If you follow 3D printing or medical news at all, you’re likely familiar with the many ways that 3D printing is changing medicine for the better. 3D printed anatomical models are helping surgeons better plan and execute surgeries, while 3D printed implants are being customized to patients for better comfort and longevity, just to name a couple of the major advancements of 3D printing in healthcare. While it may seem like things are happening quickly, however, the solutions don’t just appear and magically change the world; there are hurdles that must be addressed before these solutions can be truly widespread, particularly the dreaded R word – regulation.
In March last year, Materialise became the first company to receive FDA clearance for diagnostic use of its 3D printed anatomical model software. The company then launched an FDA-approved certification program that allows 3D printer manufacturers to have their products tested and validated for use with Materialise’s Mimics inPrint software, which converts medical images into 3D print-ready files.