MTEC Solicitation Summary: Fiscal Year 2023 USAMRDC Multi-Topic

***Amendment 01, published on 22 March 2023, serves to revise language for Focus Areas 3, 5, and 8, as reflected below and in the attachment to this posting. All other terms and conditions remain unchanged.*** The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for the MTEC-23-06-USAMRDC Multi-Topic Request for Project Proposals (RPP) focused on the advancement of 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. 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. Focus Areas of Interest: To meet the intent of this 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. Focus areas are NOT listed in order of importance. 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 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: Solutions should focus on minimally invasive intracranial access with automatic disengagement of drill to enable hematoma drainage and monitoring of intracranial pressure as. The proposed technology must have completed Technology Readiness Level (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. Focus Area 5 - En-route Care: Specific areas are as follows: Note that Offerors shall propose solutions aligned with only one Focus Area (either Focus Area 5.1 or Focus Area 5.2) Focus Area 5.1 - Solutions focused on methods and materiel to mitigate negative effects of En-route Care during long hold, long haul evacuation. Further consideration of vibration, acceleration, and altitude as well as extreme weather during long hold, long haul evacuation is encouraged. Focus Area 5.2 - Solutions focus on methods and materiel to enable high volume movement to mitigate transport effects on patient outcomes. Additional consideration of solutions to enhance ERC provider skill transfer, sustainment, and replication of best practices in a mass casualty and/or prolonged care environment Focus Area 6 - Autonomous Care and Evacuation Trauma Research: Trauma Research to enhance triage to optimize advanced medical regulating capability within the medical common operating picture towards intelligent forward deployed systems. Proposals should lead to enabling intelligent systems that assist with casualty identification and triage. Work may leverage available/ existing sensors. Focus Area 7 - Autonomous Care and Evacuation Critical Care Technologies: Studies to develop advanced autonomous critical care technologies and semi-autonomous medical devices to enable triage and medical regulating. Solutions focused to provide capabilities to conduct closed loop/lifesaving interventions (resuscitative care, airway management, hemorrhage control) during evacuation and prolonged care environments while Increasing capacity to assess, treat, and maintain severe trauma cases in forward environment using robotic and autonomous technologies. 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. Focus Area 8 - Pharmacological/Technological Approaches to Measure & Manipulate the Glymphatic/Lymphatic (G/L) System during Sleep: Solutions must be within a TRL 4-6 range that demonstrate that the G/L system can be reliably measured in humans or nonhuman primates 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 nonhuman primates; or 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 9 - Musculoskeletal Injury Prevention and Reduction: Offerors may respond to any combination of these specific areas that follow. However, a proposal shall address a minimum of one of these bullets: 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 10 - Musculoskeletal Injury Treatment and Rehabilitation: Offerors may respond to any combination of these specific areas that follow. However, a proposal shall address a minimum of one of these bullets (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 11 - Psychological Health and Resilience: Specific areas are as follows Note that Offerors shall propose solutions aligned with only one Focus Area (either Focus Area 11.1 or Focus Area 11.2) Focus Area 11.1 - Suicide Prevention (Offerors may address either or both bullets): 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. Focus Area 11.2 - 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 12 - Performance Decrement and Injury Risk in Ground Soldiers due to Head Supported Mass: An ideal solution would meet the following requirements: 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 Head Supported Mass 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 Head Supported Mass in ground Soldier populations. Develop and deliver preliminary cervical spine injury Head Supported Mass guidance for ground Soldier populations associated with extended career and environmental exposure (dismounted and/or during transport). Focus Area 13 - 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. Please see Addendum 2 contained within the full length version of the RPP for further information on this Focus Area. Focus Area 14 - Wearable Blast Exposure Sensor and Its Clinical Decision Support: The Offeror's proposal will be expected to address all of the following: Develop direction-independent wearable blast sensor for deployed environments, that is able to capture blast exposure from all directions and report critical blast parameters. [Blast parameters should include but are not limited to full waveform of blast overpressure, peak incident and reflective pressures, peak impulse, and equivalent blast overpressure.] Develop an accompanying software package for PCs and/or handheld devices to wirelessly pull raw data, analyze blast events from the sensors and produce a summary of each blast event using previously described blast parameters. Focus Area 15 - Neurosensory injury prevention and treatment: Repair, restore, monitor, preserve and maintain neurosensory system (e.g., vision, hearing, balance) function after military exposures. Research efforts should seek 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 16 - 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. See full RPP for the requirements of an ideal solution. 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. Funding Availability and Period of Performance: The U.S. Government (USG) currently has available a total of approximately $51 million (M) for anticipated awards to be made beginning in FY2023. The funding amounts and the number of expected awards will be limited and is contingent upon the availability of federal funds for each program. Awards resulting from this RPP are expected to be made under the authority of 10 U.S.C. - 4022. The Focus Area specific details regarding funding and anticipated project PoPs are provided in the full RPP. 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. The Government may evaluate Enhanced White Papers submitted on a first in, first out basis and will select those that best meet their current technology priorities using the criteria found in this 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. Notification letters will contain specific Stage 2 proposal submission requirements. 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/. Proposers Conferences: The MTEC proposers conference is a virtual webinar that provides potential Offerors the opportunity to interact directly with both MTEC and the Government Sponsors related to the Focus Areas listed in this RPP. The flow of the Proposers Conference is as follows. First, MTEC will provide an administrative overview of the solicitation. Second, the Government Sponsors will provide an overview of the technical requirements of their Focus Area. Finally, all attendees are invited to anonymously type in questions into the webinar's Q&A function, which are answered verbally and live by the appropriate presenter from MTEC or the Government. We highly encourage anyone interested in this funding opportunity to listen in and/or ask questions. Due to the number of Focus Areas being solicited for in this effort, two Proposers Conferences have been arranged to help answer Offeror questions. The first will be held on Friday, March 17th, 2023 at 1:30 PM EST and will provide a solicitation overview and a review of Focus Areas 1 through 7. See the attachment for further details on the tentative schedule. Please register for the MTEC-23-06-USAMRDC Multi-Topic - Fiscal Year 2023 USAMRDC Multi-Topic Combat Casualty Care Proposers Conference to be held on Friday, March 17th, 2023 at 1:30 PM EST at: https://ati.zoomgov.com/webinar/register/WN_MXjUy1cuRx6rxoN_4gWK0A. After registering, you will receive a confirmation email containing information about joining the webinar. The second will be held on Monday, March 20th, 2023 at 1:30 PM EST and will provide a solicitation overview and a review of Focus Areas 8 through 16. See the attachment for further details on the tentative schedule. Please register for the MTEC-23-06-USAMRDC Multi-Topic - Fiscal Year 2023 USAMRDC Multi-Topic Military Operational Medicine Proposers Conference to be held on Monday, March 20th, 2023 at 1:30 PM EST at: https://ati.zoomgov.com/webinar/register/WN_cA_iSZ9YS760Vq82roU3sA. After registering, you will receive a confirmation email containing information about joining the webinar. 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. Refer to the RPP for resources that may help Offerors form a more complete team for this requested scope of work, such as the MTEC M-Corps, MTEC's Database Collaboration Tool, and MTEC's chat forum on the Team Portal of the members-only website. 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. Points 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, 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 the MTEC Chief of Consortium Operations, Ms. Kathy Zolman, contact@example.gov To view the full length version of this solicitation, visit www.mtec-sc.org/solicitations/.