Additive, AI, Digital Health: What FDA’s Thinking on Science and Technology Means for Orthopedics


Thursday, June 16 | 11:15 am - 12:00 pm


Room 45


All Levels

Participant Type:

Product Development, Quality/Regulatory

Additive, AI, Digital Health: What FDA's Thinking on Science and Technology Means for Orthopedics

FDA reports on the science and technology areas in which it plans to advance its thinking and practices in response to innovation from industry. The Agency’s current strategic initiatives include unleashing the power of data, increasing choice and competition through innovation and empowering patients and consumers. In unpacking those three themes, R&D, product development and regulatory professionals will find a lot of overlap in the orthopedic industry. FDA’s science and technology initiatives include additive manufacturing, artificial intelligence, digital connectivity, software and sensors and regenerative medicine. This session reviews FDA’s current stance, how the Agency is collectively looking at these technologies — and, importantly, what it means to you.

Learning Objectives

  • Gain knowledge of FDA’s Regulatory Science Strategy as it pertains to orthopedics

  • Understand how FDA leverages the strategy for future initiatives

  • Learn which technologies orthopedic professionals should closely follow FDA for comment


Michelle Lott

Founder and Principal,