3D Systems, Rock Hill, S.C., and the Veterans Health Administration (VHA) have entered into a contract to employ additive manufacturing solutions to better serve Veterans with next-generation medical devices produced at the point of care.
Through this collaboration, 3D Systems will help the VHA establish FDA-compliant manufacturing facilities within their hospitals for the production of additively manufactured medical devices. This will let the VA network streamline its supply chain and accelerate innovation to enhance personalized care for patients. 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. Over time, the company will train the VHA teams so they can take ownership of the process in the long term. As part of this training, teams will learn how to run the quality management system and how to complete product submissions for regulatory clearance.
The solution will include 3D Systems’ ProX SLS 6100 3D printers and materials, and its 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,” adds Johnson. “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.”