Fiscal Year 2026 Multi-Topic Request for Project Proposals

Purpose

The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) soliciting 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 (e.g., medical devices, drugs, and biologics). Military relevance is a key feature of this RPP.

To view the full-length version of this RPP, please download using the link on this page.

Background:

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.

Scope of Work

Focus Areas of Interest

To meet the intent of this RPP, each Enhanced White Paper SHALLspecifically address ONLY ONE Focus Area of Interest 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 of Interest may not be considered for funding.

Focus Area 1: Policies and practices for cross-cutting prevention

Current efforts on prevention and reduction of harmful behaviors such as suicide, sexual assault, harassment, and substance misuse rely on policies, programs (curricula or other manualized sets of activities, e.g., trainings), and practices (discrete behaviors or actions). However, there is currently an over-reliance on programs, particularly trainings, for prevention. Additionally, a finding and associated recommendation of the Independent Review Commission on Suicide Prevention suggests that current training requirements (broadly speaking) exceed workload capacity, increase stress among service members, and should be reduced. Furthermore, there is limited awareness of approaches to design, select, and implement policies and practices to support prevention.

To enhance current cross-cutting preventions, the Government, specifically the National Guard, seeks the development and evaluation of non-training interventions/activities that address risk and protective factors for harmful behaviors. Priority risk/protective factors to address include: morale, fairness, work-life balance, passive leadership, toxic leadership, and workplace hostility. These non-training interventions may include local-level policies that can be implemented at military installations, practices or routine behaviors/processes executed in a military environment(s), or any programs that do not primarily rely on a training module.

The Government anticipates that proposed prototypes may involve data collection to gather current non-training approaches at military sites, literature review to gather potential options for non-training approaches, and evaluation of one or more non-training activities. Evaluation of proposed interventions should assess both outcome effectiveness and implementation feasibility, including a thorough assessment of the requirements for successful delivery (e.g., resources, infrastructure, personnel, and operational conditions) and the likelihood that these requirements can be met across varied military settings. Offerors should include a final deliverable with clear and specific guidance of the non-training approaches to enable implementation across the National Guard as well as information about the evidence behind each approach.

Focus Area 2: Fostering Service member total force fitness through integrated primary prevention

Total force fitness is a top priority for DoW leaders at the highest levels and is critical to unit readiness and mission effectiveness. There is a clear link between Service members’ psychological, social, and family wellbeing and their ability to maintain physical fitness and cognitive health. National Guard and Reserve members, in particular, have high rates of obesity and face more limited access to healthcare, adequate nutrition, and physical fitness resources than their Active-duty counterparts. This suggests opportunities for current efforts to reduce rates of harmful behaviors through integrated primary prevention to facilitate physical fitness and cognitive health, improve access to nutrition education, and address inequalities in availability of nutritious food options.

The Government seeks development of interventions that account for key contributors to obesity, poor nutrition, food insecurity, cognitive wellness, and/or physical inactivity in the National Guard. Solutions should be cognizant of resource/environmental constraints, geographic limitations, and social and psychological barriers. Proposed solutions should address common risk factors for physical inactivity and/or obesity and harmful behaviors and/or adapt an existing intervention for the National Guard context. Proposed intervention should be multi-faceted, i.e., include multiple components, beyond training, such as communication approaches, informal practices, processes/procedures, communication strategy, physical health and nutrition education, and local policy changes.

The Government anticipates that proposed prototypes may involve data collection to gather current nutritional/dietary patterns of Service members, literature review to enhance known physical fitness contributors, and evaluation of current education regarding dietary patterns, access to healthier foods, and healthier food options during training.

Focus Area 3: Identify and reduce barriers to help-seeking

Help-seeking is a critical element of DoW’s prevention system, and it is important to foster cultures that promote help-seeking and coordinating resource referrals. The DoW, the military Services, and local installations provide numerous resources and benefits to support Service member wellbeing and readiness. In addition, the National Guard Bureau partners with civilian organizations that extend access to resources to Service members who are not on active duty. However, research suggests that many resources are underutilized. Improving help-seeking and resource utilization requires a clear understanding of factors that influence help-seeking behavior.

The intent of this focus area is to identify and develop prototypes utilizing key drivers of help-seeking. Prototypes should prioritize high-impact resources/services and Service member populations at elevated risk for harmful behaviors. Offerors should also consider factors unique to particular contexts (e.g., very rural or geographically remote locations). After identifying key drivers, the project should develop effective approaches to increasing help-seeking, drawing from research and program evaluation conducted among both military and civilian populations. Potential approaches include but are not limited to social marketing, interpersonal communication, and policy development and implementation. Finally, the effort should culminate in the design of an intervention, tailored to military contexts (inclusive of unique National Guard drilling rhythms), that promotes help-seeking and resource utilization.

The Government anticipates that proposed prototypes may involve data collection to gather current help-seeking behaviors of Service members, literature review to enhance known drivers of help-seeking, and evaluation of current education regarding preventative and proactive measures for cross-cutting behaviors that may impact help-seeking behavior.

