Episode 16
Positioning AI-Enabled Medical Devices in the Market with Dr. Ronald Razmi
Aired On: May 7, 2024
Hosted By
Dr. Ronald Razmi, founder of Zoi Capital and author of AI Doctor, The Rise of Artificial Intelligence and Healthcare joins our host Michael Roberts to discuss the positioning of AI-enabled medical devices on the market. Learn about the status of AI-enabled medical devices today and how potential customers perceive them and why FDA approval may not be enough. We also discuss what the future of AI in healthcare could look like, and how long it might realistically take us to get there.
In this Episode
- 00:04:24 – Challenges in Healthcare AI
- 00:08:09 – The Roadmap for AI in Healthcare
- 00:12:48 – FDA Approval and Trust
- 00:20:36 – Overcoming Barriers in Healthcare Technology
- 00:26:12 – Caution and Realistic Expectations
Quotes From This Episode
I would say right now AI-enabled medical devices are at very early stages because the regulatory pathway hasn’t been fully established. These models haven’t been fully tested. Even though the FDA provides clearance and allows you to market an AI algorithm. Almost none of them have done the type of clinical studies that pharma and medical device companies have historically been required to do in order to establish that the product works in the real world.
Dr. Ronald Razmi
The clinical applications are still far off because we have to solve the data problem first, regulatory issues, clinical trial issues, reimbursement issues, much remains to be done. And if you’re talking about combining AI with a medical device, you’re talking about another layer of complexity.
Dr. Ronald Razmi
We live in a world of innovators and people who are constantly thinking about how to solve a problem, how to do things better. But from their point of view, every time you come in and you’re saying, ‘I have something to help you,’ they hear ‘EHR,’ how EHR was supposed to make their lives better and so forth. So we have to see it from their perspective and think, if we’re bringing something to you, does it automate? Does it make your life easier? Does it take away a few clicks or does it add more clicks? And has it been tested enough that you could trust it and so forth?
Dr. Ronald Razmi
