MTEC Solicitation Summary: Fiscal Year 2024 Military Prototype Advancement Initiative (MPAI)

Amendment No. 2 Issue Date: January 3, 2024 Extends the proposal due date from January 15, 2024 to January 22, 2024. All other terms and conditions remain unchanged. ************************************************************************************************************ Amendment No. 1 Issue Date: December 11, 2023 Revises Section 4.2 to add Current and Pending Support as a required submission document for all Focus Areas. Replaces Addendum 4 - Current and Pending Support template in its entirety. All other terms and conditions remain unchanged. ************************************************************************************************************ The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for the 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). See the attachment to this summary posting for a definition of "materiel." Military relevance is a key feature of this RPP, especially is 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. 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 (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. TECHNOLOGY FOCUS AREAS: To meet the intent of this RPP, each Enhanced White Paper proposal SHALL specifically 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 - 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 Focus 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. The following are Focus Areas of Interest (not listed in order of importance). See the attachment to this summary posting for details regarding each Focus Area. FA 1.1 ? Blood Product Development FA 1.2 ? Anti?shock Pharmacology FA 1.3 ? Battlefield Pain Control FA 1.4 ? Organ Support Devices and Therapeutics FA 1.5 ? Surgical Support Technologies FA 1.6 ? Complex Wound Management FA 1.7 ? Burn Wound Recovery FA 1.8 ? En Route Care FA 1.9 ? Autonomous Care and Evacuation FA 1.10 ? Semi?autonomous Procedural Support FA 1.11 - Military?Civilian Partnerships for Trauma FA 1.12 - Studies in Ukraine 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. The following are focus areas of interest (not listed in order of importance). See the attachment to this summary posting for details regarding each Focus Area. FA 2.1 ? Prophylactic to Prevent Infection in Battlefield Wounds from Complex Traumatic Penetrating Injuries in a Far?Forward, Austere Environment FA 2.2 ? Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound Infection FA 2.3 ? Antivirals for the Prevention and/or Treatment of Endemic and Emerging Infectious Diseases (Non?biothreat Pathogens) FA 2.4 ? Prevention of Endemic Diarrheal Diseases FA 2.5 ? Knowledge Product Solutions for the Prevention of Infection in Traumatic Penetrating Wounds 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. The following are focus areas of interest (not listed in order of importance). See the attachment to this summary posting for details regarding each Focus Area. FA 3.1 ? Individual Occupational and Environmental Exposure Monitoring FA 3.2 ? Advanced Research Using Multi?enclave AI Analytics of Biomedical Readiness for Formation? centric Military Performance FA 3.3 ? Understanding Tinnitus FA 3.4 ? Leverage Medical Health Data for Neurosensory Injury Prevention and Treatment Strategies FA 3.5 - Hearing Protection Communication FA 3.6 ? Brain Computer Interface (BCI) Translations FA 3.7 ? Temporary Cornea Repair (TCR) FA 3.8 ? Psychological Health, including Psychological Disorders Treatment FA 3.9 ? Objective Behavioral Health Assessment and Monitoring FA 3.10 ? Effective, Scalable Treatments for Full Remission FA 3.11 ? Postventions for Suicide FA 3.12 ? Cross?Cutting Prevention FA 3.13 ? Warfighter Fitness to include Musculoskeletal Injury Prevention and Treatment FA 3.14 ? Performance Decrement and Injury Risk in Ground Soldiers due to Head Supported Mass (HSM) FA 3.15 ? Biomechanical Tolerance of the Human Head to High?Rate Localized Blunt Impacts 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 to address focus areas of interest listed below (not listed in order of importance). See the attachment to this summary posting for details regarding each Focus Area. FA 4.1 ? Musculoskeletal Injury Prevention and Treatment for Aircrew and Maintainers FA 4.2 ? Aerospace Physiology FA 4.3 ? Carcinogens (source NDAA 2021 Sec 750) FA 4.4 ? Precision Medicine and Medical Standards FA 4.5 ? En Route Care & Expeditionary Medicine POTENTIAL FOLLOW?ON TASKS: Under awards resulting from this RPP, there is the potential for award of one or more non?competitive follow?on tasks based on the success of the project(s) (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow?on work may be awarded based on the advancement in prototype maturity during the initial Period of Performance (PoP). Follow?on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype. Examples of potential follow?on work are (but not limited to): Prototype development, refinement, maturation Nonclinical and preclinical studies required for the technical data package for a regulatory application Clinical Studies Establish robust quality system Improve efficiency and reproducibility of manufacturing process for scale up Work towards FDA clearance/ approval Military environmental and operational assessments Ruggedization for operation in military environments Advanced technical testing in relevant or simulated operational environments Offerors are encouraged, as appropriate, to discuss potential follow?on work in the Enhanced White Paper submission to demonstrate the ability to further advance the project maturity beyond the proposed PoP. This will also allow the Offeror to highlight the potential capabilities that can be explored/achieved through short term and/or