The recent news that certain Lowe's stores will offer customers the ability to custom-make 3D printed items has garnered a lot of attention. But perhaps even more exciting is that 3D printing (also known as additive manufacturing) is giving physicians new options for treating patients underserved by existing technologies. Almost daily, reports emerge about novel, life-saving procedures made possible through 3D printing, from children implanted with a customized, 3D printed medical device made of material that will resorb over time as they grow, to surgeons able to perform complex, specialized operations successfully after they were able to practice the procedure on models printed from patients' CT scans.
As one might imagine, 3D printing a medical device for use in humans carries particular challenges not present with 3D printing in other contexts. Design and design validation, quality control, cleaning, sterility, biocompatibility, and final device assessment are essential steps with any 3D printed medical device—and these processes are even more crucial for Class III, implanted devices. 3D printed medical devices already have the attention of the FDA's Additive Manufacturing Working Group, and 510(K) clearances already have been granted for some 3D printed devices, from Invisalign braces to spinal cages. But as comments made during the FDA's Additive Manufacturing Working Group's October 2014 workshop make clear, industry and regulators need to continue working together to meet those challenges, and to continue to realize the full potential of this technology for patients.
This article is presented for informational purposes only and is not intended to constitute legal advice.
