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You cannot bolt cybersecurity onto a medical device at the end of development.

FDA’s cybersecurity guidance makes a clear shift: cyber risk is now a quality system issue, a patient safety issue, and a lifecycle management issue. For connected and software-enabled devices, it is not enough to show that the software works as intended. Manufacturers also need to show how cybersecurity risks were identified, controlled, verified, traced to patient harm, and managed after release.

In this audio summary, we walk through why FDA’s expectations go beyond submission documentation and why QA/RA teams need to understand the practical connections between SPDF, threat modeling, SBOMs, vulnerability management, postmarket patching, and the medical device QMS.

Key highlights covered in the audio:

* Why cybersecurity now needs to be treated as part of the medical device QMS

* How Section 524(b) changes expectations for “cyber devices”

* Why cyber risk needs to connect to patient harm, not just IT vulnerability

* How SPDF, threat modeling, architecture views, and testing evidence fit together

* Why machine-readable SBOMs and VEX documentation matter for vulnerability management

* How postmarket patching, CVD, and cybersecurity management plans create lifecycle obligations

Keywords:

FDA cybersecurity guidance, medical device cybersecurity, cyber device, SPDF, SBOM, medical device QMS, cybersecurity risk management, patient safety, postmarket cybersecurity.

🎧Click Play above to listen to a brief audio summary about this case and lessons QA/RA and Clinical professionals can apply in practice using the newly released FDA Guidance.

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Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis:

* FDA (2026, February 3), Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Final Guidance, FDA.

* Apotech Consulting. (2026, May 14). The Software Bill of Materials (SBOM): What Every SaMD Manufacturer Needs to Know. Apotech Consulting.

* Espinosa, C. (2026). 12 Reasons the FDA Rejects Cybersecurity Submissions. Blue Goat Cyber.

* Al-Faruque, F. (2026, February 4). FDA reissues cybersecurity guidance to align with QMSR. Regulatory Affairs Professionals Society (RAPS).

* Exponent. (2026, April 6). Navigating FDA's Cybersecurity in Medical Devices Guidance. Exponent.

Summary

“The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.”

In this special episode of the Let’s Talk Risk! conversation, host Naveen Agarwal brings together a panel of medtech safety and risk management leaders to discuss key takeaways from IMSC26 in Boston.

The conversation highlights why the conference has become a unique gathering place for the medtech safety community: a forum where risk, quality, regulatory, clinical, and engineering professionals can speak a shared language and challenge each other’s thinking.

The panel explores several major themes: moving beyond compliance, bringing patient perspective into risk management, understanding QMSR as a shift toward risk-based quality systems, strengthening judgment and critical thinking, and using AI as a thinking partner rather than a replacement for expertise.

Listen to the full 47-minute podcast or jump to a section of interest listed below.

Chapters

00:00 – Introduction and Panel Overview01:23 – Bijan Elahi on the Growth and Vision of IMSC06:23 – Proactive Safety from Clinic to Home08:28 – Patient Safety as the Central Stakeholder Theme10:15 – FDA, QMSR, and the Shift Toward Risk-Based Thinking18:53 – Design Control, Agile Software, and Surgical Robotics22:11 – Hidden Influences, Judgment, and Psychological Safety34:26 – AI as a Tool, Not a Replacement for Expertise40:00 – Career Day, Final Takeaways, and IMSC27 Preview

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Suggested links:

LTR: Tips for Improving Collaboration in Risk Management.

LTR: From Procedures to Judgment - Leading Through QMSR Inspections.

LTR: LTR Risk Coach - AI-Powered Decision Support Tool.

Key Takeaways

* IMSC has become a true medtech safety community.The conference gives risk professionals a rare space to connect, compare experiences, and realize they are not alone in the challenges they face.

* Patient safety must be more than a slogan.The panel emphasized that patient perspective needs to show up directly in risk management, especially where traditional harm categories may miss emotional, psychological, or lived-experience impacts.

* Risk management is not just a compliance exercise.It is a human practice that requires collaboration, judgment, shared language, and cross-functional maturity.

* QMSR raises the bar for risk-based thinking.The discussion framed QMSR as a move toward connected quality systems where FDA may look at whether decisions, processes, and subsystems work together around patient safety.

* Judgment cannot be fully proceduralized.Procedures matter, but good risk decisions also require critical thinking, psychological safety, leadership, and comfort with ambiguity.

* AI can strengthen risk thinking, but it cannot replace expertise.The panel warned against over-reliance on AI while recognizing its value as a tool to organize thinking, challenge assumptions, and preserve institutional knowledge.

Keywords

IMSC26, medtech safety, medical device risk management, patient safety, QMSR, FDA, risk-based thinking, quality culture, critical thinking, AI in medtech, design control, safety architecture, patient perspective, regulatory strategy, risk management maturity

Guest Speakers

Bijan Elahi as an award-winning medical device risk management author, professor and consultant.

Dr. Olaf Hedrich is the Chief Medical Safety Officer at Medtronic.

Michelle Lott is an executive advisor in regulatory strategy, principal and founder at LeanRAQA, LLC.

Aaron Joseph is a principal consultant at Sunstone Pilot.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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 other Friday on LinkedIn.

Disclaimer

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

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Summary

“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”

In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Dr. Omar Al Kalaa to talk about one of the most important emerging frontiers in MedTech: remotely controlled medical systems. From telesurgery to connected infusion therapy, these technologies are expanding what is possible in patient care—but they also introduce a very different kind of system risk.

Omar brings a rare perspective at the intersection of medical devices and telecommunications. We explore why the real issue is not just connectivity, but control; why access to care is a major driver of these technologies; and why companies entering this space must think beyond the device itself to the broader ecosystem of networks, partners, responsibilities, and safeguards.

Chapters

00:00 – Introduction01:56 – What “remote control” really means in MedTech04:36 – Telesurgery vs. interoperable connected care systems08:30 – Why access to healthcare is driving adoption11:31 – Connectivity failure modes and misunderstood telecom concepts13:47 – What fail-safe means in a telesurgery environment18:24 – Risk ownership, contracts, and service level agreements22:01 – How sponsors should think about FDA for novel connected systems30:13 – Practical advice for engaging FDA in a stressed environment32:35 – Why partnership, not silos, will shape the future of this field

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

Suggested links:

* LTR: Wireless coexistence and risk in connected medical devices.

