Additive medical device update: Point-of-care 3D printing, custom blood vessels, and 20-minute contact lenses
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Article
Without a doubt, the two biggest industries for additive manufacturing (AM) are aerospace and medical devices. But while we’ve covered AM in the former industry extensively here on engineering.com—from applications to materials to benefits—our 3D printed medical device coverage is less comprehensive. That’s partly because our friends and colleagues over at Medical Design & Outsourcing do such a great job of keeping up with the latest industry news, cutting-edge research, and practical advice for medtech engineers.
Still, there’s enough happening in the world of medtech AM that we can cover it occasionally as well without worrying about stepping on anyone’s toes. So, here are a few of the latest developments in 3D printed medical devices from industry and academia.
3D Systems highlights FDA-cleared implant at point-of-care institution
In a significant milestone for AM-enabled patient care, the Defense Health Agency (DHA) and Walter Reed National Military Medical Center’s 3D Medical Applications Center (3D MAC) have received premarket clearance from the U.S. Food and Drug Administration (FDA) for the 3D MAC Titanium Cranial Plate (TCP) system. According to 3D Systems, this is the first-ever FDA-cleared implant granted to a point-of-care institution. The TCP system will be used to treat U.S. active duty personnel and war fighters suffering from traumatic head injuries around the world.
“We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalized medical devices closer to the patient,” said Jeff Graves, president and CEO of 3D Systems in a press release. “Our unique collaborations with the U.S. Defense Health Agency and the Department of Veterans Affairs underscore our leadership in this space and reinforce our commitment to expanding this business as a long-term growth driver for 3D Systems.”
According to the same release, 3D Systems worked closely with 3D MAC to establish its quality management system and provided support for design and validation as well as regulatory submission. More specifically, 3D Systems provided expertise in process controls, device design optimization, additive manufacturing workflows, and regulatory strategy.
“This clearance underscores the power of combining clinical innovation with deep expertise in additive manufacturing and regulatory compliance,” said Natalie Byrnes in the same release. Byrnes is manager of product development for patient-specific medical technology at 3D Systems.
The clearance is listed on the FDA website under submission number K253116.
EOS and PTC establishing in-house digital implant engineering center
Another point-of-care development comes from Rambam Health Care Campus in Israel, where EOS and PTC have collaborated on establishing a new digital implant engineering center. The center will host a team of engineers and physicians who will design, develop, and produce customized patient implants and medical devices using metal AM.
This joint operation aims to combine Rambam’s clinical expertise with EOS’s industrial 3D printing technology and PTC’s Creo computer-aided design (CAD) solution. By producing implants at the point of care, the center can improve collaboration between surgeons and developers as well as reducing reliance on external suppliers. Ideally, it could also shorten procedure and recovery times to accelerate patient treatment.
“Point-of-care innovation in healthcare depends on integrating advanced industrial-grade additive manufacturing with validated hospital workflows,” said EOS CSO Nikolai Zaepernick in a press release. “Our open software structure enables such scan-to-print workflows. We view this as a vital step toward a repeatable, highly responsive and digitally connected model for patient-specific care.”
“Cutting-edge personalized implants require a connected digital foundation that ties together clinical need, design, manufacturability and workflow discipline,” said Ronen Ben-Horin, VP of technology at PTC, in the same release. “The Digital Engineering Center at Rambam demonstrates how intelligent digital engineering drives innovation.”
Custom blood vessels from Harvard
In research news, a team from Harvard’s John A. Paulson School of Engineering and Applied Sciences (SEAS) has developed a new method for creating customizable synthetic blood vessel grafts in minutes using a novel 3D printing platform. The work was led by Michael Peters, a former SEAS PhD student and now visiting scholar. The goal is to provide surgeons with more options for small-diameter vessels used to replace or bypass damaged or diseased vascular tissue.
“Anything less than 6 millimeters in diameter, there are no clinically approved implants,” said Peters in a press release. To address this limitation, Peters and his colleagues used Focused Rotary Jet Spinning, an additive platform originally created to build in vitro heart models. The platform uses high-speed spinning and focused air streams to turn liquid polymer solutions into ultra-thin fibers deposited on a mandrel. This creates tubular scaffolds resembling natural blood vessels.
The new study demonstrates that the jet spinning technique can rapidly produce small vascular grafts with precisely controlled diameters and wall thicknesses, so that in principle a graft could be custom-made on demand. “We are trying to enable what we call ‘intraoperative manufacturing,’” Peters said. “The manufacturing speeds and customizability and flexibleness of our fabrication platforms can realize grafts that are made for a particular injury or a particular patient.”
The vascular grafts in the study are made from a synthetic copolymer of polylactic acid and polycaprolactone. Over time, those synthetic scaffolds degrade as the patient’s own cells rebuild the tissue. The material and structure of the grafts are also intended to limit clotting and other complications seen with existing synthetic grafts.
Kevin Kit Parker, whose lab created the 3D printing platform, said he envisions a day in which patients with specific medical needs are saved by implants custom-made in the hospital. “Dentists are doing it now with 3D printing,” Parker said in the same release. “In the case of our high-speed additive manufacturing platforms, if you are talking about limb salvage, or repairing a damaged or deformed heart, we are approaching a day where FDA-required Good Manufacturing Practices can be met in the operating suite while the patient is on the table.”
The research is published in the journal Advanced Materials.
University of Waterloo 3D prints custom contacts while you wait
Our last medtech update comes from the University of Waterloo, where researchers have combined new silicone materials with additive technology to create patient-specific contact lenses in only 20 minutes.
“We are very excited about this work because it brings us closer to contact lenses that are truly personalized,” said Dr. Shirley Tang, professor in Waterloo’s Department of Chemistry, in a press release. “Our technology produces lenses with patient-specific surfaces for a precise fit while delivering the optical clarity and mechanical performance expected of commercial contact lenses.”
To overcome the difficulties of 3D printing silicone, the researchers developed a new hydrophilic formulation specifically designed for AM. To address potential issues with layer lines impacting optical clarity, they also developed a thin non-contact coating process that smooths the printed surface without compromising the shape of the lens or its optical performance. Laboratory testing confirmed the lenses are biocompatible and the team is preparing for in vivo studies.
The research is published in the journal Materials & Design.
Missed the last additive medical device update? Don’t worry: this is the first one!
Why manufacturers might care
CAD and PLM changes matter when they shorten the redraw/email loop for custom sizes. Watch for live geometry, validation gates, and manufacturing file handoff — not slideware alone.
Source
Additive medical device update: Point-of-care 3D printing, custom blood vessels, and 20-minute contact lenses — via Engineering.com
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