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The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement for prototype projects Request for Project Proposals (RPP) that focuses ... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement for prototype projects Request for Project Proposals (RPP) that focuses on the development of prototype solutions for the prevention of infection of combat wounds. This upcoming RPP seeks a non-surgical, definitive solution(s) for a moderate to severe dermal disruption (penetrating wounds) with a focus on averting infection, with the ultimate goal of returning the Service Member to full functional duty without the need for evacuation. The proposed solution(s) may also be used as a temporary treatment when surgical capability is unavailable. Background The Joint Program Committee (JPC)-2/Military Infectious Diseases Research Program (MIDRP) is one of six major Defense Health Program (DHP) core research program areas within the DHP Medical Research Development Test & Evaluation (RDT&E). JPC-2 is a committee of DoD and non-DoD medical and military technical experts in infectious disease-related program areas. Per the MIDRP’s mission statement, JPC-2/MIDRP seeks to plan, coordinate and oversee for the DoD, a focused and responsive world class infectious diseases Science and Technology (S&T) program, leading to fielding of effective, improved means of protection and treatment to maintain effective global operational capability by maximizing Warfighter readiness and performance. Technical Requirements Combat wound infections in a prolonged care environment are a major risk to Warfighter survivability and their ability to return to duty, posing a significant burden to an Army Health System that has little to no capacity for significant periods of time during Multi-Domain Operations. Research has shown that greater than 30% of all combat wounds become infected. That percentage is expected to rise in a prolonged care environment, hence integrated interventions provided by Tactical Combat Casualty Care (TCCC) providers at the point of injury are critically important to diminish the occurrence of infection in battlefield wounds. Scope of Work The goal of this RPP will be to develop prototype solutions that enable prevention of Warfighter wound infections on the battlefield as close to the point of injury as possible to enable their speedy return to duty and without requiring evacuation to higher roles of care. Therefore, this requirement is focused on a multi-layered approach to protecting Warfighters against wound infections. The proposed solution(s) is expected to be part of a system to provide an adequate response to complex traumatic penetrating injuries that can lead to wound infections. Minimum Requirements for Submission of an Enhanced White Paper: The expected Technology Readiness Level (TRL) at start of the period of performance (PoP) is 3/4 and at the end of the PoP is TRL 6/7 [definition of TRLs can be found here: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf] At the time of submission, the Offeror is expected to have a candidate solution with non-clinical data (in vitro, toxicology, pre-clinical animal data, etc.) indicating safety and/or efficacy. The Offeror shall have demonstrated manufacturing feasibility of the candidate solution. It is preferred that Offerors have had at least one meeting with the FDA to discuss the regulatory strategy for their candidate(s). The following final product attributes are required (not listed in order of importance): [Note: Although Enhanced White Papers that propose to meet all of the product requirements outlined below are preferred, the Government may consider lesser responses based upon the specifications that could be met and the team’s approach to meeting the other requirements over time. However, it is expected that an Offeror’s White Paper will describe in detail what they plan to accomplish and how they plan to satisfy all of the product requirements either during the proposed PoP or beyond that period (Offerors should specify the projected timeline).] Broad and rapid microbicidal (bacterial and/or fungal) activity with a shelf life of at least a year. For proposed solutions that may have to be opened multiple times, it is preferred that the “use within” period is at least one year. Ease of use, small and lightweight (i.e., should fit in a combat medic’s medical bag) without the need for additional logistic considerations, e.g., cold/warm storage, impact protection, additional supplies/products to enable use. When placed into a wound, it is preferred that the product not stain the skin or surrounding exposed underlying tissue and must be easily removable (i.e., washed out of the site of placement with sterile water or saline). Usable and efficacious in austere environment conditions, as well as packaging that maintains integrity in wide temperature ranges (between 0-45oC), and also in conditions of high and low humidity. Demonstrable efficacious use of the product on the wound for at least three days in austere environmental conditions referenced above. At the end of the PoP, the performer(s) will have the following deliverables: Completed Good Laboratory Practice (GLP)-compliant study demonstrating acceptable safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use. Completed a Phase 1 clinical trial demonstrating adequate safety and preliminary efficacy profile in optimized dose and schedule. A Defined Regulatory Pathway: An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) a Phase 2 and 3 study plan validated by formal communication with the FDA. Evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development. Demonstrated stability of product(s) for at least one year at 0-45oC and under conditions of high humidity. 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: Manufacturing of prototypes Further clinical testing of candidate prototypes Potential Funding Availability and Period of Performance: The U.S. Government (USG) Department of Defense (DoD) currently has available $4 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 multiple awards to qualified Offerors to accomplish the proposed scope of work. If proposed projects are unable to sufficiently address the entire scope of work, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details. The anticipated PoP is up to 2 years. Acquisition Approach The MTEC will implement the “Enhanced White Paper” contracting methodology for this RPP, which will be an accelerated approach to award. This streamlined approach is anticipated to be 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. 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 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