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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) focused on th... 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) 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 or higher in order to be considered (see the document attached to this posting for a definition of TRL 5): Prototype must be capable of achieving an indication for use on large (>20% total body surface area (TBSA)) burns. 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. 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.) 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. Prototype must be capable of achieving a shelf life of at least two years at room temperature. Prototype must not require climate-controlled transit or storage at maturity. 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.) CAPABILITY-SPECIFIC CHARACTERISTICS In addition to the Common Characteristics for All Capabilities listed above, each capability has specific desired characteristics listed below. A. 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 B. 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 C. 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. D. 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@officer.mtec-sc.org