MTEC Prototype Acceleration Funding

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for the new MTEC Prototype Acceleration Funding mechanism to be funded with MTEC consortium funding:

Objective: To “de-risk” technology advancement toward a military application to a point that allows the MTEC member to secure follow-on funding.

Funding Available: $1,000,000 total, up to $250,000 per award.

Award Type: Grant.

Scope of Work: Tasks technical in nature.

Solicitation Process:

• Stage 1: Solution Brief
• Stage 2: Solution Brief Pitch
• Stage 3: Cost Proposal

Scope of Work

In multi-domain operations (MDO), today’s operating force will be overwhelmed with casualties, the ability to evacuate will be limited, first responders and medics will struggle with limited resources and ability to achieve the “Golden Day,” resulting in operational units and commanders rapidly losing freedom of maneuver and combat effectiveness. Therefore, medical assets must be highly mobile and more dispersed (e.g., smaller, more modular medical units), Warfighters will require greater self-sufficiency and autonomy (e.g., may have more limited medical-related communications and re-supply), and there will be an increased cognitive and physical stress on Warfighters (they will need ways to maximize lethality and return to the fight quickly).

Therefore, proposed projects shall focus on providing medical solutions to support readiness and care in future battlefield scenarios in support of the following areas:

Prolonged Field Care (PFC):

Because battlefield conditions impose severe constraints on available manpower, equipment, and medical supplies available for casualty care, there is a need for medical interventions that can be used within the battle area or as close to it as possible, before or during medical evacuation. Preferred medical techniques and materiel that can be used by combat medics must be easily transportable (i.e., small, lightweight, and durable in extreme environments and handling), easy to use and require low maintenance. Additionally, wound infection in a PFC environment poses a significant threat to operational readiness and effectiveness. It is anticipated that future battlefield scenarios will necessitate the need for medical techniques, knowledge products, and materiel to manage wound infections in theater.

Medical Readiness:

This area focuses on developing technologies that maximize medical readiness and provide mobile health solution sets for the modern Warfighter. Efforts may include diagnostics, treatments, AI-based advanced telehealth technologies, and training

Maximizing Human Potential:

This area aims to develop effective countermeasures against military-relevant stressors and to prevent physical and psychological injuries during training and operations in order to maximize the human potential, in support of the Army Human Performance Optimization and Enhancement, MDO, and the DoD Total Force Fitness concepts.

It is encouraged that potential Offerors reach out to the MTEC Contact to determine whether your proposed technology has military relevance, aligns with the mission of MTEC, and is within scope for this RPP.

The proposed scope of work should focus on tasks relevant to advance the prototype to the next major milestone that helps secure follow-on funding. Project scope should be proposed based on the prototype’s maturity at the time of submission.

Examples of the work that could be included in the scope of work are (but not limited to):

• Prototype refinement/maturation progressing towards clinical product.
• Prototype delivery for military-relevant testing: ruggedization for operation in military environments; testing of prototypes; and system prototype demonstration in a relevant or operational environment (live or simulated).
• Stability and shelf-life studies.
• Nonclinical and preclinical studies required for the technical data package for a regulatory application.
• Preparation of regulatory packages (e.g., Investigational New Drug application, Investigational Device Exemption application), including regulatory consultant costs.
• Clinical feasibility studies (as needed) to support regulatory approval/clearance.
• Clinical pivotal studies (as needed) to support regulatory approval/clearance.
• Establish robust quality system.
• Improve efficiency and reproducibility of manufacturing process for scale up.
• Establish Good Manufacturing Practice (GMP) manufacturing for clinical trials and for market release.
• Work towards clearance/ approval by the U.S. Food and Drug Administration (FDA).
• Integration of medical informatics system components and system is evaluated in a simulated environment.
• Develop interfaces to supporting systems.
• Initial production runs, first article testing, etc.
• Low-rate initial product runs.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.