* LTR: A new paradigm for building connected medical devices.

* Advent Health News: Historic telesurgery connects Central Florida and Angola in world-first medical breakthrough.

Key Takeaways

* Remotely controlled medical systems are defined by control across distance, not just data transfer.

* Access to healthcare is one of the strongest drivers behind telesurgery and other remote-care models.

* The biggest risks are not limited to “connectivity problems”; they include misunderstood failure modes, unclear terminology, and weak cross-functional alignment between medical and telecom teams.

* Fail-safe behavior cannot be defined in the abstract. It depends on intended use, clinical context, and what the system should do when communication degrades or fails.

* In distributed systems, risk ownership is shared. That makes contracts, partner roles, and service expectations critical design inputs—not afterthoughts.

* FDA is still asking the same core questions it always does: is the system safe, and is it effective? The challenge is showing evidence across components the sponsor does not fully own.

* Sponsors should engage FDA early, bring a structured plan, and ask targeted questions grounded in a clear understanding of the broader ecosystem.

* The future of this space will belong to organizations that can collaborate across silos instead of trying to build everything alone.

Keywords

Telesurgery, remotely controlled medical systems, connected medical devices, healthcare connectivity, telecom, system safety, interoperability, risk ownership, service level agreements, FDA, IDE, systems engineering, cybersecurity, access to care

About Omar Al Kalaa

Omar Al Kalaa is the Founder and Principal of Inovectrum, a technology advisory and innovation practice bridging MedTech and telecom. He advises companies on the design and deployment of high-performance connectivity solutions for medical devices, clinical environments, and digital health systems.

The team at Inovectrum supports clients across the full product lifecycle, from early design decisions through regulatory strategy and FDA submissions, with a focus on how connectivity, EMC, and system behavior translate into real-world performance. The practice also extends into interoperability and electrical safety, enabling a more complete evaluation of devices as they operate within complex, interconnected environments.

Before founding Inovectrum, Omar spent over eight years at the FDA, where he led regulatory science initiatives on 5G-enabled medical devices, developed wireless coexistence standards, and guided industry on complex compliance challenges. With a PhD in Electrical and Computer Engineering from the University of Oklahoma, he combines deep technical expertise with regulatory insight to advance future-ready connected health technologies.

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.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Summary

“You are not gong to lose your job to AI, but you may lose your job to someone who knows how to use AI better than you do”.

In this episode of the Let's Talk Risk Podcast, we explore the benefits of applying Generative AI to improve consistency of quality system documentation in MedTech with Garth Conrad, VP of Quality at Flex Health Solutions.

G…

Applications of AI in medical devices are growing rapidly. The regulatory environment in both the US and the EU is also changing fast. In this dynamic environment, it is important to stay updated and practice a flexible approach to both risk management and your regulatory strategy.

Listen to a brief audio summary above, about the emerging regulatory environment in these two major jurisdictions, and key takeaways for risk practitioners and regulatory professionals.

Regulatory environment is changing rapidly but there is new guidance

There is good news! A new guidance document in the form of a questionnaire was recently published by the Team-NB, the European Association of Medical devices Notified Bodies. The joint Team-NB/IG-NB Questionnaire on Artificial Intelligence in Medical Devices offers device manufacturers a process-oriented roadmap to demonstrate conformity to the EU-MDR (or EU-IVDR) requirements.

The term risk(s) appears 50 times in this questionnaire, highlighting the significance of risk management as a critical factor in ensuring safety and effectiveness of AI devices throughout their lifecycle. Out of a total of 189 questions across 26 categories, 32 (17%) are explicitly related to risk management!

FDA’s regulatory approach is considerably less prescriptive and more collaborative. The regulatory framework for the pre-market review is no different for AI-enabled devices compared to medical devices in general, including Software as a Medical Device (SaMD). A majority of nearly 1000 AI/ML enabled devices have been authorized as Class II devices, either through the De Novo, or the 510k pathway. The most important requirement is to demonstrate safety and effectiveness through valid scientific evidence that benefits of the intended use outweigh probable risks.

Let us take a closer look at the emerging regulatory environment in the US and EU

First, there is broad alignment at a high level between FDA and the EU

At a high level both FDA and notified bodies are generally aligned on the need to demonstrate safety and effectiveness of AI-enabled medical devices. Here are 3 specific areas of convergence in these two :

1. Focus on safety and effectiveness

Both the FDA and the European approach, reflected by Team-NB, prioritize patient safety and the effectiveness of AI-enabled medical devices.

2. Recognition of AI’s unique challenges

Both recognize that AI presents unique regulatory challenges due to its complexity, iterative nature, and reliance on data.

3. Importance of real-world monitoring

Both emphasize the need for ongoing monitoring of AI-enabled devices in real-world settings to ensure safety and performance.

Second, the Team-NB approach focuses on certifiability using a process-oriented questionnaire

1. Process-oriented approach for safety

The European approach, as evidenced by the questionnaire, focuses on ensuring the safety of AI-based medical devices through a comprehensive evaluation of processes throughout the device lifecycle.

2. Detailed requirements and documentation

The questionnaire outlines specific requirements for documentation, competence of development teams, risk management, data management, model development, and post-market surveillance.

3. Emphasis on certifiability

The questionnaire highlights the challenges of certifying AI-based medical devices, particularly those with self-learning capabilities, and emphasizes the need for robust validation processes.

4. Consideration of AI-specific security risks

The questionnaire addresses AI-specific cybersecurity risks like adversarial attacks and emphasizes the importance of security lifecycle management.

Finally, FDA’s approach is more collaborative and adaptive

1. Collaborative and adaptive

The FDA emphasizes collaboration with stakeholders (developers, patients, academia, global regulators) and a commitment to adapt regulations to the rapidly evolving AI landscape.

