It is getting less interesting to report on medical device applications of 3D printing due to their continued adoption across many areas of health care. That is very positive, and still these technologies are not yet routinely used in the ways that they will be in the future. I see three trends that show a path to a more mature use of 3D printing: production in hospitals and clinics, technology developments and reimbursement.
Going all the way back, the seminal uses for 3D printing in the medical field related to personalization of surgery. This was primarily accomplished by the medical device industry selling these 3D printing services to surgeons and hospitals. A major shift is occurring now with hospitals installing their own 3D printing labs for creating these devices. The Pew Charitable Trusts reports that over 100 hospitals have a 3D printing facility as of 2019.
Bringing these technologies closer to where they will be used has several advantages. They include organic spread of the scope of use within the hospital and more medical imaging expertise, with most of these centers being established in the department of radiology. Once 3D printing technologies are established in the hospital and used by one specialty, say orthopedic surgery, it’s easy for other specialties such as neurosurgery and urology to see the uses and start to imagine how the tools can be used in their own field.
The medical uses of 3D printing can largely be broken up into two categories, 1) personalization of surgery—one component for one patient, and 2) serial part manufacturing—off-the-shelf production, several sizes fit most.
For personalization, the technology trends include more use of color parts and a wider palette of materials that more closely mimic human tissues. Surgical guides may not need color as much as anatomic models, where surgeons want to see different tissues (think bone, arteries, ligaments) in more vivid, distinguished colors. Surgical simulation in a physical sense, such as inserting a catheter for a minimally invasive surgery of the heart, demands materials that react like human tissues, so called biomimetic materials. Multi-material 3D printers that can vary not only color but also material properties of the materials are opening up entirely new segments for use of these models in surgical simulation and medical device development.
In serial part manufacturing, the use of 3D printing in metals is offsetting traditional technologies such as machining and investment casting. Getting FDA approval for 3D-printed implants is now a more standard routine with a published FDA guidance document for reference. Faster and more robust metals printers are reducing cost. To date the best applications for 3D-printed implants are for smaller devices such as spinal fusion cages and hip cups, but now larger parts should start to enter the realm of cost feasibility.
Many would be surprised to hear that much of what you see publicized relating to personalized anatomic models and surgical guides generally are not reimbursed by insurance carriers. Hospitals need reimbursement for these services if they are to fully meet their promise in helping more surgeons and patients. A key breakthrough in 2019 was the AMA establishing Category III Current Procedural Terminology (CPT) codes for anatomic models and guides. CPT codes specify medical procedures for reimbursement, from removing ear wax to fixing a hernia. Category III CPT codes are temporary codes that describe emerging technologies. The RSNA 3D Printing Special Interest Group that I serve in the leadership of, along with the American College of Radiology (ACR), spearheaded these meaningful efforts with the AMA. In 2020 RSNA and ACR also established a 3D Printing Registry for collecting data aimed at providing further evidence toward establishing more permanent CPT codes.
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