Let's Talk Risk! Podcast

“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 Ta...

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 playin...

“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 C...

“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 o...

“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 bet...

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. Announcements Special offer - save 20% on...

“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...

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...

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...

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 sho...

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 or...

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 C...

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 ex...

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 i...

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 individu...

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...

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 Regulatio...

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 e stimate P1 and P2 for each risk? How do analyze benefit vs. risk ? How do we analyze risks associated...

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...

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...

Artificial Intelligence (AI) now affects almost every aspect of our personal and professional life. It is also changing the way we work, especially in the knowledge industry. According to a recent report from McKinsey Global Institute about the generative AI and the future of work, 30% of the hours worked in many professional activities across the US economy could be automated by 2030. But AI will...

Rapid advancement in digital technologies and cloud computing offer huge opportunities for medical devices, but they are also forcing us to change our approach to design, development and risk management. In this high energy Let’s Talk Risk! conversation Randy Horton inspires us to take a risk-based approach when building and managing connected devices. Historically, we have considered medical devi...

The increasing adoption of Medical Device Single Audit Program (MDSAP) has led to a major shift in current auditing practices in the medical device industry. MDSAP has forced auditors to apply a process-based audit approach rather than a checklist-based approach. The focus in a process-based audit is on process effectiveness and not just element-by-element compliance with regulatory requirements....

When we practice risk management mainly for the purpose of compliance, we are really faking it! A compliance-focused approach to risk management only leads to an ever increasing number of complex procedures, rules and documentation rather than nurturing a culture of empowerment and customer focus. Risk management in such an environment becomes a check-the-box exercise. In this episode, Vilma Naste...

Digital technologies are being rapidly deployed in medical applications. Buzzwords such as AI/ML, SaMD and Digital Therapeutics are fast becoming a part of our vocabulary in the medical device and the broader healthcare space. While there is new excitement about the potential to solve some of our most challenging medical problems, there is also a lot of uncertainty in the regulatory approach to de...