2. Focus on bias mitigation and health equity

The FDA prioritizes addressing bias in AI algorithms and promoting health equity by ensuring data representativeness.

3. Emphasis on lifecycle management

The FDA stresses the importance of managing AI applications throughout the medical product lifecycle, from design to deployment, monitoring, and maintenance.

4. Commitment to guidance and regulatory science

The FDA is actively developing guidance documents and supporting research to address the unique challenges of evaluating and regulating AI in medical products.

Key takeaways for risk practitioners and regulatory professionals

In this rapidly changing environment, it is very important for risk practitioners and regulatory professionals to stay current with evolving regulatory approaches. Here are 3 key takeaways to keep in mind:

1. Practice a flexible and adaptable approach to risk management

Risk practitioners and regulatory professionals need to stay informed of the latest developments and adjust their practices accordingly. They must also anticipate future changes and build flexibility into their risk management frameworks and compliance strategies.

2. Understand and address bias in AI systems

Identifying and quantifying bias in AI systems can be complex. Risk practitioners and regulatory professionals need to develop robust methodologies for assessing bias and its potential impact on patient safety and health equity. This includes understanding the sources of bias in training data, evaluating the fairness of AI algorithms, and implementing strategies for monitoring and mitigating bias in deployed systems.

3. Apply a tailored approach to address regulatory concerns in each market

The FDA is primarily focused on the end product and its intended use, while the EU is taking a more process-oriented approach that emphasizes the entire AI lifecycle. These differing approaches may lead to varying risk profiles and require adjustments to risk management strategies depending on the target market. Risk practitioners and regulatory professionals need to carefully consider these differences and develop tailored strategies that meet the specific requirements of each jurisdiction.

In conclusion

It is clear that AI applications in MedTech are going to continue growing. We are still in the early phase of AI applications, especially in healthcare.

At the same time, the regulatory environment is evolving rapidly. Both the FDA and the EU are moving fast to catch up with technology. While a focus on safety and effectiveness remains as the centerpiece of the regulatory approach, there are distinct differences in these two major jurisdictions. Good news is that new guidance from these regulators is coming out to clarify their latest thinking.

Risk management is an essential aspect of regulatory focus. There are new and emerging concerns about risks associated with AI/ML devices. Risk practitioners and regulatory professionals must stay current, and develop flexible, adaptable and tailored strategies to respond to this dynamic regulatory environment.

Disclaimer

This article was prepared with the help of Google NotebookLM, an artificial intelligence enabled research assistant, using the following sources:

* FDA white paper: Artificial Intelligence & Medical Products.

* Team-NB - Questionnaire: Artificial Intelligence in Medical Devices.

* FDA: Good Machine Learning Practice for Medical Device Development.

* IMDRF: Good machine learning practice for medical device development.

* Notes created using Google NotebookLM in response to user prompts

All output(s), including the audio summary, were reviewed by a human for accuracy and relevance. This article is intended for educational purposes only and should not be considered as regulatory advice.

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“The classic thing with AI is that the hard stuff is easy and the easy stuff is hard. It can do math I cannot do, but it cannot do the reasoning I find easy.”

In this Let’s Talk Risk! conversation, we discuss key challenges and opportunities for applying Artificial Intelligence/Machine Learning (AI/ML) in MedTech. This was an open conversation with a live audience as part of the weekly Let’s Talk Risk! conversation on LinkedIn.

AI/ML applications in MedTech are growing rapidly. FDA has authorized nearly 1000 such applications, and this trend is only expected to grow. Our conversation included a variety of topics about this rapidly evolving field.

This discussion involved comments from Emanuel Tkach, MD, Bijan Elahi, Edwin Bills, Rafael Pozos, Wag Hanna, Phil Deming, Andy David and Ritam Priya.

Jump to a section of interest using these timestamps.

00:03:30 Key factors related to AI/ML applications in MedTech

00:05:30 Dynamic nature of AI/ML causing performance drift

00:07:30 Upcoming ISO guidance on risk considerations for AI/ML applications

00:09:00 Keeping the human in the loop

00:10:25 Data quality issues and best practices for AI/ML

00:12:17 Cybersecurity considerations affecting safety

00:14:20 Lessons learned from clinical evaluation of conventional devices

00:16:25 Is agile software development for AI/ML too slow?

00:19:12 Treating AI/ML as a tool and a team member, and its limitations

00:23:30 A few examples of AI/ML applications in MedTech

00:21:35 Watch out for human over-reliance on AI/ML

00:27:44 Experience with ChatGPT prompts

00:32:22 Closing comments and key takeaways

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

Suggested links:

LTR: AI/ML in MedTech

FDA: QA/RA aspects of AI/ML devices

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.

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.

“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.

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 …

“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.

Summary

“Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.”

What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep in a fragile global supply chain?

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Dr. Sarai Pahla about why supply chain disruption is no longer just an operations problem. It is a real risk issue for life sciences companies.

Sarai brings a rare perspective to this conversation, combining medical training, ERP and IT experience, regulatory affairs, and multilingual medical writing. Together, we explore how supply shocks can disrupt patient access, why alternate sourcing is harder in regulated industries, and how predictive analytics may become essential for future supply chain resilience.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introduction05:02 Why modern life sciences supply chains are more vulnerable to disruption08:13 A real example of a single-source component risk in heart valve manufacturing10:27 How supply chain disruption connects directly to patient benefit-risk11:35 Planning ahead: second sources, business continuity, and R&D readiness13:36 Why regulatory-ready suppliers create a strategic advantage16:22 The role of AI and predictive analytics in supply chain risk management23:34 Key takeaways: interdependence, relationships, and future-ready resilience

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

Suggested links:

LTR: Rethinking Supply Chain Risk: QMSR’s New Expectations

LTR: It is Time to Focus on Supply Chain Resiliency Not Just Supplier Management.

LTR: LTR Risk Coach - AI-Powered Decision Support Tool.

Key Takeaways

* Supply chain disruption in MedTech is not just a commercial problem. It can directly affect patient access and device benefit.

* Single-source components can create outsized risk, especially when they are critical and difficult to replace.

* In regulated industries, alternate sourcing is harder because supplier changes often require new evidence, documentation, and regulatory review.

