Reducing AI Risk to Secure Regulatory Approval

Artificial Intelligence (AI) is a powerful technology that is changing the MedTech industry as we know it today. Are you approaching AI implementation into your device with intention and from an FDA regulatory perspective? If you're considering building a medical device that incorporates AI, it's important to be aware of the potential risks associated with this technology. We will explore the impact of AI for medical device development, the potential risks associated with incorporating this technology into your devices, and how to design your algorithm with a clear vision of the end-user in mind.
Key Takeaways:
- Make sure your algorithms are generalizable to your patient population
- Be mindful of how biases can be introduced
- How to make your algorithm more transparent for the end user and for the FDA
Speakers:
Isabella Schmitt, MBA, RAC is the Director of Regulatory Affairs at Proxima Clinical Research, a contract research organization guiding emerging MedTech and Biotech companies through regulatory, quality, and clinical development. She leads 100+ medical device and pharma projects and oversees the marketing team. Outside of Proxima, Isabella is a partner, judge, mentor, and speaker for multiple healthcare accelerators, including M1 MedTech Accelerator, MedTech Innovator, TMCi, MassChallenge, gBEta, and Hatch.  She also serves as a pitch coach for SXSW Pitch Competition.