Solicitations

The U.S. Army Medical Research and Development Command (USAMRDC), and other customers, offers funding opportunities to MTEC members through solicitations called Requests for Prototype Proposals (RPPs). The RPPs offer MTEC members the opportunity to propose prototype technologies to the technology requirements in each solicitation’s sub-objective area. Active and Upcoming solicitations are listed below, as are the status of RPPs for which submissions have been received.

If you are not a member and wish to become one, please click here for instructions to join.

For specific Request for Project Information or Request for Project Proposal inquiries, please direct your correspondence to the following contacts:

  • Questions concerning contractual, cost or pricing should be directed to the MTEC Contracts Administrator, Mr. Randall Fernanders, mtec-contracts@ati.org
  • Technology Readiness Levels (TRLs) for most proposed projects must be identified and included with the Technical Proposal. TRL definitions are provided here.
  • Technical related questions should be directed to the MTEC Director of Research, Dr. Lauren Palestrini, Ph.D., lauren.palestrini@mtec-sc.org 
  • All other questions should be directed to Ms. Kathy Zolman, MTEC Director of Operations, kathy.zolman@ati.org

Closed Solicitations

interoperable Medical Automated Systems (iMAS) Data Analytics and Artificial Intelligence (AI) Algorithm Development for interoperable Algorithms for Care and Treatment (iACT)

Pre-Announcement January 2021

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on providing soldiers and military medic personnel with Artificial Intelligence (AI) and Machine-Learning based decision support software to enhance their ability to provide short and long term patient care in all domain operation (ADO) environments.

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Background:

The overall objective of interoperable Algorithms for Care and Treatment (iACT) is to provide the enhanced medical knowledge, skills, and abilities for combat life savers and military medical personnel to care for injured warfighters in Prolonged Field Care (PFC) or deployed clinical settings. These capabilities are imperative not only to support injuries sustained from military munitions, but also the enduring threat of disease and use of chemical, biological, radiological, and nuclear (CBRN) weapons during Multi-Domain Operations (MDO). The effective implementation of the platform will enable a larger portion of the Joint Force to quickly and accurately assess and treat injuries sustained from a variety of mechanisms. The goal of iACT is to provide warfighters with access to an inclusive database which will utilize AI algorithms to generate indications, warnings, and suggestions to support their ability to monitor, diagnose, triage, and treat injured warfighters.

Solution Requirements:

The iACT prototype is a software system utilizing AI and Machine Learning based Clinical Decision Support algorithms to be used to support military medical personnel in their duties. The system will be developed with a Graphical User Interface (GUI) and Application Program Interface (API) to receive patient data both manually entered and automatically collected from vital sign monitors. The system will analyze the data received and provide recommendations for medical treatment. AI capabilities include, but are not limited to, predicting point of patient decompensation, predicting injury patterns, assessing patient status, identifying treatments and medications relating to the initial assessments, and providing medical alerts for personnel based on patient medical data. The prototype must enable the development of specific AI-based algorithms that are free of errors and minimizes the risks of data fitting and dimensionality through scalable data subsets.

Offerors will be expected to provide the following information in their submissions in response to this upcoming RPP:

• Prior experience developing and integrating machine learning algorithms.
• Strategy for large-scale dataset management.
• Identification of pitfalls and decision factors that should be considered when making short-term and long-term decisions.
• Description of the types of Artificial Intelligence/Machine Learning algorithms for medical purposes that could be developed and the types of data/amount of data necessary for developing those algorithms,  as well as the strategy and feasibility of successfully developing each algorithm.
• Strategy and recommended software to store large-scale datasets and how they will be optimized to build machine learning algorithms.
• Strategy for managing query costs.
• Strategy and recommended software for the processing of large-scale data sets.
• Strategy for handling different types of data and what those data types may include.

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 Awards (subject to change depending upon Government review of work completed). Note that any potential follow-on work is expected to be awarded non-competitively to resultant project awardees. Potential follow-on tasks include (but are not limited to) procurement, fielding, and sustainment for the iACT system.

