S02 JOFOC_Redacted.pdf

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 2679 – Mako Robotic Arm System

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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 2679

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Services Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541 24 3 250 0225

2. 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.

3. 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 CLE VAMC Medical Center. This will allow the Cleveland Veterans Affairs Medical Center CLE VAMC 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 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

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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 Knee 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 . Estimated delivery is 24 48 hours after award.

4. 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

5. 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.

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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 Robotic System, as well as other reasons, which establish it as the only system to satisfy the Government’s needs:

1. Mako Robotic System 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 Robotic 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.

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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 Robotic 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 Robic System 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 Robotic 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 Robotic System do not provide robotic assistance in the performance of hip replacement. The Mako Robotic 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, 36C250 24 AP 2679 – Mako Robotic Arm System

Effective Date: 02/01/2022 Page 5 of 10 usually based on the size of the femoral head measured at the time of surgery, With the Mako Robotic 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 Robotic 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 System was requested for use at the CLE VAMC 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 Stryker Mako Robotic System would be an extension of the instrumentation currently utilized to perform hip and knee replacement at the CLE VAMC. 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 Stryker Mako Robotic System was designed to be used with Stryker components. Any of the surgeons utilizing the Mako Robotic System 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 Robotic 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.

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In summary, the Mako Robotic System will meet the clinical needs of the CLE VAMC. 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.

Accordingly, Stryker is the only firm capable of providing the supplies and services described in Section III above without the Veteran's Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Sources Sought, RFI 36C25024Q0456, was posted on SAM.gov, Contract Opportunities on March 21, 2024, with a response date of March 28, 2024, utilizing NAICS code 339113, stating the key features of the MAKO Robotic System. Stating the features, the CLE VAMC was looking for. No potential equals or vendor questions were received in response to posting to SAM.gov, Contract Opportunities. There are no other actions that were taken or planned to facilitate competition for this acquisition.

7. 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.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted by the Contracting Officer and the service to identify available sources to meet the requirements as follows:

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VetCert, Sources Sought, DSBS, SAM.gov, National Contracts, Interagency Contract Directory, GSA, FPDS, DLA Troop Support, BIC, FDA, were reviewed with the following results:

VetCert was queried, as required, using NAICS 339113. The search provided 924 results.

In accordance with January 9, 2023, advisory for VetCert usage, VetCert was queried, as required, using NAICS 339113. The search provided 924 results. The SDVOSB and VOSB vendors in the market research were contacted to see if they can provide or are able to provide comparable equipment to no avail. Veteran Small Business Certification (sba.gov)

A Sources Sought, RFI 36C25024Q0456, was posted on SAM.gov, Contract Opportunities on March 21, 2024, with a response date of March 28, 2024, utilizing NAICS code 339113. No potential equals or vendor questions were received in response to posting to SAM.gov, Contract Opportunities.

A search was conducted in the Medical Surgical Prime Vendor (MSPV) Contracts:

Equipment Home (dla.mil) using key words “robotic arm system” which resulted in no results.

A search was conducted in Small Business Administration (SBA) Dynamic Small Business Search (DSBS) SBA SBA Search Results under NAICS CODE 339113 and key words “robotic arm system” which resulted with no results.

A search was conducted on SAM SAM.gov | Search under key words “robotic arm system” which resulted with Mako Robotic Arm Systems.

A search was conducted on DLA Troop Support Medical Chain dla.mil with no results.

A search was conducted on the Interagency Contract Directory Interagency Contract Directory Portal with key words “robotic arm system” which resulted in no results.

A search was conducted on GSA eLibrary Product Detail (gsaadvantage.gov) with key words “robotic arm system” which resulted in no results.

A search was conducted in Federal Procurement Data System (FPDS) FPDS NG ezSearch with key words “robotic arm system” with several results showing Stryker and several other vendors that did not meet the needs of the CLE VAMC.

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IAW OMB MemorandumM 19 13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

A search was conducted in The U.S. Food & Drug Administration (FDA) Search | FDA with key words “robotic arm system” which resulted in approval.

The NMR does apply to NAICS 339113, and SBA has not provided a class waiver for NAICS 339113.

Based on the market research conducted, no two or more VetCert verified and capable SDVOSBs or VOSBs or DSBS verified and capable small business were identified and appeared capable of performing the requirement. The VA Rule of Two cannot be met. The SBA Rule of two cannot be met.

Stryker is a Large Business with no distributors providing Stryker Mako Robotic System.

Stryker has a good past performance record.

FITARA is not needed, it is not IT related.

There are no BAA/TAA issues, the Mako Robotic System is made in America.

9. 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 number of readmissions and revisions. These features have been studied formally demonstrating that the Mako Robotic System is cost effective.

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10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Stryker (Large Business) OEM 325 Corporate Dr.

Mahwah, NJ 07430 Kristin Daugherty Kristin.Dauherty@stryker.com 757 751 4176

11. 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.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Matthew Flemming Management Analyst Louis Stokes Cleveland VAMC, VISN 10

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO 10)

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2024.07.11 09:39:30 -04'00'

MATTHEW

FLEMING

Digitally signed by

MATTHEW FLEMING

Date: 2024.07.11 10:05:40 -04'00'

36C250 24 AP 2679 – Mako Robotic Arm System

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b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Branch Chief, Supply Team #1 Network Contracting Office (NCO 10)

Thomas P. Moore Division Chief, Supply/Prosthetics Network Contracting Office (NCO 10)

Marie L. Smith Director of Contracting Network Contracting Office (NCO 10)

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Daryl A. Berg Executive Director, RPO Central Head of Contracting Activity

ADAM

WEBER

Digitally signed by ADAM

WEBER

Date: 2024.07.11 13:41:14 -04'00'

THOMAS

MOORE

Digitally signed by

THOMAS MOORE

Date: 2024.07.17 14:04:30 -04'00'

MARIE

SMITH

Digitally signed by

MARIE SMITH

Date: 2024.07.18 15:10:08 -04'00'

DARYL BERG

Digitally signed by

DARYL BERG

Date: 2024.07.29 10:01:11 -05'00'