“Continuous lifecycle approach to risk management is still not broadly understood or applied in the industry”. In this Let’s Talk Risk! conversation, Kevin Posey highlights a gap in the industry practice of risk management, especially in the context of purchasing controls. Starting with the recent Boeing issue, where a cabin door in a 737 Max 9 blew open during flight, Kevin shares that there is often a disconnect between supplier risk management and product risk management in our own industry. Many of the safety critical functionalities of a medical device rely on adequate control of purchased product through supplier controls. Yet, Supplier Quality and Product Development functions tend to operate in silos. A siloed operating model leads to device malfunctions with serious consequences in the post-market phase, that have their origin in the quality of purchased products. One area of significant vulnerability is the use of off-the-shelf products, including software, where it is sometimes not feasible to identify and implement appropriate purchasing controls. There is a renewed focus on purchasing controls in the revised Quality Management System Regulation (QMSR), which is due to go into effect in early 2026. We have to start applying a risk-based approach to ensure compliance and manage risk to patients. Listen to this Let’s Talk Risk! conversation with Kevin Posey, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.00:02:05 Introduction00:03:26 Challenges in supplier quality controls in light of recent Boeing issue00:05:30 A renewed focus on supplier controls in QMSR00:06:48 Disconnect between supplier risk management and product risks00:09:50 An example highlighting challenges in supplier risk management00:13:49 Audience Q&A00:31:13 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.About Kevin PoseyKevin Posey is currently the Director of Regulatory Affairs and Quality Assurance at Genesys Spine. He began his career in the Aerospace and Defense industry as a systems engineer. Later he moved to the medical device industry, where he advanced his career over a span of 25+ years in leading roles at multiple organizations covering a broad range of medical specialties. He holds a BS degree in Aerospace Engineering and MBA in International Business with additional Masters level studies in Systems Engineering and Biomedical Engineering.About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

“Risk management is often seen as a check the box activity”. Taylor Dieringer reminds us in this Let’s Talk Risk! conversation that risk management should be an ongoing, continuous process within your quality management system, that monitors, evaluates and controls risk throughout the product lifecycle, and not just in the pre-market phase. The post-market surveillance process serves as a link between real-world safety performance of a medical device and design and development of new products to achieve this objective. Listen to this Let’s Talk Risk! conversation with Taylor Dieringer, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.00:02:30 Introduction00:04:03 What is post-market surveillance and why it is needed00:06:51 Post-market surveillance process is a continual learning process00:08:05 Setting thresholds for action during post-market surveillance00:11:00 How to detect and evaluate safety signals00:13:40 Why we need a cross-functional team for post-market surveillance00:16:37 Audience Q&A00:30:05 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.About Taylor DieringerTaylor Dieringer is currently a staff quality engineer at iRhythm Technologies, Inc. where he leads risk management activities throughout all phases of the product lifecycle, ranging from design to post-market surveillance. He is a biomedical engineer by training with prior experience in design and development, quality assurance and risk management at multiple medical device organizations. About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Dear colleagues, hello! 👋A special welcome to the 40 new members who have joined our Let’s Talk Risk! community in the first week of April! Feel free to browse past articles in the archive section of the Let’s Talk Risk! website, and check out recordings of recent LTR conversations in the podcast section. Here are links to articles published this week.AnnouncementsSpecial offer - save 20% on annual subscriptionEnjoying the free content on Let’s Talk Risk!? Upgrade your subscription with this special offer to enjoy even more benefits:1️⃣ Premium articles: Case studies of FDA warning letters, recalls, ISO 14971 fundamentals, medical device news updates.2️⃣ Monthly LTR webinar: Build deeper knowledge of risk management and get your specific questions answered.3️⃣ 20% off training: You get automatic 20% off on training and coaching offers via ACHIEVE. 