* Strong supplier relationships still matter. Trust, transparency, and regulatory understanding are strategic assets.

* Forward-looking R&D should include supply chain scenarios, not just technical and regulatory development plans.

* Predictive analytics and AI may become important tools for stress-testing supply chains and planning for shocks.

* Risk professionals may have an opportunity to expand beyond safety risk into broader supply continuity and resilience strategy.

Keywords

Supply chain risk, business continuity, MedTech, life sciences, supplier resilience, regulatory strategy, predictive analytics, AI in supply chain, alternate sourcing, benefit-risk

About Sarai Pahla

Sarai Pahla is a medical doctor, regulatory affairs professional, and medical writer based in Düsseldorf, Germany. Her career spans clinical medicine, SAP/ERP security, multilingual medical and regulatory translation, and regulatory writing across medical devices and pharmaceuticals. She currently serves as Principal Medical Writer at Criterion Edge and also leads her own medical and regulatory writing practice. Sarai brings deep experience across EU and global regulatory environments, with particular strength in multilingual source analysis, clinical and regulatory documentation, and emerging applications of AI and data science in regulatory work.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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 other Friday on LinkedIn.

Disclaimer

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

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

“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.

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…

“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.

“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.

“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.

“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.

“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.

“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.

Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.

If you are sitting in the regulatory or risk management seat, you are likely drafting the project’s post-mortem. In a traditional risk management paradigm, you are preparing to tell the executive team that the device failed to meet any traditional safety threshold.

But what if the FDA didn’t just approve this device, but approved it specifically because the sponsors mathematically proved that patients were willing to tolerate a higher level or risk to gain access to this device?

This scenario completely dismantles the way the MedTech industry has historically viewed safety and effectiveness. As professionals, we are trained to treat clinical thresholds as objective, immutable laws of physics—a line in the sand where an adverse event rate either passes or fails. However, with the FDA’s finalized guidance issued on March 30, 2026, safety is no longer just a raw numerical threshold; it is now a quantifiable variable relative to the validated preference of the end user.

So, how does a manufacturer mathematically prove that a severe safety profile is acceptable, and how does the FDA reconcile approving it?

🎧Click Play above to listen to a brief audio summary about this case and lessons QA/RA and Clinical professionals can apply in practice using the newly released FDA Guidance.

In this episode, we discuss:

* The fundamental difference between Patient Reported Outcomes (PROs) and Patient Preference Information (PPI)—and why conflating the two leads to flawed regulatory submissions.

* The exact mechanics of how a rigorously designed Discrete Choice Experiment (DCE) rescued the alfapump system from regulatory rejection.

* How to utilize the Q-submission program to negotiate mathematical models with the FDA before collecting a single data point.

* Strategic traps to avoid, including the “subpopulation matching problem” that can engineer a massive off-label use issue for your pipeline.

Thanks for reading Let's Talk Risk!. If you liked this post, share with others.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis:

* FDA Guidance: Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (Issued March 30, 2026).

* P230044, Sequana Medical N.V., alfapump® System, Approved December 2024.

“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.

“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.

“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.

“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.

“Risk management is inherent to all our roles, whether you are in Regulatory, Quality or R&D, but it is not something we spend a lot of time on”.

Risk management in the medical device industry is often seen as a check-the-box activity for regulatory compliance. In this Let’s Talk Risk! conversation, Carolyn Blandford encourages us to not be satisfied with this status quo and help create a dedicated focus on risk management across all processes of the quality system.

How can you be a better partner? How can you help build your product’s story from start to finish during development, and later during the post-market phase?

This is a leadership opportunity for risk practitioners. It is not enough to build a deep technical knowledge of risk management, but also be mindful of how communication occurs within your organization. Combine your technical know-how with good communication skills to help your team make the best possible decision.

This is the key to success in a risk management role.

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

00:01:58 Introduction

00:04:15 How risk management helps build and sustain the product story

00:05:15 Transitioning into a risk management role

00:08:12 Why we need to create dedicated risk management roles

00:10:35 How to lead change by starting small and showing impact

00:12:50 Our role in shaping a culture of quality

00:15:13 Audience Q&A, general discussion

00:32:30 Closing comments and key takeaways

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

About Carolyn (Beres) Blandford

Carolyn (Beres) Blandford is currently a Senior Project Management Consultant at IPM Integrated Project Management Company. She has over 20 years of professional experience in the in-vitro diagnostic (IVD) industry, first in a scientific role, later moving into a Quality Management role. She developed a strong interest in risk management as a Quality Manager, where she also led the charge to create a dedicated focus on risk management in the organization. Using her strong research, communication and project management skills, she currently supports her clients in planning and implementing strategically critical initiatives.

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

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

Disclaimer

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

“The teams I see really successful are the ones that realize where their gaps lie and stive to reach out to mentors and advisors to fill those gaps”.

Developing a medical device and bringing it successfully to the market is a huge challenge, especially for early stage startups. Even for large, established manufacturers, it takes a significant amount of time to launch a new device.

In this Let’s Talk Risk! conversation, Devon Campbell encourages us to honestly acknowledge gaps in available resources, knowledge and skills, and seek to fill those gaps by collaborating with both internal and external resources.

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

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

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

00:01:50 Introduction

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

00:06:25 Success factors for startups

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

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

00:32:30 Closing comments and key takeaways

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

About Devon Campbell

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

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

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

Disclaimer

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

Listen to my reading of a recent LinkedIn article I published to cover 10 noteworthy risk-related posts recently published on LinkedIn. Listen to the recording and follow links below to read the original posts and continue the conversation.

🗞️A roundup of 10 noteworthy risk-related posts on LinkedIn!

1️⃣ Horst Simon advises risk practitioners to serve as advisors and facilitators instead of playing a traffic cop.

2️⃣ Jijo James shares a new tool that significantly reduces device-related interruptions when used with the WHO's surgical safety checklist.

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

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

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

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

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

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

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

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

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

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

“The eyes can only see what the mind understands.”

The world of medical devices is complex. There are many regulations, standards and guidance documents to read and understand, and apply them correctly during design, development and clinical investigations for regulatory success.

