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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

34:15

LTR 24: Clinical evaluation is a lifecycle process,...

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

2023/10/06

The current medical device regulation in the European Union (EU-MDR) includes the term clinical evaluation more than 140 times!Clearly, clinical evaluation is now more important than ever under EU-MDR (and IVDR). As a result, a general feeling in the medical device industry is that it is now significantly more challenging to bring innovative new devices to market.Sarah Panten advises practitioners to clearly define clinical benefits of their as part of the clinical evaluation and document the

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32:06

LTR 23: Focus on intended use in the clinical...

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

2023/09/29

At first glance, risk management of diagnostic devices, including in-vitro devices (IVD), is not overly complex. After all, you mostly have to consider the effects of false negative results, false positive results, and invalid or delayed results.However, it can be challenging to correctly assign the severity of harm(s) resulting from inaccurate and/or delayed results if we don’t fully understand the clinical context of the intended use of a diagnostic device.In this episode, Joshua Levin advises

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33:42

Ep 22: Think of post-market surveillance as a value...

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

2023/09/22

We often think of the post-market surveillance (PMS) process as a regulatory requirement for medical devices, especially because of the revised EU-MDR (and IVDR) regulations now in effect in the European Union.But it is more than compliance. According to Per Maegaard, PMS is not just an exercise in meeting regulatory requirements, but intelligence gathering that can help other functions including Marketing. We should think of the PMS process as a value-adding business process, which can provide

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30:46

Ep 21: Why risk practitioners must build the empathy...

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

2023/09/15

Why - you may ask - should risk practitioners care about empathy? After all, risk management is about managing uncertainty as objectively as possible. How does exercising the empathy muscle help risk practitioners do a better job than, let us say, focusing more on data analysis and regulatory requirements?In this episode, Christie Johnson reminds us that risk management is a team sport. When working in a cross-functional team, we have to pay attention to every individual’s unique perspective

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31:37

Ep 20: Team diversity helps boost competence in risk...

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

2023/09/01

Risk management involves making decisions based on incomplete information at any given time. One area where risk practitioners struggle a lot is in managing risk associated with reasonably foreseeable misuse. We struggle to figure out what type of misuse might be reasonable, and what might be foreseeable, because human behavior often is neither reasonable nor predictable!That is why Rene Drost advises risk practitioners to focus on building team diversity. When we include diverse viewpoints and life

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34:36

Ep 19: How QA/RA professionals can help drive...

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

2023/08/25

There is a lot of hype around artificial intelligence (AI) and machine learning (ML) these days. That is why Michael Bocchinfuso encourages Quality/Regulatory professionals in this episode to go beyond the hype and understand these rapidly emerging technologies at a deeper level. These rapidly evolving technologies offer unique opportunities in the medical device space. To succeed, QA/RA professionals should clearly articulate and emphasize the clinical benefit, anticipate regulatory questions about

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34:48

Ep 18: Risk based approach to building a QMS in a...

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

2023/08/18

In this episode, Becki Hiebert recommends taking a strategic approach to building and implementing a Quality Management System (QMS) in a startup.Unlike a mature, established organization, a startup operates in a fast-paced and rapidly changing environment. That is why you have to think about both speed to support the near term goals, and scalability to support rapid growth in the future.Her advice - focus on building the right mindset about Quality, use a risk-based approach to create a flexible

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34:49

Ep 17: Risk management lessons learned from running...

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

2023/08/11

Boston marathon is one of the most prestigious running events in the world. It takes a lot of planning to preparation to even qualify to enter the race.In this episode, Christopher Gehring shares his experience preparing for his first Boston marathon and emphasizes the need for good planning in all our projects, including risk management. We have to be both agile and detailed in our approach, and plan for different contingencies. Even then, we have to be prepared to handle surprises along the way.It

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32:25

Ep 16: Clinical evaluation is now more important than...

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

2023/08/04

There is a new scrutiny on clinical evaluations in the European Union.At the same time, medical device manufacturers are challenged to satisfy the new regulatory requirements under EU-MDR because they are no longer able to claim “equivalence” to an existing device under revised criteria. In this episode, Florian Tolkmitt emphasizes the need to consider clinical evaluation as an important process, not simply a document for compliance. The key point here is that we have to start focusing on planning

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32:45

Ep 15: Collaboration is the secret sauce for success...

