Let's Talk Risk! Podcast

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.

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 Catmur

James 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 Agarwal

Let’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.

Disclaimer

Information 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.

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 Cafe

NAMSA 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.

Disclaimer

Information 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.

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 Roberts

Daniel 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 Agarwal

Let’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.

Disclaimer

Information 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.

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 Armstrong

Mark 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 Agarwal

Let’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.

Disclaimer

Information 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.

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 Baumans

Ronald 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 Agarwal

Let’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.

Disclaimer

Information 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.

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 events

LTR weekly conversation on LinkedIn: Connecting risk management and design controls to accelerate product innovation

Join 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 QMSR

A 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 Challenge

I 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 #15

1-Question Feedback Survey

If you are finding value in reading LTR, please give us a shout out and show your love🙏

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 Elahi

Bijan 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 Agarwal

Let’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.

Disclaimer

Information 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.

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 community

It’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 events

LTR monthly webinar series: Getting ready for QMSR

A 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 networking

Join 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 Challenge

I 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 #14

1-Question Feedback Survey

If you are finding value in reading LTR, please give us a shout out and show your love🙏

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. Cafiso

Vincent 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 Agarwal

Let’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.

Disclaimer

Information 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.