In this Let’s Talk Risk! conversation, Dr. Emanuel Tkach encourages us to keep the big picture in mind. Engineers and Clinicians, who are not generally trained in regulatory affairs, also need to develop a good understanding of these requirements. As an example, we must clearly understand the intended use and indication for our device. It is in the context of the intended use that we have to plan and conduct our clinical investigations to generate evidence of safety and effectiveness.

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

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

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

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

00:02:05 Introduction

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

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

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

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

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

00:17:20 Audience Q&A

00:32:30 Closing comments and key takeaways

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

About Emanuel Tkach, MD

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

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

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

Disclaimer

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

“Continuous lifecycle approach to risk management is still not broadly understood or applied in the industry”.

In this Let’s Talk Risk! conversation, Kevin Posey highlights a gap in the industry practice of risk management, especially in the context of purchasing controls.

Starting with the recent Boeing issue, where a cabin door in a 737 Max 9 blew open during flight, Kevin shares that there is often a disconnect between supplier risk management and product risk management in our own industry.

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

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

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

00:02:05 Introduction

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

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

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

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

00:13:49 Audience Q&A

00:31:13 Closing comments and key takeaways

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

About Kevin Posey

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

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

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

Disclaimer

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

“Risk management is often seen as a check the box activity”.

Taylor Dieringer reminds us in this Let’s Talk Risk! conversation that risk management should be an ongoing, continuous process within your quality management system, that monitors, evaluates and controls risk throughout the product lifecycle, and not just in the pre-market phase.

The post-market surveillance process serves as a link between real-world safety performance of a medical device and design and development of new products to achieve this objective.

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

00:02:30 Introduction

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

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

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

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

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

00:16:37 Audience Q&A

00:30:05 Closing comments and key takeaways

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

About Taylor Dieringer

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

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

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

Disclaimer

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

Summary

“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned medical device human factors and UI design consultant, about how artificial intelligence is changing the practice of usability engineering in MedTech. Jonathan brings a rare perspective to the discussion, blending decades of experience in user interface design, human factors, and medical device development.

The conversation explores a central tension facing the industry today: while AI introduces new interaction patterns, trust challenges, and potential safety risks, the core responsibility remains unchanged - understand the user, understand the context of use, and design for safe, effective human interaction. Jonathan also shares where he sees real promise, including AI-supported training, surgical planning, and stronger cross-functional collaboration across risk, quality, regulatory, engineering, and human factors teams.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introduction02:53 Why AI changes the environment, but not the fundamentals of human factors05:46 Transparency, over-reliance, and helping clinicians stay vigilant09:36 AI-strengthened training and the shift from training to competence13:19 Promising AI use cases, especially in surgical planning and clinician support15:38 The future of human factors: creativity, collaboration, and new evaluation methods23:30 Jonathan’s upcoming workshop on advanced human factors and use-related risk26:45 Final takeaways: stay grounded in the user, fundamentals, and teamwork

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

Suggested links:

LTR: Start Treating Human Factors as Science, Not Art.

LTR: Understanding Human Factors for AR/VR Applications in MedTech.

LTR: LTR Risk Coach - AI-Powered Decision Support Tool.

Key Takeaways

* AI-enabled devices do not eliminate the need for strong human factors fundamentals; they make them more important.

* One of the biggest emerging risks is lack of transparency around what the AI is doing and how users should interpret its output.

* Accuracy alone is not enough; teams must design for the reality that AI can fail and users must remain appropriately vigilant.

* AI may create meaningful opportunities to improve training, making it more interactive, adaptive, and competence-focused.

* Some of the most promising applications of AI are those that strengthen clinician judgment rather than replace it.

* Human factors professionals will need more creativity to anticipate novel use errors, misuse, and complex real-world interactions.

* Conventional usability testing may not be enough for AI-enabled systems, especially when risks like habituation emerge over time.

* The best outcomes will come from closer collaboration across human factors, engineering, risk management, quality, regulatory, and safety teams.

Keywords

Human factors, usability engineering, AI in medical devices, machine learning, transparency, clinician vigilance, use-related risk, AI training, competence, surgical planning, usability testing, cross-functional collaboration

About Jonathan Kendler

Jonathan Kendler is a medical device human factors and UI design consultant with more than 20 years of experience supporting the development of healthcare products, including dialysis machines, infusion pumps, glucose monitors, and patient monitoring systems. He is Principal Consultant at Curiolis and previously co-founded Wiklund Research & Design, which was later acquired by UL.

Jonathan has authored numerous articles on usability engineering and co-authored Usability Testing of Medical Devices and Designing for Safe Use. He has also taught graduate-level courses in user interface design at Tufts University and delivered workshops and lectures on usability engineering across North America, Europe, and Asia.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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 other Friday on LinkedIn.

Disclaimer

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

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Dear colleagues, hello! 👋

A special welcome to the 40 new members who have joined our Let’s Talk Risk! community in the first week of April! Feel free to browse past articles in the archive section of the Let’s Talk Risk! website, and check out recordings of recent LTR conversations in the podcast section.

Here are links to articles published this week.

Announcements

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Enjoying the free content on Let’s Talk Risk!? Upgrade your subscription with this special offer to enjoy even more benefits:

1️⃣ Premium articles: Case studies of FDA warning letters, recalls, ISO 14971 fundamentals, medical device news updates.2️⃣ Monthly LTR webinar: Build deeper knowledge of risk management and get your specific questions answered.3️⃣ 20% off training: You get automatic 20% off on training and coaching offers via ACHIEVE. 4️⃣ Exclusive monthly podcast: Gain insights from industry leading voices5️⃣ Ability to start a discussion thread on LTR Chat!

Check out our Wall of Love to see what others are saying!

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

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

Ask a risk management question

Got a risk management question? Now you can submit your question and get answers through a new feature on Let’s Talk Risk!. If I pick your question for an AMA article, you will get free access to premium content for 30 days!

Weekly Knowledge Challenge

I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:

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

Here is this weeks’ knowledge challenge #28

1-Question Feedback Survey

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“Diabetes is a terrible way to die.”