Potential Funding Availability and Period of Performance:

The U.S. Government (USG) Department of Defense (DoD) currently anticipates $5.8 Million (M) for this upcoming program. The USG may apply additional dollars for follow-on efforts via post award modification to any resultant awards after the evaluation and acceptance of work and cost plan. Dependent on the results and deliverables, additional time may be added to the period of performance for follow-on tasks.

MTEC expects to make a single award to a qualified Offeror to accomplish the statement of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details.

The Period of Performance (POP) is not to exceed five years.

Acquisition Approach:

This upcoming RPP will be conducted using a two-staged approach. In Stage 1, current MTEC members are invited to submit White Papers using the format contained in the RPP. The USG will evaluate White Papers submitted and will select White Papers that best meet their current priorities using the criteria specified in the RPP. Offerors whose solution is selected for further consideration based on White Paper evaluation will be invited to submit a proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements.

The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on beta.SAM.gov to notify interested parties. The RPP is expected to be released in Quarter 2 of FY21 and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of a white paper in response to this upcoming MTEC RPP. 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 proposal 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. MTEC members are encouraged to use the 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.

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. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@mtec-sc.org

interoperable Medical Command and Control System – Joint (iMCCS-J)

Pre-Announcement January 2021

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the development of a prototype that supports the integration of medical data with the Air Force Research Laboratory, Tactical Assault Kit (TAK) suite of software and hardware in support of iMCCS-J.

BACKGROUND:
The overall objective of the interoperable Medical Command and Control System – Joint (iMCCS-J) is to support the integration of medical data with the Air Force Research Laboratory, Tactical Assault Kit (TAK) suite of software and hardware. The Android Team Awareness Kit (ATAK), for civilian uses, or Android Tactical Assault Kit (also ATAK) for military uses – is a suite of software that provides geospatial information and allows user collaboration over geography. ATAK was originally developed by the Air Force Research Laboratory (AFRL) and is now maintained by a Joint Product Center. For more information on TAK: https://www.civtak.org/tag/product-center/

Prototypes being developed must integrate with current software and hardware devices being utilized within the Nett Warrior (NW) situational awareness (SA) and mission command (MC) systems for use during combat operations. A successful prototype will visualize medical data via NW devices within the Android Tactical Assault Kit (ATAK), Windows Tactical Assault Kit (WinTAK), and Tactical Assault Kit (TAK) Servers. The iMCCS-J Medical Common Operational Picture (COP) will identify medical unit locations, unit capacity status, medical evacuation unit capacity status, and patient status. At a higher level, the Medical COP informs the intelligence cycle through wound types and rates which communicates enemy effectiveness, supports trend analysis and enemy situational template.

SOLUTION REQUIREMENTS:
This upcoming RPP aims to establish prototypes with the ability to provide commanders at all levels with visual understanding of how medical capabilities are arrayed throughout the operational environment. iMCCS-J will ingest and visualize data to identify medical unit locations, unit capacity status, medical evacuation unit capacity status, and patient status. At a higher level, iMCCS-J will parse specific data elements from near-real-time operational datasets to inform the intelligence cycle through wound types and rates which communicates enemy effectiveness, supports trend analysis, and identifies the enemy situational template. These requirements are derived from the Joint Concept for Health Services, Joint Health Services Joint Publication 4-02, and the Army Health System Doctrine Smart Book.

SCOPE OF WORK AND NON-COMPETITIVE FOLLOW-ON WORK:
This effort shall deliver an initial prototype submission package for the iMCCS-J to the Warfighter, Health, Performance and Evacuation (WHPE) Program Management Office (PMO) for submission to Tactical Assault Kit (TAK) and Nett Warrior (NW). Proposed projects shall demonstrate the ability to develop and integrate near real time data being captured from battlefield combat units, field medical platforms, and various Medical Treatment Facilities (MTF) data streams with the Department of Defense (DoD), and TAK suite of software. A successful prototype will visualize medical data via field Nett Warrior devices within the Android Tactical Assault Kit (ATAK), Windows Tactical Assault Kit (WinTAK), and TAK Servers. It is preferred that Offerors have experience with and/or sufficient knowledge of the TAK suite of software.