Focus Area 4: Prophylactic Solutions to Prevent Battlefield and Complex Traumatic Wound Infections in Austere or Contested Environments

Battlefield and complex traumatic wounds sustained in austere or contested environments are highly susceptible to infection by bacterial and fungal pathogens, including multidrug-resistant organisms. These infections can arise early after injury, complicate wound healing, increase morbidity, prolong evacuation and recovery, and reduce operational effectiveness. Prevention is the preferred countermeasure because it can reduce disease burden before infection is established, preserve force readiness, and reduce downstream treatment requirements in resource-constrained settings.

The Government seeks the development of prototypes to prevent or delay wound infections (bacterial, fungal, and/or antimicrobial-resistant) following battlefield and complex traumatic wounds, including in austere or contested environments, for use at the point of injury and in prolonged care environments (Roles 1 and 2), without negatively impacting wound healing. High-priority pathogens include Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus, and invasive fungal infections.

Specific Requirements:

This focus area of interest seeks the development of materiel solutions that have the following minimum required solution characteristics:

• Proposed prototypes should be suitable for use in operational settings where limited infrastructure, harsh conditions, and adversary actions complicate logistics, mobility, and sustainment
• Must be able to conform to 3-dimensional wound shape (i.e., not a bandage)
• Must be self-absorbing or removable through wound irrigation
• Must be effective against at least one, but preferably multiple, high priority pathogens: Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus, or a target invasive fungal infection.
• Offerors must include preclinical efficacy data in the Enhanced White Paper at the time of submission

In addition, it is strongly preferred that proposed prototypes provide the following desired solution characteristics:

• Integration of novel antibiotic drug classes against Gram-negative pathogens
• Single solution with ability to provide antibiotics, pain analgesics, and/or hemostasis compounds

At the time of proposal submission, it is required that Offerors also include the following in their Enhanced White Papers. The Offeror shall clearly indicate if either of these requirements do not apply to the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

• Toxicity data (if required by FDA)
• Regulatory strategy with documented FDA engagement (including minutes from pre-submission meetings)

Out of Scope Prototypes:

This focus area is not interested in vaccines, burn wound solutions, or discovery-stage efforts. Enhanced White Papers focused on these solutions may be deemed “Unacceptable” for failing to align to a specified Focus Area of Interest.

Focus Area 5: Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound Infection

Sepsis following battlefield and complex traumatic wounds remains a significant cause of morbidity and mortality and can substantially reduce operational effectiveness. This challenge is magnified in austere or contested environments where prolonged care, delayed evacuation, and limited critical care resources may hinder timely intervention. Improved treatment solutions are needed to mitigate the downstream effects of wound infection and sepsis, preserve force readiness, and improve outcomes for Service Members injured in operational settings.

The Government seeks the development of products, including immune modulators, novel drugs, immunotherapeutics, and other pathogen-agnostic and/or host-directed prototypes, to treat sepsis following battlefield and complex traumatic wounds (excluding burn wounds), including in austere or contested environments.

Specific Requirements:

This focus area of interest seeks the development of drug and/or biological treatments for sepsis, including host-based therapeutics.

• Offerors must include preclinical efficacy data in the Enhanced White Paper at the time of submission

At the time of proposal submission, it is required that Offerors also include the following in their Enhanced White Papers:

• Toxicity data (if required by FDA)

The Offeror shall clearly indicate if Toxicity data is not required for the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

Out of Scope Prototypes:

This focus area is not interested in vaccines, burn wound solutions, discovery-stage efforts, or proposals focused solely on direct treatment of wound infection rather than sepsis. Enhanced White Papers focused on these solutions may be deemed “Unacceptable” for failing to align to a specified Focus Area of Interest.

Focus Area 6: Knowledge Product Prototypes for the Prevention of Infection in Traumatic Penetrating Wounds

Battlefield and complex traumatic penetrating wounds sustained in austere or contested environments are highly vulnerable to bacterial and fungal contamination and subsequent infection, including infection caused by multidrug-resistant organisms. Knowledge product solutions are needed to improve prevention practices, optimize clinical practice guidelines, and support decision-making in operationally relevant trauma care settings. These efforts may improve readiness, preserve operational effectiveness, and reduce downstream morbidity associated with wound infection and sepsis.

The Government seeks the development of knowledge product prototypes to optimize clinical practice guidelines for the prevention of infection in traumatic penetrating wounds.

