Let's Talk Risk! with Dr. Naveen Agarwal

“The teams I see really successful are the ones that realize where their gaps lie and stive to reach out to mentors and advisors to fill those gaps”.Developing a medical device and bringing it successfully to the market is a huge challenge, especially for early stage startups. Even for large, established manufacturers, it takes a significant amount of time to launch a new device. In this Let’s Talk Risk! conversation, Devon Campbell encourages us to honestly acknowledge gaps in available resources, knowledge and skills, and seek to fill those gaps by collaborating with both internal and external resources.It takes a lot of humility to admit that we can’t do it alone. It is true that early stage start up companies face a lot of challenges, but working in a fast-paced environment can be a lot of fun. It does requires a strategic approach to build out the required quality processes just in time to support the overall business strategy. Whether you want to go to market with your own product, or plan an exit through acquisition, it helps to keep the end in mind.Listen to this Let’s Talk Risk! conversation with Devon Campbell, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.00:01:50 Introduction00:04:23 How it feels to be in a startup environment00:06:25 Success factors for startups00:09:46 A short story of a successful startup exit00:14:00 Audience Q&A, general discussion 00:32:30 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.About Devon CampbellDevon C. Campbell is the Founder and Managing Director at Prodct, where he and his team provides hands-on support and advisory services to early stage medical device, diagnostic, and therapeutic companies. He serves as a mentor, advisor, or board member for several startups. Additionally, he is the Chief Product Officer (CPO) and Senior Vice President of R&D/Quality at myBiometry, an early stage diagnostic company focused on asthma. He also supports the NIH RADx program as a content expert and was the lead author for Chapter 6 of the recent NIH book “Accelerating Diagnostics in a Time of Crisis” exploring quality, risk, and product developing during RADx. He has been active in the medical device industry for more than 25 years in various engineering and leadership roles. He holds BS and MS degrees in 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. 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 Horst Simon advises risk practitioners to serve as advisors and facilitators instead of playing a traffic cop.2️⃣ Jijo James shares a new tool that significantly reduces device-related interruptions when used with the WHO's surgical safety checklist.3️⃣ Aaron Joseph recommends adopting a more flexible "re-entrant design controls" approach to manage frequent design changes and upgrades.4️⃣ Stefan Hunziker, PhD, CICP offers 6 tips for boosting your risk management expertise where leaning from failures is not an option.5️⃣ Wag Hanna shares how augmented intelligence tools can help support risk management while also enabling a culture of transparency.6️⃣ Vincent F. Cafiso seeks to clarify FDA's position on requirements for clinical studies in QMSR.7️⃣ George Zack invites a conversation to identify risks in real world activities such clearing snow from sidewalks and roads.8️⃣ Chuck Ventura offers tips for considering design controls at the drug/device interface in a combination product.9️⃣ Daniel Adler spotlights a new FDA draft guidance on cybersecurity to cover any device if it includes software and internet connectivity.🔟Marco Felsberger reminds us that we can't always reliably model extreme events and managing risk exposure might be more effective.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

“The eyes can only see what the mind understands.”The world of medical devices is complex. There are many regulations, standards and guidance documents to read and understand, and apply them correctly during design, development and clinical investigations for regulatory success. In this Let’s Talk Risk! conversation, Dr. Emanuel Tkach encourages us to keep the big picture in mind. Engineers and Clinicians, who are not generally trained in regulatory affairs, also need to develop a good understanding of these requirements. As an example, we must clearly understand the intended use and indication for our device. It is in the context of the intended use that we have to plan and conduct our clinical investigations to generate evidence of safety and effectiveness. AI-enabled devices, including those used for detection and diagnosis, presents unique issues. Data privacy and security, including cybersecurity vulnerabilities need to be addressed. Risk of using open source data should carefully considered during development, testing and final use. Unless absolutely necessary, it is best not to use open source data. Another potential area of concern is physician over-reliance on AI/ML devices. Dr. Tkach reminds us to keep the following in mind:At the end of the day, an AI-enabled device is a tool to be used by the clinician and not as a substitute for clinical judgment. Listen to this Let’s Talk Risk! conversation with Dr. Emanuel Tkach, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.00:02:05 Introduction00:04:13 CADe and CADx: two types of computer aided detection and diagnosis00:05:23 Addressing physician over-reliance on technology in clinical trials00:07:14 Relevant ISO standards for AI, clinical investigations and quality00:10:14 Clinical perspective on designing AI-enabled devices and managing risk00:15:38 How non-regulatory professionals should approach regulations and standards00:17:20 Audience Q&A00:32:30 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.About Emanuel Tkach, MDDr. Emanuel Tkach is currently the Medical Advisor at HeartPoint Global, where he leads the global clinical strategy and operations of clinical trials. He also provides advice on breakthrough device designation submissions, recruiting and strategizing with key opinion leaders (KOL) to accelerate medical device innovation. His medical specialty and clinical experience includes Gastroenterology, Cardiology and Primary Care. He holds a BS degree in Biology/Biological Sciences and an MD in Medicine. 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