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 Awards (subject to change depending upon Government review of work completed). Note that any potential follow-on work is expected to be awarded non-competitively to resultant project awardees. Potential follow-on tasks include (but are not limited to) procurement, fielding, and sustainment for the iMCCS-J system.

POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE:
The U.S. Government (USG) DoD currently anticipates $5.8 Million (M) for this upcoming program. The USG may apply additional dollars for follow-on efforts via post award modification to any resultant awards after the evaluation and acceptance of work and cost plan. Dependent on the results and deliverables, additional time may be added to the period of performance for follow-on tasks.

MTEC expects to make a single award to a qualified Offeror to accomplish the statement of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details.

The Period of Performance (POP) is not to exceed five years.

ACQUISITION APPROACH:
Full proposals will be required in response to this upcoming RPP thus reflecting a single stage acquisition approach. The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on www.beta.SAM.gov to notify interested parties. The RPP is expected to be released in Quarter 2 of FY21 and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of a full proposal in response to this upcoming MTEC RPP. 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 proposal 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. MTEC members are encouraged to use the 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.

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. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@mtec-sc.org

Military Prototype Advancement Initiative (MPAI)

Pre-Announcement January 2021

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Request for Project Proposals (RPP) that aims to solicit current MTEC members for a broad range of medical prototype technological solutions [medical techniques, knowledge products, and materiel (medical devices, drugs, and biologics)] related to the following focus areas of interest (subject to change):

  • Focus Area #1: Prolonged Field Care
  • Focus Area #2: Medical Readiness
  • Focus Area #3: Emerging Technologies
  • Focus Area #4: Maximizing Human Potential

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Background:

In multi-domain operations, today’s operating force will be overwhelmed with casualties, the ability to evacuate will be limited, first responders and medics will struggle with limited resources and ability to achieve the “Golden Day”, resulting in operational units and commanders rapidly losing freedom of maneuver and combat effectiveness. Therefore, medical assets must be highly mobile and more dispersed (e.g., smaller, more modular medical units), Warfighters will require greater self-sufficiency and autonomy (e.g., may have more limited medical-related communications and re-supply), and there will be an increased cognitive and physical stress on Warfighters (they will need ways to maximize human potential  and return to the fight quickly).

This Solicitation Mechanism Will:

  • Increase information exchange between the MTEC membership and the military – This mechanism provides the MTEC membership with an official way of sending information related to their military-related solutions through MTEC to the military, and potentially make the military aware of new solutions that can address unmet needs.
  • Provide feedback to the MTEC membership – This mechanism differs from the previous MTEC Open Concepts Request for Project Information in that MTEC membership will receive feedback from the military, which can help Offerors realign to better meet the military need downstream, or even find out whether the military would be interested at all (a “not interested” is valuable feedback as well).
  • Establish an open window for the military to make awards – With an extended open submission period, awards may be made on a rolling basis. In addition, the MTEC process includes a “basket” provision that permits holding proposed projects that are approved but unfunded for up to two years, which allows for efficient contracting as funding becomes available.
  • Solicit for key areas to support achievement of the U.S. Army Medical Research and Development Command (USAMRDC) strategic objectives – The focus areas will allow MTEC members to propose relevant innovation.

Minimum Requirements for Submission of an Enhanced White Paper

Enhanced white papers submitted in response to this 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. A prototype project can generally be described as a preliminary pilot, test, evaluation, demonstration, or agile development activity used to evaluate the technical or manufacturing feasibility or military utility of a particular technology, process, concept, end item, effect, or other discrete feature. Prototype projects may include systems, subsystems, components, materials, methodology, technology, or processes. By way of illustration, a prototype project may involve: a proof of concept; a pilot; a novel application of commercial technologies for defense purposes; a creation, design, development, demonstration of technical or operational utility; clinical recommendations or guidelines; or combinations of the foregoing, related to a prototype. The quantity should generally be limited to that needed to prove technical or manufacturing feasibility or evaluate military utility.
  2. Minimum Knowledge/Technology Readiness Level (KRL/TRL): The expected KRL/TRL at the time of submission of the enhanced white paper is at least KRL/TRL 3. Offerors have achieved KRL/TRL 3 if:
  • Knowledge Products: Offeror has validated hypotheses that suggest applications (e.g., prediction for prognosis, screening for diagnosis, or treatment for prevention)
  • Pharmaceutical (Drugs): Offeror has demonstrated initial proof-of-concept for candidate drug constructs in a limited number of in vitro and in vivo research models
  • Pharmaceutical (Biologics, Vaccines): Offeror has demonstrated initial proof-of-concept for biologic/vaccine constructs in a limited number of in vitro and in vivo research models.
  • Medical Devices: Offeror has demonstrated initial proof-of-concept for device candidates in a limited number of laboratory models (may include animal studies).
  • Medical Information Management/Information Technology & Medical Informatics: Medical Informatics data and knowledge representation schema are modeled.

