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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

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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32:44

LTR 34: Build a culture of Quality to achieve...

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

2024/01/05

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

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38:00

LTR 33: AI and the future of work for QA/RA...

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

2023/12/22

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 actually enhance the work done by STEM professionals, creative and legal professionals. If there are

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35:19

LTR 32: A new paradigm for building connected medical...

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

2023/12/15

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 devices as a “fortress” with a high level of engineering control and a defensive “moat” of change control

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33:36

LTR 31: Focus on the purpose to measure process...

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

2023/12/08

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. As a seasoned auditor with more than 15 years of industry experience, Rick Rios reminds us that external

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35:05

LTR 30: It is time to unfake risk management!

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

2023/12/01

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 Nasteckiene challenges us to critically examine our current practices and adopt a more customer-centric

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31:41

LTR 29: Challenges and opportunities for digital...

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

2023/11/17

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 devices using based on these technologies.In this episode, Pascal Werner shares this enthusiasm while also

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36:54

LTR 28: It is time to build equity in medical device...

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

2023/11/10

If the US FDA has approved or cleared a medical device as safe and effective, you would expect it to be equally effective across the entire patient population within the scope of its intended use.Well, you may be surprised to learn that current industry practices in design, development, and testing of medical devices inadvertently introduce many inherent biases in these devices that can lead to preventable harm in some patients.In this episode, Lori-Ann Archer highlights that inherent bias in

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34:05

LTR 27: Practicable or not, that's the question for...

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

2023/10/27

The term practicable is used in ISO 14971, the International Standard for application of risk management to medical devices, in the context of risk controls and benefit-risk analysis of an individual residual risk.In practice, this “term” causes a lot of confusion! One source of this confusion appears to stem from the fact that the standards uses the “term” practicable as part of a requirement, but also suggests that the “word” practicable may be a part of the manufacturer’s policy for establishing

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35:50

LTR 26: Seek clinical input early in development to...

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

2023/10/20

Why do many medical devices fail to reach their adoption goal after launch? Or, hit roadblocks during the regulatory review process before launch?In this episode, Sara Vazda shares that one reason why medical device manufacturers struggle to achieve their business goals is that clinical input is generally not a natural part of the design and development (D&D) process. Medical device D&D is generally driven by Engineering, with clinical aspects considered only during the final phase prior to seeking

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35:37

LTR 25: Career tip - learn to effectively communicate...

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

2023/10/13

M&A has traditionally been a strong driver of revenue growth for medical device companies. The current M&A environment, however, is very challenging for companies because of several factors, including declining capital funding and falling market valuations.In this environment, QA/RA professionals have a unique opportunity to make an impact in their organizations, advises Steve Silverman. Quality and Regulatory professionals can help bridge the knowledge gap, and in doing so, demonstrate the business

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