Let's Talk Risk! Podcast

Summary

“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.”

Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically valid and sufficiently complete to answer the question of safety and effectiveness.

However, it is challenging to figure out what the expectations are, and it’s an unfortunate consequence of the way the system is setup. Notified bodies are not allowed to offer any guidance to manufacturers that could be considered consulting.

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Amie Smirthwaite discuss the complexities of clinical evaluation for medical devices under the EU MDR. They explore the current regulatory landscape in Europe, the role of notified bodies, and the challenges manufacturers face in demonstrating safety and effectiveness. The conversation also delves into the necessity of clinical investigations, the evaluation of software and AI/ML devices, and the implications of ISO standards. Amie shares her career journey and offers valuable advice for aspiring professionals in the QA/RA field, emphasizing the importance of collaboration between engineers and clinicians in risk management.

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

Chapters

00:30 Introducing Amie Smirthwaite

01:11 The Current Landscape of Medical Device Regulation in Europe

04:08 Notified Body Perspective on Clinical Evaluation

10:00 Challenges in Clinical Evaluation for Manufacturers

13:49 Clinical Investigations: Are They Mandatory Under EU-MDR?

21:29 Navigating Software and AI/ML Device Evaluations

20:24 Status of ISO 18969 Standard on Clinical Evaluation

22:35 Amie’s Career Journey and Insights

25:27 Advice for Aspiring QA/RA Professionals

27:30 Understanding Clinical Risks and Closing Comments

Suggested links:

* LTR - Clinical evaluation is now more important than ever under EU-MDR.

* LTR: Clinical evaluation is a lifecycle process, not a one-time activity.

* MDCG23-7: Guidance on exemptions from clinical investigations.

Key Takeaways

* Clinical evaluation is essential for medical devices under EU MDR.

* The regulatory environment in Europe has become more stringent.

* Notified bodies assess the scientific validity of clinical evidence.

* Manufacturers face challenges in understanding regulatory expectations.

* Clinical investigations are not always mandatory for all devices.

* Software and AI/ML devices have unique evaluation considerations.

* ISO standards are evolving to better guide clinical evaluations.

* Career paths in QA/RA can be shaped by passion or financial incentives.

* Collaboration between engineers and clinicians is crucial for effective risk management.

* Clear guidelines from regulators would benefit manufacturers.

Keywords

Clinical evaluation, medical devices, EU MDR, notified bodies, regulatory challenges, clinical investigations, software devices, ISO standards, career advice, risk management

About Amie Smirthwaite

Amie Smirthwaite is leading expert in clinical evidence, with over 30 years’ postdoctoral experience in medical devices spanning new product development, quality and regulatory systems, and clinical evidence. She has been involved in the development of numerous MDCG and other clinical evaluation guidance documents and has served on multiple advisory board positions, including CORE-MD, HEU-EFS, NORE, and ICEPS, amongst others. She is an active participant in several ISO committees and created the original draft of ISO 18969, which recently advanced to CD stage. She currently works as an independent consultant advising on clinical and regulatory affairs, but previously worked for BSI, where she was Global Head of Clinical Compliance. Amie was BSI’s first Head of Clinical Compliance, building their clinical compliance team and leading the development of their clinical evaluation processes, leading to BSI’s successful designation as the first notified body under EU MDR. She also developed extensive training materials while at BSI, including clinical evaluation, technical documentation, risk management, ISO 13485, EU MDR, and biological evaluation. Amie is a Fellow of the Regulatory Affairs Professional Society.

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.

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Summary

“People who were passionate about this subject (safety risk management) and were enthusiastic about it, we got together and said ‘let’s just create a conference for MedTech’, and we did.”

In this Let’s Talk Risk! conversation, Naveen Agarwal interviews Bijan Elahi, a leading authority in safety risk management of medical devices. They discuss the upcoming International Safety Risk Management Conference in Amsterdam, focusing on its significance, key speakers, and topics such as AI, cybersecurity, and post-market risk management. The conversation highlights the importance of networking, collaboration, and continuous learning in the medical device industry.

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

Chapters

00:00 Introduction to the Conference and Guest

02:57 Overview of the International Safety Risk Management Conference

05:53 Keynote Speakers and Topics

09:08 AI and Cybersecurity in Medical Devices

11:50 Post-Market Risk Management Challenges

15:09 Global Regulatory Perspectives

17:57 Designing Safety into Medical Devices

20:49 Networking and Collaboration Opportunities

23:58 Closing Remarks and Key Takeaways

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Suggested links:

* International conference on medical device safety risk management.

* LTR: Key themes in risk management and an upcoming conference.

Key Takeaways

* The International Safety Risk Management Conference is a unique event focused on medical devices.

* The conference will feature keynotes from FDA representatives and industry experts.

* AI and cybersecurity are critical topics in medical device safety.

* Post-market risk management presents significant challenges for the industry.

* Networking opportunities at the conference can enhance professional growth.

* Designing safety into medical devices from the start is essential.

* The medical device industry is still evolving compared to other sectors like aerospace.

* Collaboration among industry professionals can lead to better risk management practices.