Specific Requirements:

Proposed prototypes should optimize clinical practice guidelines for at least one of the following:

• 1 - Decipher the intricate relationship between combat polytrauma involving penetrating wounds, infections and sepsis for data-driven clinical practice guideline revisions and field medicine.
• 2 – Modernize the effectiveness of acute penetrating traumatic wound management. Proposed projects shall 1) assess the effectiveness of the Acute Traumatic Wound Management guidelines as they apply to penetrating injuries and 2) optimize these guidelines to enhance the standard of care for traumatic wound infections found in operational environments. Proposed projects are encouraged to have access to, and the ability to interpret, existing study populations and data collected from human subjects that support the goals of this Focus Area. The project shall deliver translatable processes, knowledge and technology (i.e., training, clinical practice guidelines for assessment and interventions, and clinical trial endpoints) to optimize and inform care for penetrating traumatic wound infections found in operational environments.
• 3 - Leverage polytrauma of infection preclinical models to evaluate emerging solutions and therapeutics that target infections of traumatic penetrating wounds, identifying refinements needed for solution maturation.

Focus Area 7: Bacterial Diarrhea Prevention

The Government seeks innovative prophylactic prototypes to prevent endemic and emerging infectious diseases. Proactive prevention is the most strategically desirable medical countermeasure; it eliminates the need for post-exposure treatment, offers the most cost-effective approach to disease management, and preserves force readiness by minimizing unit loss rates.

This focus area targets the development of prototypes to prevent bacterial diarrhea resulting from high-priority pathogens (Campylobacter jejuni, enterotoxigenic Escherichia coli, and Shigella) in operational settings.

Specific Requirements:

The Government seeks the development of a self-administered, oral intervention (not a vaccine) capable of targeting multiple high-priority bacterial pathogens (Campylobacter jejuni, enterotoxigenic Escherichia coli, and Shigella). Proposals may feature novel interventions, repurposed existing countermeasures, or current standard-of-care approaches evaluated for military-specific use cases.

Offerors must include preclinical efficacy data in the Enhanced White Paper at the time of submission (failure to include this efficacy data may result in an “Unacceptable” overall proposal rating). Furthermore, the inclusion of toxicity data (if required by FDA) is preferred.

Technical approaches for this focus area may include efficacy and safety testing in validated preclinical animal models; cGMP manufacture; and safety and efficacy testing in clinical trials of prophylactics.

Out of Scope Prototypes:

This focus area will not consider proposals for vaccine-based interventions. Furthermore, solutions must exclusively target the high-priority pathogens listed above (Campylobacter jejuni, enterotoxigenic Escherichia coli, and Shigella); proposals targeting other pathogens will be deemed out of scope and will receive an overall “Unacceptable” rating for failing to align to a specified Focus Area of Interest.

Focus Area 8: Dengue Fever Prevention and/or Treatment Prototypes

Dengue Fever is caused by one of four related, but distinct, viruses (serotypes), which poses a threat to the globally deployed Joint Force. Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later infection from another serotype can cause severe disease due to antibody-dependent enhancement (ADE), which is a scientific challenge that candidate solutions to prevent and treat Dengue Fever must address. Effective prevention and treatment of Dengue Fever is critical for future near-peer conflicts where prolonged care and preservation of operational effectiveness and reduce unit loss rate will be required and evacuations for severe disease will be greatly hindered.

Specific Requirements:

Offerors must indicate in their proposals their responsiveness to one of the following sub-focus areas:

• Dengue Fever Prevention: Desired prototypes include prophylactic drugs and vaccines, to prevent all four serotypes of Dengue Fever.Specific characteristics include, but are not limited to:
  • Identifying and characterizing correlates of protection for both natural infection and vaccination or determining other unknown immune markers necessary for an effective Dengue Virus vaccine.
  • Immunogenicity studies to measure type-specific antibodies in relevant animal models.
  • Evaluation of candidate vaccines to elicit a balanced type-specific immune response in relevant animal models.
  • Understand and identify ways to mitigate vaccine-induced viral enhancement risk.

• Dengue Fever Treatment: Desired prototypes include antibody (IgG and IgA) immunotherapeutics to treat Dengue Fever (against all four serotypes). These could be either monoclonal or polyclonal antibodies or a cocktail of antibodies, if relevant.

At the time of proposal submission for this Focus Area, it is required that Offerors also include the following in their Enhanced White Papers. Offerors shall clearly indicate if any of these requirements do not apply to the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

1. Preclinical efficacy data
2. Toxicity data (if required by FDA)
3. Regulatory strategy with documented FDA engagement (including minutes from pre-submission meetings)

Proposed solutions must be designed for administration via one of the following routes suitable for field or austere settings:

• Oral (PO)
• Intramuscular (IM)
• Transdermal (TD)
• Subcutaneous (SC)

Out of Scope Prototypes:

Intravenous (IV) solutions are explicitly excluded and will not be considered under this Focus Area. Enhanced White Papers focused on these solutions may be deemed “Unacceptable” for failing to align to a specified Focus Area of Interest.

Focus Area 9: Prevention and Treatment of Emerging Infectious Diseases

Emerging infectious diseases represent a significant and persistent threat to the health, mission readiness, and operational effectiveness of deployed U.S. military personnel. This modern challenge is underscored by the historical reality that diseases have often inflicted more casualties than combat. This Focus Area seeks the development of solutions for Lassa fever virus, Crimean-Congo Hemorrhagic Fever Virus (CCHFV), and various hantaviruses, which are high-consequence pathogens that pose distinct risks to the deployed Joint Force.

