By: Gayle S. Putrich
May 7, 2014
CLEVELAND — A futuristic world of personalized medicine is becoming reality for thousands of patients thanks to the innovative companies and researchers at the forefront of 3-D printing.
More than 150,000 patients have been helped by Leuven, Belgium-based Materialise NV, which offers rapid prototyping and computer-aided design (CAD) software development for medical and industrial applications, said Maarten Zandbergen, the company’s global services manager, in his keynote address at the fifth annual Plastics News Plastics in Medical Devices conference May 6-8 in Cleveland.
The company takes two dimensional “slices of a person” from MRI or CT scans and feeds them to their proprietary software to build a virtual 3-D model. From there, a surgeon can explore different craniomaxillofacial and orthopedic surgical options, practice the surgery and use a 3-D printer to produce a truly unique device that is created specifically for that patient. Materialise also prints patient-specific jigs to guide the surgeon’s drill or saw to make exactly the same cuts they practiced
virtually. The result is reduced surgery time, more accurate cuts and a more personalized process for the patient, Zandbergen said.
Materialise also works with orthopedic device partners such as Biomet, Zimmer, DePuy and others to combine standard joint replacement parts with a collaborative, personalized process, he said.
The U.S. Food and Drug Administration (FDA) is slowly granting approval to Materialise’s 3-D-focused software, devices and methods, including seven 510(k) clearances in about a decade, for devices ranging from its CT modeling system in 1997 to the Patient Specific Instruments system for Zimmer for total knee replacement surgeries in late 2009. Last month, the FDA granted Materialise 501(k) clearance for a system similar to Zimmer’s for the Biomet Signature Personalized Patient Care System, with a software component, a hardware component and guides to assist the surgeon in total knee replacements.
In fact, 3-D printing in general is capturing the attention of the FDA. The agency will be putting out a communication on 3-D printing “soon,” Benita Dair, deputy director of FDA’s Division of Chemistry and Materials Science told Plastics in Medical Devices conference-goers May 7.
“We hope to help the market and bring new technology to the United States first,” Dair said. “Coming to the FDA early with new ideas for new materials can lead to some game-changing technologies.”
3-D printing technology also provides a new method for rapid prototyping of in-house designs and fabrication of customized, biocompatible devices, said Ryan Klatte, principal research engineer in the 3-D printing lab at the Cleveland Clinic’s Lerner Research Institute. The extremely accurate — down to 0.04 millimeters — printers there are also used to make patient-specific anatomical models, with details down to the smallest features, so surgeons can look at all available surgical options and even practice entire surgeries on plastic before cutting open a person, Klatte said.
But for some applications, 3-D printing still has a long way to go. There are a lot of universities doing excellent research, Zandbergen said, but printing an entire working organ, not just a model, is “in the distant future.”
“I think we’ll have to take it steps at a time,” he said. “It’s a giant leap going from printing an inactive material like plastic or metal to living cells.”
Starting with something simpler, like skin, rather than a human heart would be a good way to start, Zandbergen said.
There are also some polymer challenges to be overcome for the 3-D printing of medical devices, he said. Klatte said his lab has simply had to learn to work with the materials available for their machines.
And FDA approval can be slow going for new materials or even new applications of old materials. Materialise has a research and development team in Belgium and the company works closely with its suppliers, but “any material that has a potential to be 3-D printed, I’m more than happy to talk to suppliers about potential collaboration,” Zandbergen said, especially if it’s a material that can stand up to the extensive sterilization processes required of implantables.