Episodios
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This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com
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…
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“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.
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 -
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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…
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 -
“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.
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 -
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com
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 …
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“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.
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 -
“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.
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 -
“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.
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 -
“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.
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 -
“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.
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 -
“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.
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 -
“There is a growing awareness that if you bring in Regulatory at the beginning of designing a product, you will end up with a more robust product.
In this Let’s Talk Risk! conversation, Christine Zomorodian highlights some of the barriers that have traditionally hindered good communication and collaboration between QA/RA and Engineering functions in MedTech. However, she also points out that there is reason to be optimistic about the future.
Gender roles are changing, with more women entering Engineering and an increasing number of men choosing the QA/RA profession due to availability of graduate level academic programs. Company cultures are also adapting to big advances in compliance infrastructure technologies and the rapidly changing regulatory landscape. Together, these really underscore the importance of open communication and cross-functional collaboration.
A good tool to foster collaboration is a Quality Plan, which continues to be under-utilized in our industry. But a Quality Plan can help your entire team come together to figure out how you could efficiently achieve a desired goal, whether it is a remediation project or developing a suitable quality system in a startup environment.
Listen to this Let’s Talk Risk! conversation with Christine Zomorodian, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:01:59 Introduction
00:05:06 An example of impact of poor cross-functional collaboration
00:08:36 Traditional barriers to cross-functional collaboration in MedTech
00:12:05 Optimistic trends helping to improve communication and collaboration
00:14:00 Audience Q&A and general discussion
00:29:00 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
Tips for improving collaboration in risk management
Collaboration is the secret sauce for success in risk management
About Christine Zomorodian
Christine Zomorodian is the Founder and Managing Consultant at Gish Consulting, LLC, advising MedTech companies in regulatory strategy, quality assurance, regulatory affairs and engineering process improvement. She also serves as a Person Responsible for Regulatory Compliance (PRRC) for EU-MDR compliance, and a guest lecturer at University of Washington. She has over 25 years of industry experience in various QA/RA roles at multiple global medical device companies. She holds a B.A. degree in International Affairs with concentration in Biology and Communication, and a M.S. degree in Biomedical Regulatory Affairs.
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 -
“There is a tendency for human factors to be very closely tied to regulatory requirements and nothing else, but human factors as a core discipline is about user-centered design.”
In this Let’s Talk Risk! conversation, Korey Johnson highlights how the current practice of human factors engineering in the medical device industry is mainly driven by regulatory requirements, which often leads to a check-the-box approach and nothing more.
But human factors is more about applying a user-centered design philosophy starting from early feasibility and throughout the product development process.
“Are we designing the right thing, and how do we design the thing right to be able to used well by people, not just safe and effective, but does it drive satisfaction?”
When viewed as a driver of customer/satisfaction, a user-centered design approach can deliver a sustainable competitive advantage.
Listen to this Let’s Talk Risk! conversation with Korey Johnson, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:01:47 Introduction
00:04:25 Regulatory emphasis on human factors in medical devices
00:06:45 Barriers to implementing user centered design philosophy
00:08:20 Connecting with risk management and design controls
00:10:15 Assessing impact of changes in software, AI/ML enabled devices
00:14:30 Why human factors must be integrated throughout product development
00:16:50 Audience Q&A and general discussion
00:37:30 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
AI and UX: Why artificial intelligence needs user experience, Published 2020.
FDA: Applying human factors and usability engineering to medical devices, Published February 2016.
ISO: IEC 62366-1:2015; Application of usability engineering to medical devices, Published 2015.
About Korey Johnson
Korey Johnson is the Managing Partner at Bold Insight, a leading research and consulting agency providing services in UX research, usability testing and human factors engineering. With over 25 years of industry experience, Korey is passionate about transforming the practice of human factors engineering in medical devices through empowerment, creativity and collaboration. He holds a B.S. degree in Psychology and an M.S. in Human Factors Psychology.
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 -
“There is a very strong push (in the EU) to look at threshold values and acceptance criteria in the clinical evaluation, and these acceptance criteria for benefit risk have to be based on the state of the art.”
State of the art (SoTA) is a very important topic in the medical device industry, because it is directly connected to risk acceptability and benefit-risk evaluation, which in turn, is directly tied to safety and effectiveness for regulatory purposes.
But what is SoTA and how do you define it for your medical device?
In this Let’s Talk Risk! conversation, Chris Whelan helps us understand the nuances of SoTA and encourages us to consider both the engineering and clinical aspects of SoTA for our devices. Also, remember that it is an iterative process and you may have to review SoTA throughout the development process and even after product launch in the post-market process.
Listen to this Let’s Talk Risk! conversation with Chris Whelan, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:00 Introduction
00:03:26 Definition of State of the art (SoTA)
00:04:57 Understanding SoTA in the context of intended use and standards
00:06:17 Two aspects of SoTA - engineering and clinical state of the art
00:06:53 How to define the SoTA for your product
00:10:20 When to start defining SoTA during product development
00:11:51 Does clinical SoTA depend on standard of care in different markets?
