‘The Sky’s The Limit’ For 3-D Printed Medical Devices, FDA Says

Article preview from "The Gray Sheet" - September 9, 2013

In an interview with “The Gray Sheet,” staff in CDRH’s Office of Science and Engineering Laboratories discuss the center’s research studies on 3-D printers used to manufacture medical devices and describe the challenges and opportunities that lie ahead.

‘The Sky’s The Limit’ For 3-D Printed Medical Devices, FDA Says

Article preview from "The Gray Sheet" - September 9, 2013

The enthusiasm for three-dimensional printing that’s inspired everyone from lampshade crafters to aerospace engineers is hitting the medical device industry, too. The process, in which specialized printers print layers of polymers or other materials to create objects, is now being researched by engineers at CDRH’s Office of Science and Engineering Laboratories so FDA can be more prepared.

“The Gray Sheet” spoke with OSEL Director Steven Pollack, research engineer James Coburn and materials scientist Matthew Di Prima to get a primer on how 3-D printing of medical devices actually works. The CDRH staffers also discussed the ongoing studies that two labs in OSEL are conducting to understand the strengths and limitations of the technology.

“We recognize that 3-D printing is coming and we need to start understanding it so that we can ask the right questions of sponsors in industry and to help them move forward,” Pollack said. “It’s very new in the medical device space. We’ve probably had 3-D printers in the office for about three or four years.”

Pollack and his colleagues highlighted the benefits, challenges and opportunities that lie ahead for medical device 3-D printing, which has increased dramatically in recent years and, FDA estimates, will only expand further in the future.

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