Inactive

This is a preannouncement only. No response is required at this time. The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Other Transactions Ag... This is a preannouncement only. No response is required at this time. The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Other Transactions Agreement for Prototype Projects 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 _____________________________________________________________________________________ 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: 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. 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. 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. Alignment to a Specified Topic Area of Interest: Enhanced White Papers shall align to a focus area of interest specified below. 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): FA1.1 Control & Sustainment of Critical Organ System & Metabolic Function FA1.2 Enabling Medical Capabilities to Support En Route and Prolonged Care in Remote, Austere Settings, & Extreme Environments FA1.3 Prophylactic to Prevent Infection in Battlefield Wounds FA1.4 Control of Wound Progression & Infection Prevention FA1.5 Enabling capabilities to increase patient movement capacity FA1.6 Blood and Blood Products – Next Generation Blood, Blood Products, Pharmaceuticals, Synthetic Replacements, & Delivery Systems FA1.7 Brain Trauma – Treatment and Objective Diagnosis, Prognosis and Assessment of Traumatic Brain Injury (TBI) in combat and prolonged care scenarios FA1.8 Tactical Combat Casualty Care – Point of Injury Control of Non-Compressible Hemorrhage & Immediate Cardiopulmonary Stabilization FA1.9 Cognition-sparing, long-duration pain control FA1.10 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 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): FA2.1 Leader and Provider Tools to Prevent, Reduce, Screen and Diagnose Musculoskeletal Injury in all Settings FA2.2 Solutions to Accelerate Return-to-Readiness following Musculoskeletal Injuries FA2.3 Solutions to Sustain Warfighter Performance in Arctic and Other Extreme Environments FA2.4 Far Forward Psychological Health Care FA2.5 Field Deployable Solutions to Prevent Degradation of Unit Performance and Soldier Psychological Health FA2.6 Medical Strategies to Sustain Soldier Alertness & Performance in all Settings FA2.7 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 FA2.8 Infectious Diseases – Rapid Diagnostic and Detection Devices FA2.9 Prophylactic for Endemic Diarrheal Diseases FA2.10 Broad Spectrum Antivirals FA2.11 Broadly protective vaccine platforms for Emerging Infectious Diseases FA2.12 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): FA3.1 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 FA3.2 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 FA3.3 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 FA3.4 Synthetic Biology – general interest as well as cell & therapeutics, diagnostics, detection platforms FA3.5 Casualty Management – Next generation casualty management, medical logistics, training and education, and medical command and control in dispersed operations and other theater/operational environments. FA3.6 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. FA3.7 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): FA4.1 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 FA4.2 Solutions to Maximize Warfighter Psychological Health and Resilience to Stressors FA4.3 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@officer.mtec-sc.org [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.