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.