, who are the user groups, and what is the level of novelty?”In this Let’s Talk Risk! conversation, Claudia Campbell-Matland highlights the broad range of in-vitro diagnostic devices (IVD), which requires a strategic approach to their development and risk management. Claudia advises IVD manufacturers to consider their risk management strategy and scope under 3 pillars - the system

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33:59

LTR 66: Understanding human factors aspect of...

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

2024/09/13

“To be able to see a virtual image over the real world - that augmented reality is - is a mind blowing, very different experience.”In this Let’s Talk Risk! conversation, Phil Deming shares some of the unique human factors engineering challenges for an augmented reality (AR) technology for 3D visualization of human anatomy in real time during a medical procedure. Phil advises manufacturers to stay current with rapidly evolving new technologies, and talk to users in their intended environment to

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35:15

LTR 65: Demystifying risk-based approach vs. risk...

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

2024/09/06

“It’s too often confused with risk management itself. Part of the risk-based approach is just the mindset, the thinking about risk, and then deciding ‘so what should we do?’, the answer to which might be a formal risk management.”In this Let’s Talk Risk! conversation, Steve Gompertz clarifies a subtle difference between a risk-based approach and formal risk management according to standards such as ISO 14971. Risk-based approach is more about a mindset and a set of behaviors that lead to risk-based

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1:24

LTR 64: Opportunities and challenges to leverage PCCP...

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

2024/08/30

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“PCCP is a great tool for your regulatory strategy but it is not for every company or for every change”. PCCP (Predetermined Change Control Plan) is a new regulatory scheme that allows device manufacturers to implement post-market changes without requiring pre-market submission to the FDA. In this episode, Yu Zhao explains how the PCCP tool offer…

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35:51

LTR 63: A lawyer's perspective on the QMSR transition

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

2024/08/23

“Don’t be comfortable saying, ‘Oh I follow the ISO (13485) to the letter’; it doesn’t matter. You have to comply with 21 CFR 820.”In this Let’s Talk Risk! conversation, Neil Di Spirito, helps us understand the full legal context behind the Quality Management System Regulation (QMSR), the amended version of 21 CFR 820 that will go into effect in February 2026. Although, the QMSR incorporates the International Standard ISO 13485:2016 by way of reference, there are points of differences and additional

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30:49

LTR 62: Overcoming barriers to cross-functional...

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

2024/08/16

“There is a growing awareness that if you bring in Regulatory at the beginning of designing a product, you will end up with a more robust product. In this Let’s Talk Risk! conversation, Christine Zomorodian highlights some of the barriers that have traditionally hindered good communication and collaboration between QA/RA and Engineering functions in MedTech. However, she also points out that there is reason to be optimistic about the future.Gender roles are changing, with more women entering

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39:23

LTR 61: Treat human factors as a driver of customer...

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

2024/08/09

“There is a tendency for human factors to be very closely tied to regulatory requirements and nothing else, but human factors as a core discipline is about user-centered design.”In this Let’s Talk Risk! conversation, Korey Johnson highlights how the current practice of human factors engineering in the medical device industry is mainly driven by regulatory requirements, which often leads to a check-the-box approach and nothing more.But human factors is more about applying a user-centered design

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31:07

LTR 60: Defining state of the art can be challenging;...

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

2024/08/02

“There is a very strong push (in the EU) to look at threshold values and acceptance criteria in the clinical evaluation, and these acceptance criteria for benefit risk have to be based on the state of the art.”State of the art (SoTA) is a very important topic in the medical device industry, because it is directly connected to risk acceptability and benefit-risk evaluation, which in turn, is directly tied to safety and effectiveness for regulatory purposes. But what is SoTA and how do you define it

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