Specific Requirements:

Offerors must indicate in their proposals their responsiveness to one of the following sub-focus areas:

• Prevention of Emerging Infectious Diseases: Develop pathogen-agnostic and/or broad-spectrum prophylactics for CCHFV and/or Lassa Fever utilizing agile platform technologies that can rapidly pivot towards future Joint Force priorities. Additional pathogens relevant to the deployed Joint Force may be included to demonstrate agility of the proposed solution.

• Treatment of Emerging Infectious Diseases: Develop pathogen-agnostic and/or broad-spectrum therapeutics for CCHFV, Lassa Fever, and/or hantaviruses utilizing agile platform technologies that can rapidly pivot towards future Joint Force priorities. Additional pathogens relevant to the deployed Joint Force may be included to demonstrate agility of the proposed solution. Products to treat hantaviruses that cause hemorrhagic fever with renal syndrome (HFRS) (e.g. Hantaan virus) are prioritized over those that cause hantavirus pulmonary syndrome (HPS) (e.g. Andes virus).

At the time of proposal submission for this Focus Area, it is required that Offerors also include the following in their Enhanced White Papers. Offerors shall clearly indicate if any of these requirements do not apply to the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.:

1. Preclinical efficacy data
2. Toxicity data (if required by FDA)
3. Regulatory strategy with documented FDA engagement (including minutes from pre-submission meetings)

Proposed solutions must be designed for administration via one of the following routes suitable for field or austere settings:

• Oral (PO)
• Intramuscular (IM)
• Transdermal (TD)
• Subcutaneous (SC)

Out of Scope Prototypes: Intravenous (IV) solutions are explicitly excluded and will not be considered under this Focus Area.Proposals focused solely on other pathogens, including endemic and emerging respiratory viruses, will not be considered and will receive an overall “Unacceptable” rating for failing to align to a specified Focus Area of Interest.

Focus Area 10: Musculoskeletal Injury Treatment

Musculoskeletal injuries are the single greatest threat to operational readiness in the armed forces. These injuries affect over 800,000 Service members annually, resulting in approximately 2.4 million medical visits and 25 million limited duty days. During training, musculoskeletal injuries account for up to 80% of the medically non-deployable force and 50% of Service members can expect to sustain at least one musculoskeletal injury each year. While deployed, combat related injuries are an ongoing threat to the Service members and there is an unmet need to accelerate the recovery from injuries that are not life-threatening and can be cared for in the pre-hospital setting.In addition, approximately 30% of all medical evacuations while deployed are due to non-battle musculoskeletal injury, with approximately 85% of those injured not returning directly to in-theater operations. Reducing this number through targeted interventions to treat musculoskeletal injuries in the pre-hospital environment has the potential to greatly impact medical readiness.

The Government is seeking prototypes for musculoskeletal injury interventions in the pre-hospital environment. To meet the intent of the funding opportunity, Enhanced White Papers submitted to this Focus Area must address ONLY one of the following sub areas:

1. Focus Area 10A: Therapeutic interventions to accelerate recovery from musculoskeletal injury: Proposed prototypes should accelerate recovery from musculoskeletal injury and are intended to be highly applicable to pre-hospital care scenarios.The goal is to reduce the timeline of recovering from non-life-threatening injuries, to include structural (bone) or soft tissue. Animal studies are not permitted.

Proposals for Focus Area 10A may propose either clinical translational research or clinical research.

1. Focus Area 10B: Preservation of musculoskeletal health: Proposed prototypes should provide initial protection and preservation to facilitate later aspects of care including reconstruction and long-term rehabilitation and recovery. The focus is intended for soft-tissue injuries but may additionally apply to other applications.

Proposals for Focus Area 10B may propose either applied research or clinical translational research.

Offerors should consider the following guidance when developing their proposals:

1. Proposed prototypes should be highly relevant to the military environment or injuries sustained by the military that would not be logically addressed by other funding agencies. When appropriate (e.g. access to certain populations, stages of training, etc.), partnering with DoW collaborators or sites may be encouraged. For any proposal involving human subjects, the proposal should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study.
2. Solutions must apply to the pre-hospital environment, which may be in garrison or in the operational setting.
3. Offerors may propose development tasks associated with applied research, clinical translational research, and clinical research. Proposed projects for clinical research may range from small proof-of-concept trials (e.g., pilot, first-in-human) to demonstrate the feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant populations.
4. Both acute trauma and overuse injuries may be included.
5. Prototypes that are broadly applicable to multiple injury types are desirable, although not required.
6. Injured areas may include upper extremities, lower extremities, and/or spine/torso.
7. Acknowledgement of transition pathways or transition partners is highly encouraged for all proposals and required for clinical research studies.
8. Offerors are encouraged to propose follow-on tasks as option periods beyond the initial scope or budget of the project.

