3D J A_Redacted.pdf

This is a Justification and Approval for Other than Full and Open Competition (Sole Source Acquisition) document dated February 19, 2026, for a new contract action with J&A Tracking No. FY26-0552.

The contracting activity is the Defense Health Agency, Contract Operations Division – National Capital Region (DHA/COD-NCR) at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. WRNMMC's Department of Radiology, 3DMAC requires specialized engineering, design, regulatory, and verification services to support two patient-specific medical device programs requiring FDA 510(k) clearance: 3D Printed PEEK Cranial Implants and 3D Printed Customized Titanium Ridge Augmentation Matrix (CTRAM). The sole source contractor is 3D Systems Healthcare, which will provide Product Development of Custom Ridge Augmentation Matrices services. The contract will be issued as a Firm-Fixed Price (FFP) arrangement with an estimated one-year base period (02/24/2026 – 02/23/2027) and one optional 12-month period (02/24/2027 – 02/23/2028), with funding designated as OEM. The justification cites FAR 6.103-1(b)(c)(i) for sole source authority, asserting that only 3D Systems Healthcare can meet the unique technical requirements due to proprietary software, licensed technologies, and specialized expertise tailored to WRNMMC's clinical workflows and regulatory standards. A Notice of Intent to Sole Source was posted on SAM.gov for five days on February 19, 2026, with no competing responses received. Fair and reasonable pricing will be determined using FAR 13.106-3(a) procedures.