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VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 36C250-24-AP-1996 Mako Robotic Arm... VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 36C250-24-AP-1996 Mako Robotic Arm System Effective Date: 02/01/2022 Page 1 of 9 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C250-24-AP-1996 Contracting Activity: Department of Veterans Affairs, NCO 10, located at 24 Frank Lloyd Wright Drive, Suite M2200, Ann Arbor, MI 48105, in support of VISN 10, Detroit VA Medical Center at 4646 John R. Street, Detroit, MI 48201. 2237: 553-24-2-063-0079. Nature and/or Description of the Action Being Processed: This procurement is for the Mako Robotic Arm System and applications in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This procurement will be completed as a new firm-fixed-price Purchase Order. It will be awarded to Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Description of Supplies/Services Required to Meet the Agency s Needs: The Mako Robotic Arm System offers innovative procedures that utilize the precision of the Mako robotic arm to assist with total knee and hip replacements. This system will extend and enhance the quality, precision and safety of total knee and total hip replacement procedures presently being completed at the Detroit VA Medical Center. This will allow the VA to offer the same competitive Orthopedic service to our veterans that is currently offered in other VA facilities across the nation and in the private sector. The MAKO Robotic Arm System (3 App) Total Knee/Partial Knee/Total Hip includes the following: 1 RIO Surgical Arm 1 RIO Guidance Module 1 RIO Camera Stand Assembly 1 RIO Accessory Kit 1 ROBOT Utilities 1.11.1 Software Disk 1 MAKO User Guide 5 Mako Power Trays 1 MAKOplasty CT Scan Kit MAKO Total Knee Application: 1 Mako Total Knee Software License 2 Mako Knee Trays 2 Pelvic Arrays 2 Stryker Leg Positioner Tray Kids 1 Surgeon and Surgical Staff Training, Total Knee Mako Partial Knee Application: 1 RESTORIS Partial Knewe Software License 2 Mako Knee Trays 2 IMP DeMayo Leg Positioner 25 Kits 1 Surgeon & Surgical Staff Training, Knee Mako Total Hip Application: 1 MAKOplasty Total Hip Software License 2 Mako Hip Instrument Kits 2 Mako THA Array Kits 2 Hip End Effector, Variable Angle 1 Surgeon & Surgical Staff Training, Hip The estimated value of the proposed action is $950,000. Estimated delivery is 24-48 hours after award. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.  Competition is restricted on this procurement for the reason below:        ( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements        ( ) Unusual and Compelling Urgency        ( )  Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services        ( ) International Agreement        ( ) Authorized or Required by Statute        ( ) National Security        ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Computer-assisted total joint arthroplasty has been shown to improve prosthetic alignment in total hip and total knee replacements. There are multiple systems available for use. They differ in many respects. Some 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. Semi-active and active systems utilize a robotic arm to perform bone cuts which are guided by the computer navigation system. These systems will offer physical assistance in the bone preparation. The advantages of these systems are they will physically limit the cuts performed, providing an additional level of patient safety by preventing inadvertent injury to adjacent neurovascular structures and supporting ligaments, and provide more precise bone cuts. This is particularly important in non-cemented applications of knee replacement. The more precise the bone cuts, the better fit of the prosthesis and the better chance of bone ingrowth with resulting long-term stability of the prosthesis. The trend in orthopedics is toward the use of non-cemented knee prostheses, especially in the younger, more active population. Non-cemented total hip replacement has become the standard of care for most patients requiring hip replacement for degenerative disease of the hip. Total hip replacement is a very gratifying procedure for patients, allowing most patients to resume an active, pain-free lifestyle. One of most important components of the hip replacement is the acetabular cup position. Cup position has an impact on limb length, impingement, post operative dislocation, range of motion, polyethylene wear, loosening, and cup failure. A study of computerized tomographic (CT) - based measurement of cup position has shown that acetabular cup placement based on surgeon assessment at the time of surgery resulted in only a minority of acetabular cups being placed in the optimal position. Use of a robotic arm allows the placement of the acetabular cup in the ideal position. A pre-operative CT scan allows the planning of ideal placement of the acetabular cup to minimize the potential complications associated with malposition of the acetabular cup. There are several features/characteristics of the Mako system, as well as other reasons, which establish it as the only system to satisfy the Government s needs: 1. 