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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 allows for tempora... 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 allows for temporary stabilization of corneal and corneoscleral injuries at a Role of Care (ROC) 1 battalion aid station. The desired prototype should be simple enough for a medic or physician’s assistant to administer it under austere circumstances with little to no additional equipment, safe enough to use on any suspected corneal or corneoscleral injuries, and effective at stabilizing the eye such that it preserves the Soldier’s eyesight. Background In future combat scenarios where the U.S. could face a peer or near-peer adversary, the ability to evacuate casualties from the battlefield, and even out of theater, will be severely hampered. Large-scale combat operations will put high numbers of Soldiers into a fight where tactical areas are highly contested and operationally degraded. Freedom of movement, whether by air or land, will be difficult such that moving supplies and causalities to/from the front lines could take days or weeks. Unfortunately, blasts will continue to be a significant source of ocular trauma in the future fight. Without surgical intervention by an ophthalmologist, seriously injured ocular tissue is not viable after 24-36 hours. Given protracted evacuation timelines and a lack of specialists in theater, it will be impossible for the necessary specialists to treat these ocular injuries early enough to preserve the eyesight of these wounded Soldiers. In order to address corneal and corneoscleral injuries earlier and in a way that is relevant to the future fight, a product that allows for temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station is needed. The desired product should be simple enough for a medic or physician’s assistant to administer it under austere circumstances with little to no additional equipment, safe enough to use on any suspected corneal or corneoscleral injuries, and effective at stabilizing the eye such that it preserves the Soldier’s eyesight. Solution Requirements This program is intended to support the development of prototype technologies that allow temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station. Offerors should only propose technology solutions that meet the following two criteria: Currently be at a Technology Readiness Level (TRL) of 4 or above [definition of TRL – https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]; and Currently be in development or commercially available. An ideal solution would meet the following requirements (not listed in order of importance): A product that will temporarily stabilize suspected full-thickness corneal and corneoscleral injuries that is capable of obtaining approval/clearance by the U.S. Food and Drug Administration (FDA) for this indication Preserves ocular tissues Effective at preserving ocular tissues in a clinical model (with intent to restore vision) such that they can be surgically repaired in 25-50% of cases, or greater Capable of stabilizing suspected full-thickness corneal and corneoscleral wounds of various shapes and sizes, with or without prolapse of other ocular structures, contributing to the preservation of ocular tissue. Some examples could include: Creates a watertight seal over the corneal or corneoscleral injury Is oxygen permeable Safe to use even in presence of intraocular foreign body(ies) Prevents infection Enables maintenance of intraocular pressure in safe ranges (product itself does not need to re-establish intraocular pressure) A non-surgical solution that can be applied to the surface of the injured eye that does not require any specialized equipment (beyond an included applicator) Topically administered to the eye Simple to use/apply (based on design of applicator, process for administration, time to prepare, etc.) Can be administered by non-licensed medical personnel quickly and easily (see attributes of Role 1 medical setting below) Doesn’t require a surgical microscope, surgical loupes, specula, etc. Can be left in place or reapplied for up to 3 days (even higher durations are ideal) Removable and/or reversible Does not cause disproportionate damage to eye when removed Either sloughs off/is resorbed into the body; or can be safely removed by ophthalmologist in preparation for/during definitive repair surgery Could be reapplied, if needed Appropriate for use at Role 1 (unit-level medical care, i.e., Battalion Aid Station) [Refer to the Emergency War Surgery for Role of Care definitions: https://www.cs.amedd.army.mil/FileDownloadpublic.aspx?docid=6f9e0685-1290-4e92-8277-c1e7b0f2fef0] Capable of achieving a shelf life of at least two years at room temperature Doesn’t require climate-controlled transit or storage Commercially viable product or technology that will be brought to market (can be marketed for different indication in civilian market than what DoD is seeking) Project Scope and Potential for Follow-on Work: Project scope will be awarded based on the initial maturity of the proposed prototype. Potential follow-on work may be awarded based on the advancement in prototype maturity during the Period of Performance (POP). The work in the initial POP and potential follow-on awards could include, but are not necessarily limited to: Prototype refinement/maturation progressing towards clinical product Pre-clinical work (as needed) to support IDE (or other appropriate FDA) submission GLP animal studies (as needed) to support IDE (or other appropriate FDA) submission IDE (or other appropriate FDA) submission 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 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 The U.S. Government (USG) currently has available approximately $3.5 million (M) Defense Health Program (DHP) Research, Development, and Engineering (RD&E) dollars for Fiscal Year (FY) 2021. An additional $6.3M of FY22 and FY23 funding may be available for potential follow-on work for the continuation of the development. Pending successful completion of the total effort, the Government 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 to qualified teams composed of teaming arrangements demonstrated to develop a temporary corneal repair prototype through demonstration in a relevant or operational environment. The initial Period of Performance (POP) is 24 months. Acquisition Approach 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 Government 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. 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