MTEC Pre-Announcement: Fiscal Year 2023 Military Prototype Advancement Initiative (MPAI)

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Other Transaction Agreement (OTA) for prototype projects Request for Project Proposals (RPP). This RPP will represent the Military Prototype Advancement Initiative (MPAI) focused on the advancement of engineering and medical prototypes and knowledge products related to a broad range of medical technological needs identified in the Focus Areas listed below. Relevance to the U.S. Army Medical Research and Development Command's (USAMRDC's) priorities related to their Combat Casualty Care Research Program, Military Infectious Diseases Research Program, and Military Operational Medicine Research Program, as well as relevance to the priorities of the US Air Force School of Aerospace Medicine are key features of the RPP. ___________________________________________________________________________ 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 upcoming RPP, each proposal SHALL specifically address ONLY ONE Focus Area described below. Offerors are not limited to a single proposal submission. Projects that fail to align with only one of these Focus Areas may not be considered for funding. Additional information on listed Focus Areas or new Focus Areas may be added prior to release of the full Request for Project Proposals (RPP) for this effort. Additionally, the information included below is only a summary; additional details on the current list of Focus Areas can be access within the attachment included in this SAM.gov Pre-Announcement posting. 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 areas of interest include battlefield resuscitation, hemorrhage and resuscitation, battlefield pain control, organ support, forward surgical capabilities, wound management, enroute care and autonomous care and evacuation. All proposed solutions should be supported with preliminary/published data with a minimum of TRL 4 and have an identified pathway to FDA approval (where required). The following is a summary of the currently identified focus areas of interest (not listed in order of importance). Additional details on the following can be access within the attachment included in this SAM.gov Pre-Announcement posting. Blood Product Development Anti-shock Pharmacology Battlefield Pain Control Organ Support Devices and Therapeutics Surgical Support Technologies Complex Wound Management Burn Wound Recovery En Route Care Autonomous Care and Evacuation Semi-autonomous Procedural Support Ukraine - The current conflict in Ukraine provides an unprecedented opportunity to understand medical care and challenges associated with modern large scale combat operations. 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 effort 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 is a summary of the currently identified focus areas of interest (not listed in order of importance). Additional details on the following can be access within the attachment included in this SAM.gov Pre-Announcement posting. Prophylactic to Prevent Infection in Battlefield Wounds from Complex Traumatic Penetrating Injuries in a Far-Forward, Austere Environment Pathogen Agnostic Countermeasures for the Treatment of Sepsis caused by wound infection Antivirals for the Prevention and/or Treatment of Endemic and Emerging Infectious Diseases (non-biothreat pathogens) Prevention of Endemic Diarrheal Diseases Knowledge Product Solutions for the Prevention of Infection in Traumatic Penetrating Wounds 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. Research and development Focus Areas are categorized into the following general areas: (1) Environmental Health and Protection (performance optimization and biomarker validation during heat/cold/altitude exposures); (2) Injury Prevention and Reduction (countermeasures against aviation stressors; blast, blunt trauma, and accelerative injury prevention strategies; neurosensory injury protection; injury return-to-duty standards and strategies; and physiological mechanisms of musculoskeletal injury); (3) Physiological Health and Performance (performance and recovery nutrition, weight balance optimization, cognitive health and performance sustainment in the face of operational challenges, restorative sleep, and establishment of a physiological basis for resilience to operational and environmental stressors); and (4) Psychological Health and Resilience (post-traumatic stress disorder, suicide prevention, resilience, substance abuse prevention, and violence prevention within the military). The following is a summary of the currently identified focus areas of interest (not listed in order of importance). Additional details on the following can be access within the attachment included in this SAM.gov Pre-Announcement posting. Individual Occupational and Environmental Exposure Monitoring Applied and advanced research using multi-enclave AI analytics of biomedical readiness for formation-centric military performance Understanding Tinnitus Leverage medical health data for neurosensory injury prevention and treatment strategies Brain Computer Interface (BCI) Translations Temporary Cornea Repair (TCR) Psychological Health, including Psychological Disorders Treatment Objective Behavioral Health Assessment and Monitoring Effective, Scalable Treatments for Full Remission Postventions for Suicide Cross-Cutting Prevention Precision Treatment Approaches for PTSD Warfighter Fitness to include Musculoskeletal Injury Prevention and Treatment (minimum TRL4) Performance Decrement and Injury Risk in Ground Soldiers due to Head Supported Mass (HSM) Biomechanical Tolerance of the Human Head to High-Rate Localized Blunt Impacts US 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 are based on urgent and near-term needs and issues identified within the Air Force (AF) population. Proposals must be appropriate for one-year, short term investigations to address specific areas of interest listed below (not listed in order of importance). Additional details on the following can be access within the attachment included in this SAM.gov Pre-Announcement posting. Musculoskeletal Injury Prevention and Treatment for Aircrew and Maintainers Aerospace Physiology Carcinogens (source NDAA 2021 Sec 750) Precision Medicine and Medical Standards MINIMUM REQUIREMENTS FOR SUBMISSION OF AN ENHANCED WHITE PAPER: Enhanced White Papers submitted in response to the upcoming RPP shall meet the following minimum requirements: 1. 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 prototype project addresses a proof of concept, model, reverse engineering to address obsolescence, pilot, novel application of commercial technologies for defense purposes, agile development activity, creation, design, development, demonstration of technical or operational utility, or combinations of the foregoing. A process, including a business process, may be the subject of a prototype project. 2. Meet the Minimum Knowledge/Technology Readiness Level (KRL/TRL): The minimum acceptable KRL/TRL is 3 at the time of proposal submission, with the following exceptions: Combat Casualty Care topics & Warfighter Fitness to include Musculoskeletal Injury Prevention and Treatment under the Military Operational Medicine topics. *NOTE: Full definitions of TRLs can be found and KRLs can be found by following the links provided in the attachment included in this SAM.gov Pre-Announcement posting. 3. Represent New Submissions to MTEC: Focus on proposed solutions that have not been submitted to MTEC under previous RPPs within the past 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 22-02-MPAI and 23-06-USAMRDC-MultiTopic; therefore, such projects are not allowed to be resubmitted here. The RPP is intended only for submission of new projects to MTEC or i.e., substantially revised, or modified proposals in accordance with previous Government feedback, not identical resubmissions. 4. Align to a Specified Focus Area: Enhanced White Papers shall align to a single Focus Area. Failure to align to a single Focus Area may result in an - Unacceptable rating and render the proposal ineligible for award. 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). POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE: The funding amount and Period of Performance (PoP) for the 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 and/or the AOME and is appropriate for a Focus Area of Interest described within the RPP may be utilized to fund Enhanced White Papers. Awards resulting from the RPP are expected to be made in FY 2024 and 2025. 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. ACQUISITION APPROACH: MTEC is once again utilizing a streamlined solicitation approach for the Military Prototype Advancement Initiative (MPAI). This approach has been shown to be a better means to highlight Offeror methodologies and skills required to address the technical requirements described in the upcoming RPP. The Enhanced White Paper process used for this effort requires quick turnaround times by Offerors. The upcoming RPP will describe the formats and requirements of the Enhanced White Paper submission. 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 Offerors form a more complete team for this requested scope of work. 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 Advisory], 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) 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 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 regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Biomedical Research Associate, contact@example.gov.