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PODCAST

Let"s Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

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All Episodes

35:19

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

Let"s Talk Risk! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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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34:15

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

Let"s Talk Risk! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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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167 results

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