The FDA usually doesn’t get a lot of love from the medical technology sector. That comes with the territory when you are an industry watchdog, of course, and the agency routinely gets accused of being behind the curve on emerging technologies and wielding a heavy, overly burdensome hand. Derek Mathers, Director of R&D at Worrell Inc., a Minneapolis-based design firm, has a different view, at least when it comes to the agency’s understanding of 3D printing.
“Some people in our industry like to think of the FDA as a part of the problem as opposed to the solution when it comes to medical product development,” Mathers told PlasticsToday. “But the recent draft guidance that the agency put out on a 3D-printing framework for metal and plastic components for devices was a well-orchestrated move to encourage medical innovators to think about their additive manufacturing programs with a new lens.”