N6264518RCP3253-Attachment_V-J&A-Stereotactic_System-Brain_Lab-NMCSD_Redacted.pdf

LOG# 18-10064

Stereotactic System/Brain Lab-NMCSD Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD on behalf of Naval Medical Center San Diego (NMCSD) to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for one (1) stereotactic system, image-guided, surgical, multi-procedure [27-302] and one (1) scanning system, computed tomography, spiral [18-443] for NMCSD. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Brainlab, Inc. (BrainLab) of 5 Westbook Corporate Center, Suite 1000 Westchester, IL 60154-5766.

3. Description of the supplies/services required.

The Naval Medical Logistics Command has a requirement for Naval Medical Center San Diego

(NMCSD) for one (1) stereotactic system, image-guided, surgical, multi-procedure [27-302] and one (1) scanning system, computed tomography, spiral [18-443]. The surgical image-guided system shall be capable of real-time navigation of instrumentation used in spinal, cranial, and trauma surgeries. The surgical image-guided system shall be capable of integrating a 3D C-arm, navigation instrumentation, and microscope instrumentation. The surgical image-guided stereotactic system shall include a mobile cart with dual-displays and infrared tracking cameras for intuitive positioning, alignment assistance, real-time instrument tracking, and volume detection. The surgical image-guided system shall provide real-time surgical and navigation updates during surgery. The surgical image-guided stereotactic system shall display a minimum of four (4) instruments simultaneously. The surgical image-guided system shall include software for 3D-reconstruction and screw placement planning, as well as surgical workflow planning software for clinicians to conduct pre-operative planning. The surgical image-guided system shall include needle guides, screws, bone fixators, drill guides, drill bits, probes, reflective markers, disposables, and all necessary software and hardware for spinal, cranial, and trauma surgeries.

An intraoperative computed tomography (iCT) system capable of integration with the surgical image-guided stereotactic system shall be provided. The mobile iCT shall be a high-resolution intraoperative helical CT scanner for total spine and cranial imaging. The iCT system shall include a patient table for imaging in cranial and spinal cases, in prone, supine, lateral, and sitting positions. The surgical image-guided system and iCT shall directly exchange images and patient data. The systems shall include clinician training and biomedical technician service training. The power requirement is 110 VAC, 60 Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system, including claims made for the product, shall be compliant with Food and Drug

Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the

United States of America. The system shall be installed in compliance with OSHA requirements.

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4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC

2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Brainlab, Inc. is the only vendor that can provide a surgical image-guided system and iCT for use in spinal, cranial, and trauma surgeries. No other vendor can provide a surgical image-guided system and an iCT. Brainlab, Inc. is the only vendor that can meet the minimum requirements of the Government.

Brainlab does not have any distributors.

An intraoperative CT (iCT) must be part of this procurement so that the surgeons can conduct full-resolution precision tissue imaging during intraoperative cranial, spinal, and trauma surgeries as well as during minimally invasive surgeries. The iCT is important for screw placement accuracy because the iCT allows for immediate intraoperative assessment of each implanted screw. Studies have shown that intraoperative imaging for screw placement using only a 3D C-arm is not always clearly assessable. A

3D C-arm remains limited by a small field-of-view scan area and reduced image quality when compared to CT imaging, particularly in patients who are obese or when imaging regions of the spine that are difficult for radiographic visualization.

The Brainlab iCT allows for full Hounsfield soft tissue imaging for better definition of the spine. The scan volume (50 x 100cm) allows surgeons to image the entire spine in a single scan and allows surgeons to visualize more anatomical context than 3D C-arms. Purchasing the iCT with the navigation system allows the systems to automatically transfer images, merging pre-operative and intra-operative scans for accurate image-guided surgery. Image-guided surgery provides pre-operative planning for screw placement, improved accuracy in placement of spinal arthrodesis, and decreases the incidence of neurological injury from misplaced instrumentation.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the NECO and/or FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in February and March 2018. It included a correspondence with an

NMCSD Neurosurgeon, as well as a search of the Internet using Google, Bing, GSA Advantage, and the

ECRI Sourcebook. Vendors which can provide a surgical image-guided stereotactic system include

Brainlab, Compass, Medtronic, and Stryker. Although Compass can provide a surgical image-guided system, the system is not FDA-cleared for use in spinal neurosurgeries and Compass cannot provide an intraoperative CT (iCT). Stryker can provide a surgical image-guided stereotactic system capable of performing all required surgeries, but the system is not compatible with the existing 3D C-arm in use at

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NMCSD. Stryker also cannot provide an iCT. Medtronic can provide a surgical image-guided system, but the system does not include software for pre-operative workflow planning. The pre-operative workflow planning software allows the surgeons to better prepare for their surgeries, maximizing efficiency of OR time. In addition, the Medtronic surgical image-guided system cannot provide real-time surgical and navigation updates as needed for spinal surgeries.

Medtronic can only provide an intraoperative C-arm (O-arm) which, according to the ECRI Sourcebook, is a radiographic/fluoroscopic unit, mobile [11-758]. This does not meet the minimum requirements because the requirement is for a full resolution scanning system, computed tomography, spiral [18-443] to work in conjunction with the surgical image-guided system. NMCSD does not require a mobile radiographic/fluoroscopic unit because they have the Siemens Arcadis 3D C-arm that they plan to use in surgery as needed. Therefore, it would be redundant to purchase another radiological/fluoroscopic system.

An iCT provides full-resolution precision tissue imaging for intraoperative surgeries. Thus, only Brainlab, Inc. can provide a surgical image-guided system and iCT for use in spinal, cranial, and trauma surgeries.

Only the products of Brainlab, Inc. can meet the minimum requirements of the Government.

A Request for Information (RFI) was posted to FBO from 14 June 2018 – 19 June 2018. The only response received was from BrainLab (sole source vendor).

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

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TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Phone Date

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this J & A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($750,000-$12.5M)