4️⃣ Exclusive monthly podcast: Gain insights from industry leading voices5️⃣ Ability to start a discussion thread on LTR Chat!Check out our Wall of Love to see what others are saying!LTR weekly conversation on LinkedIn: A physician’s view on AI in healthcareJoin me next Friday, April 12, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Dr. Niranjan Seshadri, who will share his perspectives as an interventional cardiologist on AI in healthcare.Ask a risk management questionGot a risk management question? Now you can submit your question and get answers through a new feature on Let’s Talk Risk!. If I pick your question for an AMA article, you will get free access to premium content for 30 days! Weekly Knowledge ChallengeI hope you enjoyed the knowledge challenge question last week. Here is the correct answer:The correct answer for the question, “A hazard always leads to harm” is False. Here is this weeks’ knowledge challenge #281-Question Feedback SurveyWant to share feedback? Send a message to me!If you are finding value in LTR, please give us a shout out and show your love🙏 This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

“Diabetes is a terrible way to die.”This comment from David Sturgis in our Let’s Talk Risk! conversation really moved me. As engineers and QA/RA professionals, we mainly focus on building and launching safe and effective medical devices. We don’t always get to spend time with patients and doctors to understand their perspective. That is why it is insightful to hear from David about his experience with a continuous glucose monitor (CGM) and how it changed his life in a positive way. Diabetes is a difficult chronic condition. Nearly 40 million people in the United States alone are estimated to be living with diabetes. CGMs have made a big impact in not only managing the A1C for diabetic patients, but also improving their overall quality of life. When we listen to patients - really listen - we can understand not only their “needs” but also their fears, wants and desires. For example, we may be focused on the functionality of our devices, but patients also worry about whether they will be covered by insurance. Affordability and accessibility are major concerns, even though they may not appear in our list of “user needs” during the design and development process. “I am in it to win it”, David shares in this conversation. It is a good reminder to all of us to think of patients as people, and not as an anonymous consumer. Listen to this Let’s Talk Risk! conversation with David Sturgis which also includes an open discussion with the audience. About David SturgisDavid Sturgis is an IT and Operations management professional with more than 25 years of experience in project and lifecycle management. He is skilled building and optimizing organizational processes, measurement systems and infrastructure to maximize business results. He has an MBA from University of Florida, and a BS in Computer Engineering from University of South Florida. About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.If you enjoyed this episode, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Artificial intelligence (AI) is rapidly unlocking new applications in the medical arena. It is challenging to keep up with something moving so fast. ChatGPT was launched just a couple of years ago, and we are already talking about artificial general intelligence (AGI) for medical purposes! In this Let’s Talk Risk! conversation, Prof. Papademetris shares that indeed we are in a new game with plenty of opportunities. But we have to start learning in a new way. We will fail in non-obvious ways, and we will fail often. How do we harness the power of this technology without compromising patient safety or other ethical concerns?Case in point - AI is just one part of the overall system where a medical device needs to operate safely.  We need to design the overall software for its intended use by considering the system level requirements. It is the whole software that needs to serve its intended purpose when used within the broader healthcare system.“People drive cars, not an engine!”, Prof. Papademetris reminds us so eloquently in this conversation. Patient safety is an important factor for a medical device. So far, FDA has managed the risk by including a human in the decision making loop and not allowing a stand-alone, autonomous AI system for clinical decisions. An important question is how to share information with the user? There is a human factors component to AI, which needs to be carefully considered.In practice this proves to be quite challenging. Application of AI in medical software requires a true cross-functional approach. As Prof. Papademetris reminds us, we need to learn to speak each other’s language:The biggest challenge we face is not being good in our discipline, but how to become at least competent in other disciplines to facilitate a truly cross functional problem solving approach when building medical software. In the rapidly evolving world of AI, we need a new approach to medical software development. It used to be that data was secondary to code in traditional software development, but now code is becoming fairly standard, and the question is about data. How broadly does it represent the use cases you want to represent? Bias in the model is a serious concern. Listen to this Let’s Talk Risk! conversation with Prof. Papademetris which also includes an open discussion with the audience. About Prof. Xenophon PapademetrisXenophon