3D Printing Medical Devices at the Point of Care: Understanding Manufacturing Scenarios and Potential Regulatory Oversight

3D printing is enabling innovations in manufacturing and product delivery as well as device design and functions. As part of their commitment to assuring patients and providers have access to safe, effective, and quality medical devices, the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) released a discussion paper on 3D printing of medical devices at the point of care. The paper presented a potential approach for regulatory oversight under various scenarios at the point of care(PoC) with impact for both hospitals and medical device manufacturers.

During this webinar, 3D printing leaders will share perspectives from the FDA, medical device manufacturers, and hospitals to help understand the many challenges and what may come next. Presentations will be followed by a panel discussion to address your questions and explore:

• Assuring devices 3D printed at the PoC are safe and effective
• Assuring appropriate control of devices 3D printed at the PoC
• Clarifying the responsible entity
• PoC training and capabilities

Before the Webinar, please review the FDA’s 3D Printing Medical Devices at the Point of Care: Discussion Paper.

Speakers:

• Matthew Di Prima, PhD, Materials Scientist, FDA
• Justin Ryan, PhD, Research Scientist, Rady Children’s Hospital-San Diego
• Victor Zambrano, Director, Business Model Innovation, 3D Printing Innovation, Johnson & Johnson
• James Coburn, Senior Advisor for Emerging Technology, FDA

*image source: 3D Systems