The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.
Thursday, July 14, 2016
12:00 to 1:00 p.m.
FDA Research into 3D Printing of its Regulated Products
LT James Coburn, MSc
FDA Center for Devices and Radiological Health
Remote Access Information:
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Audio will come from your PC/laptop speakers and questions can be submitted in writing.
About the Presentation:
Additive manufacturing (AM)--also known as 3D printing--has created avenues of potential in the medical product industries through newly enabled design possibilities and personalized medicine capabilities. Forecasts project significant growth of 3D printing in the medical device space by 2025.* FDA’s Center for Devices and Radiological Health has cleared and approved several types of 3D-printed medical devices through its existing regulatory pathways and FDA’s Center for Drug Evaluation and Research has also approved a 3D-printed drug product.
The speed of technology’s adoption has led to a growing need for 3D-printing best practices for medical products. FDA regulatory science research is helping the Agency develop an understanding of the unique technical aspects and challenges inherent in 3D printing and other emerging technologies to drive future innovation.
FDA internal and collaborative research underway seeks to facilitate the innovative development and assessment of innovative products in this space. This presentation will provide a snapshot of ongoing research efforts internally and in collaboration with FDA’s academic partners. Some topics will include phantoms for device testing, patient-matched devices instrumentation, cleanability assessment, material optimization, and drug printing optimization.
About the Presenter:
LT James Coburn is a Senior Researcher in the FDA’s Center for Devices and Radiologic Health. A mechanical engineer by training, he joined FDA in 2009 after completing academic and clinical research fellowships in orthopedics and human-centered outcome metrics. Lt Coburn is the co-chair of FDA’s Additive Manufacturing working group, head of the Additive Manufacturing Research Core Facility and sits on ASTM and ASME additive manufacturing Standards committees. His research focuses on patient-based design factors for device development and quality metrics for process validation.
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