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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... 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) which will be 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 and Military Operational Medicine Research Program is a key feature of this 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 this upcoming 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 submission. Projects that fail to align with only one of these Focus Areas may not be considered for funding. Additional Focus Areas may be added and will be included in the posted RPP for this effort. See the “Acquisition Approach” section below for more details on the anticipated proposal submission requirements COMBAT CASUALTY CARE – This technology area provides integrated capabilities for current and future operations to reduce the mortality and morbidity associated with major combat-related trauma across the spectrum of combat casualty care, including point of injury and pre- or out-of-hospital care, the spectrum of en-route care, and facilities-based treatment. Focus areas are as follows (NOT listed in order of importance): Focus Area 1 – Sterilization: Solutions for rapid sterilization of metal surgical instruments with low size, weight, and power requirements for use in low resource environments. Rapid sterilization with low resources will be required in future large scale combat operations to support continued surgical procedures in prolonged care and/or mass casualty scenarios. Focus Area 2 – Hemostasis: Freeze-dried platelet hemostatic agent regulatory enabling studies and manufacturing scale-up Focus Area 3 – Neurotrauma: Traumatic brain injury (TBI) is a major health burden in both military and civilian populations. In the last two decades, there have been approximately 420,000 documented incidents of Service members sustaining at least one TBI. Future operations are expected to result in higher casualty volumes, greater injury severities, and reduced capability in the forward-operating environment. Technologies to reduce the severity of life-threatening TBI casualties during times of evacuation are unavailable and will help bridge casualties until they reach more definitive care. An example of this capability includes minimally invasive intracranial access with automatic disengagement of drill to enable hematoma drainage and monitoring of intracranial pressure. The proposed technology must have completed TRL-4 and have manufacturing and sterile packaging in place, and regulatory pathway for initial U.S. Food and Drug Administration (FDA) clearance within 3 years. Focus Area 4 – Sustainment of Expeditionary Medical Skills: - Solutions for non-invasive, non-disruptive, AI-guided surgical skills assessment using marker less motion capture systems that enable longitudinal measurement and recording of detailed three-dimensional position and motion for hand, tool/instrument, and body to assess degradation and the influences of supplementary training within subject and between subject and exemplar. 2. 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). Focus areas are as follows (NOT listed in order of importance): Focus Area 5 – Pharmacological/Technological Approaches to Measure & Manipulate the Glymphatic/Lymphatic (G/L) System during Sleep: Solutions within a TRL 4-6 range that demonstrate that the G/L system can be reliably measured in humans or nonhuman primates (NHP) during sleep and directly manipulated through pharmacological/technological approaches; demonstrate efficacy of their approach to positively impact cognitive performance and psychological health outcomes; develop or adapt approaches to improve or enhance brain fluid movement in humans or NHPs; and develop models that quantify the impacts of G/L clearance in the brain on short term impacts on the restorative effects of sleep. Focus Area 6 – Musculoskeletal Injury Prevention and Reduction: Specific areas are as follows: Solutions to prevent and/or reduce common overuse tendon and ligament injuries Solutions to prevent, reduce, or mitigate joint instability Novel solutions or therapeutics to prevent muscle atrophy Focus Area 7 – Musculoskeletal Injury Treatment and Rehabilitation: Specific areas are as follows: (Clinical Studies are encouraged) Solutions to optimize short-term and/or long-term outcomes following soft tissue injury (e.g., sprains/strains) Biologic or drug therapy that can accelerate recovery of musculoskeletal injuries Therapeutic interventions to accelerate recovery timelines and/or optimize outcomes following battle-related and/or training-related musculoskeletal injury Validated assessments to optimize and inform return-to-duty guidelines following musculoskeletal injury Focus Area 8 – Psychological Health and Resilience: Specific areas are as follows: Suicide Prevention: Mature, non-clinical, upstream interventions/approaches for suicide prevention that include components of crisis response planning and