3D Printing of Medical Devices

Overview

3D printing, also known as additive manufacturing, is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or an MRI image.

The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.
 

3D printed (left to right, top) models of a brain, blood vessel, surgical guide, and (bottom) medallion printed on FDA 3D printers.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. As of December 2015, the FDA has cleared more than 85 3D printed medical devices.

Due to its versatility, 3D printing has medical applications in:

• Medical devices regulated by FDA’s Center for Devices and Radiological Health (CDRH),
• Biologics regulated by FDA’s Center for Biologics Evaluation and Research, and
• Drugs regulated by FDA’s Center for Drug Evaluation and Research