00:14:13 Audience Q&A and general discussion
00:31:25 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
LTR Podcast: Clinical evaluation is a lifecycle process, not a one-time activity
FDA Guidance: Appropriate use of voluntary consensus standards
ACHIEVE: Risk management fundamentals on-demand training which covers 25 key terms and basic concepts, including state of the art, for medical devices.
About Chris Whelan
Chris Whelan is currently the New Product Development Manager at ITL BioMedical where he leads multiple global engineering teams. He has nearly 20 years of industry experience in medical device design, engineering and project management, as well as teaching experience at a university. Other areas of expertise include design controls, usability engineering and risk management. He holds a B.S. in Industrial Design from the University of Technology, Sydney, Australia.
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 -
“You can get a lot of valuable insights from the FDA on what your regulatory pathway is when it comes to risk, and how that impacts not only the risk of the product but how you set up your quality systems and what you need to implement in the long run. ”
In this Let’s Talk Risk! conversation, Amit Guruprasad shares how small medical device manufacturers and startups can take advantage of the free pre-sub program to get early feedback from the FDA to inform their regulatory strategy and plans for collecting data to prove safety and effectiveness in their final regulatory submission.
But it requires a strategic approach and preparation before you meet with the FDA. As an example, you should plan to get FDA feedback on your proposed approach and not seek yes/no answers.
Listen to this Let’s Talk Risk! conversation with Amit Guruprasad, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:12 Introduction
00:04:20 FDA’s Q-Sub program, pre-submissions and risk determination
00:07:11 How to prepare for a pre-sub meeting with the FDA
00:10:05 Develop a strategic plan for pre-sub meetings with FDA
00:12:05 Plan to get feedback on the approach and not answers to yes/no questions
00:12:50 Lessons learned from a recent pre-sub meeting
00:14:25 Audience Q&A and general discussion
00:31:25 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
The Q-Submission Program: FDA guidance for requesting a meeting for feedback on medical device submissions.
DICE: FDA’s division of industry and consumer education.
LTR webinar on post-market surveillance
About Amit Guruprasad
Amit Guruprasad is the founder of Devan MedTech Solutions, where he provides quality and regulatory consulting services to medical device companies and startups. He has over 10 years of professional experience in R&D, quality and regulatory affairs at various medical device companies. He holds B.S. and M.S. in Biomedical Engineering.
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 reality is that, today, a lot of people are studying medicine to go into industry. But if your curriculum do not include areas like risk management, cross-functional collaboration, dFMEA and all of that, then transition for that position is going to be slower.”
In this Let’s Talk Risk! conversation, Dr. Juan Daccach shares his personal journey of transitioning into a medical safety role in MedTech as a practicing orthopedic joint reconstruction surgeon. He advises clinicians aspiring to transition into a Medical Safety role to proactively bridge gaps in their medical training and experience for success.
As an example, clinicians are trained to focus on the worst case and minimizing its impact on an individual patient. Managing risks of a medical device, on the other hand, is not just about the worst case scenario. It is about striking a positive balance between benefit and risk.
There is no quality without safety, and there is no safety without quality.
That is why broadening your view of a medical device, how it is developed and what it takes to bring it to market, is important for success. There is a need to include these topics into medical curriculum and continuing education.
Listen to this Let’s Talk Risk! conversation with Dr. Juan Daccach, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:11 Introduction
00:08:32 Overcoming challenges when transitioning as a clinician into MedTech
00:12:18 Learning to speak the language of Quality and Regulatory
00:15:00 Challenges in integrating Medical Safety with QA/RA function
00:18:11 Audience Q&A and general discussion
00:31:25 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
Fundamentals of Risk Management: An introductory on-demand course for medical device risk management on ACHIEVE.
About Dr. Juan Daccach, MD
Juan Dacach, MD is currently the Vice President of Product Safety at Metz Aesthetics. Previously he was in various leadership positions in Medical Safety and Medical Affairs at various leading MedTech companies. He specialized in Orthopedics and trauma during his medical training, residency and fellowship as an MD. As part of his continuing education in the industry, he also acquired certifications in quality, auditing, coaching and leadership communication.
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 -
“Show me the indicators, show me the KPIs and I will show you the results.”
Resiliency starts at the top. Misaligned incentives often lead to unintended and disastrous consequences. Recently, the Federal Aviation Administration (FAA) in the US grounded 171 Boeing 737-9 MAX planes following a mid-air incident where a cabin door blew open, exposing hundreds of passengers to a serious hazardous condition. The issue was traced to gaps in quality and inspection of components from suppliers.
Similar to the aviation industry, supply chains in the medical device industry are also complex and fragmented. In this conversation, Marco Felsberger emphasizes the need for focusing on supply chain resiliency, and not just managing individual suppliers. He encourages us to consider a systems view to understand various interactions and constraints, and simulate scenarios to identify potential vulnerabilities.