lethal means safety and that can be delivered by peers or other non-behavioral health provider personnel and that can be evaluated for dual efficacy and implementation trials within military installations. Develop Military-specific postventions for suicide, particularly after discharge from in-patient treatment, after suicide exposure, and during critical military transition periods such as during the first year of service, after deployment, and during the separation phase from active duty. Cross-cutting Prevention: Validate mature primary integrated prevention interventions or trainings aimed to reduce harmful behaviors (including but not limited to sexual assault and harassment, violence, alcohol/substance misuse, ostracism, and non-suicidal self-injury, and suicide) within the Military Health System (MHS) or within non-medical military installations. Focus Area 9 – Performance Decrement and Injury Risk in Ground Soldiers due to Head Supported Mass: Specific areas are as follows Develop assessments to characterize the exposures to the head/neck complex during simulated ground maneuvers, and to measure the physiological and biomechanical response during these maneuvers. Develop assessments to determine the impact of overall or full-body versus localized or isolated neck muscle fatigue on physiologic and biomechanical, performance, kinematic, and subjective metrics under varied HSM conditions. Develop solutions (computational modeling) to assess the biomechanical response of the human spine during ground Soldier operations. Develop validated guidelines to address tolerance limits for mass/center mass offset and wear duration of HSM in ground Soldier populations. Develop and deliver preliminary cervical spine injury HSM guidance for ground Soldier populations associated with extended career and environmental exposure (dismounted and/or during transport). Focus Area 10 – Metabolic Sensor: Solutions for a hand-held personal metabolic sensor that accurately measures the volume, and oxygen (O2) and carbon dioxide (CO2) concentrations, of expired breath, and calculates the rates of oxygen consumption (VO2) and carbon dioxide production (VCO2) on demand, using this information to estimate metabolic energy expenditure and the percent of energy derived from oxidation of carbohydrates versus fats. Focus Area 11 – Wearable Blast Exposure Sensor and Its Clinical Decision Support: Develop low-cost (less than $100 per sensor) blast exposure wearable sensor solution for deployed environments, that provides immediate feedback for real time blast exposure events to integrate into either continuous monitoring, medical evacuation, or triage process algorithms. Develop and/or test wearable sensor solution(s) that couple both blast overpressure and accelerative/decelerative impact measurements to inform the need for traumatic brain injury assessment. Create algorithm to account and correct for blast exposure under and over estimates due to directionality/shielding, and to distinguish reflected and incidental pressure (especially in low-cost sensor systems). Create algorithm to compensate for the impact of directionality on the accuracy of blast exposure health thresholds for acute and repeated blast measured by wearable sensors. Develop actionable health indicators, and related health economics analysis (e.g., cost/benefit analysis) for wearable sensors for acute and repeated blast exposure on the brain and other major air-filled organs. Focus Area 12 – Neurosensory injury prevention and treatment: Repair, restore, monitor, preserve and maintain neurosensory system (e.g., vision, hearing, balance) function after military exposures. Seeking research efforts to develop innovative strategies and technologies that may include medical devices, pharmaceuticals, rehabilitation strategies, and regenerative medicine-based approaches, to assess, diagnose, treat, restore, and preserve spared tissue and function, and/or rehabilitate patients due to neurosensory injury. Focus Area 13 – Biomechanical Tolerance of the Human Head to High-Rate Localized Blunt Impacts. Injury criteria for high-rate blunt impacts to the head, such as those resulting from ballistic-induced behind helmet blunt trauma, are required to develop injury -based performance criteria for DoD personal protective equipment (PPE). The purpose is to have medically based criteria for future development and evaluation of next generation PPE. There is also a need to develop medically-based performance requirements for helmets in order to protect against the whole spectrum of head/brain injuries occurring in military operational environments. The Awardee will be expected to: Leverage existing published literature, and previous DoD-funded projects investigating head injuries caused by blunt impacts at loading rates ranging from sports-related impacts and motor vehicle accidents to behind-armor blunt impacts resulting from defeated ballistic projectiles. Leverage existing and emerging clinical data