Summary

“Clinicians need to to trust the (AI) algorithm, and knowing how it works helps them understand where it might fail, or where extra attention might be needed.”

In this episode of the Let's Talk Risk Podcast, Dr. Jay Vaishnav discusses the rapid growth of artificial intelligence (AI) in the medical technology (MedTech) field, particularly in Radiology.

She shares insights from her extensive experience at the FDA and in MedTech, both in roles ranging from scientific to medical affairs and regulatory affairs, emphasizing the importance of understanding the regulatory landscape, navigating benefit-risk assessments, and the challenges of AI model validation.

The discussion also covers innovations in triage and notification systems, the future of AI in clinical care, and best practices for regulatory professionals. Dr. Vaishnav highlights the need for transparency in AI development and the importance of involving clinicians early in the process. She concludes with career insights and the value of mentorship in navigating the evolving landscape of MedTech.

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

Chapters

00:00 Introducing Dr. Jay Vaishnav

01:50 The Rise of AI/ML devices in MedTech

04:40 FDA perspective on benefit-risk

06:05 Managing risk of clinician over-reliance on AI

08:25 Case study: De Novo granted for a triage & notification AI device

11:56 Challenges in developing triage & notification AI devices

14:00 Current stat and barriers to adoption of AI technologies in healthcare

15:35 The need for explainability in AI/ML devices

17:16 Future directions for AI/ML in MedTech

18:00 Why clinician involvement in AI/ML development is important

19:12 Best Practices for QA/RA professionals

21:30 Career insights and power of mentoring

27:46 Closing comments

Suggested links:

* DEN 170073 - ContaCT viz.AI, Inc..

* LTR: AI in MedTech.

* LTR: Regulating Generative AI.

Key Takeaways

* AI is growing rapidly in MedTech, especially in radiology applications.

* Regulatory considerations are crucial for AI applications.

* Benefit-risk assessments are complex and vary by device indication.

* Triage applications can significantly improve patient outcomes.

* AI models face challenges with false positives and negatives.

* Cultural mistrust of AI algorithms can hinder adoption.

* Involving clinicians early in AI development is essential.

* Transparency about AI limitations is necessary for trust.

* The future of AI in healthcare is promising but uncertain.

* Career growth opportunities exist for regulatory professionals in AI.

Keywords

AI, MedTech, FDA, regulatory affairs, machine learning, healthcare, medical devices, radiology, clinical applications, patient safety.

About Jay Vaishnav, Ph.D.

Dr. Jay Vaishnav is currently Director of Regulatory Affairs at Canon Medical Informatics, where she leads US regulatory strategy and FDA submissions for Canon's portfolio of Healthcare IT solutions. She holds a Ph.D. from Harvard in theoretical physics, and after some time in academia moved to the FDA, spending over seven years there in positions of increasing responsibility. She eventually joined the medical device industry in Medical Affairs before moving into a Regulatory role.She is a Fellow of the Regulatory Affairs Professional Society, an occasional instructor at UCSC Silicon Valley Extension, and co-editor of the book "From X Rays to AI: Navigating US Regulations in Radiological Health."

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

“The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.”

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Yu Zhao discuss the P…

Summary

“To AI or not to AI is no longer a question.”

In this Let’s Talk Risk! conversation, Naveen Agarwal and Michelle Wu discuss the transformative role of AI in the regulatory space, particularly in healthcare and life sciences. They explore key trends observed at the JP Morgan Healthcare Conference, share real-world use cases of AI applications, and address concerns about trust, job security, and privacy in the context of AI adoption. Michelle emphasizes that AI is an enabler rather than a replacement, and highlights the importance of adapting workflows to integrate AI effectively. The discussion concludes with key takeaways on leveraging AI for enhanced productivity and strategic decision-making.

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

Chapters

00:00 Introducing Michelle Wu of NyquistAI

03:00 Key Trends from the JP Morgan Healthcare Conference

06:36 AI Use Cases in Regulatory Applications

09:59 Trusting AI in Legal Contexts

11:49 AI in Product Development, M&A and Growth

14:40 AI's Role in Regulatory Intelligence

18:25 Addressing Job Security Concerns with AI

22:11 AI in IDE and Early Clinical Phase

25:40 Managing Privacy Concerns and IP Protection

27:05 Managing Risk of Errors from Hallucination and Data Quality

28:40 Announcements, Final Thoughts and Key Takeaways

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

Suggested links:

LTR: AI and the future of work for QA/RA professionals.

LTR: A strategic approach to regulatory success with GenAI devices.

LTR: How GenAI is transforming Quality in MedTech.

Key Takeaways

* AI is an enabler, it's not a replacement.

* AI will challenge and shake up our traditional way of work.

* The best way to adopt AI is to revamp existing workflows.

* Trusting AI is a work in progress.

* AI can help optimize resources, save time, and reduce costs.

* AI can cut down the time for research and decision-making.

* We need multilingual professionals who can communicate AI effectively.

* AI will not take away jobs, but those who leverage AI will excel.

* Data privacy and security are critical in AI applications.

* Experimenting with AI solutions can build confidence and skills.

Keywords

AI, regulatory applications, healthcare, Nyquist AI, JP Morgan Healthcare Conference, trust in AI, product development, job security, data privacy, risk management

About Michelle Wu

Michelle Wu is the Co-Founder and CEO of NyquistAI, where her team is building the world’s largest AI-empowered data platform for Life Sciences innovators. She has over 10 years of hands-on experience in connecting real-life business needs with the right technical solutions, as well as a deep understanding of the challenges and opportunities in the life science industry. Previously she launched two other startups and also served as a Strategic Planning and BDL Manager at Novartis. Michelle holds a Bachelor’s degree in Foreign Languages with minor in Economics, and an MBA in Healthcare and Investment.

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

“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…

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

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

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…