The SaMD Toolbox Webinar Series

With over 15 years of experience developing Software as a Medical Device (SaMD), Orthogonal has honed a series of tricks, tips and tools that help us build, evolve and scale SaMD to improve patient outcomes faster. Our 2024 webinar series aims to share that knowledge with the MedTech industry. 

This page will host links to future webinars in the SaMD Toolkit webinar series as well as to previously hosted webinars, with a full recording of the event and a summary of main points discussed.

What Will It Take To Put Generative AI Inside Medical Devices?

Organizer: Orthogonal
Date: Tuesday, May 21st, 2024
Time: 11:00 AM CT
Venue: Virtual

Generative AI has been a massive buzzword across every industry since the release of ChatGPT a mere 17 months ago. Organizations are rushing to develop a wide range of applications for the technology, hoping to transform their businesses and how they serve their customers ahead of their competitors. In MedTech, there’s been significant efforts to apply generative AI to different parts of the industry. However, the discussion on the role of generative AI inside medical devices has been more measured. There are questions as to how this nascent technology would fit under the design controls of ISO 13485 and IEC 62304.

The emerging consensus among Orthogonal and many of our colleagues in the Software as a Medical Device (SaMD) space is that, barring very specific use cases, generative AI is unlikely to be a core component of medical devices anytime soon. The technology is simply too immature and unpredictable to meet the device industry’s benchmarks for safety and effectiveness. However, like other technologies over the last 100+ years, we expect that generative AI will eventually work its way into the functioning of medical devices.

What will it take for generative AI to become a tool in the toolbox of medical device manufacturers, and what does the history of MedTech teach us about how this might happen?