Sole Source Justification FAR 13.5 Stryker Mako Redacted.pdf

Acquisition ID#:

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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:

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office-East (RPOE), Network Contracting Office 4 (NCO 4) provides contracting support for Veterans Integrated Services Network 4 (VISN 04), Wilkes Barre VA Medical Center, 1111 East End Blvd, Wilkes Barre, PA, 18711.

The funding purchase request has been approved and identified as:

2. Nature and/or Description of the Action Being Processed: This procurement is for a new requirement for preventive maintenance and repair of the Stryker Mako Robotic-Arm System 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. The usage of a Firm Fixed Price (FFP) type order is appropriate for this procurement action.

The Stryker Mako Robotic-Arm System was purchased in 2023 and is used to assist surgeons with the use of a computer guided robotic arm in the performance of both total hip replacement, partial knee replacements, and cemented and non-cemented total knee replacements. The system enhances the quality, precision, and safety of knee and hip replacement procedures being completed at the Wilkes Barre Medical Center. The purchase included a one-year warranty for maintenance and repairs. The warranty expired on October 10, 2024, and preventive maintenance is required immediately to ensure safety and operability; otherwise, the unit must be pulled from service. Removing the system from use would have a detrimental impact to patient care as the system is utilized to increase patient safety, recovery, and prognosis from knee and hip replacement surgery.

Only Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics, can provide the required support services including manufacturer recommended operational and safety improvements through the preventative maintenance and repair of the Wilkes Barre VA Medical Center’s Stryker Mako Surgical Robot. This requirement is crucial to ensure the continuous reliability of the Stryker Mako Surgical Robot identified in the Statement of Work (SOW), as the equipment requires continual maintenance and support to uphold the system’s efficacy and availability. The reliable and accurate operation of the system is considered critical to the health of patients and continuous operations at VA Wilkes Barre.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Wilkes Barre VAMC requires full equipment and software support for the continuous reliability of the Stryker Mako Robotic-Arm System. Requirements include:

A. Stryker Maintenance Agreement

1. Service coverage of all hardware, firmware, installation, parts, labor, and preventive maintenance

2. On-site response within twenty-four (24) hours, during local business hours (refer to SOW)

Acquisition ID#: Page 3 of 5 the needed requirements for Wilkes Barre knee and hip replacements.

Each company that manufactures prosthetic components also 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 Stryker Mako would not be compatible with the current operations which the three orthopedic surgeons performing joint replacement are currently familiar. To switch from our 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 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 higher rate of adverse events. This is obviously 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.

The purchase of the Stryker Mako Robotic-Arm System cost when purchased

Replacing the surgical robot, all the required surgical instruments, and providing training to surgical teams would have an estimated cost of more procure a new system that did not meet the full requirements of Wilkes Barre Medical Center and would increase patient risk during transition and familiarization of a new system.

Reprocuring this requirement would require use of a sole source again or risk acquiring a system that would result in degraded medical capabilities and increase patient risk. In conclusion, procurement would cause significant duplication of cost that could not be recovered from an increase in competition for the requirement.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A special notice was posted to Sam.gov on October 21, 2024, that the Government intends to issue a sole source award to Howmedica Osteonics Corporation. The posting closed October 28, 2024, with no challenges received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price analysis will be conducted using comparison of proposed price with prices found reasonable on previous purchases. A determination will be made by the Contracting Officer that the anticipated cost to the Government is fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A sole source letter was provided by the original equipment manufacturer, Stryker Orthopaedics, who provides the hardware, software, support, and trained field technicians for their proprietary technology. Market research was conducted utilizing VetCert, SBA Dynamic Small Business Search (DSBS), FPDS, and Sam.gov. No sources were identified using search terms, “Stryker Mako”. VetCert identified 311 possible SDVOSB/VOSB vendors under NAICS “811210”. SBA DSBS search using VOSB or SDVOSB limiters and search term “Stryker Mako” yielded

Acquisition ID#: Page 4 of 5 no results. A search of all small businesses using only the search term “Stryker Mako” was then conducted and returned no results. A search of FPDS using “Stryker Mako” yielded only results with Howmedica Osteonics Corp. as the vendor. NAC and GSA eLibrary were searched for available contracts to place an order under. No NAC contract or GSA Schedule available to place an order for service requirements. In conclusion, market research did not yield any additional sources that can meet the Government’s minimum requirements.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Utilizing sole source award to Howmedica Osteonics Corporation is in the Government’s best interest to procure needed maintenance and support services for the Stryker Mako Surgical Robotic-Arm System. Sole source supports the VA mission to care for Veterans seeking treatment requiring surgical joint replacements.

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

Howmedica Osteonics Corporation DBA: Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 Business size: Large Business

UEI: E5DLYCJBNYX7

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:

Competition is limited due to the proprietary technology of equipment for the medical system. The Government will continue to conduct market research to ascertain if there are changes in the market or requirement that would enable future actions to be competed.

12. Requirements Certification: I certify that the requirement outlined in this justification is critical to 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.

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.

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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.