Let's Talk Risk! Podcast

In this Let’s Talk Risk! conversation, Ritam Priya advises device manufacturers to engage early with the FDA through the Q-sub program. Applications of AR/VR in MedTech are growing rapidly, but the regulatory science is still evolving. There are many specific safety and performance concerns unique to AR/VR technologies used for medical purposes. Early engagement with the FDA can help in developing adequate plans for verification and validation of these devices.

Image quality, cyber-sickness, rapidly changing hardware and software technologies used in AR/VR applications, for example, are some of the concerns that need careful planning throughout design and development and in the post-market phase.

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

00:02:05 Introduction

00:01:30 Transitioning into a medical safety role from clinical practice

00:02:31 Overview of AR/VR applications in MedTech

00:06:15 Example of a recently cleared AR/VR based medical device

00:08:27 Image quality is a major concern for FDA in AR/VR devices

00:09:20 How FDA is advancing regulatory science for AR/VR technologies

00:11:18 Special safety and performance considerations for AR/VR devices

00:13:27 Audience Q&A and open discussion

00:31:11 Closing comments and key takeaways

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

Suggested links:

LTR: A fast growing frontier: AR/VR driving innovation in MedTech.

FDA: Augmented Reality and Virtual Reality in Medical Devices.

About Ritam Priya

Ritam Priya is currently the Founder & Principal at Novarum MDRQ Consulting where she provides regulatory consulting services to MedTech clients in both pre- and post-market phases. She has over 20 years of experience in the medical industry, including leadership experience at top organizations. Her expertise includes regulatory requirements for marketing authorization of medical devices in major global markets including US, EU, UK, Australia and Canada. She holds a Bachelor’s degree in Mathematics, Computer Science and Economics, and an MBA in Strategy.

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.

“It comes down to collaboration. It comes down to intentional communication and ensuring there is trust and familiarity on both sides.”

In this Let’s Talk Risk! conversation, Dr. Olaf Hedrich emphasizes the need for collaboration, building trust and familiarity between clinicians and engineers. We all have a mutual desire to do the right things for our patients, but sometimes our lens is a bit narrow. It is important to understand some of the technical side of our individual functions so we can learn to speak the same language and broaden the aperture on our collective view.

Clinicians should learn some of the technical language and concepts of risk, and engineers should gain exposure to the practice of medicine relevant to their device.

He shares a specific example of how clinicians can help uncover the true nature of risk and find innovative solutions to challenging problems. It is not unusual for harm to occur even when there is no device malfunction or defect. In these situations, clinicians can help understand the true nature of risk through peer-to-peer communication with other clinicians in the field directly involved with the device.

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

00:00:40 Introduction

00:01:30 Transitioning into a medical safety role from clinical practice

00:03:50 How clinicians can help understand the true nature of risk

00:06:25 Keeping the patient in the center of everything we do

00:07:57 How intentional communication and trust drives collaboration

00:08:50 Emerging challenges for MedTech in a rapidly changing environment

00:11:25 Career advice to industry professionals for growth in this new environment

00:14:27 Audience Q&A and open discussion

00:32:10 Closing comments and key takeaways

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

Suggested links:

LTR: Tips for clinicians transitioning into a medical safety role in MedTech.

LTR: Communicate to facilitate collaboration, not to impose opinions.

About Dr. Olaf Hedrich, MD

Dr. Olaf Hedrich is currently the Chief Medical Safety Officer at Medtronic. Previously he was at Boston Scientific in a career spanning more than 10 years in various roles of increasing responsibility. He transitioned into MedTech from his clinical practice as a cardiac electrophysiologist. He also served as instructor of medicine and clinical fellow at Tufts-New England Medical Center, and as instructor of medicine and chief resident at Saint Louis University. He is a Fellow of the Heart Rhythm Society and a Fellow of the American College of Cardiology.

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.

Summary

“PCCP is a great tool for your regulatory strategy but it is not for every company or for every change”.

PCCP (Predetermined Change Control Plan) is a new regulatory scheme that allows device manufacturers to implement post-market changes without requiring pre-market submission to the FDA.

In this episode, Yu Zhao explains how the PCCP tool offer…

“It is not just about protecting your data. It is also about protecting safety of a medical device.”

