Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 76: Challenges and opportunities of AI/ML in MedTech
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LTR 76: Challenges and opportunities of AI/ML in MedTech

Insights from an open conversation with the Let's Talk Risk! audience.

“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

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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.

Discussion about this podcast

Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!