long?term advancement of the project in a way that is beneficial to the Government. POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE: The funding amount and PoP for this RPP is unspecified, and the number of awards is indeterminate and contingent upon funding availability. Selection of prototype projects is 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. Any funding that is received by the USAMRDC (or any other Government Sponsor's Office) and is appropriate for a Focus Area of Interest described within this RPP may be utilized to fund Enhanced White Papers. Awards resulting from this RPP are expected to be made in FY 2024 and 2025 under the authority of 10 U.S.C. - 4022. A proposed budget and PoP should be commensurate with the nature, scope and complexity of the proposed research. Offerors should submit budgets that include the entire PoP of the research project. Yearly budgets should include all direct and indirect costs, based on supportable, verifiable estimates. Offerors are encouraged to scope out their budgets in alignment with major deliverables of their proposed work so that large budgets are easier to evaluate, and Sponsors can more easily allocate available funding. 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 unless otherwise specified in Section 3 of the full-length RPP. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s). Award funding may be structured incrementally and based upon completion of Milestones and Deliverables. Dependent on the results and deliverables under any resultant award(s), the U.S. Government (USG) may, non?competitively, award additional dollars and/or allow for additional time for scope increases and/or follow?on efforts with appropriate modification of the award. See Section 3.6. of the full-length RPP for additional details. ACQUISITION APPROACH: This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit proposals in the form of Enhanced White Papers using the mandatory format contained in the full length version of the RPP (see Section 8 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 such as those examples listed in the full length RPP). Notification letters will contain specific Stage 2 proposal submission requirements. The Government?selected prototype project(s) awarded as a result of this solicitation will be funded under the Other Transaction Agreement for prototype projects (OTA) Number W81XWH?15?9?0001 with MTEC administered by the Consortium Manager (CM), ATI. The CM will negotiate and execute a Base Agreement with MTEC members (if not yet executed). The same provisions will govern this Base Agreement as the OTA for prototype projects between the Government and MTEC. Subsequently, any proposal that is selected for award will be funded through a Research Project Award (RPA) issued under the member's Base Agreement. The MTEC Base Agreement can be found on the MTEC website and Members?Only website at www.mtec? sc.org. At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their Enhanced White Paper that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its Enhanced White Paper that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement. For more information regarding the requirements of the Enhanced White Paper process and template, refer to the RPP which has been posted to the MTEC website (mtec-sc.org); this notice is intended only to notify interested parties of the available solicitation. MTEC membership is required for the submission of an Enhanced White Paper. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC MEMBER TEAMING: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper 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. The following resources may help prime contractors provide a more complete team for this requested scope of work. MTEC intends to host a series of virtual - connect session via webinar to help the membership collaborate and partner in relation to 24?01?MPAI RPP. Each organization will be allotted 1 minute to pitch accompanied by a slide. Your pitch can be focused on whatever you think would be most beneficial to you in relation to your work, for example, seeking a partner or offering a capability. There will be contact info on each slide so that you can follow?up directly with whomever you would like. The MTEC M?Corps is 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. M?Corps offers members a wide variety of support services, including but not limited to: business expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction advice], and technical expertise [i.e., chemistry, manufacturing and controls, clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec?sc.org/m?corps/ for details on current partners of the M?Corps. MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow?up conversations between members as needed. The Collaboration Database Tool can be accessed via the - MTEC Profiles Site tab on the MTEC members?only website (https://private.mtec?sc.org/). A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity. The chat forum can be accessed via the - Discuss Portal on the MTEC members?only website ? https://private.mtec?sc.org/. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) 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 U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, - nontraditional defense contractors, academic research institutions and not?for?profit organizations. POINT OF CONTACT: For inquiries, please direct your correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator, mtec?contact@example.gov Technical and membership questions should be directed to the MTEC Research Associate, Dr. Chuck Hutti, Ph.D., contact@example.gov All other questions should be directed to Evan Kellinger, MTEC Program Manager, mtec? contact@example.gov