“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

A common challenge for risk practitioners in the medical device industry is to efficiently link their risk management process with the design controls process.The output of risk management activities needs to be linked to the design process before design inputs are finalized. However, this proves to be quite challenging in practice. One reason is that a lot of work in the industry is often done in functional silos In this Let’s Talk Risk! conversation, Daniel highlights the importance of building trust between different functions, especially Quality and R&D organizations. Leaders in these organizations need to create and nurture a collaborative work environment where engineers can feel safe and empowered to work together for the common goal of developing innovative, safe and effective products. One specific example where cross-functional collaboration is especially useful is when we are try to establish reliability levels required for different functional requirements for a device under considerations. It requires a lot of trade-offs, which should be driven by a careful analysis of stakeholder expectations, regulatory requirements and the state of art. It is also useful to engage with medical/clinical colleagues to collect early clinical input to support these decisions. Listen to this Let’s Talk Risk! conversation with Daniel Roberts which also includes an open discussion with the audience. About Daniel RobertsDaniel Roberts is currently the Founder and Principal at Medical Device How, a MedTech consulting firm focused on personalized medical device strategies in the areas of Design Controls, Digitalization, Smart QMS, QMS training, Cybersecurity and Career Coaching. He has worked at several leading medical device manufacturers over the last 20 years in a variety of roles ranging from Quality and Compliance to R&D. He is also a certified ISO 13485 Internal Auditor. 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

Who is responsible for patient safety in a medical device manufacturing organization?When asked this question, a common response is likely to be that it is a shared responsibility across the entire organization. After all, everyone should be thinking about patient safety in their specific role and perform their duties such that patient safety is not compromised. It is true that no single individual or department can be held completely responsible for safety. But when everyone is responsible, no one is really responsible! In this Let’s Talk Risk! conversation, Mark Armstrong explains how medical safety professionals can serve as culture brokers by translating the language of different functions to help create a central awareness of patient safety. Each function within a large, complex organization, is understandably focused on their specific goals and objectives. R&D is responsible for developing new products and improving the existing ones with design changes. Clinical affairs is responsible for planning and generating clinical evidence to support regulatory submissions. Manufacturing is responsible for consistently producing high quality product at low cost. Medical affairs is responsible for building external relationships with key opinion leaders.There is a need to bridge the gap among these functional areas which often operate in silos. This is where Medical Safety professionals have a key role to play as a culture brokers to create and nurture a common culture of patient safety. Listen to this Let’s Talk Risk! conversation with Mark Armstrong which also includes an open discussion with the audience. About Mark ArmstrongMark Armstrong is currently the Director of Medical and Pharmacovigilance Safety and Beckton Dickinson. Combining his advanced education in both Medicine and Biomedical Engineering, he has served in clinical and medical safety roles for over 10 years at various leading MedTech organizations. In his current role, he serves as the primary Safety Physician support for Pharmacovigilance and provides internal medical/clinical consultation during design and development as well as during post-market surveillance activities. 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

