Foundational Tools for Your Next AI/ML Technology


Wednesday, June 15 | 2:00 pm - 2:45 pm


Room 49

Participant Type:

Product Development, Quality/Regulatory

Artificial intelligence (AI)- and machine learning (ML)-based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day. Example high-value applications include earlier disease detection, more accurate diagnosis, identification of new observations or patterns on human physiology, and development of personalized diagnostics and therapeutics. One of the greatest benefits of AI/ML in software resides in its ability to learn from real-world use and experience, and its capability to improve its performance. The ability for AI/ML software to learn from real-world feedback (training) and improve its performance (adaptation) makes these technologies uniquely situated among software as a medical device (SaMD) and a rapidly expanding area of research and development. FDA’s vision is that with appropriately tailored regulatory oversight, AI/ML-based SaMD will deliver safe and effective software functionality that improves the quality of care that patients receive. The traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies, which have the potential to adapt and optimize device performance in real-time to continuously improve healthcare for patients. These tools’ highly iterative, autonomous, and adaptive nature requires a new, total product lifecycle regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve while providing effective safeguards. This presentation will provide attendees with a foundation of understanding about AI- and ML-based technologies. It will direct you to the pertinent information required as your orthopedic company prepares an AI/ML compliance strategy.

Learning Objectives

  • Understand the definitions of AI/ML and SaMD technologies

  • Understand how AI/ML is emerging in the orthopedic device industry

  • Gain awareness of where FDA is in their thinking on AI/ML – SaMD

  • Gain access to resources to assist your firm in moving forward with AI/ML


Monica Burt

Senior Partner,