This comment from David Sturgis in our Let’s Talk Risk! conversation really moved me.

As engineers and QA/RA professionals, we mainly focus on building and launching safe and effective medical devices. We don’t always get to spend time with patients and doctors to understand their perspective. That is why it is insightful to hear from David about his experience with a continuous glucose monitor (CGM) and how it changed his life in a positive way.

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

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

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

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

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

About David Sturgis

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

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

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

Disclaimer

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

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

Artificial intelligence (AI) is rapidly unlocking new applications in the medical arena. It is challenging to keep up with something moving so fast. ChatGPT was launched just a couple of years ago, and we are already talking about artificial general intelligence (AGI) for medical purposes!

In this Let’s Talk Risk! conversation, Prof. Papademetris shares that indeed we are in a new game with plenty of opportunities. But we have to start learning in a new way. We will fail in non-obvious ways, and we will fail often. How do we harness the power of this technology without compromising patient safety or other ethical concerns?

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

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

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

In practice this proves to be quite challenging.

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

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

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

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

About Prof. Xenophon Papademetris

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

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

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

Disclaimer

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

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

Listen to my reading of a recent LinkedIn article I published to cover 10 noteworthy risk-related posts recently published on LinkedIn. Listen to the recording and follow links below to read the original posts and continue the conversation.

🗞️A roundup of 10 noteworthy risk-related posts on LinkedIn!

1️⃣ Randy Horton spotlights top 10 Health Technology Hazards for 2024 compiled by ECRI.

2️⃣ Marco Felsberger reminds us that planning is useful, but building capability is even more important to handle uncertainty in our complex world.

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

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

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

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

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

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

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

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

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

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

One of the key requirements of ISO 13485, the International Standard for medical device Quality Management Systems is establish a link between risk management and the design and development process.

In practice this proves to be quite challenging.

In this Let’s Talk Risk! conversation, Chuck Ventura shares that medical device design and development process is a chaotic process. Design controls should be considered as a way to keep track and stay organized in the face of inherent chaos of the process. In the context of Design Controls, it is helpful to see risk analysis as an aspect of good engineering and not just a paper exercise.

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

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

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

About Chuck Ventura

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

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

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

Disclaimer

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

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

Listen to my reading of a recent LinkedIn article I published to cover 10 of my favorite LinkedIn posts on risk-related topics. Listen to the recording and follow links below to read the original posts and continue the conversation.

🗞️A roundup of my favorite risk-related posts on LinkedIn!

1️⃣ Bryan Whitefield says the job of a risk practitioner is to uncover the elephant in the room! Read the original post here and continue the conversation.

2️⃣ Annmarie Nicolson explains why Human Factors Engineering is more than a tick-box exercise. Read the original post here and continue the conversation.

3️⃣ Chuck Ventura shares tips to accelerate Product Development with "Great Design Inputs". Read the original post here and continue the conversation.

4️⃣ Helen Gerhard invites conversation to understand underlying problems behind recent Philips CPAP issues, especially around design controls. Read the original post here and continue the conversation.

5️⃣ HATEM RABEH, MD, MSc ing RABEH, MD, MSc  shares insights to help estimate sample sizes for clinical studies. Read the original post here and continue the conversation.

6️⃣ Vincent F. Cafiso reminds us to follow requirements for rework in light of the recent Boeing 737 max issue. Read the original post here and continue the conversation.

7️⃣ George Zack highlights a common software testing trap in medical device design and development. Read the original post here and continue the conversation.

8️⃣ Korey Johnson discusses human factors issues in medical software with Xenophon Papademetris. Read the original post here and continue the conversation.

9️⃣ Wag Hanna reminds us that risk management is not about eliminating risk. Read the original post here and continue the conversation.

🔟On a lighter note, the modern approach to risk really began with a gambling problem! Read the original post here and continue the conversation.

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

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

We have been used to treating the term hazard as a potential source of harm. We are also familiar with the concept of exposure to hazard in a hazardous situation as a necessary condition for harm to occur.

The question, often left unanswered, is whether the duration of exposure has any effect on the type and severity of harm experienced by the user/patient.

In this insightful conversation, James Catmur challenges us to consider the duration factor of a hazard as a factor when conducting risk assessments. Drawing on his years of experience across multiple industry sectors, James shares that considering a hazards as states or events can help us more accurately assess each risk in terms of their frequency and/or duration. As an example:

In the chemical sector, if it is a state, then the dose is what you use use to assess the risk . If it is an event, then you consider the direct impact. An explosion is the over-pressure. If it is a chemical release then how long that release is for. If you release chlorine for 30 minutes the severity would be very different from releasing for 10 seconds.

In the medical device industry, a common challenge is to consider the impact of delay in treatment. It depends on how long it lasts and what else happens during that state. There is also a difference between delay in treatment vs. denial of treatment, or service, for example as a result of a cyberattack. A clear understanding of the type and duration of delay can be helpful in a better understanding of the nature and severity of risk.

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

About James Catmur

James Catmur is currently the Director of JC&A Ltd., where he advises clients on risk projects in R&D implementation, safety management and risk assessments. Previously he was at Arthur D. Little in a variety of roles with increasing responsibility in a career spanning over 25 years.

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

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

Disclaimer

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

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

Recently, I was invited by Richard Granquist and Linford Leitch from NAMSA to talk about risk management as part of their monthly RA QA Cafe podcast.

In part 1 of a 2 part series, we discussed the following topics in a very open and engaging conversation!

* How I got into risk management.

* How I think about risk management in a small vs. large organization.

* Why risk management is not a paper exercise, it is a process.

* Why risk management approach should align with business goals.

* A leadership opportunity for risk practitioners to shape culture.

* How a systematic approach helps you do risk management well.

* Risk management is a cross-functional activity; involve regulatory early.

* Treat risk management not as an add-on but part of your quality system.

* Documentation is important but we need to make it easy and less burdensome.

Listen to the podcast above and share your views in comments below.

