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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 an organization able to serve as a... 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 an organization able to serve as an “integrator” proficient at leveraging the capabilities of an existing network of performers to advance materiel and knowledge products that improve the physical, cognitive, and psychological health and performance of Service Members (SM). The goal is to create an actively coordinated “mini-consortium” program that incorporates organizations dedicated to researching, developing, testing/evaluating, and manufacturing human health and performance products. Due to the Integrator’s specialized expertise, this approach will de-risk technology development by providing capability/expertise to companies that have promising technologies but lack the ability or experience to bring their technologies to market. This structure also allows flexibility to incorporate service member feedback into the testing/evaluating process, identifying and replacing failing prototypes with more promising ones throughout the Period of Performance (PoP). Additionally, the integrator will continually synchronize and integrate awardee efforts so that prototype development might advance further and faster than if the awardee were to conduct development on their own. ____________________________________________________________________________________ Background: Current wartime operations assume that the United States and our allies will maintain air, land, maritime, space and cyber superiority. Future conflicts against peer and near-peer adversaries are expected to be layered stand-offs, fought across multiple domains (Multi-Domain Operations, MDO) in large scale combat operations. Mission success will be determined by our ability to compete to expand the competitive space, penetrate both strategically and operationally, disintegrate enemy’s defenses, exploit enemy weaknesses and re-compete to consolidate gains. Warfighter performance plays a critical role in each aspect of MDO and enhancements to human performance will maintain Force readiness and increase soldier lethality. In order to modernize the DOD to be a ready and resilient Force, MOMRP is seeking to build a capability through MTEC that is poised to rapidly advance prototypes related to Warfighter performance and transition these to both the Warfighter and the commercial marketplace as appropriate. This effort requires multiple prototype solutions (hereafter referred to as performance technologies) that address: preventing or reducing physical injuries (e.g. musculoskeletal injuries (MSKI), cognitive degradation, psychological health challenges) and speeding recovery/return to duty/combat; maintaining health and performance in a multi-stressor environments common in the DoD in garrison, during training, and on operations; and enhancing baseline physical and mental health and performance in a safe and ethical way Scope of Work: Two tasks have been identified for funding under this RPP. The intent of this RPP is to initially award Task 1 as a Prime contractor with Task 2 performers added to the award as subcontractors within the first 12 months of the PoP. It is the Government’s intent that this initial award will be part of a larger and longer project, with the potential for follow-on funding (pending availability of funding and technical progress). All submissions shall detail how the Offeror will accomplish/achieve all aspects of these requirements to include a clear approach to execute all tasks based upon the Offeror’s unique methodology. Therefore, the Offeror shall also clearly identify the major milestones in the SOW/Milestone Payment Schedule associated with accomplishing these requirements. Task 1 – Prime Integrator capabilities to translate prototypes. The project shall be led by a centralized point of contact at the prime performer to serve as the “Integrator.” It is possible that several subcontractors will be required to accomplish the full scope of the project and each effort thereunder. Agreements among the established consortium members shall be handled by the Integrator to the greatest extent possible. A centralized POC for the established consortium at the Integrator shall be named and will be ultimately responsible for official communication and deliverables. Offerors are expected to propose a consortium structure that is comprised of the necessary qualified personnel, facilities (including military relevant testing environments), equipment, supplies, services, and subcontractors and related administrative and information technology support to accomplish the objectives. It is preferred that the integrator have established experience in the advancement and commercialization of technologies related to human performance. Furthermore, the Government recognizes that the composition of the team may change as the project requirements evolve over time. Therefore, the Offeror shall include the overall project management plan as part of the Enhanced White Paper submission. The Offeror shall also describe its strategy to adjust (i.e. expand) the team, as needed, throughout the period of performance (to include potential follow on tasks) to ensure the proper level of effort, access to the necessary subject matter experts, etc. The Integrator’s role may include (but is not limited to) the following activities: Report directly to the SOTR at MRDC Military Operational Medicine Research Program (MOMRP). Project portfolio expansion Bring forth prototypes relevant to the military priorities set forth by MOMRP. The Integrator will work solely with MTEC to draft the necessary Requests for Project Information (RPI) to solicit for additional prototypes (as needed and with concurrence from MOMRP). MTEC will use its standard processes to post the RPI and collect the project information paper submissions. The Integrator will implement an objective review process for the evaluation of project information papers. Based on the recommendation and approval from MOMRP, the Integrator will work with selected project Offerors to be formally incorporate into the project under Task 2. Support the development activities required to advance prototypes along their maturation pipeline. The Offeror shall propose how to expand their network of vetted translational services and expertise to address specific challenges related to prototype development. The network shall also include military-relevant testing environments. The Integrator is encouraged to work with MTEC M-Corp members to expand their capabilities and more readily assist with the advancement of prototype development. Oversee and manage the project portfolio to enhance the likelihood of prototype success Conduct strategic planning to ensure successful transition of candidate prototypes to the commercial marketplace and the Warfighter Provide resources and collaborative events for early translational activities, such as team building, strategy, project management and planning, etc. Allocate funding based on progress of award milestones and deliverables Provide routine technical and programmatic review of awarded projects, including multiple execution tests and evaluation events throughout the prototype advancement process Make recommendations to MOMRP for approval regarding project status (e.g., termination, modification, continuation, etc.), implement changes to SOWs, re-partnering, terminations, reallocation of funding to current projects, adding on new projects) Results dissemination Conduct a yearly symposium that brings together key personnel from the Government, projects, and other key stakeholders [Offerors should plan for this to be tagged onto the MTEC Annual Membership Meeting] Task 2 – Development of performance technology prototypes. The Integrator shall propose a portfolio of candidate performance technology prototype projects for consideration for funding under Task 2. This portfolio of projects will be preliminarily evaluated as due diligence on the quality of prototypes that the Integrator is able to offer. Full evaluation of the candidate prototypes will be executed by MOMRP. All prototype projects will require approval by MOMRP for their addition to this award. The Government may approve for funding all, some, or none of the projects proposed under Task 2. If funding remains available after the evaluation of the portfolio of projects proposed in Task 2, additional prototypes for consideration may be offered by the Integrator and/or collected using the MTEC Request for Project Information as described in Task 1. Letters of intent from a portfolio of proposed prototypes will be expected at the time of submission. The performance technology prototypes being developed in this effort must meet the following criteria: Prototype Maturity: The prototypes may span the pipeline of maturity, but be at a minimum of a Technology Readiness Level (TRL) of 4. This program prefers prototype technologies that are ready for user testing. Military Relevance: Prototypes must be relevant to the following needs of the warfighter: preventing or reducing physical injuries (e.g. musculoskeletal injuries (MSKI), cognitive degradation, psychological health challenges) and speeding recovery/return to duty/combat; maintaining health and performance in a multi-stressor environments common in the DoD in garrison, during training, and on operations; and enhancing baseline physical and mental health and performance in a safe and ethical way Commercial Partners: It is preferred that prototypes shall include partnerships with commercial entities/industry partner(s) committed to bringing the product to market. Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has available a total of approximately $6.7 million (M) of Fiscal Year (FY) 2022 (FY22) research, development, testing, and evaluation (RDT&E) funds for this effort. It is the Government's intent that this initial award is part of a larger and longer project, potentially providing approximately $7M per year for follow-on work for up to 5 years (pending availability of funding and technical progress). Award and funding from the Government is expected to be limited (initially) to the funding specified above (only $6.7M at present, but with an additional $7M possible per year) and is contingent upon the availability of federal funds for this program. MTEC expects to make a single award to a qualified Offeror 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 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 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 two 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. 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 Project Team