Listen to this Let’s Talk Risk! conversation with Marco Felsberger, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:15 Introduction
00:04:35 Why supply chain resiliency is critical in a complex world
00:06:40 How misaligned incentives create supply chain vulnerabilities
00:10:10 What we can learn from the automotive industry
00:12:33 Applying systems thinking to improve supply chain resiliency
00:17:01 Audience Q&A and general discussion
00:31:25 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
On the Edge of Resilience: Marco’s Substack publication
About Marco Felsberger
Marco Felsberger is a resilience and risk manager with over 20 years of experience across diverse industries including banking and consumer products. He is currently a Senior Advisor of Supply Chain Resilience at Prewave, specializing in risk and resilience management, business continuity strategies, crisis management protocols and security management. He holds a B.Sc. degree in Integrated Security & Safety 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.
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 -
“As professionals in these areas, we are so versed in regulations that we get so deep into the woods with management that 30 seconds after you start speaking, they are gone! They can’t even think about it anymore.”
Know your audience, prepare your topic and respect your listener.
Victor Mencarelli shares these 3 tips for effective communication in this Let’s Talk Risk! conversation.
Remember, effective communication is about connecting and making sure your message is heard. It is not meant to be an information dump on your audience. That is why, it is important to carefully consider the perspectives and preferences of your target audience. To some, details are important. Others want you to be brief, be quick and be gone!
Listen to this Let’s Talk Risk! conversation with Victor Mencarelli, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:13 Introduction
00:03:20 New regulation for personal care products as OTC products
00:05:40 Challenges for QA/RA professionals in communicating with senior leaders
00:07:15 An example of effective communication
00:08:35 An example of ineffective communication
00:11:46 Can we learn to be good communicators?
00:14:50 Audience Q&A and general discussion
00:29:20 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
Supercommunicators: How to unlock the secret language of connection, by Charles Duhigg
About Victor Mencarelli
Victor Mencarelli is currently the Director of Regulatory Affairs at Orveon Global where he leads all aspects of international regulatory affairs including registration, documentation and formulation review for new startup venture capital backed businesses in the cosmetics and personal care industry. He has more than 25 years of industry experience specializing in microbiology, toxicology and regulatory affairs. He holds a B.S. degree in Biology and an M.S. in Biotechnology regulatory affairs.
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 first thing I do whenever I am starting design control or risk is that I make sure that the intended use and the indication of the device are as nailed down as they can be.”
Yes, design control and risk management can be challenging, especially in a startup or a small medical device company. Generally, there is just one person, a “team of one”, responsible for setting up the entire quality system and the risk management process.
That is why Becki Hiebert advises practitioners to focus on the intended use first. Get to know what your device is supposed to do, where, on whom, and who interacts with it, to set the framework for your quality system. She recommends following the steps outlined in ISO 14971 for risk analysis, and involving your medical/clinical subject matter experts as early in the design process as possible.
Listen to this Let’s Talk Risk! conversation with Becki Hiebert, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.
00:02:20 Introduction
00:04:32 How to succeed as a “team of one” in a startup
00:06:24 Getting started with design controls and risk management in a startup
00:08:41 Best practices for following ISO 14971 steps in risk analysis
00:12:31 Connecting risk analysis to design controls
00:14:15 Lessons learned in managing cybersecurity risk
00:17:05 Overcoming challenges in risk management documentation
00:19:57 Audience Q&A and general discussion
00:30:19 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
About Becki Hiebert
Becki Hiebert is currently a consultant specializing in implementation and improvement of quality management systems in medical device industry in compliance with ISO 13485, 21 CFR 820 and MDSAP. In her 10+ years of professional experience across both pharmaceutical and medical device industries, she has developed a hands-on expertise in regulatory requirements for current good manufacturing practices. She has served in a variety of roles in quality planning, process improvement, internal audits, quality system training and supplier/purchasing programs.
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 regulatory landscape is changing significantly and it is too hard to keep up.”
That is why Jennifer Mascioli-Tudor advises risk practitioners to be “super proactive” in following these rapid changes, understand the impact, and take a leading role in preparing their organizations.
In this Let’s Talk Risk! conversation, we focus on three big trends in MedTech - the shift from Quality System (QS) regulation to Quality Management System Regulation (QMSR), a new regulatory focus on cybersecurity in medical devices, and shifting regulations of lab developed tests (MDT).
Listen to this Let’s Talk Risk! conversation with Jennifer Mascioli-Tudor, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.
00:02:30 Introduction
00:04:00 Trend 1: Shift from QSR to QMSR in the US
00:07:40 Trend 2: Regulatory focus on cybersecurity in medical devices
00:10:30 Trend 3: Regulating Lab Developed Tests (LDT) in the US
00:13:10 General discussion: Learning opportunities at universities
00:33:07 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
Suggested links:
* UC San Diego: Regulatory Affairs for Medical Devices
* Pathway for patient health
* Drexel University: Doctoral program in Biomedical Engineering
About Jennifer Mascioli-Tudor
Jennifer Mascioli-Tudor is currently the Founder and Principal Consultant at JMT consulting offering advisory services to MedTech startups and small manufacturers in business, regulatory and quality management strategy. She is also an instructor at UC San Diego where she teaches regulatory fundamentals and design controls. Her industry experience includes leading roles at J&J, Boston Scientific, Medtronic and GE. She holds a B.S. degree in Physiology/Chemistry/French, and an MBA in Global Business Management.
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 - Mostrar más
