H174 - 36C10X21P0127 - J&A 3D Systems: 3D Medical Device Design, Testing, Production and Quality Management

A primary goal of the Veterans Health Administration (VHA) Innovation Ecosystem's (IE) Agile Design and Production Transformation (ADAPT) is to transition the Enterprise's growing advanced manufacturing capabilities from the creation of 3D printed products to meet supply chain deficiencies during the COVID-19 pandemic to the creation of patient-matched medical devices to improve the care of Veterans, secure access to needed medical supplies in the face of unforeseen supply chain disruptions, and secure VA's position as a leader in healthcare innovations. One year ago, VA acquired five ProX6100 SLS printers, running Duraform ProX PA polyamide material and manufactured by 3D Systems, for use at three initial VA hospitals under the ADAPT initiative. These printers were chosen because they could significantly boost VA internal production of 3D printed nasal swabs, with each printer having the capability to produce 4000 swabs a day. Since the successful creation of nasal swabs, VA has sought to extend the capabilities and reach of these printers, using the technology as the backbone for the creation of 3D printed patient-matched surgical guides for maxillofacial surgeries. VA now seeks to expand upon this foundation, taking multiple 3D printed medical devices from concept through design, prototyping, testing and FDA registration as a VA-manufactured product. The success of this endeavor rests on VA strategically partnering with a consultant who is an OEM of 3D printers owned by VHA and has 1) experience in bringing 3D printed medical devices through the concept phase to FDA clearance and clinical deployment, 2) experience with distributed manufacturing of these devices within the United States and 3) willingness to assist VA in developing and listing products under the VHA brand, distinct from the consultant. Market analysis was conducted to identify potential partners, and 3D Systems was the only company that met the requirements. See attached J&A.