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The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) with the objective to identify and enable the development of solu... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) with the objective to identify and enable the development of solutions to accelerate recovery following acute or cumulative musculoskeletal injury. Prototypes may include developing medical technologies (e.g. drugs, biologics, and devices) and treatments or rehabilitative strategies (e.g. methods, guidelines, standards, knowledge products) for musculoskeletal injuries. ____________________________________________________________________________________ BACKGROUND: It is difficult to overstate the burden of musculoskeletal disease or the need for more research. According to the United States Bone and Joint Initiative’s The Burden of Musculoskeletal Diseases in the United States (fourth edition), more than a third of the population, over 107 million people, was affected by a musculoskeletal condition during the three-year period of 2012-2014. Moreover, the 2020 Health of the Force Report (citation 1) shows a majority of Service member injuries (72%) being cumulative musculoskeletal overuse injuries, singling musculoskeletal injury as one of the largest threats to warfighter readiness. The threat relates to both the operational and training environments. Battlefield orthopaedic injuries cause the majority of long-term disabilities. Moreover, while deployed, non-battle injuries account for 30% of all medical evacuations and more than 85% of Service members medically evacuated for musculoskeletal injury do not return to theater (citation 2). In the training environment, musculoskeletal injury accounts for up to 80% of causes for a Service member being medically non-deployable. Overall, fifty percent of soldiers can expect to sustain at least one musculoskeletal injury each year (citation 2). This effort focuses on developing or advancing technologies that maximize medical readiness and provide orthopedic and rehabilitation solutions for the modern Warfighter to inform and/or accelerate recovery from musculoskeletal injury. It is believed that prototypes developed through this effort will be commercially applicable and improve the health and quality of life for the broader population of patients enduring orthopedic trauma. 1 U.S. Army. 2020 Health of the Force Report. https://phc.amedd.army.mil/PHC%20Resource%20Library/2020-hof-report.pdf 2 Malloy et al. 2020, Mil Med. Musculoskeletal Injuries and the United States Army Readiness Part I: Overview of Injuries and their Strategic Impact Scope of Work: This RPP focuses on developing technologies that maximize medical readiness for the modern Warfighter. Efforts may include treatments and/or interventions to accelerate recovery following musculoskeletal injury including: Capability to treat, repair or regenerate functional muscle following acute injury. Capability to enable faster recovery timelines after soft tissue injury (e.g. strain/sprain) Additional points of consideration: Project Maturity: Proposed prototypes must be at a minimum of a Technology Readiness Level (TRL) of 3, however, it is preferred that proposed prototypes are at a stage where they are ready for user testing. Studies involving human subject testing are highly encouraged. For TRL definitions: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf Proposed Scope: The proposed scope of work should be focused on tasks relevant to advance the prototype to the next TRL. Project scope should be based on the prototype’s maturity at the time of submission. The work could include, but is not limited to: Prototype refinement/maturation progressing towards clinical product Clinical studies (as needed) to support regulatory approval/clearance Prototype delivery for military-relevant testing (prototype testing or demonstrations) First article testing Industry Partners: MTEC considers that a white paper involving an industry partner (or alternative organizations) to serve as the regulatory sponsor and commercialization partner may have the greatest level of success, especially considering that the eventual goal is to obtain clearance/approval by the U.S. Food and Drug Administration (FDA). Academic or Not-for-Profit Partners: MTEC is excited to bring forth Orthopaedic Research and Education Foundation as a potential co-funder to this solicitation. OREF has committed $100,000 to support a portion of the proposed work that will be conducted by either an academic or not-for-profit partner organization. If the Offeror (prime contractor) is a for-profit organization, it is encouraged that the Offeror include an academic or not-for profit partner as a subcontractor who is capable and well poised to execute the OREF-funded portion of the work. POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE: The U.S. Government (USG) currently has available a total of approximately $1.47 million (M) of Fiscal Year (FY) 2022 (FY22) research, development, testing, and evaluation (RDT&E) funds for this effort. Please note that additional funds of at least $100,000 may be provided by the OREF to support a small portion/deliverable of the funded SOW. These additional funds are only available for use by academic or not-for-profit organizations based on OREF’s guidelines. Therefore, the Offeror or one of its subcontractors should be an academic institution or a not-for-profit organization to be eligible for the additional funds to be provided by OREF. Please note, eligibility for the additional OREF funding is not required for submission of an enhanced white paper or consideration for award. OREF gratefully acknowledges funding support from The Aircast Foundation. MTEC expects to make up to two awards to a qualified Offeror(s) to accomplish the scope of work with a Period of Performance not to exceed 36 months. ACQUISITION APPROACH: This upcoming RPP will be conducted using the Enhanced White Paper approach. In Stage 1, Offerors are invited to submit Enhanced White Papers using the mandatory format contained in this upcoming RPP. The Government will evaluate Enhanced White Papers submitted and select those that best meet their current priorities using the evaluation criteria described in the upcoming 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. This upcoming RPP will be posted to the MTEC website (mtec-sc.org) and SAM.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a short proposal preparation period (approximately 30 days). MTEC membership is NOT required for the submission of an Enhanced White Paper in response to this MTEC RPP. However, membership WILL BE required for Offerors recommended for award. Subcontractors (including all lower tier subawardees) do not need to be MTEC members. 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 Enhanced White Paper 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. The following resources may help Offerors form a more complete team for this requested scope of work. • The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: Business Expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction Advisory], and Technical Expertise [i.e., chemistry, manufacturing and controls (CMC), clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps. • 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 (https://private.mtec-sc.org/). • A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity. The chat forum can be accessed via the “Team Portal” on the MTEC members-only website - https://private.mtec-sc.org/. 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. Chuck Hutti, MTEC Research Associate, chuck.hutti@ati.org. Sincerely, MTEC Team