As 3D printing continues to make inroads as a medical device manufacturing process—see last week's article on the FDA-approved 3D printed facial implant from Oxford Performance Materials—FDA has scheduled a public workshop in October to discuss the technological challenges and regulatory implications of this technology.
Scheduled for October 8 and 9, 2014, Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing will provide a forum for FDA, medical device manufacturers, researchers, and members of academe to explore these issues that will increasingly confront regulatory agencies in the years ahead. In setting up this workshop, FDA's stated goal is to garner "input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions."
Along with several FDA officials, speakers will include experts from EOS GmbH, Materialise, Steris Corp., Stratasys, 3D Systems, Renovis Surgical, GE Aviation, and Oxford Performance Materials. Among attendees representing the academic and research communities are Dr. James Yoo, Wake Forest University; John Slotwinski, PhD, Johns Hopkins University Applied Physics Laboratory; Axel Krieger, PhD, Children's National Hospital; and Scott J. Hollister, PhD, University of Michigan.
In a recent interview with PlasticsToday, FDA's Steven K. Pollack, PhD, Director of the Office of Science & Engineering Labs, offered some insights on the agency's current thinking regarding the use of 3D printing in medical applications.
"The benefit of 3D printing is that it greatly expands the ability to create devices that are matched to individual patient anatomy," Pollack told PlasticsToday. "3D-printing techniques have different technical considerations than standard manufacturing," he added, and to establish product safety, "devices manufactured using this technology may need additional or different testing than is normally required of products manufactured using traditional (or subtractive) techniques.
"Furthermore, traditional manufacturing settings have design controls and systems for complaint handling, and so forth. As 3-D printing technology develops, manufacturing may shift to the bedside and FDA may need to provide clarity on these requirements as well as other quality control issues such as material qualifications and sterility," said Pollack.
Pollack explained how this shift in manufacturing raises some fundamental issues in terms of the responsible party in an article titled, "FDA Grapples with Future Regulation of 3-D Printed Medical Devices," published by sister brand MD+DI.
As more complex devices are developed and 3-D printing allows for on-demand patient matching or customization, the most pressing issue for FDA centers on engineering versus clinical decisions, said Pollack. "Where is the point where the machine building the device becomes an extension of the clinician?"
To illustrate this point, Pollack described a potential future scenario in which a clinician simply goes to an area within the medical facility for a custom implant sized for a specific patient, but perhaps with slight modifications based on the clinician's input or preference, writes Shana Leonard, Group Editorial Director, Medical Content, at UBM Canon.
This on-demand printing scenario prompts several questions and concerns from a regulatory perspective, according to Pollack. "Who is the manufacturer?" he mused. "What are going to be FDA's roles in looking at the controls for what would potentially be manufactured in a [healthcare] facility? On the shop floor, there may be one level of quality control, but in a medical institution, it may not be as well set up."
These and many other provocative questions will be sure to spark a lively debate at the workshop, which will be held at the FDA White Oak Campus in Silver Spring, MD, on October 8 and 9, 2014.