Strong and rigid with a high shatter resistance ratingĬan be easily machined with diamond-filmed, polycrystalline diamond (PCD), or polished carbide toolingĮxcellent resistance to seawater, solvents, chemicals, hydrolysis, and many other submerged environmentsĬan be exposed to prolonged temperatures of around 480☏ (250☌). Some of the main benefits of PEEK include: In addition, its polymer structure allows for exceptional environmental resistance, dimensional stability, and mechanical strength. What we’re seeing today, however, are the innovators taking the first steps.PEEK is a highly-machinable semi-crystalline thermoplastic that has excellent heat resistance, mechanical strength, and chemical resistance. Regulatory hurdles remain, clinical studies are still in progress, and building buy-in from hospitals will take time. The first ones will be active within the next five years."Ī 3D printing lab situated next to the operating room ready to churn out individualized implants designed from patient data at a moment’s notice is still a long way off. "We are working with a couple of hospitals on already. "Today, PEEK can be designed with additives to gain new features, such as better osteointegration," says Knebel. But PEEK has changed, says Marc Knebel, head of medical systems at Evonik, which manufactures PEEK for 3D printing as well as injection molding and milling. Over the years 3D-printed titanium gained a reputation for better bone integration and thousands of joint and spine implants are 3D printed every year by major manufacturers, such as Stryker. Overall, this bio-compatible material has several perceived advantages over stainless steel and titanium: it's lightweight, permeable to ultrasound, and practically invisible to CT and MRI scans enabling better post-op monitoring. G, that can be used in permanent medical implants. German materials manufacturer Evonik produces an implant grade, 3D printing filament, VESTAKEEP i4. Although PEEK is used in numerous implants on the market today from spinal cages to ankle joints, 3D-printed PEEK still has to prove it has the same weight bearing and wear attributes as milled or molded PEEK. PEEK has had FDA approval as an implant material for years when machined, but not yet when 3D printed. This could be managed on-site in a cooperative agreement by current medical device manufacturers, Haerst says. “Shifting the manufacturing to the hospitals will be a game-changer when it comes to the availability of implants,” says Haerst.įor hospitals to become manufacturers, however, requires technical and engineering staff, regulatory processes, along with equipment. The Kumovis acquisition fits nicely into 3D Systems' established healthcare business and adds a new focus on decentralizing the production of medical implants. “This will disrupt existing healthcare models, improve the quality of care, and crucially, save more lives.” “As technology becomes more user-friendly for medical professionals, more hospitals will be able to implement end-to-end solutions for personalized surgery,” says Gautam Gupta, vice president and general manager of 3D Systems medical devices practice. South Carolina-based 3D Systems, one of the oldest and largest 3D printer manufacturers in the world, recently announced its plans to acquire Kumovis in order to expand from metal implants to PEEK implants at the point of care. "There's a lot of excitement around 3D printing on-site at hospitals and the projects that are driving manufacturing at the point of care and showing what is possible," says Miriam Haerst, co-founder and co-CEO of Kumovis. 3D printing the implants as needed also relieves the hospital from having to keep an inventory of expensive implants on hand.Īlthough, as of today, there are no 3D-printed PEEK implants manufactured at hospitals approved by the FDA, that may soon change.Ī German start-up specializing in 3D-printed PEEK skull implants, Kumovis, says it’s completing the final hurdles in the FDA approval process. Studies show that patient-specific implants shorten surgery time, lower risks of infection, result in better outcomes, and dramatically reduce the length of a hospital stay. This means faster implants, lower costs, and closer coordination between the surgeon and the technicians producing the implant.īy using the patient's data from scans and X-rays, hospitals can 3D print a custom implant that fits precisely into the defect space. The method, when compared to traditional ways medical devices are made, namely machining and injection molding, can be done on-site at the point of care. Using a 3D printer and PEEK filament brings a long list of benefits to hospitals, while still having substantial hurdles.
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