By Sean Fenske
Once upon a time, long ago, identifying what we covered in the pages of MDT was a much easier task. There were essentially two “worlds” — the pharmaceutical “world” and the medical device “world.” Sure there were other outlier technologies that weren’t exactly grouped in either, and there were also drug delivery technologies (or combination products, if you prefer) that brought the two worlds together in one drug/device solution. But for the most part, there was a clear division of medical technologies that made things very neat and clean.
In more recent years, those lines between types of technologies aren’t so crystal clear. As such, you start to see these areas creep into the focus of MDT. That’s already been happening with technologies such as biologics, which have been combined with medical devices similar to how pharmaceuticals are being merged with them, a practice that only continues to grow. Another example of “recent” changes is the entire realm of in vitro diagnostics. These technologies are really their own “world,” not exactly matching the more traditional definitions for pharmaceutical or medical device. 
While biologics and IVD were perhaps responsible for the beginning of the lines being blurred, there are even more emerging technologies that will really make an impact on the medical device industry as they become more common.
3D Printed MedTech
Additive manufacturing in the form of 3D printing is a fantastic technology that’s already influencing and changing the way things are being produced. In the design and manufacturing realm, it offers great time and cost savings in the creation of physical prototypes, is being employed for molds, and is even being used to generate short run production ready parts. Undoubtedly, advantages with this process will continue to be realized.
In the realm of medtech, however, 3D printing creates a conundrum. If a doctor wants to print a part or tool in his or her office to use in a clinical procedure, what’s the FDA going to say about that? What about the patient’s insurance company? Should these considerations stifle the innovation that 3D printing in the healthcare space offers? I doubt anyone would say yes, but there does need to be a review of how we can ensure this is being done safely. Could 3D printed medical device designs be submitted to the FDA for approval, thus allowing them to be sold to doctors to print in their offices? Do 3D printing machines need to go for review to determine that they can ensure the repeatability necessary to generate the parts or tools to spec each time without fail? These are only a few of the disruptive questions that are brought up by 3D printing in healthcare.