JEFO_MEDTRONIC_SPE2D1-19-F-0042.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

(JEFO)

MEDTRONIC USA, INC.

CONTRACT SPM2D1-13-D-8307

Stereotactic Neurosurgical Equipment

(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 an acquisition from Medtronic USA, Inc.’s (Medtronic) Radiology and Imaging contract SPM2D1-13-D-8307, valid through May 31, 2019.

(3) The item to be acquired is a StealthStation S8 neurosurgical intracranial surgical navigation system for Landstuhl Regional Medical Center (LRMC), Germany. The total estimated dollar value of this action is $401,697.95.

(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 StealthStation S8 identified above from Medtronic is essential to LRMC’s requirements.

The requested neurosurgical intracranial surgical navigation system is exclusively provided by Medtronic USA, Inc. for its proprietary electromagnetic (EM) tracking technology which provides for active tracking. Active tracking is a key enabling technology in the context of computer-assisted medical interventions. It allows the continuous localization of medical instruments and patient anatomy. It provides instrument guidance to subsurface anatomical structures in real time through the use of electromagnetic tracking technology. The StealthStation S8 has advanced visualization with 3D electromagnetic tracking capabilities that creates tumor models, allows for rapid visualization of anatomy and structures, and the ability to seamlessly merge radiographic images from CT, SPECT, MRI, MRA, PET, functional MRI and the mobile O-Arm surgical imaging system. This unit is critical in treating seriously injured patients coming from down range. Injuries seen at LRMC include: gunshot wounds to the head and spine;

abdominal wounds which penetrate to the spine; and facial disfigurement with brain involvement. The StealthStation S8 system assists the surgeon in locating and stabilizing the location of injuries with precision application. Having all cranial surgery, spinal neurosurgery, endoscopic sinus surgery capabilities in one system along with active tracking will lead to better patient care and may save patients’ lives.

(5) The Medtronic USA, Inc. items required are available on the Medtronic USA, Inc. contract SPM2D1-13-D-8307. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing and other than certified cost or pricing data. In view of this earlier determination, the Contracting Officer has determined that the anticipated cost will be fair and reasonable to the Government, and that the subject procurement represents the best value.

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

(JEFO)

MEDTRONIC USA, INC.

CONTRACT SPM2D1-13-D-8307

Stereotactic Neurosurgical Equipment

(6) DLA Troop Support continues to perform market research through internet searches and the use of ECRI Institute Comparison System on the availability of stereotactic neurosurgical equipment that can support the needs of DLA Troop Support customers. The results of the market research performed in December 2018 indicate that other companies’ similar products cannot meet the needs of LRMC. No other vendor has all the cranial surgery, spinal neurosurgery, and endoscopic sinus surgery capabilities such as Chiari surgery, Pituitary Tumor removal, Tumor resection or Biopsy, and Shunt placement that are included in Medtronic’s StealthStation S8. Likewise, as discussed above in paragraph (4), the StealthStation S8 features active tracking, and all other vendors’ products use passive tracking. Vendors with Radiology and Imaging contracts have the opportunity to add products, including neurosurgical systems, which fall within the scope of the Radiology and Imaging program at any time. The ongoing addition of new products to the Radiology and Imaging program will enhance competition for future acquisitions.

(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 and belief.