*NOTE: Full definitions of TRLs can be found here. More information regarding KRLs can be found here.

  1. New Submissions to MTEC: Focus on proposed solutions that have not been submitted to MTEC under previous RPPs within the past 2 years. The Government is already aware of concepts submitted in response to previous MTEC solicitations, and therefore, such projects are not allowed to be resubmitted here. This RPP is intended only for submission of new projects to MTEC, not direct resubmissions or modifications of projects previously submitted.
  1. Alignment to a Specified Topic Area of Interest: Enhanced White Papers shall align to a focus area of interest specified
  1. Military Relevance: Proposed projects shall focus on providing medical solutions to support readiness and care in future battlefield scenarios.

Focus Areas of Interest:

  • FOCUS AREA #1: Prolonged Field Care (PFC): A primary emphasis in 2021 is to identify and develop medical techniques, knowledge products, and materiel[1] (medical devices, drugs, and biologics) for early intervention in life-threatening battle injuries and prolonged field care[2] (PFC). 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.  Preferred medical techniques and materiel that can be used by combat medics must be easily transportable (i.e., small, lightweight, and durable in extreme environments and handling); devices must be easy to use and require low maintenance, with self-contained power sources as necessary.  The following technical areas of interest are (not listed in order of importance):
    • 1 Control & Sustainment of Critical Organ System & Metabolic Function
    • 2 Enabling Medical Capabilities to Support En Route and Prolonged Care in Remote, Austere Settings, & Extreme Environments
    • 3 Prophylactic to Prevent Infection in Battlefield Wounds
    • 4 Control of Wound Progression & Infection Prevention
    • 5 Enabling capabilities to increase patient movement capacity
    • 6 Blood and Blood Products – Next Generation Blood, Blood Products, Pharmaceuticals, Synthetic Replacements, & Delivery Systems
    • 7 Brain Trauma – Treatment and Objective Diagnosis, Prognosis and Assessment of Traumatic Brain Injury (TBI) in combat and prolonged care scenarios
    • 8 Tactical Combat Casualty Care – Point of Injury Control of Non-Compressible Hemorrhage & Immediate Cardiopulmonary Stabilization
    • 9 Cognition-sparing, long-duration pain control
    • 10 Large animal studies for the development of a portable non-pharmaceutical device that provides regional analgesia at the point of injury and/or during medical evacuation__________________
      [1] Materiel is defined as equipment and supplies of a military force.
      [2] Prolonged field care is defined as field medical care, applied beyond “doctrinal planning timelines” by a North Atlantic Treaty Organization (NATO) Special Operations Combat Medic (NSOCM) or higher, in order to decrease patient mortality and morbidity.  PFC utilizes limited resources and is sustained until the patient arrives at an appropriate level of care.  Rasmussen TE, Baer DG, Cap AP, et al.  2015.  Ahead of the Curve.  J Trauma Acute Care Surg 79: S61-64.
  • FOCUS AREA #2: Medical Readiness: This area focuses on developing technologies that maximize medical readiness. Efforts may include diagnostics, treatments, and training solutions to prevent or reduce injury and improve physiological and psychological health and resilience. This objective includes environmental health and protection including the assessment and sustainment of health and the operational effectiveness of Service members exposed to harsh operational environments including altitude, cold, heat, and exposure to environmental health. This focus area also includes medical readiness in response to infectious diseases encountered by service members during deployment and those that can significantly impact performance. The following technical areas of interest are (not listed in order of importance):
    • 1 Leader and Provider Tools to Prevent, Reduce, Screen and Diagnose Musculoskeletal Injury in all Settings
    • 2 Solutions to Accelerate Return-to-Readiness following Musculoskeletal Injuries
    • 3 Solutions to Sustain Warfighter Performance in Arctic and Other Extreme Environments
    • 4 Far Forward Psychological Health Care
    • 5 Field Deployable Solutions to Prevent Degradation of Unit Performance and Soldier Psychological Health
    • 6 Medical Strategies to Sustain Soldier Alertness & Performance in all Settings
    • 7 Medical Criteria and brain injury-based thresholds for Informing Development of New Tactical Headborne Systems and personal protection equipment against blast, ballistic, and blunt trauma threats
    • 8 Infectious Diseases – Rapid Diagnostic and Detection Devices
    • 9 Prophylactic for Endemic Diarrheal Diseases
    • 10 Broad Spectrum Antivirals
    • 11 Broadly protective vaccine platforms for Emerging Infectious Diseases
    • 12 Novel, adaptive, and tailored simulation education trainings that optimize practice and effectiveness (i.e., brain focused and learning retention)