Papademtris is currently a Professor at the Yale University School of Medicine where he focuses on research in image analysis and software development. He has recently launched a certificate course for industry professionals to provide a comprehensive understanding of both technical and regulatory aspects of medical software and medical AI. He is also the lead author of a new textbook Introduction to Medical Software: Foundations for Digital Health, Devices and Diagnostics (Cambridge University Press, 2022), and the main instructor for the companion Coursera Class. About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.If you enjoyed this episode, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Listen to my reading of a recent LinkedIn article I published to cover 10 noteworthy risk-related posts recently published on LinkedIn. Listen to the recording and follow links below to read the original posts and continue the conversation.🗞️A roundup of 10 noteworthy risk-related posts on LinkedIn! 1️⃣ Randy Horton spotlights top 10 Health Technology Hazards for 2024 compiled by ECRI.2️⃣ Marco Felsberger reminds us that planning is useful, but building capability is even more important to handle uncertainty in our complex world.3️⃣ Chad Johnson explains how using a QFD can help us focus on the customer when building an FMEA4️⃣ Mark F. Witcher, Ph.D. encourages us to take a systems-view of risk instead of an event-based view during risk analysis.5️⃣ Boris Gurevich shares a draft document from IMDRF on SaMD device considerations and risk characterization.6️⃣ Darrin Carlson, RAC-Devices, PMP highlights the omission of DHF, DMR and DHR from the QMSR and how to map them under ISO 13485.7️⃣ Jan Beger shares a study that focuses on factors affecting patients' trust in AI for treatment decisions.8️⃣ Joseph Kvedar shares a review article about risk prediction models using AI for diabetes care and unresolved issues for implementation.9️⃣ Stefan Hunziker, PhD, CICP highlights an unintended consequence of ignoring correlation among individual risks.🔟Annmarie Nicolson shows how HFE activities interact with multiple workstreams during design and development.Share in comments 👇your favorite risk-related post covered in this podcast. Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

One of the key requirements of ISO 13485, the International Standard for medical device Quality Management Systems is establish a link between risk management and the design and development process.In practice this proves to be quite challenging. In this Let’s Talk Risk! conversation, Chuck Ventura shares that medical device design and development process is a chaotic process. Design controls should be considered as a way to keep track and stay organized in the face of inherent chaos of the process. In the context of Design Controls, it is helpful to see risk analysis as an aspect of good engineering and not just a paper exercise. When risk analysis is integrated early in the design process, it helps inform design choices to optimize both safety and performance of the medical device. As an example, when you are trying to decide among various design choices represented by different prototypes, it may be helpful to conduct early usability studies to find out potential use-related issues and failures. Design choices that eliminate potential use-errors are more effective in reducing risk and delivering a final product that is both safe and effective. A best practice is to start with a systems-level risk analysis to develop a preliminary understanding of hazards and hazardous situations. As our understanding of risks evolves, more sophisticated techniques such as design FMEAs can be applied to different design concepts to fully analyze failure risks in the context of identified hazards and hazardous situations. Listen to this Let’s Talk Risk! conversation with Chuck Ventura which also includes an open discussion with the audience. About Chuck VenturaChuck Ventura is currently the Founder and CEO at Ventura Solutions, LLC, a consulting firm specializing in end-to-end consulting, staffing and training services for the medical device and combination products industry. He has nearly 20 years of experience in the Life Sciences industry across a variety of roles in product development, risk management, design controls, project management audits and inspection readiness. He is a biomechanical engineer with advanced graduate degrees in aerospace and mechanical engineering. About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.If you enjoyed this episode, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Listen to my reading of a recent LinkedIn article I published to cover 10 of my favorite LinkedIn posts on risk-related topics. Listen to the recording and follow links below to read the original posts and continue the conversation.🗞️A roundup of my favorite risk-related posts on LinkedIn! 1️⃣ Bryan Whitefield says the job of a risk practitioner is to uncover the elephant in the room! Read the original post here and continue the conversation. 2️⃣ Annmarie Nicolson explains why Human Factors Engineering is more than a tick-box exercise. Read the original post here and continue the conversation. 