The following Addendums are required to be included in addition to those listed in Section 4 of this RPP (as applicable). The Offeror shall clearly indicate if either of these requirements do not apply to the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

1. Additional Data Addendum: Offerors should include any preliminary and/or published data relevant to the proposed research.
2. Letters of Support: Offerors must include letters of support if the proposed project involves accessing military populations or collaborators.

Out of Scope Solutions:

The following topic areas are out of scope for this focus area and will not be considered for award. Enhanced White Papers focused on these solutions may be deemed “Unacceptable” for failing to align to a specified Focus Area of Interest:

1. injury prevention,
2. injury diagnosis/imaging,
3. human performance optimization,
4. personal protective equipment,
5. definitive care interventions,
6. external stabilization, such as exoskeletons, braces, and splints,
7. arthritis,
8. neuropathy,
9. spinal cord injuries,
10. head and neck injuries,
11. compartment syndrome,
12. infection,
13. ACL tears/reconstruction,
14. prosthetics/orthotics,
15. training protocols,
16. and nutrition.

Additionally, funding from this award must NOT be used for:

• Basic science.
• Purely retrospective or database-related research.

Additional Information:

Awards made from this Focus Area are anticipated to begin in FY27.

For Focus Area 10A: Therapeutic interventions to accelerate recovery from musculoskeletal injury, the Government anticipates 1-2 awards of approximately $3M each with a period of performance not to exceed 36 months.

For Focus Area 10B: Preservation of Musculoskeletal Health focus area, the Government anticipates 2-3 awards of approximately $1.5M each for a period of performance not to exceed 36 months.

Focus Areas 11 - 14: Pain Treatment

One of the most critical challenges in Warfighter care is how to control severe pain without compromising a Warfighter's ability to fight. Pain is the single most common cause for medical evacuation from the battlefield. Current doctrine for far-forward pain management, outlined in the Joint Trauma System (JTS) Clinical Practice Guidelines (CPGs) and Tactical Combat Casualty Care (TCCC) protocols, is centered on the use of opioids (fentanyl) and ketamine. While effective, these interventions carry significant risks in a military context, including respiratory depression, cognitive impairment, and hemodynamic instability, which can be exacerbated by polytrauma and hemorrhagic shock. These side effects endanger the casualty and place additional burdens on medical personnel.

Furthermore, there is a critical need for advanced anesthetic capabilities that can support damage control resuscitation and surgery in austere settings (Role 1 and 2), where access to anesthesiologists and robust medical equipment is not guaranteed. The current reliance on specialist-dependent techniques limits the military's ability to provide life-saving surgical interventions closer to the point of injury.

To address these challenges, the Sensory Systems Program is interested in solutions for combat-relevant pain and anesthesia across the following four primary areas of interest (listed below).

As previously stated, each Enhanced White Paper SHALL specifically address ONLY ONE Focus Area of Interest. Offerors are not limited to a single Enhanced White Paper submission.

General Requirements for Focus Areas 11–14

The following guidelines apply to all submissions under Focus Areas 11, 12, 13, and 14:

All responses, regardless of the topic area addressed, should be submitted with sufficient detail to allow for a thorough evaluation of the proposed solution's scientific merit, feasibility, and relevance to the DoW. Offerors are encouraged to provide the following information, where applicable, to strengthen their submission. All proposals must clearly articulate how the proposed effort addresses a specific capability gap identified in current Joint Trauma System (JTS) Clinical Practice Guidelines (CPGs), Tactical Combat Casualty Care (TCCC) guidelines, or other formal DoW requirements documents.

Mandatory Submission Requirements (As Applicable)
As specified within each individual Focus Area (11, 12, 13, and 14), certain documentation is required for a proposal to be considered for evaluation. Offerors must refer to the specific Focus Area they are addressing to ensure all mandatory documents are included.

Strongly Encouraged Supplementary Information (All Focus Areas)
While not a mandatory requirement for all focus areas, offerors are strongly encouraged to provide the following supplementary information. These materials will assist our evaluation team in assessing the maturity, feasibility, and strategic alignment of the proposed solution. Providing this information can significantly strengthen a submission by demonstrating a comprehensive understanding of the technology development and transition lifecycle.

• Additional Data Addendum:
  • Comprehensive Data Sets: Any existing preliminary or supporting data sets that were not included in the main proposal. This may include exploratory toxicology, secondary pharmacology, in vitro assays, or full-study reports from which summary data was drawn.
  • Letters of Support from End-Users: For later-stage or device-based technologies, letters of support from military medical providers or relevant DoW laboratories (e.g., Joint Trauma System, OPMED, USAARL) are highly encouraged.
  • Biographies of Key Personnel: Brief biographies or CVs for the Principal Investigator and other key technical personnel, highlighting their relevant experience.
• Regulatory Documentation:
  • A draft regulatory plan or a more detailed description of the proposed FDA regulatory strategy.
  • If applicable, evidence of prior engagement with the FDA (e.g., a summary of Pre-Investigational New Drug (IND) meeting minutes).
  • A summary of the proposed quality system (e.g., cGMP, ISO 13485) that will be used during development and manufacturing.
• Letters of support from potential commercial partners, manufacturing organizations (CMOs/CDMOs), or clinical research organizations (CROs) that would be involved in the project.

