6515--Notice of Intent to Sole Source Mako Surgical Robot This is not a request for quote

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A NOTICE OF INTENT TO SOLE SOURCE: Stryker Mako Surgical Robot This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this source sought notice. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. Stryker Mako Surgical Robot INTRODUCTION: The Corporal Michael J. Crescenz VA Medical Center continually seeks avenues for enhancing the quality of care provided to Veterans. An exemplary illustration to this commitment lies within the operating room where the Medical Center would like to deploy the MAKO robotic arm for Orthopedic Surgeries. The MAKO represents a breakthrough in surgical outcomes for Veterans undergoing total hip and knee replacement procedures. Engineered by Stryker, this robotic-assisted surgical system employes 3D imaging to devise a tailored surgical plan for each patient. The surgeon can execute precise incisions and achieve accurate implant placements, resulting in great outcomes and increasing recovery periods after joint replacement surgery. The Mako surgical system is the only system that will provide robotic assistance in the performance of both total hip and total knee replacement. There are other systems available but they do not provide robotic assistance of total hip replacement. Computer-assisted total joint arthroplasty has been shown to improve prosthetic alignment in total hip and total knee replacement. Most systems are passive. They provide feedback to the surgeon on alignment and orientation, but the surgeon has complete control over the procedure. This is an example of the computer navigation system. The computer directs the surgeon, but the surgeon ultimately decides how to proceed. The Mako is a semi active system. The Mako robotic arm will guide the surgeon to precise bone cuts in total knee replacement. The surgeon utilizes a saw attached to a robotic arm. The robotic arm will have a defined area of resection based on the preoperative CT scan performed. This will minimize the potential for soft tissue injury such as neurovascular injury, ligamentous injury, or tendon injury. The robotic arm will not allow the surgeon to make cuts beyond the defined area of resection established by the preoperative CT scan. The Mako robotic arm is FDA approved for both cemented and non-cemented total knee replacement, the other systems are FDA approved for cemented use only. The trend in current orthopedic surgery is toward the use of non-cemented components especially for the younger and more active patient. The Mako system is utilized as a semi active system for total knee replacement, partial knee replacement, and total hip replacement. The system will guide the surgeon in performing bone cuts in total knee replacement, partial knee replacement, and in acetabular reaming in total hip replacement. The major competitors of the Mako system do not provide robotic assistance in the performance of hip replacement. The Mako system provides direct surgeon assistance in the placement of the acetabular component by directing the surgeon through the use of a robotic arm in reaming of the acetabulum. The ideal placement of the acetabular cup is determined by the preoperative CT scan and allows for placement of the acetabular cup to reduce the potential for dislocation, that optimizes the leg length, and minimize the potential for impingement of the femur on the acetabulum. The size of the acetabular cup can be determined from the preoperative CT scan, reaming of the acetabulum is minimized, typically in a traditional hip replacement without the use of computer navigation, the acetabulum is enlarged progressively by 1-2mm increments until the ideal size is obtained, usually based on the size of the femoral head measured at the time of surgery, With the Mako system, the size of the acetabular cup is determined preoperatively and a single reaming is performed with the predetermined acetabular size based on the pre operative CT scan. This can significantly reduce operation time. The placement of the acetabular cup is directed by the robotic arm, the Mako system allows for the precise placement of the acetabular cup determined by preoperative planning. This will reduce the incidence of cup malposition and associated complications including post operative dislocation, premature polyethylene wear, leg length discrepancy, and impingement. The Stryker Mako robotic arm system offers state of the art innovative robotic system that is FSA 510K complaint. The system was subject to extensive clinical trials and performance testing in order to gain FDA clearance. The system is designed with bulit-in features to ensure data encryption, secure patient information storage, and HIPAA compliance. Stryker maintains ISO13485 certification for its manufacturing processes, which is an internationally recognized standard for medical device manufacturing. Additionally the company follows the FDA s quality assurance rating to ensure that the Mako system is manufactured and tested to meet the highest safety and performance standards. The Mako surgical system is manufactured in the United States. As a 1B High Complex Facility, the Corporal Michael J. Crescenz VA Medical Center (CMC VAMC) would like to revolutionize the current clinical pathways for