Let's Talk Risk! Podcast

“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, knowledge and skills, and seek to fill those gaps by collaborating with both internal and external resources.

It takes a lot of humility to admit that we can’t do it alone.

It is true that early stage start up companies face a lot of challenges, but working in a fast-paced environment can be a lot of fun. It does requires a strategic approach to build out the required quality processes just in time to support the overall business strategy. Whether you want to go to market with your own product, or plan an exit through acquisition, it helps to keep the end in mind.

Listen to this Let’s Talk Risk! conversation with Devon Campbell, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:01:50 Introduction

00:04:23 How it feels to be in a startup environment

00:06:25 Success factors for startups

00:09:46 A short story of a successful startup exit

00:14:00 Audience Q&A, general discussion

00:32:30 Closing comments and key takeaways

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About Devon Campbell

Devon C. Campbell is the Founder and Managing Director at Prodct, where he and his team provides hands-on support and advisory services to early stage medical device, diagnostic, and therapeutic companies. He serves as a mentor, advisor, or board member for several startups. Additionally, he is the Chief Product Officer (CPO) and Senior Vice President of R&D/Quality at myBiometry, an early stage diagnostic company focused on asthma. He also supports the NIH RADx program as a content expert and was the lead author for Chapter 6 of the recent NIH book “Accelerating Diagnostics in a Time of Crisis” exploring quality, risk, and product developing during RADx. He has been active in the medical device industry for more than 25 years in various engineering and leadership roles. He holds BS and MS degrees in Mechanical Engineering.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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 when used with the WHO's surgical safety checklist.

3️⃣ Aaron Joseph recommends adopting a more flexible "re-entrant design controls" approach to manage frequent design changes and upgrades.

4️⃣ Stefan Hunziker, PhD, CICP offers 6 tips for boosting your risk management expertise where leaning from failures is not an option.

5️⃣ Wag Hanna shares how augmented intelligence tools can help support risk management while also enabling a culture of transparency.

6️⃣ Vincent F. Cafiso seeks to clarify FDA's position on requirements for clinical studies in QMSR.

7️⃣ George Zack invites a conversation to identify risks in real world activities such clearing snow from sidewalks and roads.

8️⃣ Chuck Ventura offers tips for considering design controls at the drug/device interface in a combination product.

9️⃣ Daniel Adler spotlights a new FDA draft guidance on cybersecurity to cover any device if it includes software and internet connectivity.

🔟Marco Felsberger reminds us that we can't always reliably model extreme events and managing risk exposure might be more effective.

Share in comments 👇your favorite risk-related post covered in this podcast.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

“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 of these requirements. As an example, we must clearly understand the intended use and indication for our device. It is in the context of the intended use that we have to plan and conduct our clinical investigations to generate evidence of safety and effectiveness.

AI-enabled devices, including those used for detection and diagnosis, presents unique issues. Data privacy and security, including cybersecurity vulnerabilities need to be addressed. Risk of using open source data should carefully considered during development, testing and final use. Unless absolutely necessary, it is best not to use open source data.

Another potential area of concern is physician over-reliance on AI/ML devices. Dr. Tkach reminds us to keep the following in mind:

At the end of the day, an AI-enabled device is a tool to be used by the clinician and not as a substitute for clinical judgment.

Listen to this Let’s Talk Risk! conversation with Dr. Emanuel Tkach, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:02:05 Introduction

00:04:13 CADe and CADx: two types of computer aided detection and diagnosis

00:05:23 Addressing physician over-reliance on technology in clinical trials

00:07:14 Relevant ISO standards for AI, clinical investigations and quality

00:10:14 Clinical perspective on designing AI-enabled devices and managing risk

00:15:38 How non-regulatory professionals should approach regulations and standards