About NAMSA and RA QA Cafe

NAMSA is a leading service provider to the global MedTech industry specializing in CRO (Clinical Research Organization) services, medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction. Learn more about NAMSA, their services and expertise here.

The RA QA Cafe is a conversational podcast where each episode features NAMSA consultants and invited guests to discuss Quality and Regulatory Affairs related topics relevant to the MedTech industry.

Disclaimer

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

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

A common challenge for risk practitioners in the medical device industry is to efficiently link their risk management process with the design controls process.

The output of risk management activities needs to be linked to the design process before design inputs are finalized. However, this proves to be quite challenging in practice. One reason is that a lot of work in the industry is often done in functional silos

In this Let’s Talk Risk! conversation, Daniel highlights the importance of building trust between different functions, especially Quality and R&D organizations. Leaders in these organizations need to create and nurture a collaborative work environment where engineers can feel safe and empowered to work together for the common goal of developing innovative, safe and effective products.

One specific example where cross-functional collaboration is especially useful is when we are try to establish reliability levels required for different functional requirements for a device under considerations. It requires a lot of trade-offs, which should be driven by a careful analysis of stakeholder expectations, regulatory requirements and the state of art. It is also useful to engage with medical/clinical colleagues to collect early clinical input to support these decisions.

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

About Daniel Roberts

Daniel Roberts is currently the Founder and Principal at Medical Device How, a MedTech consulting firm focused on personalized medical device strategies in the areas of Design Controls, Digitalization, Smart QMS, QMS training, Cybersecurity and Career Coaching. He has worked at several leading medical device manufacturers over the last 20 years in a variety of roles ranging from Quality and Compliance to R&D. He is also a certified ISO 13485 Internal Auditor.

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

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

Disclaimer

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

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

Who is responsible for patient safety in a medical device manufacturing organization?

When asked this question, a common response is likely to be that it is a shared responsibility across the entire organization. After all, everyone should be thinking about patient safety in their specific role and perform their duties such that patient safety is not compromised.

It is true that no single individual or department can be held completely responsible for safety. But when everyone is responsible, no one is really responsible!

In this Let’s Talk Risk! conversation, Mark Armstrong explains how medical safety professionals can serve as culture brokers by translating the language of different functions to help create a central awareness of patient safety. Each function within a large, complex organization, is understandably focused on their specific goals and objectives. R&D is responsible for developing new products and improving the existing ones with design changes. Clinical affairs is responsible for planning and generating clinical evidence to support regulatory submissions. Manufacturing is responsible for consistently producing high quality product at low cost. Medical affairs is responsible for building external relationships with key opinion leaders.

There is a need to bridge the gap among these functional areas which often operate in silos. This is where Medical Safety professionals have a key role to play as a culture brokers to create and nurture a common culture of patient safety.

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

About Mark Armstrong

Mark Armstrong is currently the Director of Medical and Pharmacovigilance Safety and Beckton Dickinson. Combining his advanced education in both Medicine and Biomedical Engineering, he has served in clinical and medical safety roles for over 10 years at various leading MedTech organizations. In his current role, he serves as the primary Safety Physician support for Pharmacovigilance and provides internal medical/clinical consultation during design and development as well as during post-market surveillance activities.

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

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

Disclaimer

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

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

Summary

“The clinical study is actually where your risk analysis is going to meet reality.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory Affairs Specialist at Insulet, about what it really takes to prepare for an IDE and why early-phase risk work is far more than a documentation exercise. Drawing on her experience in diabetes technology, SaMD, and closed-loop systems, Lavanya explains how regulatory, clinical, engineering, and usability thinking must come together long before a device ever reaches a patient.

The conversation also goes deeper than process. Lavanya shares the personal connection that drew her into MedTech, how family experiences with diabetes and cardiac disease shaped her career, and why she approaches device development with a simple principle: build as if it were intended for your own family. From significant-risk judgments and feasibility studies to alarm design, human factors, and mentorship, this episode is a thoughtful reminder that good regulatory work is ultimately about real people, real uncertainty, and real consequences.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introduction03:23 The personal story behind Lavanya’s commitment to MedTech05:01 What an IDE is and why it matters07:53 When companies decide they need an IDE09:08 Significant vs. non-significant risk in early clinical development12:36 In silico testing, risk analysis, and the three buckets of risk work16:07 Human factors, usability, and improving confidence in risk judgments19:00 Alarm design, patient preference, standards, and practical tradeoffs20:49 Learning regulatory on the job and the role of mentorship25:40 Final takeaways: patient focus, study design, and risk as strategy

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

Suggested links:

LTR: Decoding Privacy Laws in Clinical Research.

LTR: A Patient Centric Approach to Medical Device R&D.

LTR: A 90-Day Plan to Review QMSR Readiness.

Key Takeaways

* An IDE is not a marketing authorization. It is the permission to study a device in humans, and it often begins much earlier in development than many teams expect.

* Early risk work is a judgment exercise under uncertainty. Teams must assess whether a device could cause serious harm even before every failure mode is fully known.

* Risk analysis should not stop at a table. Lavanya frames it as a broader strategy spanning system hazards, component-level failure analysis, and an overall residual-risk rationale.

* Clinical studies are where risk analysis meets reality. They help confirm whether residual risk is truly acceptable in real-world use.

* Human factors matters directly to safety. User behavior, interface design, age, familiarity with technology, and real-use conditions all shape risk.

* Good design requires balancing competing needs. The insulin pump alarm example shows the tension between patient preference, safety urgency, and standards compliance.

* Regulatory growth happens through cross-functional learning. Lavanya emphasizes partnering with other functions, asking questions, and staying open to how the full product puzzle fits together.

* Mentorship can accelerate confidence and visibility. The episode closes with a strong message about seeking mentors, giving back, and finding your voice in the profession.

Keywords

IDE, Investigational Device Exemption, clinical trials, risk management, ISO 14971, human factors, IEC 62366, usability engineering, insulin pumps, SaMD, digital health, regulatory affairs, benefit-risk, design controls, mentorship

About Lavanya Ramnath

Lavanya Ramnath is a Senior Regulatory Affairs Specialist at Insulet, where she supports U.S. new product development for SaMD and closed-loop insulin delivery systems, including feasibility and pivotal clinical studies, IDE submissions, and FDA interactions. She has also contributed to indication expansion work for Omnipod 5 and supports broader regulatory documentation, process improvement, and global compliance activities.

