I've mentioned here many times how technology is helping medicine (and medical devices) get more personalized. We've also talked about 3D printing for quick, custom, more livable casts, and even custom-made tracheal splints. Well, FDA is now recognizing this new personalized medicine movement with specific pages and programs targeted at 3D printing.
At the end of 2016, FDA published a consumer update page outlining the role of 3D printing in medical devices. This outtake is a bit long, but they really hit the nail on the head in explaining the importance of these devices, and why FDA is now publicizing a formal approach to these products:
"Right now, manufacturers use 3D printing to create devices matched to a patient’s anatomy (called “patient-specific” devices) as well as devices with very complex internal structures. These capabilities have sparked huge interest in the 3D printing of medical devices and other products, including food, household items, and automotive parts.
And since the U.S. Food and Drug Administration is responsible for protecting the public health, the agency is reviewing these 3D printed products—and researching them—to make sure they are safe and effective for the public.
So how are these products used? Well, 3D printed medical devices can help doctors better visualize complex health cases. This process can be used to make patient-specific medical devices (yes, we’re talking about “personalized medicine”). Because of its versatility, 3D printing also has medical applications for FDA-regulated drugs and biologics. Plus, the FDA is studying this technology to better understand it when conducting those medical product reviews—and to offer guidance to manufacturers."
FDA also offers a video (below) on the "3 R's of 3D Printing": Regulate, Research, Resource. In short, FDA seeks to foster innovation in this field while also carefully monitoring it as they continue to protect and advance public health.
3D printing (also known as additive manufacturing) goes beyond personalized devices like casts and tracheal splints: it can replicate patient anatomy exactly as it is, so that doctors can work with patient models before a surgery or procedure. Think skulls, blood vessels, jaws, etc.
3D printing with cells is another area that will continue to advance in the future. While we're still a ways away from, say, 3D printed human organs, the process to get there has begun, and FDA is and wants to be part of that. They're working with industry, universities, and research organizations to help ensure the path forward is smooth, health is protected, and lives are improved.
Additive manufacturing has implications for many fields at FDA. On its page 3D Printing of Medical Devices, FDA states, "Due to its versatility, 3D printing has medical applications in: Medical devices regulated by FDA’s Center for Devices and Radiological Health (CDRH), Biologics regulated by FDA’s Center for Biologics Evaluation and Research, and Drugs regulated by FDA’s Center for Drug Evaluation and Research."
There is a lot of territory for FDA to cover when it comes to this new technological frontier. On their page Process of 3D Printing Medical Devices, they give a list of areas this technology touches with explanations for each, including device design, software workflow, material controls, printing, post-processing, process validation & verification, and testing. A partial example:
In sum, there are many factors to consider when a new technological frontier is being explored. The benefits to human health are potentially significant, but only if the process can be properly monitored for safety and effectiveness. FDA is doing the right thing by getting on board and opening up pathways and communication about this exciting new area of medical technology.
There's lots of good and interesting reading, as follows, and I recommend taking some time to poke around and see what FDA is saying: