Additive manufacturing at the point-of-care (POC) might seem to open the world of medical device litigation to new theories of liability, but that isn’t likely in part because hospitals are wary of assuming the elevated legal risk associated with taking ownership of POC manufacturing activities.
Bellaseno GmbH and Evonik Industries AG joined forces to commercialize 3D-printed scaffolds used in bone regeneration. The scaffolds are made with Evonik’s Resomer polymers to address large and complex bone defects as an alternative to frequently less stable conventional methods.
Limacorporate SpA reported U.S. FDA approval for Prima, its new shoulder platform focused on versatility and operating roam efficiency. “For the first time in our history, both the glenoid base plate and humeral stem are fully 3D-printed, leveraging our long legacy in additive manufacturing,” Massimo Calafiore, CEO of Limacorporate, told BioWorld.
Limacorporate S.p.A has outlicensed to Orthofix Medical Inc. new medical technology for patients suffering from chronic high dislocation of the hip. The deal, for U.S. market rights, will see the companies combine the limb-lengthening technology of Orthofix’s Fitbone intramedullary nail system with Limacorporate’s 3D-printed pelvic fixation device to form what Emmanuel Bonhomme, CEO of Limacorporate, told BioWorld is “a personalized and unique complex hip replacement solution.”
About 1,500 babies are born each year in the U.S. with microtia, which happens when the external ear is small and not formed properly, but 3Dbio Therapeutics Corp., and the Microtia-Congenital Ear Deformity Institute (MCEDI) of San Antonio have brought to patients a solution that avoids biocompatibility issues seen with existing solutions. The Auri Novo device, a 3D-printed reconstruction of the outer ear that leverages the patient’s own ear cartilage, eliminates the need to harvest rib cartilage or use porous polyethylene in lieu of native cartilage, another indication that the era of personalized medicine is finally in view.
At long last, the FDA has released information on a potential regulatory framework for 3D device printing at the point of care (POC), just the first step in the implicit guidance development process. The document highlights several potential tripwires for device manufacturers and operators of health care facilities, but the large number of complex questions posed by the paper suggests that a final guidance is not likely to arrive any time soon.
