JEFO- Medtronic S8 signed posted.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 StealthStation S8 under Medtronic contract SPM2D1-19-D-0018.

(3) The required item is a hardware and software neurosurgical intracranial surgical navigation system StealthStation S8 to be used at Madigan AMC. 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 for neurosurgical/intracranial and otolaryngology surgical procedures. Equipment will be located at Madigan AMC in the operating rooms. The required item is a highly complex medical device that is only provided by Medtronic.

The requested neurosurgical intracranial surgical navigation system is exclusively provided by Medtronic USA, Inc. for its proprietary equipment. 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 existing CT, SPECT, MRI, MRA, PET, functional MRI, 3D C-Arm, and O-Arm equipment at Madigan AMC. The advanced visualization software and seamless integration between the Stealth Station 8 and the existing C-Arm or 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 Madigan AMC for a hardware and software neurosurgical intracranial surgical navigation system to be used with the existing equipment at Madigan Army Medical Center.

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

The Contracting Officer determined that the subject procurement represents the best value to the Government.

(6) Madigan AMC conducted current market research, assessing whether manufacturers other than

Medtronic could offer guidance systems that meet all their minimum requirements and have all the required features to support cranial surgery, spinal neurosurgery, endoscopic sinus surgery

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY (JEFO)

capabilities as follows: Chiari surgery to stop or control the progression of symptoms caused by tonsillar herniation, to relieve compression of the brainstem and spinal cord, and to restore the normal flow of cerebrospinal fluid (CSF); Pituitary tumor removal to remove as much of the tumor as possible or obtain biopsies to recommend treatment; Shunt replacement to help drain cerebrospinal fluid and redirect it to another location in the body where it can be absorbed; and localization method with the ability to utilize passive tracking as well as active tracking. Other vendors use only passive tracking via the use of optical tracking or electromagnetic sensors. Active tracking provides the ability to precisely track the location of surgical instruments throughout a procedure. This tracking is referred to as “active tracking” being it is accomplished in real-time. This is critical in treating extensively injured patients coming from down range. Injuries often make it difficult for surgeons to identify brain margins clearly and the imagery via this technology assist visualization. Injury seen at Military Treatment Facilities (MTF) include injuries to the head and spine, abdominal wounds which penetrate to the spine, facial disfigurement with brain involvement, etc.

The results of current market research indicate Medtronic is the only supplier on contract that offers a surgical navigation system that meets all the minimum requirements as stated above. Market research findings indicate that other vendors (ClaroNav, Stryker, Compass International Innovations, Zimmer Biomet, Karl Storz) do not all have all the required features to support Cranial surgery, Spinal neurosurgery, and Endoscopic sinus surgery capabilities. The Stealth Station S8 Navigation system is the only system that assists the surgeon in locating and stabilizing the location of injuries that require precision in application.

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

(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.

Date Contracting Officer

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

Date Biomedical Engineer