AI in MedTech: Navigating FDA Regulations & Innovation

The MedTech Spotlight Live videocast was in full swing at the 2025 MD&M West Conference in Anaheim, California, which boasted over 13,000 attendees across the MedTech industry. Orthogonal's Randy Horton and Ben Trombold, MBA interviewed several industry thought leaders at the frontlines of MedTech Innovation.

We had an engaging conversation with Attrayee C. (Atty) from 亚德诺半导体 , a quality systems engineer who is redefining how we integrate AI into the medical device lifecycle. Focusing on traditional locked algorithms (the foundation of FDA -cleared devices), Atty is merging the FDA’s AI lifecycle framework with established design controls to streamline development and regulatory submission.

Key Takeaways:

• Integrated Lifecycle Approach: Atty shares a visual framework that overlays the AI lifecycle onto traditional medical device development processes. This clear roadmap outlines when to plan for AI infrastructure, run tests, monitor quality metrics, and update models, all critical steps for successful FDA submissions.
• Navigating Evolving Regulations: With emerging standards like 63450, 63521, and an updated 62304 on the horizon, she stressed the importance of proactive planning to meet domestic guidelines and stay ahead of international regulatory trends.
• Practical Insights & Career Lessons: Atty also shared her personal journey transitioning from biotech research in India to MedTech in the U.S., highlighting the value of translational expertise and collaborative innovation in overcoming industry challenges.

The views and opinions expressed in this article are those of the interviewee and do not reflect the views or policies of any organization. The work discussed is an independent contribution and is not affiliated with any company or organization. Any references to specific entities or organizations are for contextual purposes only.

Looking for a MedTech developer who's AI-ready?

Orthogonal has operated on the leading edge of medical device software development for over 15 years, helping companies navigate AI-enhanced connected medical devices and Software as a Medical Device (SaMD) through FDA clearance and onto the market.

Schedule your call now: https://orthogonal.io/contact-orthogonal/