 

  • FOCUS AREA #3: Emerging Technologies: : This area is focused on the Multi-Domain Battle, an operational environment involving greater dispersion and near isolation over great distances, which is likely to cause severe restrictions on mobility for medical missions and shortfalls in both human and materiel human resources due to area denial challenges. Combat units will need to be more self-sufficient and less dependent on logistical support.  Combatant commanders with increased sick or wounded Soldiers will face degradation of medical resources and encumbered combat effectiveness without new combat casualty management and Force multiplication strategies. This focus area is searching for emerging technologies that will increase medical mobility while ensuring access to essential medical expertise and support regardless of the operating environment. The following technical areas of interest are (not listed in order of importance):
    • 1 Artificial Intelligence (AI) at point of need – focus on employment of AI to support providing care at point of need in remote and austere environment
    • 2 AI for information and technology – focus on employment of AI to support medical resupply in theater to improve real-time information access, security and mobility; interoperable data capture and documentation technologies; advance telehealth technologies
    • 3 Autonomy – use of autonomy solutions in austere environments in PFC to help with resuscitation, stabilization, airway management, reduce major bleeding, help MEDICs in degraded environments, etc. to support autonomous care, Decision Support Systems, and/or Intelligent Evacuation and Prolonged Care
    • 4 Synthetic Biology – general interest as well as cell & therapeutics, diagnostics, detection platforms
    • 5 Casualty Management – Next generation casualty management, medical logistics, training and education, and medical command and control in dispersed operations and other theater/operational environments.
    • 6 Human Machine Integration Best Practices and Trust – Efficacy of integrating robotics into the far forward mission that consider best practices to encourage trust by the user. Understanding the extent to which Warfighters may trust robots and how to achieve this capability.
    • 7 Nano, micro, and macro interoperable haptic platforms – This aspect of performing Live, Virtual, Augmented, and Gaming education tools is limited by the ability to experience force and real life tactile sensations especially in the medical field. The limiting factor in realistic environments is the ability to provide this factor to assist in cognitively remembering and understanding how the action should feel to be correct.  Haptic gloves available utilize wires and limit the perimeter because the user is tethered.

 

  • FOCUS AREA #4: Maximizing Human Potential: This technology area aims to develop effective countermeasures against military-relevant stressors and to prevent physical and psychological injuries during training and operations in order to maximize the human potential, in support of the Army Human Performance Optimization and Enhancement, Human Dimension, Multi-Domain Battle, and the DoD Total Force Fitness concepts. The following technical areas of interest are (not listed in order of importance):
    • 1 Maximizing Human Potential – cognitive, physical and emotional potential in MDO by optimizing physical and psychological health and resilience and provide safe, impactful, and ethical human performance; optimizing the interactions between systems and Soldiers, leaders, and teams
    • 2 Solutions to Maximize Warfighter Psychological Health and Resilience to Stressors
    • 3 Repair, restore, preserve, mitigate and maintain vision, hearing, tinnitus, or balance (sensory system function) after combat-related threats (e.g., blast exposure, noise exposure). Seeking research efforts to support the development of strategies and technologies including, but not limited to, medical devices, pharmaceuticals, rehabilitation strategies, and regenerative medicine-based approaches, to treat, restore, and preserve spared tissue and function, and/or rehabilitate patients due to any trauma.

