Let's Talk Risk! with Dr. Naveen Agarwal Casual and informal conversations about practical aspects of medical device risk management.

“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? How can you help build your product’s story from start to finish during development, and later during the post-market phase?
This is a leadership opportunity for risk practitioners. It is not enough to build a deep technical knowledge of risk management, but also be mindful of how communication occurs within your organization. Combine your technical know-how with good communication skills to help your team make the best possible decision.
This is the key to success in a risk management role.
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.
00:01:58 Introduction
00:04:15 How risk management helps build and sustain the product story
00:05:15 Transitioning into a risk management role
00:08:12 Why we need to create dedicated risk management roles
00:10:35 How to lead change by starting small and showing impact
00:12:50 Our role in shaping a culture of quality
00:15:13 Audience Q&A, general discussion
00:32:30 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
About Carolyn (Beres) Blandford
Carolyn (Beres) Blandford is currently a Senior Project Management Consultant at IPM Integrated Project Management Company. She has over 20 years of professional experience in the in-vitro diagnostic (IVD) industry, first in a scientific role, later moving into a Quality Management role. She developed a strong interest in risk management as a Quality Manager, where she also led the charge to create a dedicated focus on risk management in the organization. Using her strong research, communication and project management skills, she currently supports her clients in planning and implementing strategically critical initiatives.
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.



This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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



This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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.



This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

“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.



This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

“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.



This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

“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.



This is a public episode. If you’d like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe