Additive manufacturing (AM) is a truly revolutionary innovation. The ability to create a three-dimensional, production-ready part just about anywhere with a device the size of a microwave (depending on the size of the part you want, of course) is simply remarkable. Whether using it for a prototype, a replacement part, or just for fun, AM is only limited by the user’s imagination (and perhaps their CAD design ability).

Soon after hearing about the capabilities of this technology (more than a decade ago, already), I was writing about its use (and potential use) within the medtech manufacturing space. While much of the prospective applications were somewhat obvious and indeed came to pass in real-world use, there were some creative, not-so-definitive functions that were more speculative. One such utility was within the healthcare environment itself, giving doctors, surgeons, and other healthcare professionals direct access to a manufacturing capability to develop a needed instrument or, perhaps one day, even a replacement body part.

I thought the idea of being able to leverage AM within the healthcare environment would be fantastic. Unfortunately, I was met with some very fair and realistic counter-arguments for why it would never happen.

For one, how would this be handled at the regulatory level? Since the FDA doesn’t regulate the practice of medicine, would they oversee the printer itself? What about the materials used? Would either have to be approved or cleared as a medical device as if it were a surgical instrument or implant? What about the software used for the design of the output to be created? Would that be a medical device from a regulatory standpoint? All good questions, but nothing that couldn’t be worked out.

The next level of resistance was a little more substantial and one I didn’t have an answer for—liability. I was told a hospital would never take on the risk and/or liability that would be associated with 3D printing a device, instrument, or implant within the healthcare environment. Certainly seemed like a sound counter argument and one I was not equipped to debate. Any skilled attorney would likely be able to punch holes in any points I could pose.

Fast-forward to my trip earlier this year to the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) in Las Vegas, where I was informed of some interesting developments in this area. A partnership between Stratasys and Ricoh USA had established a foothold in the point-of-care 3D-printing innovation I had speculated about a decade earlier. Sure, it was “only” for anatomical modeling, but it was a start.

Back in May 2021, RICOH 3D for Healthcare was announced. According to the a company release, the solution was “an end-to-end workflow that simplifies the development, design, and production of anatomic models for healthcare providers.” One aspect of the service would position Ricoh staff on-site at a healthcare facility to manage the Stratasys equipment to deliver the point-of-care offering. Then, in June 2022, Ricoh USA announced it had gained 510(k) clearance from the FDA for its craniomaxillofacial and orthopedic patient-specific anatomic modeling.

Just before the AAOS event, the companies informed the industry they had expanded on their established relationship. The service offering now included the cloud-based Segmentation-as-a-Service solution from Axial3D. This additional capability enables healthcare professionals to transfer DICOM data (MRI or CT) into a segmented 3D visual file that can then be printed through the Ricoh-managed unit.

“We are providing an opportunity for healthcare providers to access state-of-the-art, precision additive manufacturing without absorbing the overhead costs,” said Gary Turner, managing director of Additive Manufacturing at Ricoh USA. “Offering this solution means democratized, wider access to patient-specific 3D-printed models that can improve outcomes and the patient experience, while also enhancing physician education and training.”

While this service may “only” be anatomical modeling, it is astonishing just how far additive manufacturing has come. On display at the Stratasys booth at AAOS was a banana—an additively manufactured banana. If I handed you a group of bananas and included this one among them, you would not easily identify it right away. The colors, bruising, and feel were all nothing short of remarkable. It “was” a banana. I couldn’t peel it and consume it, but I was amazed. (The apple, on the other hand, had some more easily identified tells such as the weight and feel, but it looked incredible.)

So perhaps this is a first step to a future that sees additively manufactured devices and replacement body parts printed at the point of care. As more initiatives like this one emerge, it will increase demand for more solutions and there will be companies like Stratasys, Ricoh, and Axial3D who answer that call. 

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com