The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary 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. Awards resulting from this RPP are expected to be made under the authority of 10 U.S.C. § 4022 (Authority of the Department of Defense to carry out certain prototype projects). As stated at the end of this announcement, the full RPP is posted to the MTEC website (https://mtec-sc.org/); this notice is intended only to notify interested parties of the available solicitation. ____________________________________________________________________________________ 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. Focus Areas: To meet the intent of the RPP, each Enhanced White Paper proposal SHALL specifically address ONLY ONE Focus Area described below. Offerors are not limited to a single Enhanced White Paper proposal submission. Projects that fail to align with only one of these Focus Areas may not be considered for funding. The following Focus Areas of Interest are not listed in order of importance; the detailed requirements for each are described in the full version of the Request for Project Proposals. Focus Area 1: Policies and practices for cross-cutting prevention – the aim of this focus area is to develop and evaluate 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. Focus Area 2: Fostering Service member physical fitness through integrated primary prevention – the aim of this focus area is to develop interventions or trainings to combat the key contributors to force readiness and physical fitness. This focus area encourages offerors to consider resource/environmental constraints and social and psychological barriers present for warfighters when developing solutions. Focus Area 3: Identify and reduce barriers to help-seeking – the aim of this focus area is to identify and develop prototypes against key drivers of help-seeking. Proposed prototypes should prioritize high-impact resources/services and Service member populations at elevated risk for harmful behaviors. Focus Area 4: Prophylactic Solutions to Prevent Battlefield and Complex Traumatic Wound Infections in Austere or Contested Environments – the aim of this focus area is 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. NOTE: This focus area is not interested in vaccines, burn wound solutions, or discovery-stage efforts. Focus Area 5: Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound Infection – the aim of this focus area is 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. NOTE: 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. Focus Area 6: Knowledge Product Prototypes for the Prevention of Infection in Traumatic Penetrating Wounds – the aim of this focus area is the development of knowledge product prototypes to optimize clinical practice guidelines for the prevention of infection in traumatic penetrating wounds. Focus Area 7: Bacterial Diarrhea Prevention – the aim of this focus area is the development of prototypes to prevent bacterial diarrhea resulting from high-priority pathogens (Campylobacter jejuni, enterotoxigenic Escherichia coli, and Shigella) in operational settings. NOTE: Proposals targeting other pathogens will be deemed out of scope. Furthermore, this focus area will not consider proposals for vaccine-based interventions. Focus Area 8: Dengue Fever Prevention and/or Treatment Solutions – the aim of this focus area is the development of drugs and vaccines to prevent or treat all four serotypes of Dengue Fever. NOTE: Intravenous (IV) solutions are explicitly excluded and will not be considered under this Focus Area. Focus Area 9: Prevention and Treatment of Emerging Infectious Diseases – the aim of this focus area is on developing pathogen-agnostic and/or broad-spectrum solutions for prevention or treatment of 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. NOTE: IV solutions as well as proposals focused solely on other pathogens, including endemic and emerging respiratory viruses, are explicitly excluded and will not be considered under this Focus Area. Focus Area 10: Musculoskeletal Injury Treatment – the aim of this focus area is the development of prototypes for musculoskeletal injury interventions for the pre-hospital environment. Specifically, this focus area seeks (1) therapeutic interventions to accelerate recovery from musculoskeletal injury or (2) solutions for the preservation of musculoskeletal health. To meet the intent of the funding opportunity, Enhanced White Papers submitted to this Focus Area must address ONLY one of the above listed sub areas. Focus Area 11: Operational Suitability of Existing Pain Treatments – the aim of this focus area is for the development of a knowledge product to generate definitive human performance data to inform risk/benefit decisions and create evidence-based recommendations for the Joint Trauma System (JTS) to refine and optimize existing Clinical Practice Guidelines (CPGs) and Tactical Combat Casualty Care (TCCC) protocols. Focus Area 12: Repurposing and Novel Delivery of Approved Compounds – the aim of this focus area is to accelerate the development of safer, opioid-sparing analgesics by leveraging the FDA's 505(b)(2) regulatory pathway for repurposed drugs delivered via novel administration methods. The desired end-state is a candidate drug/device combination ready to enter Phase I clinical trials. Focus Area 13: Development of Novel