and emerging field data on head injuries being collected by the DoD, law enforcement community, industry, and academia. Develop and conduct, in cooperation with DoD laboratories, innovative medical research to characterize physiological response (e.g., head injury, traumatic brain injury), and head impact parameters under military-relevant exposures, using mechanical, cadaveric, or animal surrogates. Collaborate with DoD laboratories, industry, and academia to leverage existing computational models of the head, brain, and torso to support, and potentially expand, the experimental studies mentioned above. Correlate physiological response to impact parameters to develop and deliver injury risk thresholds or probability risk curves for head injuries related to high rate localized blunt impacts. Collaborate with DoD laboratories with complementary capabilities to leverage DoD research expertise and to ensure operational relevance of the proposed research. Minimum Requirements for Submission of an Enhanced White Paper: Enhanced White Papers submitted in response to this RPP shall meet the following minimum requirements: 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. Meet the Minimum Knowledge/Technology Readiness Level (KRL/TRL): The minimum acceptable KRL/TRL is 3 at the time of submission of the Enhanced White Paper, with the following exceptions: Focus Area # 3 and 5 are a minimum TRL/KRL of 4. *NOTE: see the document attached to this posted for full definitions of TRLs and to access more information regarding KRLs. 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 21-06-MPAI and 22-02-MPAI. The Government is already aware of concepts submitted in response to previous MTEC solicitations including the 21-06-MPAI and 22-02-MPAI; therefore, such projects are not allowed to be resubmitted under this upcoming solicitation. This 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. 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 U.S. Government (USG) currently has available a total of approximately $43.3 million (M) beginning in Fiscal Year (FY) 2023. The funding amounts and the number of expected awards will be limited and is contingent upon the availability of federal funds for these programs. See below for information specific to each Focus Area. Awards resulting from this RPP are expected to be made under the authority of 10 U.S.C. § 4022. The estimated total available funding per Focus Area is as follows (additional information may be provided in the posted RPP for this effort): Focus Area 1 - Sterilization: ~$1M -$4.18 M total with award(s) ranging from $1-2.5 M with a Period of Performance (PoP) not to exceed 36 months. Focus Area 2 – Hemostasis: ~$4.5 M total for a single award with a PoP not to exceed 36 months. Focus Area 3 – Neurotrauma ~$1.2 M total for a single award with an initial PoP not to exceed 24 months. Focus Area 4 – Sustainment of Expeditionary Medical Skills: ~$1 M for a single aware with a PoP not to exceed 36 months. Focus Area 5 – Pharmacological/Technological Approaches to Measure & Manipulate the Glymphatic/Lymphatic (G/L) System in Humans during Sleep: ~$2.5 M total with award(s) ranging from $1-2.6 M with a PoP not to exceed 36 months. Focus Area 6 – Musculoskeletal Injury Prevention and Reduction: ~$1.965 M total with award(s) ranging from $1-2 M with a PoP not to exceed 48 months. Focus Area 7 – Musculoskeletal Injury Treatment and Rehabilitation: ~$8.845 M total for multiple awards ranging from $1-5 M and a PoP not to exceed 48 months. Focus Area 8 – Psychological Health and Resilience: ~$4.914 M total with award(s) ranging from $2-3 M with a PoP not to exceed 60 months. Focus Area 9 –Performance Decrement and Injury Risk in Ground Soldiers due to Head Supported Mass: ~$400 K total with award(s) (up to 2) ranging from $200K to 400K M with a PoP not to exceed 18 months. Focus Area 10 – Metabolic Sensor: ~$600 K total for a single award with a PoP not to exceed 18 months. Focus Area 11 – Wearable Blast Exposure Sensor and Its Clinical Decision Support: ~$1.965 M total with awards (up to 4) for up to $1M each with a PoP not to exceed 18 months. Focus Area 12 – Neurosensory Injury Prevention and Treatment: ~$9.8 M total for multiple awards with a PoP not to exceed 18 months. Focus Area 13 – Biomechanical Tolerance of the Human Head to High-Rate Localized Blunt Impacts: A single award with the details for funding available and expected PoP to be provided in the RPP. Acquisition Approach: This RPP will be conducted using 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 upcoming RPP. The Government will evaluate Enhanced White Papers and will select those that best meet their current technology priorities using the criteria listed in the upcoming 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). 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 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) 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, chuck.hutti@ati.org.