Scope of Work

The scope of work should be focused on tasks relevant to advance the prototype to the next KRL/TRL. Project scope should be proposed based on the prototype’s maturity at the time of submission.

Potential Funding Availability and Period of Performance (PoP):

The funding amount and PoP for this upcoming RPP is unspecified, and the number of awards is indeterminate and contingent upon funding availability. Selection of projects is a highly competitive process and is based on the evaluation of the proposal’s technical merit, programmatic considerations, and the availability of funds.  Any funding that is received by the USAMRDC and is appropriate for a topic 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 Fiscal Year 2021 and Fiscal Year 2022 under the authority of 10 U.S.C. § 2371b.

There are no specified funding limitations identified for an Enhanced White Paper submitted under this RPP. A budget and PoP should be commensurate with the nature and complexity of the proposed research. Offerors should submit budgets that include the entire period of performance of the research project. Yearly budgets should include all direct and indirect costs, based on supportable, verifiable estimates.

Potential Follow-on Tasks:

There is the potential for award of one or more follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work). Potential follow-on work may be awarded based on the advancement in prototype maturity during the initial PoP. Follow-on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype.

Acquisition Approach

The MTEC will implement the “Enhanced White Paper” contracting methodology for this RPP, which is a streamlined approach to provide a better means to highlight company methodologies and skills required to address the technical and transition requirements. Offerors whose technology solution is selected for further consideration based on the Enhanced White Paper evaluation may be invited to submit a detailed cost proposal in Stage 2. Notification letters will contain specific Stage 2 cost proposal and submission requirements.

This upcoming RPP will be posted (anticipated in Quarter 2 of Fiscal Year (FY)  2021) to the MTEC website (mtec-sc.org) and beta.SAM.gov to notify interested parties. MTEC membership is required for the submission of an enhanced white paper in response to this upcoming MTEC RPP. 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 proposal 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. MTEC members are encouraged to use the 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.

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. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@mtec-sc.org

Far Forward Burn Treatment (FFBT)

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the development of treatments for severe burn injuries in a far-forward, austere environment to address the harmful sequelae of the burn injury during prolonged care, which could extend for several weeks post-injury.  This upcoming RPP will address the following four capability gaps: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing cover.

Background

It is anticipated in future conflicts that the Army will have to fight and win across multiple domains in contested locations where air, ground, and nautical evacuations of casualties will be extremely challenging.  Evacuating casualties within theater may take days or weeks.  Additionally, the explosive weapons that will likely be used against US forces will be more powerful than what has been used to date, resulting in higher numbers of casualties with significant burn injuries including larger, more severe burns.  Only minimal burn wound management tools are available in the pre-hospital environment, consisting primarily of silver-containing wound dressings to prevent/minimize infection until the casualties’ expedient evacuation to the San Antonio Military Medical Center Burn Center for definitive treatment.  Unfortunately, the future burn casualty may not have the benefit of the early evacuation to the burn center that was available during recent conflicts.  As such, there is a significant need to push burn treatment capabilities much farther forward in order to begin burn treatment as early as possible.  By closing the time gap between burn injury and burn treatment with solutions that can be reasonably provided by non-medical personnel (i.e., buddy care) or medical first responders (e.g., medics) in a pre-hospital setting, morbidity and mortality rates can be significantly decreased.

The U.S. Government (USG) is seeking burn interventions that are simple and effective enough to be used in a pre-hospital setting.  These tools will need to enable providers from the point of injury through Role 3 Hospital Centers to treat severe burn injury for up to several weeks post-injury.  It is imperative that these solutions be simple enough that non-licensed medical providers (e.g., medics) can administer them, and effective enough to decrease morbidity and mortality rates and improve outcomes over current in-theater burn treatment options.

It is expected that multiple burn treatment solutions will be needed, and may be used in concert with one another, to provide the needed burn treatment capabilities in theater.  These solutions will need to address: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing coverage/dressings that protect the burn wound and may promote early healing.  Technological advances that contribute to product solutions that meet these requirements will be considered as possible candidates for fielding by the Burn Treatment Skin Repair acquisition program.

