Let's Talk Risk! Podcast

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 p...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “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 C...

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, a...

“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...

Summary “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 … This is a public episode. If you'd like to...

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 developin...

“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 na...

Summary “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… This is a public episode. If you'd like to...

“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. Man...

“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 manufa...

“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...

“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 adv...

“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 sta...

“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...

“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...

“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 ther...

“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 che...

“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 direc...

“You can get a lot of valuable insights from the FDA on what your regulatory pathway is when it comes to risk, and how that impacts not only the risk of the product but how you set up your quality systems and what you need to implement in the long run. ” In this Let’s Talk Risk! conversation , Amit Guruprasad shares how small medical device manufacturers and startups can take advantage of the free...

“The reality is that, today, a lot of people are studying medicine to go into industry. But if your curriculum do not include areas like risk management, cross-functional collaboration, dFMEA and all of that, then transition for that position is going to be slower.” In this Let’s Talk Risk! conversation , Dr. Juan Daccach shares his personal journey of transitioning into a medical safety role in M...

“Show me the indicators, show me the KPIs and I will show you the results.” Resiliency starts at the top. Misaligned incentives often lead to unintended and disastrous consequences. Recently, the Federal Aviation Administration (FAA) in the US grounded 171 Boeing 737-9 MAX planes following a mid-air incident where a cabin door blew open, exposing hundreds of passengers to a serious hazardous condi...

“As professionals in these areas, we are so versed in regulations that we get so deep into the woods with management that 30 seconds after you start speaking, they are gone! They can’t even think about it anymore.” Know your audience, prepare your topic and respect your listener. Victor Mencarelli shares these 3 tips for effective communication in this Let’s Talk Risk! conversation. Remember, effe...

“The first thing I do whenever I am starting design control or risk is that I make sure that the intended use and the indication of the device are as nailed down as they can be.” Yes, design control and risk management can be challenging, especially in a startup or a small medical device company. Generally, there is just one person, a “team of one”, responsible for setting up the entire quality sy...

“The regulatory landscape is changing significantly and it is too hard to keep up.” That is why Jennifer Mascioli-Tudor advises risk practitioners to be “super proactive” in following these rapid changes, understand the impact, and take a leading role in preparing their organizations. In this Let’s Talk Risk! conversation, we focus on three big trends in MedTech - the shift from Quality System (QS...

“Risk management is inherent to all our roles, whether you are in Regulatory, Quality or R&D, but it is not something we spend a lot of time on”. Risk management in the medical device industry is often seen as a check-the-box activity for regulatory compliance. In this Let’s Talk Risk! conversation, Carolyn Blandford encourages us to not be satisfied with this status quo and help create a dedicate...