When it comes to medical devices, we generally think about only clinical benefits as we plan our clinical investigations to generate scientific evidence for demonstrating safety and effectiveness. However, medical devices also provide many other quality-of life-benefits that are often overlooked during benefit-risk evaluation. One reason is that these benefits are often subjectively experienced by patients, and not usually quantified during clinical investigations. In this LTR conversation, Ronald challenges us to consider quality-of-life benefits in a quantifiable way during clinical investigations. He shares an example of a minimally invasive orthopedic device to support the meniscus without the need for a total knee replacement. In this case the risk of frequent revision surgery is offset by the significant quality-of-life benefits. That is why it is important to also consider quality-of-life benefits in the overall benefit-risk evaluation. A good practice is to develop a method to quantify quality-of -life benefits important to patients, and generate data to demonstrate measurably significant difference in these benefits using the device. Ronald also shares some of the emerging expectations of notified bodies for the newly created role of a PRRC. Personal risk and liability for a PRRC is limited, but you must demonstrate training and competence. However, negligence and intentional mistakes on part of PRRC can result in legal liability. A best practice is to assign a dedicated role as PRRC and not serve in a dual capacity as department head and PRRC at the same time. Listen to this Let’s Talk Risk! conversation with Ronald Boumans which also includes an open discussion with the audience. About Ronald BaumansRonald Baumans is currently the founder and strategic consultant at Boumans Regulatory Consulting B.V, providing consulting and PRRC services to medical device companies across Europe. Previously he served as Senior Global Regulatory Consultant and Program Manager for European Regulatory Affairs at Emergo by UL. His professional experience spans over 30 years across multiple industry-leading organizations. He is also the founder of PRRC Academy, where he provides training about this emerging role in the medtech industry. 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

Dear colleagues, hello! 👋A special welcome to 75+ new members who have joined our Let’s Talk Risk! community this month! 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. Check out these recent articles published last week on LTR➡️The upcoming Quality Management System Regulation (QMSR) is expected to place a heavy emphasis on risk as the FDA seeks to align the current regulation with global standards. This premium article offers a review of risk-based requirements in ISO 13485 and guidance for implementation. ➡️In this Let’s Talk Risk! conversation, Bijan Elahi shares tips for creating and nurturing an environment of collaboration in risk management. ➡️A common challenge in risk management is to fully understand and control risks due to reasonably foreseeable misuse. This is why you need a robust post-market surveillance process so you can take timely action to ensure your devices continue to remain safe and effective. Upcoming eventsLTR weekly conversation on LinkedIn: Connecting risk management and design controls to accelerate product innovationJoin me next Friday, January 19, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Chuck Ventura, who will share insights on how we can connect risk management and design controls to accelerate medical device innovation.LTR monthly webinar series: Getting ready for QMSRA quick reminder to join me in this month’s webinar, where I will review some of the risk-based requirements of ISO 13485:2016 that may be relevant for your QMS as you prepare for the upcoming Quality Management System Regulation (QMSR) expected to be finalized soon. If you are a paid subscriber, an email has been sent to you with a link to register for this month’s webinar on January 16, 2023 at 11:00 AM EST. You don’t need to pay extra. Please check your spam or promotions folder if you cannot find it in your inbox.If you a free subscriber, you can upgrade your subscription to attend this webinar, or with a one time payment of only $25. Click the link below to complete your payment and secure your spot. Once you complete the payment, you will receive the registration link by email.Pre-registration is now open for the next session of Live ISO 14971 training on ACHIEVE. Paid subscribers get 20% off regular price!Save your spot here to join the next cohort of the LIVE ISO 14971 certification training course starting in January 2024. Watch a course introduction video and check out testimonials from past attendees!Weekly Knowledge ChallengeI hope you enjoyed the knowledge challenge question last week. Here is the correct answer:The correct answer for the question, “What is your best estimate of the number of times the terms “risk” or “risks” appear in ISO 13485:2016?”, is between 30-40 times. Here is this weeks’ knowledge challenge #151-Question Feedback SurveyIf you are finding value in reading 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

The practice of risk management in a heavily regulated industry such as medical devices is hard. There are many challenging questions that must be resolved in a simple way that is both sensible and defensible to demonstrate compliance with regulatory requirements.Questions such as how should we estimate P1 and P2 for each risk? How do analyze benefit vs. risk? How do we analyze risks associated with use of artificial intelligence and machine learning (AI/ML)? What should be our criteria for risk acceptability? How do we manage the many moving parts of our risk management file to ensure its integrity? There are no clear cut answers to these practical challenges. That is why Bijan Elahi, a leading expert in safety risk management of medical devices, encourages us to collaborate more to find creative solutions to these thorny problems. There is no shortage of tough problems in risk management. Talking to each other will open up ways and solutions that you may not have imagined. Collaboration cannot be forced. It requires a willingness and a sense of generosity in sharing our unique insights openly with each other. Management can help by creating an environment where everyone feels safe to engage and share freely. But it is up to all of us to work together and collaborate. Risk management is truly a team sport!In this highly inspirational conversation, Bijan shares his perspective and tips for improving collaboration in risk management. About Bijan ElahiBijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. He currently serves as a technical fellow and corporate advisor on product safety risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. He has trained over 10,000 people worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.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