Non-Addictive Analgesics – the aim of this focus area is to advance the preclinical development of a novel, non-addictive analgesic compound with a mechanism of action suitable for treating acute, combat-related trauma. The desired end-state is a promising lead candidate with a data package sufficient to justify further investment in IND-enabling studies. Focus Area 14: Advanced Anesthesia and Procedural Pain Solutions – the aim of this focus area is to develop and demonstrate a prototype system or therapeutic for the management of anesthesia and procedural pain in austere environments (Role 1 and 2). The goal is to produce a solution that reduces the cognitive burden on providers and can be used by non-specialists. Focus Area 15: Blast and Blunt Sensors for Exposure Monitoring - this focus area seeks to develop and deploy technologies that monitor blast and blunt impact exposure in regards to the following two pathways: 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. 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. Additional background and full solution requirements and considerations (to include minimum Technology Readiness Levels and specific data submission requirements) for each of the abovementioned Focus Areas are included within Section 3 of the full- RPP. Potential Funding Availability and Period of Performance: Due to the wide variety and inherent diversity of Focus Areas being solicited for in the RPP, the funding amount, expected Period of Performance (PoP), number of anticipated awards, and timing of funding availability for each Focus Area is contingent upon the availability of federal funds for each program and are described further in the Request for Project Proposals. Selection of prototype projects will be a highly competitive process and is based on the evaluation of the proposal’s technical merit, programmatic considerations (to include program portfolio composition), and the availability of funds. The quantity of meaningful submissions received normally exceeds the number of awards that the available funding can support. For informational purposes, the average size of MTEC awards for the initial PoP is approximately $2.0 – 3.5M over a 2-3-year PoP. Minimum Requirements for proposal submission: Enhanced White Paper proposals submitted in response to the 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, or process, including a business process, (B) reverse engineering to address obsolescence, (C) a pilot or novel application of commercial technologies for defense purposes, (D) agile development activity, (E) the creation, design, development, or demonstration of technical or operational utility, or (F) combinations of the foregoing Meet the Minimum Knowledge/Technology Readiness Level (KRL/TRL): Each of the topics solicited for within this RPP may have their own minimum KRL/TRL requirements. Offerors should note that a minimum KRL/TRL of 3 at the time of proposal submission will be required to meet the prototype definition. Please refer to the individual topic areas in the full version of the RPP for more information. *NOTE: Full definitions of TRLs and KRLs can be found on the MTEC website (https://mtec-sc.org/proposal-submit).* Represent New Submissions to MTEC: Proposed solutions should not have been submitted to MTEC under previous RPPs within the past 2 years. The Government is already aware of concepts submitted in response to previous MTEC solicitations; therefore, such projects are not allowed to be resubmitted here. Potential Follow-on Tasks: There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Award(s) (subject to change depending on Government review of work completed and successful progression of milestones). Note that any potential follow-on work is expected to be awarded non-competitively to the resultant project awardee(s). Acquisition Approach: This RPP uses the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in the full length version of the RPP. The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria in Section 5 of the RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2 (and may be required to submit additional documentation or supplemental information, upon request). Notification letters will contain specific Stage 2 proposal submission requirements. 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. MTEC’s New Member Profiles can help Offerors identify potential teaming partners among other MTEC members, including innovators, service providers, and MTEC M-Corps [a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development]. It can be accessed via https://mtec-sc.org/members. If an Offeror is in need of additional teaming assistance, the Offeror is encouraged to reach out to the points of contact listed below. MTEC: The MTEC mission is to assist the Department of Defense (DoD) Defense Health Agency (DHA), and other Government agencies by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the Defense Health Agency Contracting Activity (DHACA). For more information on the MTEC mission, see the MTEC website at https://mtec-sc.org/. Point of Contact: For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Senior Technical Program Manager,
[email protected]. ____________________________________________________________________________________ To view the full-length version of this solicitation visit https://mtec-sc.org/solicitations.