Solution Requirements

Simple and effective solutions are required to treat severe burn injuries as early as the point of injury and throughout in-theater care.  The Army has identified four capability areas that would enable this far-forward burn treatment: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing cover. The desired prototype(s) will address one or more of these capabilities.  Prototypes could include (but are not limited to) hydrogels, wound coverings, intravenous (IV) medications, topical medications, or bandages. While there are specific requirements for each of the burn treatment capability areas being sought, there are some requirements that are common to them all.  It is also anticipated that some product solutions may satisfy, or have the potential to satisfy, more than one of these capabilities.  In instances where a product has sufficient data supporting its use in one area (e.g., infection prevention), but there is evidence that is may also be useful in another area (e.g., burn conversion prevention), optional tasks can be incorporated into any award to work to address indications for additional areas where the product solution may have utility.

Common Characteristics for All Capabilities

In the far forward environment, it is important for interventions to be as simple, safe and effective as possible.  As such, the following characteristics apply to all four desired capabilities.  All prototypes must currently be at a technology readiness level (TRL) of 5[1] or higher in order to be considered.

  1. Prototype must be capable of achieving an indication for use on large (>20% total body surface area (TBSA)) burns.
  2. Prototype must be capable of achieving an indication for use on full-thickness burns. Regulatory strategies can include a seeking a deep-partial thickness indication as a bridge to a full-thickness burn indication.
  3. Prototype must not negatively impact use of other downstream burn or lifesaving treatments in the care of burn-injured individuals, specifically those treatments being sought after within this RPP. (Most casualties will have polytrauma beyond their burn injuries.)
  4. Prototype must be capable of being administered by a medic quickly and easily at the point of injury and Role 1. This includes minimal preparation time (no more than five minutes) prior to administration.  Topical solutions are preferred, but not required.  Products that could be administered by a non-medical responder (a “buddy” or even self-administration) are encouraged but not required.
  5. Prototype must be capable of achieving a shelf life of at least two years at room temperature.
  6. Prototype must not require climate-controlled transit or storage at maturity.
  7. Prototype must eventually become a commercially viable product or technology that will be brought to market. (NOTE: can be marketed for the same or a different indication in civilian market than what DoD is seeking. If a different indication will be sought for the civilian market, FDA approval for the military’s intended use/indication will still need to be secured.)

[1] TRL 5 for medical devices defined as: “Investigational Device Exemption (IDE) review by CDRH results in determine that investigation may begin.  For 510(k), preliminary findings suggest the device will be substantially equivalent to a predicate device.”  TRL may be demonstrated with formal feedback from the FDA on regulatory plan via a pre-sub meeting.  TRL 5 for pharmaceuticals defined as: “Preclinical studies, include GLP animal safety and toxicity, sufficient to support IND applications.”  TRL may be demonstrated with formal feedback from the FDA on regulatory plan via a pre-sub meeting.

Capability-specific Characteristics

In addition to the Common Characteristics for All Capabilities listed above, each capability has specific desired characteristics listed below.

  1. Burn conversion prevention
    • Prevents conversion of partial-thickness burns to deep partial-thickness or full-thickness burns, ideally within 24 hours of being administered
    • Single dose/application per 24 hours is preferred, but not required
    • Shows efficacy in limiting the expansion and/or depth progression of burns
  2. Infection prevention
    • Topically administered product that can be applied immediately after a burn to prevent infection and/or after infection has set in as a treatment
    • Control broad range of bacterial infections; control of fungal infections and resistant pathogens preferred
    • Low risk of causing resistance
  3. Non-surgical debridement in pre-hospital setting
    • Complete procedure/course of treatment is 24 hours or less
    • Does not require sedation or anesthesia for pain management; causes minimal pain per FDA-approved scales preferred
    • Fully mitigates the toxicity of eschar
    • Requires minimal ancillary equipment such as batteries, power supply, etc.
  4. Temporizing coverage/dressing for burn wounds that may promote healing
    • Can be used to cover/dress burn wounds both at initial treatment and also after debridement
    • Provides a barrier over the burn wound in the absence of grafting
    • Coverage material is thin, conformable, breathable, able to move with patient and non-toxic; preference for coverage materials that are bio-absorbable, and enable healing of the burn wound preferred but not required
    • Can be left in place for up to 5 days, preferably longer
    • Does not require multiple dressing changes and/or mitigates/eliminates the deleterious effects of dressing changes