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

2023/07/08

Risk management is a team sport. In this episode, Hugo Felix reminds us that takes expertise from different functions to fully understand the nature of risk and identify appropriate risk control options. It is not just engineering or manufacturing or quality or clinical; it is all functions working together.This is more important now than ever as technology is rapidly advancing and medical devices are becoming more complex. About Hugo FelixHugo Felix has 25 plus years of industry experience in

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33:45

Ep 14: The most important question for risk...

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

2023/07/01

In this episode, Adam Saltman reminds us to not consider risk as an absolute concept; rather think about it in the context of the end user or the patient who is being asked to take the risk in return for a benefit to their health. There is a disconnect in the medical device industry between patients, manufacturers and regulators. By considering the question “who is taking the risk?”, we can stay focused on the end user or patients as we build and launch medical devices. About Dr. Adam SaltmanDr

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41:01

Ep 13: Compliance: an obstacle or an opportunity?

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

2023/06/24

The term compliance is generally viewed as a “necessary evil”, or as a “tax on production”. But it doesn’t have to be this way.In this episode, Raimund Laqua encourages us to view compliance as an opportunity to consider compliance requirements as part of the overall performance standards generally expected by our stakeholders, including customers and regulators. Compliance can be seen as just doing the minimum required and check the box, but it also offers an opportunity to compare our current

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36:01

Ep 12: Risk lessons learned from working on a...

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

2023/06/17

Sometimes it is a good idea to learn from best practices used in other industries! In this episode, Andy David shares risk lessons learned while working with hydrogen-powered cars. He shares how design choices are driven by a central idea, which also greatly influences are approach to safety risk management. In the end, safety is an output of our risk mitigation activities. We have to keep the end user in mind and understand their needs for both safety and performance. We also need to challenge our

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39:15

Ep 11: Understanding a physician's view on risk

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

2023/06/10

Risk practitioners, including engineers and quality/regulatory experts, mostly focus on device-related risks to ensure safety and effectiveness. Physicians, on the other hand, have to consider the totality of risks, including those arising from the procedure or patient-related factors. Physician’s have to tailor the overall benefit-risk to an individual patient. In this episode, Dr. Elisha Patel helps us understand a physician’s view on risk. About Dr. Elisha PatelElisha Patel is a qualified dentist

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43:03

Ep 10: Safety is important, but not the only...

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

2023/05/27

The term risk is generally understood as something to be avoided or minimized. In the medical device and pharma industries, risk is generally associated with harm to patients. Regulatory agencies expect the benefits of a medical product to outweigh the risks associated with its use before it can be considered as safe and effective. As a result, the dominant view of risk in the medical device world is that risk needs to be controlled and minimized for patient safety and regulatory compliance. ISO

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38:06

Ep 09: Tips for a risk-based approach to auditing...

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

2023/05/20

Medical device manufacturers operate under a heavy load of audits and inspections. Even the regulatory authorities across the world are recognizing the heavy burden of multiple audits and inspections on manufacturers, which take away resources and time that could otherwise be invested in new product development and continuous improvement activities.There is a movement in the regulatory compliance world to adopt a least-burdensome approach for regulatory decision making throughout the device

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31:22

Ep 08: Understanding the interface between clinical...

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

2023/05/13

The medical device regulation in the European Union (EU-MDR) outlines many new requirements for conducting clinical investigations and clinical evaluation throughout the device lifecycle. The challenge is that the term “clinical risk” is not clearly defined in the EU-MDR. This has created a lot of confusion in the medical device industry about the scope of clinical risks that need to addressed through a clinical evaluation and appropriately integrated with the risk management system.In this episode,

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34:10

Ep 07: Risk management of IVDs requires a different...

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

2023/05/06

Unlike a typical medical device, most in-vitro diagnostics (IVD) “do not touch” a patient. IVD-related risks to patient safety are considered to be indirect risks, because the information generated by an IVD is an intermediate step in the sequence of events. In the IVD world, a trained technician will generally run the assay and provide the information to a clinician. In case of an over the counter (OTC) test, such as a rapid COVID-19 test, the end-user directly receives the test results.How this

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32:49

Best practices for using FMEAs for medical devices

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

2023/04/22

FMEA is a commonly used technique by engineers in the medical device industry to analyze different failure modes, their causes and effects. When used correctly, it is highly effective in identifying and implementing appropriate control measures to improve product quality and reliability.However, FMEAs are also overused in the industry; often almost exclusively for risk analysis. The main problem with this approach is that system level hazards and hazardous situations cannot be easily linked to

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