* The conference will offer both in-person and online participation options.

* Early bird registration is available for attendees.

Keywords

Safety risk management, medical devices, conference, AI, cybersecurity, post-market, regulatory, design, networking, collaboration

About Bijan Elahi

Bijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. 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.

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, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“As a Quality leader, you need to be empathetic to other departments that are impacted by whatever change(s) you are making.”

In this Let’s Talk Risk! conversation, Naveen Agarwal and Amit Tyagi explore the intersection of quality management and career growth. Amit shares insights from his extensive experience in quality engineering, emphasizing the importance of innovative thinking, risk management, and effective CAPA processes. They discuss the challenges of navigating change in quality practices and the human element of leadership. Amit also provides valuable career coaching tips for entry-level professionals, highlighting the significance of networking and showcasing relevant skills. The conversation concludes with key takeaways on the importance of quality as a driver for business success and personal career development.

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

Chapters

00:00:05 Introducing Amit Tyagi

00:04:10 Why Quality is more than a paper exercise

00:06:45 Understanding CAPA: correction vs. corrective action

00:11:27 Leading change to improve and sustain Quality

00:15:02 Growing your career as a Quality leader

00:20:05 Bridging the gap from the WHAT to the HOW

00:23:30 Career tips for early stage Quality professionals

00:29:26 Closing comments and key takeaways

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

Suggested links:

LTR: Why risk practitioners must build the empathy muscle.

LTR: Communicate to facilitate collaboration, not impose opinions.

Career Grow System: A CareerLaunch program with Amit Tyagi.

Key Takeaways

* Quality should not be seen as just a paperwork exercise.

* Effective CAPA processes are crucial for long-term success.

* Networking is essential for career growth.

* Quality leaders must facilitate change and guide teams.

* Understanding the human element is key in quality leadership.

* Tools like the 5 Whys can help in root cause analysis.

* Communicating value is vital during interviews.

* Entry-level professionals should focus on relevant experiences.

* Continuous improvement should be a goal for quality management.

* Quality impacts not just compliance but also business success.

Keywords

Quality management, career growth, risk management, CAPA, quality leadership, engineering, professional development, networking, quality tools, career coaching

About Amit Tyagi

Amit Tyagi is currently a Senior Director, Quality Engineering at Abzena. He is also a professional career coach committed committed to helping QA/RA professionals to new heights. With 18 years of experience in empowering individuals across industries, he fine-tuned the art of turning ambitions into accomplishments. His prior industry experience include leadership roles in various pharmaceutical and medical device companies. He holds a Bachelor and Master degrees in Biomedical Engineering, and a Certified Quality Engineer certification from ASQ.

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, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“For the foreseeable future, core FDA practices such a reviewing submissions and post-market oversight are going to continue. Smart Money says FDA in 6 months or an year from now, as to these core responsibilities, is operating similarly to FDA of mid-2024.”

Yes, there is a lot of uncertainty due to the current political environment in the USA, a…

Summary

“The root cause of most privacy missteps is a lack of education, training and understanding of what the privacy rule actually is.”

In this Let’s Talk Risk! conversation, Naveen Agarwal and Edye Edens delve into the critical intersection of privacy laws and clinical trials. They explore the significance of privacy regulations like HIPAA and GDPR, the implications of proposed changes to HIPAA, and the role of AI in enhancing compliance and efficiency in clinical research. Edye shares real-world examples of privacy violations and emphasizes the importance of ongoing education and risk management in navigating the complex landscape of healthcare privacy.

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

Chapters

00:00:05 Introduction

00:02:12 Why privacy of patient information is important

00:04:57 Brief history of HIPAA regulation in the United States

00:08:03 Surprising fact: Clinical trial data is not Protected Health Information (PHI)

00:10:10 Brief overview of GDPR in EU

00:12:20 When to seek legal input during risk analysis

00:15:48 Implications of HHS proposed HIPAA security rules for clinical trials

00:19:16 Best practices for privacy law compliance

00:23:30 Application of AI in clinical trials space

00:26:43 Areal-world example of privacy non-compliance and liability

00:30:30 Closing comments and key takeaways

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

Suggested links:

LTR: Clinical evaluation is a lifecycle process, not a one time activity.

LTR: Clinical evaluation under EU-MDR.

Key Takeaways

* Privacy laws are essential for protecting patient data.

* HIPAA allows patients to own their medical records.

* GDPR covers a broader scope of personal data than HIPAA.

* Understanding state laws is crucial for compliance.

* Risk identification is key to managing privacy concerns.

* AI can streamline regulatory processes in clinical trials.

* Education and training are vital to prevent privacy violations.

* Data breaches can lead to significant financial penalties.

* The sharing of clinical trial data must be managed carefully.

* Continued education helps organizations stay compliant.

