Helmet Integration of Thera Tactics Enhanced Pulse Oximeter

Description

The United States Department of the Naval Medical Research Command (NMRC) intends to award a sole source contract to, Thera Tactics, Inc. in Tahoma, CA. This requirement is for authorized approved vendors to provide prototype development for brand name equipment. This notice is not a request for competitive proposals however If interested Government shall consider all responses. The Naval Medical Research Unit - Dayton (NAMRU-D) is seeking to incorporate wearable physiological monitoring systems into tactical aircraft for real-time and post-flight analysis of aviator physiological status. This has been done by assessing sensors proposed for use in aircraft and in investigating putative causes of PEs. Both tasks require specialized capability for accurate and fast response and real-time analysis of blood oxygenation (SpO2) and heart rate (HR) across various flight profiles and aircraft types as part of the initiative to address, identify, and mitigate PEs through the use of various aircrew physiological monitors. As part of this initiative, Thera Tactics holds a patent in their blood oxygenation measurement methodology, and has previously been contracted with NAVAIR and NAMRU-D to develop a pulse oximetry system for use in tactical aviation platforms needing to be resistant to high-G forces, and not negatively impact the wearer. The device has since completed benchtop and manned verification and validation (V&V) testing, and limited safe-to-fly (StF) and airworthiness testing through Electro Magnetic Interference (EMI) and windblast testing in order to be cleared for in-flight use. The pulse oximetry market for military applications is specialized, with total DoD spending on related medical devices estimated at $50-100 million annually (based on aggregated SAM.gov data). Navy-specific procurements often prioritize systems for tactical aviation (e.g., rotary-wing aircraft like helicopters), where vibration, G-forces, and hypoxia pose unique challenges. Traditional finger-based sensors are common but prone to inaccuracies in these environments due to peripheral vasoconstriction and blood shunting. Forehead reflectance sensors, which probe dermal capillaries fed by the internal carotid artery (arising from the brain's circulation), offer superior stability as they are less affected by external stressors, supported by patent US20060264726A1 and studies showing 90-second faster hypoxia detection compared to digit sensors. Navy contracts frequently involve sole source awards for proven systems, as seen in Naval Medical Logistics Command (NMLC) procurements. Companies like Thera Tactics introduce innovative, patent-protected technologies tailored to these needs, often through RDT&E pathways. Common challenges include integrating multi-wavelength spectral analysis for accurate desaturation curves, ensuring compliance with military standards like MIL-STD-810G for environmental testing, and incorporating reliability metrics like signal quality indicators to flag low-confidence data, which is critical in high-stakes operational scenarios where false readings could impact decision-making. The NAICS code for this action is 339112. NMRC requires that all contractors doing business with the Acquisition Office must be registered with the Systems for Award Management (SAM). No award can be made unless the vendor is registered in Systems for Award Management. For additional information and to register in SAM, please access the following website: https://www.sam.gov/. In order to register with the SAM and to be eligible to receive an award from this Acquisition Office, all offers must have a Unique Entity Identification Number (UEI). A Sam.gov number may be acquired free of charge by contacting Sam.gov online at www.sam.gov or by phone at (866) 606-8220