MTEC-24-06-SimulationEcosystem Request for Project Proposals Announcement

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for the MTEC-24-06-SimulationEcosystem Request for Project Proposals (RPP) with the objective of establishing an array of venues where medics, other caregivers and simulated patients agree to participate in tactical combat casualty care (TCCC) training while wearing suites of sensing technologies. This effort is aimed at providing a controlled venue to conduct these training events that is hyper realistic with respect to battlefield conditions. 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: The Military Health System (MHS) lacks a robust, accurate, and reliable methodology to collect, store, and track Tactical Combat Casualty Care (TCCC) data. Establishing a prehospital environment data set (e.g., TCCC, prolonged casualty care and/or en route casualty care) is an essential, foundational step to modernizing Military TCCC medical care. Without a means to collect data reliably and passively from the point of injury through higher echelons of care, the MHS will continue to lack the essential data to develop a trustworthy artificial intelligence to support future concepts that will sustain medical operations in the various environments of Multi-Domain Operations. Military medics and combat lifesavers often find that pausing care delivery to generate medical documentation is challenging, if not impossible, in many instances. Being able to capture the medical care being delivered in these venues may be secondary to saving lives in that moment; however, the need for timely, accurate medical documentation remains. To enhance TCCC and improve medical documentation in the MHS, a passive (e.g., with minimal human effort) documentation solution of medical care in operational environments is an essential requirement to establishing these critical TCCC data sets. Furthermore, it is vital that the processes in collecting this data does not distract the medic/caregiver's capability and capacity to deliver care. To address this need, the USA TATRC has recently initiated the Autonomous Casualty Care (AC2) Research Portfolio. This research portfolio seeks to develop systems of sensor suites that passively collect accurate and reliable data about casualty status, caregiver (e.g., medic and/or combat lifesaver) actions, and real time resource usage. USA TATRC will collect data during TCCC to develop a data set that describes casualty care. One use of this data (and associated algorithms) is to automate documentation of TCCC (e.g., DD Form 1380). Please note that this RPP is one piece that all contributes to the USA TATRC's AC2 Research Portfolio, in this instance, to collect data from prolonged casualty care simulation events that will be leveraged to drive algorithms for autonomous documentation in a future phase of the overarching effort. Technical Objective: A key aim of the AC2 research portfolio is to build a repository of data collected through combat medics/care givers wearing multimodal passive sensing technologies while performing TCCC tasks in laboratory, training, and hyper-realistic battlefield settings. To accomplish this will require access to an array of venues where medics, other caregivers and simulated patients agree to participate in TCCC training while wearing suites of sensing technologies. This prototype is specifically for providing a controlled venue to conduct these training events that is hyper realistic with respect to battlefield conditions. The overarching A2C research portfolio objective is to complete 100,000 TCCC encounters/scenarios (e.g., TCCC tasks in prioritized care contexts) that generate data elements (DD Form 1380 et al.) which are aggregated and stored by 31 March 2025. The use of a collaborator/partner data collection site/training facility will allow the government to achieve this overarching research data collection goal. The only follow on action with this OTA is the funding of the optional year 2 efforts. Desired Solution Characteristics: The government requires the following specific tasks from a qualified Offeror: Task 1. Development of novel, realistic prehospital (e.g., TCCC, PCC, PFC, ERCC, et al) simulation scenarios scripts that meet the objectives of the AC2 Research Portfolio. Task 2. Participate in a USA TATRC (government) led orientation about the human subject research protocol/data collection process. Task 3. Provide training or recertification of performer team members to serve as research associates on a human subject research protocol(s) Task 4. Conduct novel prehospital simulation events at the performer venue/location(s) with human subject participants in accordance with approved HSR protocol(s) for the AC2 research portfolio. This includes collecting data outcomes and specific measures and providing that data to the government team. Discrete data collection events, at a minimum should include 50 participants and occur monthly for a minimum of 21 months throughout the period of performance. To accomplish these aforementioned critical tasks, the government must work directly with an experienced performer capable of: Developing novel, realistic prehospital (TCCC/PCC/ERCC) simulation/scenario scripts to include measures of effectiveness and clinical outcome measures. Integration of the novel prehospital simulation scenario/scripts into data collection events at the performer location. Participate in a government led orientation session on human subject research protocol requirements and research data collection requirements. Serve as qualified, trained research associates for data collection in accordance with government approved HSR protocol(s). Provide a performer venue/location(s) with high fidelity, hyper realistic battlefield environments where the novel prehospital simulation/scripts can be integrated and executed to provide data collection opportunities in accordance with approved HSR protocol(s). This includes, but is not limited to video recordings, audio recordings and collection of physiological data elements. Provide for a total of 21 months of data collection opportunities at the performer venue/location(s) in accordance with (IAW) USA TATRC HSR inclusion and exclusion criteria. This data collection will include participants, specifically, military operations (special forces operations personnel). A minimum of 50 eligible human subjects per month is required. Specifically, as care team members human subjects must be: a. Between the ages of 18 and 65; b. Have no preexisting conditions that would negatively impact their ability to provide care in a simulated trauma care scenario or work outside for prolonged periods of time (e.g., extreme allergies, extreme reactions to sun exposure, etc.); c. Be willing to have video and audio recordings and physiological monitors used to record their actions during the simulated data collection events; d. Have one or more of the following credentials: i. An active TCCC certification (e.g., All Service Members [ASM] Tier 1 course); ii. A working knowledge of combat casualty care skills and curriculum through medical-related curriculum (i.e., combat medic or equivalent training); or iii. Deployment with medical experience in the last 36 months. 7. Collect, compile, and return data collection from human subject research simulation events to a government data repository IAW USA TATRC approved human subject research protocols. This includes but is not limited to having appropriate hardware and software resources to conduct the required data collection activities. 8. Provide a point of contact to serve as a hand receipt holder for government equipment, as required. 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 (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 PoP. Potential follow-on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype. Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has available up to $442,000 for anticipated awards to be made through this effort during Fiscal Year (FY) 2024. Award and funding from the Government is expected to be limited to the funding specified above and is contingent upon the availability of federal funds for this program. MTEC expects to make one award to a qualified Offeror(s) to accomplish the scope of work with a Period of Performance (PoP) not to exceed 24 months. Acquisition Approach: This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in the RPP. The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria listed in the 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. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to 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 the dedicated MTEC Teaming Connect. 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, 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 Program Manager, Mr. Evan Kellinger, contact@example.gov To view the full-length version of this RPP, visit www.mtec-sc.org/solicitations/.