Project Scope (PoP1 & PoP2) and Non-competitive Follow-on Work:

The USG and MTEC expect that Offerors’ proposed project scope and maturity will vary based on the initial maturity of the proposed prototype and the ability to meet the solution requirements listed above. Therefore, USG decisions regarding both the rolling down-select and potential non-competitive follow-on work will be based on the advancement in prototype maturity (among other considerations), as it applies to each resultant award(s) during the performance of the prototype project(s). The USG may consider funding any of the following (but not necessarily limited to the) work listed below during any period (i.e., PoP1, PoP2 – see the section below entitled “ACQUISITION APPROACH & ROLLING DOWNSELECTION” for additional information and an explanation of “PoP1” and “PoP2”) of the awarded prototype project(s) to include any non-competitive follow on work (which may proceed PoP2 tasks):

  • Prototype refinement/maturation progressing towards clinical product
  • Clinical feasibility studies (as needed) to support regulatory approval/clearance
  • Clinical pivotal studies (as needed) to support regulatory approval/clearance
  • Stability and shelf-life studies
  • Prototype delivery for military-relevant testing
    • Testing of prototypes at US Army Institute of Surgical Research (USAISR)
    • Testing of prototypes at Army Medical Department (AMEDD)
    • Product demonstrations
  • Establishment of Good Manufacturing Practice (GMP) manufacturing for clinical trials and for market release
  • Initial production runs; first article testing, etc.
  • Low rate initial product runs to reach Full Operating Capability (FOC)
  • Draft product support documentation (e.g., training guides, product inserts, etc.)
  • Development of a business and/or commercialization plan for market release

Potential Funding Availability and Period of Performance:

The USG currently has available approximately $3 million (M) for Fiscal Year (FY) 2022.   Additional FY23 funding may be available for PoP1 work; and FY24 funding may be available for potential follow-on work for the continuation of the development and/or for expanded indications that will satisfy additional capability areas sought under this upcoming RPP.  Pending successful completion of the total effort, the USG may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.

MTEC anticipates that one or more awards will be made.

The initial Period of Performance (POP1) is expected to be 24 months.

Acquisition Approach & Rolling Downselection

This RPP will be conducted using a two-staged approach. In Stage 1, current MTEC members are invited to submit White Papers using the format contained in the RPP. The USG will evaluate White Papers submitted and will select White Papers that best meet their current technology priorities using the criteria specified in the RPP. Offerors whose technology solution is selected for further consideration based on White Paper evaluation will be invited to submit a proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements.

Offerors are hereby notified that the Government intends to utilize a rolling downselect approach during the performance of prototype projects awarded as a result of the upcoming RPP. Using this approach, the Government intends to award projects, structured into two Periods of Performance (PoPs), with an initial base period (PoP1) reflecting the first of the two PoPs. After an In-Process Review (IPR), an evaluation of project deliverables and other considerations to include progress towards completion of the base PoP tasks, the Government intends to award a second PoP, referred to as the subsequent PoP (PoP2), to the performer(s) that demonstrates a best value approach for follow-on tasks. Award decisions for the subsequent PoP (PoP2) work will be completed during the Go/No-go Decision Point which is expected to occur prior to the end of the base PoP (PoP1). Additional details will be providing in the upcoming RPP regarding the Go/No-go Decision Point, the estimated timeframe of the IPR, etc.

The RPP will be posted to the MTEC website (mtec-sc.org) and beta.SAM.gov to notify interested parties. MTEC membership is required for the submission of a white paper in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/

MTEC

The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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.

MTEC Member Teaming

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the white paper preparation period (prior to submission of your white paper) if you cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government Sponsor.

MTEC members are encouraged to use the 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.

Point of Contact

For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@mtec-sc.org