A dedicated follower of 3D printing in the medical space, Steven K. Pollack, PhD, Director of the Office of Science and Engineering Laboratories at FDA, will participate in a panel discussion on 3D printing at next month's MD&M West exhibition and conference. In addition to the regulatory issues surrounding 3D printing, industry experts, researchers, and academics will discuss material developments, functional prototyping, bioprinting, and IP concerns during the daylong conference. In advance of the session, which is scheduled for Feb. 10, 2015, at the Anaheim Convention Center in Anaheim, CA, Pollack agreed to answer some questions related to FDA's perspective on 3D printing.
Back in October, FDA organized a 3D-printing workshop in the company of an array of stakeholders. I have heard some positive remarks from industry participants. What were your impressions?
We were very happy with the 3D-printing workshop in October. The presenters and participants came from all aspects of the industry—OEMs, device manufacturers, testing labs, hospitals, and government agencies. Given the breadth of perspectives and expertise, there was a surprising amount of agreement on the core issues with 3D printing of medical devices. The majority of participants emphasized that close attention to quality control and process validation procedures was essential to their success. We certainly thought the conversations with stakeholders, both formal and informal, were very productive. Many participants were excited to see that the FDA is addressing 3D printing at this early stage of its adoption in medical devices.