Justification and Approval Form_SW KO signed.pdf

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Helmet Integration of Thera Tactics Enhanced Pulse Oximeter
Solicitation number
N3239826Q4439
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This document is a Justification and Approval for Other Than Full and Open Competition (sole source acquisition) executed by the Naval Medical Research Command (NMRC), Silver Spring, Maryland, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements. The procurement action supports previous contracting for the Thera Tactics Enhanced Pulse Oximeter, a proprietary tactical aviation pulse oximetry system designed for forehead-mounted deployment on military aircraft. The system monitors pilot heart rate, blood oxygenation, and environmental conditions in real time to enable early detection of physiological episodes and adverse events. The device has been flight-tested and validated on Navy platforms including the T-45, F-18, and F-35 aircraft.

The acquisition is justified as a sole source under 10 U.S.C. 2304(c)(1) and 2304(c)(3) and FAR 6.302-1(c) for brand name justification because Thera Tactics is the only vendor capable of providing the specified pulse oximetry system. The technology is not commercially available, was developed specifically for military aviation, and is protected by multiple patents (US11517227B2, US20210076471A1, US10772562B2, and US20183442471A1). The procurement specification requires clinical-grade pulse oximetry capable of integration into tactical aviation helmets with demonstrated capability to meet arterial blood gas validation and military airworthiness standards. Market research identified only one potential source, and NMRC has no plans to compete future contracts for these supplies unless another qualified vendor emerges. The Contracting Officer will determine fair and reasonable pricing through analysis and negotiation, with the Government anticipating a discount from the vendor's commercial price list.

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JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

3. Description of Supplies or Services.

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

As of 20 November 2025

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

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 government point of entry in accordance with FAR 5.202.

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

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

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

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

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.

For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements are feasible.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

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 POC

Phone Date Name Title Department/Command

Department Head

Phone Date Name Title Department/Command

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date

Technical Cognizance

Phone: 937-938-3917
Date: 12 JUN 2026
Name_2:
0:
0: LT Kaila Vento

Department Head

CHC/NAMRU-D

1:
0: Stephanie Warner

Biomedical Engineer

EP/NAMRU-D

2026-06-12T10:07:44-0400
WARNER.STEPHANIE.ANN.1409469210
2026-06-12T10:26:43-0400
VENTO.KAILA.ANN.1513071120
Phone_2: 385-636-1146
Date_2: 12 JUN 2026
Text2: Market research was conducted, but only 1 vendor (Thera Tactics) was contacted due to the company being the only provider for the system, maintenance, and service for the device. The technology is not commercially available and was developed specifically for military aviation.
Text3: 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.
Text4: Thera Tactics is the only vendor capable of providing the specified pulse oximetry system. The technology is not commercially availably and was developed specifically for military aviation. The technology is protected by patents US11517227B2, US2021007647A1, US10772562B2, and US2018344247A1.
Text5: The procurement action supports previous contracting of the Thera Tactics Enhanced Pulse Oximeter, an intended for tactical aviation, forehead mounted pulse oximeter system with correction factors for accuracy at altitude. The Thera Tactics system is designed to monitor pilot heart rate, blood oxygenation, and environmental conditions in real time, enabling early detection of physiological episodes or other adverse events experienced by aircrew. This system has been flight-tested and validated on Navy platforms including the T-45, F-18, and F-35
Text1: The proposed procurement is for a sole source due to the proprietary nature of the Thera Tactics measurement methodology, which collects samples at the capillary bed that is supplied by the supra-orbital artery. The planned advancements for the device include integration into currently used and in development tactical aviation helmets. The required technical specifications demonstrate the Thera Tactics' uniqe capability in clinical-grade pulse oximetry development, design, and field deployment, particularly under tactical aviation conditions, that are met by a limited number of qualified vendors based on prior validation against arterial blood gas (ABG) analysis and military airworthiness standards. See Salient Characteristics for explicit requirements.
2026-07-01T15:39:29-0400
JOHNSON.NATAKI.SHIDONA.1515567492
Phone_3:
Date_3:
Text6: 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 U.S.C.2304(c)(1) or 10 U.S.C.2304(c)(3) and FAR 6.302-1(c) for brand name justification.

Text7: 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions or FAR 13.106-1(b)(1) soliciting from a single source.
Text8: Not applicable
Text9: Not applicable

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