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DEPARTMENT OF VETERAN AFFAIRS STATEMENT OF NEED Velys Robotic System Introduction: The Pittsburgh VA Medical Center (646) located at University Drive C., Pittsburgh, PA 15240, has a brand name or equa... DEPARTMENT OF VETERAN AFFAIRS STATEMENT OF NEED Velys Robotic System Introduction: The Pittsburgh VA Medical Center (646) located at University Drive C., Pittsburgh, PA 15240, has a brand name or equal requirement for one (1) Robotic Spine System, and components. Background and Scope of Work: The Pittsburgh VAMC (646) is requesting a Brand Name or Equal requirement for one (1) Velys Spine Robot, along with components. The purpose of this Statement of Need is to outline the necessity for the acquisition of the Velys Robotic Spine System to support the expansion of neurosurgery workloads, specifically for spinal navigation surgeries at our facility. The advanced capabilities of this robotic system will enhance the precision and efficiency of spinal surgeries, ultimately improving patient outcomes. Pittsburgh Surgical Services currently have four (4) Neuro/Spine Surgeons that have agreed upon the Salient Characteristics for a Robotic Surgical System. This additional system will help with the caseload of 2-4 procedures a week. Salient Characteristics: Robotic-assisted Surgical System overall must assist the surgeon in the following: Be able to Identify anatomical structures and placement of spinal implants for spinal fusion procedures. Help position and orientate surgical instruments. To be used in Freehand Navigation Guidance Mode and Robotic-Assisted Guidance mode. Spinal Fusion Implant compatibility: Must be compatible with the existing DePuy Synthes Spine Systems; CROSSNAV , EXPEDIUM VERSE Spine System, VIPER PRIME System, SYMPHONY OCT System, TriALTIS , ANSPACH EG1 High Speed Electric System already in-use at the Pittsburgh VA Healthcare System. Imaging Requirements: Must be image agnostic (able to be utilized with any 3D CT or CBCT intraoperative imaging device on the market) such as the GE 3D C-Arm, O-Arm System, Ziehm 3D CArm system, BrainLab Airo,Siemens C-Artic Move, and Siemens Cios Spin arm. Single-Use Arrays: The system must have Single-Use arrays that are opened for each spine procedure. Active-Robotic Assist Station/Hardware: The system must have the ability to be a modular system; the Navigation system can act independently of the Robotic Assist station. Must have the ability to manually manipulate the robotic arm in any direction that the surgeon desires. The Robotic arm must have a handgrip that has infrared LEDs at its proximal and distal ends; these infrared LEDs must create the Robotic arm array which allows the robotic arm to be tracked by the camera. The arm must have the ability to actively track patient movement based on the patient reference array; and thereby will also maintain alignment to the target. Must have the ability to when an external force is placed on the robotic arm or tool holder, the robotic arm will maintain its alignment. The system must have the ability to be a modular system which the Navigation system can act independently of the Robotic Assist station. The robotic system must have the ability to activate screw release mode; allowing for to ease the removal of the Screwdriver once the inserted screw tip reaches 20% of the length to tip of planned screw length. Technology/Software: System software must assist in planning pedicle screws for spinal fusion procedures. System software must track the positioning of the arrays in real-time. Must contain graphical user interface (GUI) with touchscreen technology. Software must contain a feature known as screw release mode - standout innovation, this feature automatically manages the controlled release of the screwdriver once a pedicle screw reaches its target. By sensing positional relationships and adjusting accordingly, it prevents mechanical shudder and workflow interruptions a direct response to challenges in earlier robotic designs. The system must have a simplified and user-friendly interface that is designed based on click efficiency. Streamlined icons, thoughtful button placement, and a deliberate color scheme. Ability to toggle between Robotic Assist mode and Freehand Mode throughout the procedure. The acquisition and integration of the Velys Robotic Spine Robot System is crucial for the neurosurgery department to keep pace with increasing surgical demands and advancements in spinal surgery technology. This investment will enhance our facility s ability to provide high-quality patient care, improve surgical outcomes, and maintain our position at the forefront of medical innovation. Delivery Requirement: Deliver all line items specified under Data/Deliverables to: VAMC Pittsburgh ATTN: Warehouse/BioMed University Drive C. Room 2A118 Pittsburgh, PA 15240 During normal operating hours, M-F 8:00am 3:30pm Reports/Deliverables: Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Pittsburgh (646). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. The Contractor will provide training sessions for any relevant surgical and support staff upon request, coordinate installation with facility POC/COR to minimize disruptions and provide timely and Warranty: The Contractor will provide a one (1) year warranty covering equipment. This one (1) year warranty period will commence upon successful installation and validation of the Velys Robotic Spine System. Security: The Contractor will come on-site to Pittsburgh VAMC located at University Drive C. Pittsburgh, PA 15240 to provide installation. The Contractor will not have access to any sensitive data. REQUEST FOR INFORMATION INSTRUCTIONS: The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112 (size standard of 1000 employees). Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees; Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Must have an authorized distributor letter from the original equipment manufacture. If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. Equipment manufacture, Country of origin Please provide your UEI number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 12. Telephone responses will not be accepted. Responses must be received via e-mail to andrew.taylor3@va.gov no later than, 4:00 PM Eastern Time (ET) on January 19, 2026. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Officer, Andrew Taylor. Questions or responses will include the Source Sought number 36C24526Q0174 in the subject line. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. Any interested business concern must submit a no longer that 10-page capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer. If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at andrew.taylor3@va.gov include 36C24426Q0174 in the subject line. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. End of Document