N231-057 TITLE: Real-Time Training Heat and Load Monitoring Kits for Ground Forces
OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Artificial Intelligence (AI)/Machine Learning (ML); Biotechnology; General Warfighting Requirements (GWR)
OBJECTIVE: Develop a Heat Illness Prevention System (HIPS) kit that provides technologies for real-time monitoring to prevent exertional heat illness in a training environment, at scale, for active-duty service members � specifically for Marine Corps and Army personnel.
DESCRIPTION: The U.S. Army Medical and Material Development Agency (USAMMDA), under the Health Readiness and Performance System (HRAPS) program of record has developed a suit of technologies and capabilities for use in a training environment. In addition, the U.S. Army Research Institute of Environmental Medicine (USAIRIEM) has developed several critical heat strain state algorithms that estimate core body temperature, heat illness risk, and predict heat stroke. Together, the HRAPS technologies and algorithms have been combined into a prototype heat illness prevention system. The HIPS has been used in a prototype form with Special Forces (Ranger Assessment and Selection Program � 75th Ranger Regiment) Sapper Leader Course (169th Engineers), and with regular trainees to include 198th Infantry Brigade (Ft. Benning), Maneuver Support Center of Excellence (MSCoE), and with the U.S. Marines � Marine Corps Recruiting Depot � Parris Island. While these prototypes are useful in the management and prevention of exertional heat illnesses in the training environment, they are comprised of separate technologies and do not scale to support the numbers for Marine Corps and Army training environments, requiring further science and technology to ensure that the technologies and algorithms support the scale needed.
The HIPS system is composed of core system capability with additional add on components. The key technical challenges require addressing the scale requirements provided below (threshold), and then the additional add on components (objective). The core system is comprised of an on-body sensor system and local phone status app.
On-Body Sensor System Requirements:
1) Human factors: Wearable with minimal comfort impact and functional for extended periods of time: Threshold is 4 days, Objective is 7 Days
a) While we do not explicitly define size/weight requirements these will be constrained by the human factors and expected wear/function times.
2) Environment: up to 50 �C, fully immersible in water
3) Battery life: Threshold is 4 days, Objective is 7days
4) Communications: Bluetooth Low Energy (BLE)
5) Scalability: Ability to use on large Company size units simultaneously, e.g., 500 � 600 individuals
6) Gang charging systems to manage devices in at least multiples of 25
a) Skin temperature (every 5s)
b) Heart Rate Threshold is every 5s; Objective is ECG waveform
c) 3 axis accelerometry
8) Must run Government Furnished algorithms in real time on the device to determine heat strain risk state:
a) Estimated Core Body Temperature (ECTemp)
b) Adaptive Physiological Strain Index (aPSI)
c) Gait Instability Index (GInI) aka Wobble Index
d) Heat Stroke Prediction Algorithm
e) Exertional Heat Illness Alerting Algorithm (EHIAA)
9) Data logging capable of storing and downloading high resolution data from all sensors exceeding the battery life time
10) Must be manageable for Company size group by 1 or 2 staff members
Local Phone Applications (App):
1) Receive and display transmissions from the On-Body Sensor System: Android (Threshold), Android and Apple (Objective)
2) Display status for a defined set training Company personnel on individual tiles that represent the EHIAA algorithm and change colors based upon risk level
3) Tiles ordered by EHI risk level
4) Must have the ability to define sub-groups of personnel and display these sub-groups independently
Additional Capabilities (Objective):
If the Threshold requirements have been met, then the following Objective capabilities are desired.
1) Individual Smart Watch or Phone
a) Provide individuals with their own display of their own data
b) Alert to pre-set thresholds based upon EHIAA, aPSI, or ECTemp
c) Ability to track geo-location
d) Ability to transmit heat strain state and geolocation to a web-server application through cellular communications (Threshold) or other long-range means (Objective)
e) Provide the ability to only transmit data that by itself does not constitute either personal identifiable information (PII) nor protected health information (PHI).
a) Display geo-location and heat strain state
b) Allow different log-ins to provide independent events with their own view of participants
In addition, this effort requires the compilation of training materials and the ability to support training units in the issue and roll out of the HIPS monitoring system.
PHASE I: Develop a concept and prototype for a HIPS kit that provides technologies for real-time monitoring to prevent exertional heat illness in a training environment. Demonstrate the feasibility of the proposed concept (hardware/software HUD-centric system) to meet Marine Corps infantry needs through a set of specific Phase I deliverables. As part of Phase I the Government will provide at least one heat strain risk algorithm to support testing.
Deliverables specific to this SBIR topic (in addition to the standard Phase I deliverables identified in the DON instruction for this BAA) include: 1) an initial prototype kit; 2) documentation that kit components can achieve the request requirements listed in topic call; 3) concept of operations for how the kit will be employed by end users; and 4) human subjects testing plan for testing that will occur during Phase II.
No Human Subjects Research can be conducted as part of Phase I.
