JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

STRYKER CORPORATION

CONTRACT SPE2D1-20-D-0011

(1) Department of War (DoW), Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

(2) This action is a request to approve a Justification for an Exception to Fair Opportunity (JEFO) for the acquisition of new Stryker Information Management Systems to facilitate the repair of existing Operating Room (OR) integration systems at Naval Medical Center (NMC) San Diego.

(3) The requirement is for the procurement of five (5) Stryker Connected OR HUB and Connected OR Integration Platform (IP) systems. These items are required to repair existing Stryker OR integration systems that currently have failed Stryker Sustainable Data Capture 3 (SDC3) Information Management Systems. The current SDC3 systems are obsolete and are no longer supported by Stryker, the Original Equipment Manufacturer (OEM). The order will be placed against Stryker Corporation’s (Stryker) Patient Monitoring and Capital Equipment (PMCE) Contract SPE2D1-20-D-0011 which expires on July 16, 2030.

The total estimated dollar value of this requirement is

(4) The authority waiving the fair opportunity requirements is FAR16.507-6(b)(2) (as implemented by DOD Class Deviation 2026-O0045 (MAR 2026)), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. Stryker is the Original Equipment Manufacturer (OEM) and the only vendor capable of providing the proprietary replacement systems and specialized repair services required to restore NMC San Diego’s operating rooms to full functionality. Due to the current failure of the legacy SDC3 systems, there is an immediate need for these repairs to resolve critical capability gaps in the operating rooms and ensure the facility can continue providing seamless, safe, and uninterrupted patient care.

The required systems must meet the following minimum operational requirements:

a) The Information Management System shall be able to store, display, and transfer 4K video and image data.

b) The Information Management System shall have the ability to provide integrated device control from the existing Stryker endoscopy camera system.

The requested systems are highly specialized and uniquely compatible with NMC San Diego’s existing infrastructure. The Stryker 1588 AIM (Advanced Imaging Modalities) Endoscopy Camera Systems are currently installed at the NMC San Diego operating rooms. The requested Stryker Information Management System is the only system certified to be fully compatible and capable of providing integrated device control with the current Stryker Endoscopy Camera Systems.

This full compatibility is mission-critical, as it allows users to control existing connected devices directly via camera buttons. This integrated control enables surgical teams to remotely start/stop image capture and adjust connected device settings during surgical procedures without leaving the sterile field. While other Information Management Systems possess basic routing and recording capabilities, full functionality and integrated device control can only be achieved when both the Information Management System and the Endoscopy Camera Systems are certified to work with one another.

Furthermore, Stryker holds the sole proprietary license for the operating software on both the Stryker OR Integration Systems and Endoscopy Systems. Any repairs or integrations requiring interaction with this proprietary operating software must be conducted by an entity possessing the appropriate software licenses. Stryker does not authorize any third-party entities to perform repairs on their OR Integration Systems or Endoscopy Systems.

Market research was conducted in May 2026 by DLA Troop Support Biomedical Engineer.

The research confirmed that Stryker possesses the ability to provide the required systems and repair services.

The market research efforts included:

(5) The required Information Management System is available on Stryker’s PMCE Contract

SPE2D1-20-D-0011. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing, invoices, and other than certified cost or pricing data. The contracting officer has determined, based on a review of the above, that the anticipated cost to the Government will be fair and reasonable.

(6) There are no other facts supporting the use of this JEFO.

(7) In an effort to overcome barriers to fair opportunity for subsequent acquisitions, DLA Troop Support will continue to allow PMCE vendors to have the opportunity to add products that fall within the scope of the PMCE solicitation at any time, thereby increasing competition within the program. However, currently there are no other known PMCE vendors that can meet NMC San Diego’s requirements and perform the necessary repair for existing Stryker OR Integration Systems.

(8) As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

Date ANTHONY GIUNTA Contracting Officer, FSD

(9) I hereby certify that the requirements, which form the basis of this justification, are accurate, that these supplies and services meet the Government's minimum needs, and that this justification is accurate and complete to the best of my knowledge and belief.

Date Biomedical Engineer, FSDC

GIUNTA.ANTHO

NY.

Digitally signed by

GIUNTA.ANTHONY

Date: 2026.05.15 10:52:13 -04'00'