S02 Notice of Intent to Sole Source - 3D systems.pdf

NOTICE OF INTENT TO ISSUE SOLE SOURCE AWARD

The Department of Veterans Affairs (VA) Strategic Acquisition Center – Frederick (SAC- F) on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Office of Healthcare Innovation and Learning (OHIL) VA’s X_Labs Program Office intends to negotiate, with 3D Systems, Inc. on a sole source basis, under the authority of Federal Acquisition Regulation FAR Subpart 13.5 entitled, “Sole Source Justification Under Simplified Procedures for Certain Commercial Items.” This action is based on the proprietary nature of the inner workings of the ProX 6100 SLS printers, MJP 2500 printer, and NextDent printers that X_Labs owns, which is exclusively distributed and supported by 3D Systems, Inc. The required services and support are inextricably linked to existing Government-owned equipment, software integrations, and instructional systems that rely on 3D Systems, Inc., proprietary content, maintenance protocols, and digital certifications. No other vendor is authorized or technically capable of providing these integrated services.

The proposed action will continue to provide support to OHIL, X_Labs VHA’s efforts in the creation of patient-matched medical devices to improve the care of Veterans, secure access to critical medical supplies in the face of unforeseen supply chain disruptions, and secure VA’s position as a leader in healthcare innovations. To support these initiatives, X_Labs has a requirement for 3D printers, printer maintenance services, materials, software, and product development and staffing support to take multiple 3D printed medical devices from concept through design, prototyping, testing and Food and Drug Administration (FDA) registration as a VHA-manufactured product. X_Labs owns and operates five 3D Systems 3D printers to manufacture patient-matched medical devices. The success of X_Labs’ ongoing patient-matched medical device manufacturing and future development of innovative devices requires a contract action with an industry partner Original Equipment Manufacturer (OEM) of 3D Systems, Inc., 3D printers owned by the 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 industry partner’s brand.

The scope of work for this requirement includes providing the VA with 3D printers and maintenance, ancillary post-processing equipment, software, and materials and consumables to support printer operation. Also included in the scope is staffing and product development support to bring multiple 3D-printed medical devices through 5 phases: 1. Initiation, 2. Planning, 3. Development, 4. Validation, and 5. Transfer. The work in these phases addresses specific deliverables within the product development process as well as ongoing support on Quality Management System (QMS) activities, workflow optimization, and strategies for management of critical supply chains, including analysis of the benefits and costs of bringing the manufacture of some 3D-printing feedstocks under VHA control.

The NAICS code is code 339113 - Surgical Appliance and Supplies Manufacturing and the size standard is 800 Employees. SAC-F anticipates negotiating and awarding a 3-year Hybrid Firm-Fixed-price/Labor hour contract to 3D Systems, Inc., to include the FAR clause 52.217-8, should an extension be required, for this requirement, by September 28, 2025.

Interested parties that believe they could satisfy the requirements listed above for SAC- F may clearly and unambiguously identify their capability to do so in writing on or before the response date for this notice. This is not a request for competitive proposals and a solicitation will not be issued. A determination not to compete this requirement based on responses to this notice is solely within the discretion of the Government. Information submitted in response to this notice will be used solely to determine whether competitive procedures could be used for this acquisition.

Any questions regarding this notice must be submitted in writing via email to Jaime.Bennett@va.gov and William.Justiniano@va.gov. All responses to this notice of intent must be submitted so that they are received at Jaime.Bennett@va.gov and William.Justiniano@va.gov no later than September 15, 2025, at 9:00 AM ET.

mailto:Jaime.Bennett@va.gov mailto:William.Justiniano@va.gov mailto:Jaime.Bennett@va.gov mailto:William.Justiniano@va.gov