PHASE II: Based on the results of Phase I deliverables evaluation, performers will develop a working proof-of-concept of the HIPS kit for the ground forces. This phase shall include prototyping the HIPS kit, conducting critical design reviews, and demonstrating that initial capabilities are sufficient for existing training environments. The prototypes will be evaluated to determine their capability to meet ground force needs and requirements for a heat monitoring system.
Deliverables include: 1) a final bill-of-materials (BOM); 2) all component parts and specs; and 3) proof of concept devices (at least 100) for evaluation.
Human Subjects Research is expected to be conducted as part of Phase II, but may be done in partnership with a Government lab as part of ongoing active-duty service member (e.g., Marine Corps or Army) research.
PHASE III DUAL USE APPLICATIONS: Support the Marine Corps and Army with transitioning and integrating the HIPS kits into existing training environments. Assist with certifying and qualifying the HIPS kits for Marine Corps and Army use. Assist in writing Marine Corps and Army device user manual(s) and system specifications/materials. As appropriate, focus on scaling up manufacturing capabilities and commercialization plans that will extend the technology to the civilian with a focus on athletic activities � e.g., collegiate, endurance races, etc.
1. Buller, Mark J.; Welles, Alexander P. and Friedl, Karl E.. "Wearable physiological monitoring for human thermal-work strain optimization." Journal of Applied Physiology, 124.2 (2018): 432-441.
2. Buller, M., Fellin, R., Bursey, M., Galer, M., Atkinson, E., Beidleman, B. A., ... & Williamson, J. R. (2022). "Gait instability and estimated core temperature predict exertional heat stroke." British Journal of Sports Medicine, 56(8), 446-451.
KEYWORDS: Infantry; Training; Heat; Safety; Monitoring, Wearables
** TOPIC NOTICE **
The Navy Topic above is an "unofficial" copy from the Navy Topics in the DoD 23.1 SBIR BAA. Please see the official DoD Topic website at www.defensesbirsttr.mil/SBIR-STTR/Opportunities/#announcements for any updates.
The DoD issued its Navy 23.1 SBIR Topics pre-release on January 11, 2023 which opens to receive proposals on February 8, 2023, and closes March 8, 2023 (12:00pm ET).
Direct Contact with Topic Authors: During the pre-release period (January 11, 2023 thru February 7, 2023) proposing firms have an opportunity to directly contact the Technical Point of Contact (TPOC) to ask technical questions about the specific BAA topic. Once DoD begins accepting proposals on February 8, 2023 no further direct contact between proposers and topic authors is allowed unless the Topic Author is responding to a question submitted during the Pre-release period.
SITIS Q&A System: After the pre-release period, and until February 22, 2023, (at 12:00 PM ET), proposers may submit written questions through SITIS (SBIR/STTR Interactive Topic Information System) at www.dodsbirsttr.mil/topics-app/, login and follow instructions. In SITIS, the questioner and respondent remain anonymous but all questions and answers are posted for general viewing.
Topics Search Engine: Visit the DoD Topic Search Tool at www.dodsbirsttr.mil/topics-app/ to find topics by keyword across all DoD Components participating in this BAA.
|2/21/23||Q.||In the past, SBIR phase 1 proposals were limited to $100K. We do not see that limit in the SBIR topic nor in the several instructions documents. Is there a cost limit, or does cost simply factor into the decision when selecting a winning proposal?|
|A.||Please review the Navy SBIR 23.1 Instruction posted with this BAA. Cost requirements specific to Navy topics are detailed within this document under the heading Cost Volume (Volume 3).
|2/21/23||Q.||The instructions indicate that if human trials are to be performed, then IRB and other approvals will be necessary. Is it your impression that human trials will be needed to evaluate the performance of the phase 1 and phase 2 deliveries, thus necessitating proper approvals? Or can on-body tests be limited to demonstrations that can be used to evaluate performance? How might the Army support testing?|
|A.||Per the topic details, no Human Subjects Research can be conducted as part of Phase I. For Phase II section, Human Subjects Research is expected to be conducted as part of Phase II, but may be done in partnership with a Government lab as part of ongoing active-duty service member (e.g., Marine Corps or Army) research. This will be done based on the work completed in Phase I, and part of the discussion for a Phase II.|
|2/21/23||Q.||The instructions state that this is only a solicitation for the Phase 1 effort, so just to be clear, you are not looking for a costed phase 2 proposal as part of the submission? And, would the phase 1 proposal benefit from a description of the approach we would take for phases 2 and 3?|
|A.||It is highly recommended that proposing small business concerns use the Phase I proposal template, specific to DON topics, at https://navysbir.com/links_forms.htm to meet Phase I Technical Volume (Volume 2) requirements. This template will provide the information required to complete the Phase I Technical Volume (Volume 2).|
|1/17/23||Q.||In the Phase I section the term �HUD-centric system�. Can the acronym �HUD� be defined?|
|A.||The acronym HUD stands for Human User Design.