Out of Scope Prototypes:

The primary objective of these focus areas is to identify and advance materiel prototypes for acute pain and anesthesia in military operational settings. To ensure responses are aligned with the programmatic needs of the DoW, the following research areas, technologies, and therapeutic classes are considered out of scope for these Focus Areas of Interest and will not be considered for evaluation (i.e., may be deemed “Unacceptable” for failing to align to a specified Focus Area of Interest):

• Solutions for Chronic Pain: Research focused exclusively on the treatment of pre-existing or non-trauma-related chronic pain conditions. The scope of these focus areas is limited to acute, combat-related injury. However, proposals addressing the prevention of the acute-to-chronic pain transition will be considered in scope.
• Large, Capital-Intensive, or Infrastructure-Dependent Equipment: Solutions that require large, stationary equipment, stable power grids, or clinical infrastructure not typically available at Role 1 or Role 2 medical facilities.
• Specialist-Dependent Therapies: Techniques or therapies that require administration or oversight by specialist providers (e.g., anesthesiologists, pain medicine specialists, neurologists) for routine use.
• Late-Stage Clinical Trials: Proposals for the funding of Phase II or Phase III clinical trials. This program is focused on preclinical and early-stage (Phase I) clinical development.
• New Opioid Agonists: The development of novel molecular entities that function primarily as traditional opioid receptor agonists. The program's priority is to identify opioid-sparing or non-addictive alternatives.
• Dietary Supplements and Nutraceuticals: Solutions that are not intended for development under a formal FDA regulatory pathway as a drug or medical device.
• Basic Science and Discovery Research: Foundational research that has not yet identified a lead candidate compound or a clear technological approach. Proposals must be focused on a tangible product (therapeutic, device, or knowledge product).
• Non-Materiel Solutions: Proposals focused on market research, literature reviews, policy development, or modifications to training curricula without an associated technology development component.

Focus Area 11: Operational Suitability of Existing Pain Treatments

The Government seeks the development of a knowledge product based on quantifying the impact of currently fielded battlefield analgesics (e.g., ketamine, oral transmucosal fentanyl citrate) on the operational effectiveness of a Service Member. The primary goal of this focus area is to generate definitive human performance data to inform risk/benefit decisions and create evidence-based recommendations for the JTS to refine and optimize existing CPGs and TCCC protocols.

Prototypes for this focus area must include human-subject trials designed to measure the cognitive and physical performance of individuals following the administration of COTS/GOTS analgesics. Proposed trials should assess mission-relevant tasks (e.g., marksmanship, decision-making under stress, communication clarity, memory) in environments that simulate operational stressors like fatigue, high altitude, or temperature extremes. Proposals may investigate dosing strategies or use cases that differ from the FDA-approved label but must include a strong scientific and clinical rationale for such deviations and a clear plan to address the associated regulatory and safety considerations. The central question to be answered is: "To what extent can a Warfighter perform their duties safely and effectively after receiving this medication?"

By the end of the period of performance, prototypes are expected to provide a comprehensive data package suitable for review by military medical authorities, including:

• A Detailed Study Protocol: A complete, Institutional Review Board (IRB) and Human Research Protection Office (HRPO) / Office of Human Research Oversight (OHRO) ready protocol, including study design, primary and secondary endpoints (e.g., cognitive function, reaction time, marksmanship), and statistical analysis plan.
• Validated Human Performance Model: A final report detailing the validation of the proposed human testing model and its relevance to military operational scenarios.
• Pharmacokinetic & Pharmacodynamic (PK/PD) Data Package: Analyzed data demonstrating the absorption, distribution, and effect of the targeted analgesic(s) under the tested stress conditions compared to baseline.
• Final Technical Report & Recommendations: A comprehensive report summarizing all findings, including a "risk/benefit" analysis focused on operational performance decrements versus analgesic efficacy, and concrete, data-driven recommendations for modifying existing CPGs or TCCC guidelines.

At the time of submission, the Enhanced White Paper must include:

• A summary of previous experience conducting human performance studies, particularly those involving physiological stressors.
• A scientific justification for the proposed human performance model and its relevance to military operational tasks.

Failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

Focus Area 12: Repurposing and Novel Delivery of Approved Compounds

The Government seeks the accelerated development of safer, opioid-sparing analgesics by leveraging the FDA's 505(b)(2) regulatory pathway for repurposed drugs delivered via novel administration methods. Proposed solutions are expected to be candidate drug/device combinations ready to enter Phase I clinical trials. Proposals must focus on the formulation of an existing FDA-approved drug into a rugged, easy-to-use delivery system (e.g., intranasal spray, sublingual film, pre-filled auto-injector) suitable for use at the point of injury.