In this Let’s Talk Risk! conversation, Nidhi Gani highlights the important difference between data security and cybersecurity, especially for a life-saving medical device such as a pacemaker. As medical devices become more inter-connected, they are also increasingly vulnerable to cyberattacks. Managing the risk of these vulnerabilities is a key party of cybersecurity risk management of medical devices and healthcare systems they are a part of.

Although the regulatory environment is changing rapidly, Nidhi encourages risk practitioners to apply the same basic principles of medical device safety to cybersecurity. A best practice is to apply the secure product development framework (SPDF) across the entire lifecycle of a medical device.

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

00:01:25 Introduction

00:02:12 Why cybersecurity is important for medical devices

00:04:32 Medical devices today operate in a complex, connected environment

00:05:22 The SPDF approach to medical device development for cybersecurity

00:07:19 Current industry challenges in applying the SPDF approach

00:09:28 Cybersecurity challenges in the post-market phase

00:11:28 Exciting career opportunity for QA/RA professionals

00:15:13 Audience Q&A and open discussion

00:29:24 Closing comments and key takeaways

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

Suggested links:

AAMI TR57:2016: Principles for medical device security - Risk management, Revised 2023.

FDA: Cybersecurity webpage, Current as of March 2024.

LTR: Cybersecurity is the next frontier in medical device risk management.

LTR: Security risk assessment and vulnerability monitoring.

About Nidhi Gani

Nidhi Gani is currently a Cybersecurity regulatory affairs consultant at MCRA and an adjunct professor at Northeastern University. She holds a Bachelor’s degree in Biotechnology and Master’s degrees in Microbiology and Regulatory Affairs in Drugs, Biologics, and Medical Devices. She also has a certification in Cybersecurity from Harvard University. She applies her extensive technical and regulatory experience to help develop innovative solutions for medical device clients in this rapidly evolving space.

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.

“Technology has changed, we need to move with the technology change.”

In this Let’s Talk Risk! conversation, Leo Eisner shares a brief history of IEC 60601, the comprehensive global safety standard for active medical devices, and the work currently ongoing on the 4th edition. He is leading the group currently working on the user-interface aspects, which includes information provided by the manufacturer, usability, alarm system and also user interfaces aspects. There are a total of 12 working groups involved in various aspects of the standard, each focusing on a source of harm or hazardous situation.

Leo encourages risk practitioners in the industry to stay current with safety standards and consider taking an active role in the standards development process. This is a good way to be recognized as an industry expert and have an opportunity to shape the future direction of best practices.

Listen to this Let’s Talk Risk! conversation with Leo Eisner, the IEC 60601 Guy, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:25 Introduction

00:03:39 A brief overview and history of IEC 60601

00:06:30 A quick update on the work currently ongoing on the 4th edition

00:10:30 Reference documents for the 4th edition project

00:12:32 Why risk practitioners should get involved in standards development

00:14:25 Audience Q&A and open discussion

00:32:30 Closing comments and key takeaways

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

Suggested links:

IEC: Architectural specification for safety standards of medical electrical equipment, medical electrical systems, and software used in healthcare, v 3.0.

IEC: Design specification for the 4th edition of IEC 60601-1

About Leonard (Leo) Eisner

Leonard Eisner the “60601 Guy” is the Founder and Principal compliance/regulatory consultant at Eisner Safety Consultants. He has worked at 3 notified bodies and in the medical device industry for over 30 years. His career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417 and other Working Group (WG), Maintenance Teams, and committees. He is an expert member of the development teams on IEC 60601-1, edition 3.2, and currently leading one of the WGs, an expert member of an another WG, and on the editing team (AG50) involved in the 4th edition of the standard.

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.

“Before making a decision, we have to look at the issues end-to-end. We have to consider how our actions will impact the customer.”

In this Let’s Talk Risk! conversation, Rajesh Kathuria emphasizes the need to consider the full impact of our actions on safety of customers and users and quality of performance. As an example, when working at the component level, we should consider the impact of any changes at the system level and how it could affect the safety of end user or the patient.

Rajesh advises industry colleagues to take the emotions out, and rely on data as much as possible. If you don’t have good quality data, your first decision could be to take the time and gather more information, especially when the potential consequences of failure could be catastrophic. He also recommends to consider diverse viewpoints from a cross-functional experienced team as part of the decision making process.

