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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

32:13

LTR 59: FDA's pre-sub program and how it can...

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

2024/07/26

“You can get a lot of valuable insights from the FDA on what your regulatory pathway is when it comes to risk, and how that impacts not only the risk of the product but how you set up your quality systems and what you need to implement in the long run. ”In this Let’s Talk Risk! conversation, Amit Guruprasad shares how small medical device manufacturers and startups can take advantage of the free pre-sub program to get early feedback from the FDA to inform their regulatory strategy and plans for

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41:23

LTR 59: Tips for clinicians transitioning into a...

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

2024/07/19

“The reality is that, today, a lot of people are studying medicine to go into industry. But if your curriculum do not include areas like risk management, cross-functional collaboration, dFMEA and all of that, then transition for that position is going to be slower.”In this Let’s Talk Risk! conversation, Dr. Juan Daccach shares his personal journey of transitioning into a medical safety role in MedTech as a practicing orthopedic joint reconstruction surgeon. He advises clinicians aspiring to

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34:09

LTR 57: It's time to focus on supply chain resiliency...

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

2024/07/12

“Show me the indicators, show me the KPIs and I will show you the results.”Resiliency starts at the top. Misaligned incentives often lead to unintended and disastrous consequences. Recently, the Federal Aviation Administration (FAA) in the US grounded 171 Boeing 737-9 MAX planes following a mid-air incident where a cabin door blew open, exposing hundreds of passengers to a serious hazardous condition. The issue was traced to gaps in quality and inspection of components from suppliers. Similar to the

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31:28

LTR 56: How to communicate effectively with senior...

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

2024/07/05

“As professionals in these areas, we are so versed in regulations that we get so deep into the woods with management that 30 seconds after you start speaking, they are gone! They can’t even think about it anymore.”Know your audience, prepare your topic and respect your listener. Victor Mencarelli shares these 3 tips for effective communication in this Let’s Talk Risk! conversation. Remember, effective communication is about connecting and making sure your message is heard. It is not meant to be an

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33:18

LTR 54: Start your risk analysis by first defining...

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

2024/06/21

“The first thing I do whenever I am starting design control or risk is that I make sure that the intended use and the indication of the device are as nailed down as they can be.”Yes, design control and risk management can be challenging, especially in a startup or a small medical device company. Generally, there is just one person, a “team of one”, responsible for setting up the entire quality system and the risk management process. That is why Becki Hiebert advises practitioners to focus on the

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35:41

LTR 53: Three big trends to watch in MedTech

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

2024/06/07

“The regulatory landscape is changing significantly and it is too hard to keep up.”That is why Jennifer Mascioli-Tudor advises risk practitioners to be “super proactive” in following these rapid changes, understand the impact, and take a leading role in preparing their organizations. In this Let’s Talk Risk! conversation, we focus on three big trends in MedTech - the shift from Quality System (QS) regulation to Quality Management System Regulation (QMSR), a new regulatory focus on cybersecurity in

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34:20

LTR 52: The key to success as a risk practitioner in...

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

2024/05/31

“Risk management is inherent to all our roles, whether you are in Regulatory, Quality or R&D, but it is not something we spend a lot of time on”.Risk management in the medical device industry is often seen as a check-the-box activity for regulatory compliance. In this Let’s Talk Risk! conversation, Carolyn Blandford encourages us to not be satisfied with this status quo and help create a dedicated focus on risk management across all processes of the quality system. How can you be a better partner

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35:16

LTR 50: Humility is the key to startup success

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

2024/05/17

“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,

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21:51

RM roundup #3: 10 noteworthy risk-related LinkedIn posts

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

2024/05/10

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

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34:41

LTR 49: A clinician's view on AI/ML enabled medical...

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

2024/05/03

“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

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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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