00:17:20 Audience Q&A

00:32:30 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

About Emanuel Tkach, MD

Dr. Emanuel Tkach is currently the Medical Advisor at HeartPoint Global, where he leads the global clinical strategy and operations of clinical trials. He also provides advice on breakthrough device designation submissions, recruiting and strategizing with key opinion leaders (KOL) to accelerate medical device innovation. His medical specialty and clinical experience includes Gastroenterology, Cardiology and Primary Care. He holds a BS degree in Biology/Biological Sciences and an MD in Medicine.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

“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 of the safety critical functionalities of a medical device rely on adequate control of purchased product through supplier controls. Yet, Supplier Quality and Product Development functions tend to operate in silos. A siloed operating model leads to device malfunctions with serious consequences in the post-market phase, that have their origin in the quality of purchased products. One area of significant vulnerability is the use of off-the-shelf products, including software, where it is sometimes not feasible to identify and implement appropriate purchasing controls.

There is a renewed focus on purchasing controls in the revised Quality Management System Regulation (QMSR), which is due to go into effect in early 2026. We have to start applying a risk-based approach to ensure compliance and manage risk to patients.

Listen to this Let’s Talk Risk! conversation with Kevin Posey, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:02:05 Introduction

00:03:26 Challenges in supplier quality controls in light of recent Boeing issue

00:05:30 A renewed focus on supplier controls in QMSR

00:06:48 Disconnect between supplier risk management and product risks

00:09:50 An example highlighting challenges in supplier risk management

00:13:49 Audience Q&A

00:31:13 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

About Kevin Posey

Kevin Posey is currently the Director of Regulatory Affairs and Quality Assurance at Genesys Spine. He began his career in the Aerospace and Defense industry as a systems engineer. Later he moved to the medical device industry, where he advanced his career over a span of 25+ years in leading roles at multiple organizations covering a broad range of medical specialties. He holds a BS degree in Aerospace Engineering and MBA in International Business with additional Masters level studies in Systems Engineering and Biomedical Engineering.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

“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 achieve this objective.

Listen to this Let’s Talk Risk! conversation with Taylor Dieringer, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:02:30 Introduction

00:04:03 What is post-market surveillance and why it is needed

00:06:51 Post-market surveillance process is a continual learning process

00:08:05 Setting thresholds for action during post-market surveillance

00:11:00 How to detect and evaluate safety signals

00:13:40 Why we need a cross-functional team for post-market surveillance

00:16:37 Audience Q&A

00:30:05 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

About Taylor Dieringer

Taylor Dieringer is currently a staff quality engineer at iRhythm Technologies, Inc. where he leads risk management activities throughout all phases of the product lifecycle, ranging from design to post-market surveillance. He is a biomedical engineer by training with prior experience in design and development, quality assurance and risk management at multiple medical device organizations.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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.

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LTR weekly conversation on LinkedIn: A physician’s view on AI in healthcare

Join me next Friday, April 12, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Dr. Niranjan Seshadri, who will share his perspectives as an interventional cardiologist on AI in healthcare.

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The correct answer for the question, “A hazard always leads to harm” is False.

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“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 difficult chronic condition. Nearly 40 million people in the United States alone are estimated to be living with diabetes. CGMs have made a big impact in not only managing the A1C for diabetic patients, but also improving their overall quality of life.

When we listen to patients - really listen - we can understand not only their “needs” but also their fears, wants and desires.

For example, we may be focused on the functionality of our devices, but patients also worry about whether they will be covered by insurance. Affordability and accessibility are major concerns, even though they may not appear in our list of “user needs” during the design and development process.

“I am in it to win it”, David shares in this conversation. It is a good reminder to all of us to think of patients as people, and not as an anonymous consumer.

Listen to this Let’s Talk Risk! conversation with David Sturgis which also includes an open discussion with the audience.

About David Sturgis

David Sturgis is an IT and Operations management professional with more than 25 years of experience in project and lifecycle management. He is skilled building and optimizing organizational processes, measurement systems and infrastructure to maximize business results. He has an MBA from University of Florida, and a BS in Computer Engineering from University of South Florida.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 will fail often. How do we harness the power of this technology without compromising patient safety or other ethical concerns?

