BETHESDA, Md.   –   In June, Walter Reed National Military Medical Center (WRNMMC) once again led the way by becoming the nation’s first point-of-care facility to receive premarket clearance from the U.S. Food and Drug Administration for a patient-specific implant. Designed by Dr. Peter Liacouras, director of services for Walter Reed’s 3D Medical Applications Center (3D MAC), the pioneering Titanium Cranial Plate (TCP) system reconstructs complex cranial and facial defects resulting from trauma, disease or cancer.

The 3D MAC, part of Walter Reed’s Department of Radiology, focuses on the design, development and production of medical models, implants, surgical guides and custom devices.

“The former National Naval Medical Center (NNMC) began using medical 3D printing in the late 1990s, and the former Walter Reed Army Medical Center (WRAMC) created the 3D MAC in the early 2000s,” Liacouras said. “When I came on board in 2006, I helped to streamline a lot of the methods used to create the models, devices, and implants.” NNMC and WRAMC integrated in 2011 to form WRNMMC.

Before titanium became widely used for implants, polymethyl methacrylate, or PMMA, was commonly used because of its ability to restore structural integrity. However, unlike titanium, PMMA does not effectively integrate with surrounding tissues. Titanium implants are biocompatible and can promote tissue integration, helping establish a stable, long-term connection.

“One feature of the TCP is that the fixation bars are already incorporated into the design, so you can simply place it and screw it down,” Liacouras said of the system. “You can also plan the fixation locations using the CT scans and the 3D reconstructions. We can get these out quite quickly because we receive the CT scans and do all the design and manufacturing in-house.”

In 2020, Liacouras and his team began coordinating with Dr. Beth Ripley, deputy chief of the Office of Healthcare Innovation and Learning at the VA Puget Sound Health Care System.

“While point-of-care 3D printing has been around for quite a while, there have been no clear regulations around it,” Liacouras said. “When the FDA began talking about applying more regulations a few years ago, Dr. Ripley and I decided to get ahead of the situation. We applied for a joint incentive fund (JIF), which helped us each implement a quality management system, which you need to comply with FDA regulations.”

To receive clearance for U.S. commercial distribution, manufacturers must submit a 510(k) application to the FDA demonstrating that a device is substantially equivalent to a previously cleared product and supported by adequate testing.

Nikki McMinn, one of the 3D MAC’s biomedical engineers said this was a lengthy process, as it normally is, but went smoothly overall. “We received clearance the first time around, which isn’t always the case for new companies or new groups like ours. This was our first submission.”

Walter Reed’s 510(k) submission for the TCP system was sponsored by the Defense Health Agency’s (DHA) Office of Regulated Activities (ORA). With FDA clearance, Walter Reed can now distribute the system to other point-of-care facilities within the Department of War and potentially the Department of Veterans Affairs.

“Additive manufacturing is changing how we deliver patient care and puts a critical capability directly into the hands of our military providers,” said U.S. Army Lt. Col. Andrea Mountney, deputy director for the ORA. “By securing 510(k) clearance for the 3D MAC Titanium Cranial Plate System, we are delivering personalized patient-unique implants at the point-of-care – accelerating casualty treatment, sharpening surgical outcomes and speeding the recovery of our wounded service members. The Defense Health Agency Research and Development’s ORA is proud to have partnered with Walter Reed to provide the regulatory support that has transformed battlefield-driven innovation into an FDA-cleared standard of care for those who serve.”

Following receiving the FDA clearance for the TCP, the 3D MAC is pursuing several other additional implant capabilities. One project involves a polyether ether ketone implant. Known as PEEK, the material closely resembles human bone and may help distribute stress more naturally, potentially supporting bone repair and healing. This also provides a non-metallic alternative to surgeons.

The group is also developing another option for dental reconstruction when a lack of bone prevents placement of an implant. A custom titanium ridge augmentation matrix (CTRAM) is designed and manufactured to help regenerate bone in the precise location needed. After six to eight months, enough bone regenerates to allow placement of a dental implant.

The FDA clearance also enables the 3D MAC to pursue broader opportunities in implant development and collaboration across military medicine.

“One of the other aspects we’re trying to encompass is implementing other facilities as contract designers too,” Liacouras said. “They’ll be able to work under our quality management system and comply with our design envelope for these implants. We can have other military institutions design these devices for their patients, send us the files, and we can manufacture them here and send them back out. So, we’re essentially setting up design hubs within the Department of War and the VA.”

To learn more about Walter Reed’s 3D MAC, visit the 3D MAC's website or call (301) 295-8594 to speak with a member of their team.