Listen to this Let’s Talk Risk! conversation with Rajesh Kathuria which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:10 Introduction

00:05:42 Considering risks in decision making

00:08:25 An example of missing long-term factors in decision making

00:10:09 Taking a systems approach to finding solutions

00:12:13 An example of a difficult decision to delay a project to ensure safety

00:14:30 Difficult decisions require courage to do the right thing

00:16:30 Leadership advice for QA/RA professionals

00:17:50 Audience Q&A and open discussion

00:35:50 Closing comments and key takeaways

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

Suggested links:

LTR podcast: Understanding risk-based thinking

LTR podcast: Getting comfortable with a probabilistic way of thinking about risk

About Rajesh Kathuria

Rajesh Kathuria is a currently the Owner and Director at KMS Solutions, B.V, providing strategic consulting services in Quality and Regulatory for medical device companies. He is a seasoned leader with over 20 years of industry experience in senior leadership positions. He holds a Bachelors degree in Mechanical Engineering and Graduate degree in Management with specialization in International Marketing and Finance. He is also a certified ISO 13485 lead auditor and has extensive experience of auditing/working in various geographies and different global regulations.

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.

“There are 3 pillars I consider essential to defining a strategy for IVD risk management. What is the system definition, who are the user groups, and what is the level of novelty?”

In this Let’s Talk Risk! conversation, Claudia Campbell-Matland highlights the broad range of in-vitro diagnostic devices (IVD), which requires a strategic approach to their development and risk management.

Claudia advises IVD manufacturers to consider their risk management strategy and scope under 3 pillars - the system definition, the target user groups and the level of complexity. A simple, home-based IVD requires a very different approach than a highly complex analytical system used as a companion diagnostics for highly sophisticated immunotherapies.

She recommends taking some time to develop a business strategy first before jumping into product development and risk management activities.

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

00:01:33 Introduction

00:03:03 Strategic questions to ask for IVD risk management

00:05:10 3 pillars of IVD risk management strategy

00:06:45 Example of a strategy for a simple point-of-care assay IVD

00:08:31 Special considerations for home-based IVDs

00:09:20 Leadership opportunity for QA/RA professionals in setting strategy

00:10:15 Practical tips for assigning severity and probability for IVD risks

00:12:51 Latest update on LDTs

00:14:50 Audience Q&A and open discussion

00:35:50 Closing comments and key takeaways

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

Suggested links:

LTR podcast: Focus on intended use in the clinical environment for IVD risk management

LTR podcast: Risk management of IVDs requires a different approach

About Claudia Campbell-Matland

Claudia Campbell-Matland is a consultant and managing member at CNCM Consulting LLC providing services to medical device and IVD manufacturers in product development, risk management, project management and strategy development. She has nearly 30 years of experience in the clinical space at various global organizations. She holds a Masters degree in Microbiology and Bachelors in Biology, as well as multiple certifications in auditing and project management.

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.

“To be able to see a virtual image over the real world - that augmented reality is - is a mind blowing, very different experience.”

In this Let’s Talk Risk! conversation, Phil Deming shares some of the unique human factors engineering challenges for an augmented reality (AR) technology for 3D visualization of human anatomy in real time during a medical procedure.

Phil advises manufacturers to stay current with rapidly evolving new technologies, and talk to users in their intended environment to figure out how best to deploy a system so it does not interfere with their standard work flow. This is the essences of human factors engineering, which involves developing a solid understanding of how users interact with a system and minimizing risks at the user interface.

He also shares some of the differences between usability engineering according to IEC 62366 and FDA guidance for human factors engineering.

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

00:01:40 Introduction

00:02:30 Human factors engineering in medical industry vs. consumer electronics

00:05:15 Introducing AR technology to visualize human anatomy in 3D space

00:07:15 Human factors considerations for AR technology

00:08:42 Considering use-related risks associated with AR technology

00:10:05 Tackling new challenges in human factors emerging with technology

00:11:35 Audience Q&A and general discussion

00:30:52 Closing comments and key takeaways

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

Suggested links:

Understanding risk-based thinking

MediView XR: OmnifyXR holographic display with real-time imaging and 3D anatomy visualization.

FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices, issued February 2016.

IEC 62366-1:2015: Application of usability engineering to medical devices, issued 2015.