Case in point - AI is just one part of the overall system where a medical device needs to operate safely.  We need to design the overall software for its intended use by considering the system level requirements. It is the whole software that needs to serve its intended purpose when used within the broader healthcare system.

“People drive cars, not an engine!”, Prof. Papademetris reminds us so eloquently in this conversation.

Patient safety is an important factor for a medical device. So far, FDA has managed the risk by including a human in the decision making loop and not allowing a stand-alone, autonomous AI system for clinical decisions. An important question is how to share information with the user? There is a human factors component to AI, which needs to be carefully considered.

In practice this proves to be quite challenging.

Application of AI in medical software requires a true cross-functional approach. As Prof. Papademetris reminds us, we need to learn to speak each other’s language:

The biggest challenge we face is not being good in our discipline, but how to become at least competent in other disciplines to facilitate a truly cross functional problem solving approach when building medical software.

In the rapidly evolving world of AI, we need a new approach to medical software development. It used to be that data was secondary to code in traditional software development, but now code is becoming fairly standard, and the question is about data. How broadly does it represent the use cases you want to represent? Bias in the model is a serious concern.

Listen to this Let’s Talk Risk! conversation with Prof. Papademetris which also includes an open discussion with the audience.

About Prof. Xenophon Papademetris

Xenophon Papademtris is currently a Professor at the Yale University School of Medicine where he focuses on research in image analysis and software development. He has recently launched a certificate course for industry professionals to provide a comprehensive understanding of both technical and regulatory aspects of medical software and medical AI. He is also the lead author of a new textbook Introduction to Medical Software: Foundations for Digital Health, Devices and Diagnostics (Cambridge University Press, 2022), and the main instructor for the companion Coursera Class.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 uncertainty in our complex world.

3️⃣ Chad Johnson explains how using a QFD can help us focus on the customer when building an FMEA

4️⃣ Mark F. Witcher, Ph.D. encourages us to take a systems-view of risk instead of an event-based view during risk analysis.

5️⃣ Boris Gurevich shares a draft document from IMDRF on SaMD device considerations and risk characterization.

6️⃣ Darrin Carlson, RAC-Devices, PMP highlights the omission of DHF, DMR and DHR from the QMSR and how to map them under ISO 13485.

7️⃣ Jan Beger shares a study that focuses on factors affecting patients' trust in AI for treatment decisions.

8️⃣ Joseph Kvedar shares a review article about risk prediction models using AI for diabetes care and unresolved issues for implementation.

9️⃣ Stefan Hunziker, PhD, CICP highlights an unintended consequence of ignoring correlation among individual risks.

🔟Annmarie Nicolson shows how HFE activities interact with multiple workstreams during design and development.

Share in comments 👇your favorite risk-related post covered in this podcast.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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. In the context of Design Controls, it is helpful to see risk analysis as an aspect of good engineering and not just a paper exercise.

When risk analysis is integrated early in the design process, it helps inform design choices to optimize both safety and performance of the medical device. As an example, when you are trying to decide among various design choices represented by different prototypes, it may be helpful to conduct early usability studies to find out potential use-related issues and failures. Design choices that eliminate potential use-errors are more effective in reducing risk and delivering a final product that is both safe and effective.

A best practice is to start with a systems-level risk analysis to develop a preliminary understanding of hazards and hazardous situations. As our understanding of risks evolves, more sophisticated techniques such as design FMEAs can be applied to different design concepts to fully analyze failure risks in the context of identified hazards and hazardous situations.

Listen to this Let’s Talk Risk! conversation with Chuck Ventura which also includes an open discussion with the audience.

About Chuck Ventura

Chuck Ventura is currently the Founder and CEO at Ventura Solutions, LLC, a consulting firm specializing in end-to-end consulting, staffing and training services for the medical device and combination products industry. He has nearly 20 years of experience in the Life Sciences industry across a variety of roles in product development, risk management, design controls, project management audits and inspection readiness. He is a biomechanical engineer with advanced graduate degrees in aerospace and mechanical engineering.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.