Additive Manufacturing at the Point of Care Is Here

While having now been around for decades, additive manufacturing continues to advance and substantially impact virtually all industries, including the medtech sector. It is an impressive technology that proves to be extremely versatile and for which materials continue to be incorporated. I have no doubt the innovation around it, from machinery to processes, will continue to advance as companies continue to push its limits forward. 

Putting the great strides being made aside, the technology’s impact wasn’t always clear. Back in May 2014, I authored an editor’s letter (for another publication) that spoke to the potential of 3D printing in healthcare. In that presentation, I discussed the challenges involved with incorporating 3D printing at the point of care. I posed the idea of doctors having the ability to print a device, such as a cardiovascular stent or another type of implantable, during a procedure. 

Sure, I hadn’t yet thought of imaging being used pre-operatively to visualize the patient’s anatomy, permitting the ability to print a device well in advance. However, I had considered where the design of the implant would originate and questioned whether that would be a type of licensing agreement or perhaps something the material provider supplied. As this was all hypothetical, I posed possible solutions to this situation without indicating a preference for one idea over the other.

Another obstacle I brought up was the FDA’s involvement. Would the agency need to inspect a point-of-care 3D printing facility that was housed within a hospital? How would testing be handled? How would the process be validated? 

Granted, I was unaware of the phrase I’d hear numerous times years later from my “Mike on Medtech” podcast co-host, Mike Drues: “The FDA does not regulate the practice of medicine.” Then again, does this fall under the realm of the practice of medicine or is it more medical device manufacturing? 

Regardless of the FDA’s authority over the process, I brought up another question: If (or when) something goes wrong, where does the liability lie? Who would be on the hook financially should a patient be harmed from a device printed within a point-of-care facility? While it’s likely a lawsuit would put a net over all the parties involved, from the doctor to the hospital to the material provider to the 3D printer manufacturer, I still wondered which party would ultimately pay the price for a problem (literally). 

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Fortunately, naysayers aside (someone reached out to me to explain that there’s no way any healthcare facility would take on the liability or regulatory risk involved for this to happen), we now have a model in place for this very scenario. 

In late July, 3D Systems announced it participated in an effort to make point-of-care additive manufacturing a reality. Teaming with the Defense Health Agency (DHA) and the Walter Reed National Military Medical Center’s 3D Medical Applications Center (3D MAC), the collaboration achieved FDA clearance for the 3D MAC Titanium Cranial Plate (TCP) System—a novel accomplishment. The solution will be used to treat active-duty personnel and warfighters who suffer from traumatic head injuries. 

“We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalized medical devices closer to the patient. Our unique collaborations with the U.S. Defense Health Agency and the Department of Veterans Affairs underscore our leadership in this space and reinforce our commitment to expanding this business as a long-term growth driver for 3D Systems,” said Jeff Graves, president and CEO of 3D Systems. 

The FDA submission can be viewed under number K253116.

The fact this clearance is indicated for procedures that will likely involve emergency trauma situations in a wartime theater isn’t irrelevant; however, it does provide a pathway (and clear predicate) for future facilities to establish similar capabilities that involve civilian-based use cases. Does it make sense to have this capability in a hospital emergency room for car accident victims or others suffering from substantial trauma? 

While it’s unlikely a point-of-care facility will yet be of use for elective surgeries, providing custom solutions for trauma situations seems to be a significant step toward making this element of a hospital more commonplace. In addition, with a model in place, will administrators be emboldened that this idea isn’t completely out of the realm of possibility?

I’ll be anxiously following the future of point-of-care additive manufacturing, but I also realize more questions must be answered. In the meantime, what’s your opinion? Do you think having this for a trauma situation for the military is an isolated use case or a model for rolling out similar facilities across the U.S.?

Sean Fenske, Editor-in-Chief
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