joint replacement surgical procedures with the integration of a robotic-assisted technology exemplified by the MAKO system. The MAKO Robot has proven clinical outcomes that enhance patient outcomes through various means. Patients who have undergone the MAKO-assisted procedures experience reduced pain, shorter hospital stays, and quicker recoveries described in published journal articles. The nature of the robotic system minimizes the risk of errors and complications thereby enhancing alignment, bolstering joint stability, and mitigating postoperative pain. CMC VAMC Surgical Service would like to offer the same competitive orthopedic services to our Veterans that is currently being offered at the University of Pennsylvania and in facilities outside of VISN 4. Robotic-assisted surgery augments the surgeon s capability by providing precise guidance and feedback. It does not take away the surgeon s capability but extends their expertise enabling the attainment of the utmost in patient outcomes. The addition of the robotic device does not require any construction or modification of the operating room suites. The addition of this system will allow CMC VAMC to increase surgical procedures, provide better surgical outcomes, improve patient satisfaction, strengthen the joint program. The orthopedic robotic program will assist with competitive recruitment and retention and align the Medical Center with the University of Pennsylvania. CMCVAMC has four (4) part-time Orthopedic Joint Surgeons, and the procurement of this system and application would allow for expansion of the current robotic surgery program. The orthopedic joint replacement program utilizes Stryker hip/knee implants and this robot only works with it s own instruments and implants. SCOPE: The contractor shall furnish all labor, hardware, firmware, installation, materials, parts, equipment, tools, transportation, trained/licensed personnel, management, and supervision required to perform annual Preventative Maintenance (PM) and repair service on Stryker equipment listed under equipment request. INSTALLATION: The vendor is responsible for transporting the robot from the warehouse up to the operating room after biomedical engineering inspection. Since the robot comes fully installed the vendor will be responsible for queuing up the software and plugging the machine into an electrical outlet to run test cases. DELIVERY REQUIREMENTS: CMC VAMC 3900 WOODLAND AVENUE, PHILADELPHIA PA 19104 WAREHOUSE DELIVERY Materials must be delivered in manufacturers original sealed containers with brand name marked thereon or maintain coverings in place and in good repair. PO# must be on the outside of the shipping box for easy identification Deliveries must be coordinated between the COR and Warehouse personnel Delivery days are Monday through Friday during normal business hours which are defined as 7:30am 3:00pm. National Holidays are excluded. Any delivery service performed for emergency orders may be delivered other than normal business work hours and must be approved. The Contractor is not required to provide delivery services on the following National Holidays, nor shall the Contractor be paid for these Holidays and any other declared national holiday by the President. HOLIDAY MONTH New Year s Day January Martin Luther King s Birthday January President s Day February Memorial Day May Juneteenth June Independence Day July Labor Day September Columbus Day October Veterans Day November Thanksgiving Day November Christmas Day December The Contractor shall provide calibration and preventative maintenance inspections in accordance with the manufacturer s latest specifications. The Contractor shall provide calibration and preventative services by authorized Service providers of the equipment during installation and through the warranty period. Vendor must provide preventive maintenance services or preventive maintenance training for users and biomedical technicians. Vendor will provide training to OR personnel and be present during orthopedic cases. Warranty: The Contractor shall provide at least a one-year manufacturer s warranty on all parts. Any recalls to the equipment, the vendor agrees to replace within three business workdays without any additional cost to the government. The Government understands there could be global supply and shipping issues for replacement parts. The warranty shall include shipping costs associated with any warranty repair. 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 noice 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) 339113 (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 notice? 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 under NAICS 339113 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 directly from the original equipment manufacturer. 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. Please provide your UEI number. This notice will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to contact@example.gov no later than, 4:00 PM Eastern Time (ET) on March 7, 2025. 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 Specialist, Andrew Taylor. Questions or responses will include the Source Sought number 36C24425Q0314 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 contact@example.gov include 36C24425Q0314 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