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.
What do you see as FDA's primary challenges when it comes to regulating the use of 3D printing in the medical device arena?
3D printing techniques have different technical considerations than standard manufacturing, with each type of 3D printing technology having its own specific set of considerations. However, devices constructed using 3D printing technology are subject to the same regulatory review standards as devices constructed using traditional manufacturing practices.
Traditional manufacturing settings have design controls and systems, such as for complaint handling, that 3D printing settings may not have. Devices manufactured using 3D printing technology may need additional or different testing than what is normally performed for products that are manufactured using traditional (subtractive) techniques. As 3D printing technology develops, FDA may provide further clarity on quality control issues such as material qualifications and sterility.
What advice would you give to designers/developers intending to use 3D printing in a medical application to optimize their interactions with FDA?
To optimize interactions with the FDA and achieve timely clearance with 3D printing or other novel technologies, we recommend that anyone wishing to submit an application schedule a pre-submission meeting (or Q-sub) to directly interact with the review team who will ultimately be reviewing the device submission. This is a free meeting that allows early interaction with the FDA. More on this process can be found here.
As with other manufacturing techniques, understanding the technology is key. Their strong understanding of the capabilities and limitations of the 3D printing processes can facilitate interactions with the FDA regarding device design and testing.
Can you give us a brief preview of the topics that you intend to touch on at MD&M West?
I will be presenting what our experience has been in devices that have either incorporated 3D printing into the manufacturing process of existing medical devices or where new devices have been wholly enabled by this technology. I will discuss where our existing regulatory framework is adequate to handle safety and efficacy questions that this technology can raise and when it raises new regulatory questions. Finally, I will be discussing the ramifications of a manufacturing technology that can allow for in situ manufacturing of patient medical devices in the healthcare facility.
"Enter the 3D Printing Era" is one of three conference tracks scheduled for Feb. 10 at MD&M West, the largest medtech event in the United States, in Anaheim, CA. The three day exhibition and conference is co-located with PLASTEC West at the Anaheim Convention Center from Feb. 10 to 12.