JEFO- Medtronic Surgical Navigation System_Redacted.pdf

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY (JEFO)

(1) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment

Division, is the contracting activity.

(2) The action submitted for approval is a JEFO for the acquisition of a surgical navigation system under Medtronic contract SPM2D1-19-D-0018.

(3) The required item is a neurosurgical intracranial surgical navigation system (Stealth Station S8) for Brooke Army Medical Center (BAMC). The total estimated dollar value of this action is

(4) The authority waiving the competition requirements is FAR 16.505(b)(2)(i)(b), 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. The surgical navigation system identified above is the only product that can meet the customer’s needs.

This procurement is necessary to meet Government requirements for a surgical navigation system to be used for sinus, brain, and spine surgical procedures at Brooke Army Medical Center. The required item is a highly complex medical device that is mainly software driven and only provided by Medtronic.

The Stealth Station S8 provides unique features including advanced visualization software proprietary to Medtronic that creates tumor models, allows for rapid visualization of anatomy and structures, and has the ability to merge radiographic images from the existing Medtronic O-Arm at BAMC. The advanced visualization software and seamless integration between the Stealth Station 8 and the existing Medtronic O-Arm is necessary for deep brain stimulation procedures. Only Medtronic can offer this seamless integration due its proprietary software. Further, the Medtronic Stealth Station 8 is the only platform that can be used by multiple surgical platforms including neurosurgery, otolaryngology, and spine surgery, and has the ability to utilize passive tracking as well as active tracking. Active tracking provides the ability to precisely track in real-time the location of surgical instruments throughout a procedure. Active tracking is a required capability for patient care because it is critical in treating extensively injured patients.

Medtronic is the only vendor that offers the surgical navigation system identified above that can meet the requirements of BAMC for a hardware and software neurosurgical intracranial surgical navigation system to be used with the Medtronic O-Arm at BAMC. No other vendors offer equipment with all the above surgery capabilities.

(5) The Medtronic items required are available on the Medtronic radiology contract SPE2D1-19-D-

0018. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing and other than cost or pricing data. The Contracting Officer determined that the subject procurement represents the best value to the Government.

(6) DLA Troop Support continues to perform market research on the availability of surgical navigation systems. The results of market research indicate that presently, Medtronic is the only known supplier that can meet the requirements of Brooke Army Medical Center. Other vendors do not have all required cranial surgery, spinal neurosurgery, and endoscopic sinus surgery capabilities.