3️⃣ Chuck Ventura shares tips to accelerate Product Development with "Great Design Inputs". Read the original post here and continue the conversation. 4️⃣ Helen Gerhard invites conversation to understand underlying problems behind recent Philips CPAP issues, especially around design controls. Read the original post here and continue the conversation. 5️⃣ HATEM RABEH, MD, MSc ing RABEH, MD, MSc  shares insights to help estimate sample sizes for clinical studies. Read the original post here and continue the conversation. 6️⃣ Vincent F. Cafiso reminds us to follow requirements for rework in light of the recent Boeing 737 max issue. Read the original post here and continue the conversation. 7️⃣ George Zack highlights a common software testing trap in medical device design and development. Read the original post here and continue the conversation. 8️⃣ Korey Johnson discusses human factors issues in medical software with Xenophon Papademetris. Read the original post here and continue the conversation. 9️⃣ Wag Hanna reminds us that risk management is not about eliminating risk. Read the original post here and continue the conversation. 🔟On a lighter note, the modern approach to risk really began with a gambling problem! Read the original post here and continue the conversation. Share in comments 👇your favorite risk-related post covered in this podcast. Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

We have been used to treating the term hazard as a potential source of harm. We are also familiar with the concept of exposure to hazard in a hazardous situation as a necessary condition for harm to occur.The question, often left unanswered, is whether the duration of exposure has any effect on the type and severity of harm experienced by the user/patient.In this insightful conversation, James Catmur challenges us to consider the duration factor of a hazard as a factor when conducting risk assessments. Drawing on his years of experience across multiple industry sectors, James shares that considering a hazards as states or events can help us more accurately assess each risk in terms of their frequency and/or duration. As an example:In the chemical sector, if it is a state, then the dose is what you use use to assess the risk . If it is an event, then you consider the direct impact. An explosion is the over-pressure. If it is a chemical release then how long that release is for. If you release chlorine for 30 minutes the severity would be very different from releasing for 10 seconds. In the medical device industry, a common challenge is to consider the impact of delay in treatment. It depends on how long it lasts and what else happens during that state. There is also a difference between delay in treatment vs. denial of treatment, or service, for example as a result of a cyberattack. A clear understanding of the type and duration of delay can be helpful in a better understanding of the nature and severity of risk.Listen to this Let’s Talk Risk! conversation with James Catmur which also includes an open discussion with the audience. About James CatmurJames Catmur is currently the Director of JC&A Ltd., where he advises clients on risk projects in R&D implementation, safety management and risk assessments. Previously he was at Arthur D. Little in a variety of roles with increasing responsibility in a career spanning over 25 years. About Let’s Talk Risk! with Dr. Naveen AgarwalLet’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.If you enjoyed this episode, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Recently, I was invited by Richard Granquist and Linford Leitch from NAMSA to talk about risk management as part of their monthly RA QA Cafe podcast. In part 1 of a 2 part series, we discussed the following topics in a very open and engaging conversation!* How I got into risk management.* How I think about risk management in a small vs. large organization.* Why risk management is not a paper exercise, it is a process.* Why risk management approach should align with business goals.* A leadership opportunity for risk practitioners to shape culture.* How a systematic approach helps you do risk management well.* Risk management is a cross-functional activity; involve regulatory early. * Treat risk management not as an add-on but part of your quality system.* Documentation is important but we need to make it easy and less burdensome.Listen to the podcast above and share your views in comments below.About NAMSA and RA QA CafeNAMSA is a leading service provider to the global MedTech industry specializing in CRO (Clinical Research Organization) services, medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction. Learn more about NAMSA, their services and expertise here. The RA QA Cafe is a conversational podcast where each episode features NAMSA consultants and invited guests to discuss Quality and Regulatory Affairs related topics relevant to the MedTech industry. DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.If you enjoyed this episode, consider becoming a free or paid subscriber. This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe