3D Systems, VHA Collaborate to Transform Patient Care
The Veterans Health Administration is collaborating with 3D Systems to establish FDA-compliant medical device manufacturing facilities using additive solutions.
3D Systems and the Veterans Health Administration (VHA) are partnering 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 it establishes FDA-compliant manufacturing facilities within its hospitals for the production of AM medical devices. The goal is for the VA network to streamline its supply chain and accelerate innovation to enhance personalized care for its U.S. veteran patients.
The VA will collaborate with 3D Systems’ health care AM 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 3D Systems’ ProX SLS 6100 3D printers and materials, as well as its VSP-related workflows and software.
“In a highly regulated environment like health care, the technology is only a small part of the solution,” says Ben Johnson, director of product development, healthcare, 3D Systems. “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.
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