By the end of the period of performance, proposed prototypes are expected to deliver the technical and regulatory components required to transition a repurposed compound from concept to clinical-stage development. This includes:

• Candidate Justification Report: A technical report providing the scientific rationale for the selected drug and delivery device combination, including its mechanism of action and anticipated military benefit.
• Prototype Delivery Device: A functional, lab-scale prototype of the proposed drug delivery system.
• Formulation & Stability Data Package: A comprehensive data package demonstrating the feasibility, stability, and characterization of the final drug formulation within the prototype delivery system.
• Preclinical Data Package: To strengthen the regulatory position, this package should include:
  1. A Good Laboratory Practice (GLP) Pharmacokinetic/Pharmacodynamic (PK/PD) study in a relevant animal model to characterize the drug's profile with the new delivery method.
  2. A preliminary, non-GLP toxicology study to demonstrate the safety of the new formulation and route of administration.

1. Pre-IND Meeting Package: A complete data package and briefing document, supported by the preclinical PK/PD and toxicology data, suitable for a Pre-IND meeting with the FDA.

At the time of submission, the Enhanced White Paper must include the following. The Offeror shall clearly indicate if either of these requirements do not apply to the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

• Proof-of-Concept Data: As part of the Additional Data Addendum, preliminary data demonstrating the feasibility of the proposed drug formulation (e.g., initial stability, dissolution, or characterization data).
• Letter(s) of Support: Letters from potential commercialization partners or manufacturing organizations are highly encouraged.

Focus Area 13: Development of Novel, Non-Addictive Analgesics

The Government seeks the development of a novel, non-addictive analgesic compound with a mechanism of action suitable for treating acute, combat-related trauma. Proposed prototypes are expected to include a promising lead candidate with a data package sufficient to justify further investment in IND-enabling studies.

Prototypes for this focus area are expected to include advanced preclinical assessment of new molecular entities or biologics. Proposals should utilize established, military-relevant animal models of trauma (e.g., polytrauma, burn, penetrating injury) to demonstrate efficacy and a superior safety profile compared to morphine or ketamine.

By the end of the period of performance, proposed prototypes are expected to provide a robust preclinical data package to establish proof-of-concept and de-risk the candidate for future development. This includes:

• Efficacy Data Package: Analyzed data from military-relevant animal models demonstrating statistically significant analgesic efficacy of the lead candidate compared to standard-of-care controls.
• Safety & Toxicology Report: A report detailing the preliminary safety profile of the candidate, including data on its effects on respiratory rate, cardiovascular function (heart rate, blood pressure), and cognitive function in a relevant animal model.
• Pharmacokinetic (PK) Profile: A data set characterizing the absorption, distribution, metabolism, and excretion (ADME) of the compound in the selected animal model.
• Addiction Liability Report: A data package from a recognized animal model of abuse potential (e.g., self-administration, conditioned place preference) demonstrating a lower addiction liability compared to standard opioids.
• Lead Candidate Nomination Report: A final, comprehensive report summarizing all data and formally nominating a lead candidate for progression into IND-enabling toxicology studies, including a preliminary plan for scale-up manufacturing.

At the time of submission, the Enhanced White Paper must include the following. Failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

• Preliminary Data Package: Existing preclinical data, to be included in the Additional Data Addendum, demonstrating the compound's mechanism of action, analgesic efficacy in a relevant pain model, and any available preliminary safety/toxicology data (e.g., results of an Ames test, preliminary cardiovascular or respiratory assessments).
• Freedom to Operate: As part of the Letters of Support, a statement regarding the offeror's freedom to operate or an analysis of the patent landscape for the proposed novel compound.

Focus Area 14: Advanced Anesthesia and Procedural Pain Solutions

The Government seeks the development and demonstration of a prototype system or therapeutic for the management of anesthesia and procedural pain in austere environments (Role 1 and 2). Proposed prototypes are expected to reduce the cognitive burden on providers and can be used by non-specialists.

Proposals must address one of the two following solution pathways:

1. A) a closed-loop anesthetic delivery system that integrates physiological monitoring to autonomously control sedation, or
2. B) a long-acting, single-administration anesthetic/analgesic suitable for providing procedural pain control without continuous infusion.

By the end of the period of performance, proposed prototypes are expected to deliver a functional prototype and a supporting data package demonstrating feasibility in a relevant simulated or preclinical environment. This includes:

• For Closed-Loop Systems:
• Prototype System: A functional, TRL 4/5 prototype of the integrated monitoring and infusion system.

• Algorithm & Software Package: The documented software algorithm that controls drug delivery, including the physiological parameters it responds to.

• System Performance Report: A report detailing the performance of the prototype in a simulated or large animal model, demonstrating its ability to maintain a stable plane of anesthesia compared to manual control.
• For Long-Acting Therapeutics:
• Formulation Data Package: Data demonstrating the successful formulation and stability of the long-acting anesthetic/analgesic.

