“Time is the only thing you really own.” – Annonymous
Tradeshows can be chaotic and draining for those predisposed to introversion. While I did not get all the answers I was looking for during the 36 hours I spent at RAPID2019, I did connect with our 3DHEALS community managers, our partners/friends, and made three observations that I want to share with the rest of the 3DHEALS audience.
1. FDA’s Risk-Based Approach
Compared to similar regulatory bodies from the other parts of the world, this team is very transparent and engaging. Either during the small group discussion organized by RSNA-SIG or its more formal presentation, the word “risk” is repeated over and over again. In fact, a central focus of FDA’s presentation by James Coburn and Matthew Di Prima’s was a proposal to categorize 3D printed devices into five risk-based clinical and manufacturing scenarios:
Scenario A: Minimal risk 3D printed device by healthcare facility (HCFP); This would exclude any implants.
Scenario B: Device designed by the manufacturer using a validated process; Turn-key system available (e.g. Materialise’ inPrint software) A related announcement from RAPID2019 is regarding HP joins Formlabs, Stratasys and Ultimaker, becoming the fourth certified printer manufacturers to be certified as compatible with Materialise Mimics and inPrint software.
Scenario C: Device designed by the manufacturer using a validated process; Additional HCFP capability requirements (i.e. Scenario B + additional human factor validation)
Scenario D: Manufacturer co-located at PoC (Point of Care); One recent example is Lima Corp co-location with Hospital for Special Surgery. However, the outcome of this collaboration is still to be evaluated.
Scenario E: HCFP becomes a manufacturer.
Scenario F: Others
The goal of standards is to ensure that there is no difference in the quality of the devices manufactured either at by traditional device manufacturer or by HCFP at the point of care.
2. Decentralized Healthcare is Taking Off
During the session overviewing the Veterans Affairs 3D Printing network, Dr. Beth Ripley described that a VA 3D Printing care team typically include surgeons/physicians, radiologist, therapist, engineers, depending on the application focus. However, because of the nature of digital manufacturing, not all players need to be in the same location, therefore making 3D printing service available to other VA centers not equipped with the actual machine or human resource. Although a mature unified quality control process with this VA system is yet to be further defined, the aim of increasing access to personalized care within the constraint of resources really fulfills the trend of decentralized and personalized healthcare at a scale that I wrote about a while back. For example, currently, at VA, a digitalized personalized hand brace for the patient can solve the cost of time and money on future replacements. What required several people to accomplish in creating an orthotics now can be managed by one person. 3D printing technology is providing the possibility of higher quality care with lower cost.
A relevant announcement from RAPID2019 is on the collaboration between HP and SmileDirectClub, which utilizes not only 3D printing but also teledentistry to achieve orthodontics care at a massive level at a lower cost to individual patients.
3. Pay to scale, scale to pay
The business model behind 3D printing based healthcare endeavor has been the central focus of many conversations. RSNA-SIG group is an interest group created mainly by the radiologists to clear the pathway to reimbursement for 3D printed anatomical models for surgical planning. The group has succeeded in getting category III CPT code from AMA last year. However, category III code does not guarantee payment, and the group aims to eventually achieve category I code to be more consistently paid for the work done. To achieve that, more cases must be registered and more data must be collected by the group. That said, getting paid in medicine for a new procedure is a relatively opaque process, and I do plan to elaborate on that in a future post, comparing 3D printing with reimbursement pathways of other procedures.
For the rest of the healthcare 3D printing world, “production” is the king. From Stryker, Carbon, to Formlabs, everyone now cares about the economy of scale, as what is truly disruptive needs to be self-sustainable economically at the least. Along with this goal is improved design, more focus on volume-based applications (e.g. dental), and more room to stay agile (e.g. open material systems).