3D Systems and the Veterans Health Administration (VHA) entered a contract to employ additive manufacturing (AM) solutions to better serve veterans with next-generation medical devices produced at the point of care. Through this collaboration, 3D Systems will support the VHA as they establish U.S. Food and Drug Administration (FDA)-compliant manufacturing facilities within their hospitals for production of additively manufactured medical devices. As a result, the VA network will streamline its supply chain and accelerate innovation to enhance personalized care for their patients – U.S. veterans.
The VA will collaborate with 3D Systems’ healthcare additive manufacturing team to design medical devices and take them through FDA clearance. 3D Systems’ application experts will initially manage the regulatory paperwork and development of a quality management system at VHA facilities, and over time will train the VHA teams to take ownership of the process. The training will also include how to run the quality management system, and how to complete product submissions for regulatory clearance. The solution will include the company’s ProX SLS 6100 3D printers and materials, as well as 3D Systems’ VSP-related workflows and software.
“In a highly regulated environment like healthcare, the technology is only a small part of the solution,” says Ben Johnson, director of product development, healthcare, 3D Systems. “What becomes more critical to customer success is the partnership with a company that has knowledge and expertise operating in a regulated environment. Through this collaboration, 3D Systems will not only be installing 3D printers at the VHA sites, but we’ll also be helping them install a quality management system that includes the processes, documentation, and training required to be compliant as a medical device manufacturer.”
This initiative is an expansion of the collaboration formed between 3D Systems and the VHA to address supply chain issues in the early days of the COVID-19 pandemic. At the time, the VA needed PPE – specifically face masks. As the final design for the Stop Gap face mask went into production, the VHA next turned to the 3D Systems team to help develop a 3D-printed nasopharyngeal swab that could be printed on production level equipment.
“What began during the pandemic in response to a critical need has expanded to change the way healthcare is delivered,” says Menno Ellis, executive vice president, healthcare solutions, 3D Systems. “This is a one-of-a-kind collaboration between an additive manufacturing solutions provider and one of the world’s largest integrated health care systems to accelerate innovation in the medical device production and deployment arena. 3D Systems’ team of experts is collaborating with the VHA team both in our facilities and on-site at the VHA to enable on-site production of medical devices, and help improve the quality of care they deliver to this very important patient population.”