As a rule, the healthcare infrastructure doesn’t dabble in manufacturing, but that is changing in dramatic ways, and that transformation is enabled by 3D printing. A white paper published by SME (Dearborn, MI), a nonprofit organization promoting manufacturing technology, explains how point-of-care (POC) manufacturing is reducing healthcare costs while improving patient experience.
In the white paper, “Physicians as Manufacturers: The Rise of Point-of-Care Manufacturing,” SME describes POC manufacturing as a “non-traditional form of manufacturing referring to just-in-time creation of anatomical models, surgical instruments, prosthetics, scaffolds and other 3D-printed applications at the place of patient care based on their personal medical imaging data.” It’s happening today in hospitals and within the Veterans Affairs System as well as university engineering departments and contract manufacturers collaborating with healthcare providers. According to data provided by 3D technology company Materialise, the number of U.S. hospitals with a centralized 3D-printing facility has increased 3200% between 2010 and 2016. Sixteen of the top 20 hospitals, as ranked by U.S. News and World Report, have implemented a medical 3D printing strategy.
The top three applications of POC 3D printing, according to a survey conducted by SME, are anatomical models (71%), prototyping (56%) and tooling, jigs, fixtures and molds (46%). Other applications include surgical instrument cutting guides (43%), dental (28%) and prosthetics and orthotics (26%). Both resorbable and non-resorbable patient-matched implants tied at 13%.
When asked which materials would see the greatest increase in both POC and traditional manufacturing, 84% of POC manufacturers voted for polymers and 63% said metals.
|Chart courtesy SME|
The benefits of POC manufacturing cited by SME in the white paper include reduced operating room time for practitioners and lower patient readmission rates, which “directly translate to cost savings for the institution,” notes the report. Another advantage, according to the authors, is that “clinicians can regularly visit the manufacturing lab and provide iterative feedback during the process of anatomical modeling.” The U.S Department of Veterans Affairs (VA), for one, is on board.
The VA, which runs 150 hospitals and more than 800 outpatient clinics, has established a 3D Printing Advisory Board. Board chairman Beth Ripley told SME, “we are located across the country and we come from different backgrounds but we all see how 3D printing can help us do our jobs better, whether that is creating a customized splint for a patient, designing a modification for a wheelchair to improve a veteran’s ability to manipulate that chair or converting a CT scan into a physical model of a patient’s anatomy to help the surgeon plan a safer procedure.” According to the white paper, there are currently 30 3D printers across the VA system and the network is growing with the collaboration of Stratasys.
The world-renowned Mayo Clinic also is using 3D printing on site for anatomical modeling, surgical planning and some Class 2 medical devices. Turn-around time is one of the biggest advantages of the technology, according to Jonathan Morris, MD, co-director of the Mayo Clinic’s 3D Anatomic Modeling Lab. “We can go from a clinical problem to an idea to protocoling a radiology study tailored to 3D printing . . . as soon as the patient leaves the CT scanner.” The case study published in the white paper cites the example of a 3D-printed aorta to test a patient-specific stent. The patient was not operative and no stent on the market could fix the issue. “In four days, the stent was created, tested on the patient-specific simulator and on the fifth day, it was put into the patient,” according to the white paper.
POC manufacturing is not without its challenges, of course, many of which will be familiar to the manufacturing community at large. They include the logistics of engineering within a hospital setting; establishing a reliable, just-in-time supply chain and developing a broader selection of compatible materials. Other obstacles noted in the white paper include regulatory requirements (although FDA has been forward thinking on this topic and released guidance in December 2017), funding, reimbursement, quality control and building a qualified workforce.
These hurdles will be overcome in time simply because the potential benefits of POC manufacturing are undeniable. "The number-one priority for healthcare providers remains patient care," said Lauralyn McDaniel, SME's medical additive manufacturing industry expert. "The focus is helping fuel the rise of POC manufacturing enabled by additive manufacturing, providing benefits for patients and physicians/institutions including better patient outcomes, less time in the operating room and reduced costs.”
“Physicians as Manufacturers: The Rise of Point-of-Care Manufacturing” can be downloaded free of charge from the SME website.