By Casual and informal conversations about practical aspects of medical device risk management.
The podcast currently has 70 episodes available.
Summary
“Apply the usability engineering process diligently, and with the spirit of inquiry. You will learn things that you never thought. And these are the things that make your device possible”.
Human factors engineering, or usability engineering, is often thought of as a check-the-box activity for the purpose of regulatory compliance. But it is a lot …
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.
Summary
“Medical devices are now increasingly connected in a hospital network. Or even if they are not, they are vulnerable to cyber attacks”.
In this episode of the Let's Talk Risk Podcast, Eric Henry highlights the growing concern about security and cybersecurity of medical devices. As technology evolves and medical devices increasingly operate in an i…
“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.
The podcast currently has 70 episodes available.