FDA Begins to Examine Recent Innovations in 3-D Printing

Three-dimensional (3-D) printing has been around since the early 1980s; manufacturers in various fields have used additive manufacturing—the more technical term for 3-D printing, so-called for how the process adds layer upon layer of material to form a component—for many years. Recently, though, innovations in the field have brought the capability to the forefront of medtech research and development. Researchers in China are making titanium bone implants with a 3-D printer; a researcher at Missouri Science and Technology University has made a strong glass scaffolding bone implant with the technology; and other researchers have succeeded in laying down live human cartilage and liver tissue with 3-D printers.

In August 2012, President Obama launched the National Additive Manufacturing Innovation Institute (NAMII), a national effort bringing together industry, universities and the federal government to provide innovation infrastructure to support new technologies and products created with additive manufacturing.

The U.S. Food and Drug Administration is paying closer attention to the technology, now that scientists are beginning to make implantables and even live tissue with the printers. A new post on the agency’s blog, FDA Voice, said, “Here at FDA, we’re using [3-D printing] to expand our research efforts and expand our capabilities to review innovative medical products. In fact, 3-D printing is fast becoming a focus in our practice of regulatory science—that is, the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.”

FDA Voice contributors Steven K. Pollack, Ph.D., and James Coburn, M.S., reported that two FDA laboratories in the agency’s Office of Science and Engineering Laboratories are investigating how 3-D printing will affect medical device manufacture in the future. The Functional Performance and Device Use Laboratory has developed computer-modeling methods to help determine the effect of design changes on the safety and performance of devices when used in different patient populations. Scientists in the Laboratory for Solid Mechanics are investigating how different printing techniques and processes affect the strength and durability of the materials used in medical devices.

Currently, the FDA does not regulate 3-D manufactured devices any differently than any other device, agency spokeswoman Susan Laine told LiveScience.

“We evaluate all devices, including any that utilize 3-D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used,” Laine said. “In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device.”