LTR podcast: Treat human factors as a driver of customer satisfaction, not a check-the-box activity, August 2024.

About Phil Deming

Phil Deming III is a human factors engineer at MediView XR, Inc., a digital health company that leverages augmented reality, remote connectivity and spatial computing data to create revolutionary surgical navigation and tele-procedure platforms. He has over 20 years of usability and human factors, first in the consumer electronics, later transitioning into medical devices. He holds a Bachelors degree in Business Management, Marketing and related support services, and a certification in Automotive Engineering Technology.

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.

“It’s too often confused with risk management itself. Part of the risk-based approach is just the mindset, the thinking about risk, and then deciding ‘so what should we do?’, the answer to which might be a formal risk management.”

In this Let’s Talk Risk! conversation, Steve Gompertz clarifies a subtle difference between a risk-based approach and formal risk management according to standards such as ISO 14971. Risk-based approach is more about a mindset and a set of behaviors that lead to risk-based decisions, rather than application of specific risk management tools such as FMEAs.

Steve advises manufacturers to consider adding a section in each procedure to describe a risk-based approach appropriate to that process. Another good practice is to create an alignment matrix to map differences in the risk-based approach to different processes of the quality system.

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

00:01:40 Introduction

00:03:38 What is risk-based approach and why it is not the same as risk management

00:06:22 How to practice and demonstrate a risk-based approach

00:08:15 A practical way to document risk-based approach

00:11:23 How auditors assess the practice of risk-based approach

00:13:41 Striking the right balance between documentation and operating culture

00:17:38 Audience Q&A and general discussion

00:32:57 Closing comments and key takeaways

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

Suggested links:

Understanding risk-based thinking

Risk-based approach to building a QMS in a startup

Tips for applying a risk-based approach to auditing Quality Systems

About Steve Gompertz

Steve Gompertz is a Partner at QRx Partners, providing consulting services to medical device companies in quality system assessment, development and remediation, audit preparation, SOP and forms development, regulatory body response guidance and quality system education. He has over three decades of industry experience at many leading organizations including Medtronic, Boston Scientific and Canon. He is also a Senior Adjunct Instructor at St. Cloud University. Steve has a Bachelor’s degree in Mechanical Engineering, a mini-MBA certificate in Medical Technology, and multiple certifications including ASQ Manager of Quality/Organizational Excellence, Medical Device Auditor, EU-MDR auditor and MDSAP.

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.

“Don’t be comfortable saying, ‘Oh I follow the ISO (13485) to the letter’; it doesn’t matter. You have to comply with 21 CFR 820.”

In this Let’s Talk Risk! conversation, Neil Di Spirito, helps us understand the full legal context behind the Quality Management System Regulation (QMSR), the amended version of 21 CFR 820 that will go into effect in February 2026.

Although, the QMSR incorporates the International Standard ISO 13485:2016 by way of reference, there are points of differences and additional requirements for compliance to 21 CFR 820.

That is why it is important to carefully consider gaps from the current QSR against the full scope of QMSR, not just ISO 13485 requirements. It is not simply a technical matter, but also a legal matter that manufacturers should consider evaluating with help from a legal expert.

Neil advises manufacturers to consider operating two parallel processes right up to the exact date of QMSR enforcement, gain working experience to appropriately modify their approach for compliance. A good way to do this is through a Quality Plan.

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

00:02:45 Introduction

00:06:45 The legal basis of 21 CFR 820 modification to QMSR

00:11:20 QMSR lowers the compliance burden by harmonization with ISO 13485

00:15:59 Recommendations for manufacturers to prepare a transition to QMSR

00:18:50 Audience Q&A and general discussion

00:32:28 Closing comments and key takeaways

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

Suggested links:

FDA: Frequently asked questions about QMSR

LTR webinar: Getting ready for QMSR

About Neil Di Spirito

Neil Di Spirito is the Principal at DiSpirito Law, PLLC, where he represents pharmaceutical, biologic and medical device companies in regulatory, commercial and FDA enforcement defense matters. He has 20+ years of industry experience in various roles including business management with P&L responsibility. He teaches introductory courses in pharmaceutical and medical device law to FDA new hires and industry legal professionals. He holds an MBA degree with specialization in Pharmaceutical Marketing and Management, and a Juris Doctor, Law degree.

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.