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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

38:09

LTR 67: 3 pillars for defining your IVD risk...

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

2024/09/20

“There are 3 pillars I consider essential to defining a strategy for IVD risk management. What is the system definition, who are the user groups, and what is the level of novelty?”In this Let’s Talk Risk! conversation, Claudia Campbell-Matland highlights the broad range of in-vitro diagnostic devices (IVD), which requires a strategic approach to their development and risk management. Claudia advises IVD manufacturers to consider their risk management strategy and scope under 3 pillars - the system

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33:59

LTR 66: Understanding human factors aspect of...

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

2024/09/13

“To be able to see a virtual image over the real world - that augmented reality is - is a mind blowing, very different experience.”In this Let’s Talk Risk! conversation, Phil Deming shares some of the unique human factors engineering challenges for an augmented reality (AR) technology for 3D visualization of human anatomy in real time during a medical procedure. Phil advises manufacturers to stay current with rapidly evolving new technologies, and talk to users in their intended environment to

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35:15

LTR 65: Demystifying risk-based approach vs. risk...

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

2024/09/06

“It’s too often confused with risk management itself. Part of the risk-based approach is just the mindset, the thinking about risk, and then deciding ‘so what should we do?’, the answer to which might be a formal risk management.”In this Let’s Talk Risk! conversation, Steve Gompertz clarifies a subtle difference between a risk-based approach and formal risk management according to standards such as ISO 14971. Risk-based approach is more about a mindset and a set of behaviors that lead to risk-based

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1:24

LTR 64: Opportunities and challenges to leverage PCCP...

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

2024/08/30

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“PCCP is a great tool for your regulatory strategy but it is not for every company or for every change”. PCCP (Predetermined Change Control Plan) is a new regulatory scheme that allows device manufacturers to implement post-market changes without requiring pre-market submission to the FDA. In this episode, Yu Zhao explains how the PCCP tool offer…

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35:51

LTR 63: A lawyer's perspective on the QMSR transition

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

2024/08/23

“Don’t be comfortable saying, ‘Oh I follow the ISO (13485) to the letter’; it doesn’t matter. You have to comply with 21 CFR 820.”In this Let’s Talk Risk! conversation, Neil Di Spirito, helps us understand the full legal context behind the Quality Management System Regulation (QMSR), the amended version of 21 CFR 820 that will go into effect in February 2026. Although, the QMSR incorporates the International Standard ISO 13485:2016 by way of reference, there are points of differences and additional

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30:49

LTR 62: Overcoming barriers to cross-functional...

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

2024/08/16

“There is a growing awareness that if you bring in Regulatory at the beginning of designing a product, you will end up with a more robust product. In this Let’s Talk Risk! conversation, Christine Zomorodian highlights some of the barriers that have traditionally hindered good communication and collaboration between QA/RA and Engineering functions in MedTech. However, she also points out that there is reason to be optimistic about the future.Gender roles are changing, with more women entering

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39:23

LTR 61: Treat human factors as a driver of customer...

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

2024/08/09

“There is a tendency for human factors to be very closely tied to regulatory requirements and nothing else, but human factors as a core discipline is about user-centered design.”In this Let’s Talk Risk! conversation, Korey Johnson highlights how the current practice of human factors engineering in the medical device industry is mainly driven by regulatory requirements, which often leads to a check-the-box approach and nothing more.But human factors is more about applying a user-centered design

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31:07

LTR 60: Defining state of the art can be challenging;...

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

2024/08/02

“There is a very strong push (in the EU) to look at threshold values and acceptance criteria in the clinical evaluation, and these acceptance criteria for benefit risk have to be based on the state of the art.”State of the art (SoTA) is a very important topic in the medical device industry, because it is directly connected to risk acceptability and benefit-risk evaluation, which in turn, is directly tied to safety and effectiveness for regulatory purposes. But what is SoTA and how do you define it

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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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