Additive Manufacturing of Medical Devices: FDA Perspective
April 25, 2023, 2:00 PM – 3:00 PM EDT
Matthew Di Prima, Ph.D., Materials Scientist
U.S. Food and Drug Administration
Dr. Dianne Poster, NIST
Additive Manufacturing (AM) is now commonly used in the production of medical devices with significant adoption of the technology occurring between 2010 and 2020. This talk will discuss the broad medical applications that makes AM attractive to medical devices along with the applicability of the different AM technologies to the medical device space. Trends in 510(k) cleared devices from 2010 – 2020 will then be discussed in terms of AM technology, material, and device being built to highlight the breadth of AM adoption. This adoption has in part been facilitated by the 2017 FDA Guidance “Technical Considerations for Additively Manufactured Medical Devices” which provided industry and FDA reviewers the key technical considerations to address in pre- and post- market activities. Looking to the future, this talk will end with discussing the 2020 FDA Discussion paper “3D Printing Medical Devices at the Point of Care: Discussion Paper” which presented a potential framework for hospitals and other health care facilities to use this technology at the point of care.
Dr. Matthew Di Prima received his doctorate in Materials Science and Engineering from the Georgia Institute of Technology. Since 2010, he has been working as research materials scientist at the Center for Devices and Radiological Health (CDRH) in the US Food and Drug Administration. His areas of research are investigating how the additive manufacturing process can affect device performance, the interplay between corrosion and durability testing, and explant analysis. Along with his research duties, he is the co-Chair of the Advanced Manufacturing Technologies Working Group and Chair of the CDRH Additive Manufacturing Working Group. He is also active in standards development and is co-Chair of ASTM F42.07.03, Additive Manufacturing Applications: Medical/Biological.