Fiscal Year 2023 USAMRDC Multi-Topic

Purpose

This solicitation, issued by MTEC, represents a 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 in the RPP. Relevance to the U.S. Army Medical Research and Development Command (USAMRDC) priorities related to their Combat Casualty Care Research Program (CCCRP) and Military Operational Medicine Research Program (MOMRP) and is a key feature of this RPP.

Scope of Work

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.

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) a prototype project addresses a proof of concept, model, (B) reverse engineering to address obsolescence, (C) pilot, novel application of commercial technologies for defense purposes, (D) agile development activity, (E) creation, design, development, demonstration of technical or operational utility, or (F) 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, 5, and 7 are a minimum TRL/KRL of 4 (see Section 3.3 for more detail).

Represent New Submissions to MTEC: Focus on proposed solutions that have not been submitted to MTEC under previous RPPs within the past two (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 here. This RPP is intended only for submission of new projects to MTEC or 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 specified in Section 3.3 of the RPP. Failure to align to a single Focus Area of Interest may result in an “Unacceptable” rating and render the proposal ineligible for award.

Note: Failure to meet any or all of these minimum requirements may result in an overall “Unacceptable” rating of the Enhanced White Paper with minimum or no additional feedback provided.

Focus Areas of Interest

To meet the intent of this RPP, each Enhanced White Paper shall specifically address only one (1) Focus Area described below. Offerors are not limited to a single Enhanced White Paper submission. Projects that fail to align with only one of (1) these Focus Areas may not be considered for funding.

COMBAT CASUALTY CARE

This technology area provides integrated capabilities for current and future operations to reduce the mortality and morbidity associated with major combatrelated 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. Solutions should focus on 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. As a note: The DoD requires that awardees make TBI research data generated by this award mechanism available to the research community through the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System. More information on FITBIR and this requirement can be found in Addendum 1 of this RPP.

• Focus Area 4 – Sustainment of Expeditionary Medical Skills: Solutions for noninvasive, 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 focused 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. 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 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 (1) of these areas: (A) Solutions to prevent and/or reduce common overuse tendon and ligament injuries. (B) Solutions to prevent, reduce, or mitigate joint instability. (C) 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 (1) of these areas (clinical studies are encouraged): (A) Solutions to optimize short-term and/or long-term outcomes following soft tissue injury (e.g., sprains/strains). (B) Biologic or drug therapy that can accelerate recovery of musculoskeletal injuries. (C) Therapeutic interventions to accelerate recovery timelines and/or optimize outcomes following battle-related and/or training-related musculoskeletal injury. (D) 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): (A) 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 nonbehavioral health provider personnel and that can be evaluated for dual efficacy and implementation trials within military installations. (B) 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 (not listed in order of importance). Proposed prototypes do not have to meet all the following Requirements/Specifications at the time of Enhanced White Paper submission, but Offerors must describe what they do plan to accomplish during the proposed PoP. The Government may consider responses proposing how to achieve only a portion of these Ideal Solution Requirements if the Offeror’s approach sufficiently demonstrates how the remaining requirements/specifications can be met over time (Offerors should specify the projected timeline). Therefore, an Offeror’s Enhanced White Paper will describe in detail how they plan to satisfy all the following Requirements (either during the proposed PoP of the resultant award or beyond that period):
  • 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 of this 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. An ideal solution would meet the following requirements (not listed in order of importance). Proposed prototypes do not have to meet all the following Requirements/Specifications at the time of Enhanced White Paper submission, but Offerors must describe what they do plan to accomplish during the proposed PoP. The Government may consider responses proposing how to achieve only a portion of these Ideal Solution Requirements if the Offeror’s approach sufficiently demonstrates how the remaining Requirements/Specifications can be met over time (Offerors should specify the projected timeline). Therefore, an Offeror’s Enhanced White Paper will describe in detail how they plan to satisfy all the following Requirements (either during the proposed PoP of the resultant award or beyond that period):
  • 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.

Additional Points of Consideration

• Project Maturity: This solicitation is not meant to support development of a new prototype and shall meet the minimum TRL or KRL requirement described in Section 3.2 (unless otherwise stated in Section 3.3.). Offerors shall adequately describe how their proposed technology meets the definition of a prototype and should clearly address how the prototype meets the indicated TRL at the time of submission.
• Industry Partners: Proposed projects are encouraged to include relevant industry partners, especially considering that the eventual goal is to transition products to industry for FDA approval and/or commercialization.
• Cost Share: It is anticipated that the Government funds would provide incentive for industry funding to join the project. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.