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PODCAST

Let"s Talk Risk! with Dr. Naveen Agarwal

Casual and informal conversations about practical aspects of medical device risk management.

Every Friday, Dr. Naveen Agarwal leads a Let"s Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a

technology how to

All Episodes

34:38

LTR 48: Integrating purchasing controls across...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/04/26

“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

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4:09

LTR Weekly Digest #32 - 13th April, 2024

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/04/13

Dear colleagues, hello! 👋A special welcome to the 45 new members who have joined our Let’s Talk Risk! community this week! 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.AnnouncementsLTR monthly webinar series: Case study discussion and general Q&AA quick reminder to join me in this month’s webinar, where I will review a case study

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33:22

LTR 46: Tips to boost effectiveness of medical device...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/04/12

“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

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2:55

LTR Weekly Digest #31 - 6th April, 2024

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/04/06

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

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31:23

LTR 45: A patient's perspective on CGMs

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/04/05

“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

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34:18

LTR 44: Why we need a new approach to learning...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/03/22

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

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20:43

RM roundup #2: 10 noteworthy risk-related LinkedIn posts

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/03/14

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

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38:14

LTR 43: Tips for integrating risk analysis with...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/03/08

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

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3:49

LTR Weekly Digest #26 - 2nd March, 2024

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/03/02

Dear colleagues, hello! 👋Let’s Talk Risk! is celebrating our 1st birthday 🎂🙌! Thank you for our support and continued engagement! I am looking forward to continuing our journey of shared learning this year. Please reach out anytime if you have any feedback or suggestions to enhance your learning experience on LTR.A special welcome to 130+ new members who have joined our Let’s Talk Risk! community in the month of February! Feel free to browse past articles in the archive section of the Let’s Talk

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20:58

RM roundup #1: 10 of my favorite risk-related...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/03/01

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

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33:55

LTR 42: State or event? Thinking clearly about...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/02/23

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

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42:01

LTR 40: A guest podcast with NAMSA - Part 1

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/02/16

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

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33:19

LTR 39: Overcoming challenges in linking risk...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/02/09

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

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34:58

LTR 38: How medical safety professionals can serve as...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/02/02

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

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76:06

LTR 37: QMSR, Inspection Readiness and Career Tips...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/01/26

LTR podcast is a new monthly feature on Let’s Talk Risk!. Each month, we sit down with an industry leader to go deeper into Quality/Regulatory topics in MedTech to gain deeper, more actionable insights. This month, we talk about FDA’s upcoming Quality Management System Regulation (QMSR) and inspection readiness with Vincent Cafiso. As an ex-FDA investigator, he offers a unique perspective on the medical device regulation amendments under QMSR, which are expected to go into effect very soon. Medical

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8:29

Webinar 5: Getting ready for QMSR

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/01/24

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comIn February 2022, the FDA proposed an amendment to the current Quality System Regulation (QSR) for medical devices to align it more closely with the international consensus standard ISO 13485:2016. The amended regulation, when approved, will be referred to as the Quality Management System Regulation (QMSR) to better reflect the emphasis on the managemen…

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33:39

LTR 36: Why we should not overlook the...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/01/19

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

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3:25

LTR Weekly Digest #19 - 13th January, 2024

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/01/13

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

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34:29

LTR 35: Tips for improving collaboration in risk...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/01/12

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

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3:23

LTR Weekly Digest #18 - 6th January, 2024

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2024/01/06

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

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