Keywords

Privacy laws, clinical trials, HIPAA, GDPR, risk management, data protection, healthcare compliance, regulatory frameworks, AI in research, patient privacy

About Edye Edens

Edye Edens is a seasoned legal and compliance professional specializing in clinical research and life sciences. With a Juris Doctor from Indiana University Robert H. McKinney School of Law and a Master’s in International Research Ethics, she brings over 15 years of experience in research compliance, regulatory operations, and clinical trial oversight. Her expertise spans clinical trial compliance, privacy law (HIPAA, GDPR), and research operations, with a focus on oncology and scaling HRPP and site-specific operational needs. Edye’s background includes leadership roles at Indiana University and First Class Solutions, where she served as an adjunct professor, research administrator, and a research business development leader. She currently acts as Senior Attorney for the Kulkarni Law Firm where she advises AMCs, sponsors, CROs, and research sites.

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, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Summary

“You can definitely use (GenAI) as your core algorithm, but you need to enforce that it can only do one specific thing or at least a very clarified labeling. ”

In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal engages with Dr. Yujan Shrestha to explore the rapid advancements of AI and ML in the medical device industry. They dis…

Summary

“Mismatched design controls can feel like driving through two feet of mud. You will eventually get to your destination, but it will take a lot more time and effort than it really should. ”

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Aaron Joseph discuss the ongoing challenges of design controls in medical devices, particula…

“If you frame something in a certain way, you can influence the perception of its cause and the solution. ”

In this Let’s Talk Risk! conversation, Jack Garvey cautions against starting a CAPA with a problem statement first. Rather, he recommends the analysis to initially begin from a factual review of both technical and situational context leading up to a CAPA, and then defining a specific problem statement appropriately to guide the subsequent investigation of root cause(s) and identification of corrective/preventive actions.

Starting with a problem statement, as required by many of the current computer-based tools, leads to bias that can influence the perception of causes and potential solution. Conformity bias, subjectivity, and over-generalization

Listen to this Let’s Talk Risk! conversation with Jack Garvey, we cover a range of topics related to CAPA and risk analysis. Jump to a topic of interest using the timestamps below.

00:01:02 Introduction

00:02:35 A quick recap of top issues in FDA inspections

00:05:50 Why not to start your CAPA with a problem statement

00:10:00 How to conduct good investigations in CAPA

00:17:00 Analyzing risks in a relative context and diversity of risk flow

00:24:10 Why training is necessary for appropriate use of FMEAs for risk analysis

00:29:10 Closing comments and key takeaways

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

Suggested links:

LTR: 5 blind spots to check in your CAPA process.

LTR: A risk-based approach to CAPA.

Compliance Architects: Writing for compliance.

About Jack Garvey

Jack Garvey is currently the managing partner at Compliance Architects, LLC providing services in compliance and quality consulting, outsourcing, staff augmentation technology-related services to companies regulated by the US FDA. In a career spanning over 30 years, he has held a variety of roles ranging from engineering to regulatory attorney, and leadership roles in Quality and Regulatory functions. Jack holds a Bachelor’s degree in Chemical Engineering, and Juris Doctor in Environmental Law. He has been admitted to practice law in NY and NJ since 1991.

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.

“Many of the AI/ML devices are going through De Novo and (in these) human factors considerations are specifically being called out as special controls.”

In this Let’s Talk Risk! conversation, Shannon Hoste highlights some of the new concerns emerging for human factor considerations for AI/ML devices in MedTech. She explains how we could consider the level of automation as we think about new hazards related to the user interface.

For example, in a clinical decision support system, having appropriate levels of trust with the physician is important. Shannon emphasizes the need for transparency and explainability of AI models, and highlights the potential for over-reliance as a reasonably foreseeably misuse by physicians. FDA is increasingly looking for human factors studies as part of De Novo submissions of novel AI/ML applications.

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

00:01:35 Introduction

00:03:00 Understanding human factors in AI as levels of automation

00:07:30 Two useful guidance documents for human factors in AI

00:09:23 Current state of AI/ML devices in MedTech

00:11:07 FDA questions/concerns related to human factors in AI/ML

00:14:40 Handling reasonably foreseeable misuse for AI/ML devices

00:16:10 Open discussion and audience Q&A

00:31:20 Closing comments and key takeaways

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

Suggested links:

FDA: Clinical Decision Support Software, Final Guidance issued Sep 2022.

FDA: Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, Final Guidance issued Sep 2023.

LTR: Treat human factors as a driver of customer satisfaction.

About Shannon Hoste

Shannon Hoste is currently the Chief Scientific Offer at Pathway for Patient Health, where she is actively creating and sharing knowledge to drive innovation in MedTech. In a career spanning over 25 years, Shannon has served in a variety of roles, including a Human Factors Team Lead at the US FDA. Her extensive experience includes engineering and product development roles, as well as continuing to consult in human factors engineering through Kymanox. She holds a Bachelor’s degree in Mechanical Engineering, and Graduate degrees in Management and Cognitive Systems Engineering, and is currently working on a Graduate Certificate in Epidemiology.

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

“Manufacturers that want to go to the European market, thinking about AI devices, it’s really important that you don’t look only at the MDR. You really have to look at the AI Act as well.”

In this episode of the Let's Talk Risk Podcast, Florian Tolkmitt discusses the rapidly evolving regulatory landscape for medical devices in Europe, particularl…