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. After a thorough surgical plan is created and approved by the surgeon, the Mako system assists surgeons with executing that plan using AccuStop haptic technology. The implant position, tracking and soft tissue balancing are assessed in a virtual 3D model by combining a preoperative CT and intraoperative bone registration. A CT scan uses a combination of 2D and digital geometry processing to generate a 3D image of the body. While plain film radiographs (X-rays) provide a 2D image of the scanned area, anatomic structures may overlap, creating an image which is less detailed than a CT scan. In a CT image, overlapping structures are eliminated, making the internal anatomy easier to visualize. In knee and hip arthroplasty procedures, the femoral version and tibial torsion 76 can provide critical guidance when planning a case. Bony anatomic landmarks of the femur and tibia can be clearly identified using 3D imaging technologies. After the surgeon assesses implant size and position in the preoperative plan, the robotic arm is introduced to the surgical site. The robotic arm uses AccuStop haptic technology to help ensure only the desired bone is resected. The robotic arm will give resistance, an audible warning and ultimately turn off if the surgeon attempts to move the cutting tool on the robotic arm outside the boundaries created in the preoperative plan. In addition, when the surgeon prepares the bone for the implant, the robotic arm guides the surgeon within the predefined area, allowing for a more accurate and better-aligned knee. The Mako system 1) provides the surgeon real-time sensory feedback, 2) places the surgeon in complete control, 3) helps ensure proper preparation of the bone 4) allows for precise placement of the implant, 5) produces minimal blood loss and a smaller scar, 6) helps preserve healthy bone and soft tissue, 7) results in less post-operative pain than manual techniques, and 8) provides a quicker recovery and shorter hospital stay. 2. The Mako robotic arm is FDA-approved for both cemented and non-cemented total knee replacement. The trend in current orthopedic surgery is toward the use of non-cemented components to allow bone ingrowth into the knee prosthesis and reduce the incidence of bone -cement interface failure with subsequent loosening and need for revision surgery. It is beneficial especially for the younger and more active patients. 3. 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, optimize the leg length, and minimize the potential for impingement of the femur on the acetabulum. In addition, because 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 operative time. In addition, since 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 op dislocation, premature polyethylene wear, leg length discrepancy, and impingement. 4. Stryker Mako robotic arm was requested for use at the Detroit VA to assist in joint replacement procedures - specifically total hip replacement and total knee replacement. Currently, the three orthopedic surgeons who perform hip and knee replacement surgery use Stryker instrumentation and implants to perform total joint replacement. The Mako robotic arm would be an extension of the instrumentation currently utilized to perform hip and knee replacement at the Detroit VA. Should a problem occur with the robot utilization, the procedure would need to be converted to the traditional type of open procedure which the facility currently performs, utilizing the various instrumentation available for intramedullary and/or extra medullary alignment, bone cuts, prosthetic trials, and prosthesis insertion. The Mako robot was designed to be used with Stryker components. Any of the surgeons utilizing the Mako robotic arm would easily be able to switch to a traditional approach currently used should the need arise. Each company that manufactures prosthetic components supplies their own instrumentation to allow for the appropriate placement of the final prosthesis. The instrumentation utilized for joint replacement can be extensive, and typically 5 or more trays of instruments and prosthetic trials are used during joint replacement. Utilizing a robot system other than the Mako system would not be compatible with the current system for which the three orthopedic surgeons performing joint replacement are currently familiar. To switch from the current system would require retraining of the current orthopedic surgeons performing joint replacement to become familiar with an entirely new system for alignment, bone cuts, and prosthesis insertion. This would be absolutely necessary since there is always a risk of robot