Dear colleagues, hello! 👋Happy New Year to you! I am super excited to continue our work here on Let’s Talk Risk! (LTR) with the single-minded focus on helping all of us achieve success in risk management. Our industry is going through a major transition, with rapidly advancing technology and evolving regulatory landscape across the globe. That is why it is even more important now to support the risk practitioner community through LTR. In 2024, we will focus on the following themes:* Getting ready for the QMSR transition in the US* Tracking AI/ML applications in MedTech* Navigating the evolving regulatory environment, especially for SaMD and Cybersecurity* Growing the LTR communityIt’s going to be a great year! Best wishes to all of you in your work and I look forward to continuing our risk management journey together!Here are links to the articles published last week on LTR➡️Here is an update on FDA device approvals, 510ks, De Novos, recalls and warning letters issued during the month of November 2023. This is part of our monthly Medical Device News Update series. ➡️What does it take to be “inspection ready” at all times? “Inspection readiness is a frame of mind, a daily practice, not a destination or a project deliverable”, says Vincent F. Cafiso in this Let’s Talk Risk! conversation. ➡️Generally speaking, design and development of medical devices is primarily driven by engineering considerations focused on desired functionality. Although, early clinical input is highly desired, direct access to physician’s and other users of a device in the clinical setting is not available to the design team.This quick tip reminds us that understanding the full clinical context of use and physician’s view is essential for designing safe and effective devices. Upcoming eventsLTR monthly webinar series: Getting ready for QMSRA quick reminder to join me in this month’s webinar, where I will review some of the risk-based requirements of ISO 13485:2016 that may be relevant for your QMS as you prepare for the upcoming Quality Management System Regulation (QMSR) expected to be finalized soon. If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on January 16, 2023 at 11:00 AM EST. You don’t need to pay extra.If not, you can still attend this webinar with a one time payment of only $25. Click the link below to make a payment and secure your spot. Once you complete the payment, you will receive the registration link by email.Pre-registration is now open for the next session of Live ISO 14971 training on ACHIEVE. Paid subscribers get 20% off regular price!Save your spot here to join the next cohort of the LIVE ISO 14971 certification training course starting in January 2024. Watch a course introduction video and check out testimonials from past attendees!LTR weekly conversation on LinkedIn: Listening session for feedback and networkingJoin me next Friday, January 12, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. This will be a general networking and feedback session. Weekly Knowledge ChallengeI hope you enjoyed the knowledge challenge question last week. Here is the correct answer:The correct answer for the question, “Which of the following best represents the full scope of the term risk applicable to a medical device in the context of ISO 13485:2016”, is “Safety + Performance + Regulatory Requirements”. Only 50% of the respondents got it right!Here is this weeks’ knowledge challenge #141-Question Feedback SurveyIf you are finding value in reading 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

The news of an FDA investigator showing up unannounced at a medical device manufacturing facility generally sends a wave of panic throughout the organization! Even when it is a planned inspection, or an audit visit from a notified body, there is a high level of stress before, during and after the inspection. A lot of effort is spent in “getting ready” for the inspection or the audit, documentation is checked and re-checked, work areas are cleaned up and people are asked to be on their best behavior!It is like cramming for a test, desperately hoping for a passing grade!“Inspection readiness is a frame of mind, a daily practice, not a destination or a project deliverable”, says Vincent F. Cafiso in this Let’s Talk Risk! conversation. It is not about "managing” an inspection or audit; rather it is about creating a culture of Quality, open communication and collaboration where everyone feels confident in their work, and they are not afraid to be observed and challenged by an auditor. In such an environment, every team member has a clear understanding of how their work relates to product quality and how it affects their end users and patients. They seek to improve on a daily basis, finding gaps and promptly addressing them. When people show passion and commitment to quality, working as if the product they are making will be used by a family member, you can feel a culture of Quality.When it becomes a matter of daily practice, supported by a culture of Quality, you can be inspection ready any day!About Vincent F. CafisoVincent F. Cafiso started his career as an investigator at the US FDA, where he conducted hundreds of complex investigations at medical device and IVD manufacturers, both domestic and outside the United States. Subsequently, he spent over 25 years at leading medical device manufacturers helping them become inspection-ready through robust internal audit and compliance programs and a strategic focus on developing a culture of Quality. He is currently the Founder and Managing Consultant at Practical Compliance Results, LLC where he offers advisory services to clients in inspection readiness, compliance, quality assurance and quality systems consulting. 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