• Preclinical Efficacy Report: A report from a relevant animal model demonstrating the duration and depth of procedural analgesia/anesthesia from a single administration.

• Preclinical Characterization Report: A report from a relevant animal model detailing:
  1. Pharmacokinetic/Pharmacodynamic (PK/PD) analysis to confirm the duration of action and therapeutic effect.

1. A preliminary, non-GLP toxicology analysis to provide an initial assessment of the safety profile and justify progression into more formal GLP studies.

At the time of submission, the Enhanced White Paper must include the following, as applicable to the proposed prototype:

• Technical Specification Document: For device-based solutions, a document detailing the system architecture, hardware/software components, and current Technology Readiness Level (TRL) to be included in the Additional Data Addendum.
• Preclinical Data: For therapeutic-based solutions, any existing data, to be included in the Additional Data Addendum, from animal models demonstrating the duration and efficacy of the anesthetic/analgesic effect.

Failure to include the applicable information/documentation may result in an “Unacceptable” overall proposal rating.

Focus Area 15: Blast and Blunt Sensors for Exposure Monitoring

Soldiers are frequently exposed to blast and blunt impacts during training and operations, which can lead to significant brain health decrements and safety risks. Single or repetitive exposures can link to immediate and long-term health problems such as traumatic brain injury and cognitive difficulties. To address these risks, this focus area seeks to develop and deploy technologies that monitor blast and blunt impact exposure.

The Government is seeking prototypes to address:

1. A) Monitor service member brain health and/or cognitive performance.
2. B) Advance human blast exposure surrogates.
3. C) Develop integrated blast overpressure exposure software tools.

Proposals must address one of the two following pathways and their associated deliverables:

• Pathway A - Advanced Blast Surrogate:
• A prototype of an advanced, sensor-integrated surrogate with software-enabled tunable structures that mimic human blast responses. The system must automatically report BOP exposure injury risk using both sensor and surrogate data.
• Pathway B - TBI Incidence and Performance Tracking:
• A methodology and system for the precise determination of TBI incidence, alongside a neurocognitive performance assessment and tracking method designed to enhance mission readiness.

All selected performers shall deliver quarterly progress reports, a final project report, and all technical documentation required for support, verification, and validation. This includes all collected data and documentation of development efforts used to refine BOP exposure leadership requirements for tracking service member concussions and mission readiness in the training environment.

At the time of submission, the Enhanced White Paper must include the following, as applicable. The Offeror shall clearly indicate if any of these requirements do not apply to the proposed project. Otherwise, failure to include this information/documentation may result in an “Unacceptable” overall proposal rating.

1. Letters of Support: Offerors must include letters of support if the proposed project involves accessing military populations or collaborators.
2. IRB approval documentation: approval from an Institutional Review Board (IRB) to conduct research involving human subjects
3. Regulatory Engagement: proof of regulatory engagement

Out of Scope Prototypes: Animal studies are considered out of scope for this focus area,will not be considered for award, and may be deemed “Unacceptable” for failing to align to a specified Focus Area of Interest.

Funding Availability, the Government currently has available a total of $10.5M for this topic. 2 awards of up to $7M are anticipated with a PoP not to exceed 48 months. These awards are expected to start in FY27.

Proposers Conference

MTEC intends to host a Proposers Conference series that will be conducted via webinar(s) within several weeks of the release of the RPP and may include multiple sessions as deemed appropriate. Further instructions will be forthcoming via email. The intent of the Multi-Topic Proposers Conference series is to provide an administrative overview of this RPP process to award and to present further insight into the Focus Areas of Interest outlined in Section 3. Offerors are advised to check the MTEC website periodically during the proposal preparation period for any clarifications found in Frequently Asked Questions (FAQ) responses.

MTEC Member Teaming

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government.

MTEC’s new website features a new functionality to assist members in team building.To facilitate collaboration, MTEC members can utilize the Member Profiles directory to identify potential teaming partners, including technology innovators and specialized service providers. This resource is accessible via the MTEC portal at www.mtec-sc.org/members.

MTEC also intends to hold Teaming Connects for this effort, these will be virtual Teams meetings to help the membership collaborate and partner in relation to specific focus areas listed in the RPP. Organizations interested in presenting during the Teaming Connect event will be allotted three (3) minutes to pitch their capabilities, supported by one (1) slide. More information on registering for these events will be available on the MTEC website within the next several weeks.

If an Offeror is in need of additional teaming assistance, the Offeror is encouraged to reach out to the points of contact listed in Section 6.

Points of Contact

For inquiries, please direct your correspondence to the following contacts:

• Technical and membership questions should be directed to the MTEC Senior Technical Program Manager, Chuck Hutti, Ph.D., chuck.hutti@mtec-sc.org
• All other questions should be directed to the MTEC Program Manager, Daniel Vala, Daniel.vala@mtec-sc.org