Fiscal Year 2024 Military Prototype Advancement Initiative (MPAI)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) to solicit current MTEC members for a broad range of medical prototype technological and knowledge solutions related to the Focus Areas of Interest (also called “Focus Area(s)”) listed below. Proposed solutions may include medical techniques, knowledge products, and materiel (medical devices, drugs, and biologics). Military relevance is a key feature of this RPP, especially as it relates to the USAMRDC’s Combat Casualty Care Research Program (CCCRP), Military Infectious Diseases Research Program (MIDRP), and Military Operational Medicine Research Program (MOMRP), as well as the U.S. Air Force School of Aerospace Medicine.

Scope of Work

Current wartime operations assume that the United States and our allies will maintain air, land, maritime, space, and cyber superiority. Future conflicts against peer and near-peer adversaries are expected to be layered stand-offs and fought across multiple domains. Mission success will be determined by our ability to compete to expand the competitive space, penetrate both strategically and operationally, disintegrate enemy’s defenses, exploit enemy weaknesses, and re-compete to consolidate gains. Medical capabilities play a critical role in each aspect of the future battlespace and must modernize rapidly to maintain Force readiness and increase soldier lethality.

Minimum Requirements for Submission of an Enhanced White Paper

Enhanced White Papers submitted in response to this RPP shall meet the following minimum requirements:

Demonstrate Military Relevance: Proposed projects shall focus on providing medical solutions to support readiness and care in future battlefield scenarios.

Fit the Prototype Definition: Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. The definition of a “prototype” is as follows: (A) a prototype project addresses a proof of concept, model, (B) reverse engineering to address obsolescence, (C) pilot, novel application of commercial technologies for defense purposes, (D) agile development activity, (E) creation, design, development, demonstration of technical or operational utility, or (F) combinations of the foregoing. A process, including a business process, may be the subject of a prototype project.

Meet the Minimum Knowledge/Technology Readiness Level (KRL/TRL): The minimum acceptable KRL/TRL at the time of submission of the Enhanced White Paper is at least KRL/TRL 3 for most of the focus areas listed herein. Offerors have achieved KRL/TRL 3 if:

• Knowledge Products: Offeror has validated hypotheses that suggest applications (e.g., prediction for prognosis, screening for diagnosis, or treatment for prevention).
• Pharmaceutical (Drugs): Offeror has demonstrated initial proof-of-concept for candidate drug constructs in a limited number of in vitro and in vivo research models.
• Pharmaceutical (Biologics, Vaccines): Offeror has demonstrated initial proof-of concept for biologic/vaccine constructs in a limited number of in vitro and in vivo research models.
• Medical Devices: Offeror has demonstrated initial proof-of-concept for device candidates in a limited number of laboratory models (may include animal studies).

Offerors should note that all topics within Focus Areas 1 (Combat Casualty Care), as well as Focus Areas 3.10 and 3.13, require a minimum TRL/KRL of 4. Full definitions of TRLs can be found here. More information regarding KRLs can be found here.

Represent New Submissions to MTEC: Focus on proposed solutions that have not been submitted to MTEC under previous RPPs within the past two (2) years, including the 22-02-MPAI and 23-06-USAMRDC-MultiTopic. The Government is already aware of concepts submitted in response to previous MTEC solicitations including the 21-06-MPAI and 22-02-MPAI; therefore, such projects are not allowed to be resubmitted here. This RPP is intended only for submission of new projects to MTEC or substantially revised or modified proposals in accordance with previous Government feedback, not identical resubmissions.

Align to a Specified Focus Area: Enhanced White Papers shall align to a single Focus Area specified in Section 3.3 of the RPP. Failure to align to a single Focus Area of Interest may result in an “Unacceptable” rating and render the proposal ineligible for award.

Note: Failure to meet any or all of these minimum requirements may result in an overall “Unacceptable” rating of the Enhanced White Paper with minimum or no additional feedback provided.

Focus Areas of Interest

To meet the intent of this RPP, each Enhanced White Paper shall specifically address only one Focus Area described below. Offerors are not limited to a single Enhanced White Paper submission. Projects that fail to align with only one of these Focus Areas may not be considered for funding.

Focus Area 1 – Combat Casualty Care

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. This area prioritizes technologies that are easily transportable (i.e., small, lightweight, and durable in extreme environments and handling), easy to use, and require low maintenance.

Focus Area 2 – Military Infectious Diseases

This technology area focuses on vaccines, drugs, vector detection assays, and novel therapeutics to treat multidrug-resistant organisms in combat wound infections, as well as vector control measures for insect vectors that transmit naturally occurring endemic diseases with demonstrated or potential capability to decrease military operational effectiveness. This area specifically focuses on solutions for prolonged care scenarios, where wound infection poses a significant threat to operational readiness and effectiveness, as well as solutions enhancing medical readiness in response to infectious diseases encountered by Service members during deployment that can significantly impact performance.

Focus Area 3 – Military Operational Medicine

This technology area aims to maximize health, readiness, and performance by countering stressors and preventing physical and psychological injuries during training and operations.

Focus Area 4 – U.S. Air Force School of Aerospace Medicine

The Air Force Aerospace and Operational Medicine Enterprise (AOME) seeks to maximize Airman performance and readiness, as well as the development of mitigation measures for physical and psychological stressors, illness, and injuries during Airman training and operations by executing studies and analyses. The Studies and Analysis Portfolio general focus areas can be broadly categorized into the following areas of interest: Aerospace Medicine and Physiology, Public Health and Preventative Medicine, Occupational Medicine and Bioenvironmental Engineering, and En Route Care and Expeditionary Medicine. The following focus areas of interest are based on urgent and near-term needs and issues identified within the Air Force (AF) population. Proposals must be appropriate for one-year (12 month), short term investigations.

Additional Points of Consideration

• Project Maturity: This solicitation is not meant to support development of a new prototype and shall meet the minimum TRL or KRL requirement of 3 or otherwise stated in Section 3.3 (see Section 3.2 for more information regarding TRLs and KRLs). Offerors shall adequately describe how their proposed technology meets the definition of a prototype and should clearly address how the prototype meets the indicated TRL or KRL at the time of submission. See Addendum 1 for a reference checklist to assist in assessing the TRL of the proposed project.
• Industry Partners: Proposed projects are encouraged to include relevant industry partners, especially considering that the eventual goal is to transition products to industry for U.S. FDA approval and/or commercialization.
• Cost Share: It is anticipated that the Government funds would provide incentive for industry funding to join the project. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.

Points of Contact

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