Previously, Lavanya held regulatory roles at Abbott, CR Bard, and Medtronic, building experience across the full device lifecycle for both low- and high-risk devices in U.S., EU, and international markets. A biomedical engineer by training, she is especially passionate about helping bring safe, effective, and innovative devices to patients worldwide — a mission shaped by personal family experiences with diabetes and cardiac disease.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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 other Friday on LinkedIn.

Disclaimer

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

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

When it comes to medical devices, we generally think about only clinical benefits as we plan our clinical investigations to generate scientific evidence for demonstrating safety and effectiveness.

However, medical devices also provide many other quality-of life-benefits that are often overlooked during benefit-risk evaluation. One reason is that these benefits are often subjectively experienced by patients, and not usually quantified during clinical investigations.

In this LTR conversation, Ronald challenges us to consider quality-of-life benefits in a quantifiable way during clinical investigations. He shares an example of a minimally invasive orthopedic device to support the meniscus without the need for a total knee replacement. In this case the risk of frequent revision surgery is offset by the significant quality-of-life benefits.

That is why it is important to also consider quality-of-life benefits in the overall benefit-risk evaluation. A good practice is to develop a method to quantify quality-of -life benefits important to patients, and generate data to demonstrate measurably significant difference in these benefits using the device.

Ronald also shares some of the emerging expectations of notified bodies for the newly created role of a PRRC. Personal risk and liability for a PRRC is limited, but you must demonstrate training and competence. However, negligence and intentional mistakes on part of PRRC can result in legal liability. A best practice is to assign a dedicated role as PRRC and not serve in a dual capacity as department head and PRRC at the same time.

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

About Ronald Baumans

Ronald Baumans is currently the founder and strategic consultant at Boumans Regulatory Consulting B.V, providing consulting and PRRC services to medical device companies across Europe. Previously he served as Senior Global Regulatory Consultant and Program Manager for European Regulatory Affairs at Emergo by UL. His professional experience spans over 30 years across multiple industry-leading organizations. He is also the founder of PRRC Academy, where he provides training about this emerging role in the medtech industry.

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

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

Disclaimer

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

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

Dear colleagues, hello! 👋

A special welcome to 75+ new members who have joined our Let’s Talk Risk! community this month! Feel free to browse past articles in the archive section of the Let’s Talk Risk! website, and check out recordings of recent LTR conversations in the podcast section.

Check out these recent articles published last week on LTR

➡️The upcoming Quality Management System Regulation (QMSR) is expected to place a heavy emphasis on risk as the FDA seeks to align the current regulation with global standards. This premium article offers a review of risk-based requirements in ISO 13485 and guidance for implementation.

➡️In this Let’s Talk Risk! conversation, Bijan Elahi shares tips for creating and nurturing an environment of collaboration in risk management.

➡️A common challenge in risk management is to fully understand and control risks due to reasonably foreseeable misuse. This is why you need a robust post-market surveillance process so you can take timely action to ensure your devices continue to remain safe and effective.

Upcoming events

LTR weekly conversation on LinkedIn: Connecting risk management and design controls to accelerate product innovation

Join me next Friday, January 19, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Chuck Ventura, who will share insights on how we can connect risk management and design controls to accelerate medical device innovation.

LTR monthly webinar series: Getting ready for QMSR

A quick reminder to join me in this month’s webinar, where I will review some of the risk-based requirements of ISO 13485:2016 that may be relevant for your QMS as you prepare for the upcoming Quality Management System Regulation (QMSR) expected to be finalized soon.

If you are a paid subscriber, an email has been sent to you with a link to register for this month’s webinar on January 16, 2023 at 11:00 AM EST. You don’t need to pay extra. Please check your spam or promotions folder if you cannot find it in your inbox.

If you a free subscriber, you can upgrade your subscription to attend this webinar, or with a one time payment of only $25. Click the link below to complete your payment and secure your spot. Once you complete the payment, you will receive the registration link by email.

Pre-registration is now open for the next session of Live ISO 14971 training on ACHIEVE. Paid subscribers get 20% off regular price!

Save your spot here to join the next cohort of the LIVE ISO 14971 certification training course starting in January 2024. Watch a course introduction video and check out testimonials from past attendees!

Weekly Knowledge Challenge

I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:

The correct answer for the question, “What is your best estimate of the number of times the terms “risk” or “risks” appear in ISO 13485:2016?”, is between 30-40 times.

Here is this weeks’ knowledge challenge #15

1-Question Feedback Survey

If you are finding value in reading LTR, please give us a shout out and show your love🙏

The practice of risk management in a heavily regulated industry such as medical devices is hard. There are many challenging questions that must be resolved in a simple way that is both sensible and defensible to demonstrate compliance with regulatory requirements.

Questions such as how should we estimate P1 and P2 for each risk? How do analyze benefit vs. risk? How do we analyze risks associated with use of artificial intelligence and machine learning (AI/ML)? What should be our criteria for risk acceptability? How do we manage the many moving parts of our risk management file to ensure its integrity?

There are no clear cut answers to these practical challenges. That is why Bijan Elahi, a leading expert in safety risk management of medical devices, encourages us to collaborate more to find creative solutions to these thorny problems.

There is no shortage of tough problems in risk management. Talking to each other will open up ways and solutions that you may not have imagined.

Collaboration cannot be forced. It requires a willingness and a sense of generosity in sharing our unique insights openly with each other. Management can help by creating an environment where everyone feels safe to engage and share freely. But it is up to all of us to work together and collaborate. Risk management is truly a team sport!

In this highly inspirational conversation, Bijan shares his perspective and tips for improving collaboration in risk management.

About Bijan Elahi

Bijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. He currently serves as a technical fellow and corporate advisor on product safety risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. He has trained over 10,000 people worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.

About Let’s Talk Risk with Dr. Naveen Agarwal

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

Disclaimer

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

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