failure and the need to convert the robotic-assisted procedure into a traditional instrument-guided procedure. There is a learning curve associated with switching to a new system and during that time procedures would take longer to perform, and patients may be subject to a higher rate of adverse event, which is not in the patient s best interest. Each system has its own nuances and experience using a system helps to provide a more fluid surgical procedure, reduce operative time, and minimize errors during the surgical procedure. In summary, the Mako robotic system will meet the clinical needs of the Detroit VA. It 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 that do not provide robotic assistance of total hip replacement. In addition, preoperative evaluation with use of CT scan in hip replacement has the potential to reduce operative times by limiting the amount of reaming to prepare the native acetabulum for placement of the prosthetic cup. The Mako robotic system is a product of Stryker. There are no other companies that produce this specific product. There are other companies that produce computer navigation or robotic arms for joint replacement, however, the Mako robotic system is FDA-approved for total knee replacement both cemented and non-cemented total knee replacement, partial knee replacement, and total hip replacement. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought (36C25024Q0366) was posted to Contract Opportunities from 2/28/2024 3/4/2024 including information as to what the requirements were that another system would have to meet should another vendor propose equipment that would be equal to the Mako robotic system. A response was received from Buffalo Supply, Inc. (a small business); however, they proposed Smith & Nephew equipment but did not provide information to demonstrate how it meets the Detroit VA s requirements as identified in the Sources Sought. One requirement was that it included a CT scan. The documents provided stated no CT required . Since they do not use a CT, they do not get a CT-based preoperative model and plan that is specific to the patient. Their navigation is activated during the procedure without the preoperative CT based plan/model and no robotic arm assist. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable by comparing the pricing provided to past purchases found through market research IAW FAR 13.106-3(a)(2)(ii). Additionally, if necessary, the CO will use any other price analysis techniques identified in FAR 13.106-3(a)(2) to determine fair and reasonable pricing. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VetCert was queried under NAICS 339112 and 660 concerns were found. DSBS was searched under NAICS 339112 and robotic arm system and 0 results were found. SAM was searched under hip and knee robotic surgery system and no results were found. GSA was searched under robotic arm system , hip , knee , and surgery and no results were found. NAC was searched under robotic arm system and no results were found. SCMC was searched under robotic arm system and knee and no results were found. SEWP was searched under robotic arm system and no results were found. NAICS 339112 currently only has an NMR Class Waiver for CPAP devices. This type of surgical equipment does not have a waiver. The manufacturer, Howmedica Osteonics Corp., a large business, does not have any distributors. Therefore, the VA Rule of Two cannot be met, nor can the SBA Rule of Two. As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. A sources sought (36C25024Q0366) was posted to Contract Opportunities from 2/28/2024 3/4/2024 including information as to what the requirements were that another system would have to meet should another vendor propose equipment that would be equal to the Mako robotic system. A response was received as described in Section 6 above. The Buy American Act Applies. The products are made in the United States. Any Other Facts Supporting the Use of Other than Full and Open Competition: The patient benefit that will be experienced through the use of this equipment offsets the added cost per case by decreasing length of stay reducing the number of physical therapy sessions and reducing the number of readmissions and revisions. These features have been studied formally demonstrating that the Mako is cost-effective. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Howmedica Osteonics Corp. (Large Business) Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430 Kristin Daugherty Kristin.Dauherty@stryker.com 757-751-4176 Buffalo Supply, Inc. (Small Business) Distributor of Smith & Nephew (Large Business) 1650A Coal Creek Drive Lafayette, CO 80026 Ally Bowlin ally.bowlin@buffalosupply.com 800-366-1812 A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: For any forthcoming procurements of this nature, market research will be conducted to identify comparable and competitive products in the commercial marketplace.