MTEC Pre-Announcement: National Disaster Medical System (NDMS) - Modular/Convertible Surge Capability Pilot

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement (OTA) for prototype projects Request for Project Proposals (RPP) that will aim to plan, design, develop and test modular and/or convertible medical facilities to increase the medical surge capabilities and capacity of the National Disaster Medical System (NDMS). The overarching goal of NDMS is to strengthen our Nation's response to national disasters and our capacity to care for casualties returning from an overseas wartime contingency, an attack on homeland, or other national security medical emergencies. The United States Government (USG) intends to solicit proposals from healthcare facilities, academic institutions, and professional entities and leverage ongoing analysis and outcomes of the ongoing NDMS Pilot being led by the Uniformed Services University to ensure the alignment of efforts and support the overall objective of the NDMS. ____________________________________________________________________________________ Background: In accordance with the Fiscal Year 2020 (FY20) and FY21 National Defense Authorization Acts (NDAA), the National Disaster Medical System (NDMS) Pilot Program commenced on 30 September 2021. The Pilot's intent is to increase medical surge capabilities and capacities to care for our Nation's combat casualties by strengthening interoperable NDMS partnerships at five Pilot medical facility sites (referred to as - Pilot sites). As directed by the FY21 NDAA, the Pilot is a collaboration between the Secretary of Defense and the Secretaries of Veteran Affairs, Health and Human Services, Homeland Security, and Transportation. These agencies are supporting the five Pilot sites: Washington, DC / National Capital Region; San Antonio, TX; Sacramento, CA; Omaha, NE; and Denver, CO. For additional background on previous MTEC NDMS solicitations (for OT prototype projects) which requested proposals in support of the broader mission of the NDMS Pilot Program, please refer to MTEC-21-11-NDMS and MTEC-23-01-NDMS-PSP. Solution Requirements: The specific objective of this upcoming RPP is to resolve the issue of limited medical surge capabilities during a national disaster to support the Nation's homeland security defense mission through the development of modular and/or convertible medical facilities. This part of the NDMS Pilot will be led by the Defense Health Agency (DHA) where an integrated product team has already been established to lead the pilot modular program plan and that will be responsible for identifying the appropriate materiel solution(s) to meet congressional intent for this pilot. The modular and/or convertible surge capability prototype is required to be physically adjacent to one of the existing five Pilot sites (Washington, DC/National Capital Region; San Antonio, TX; Sacramento, CA; Omaha, NE; and Denver, CO). Prototypes shall be able to utilize the current capabilities of the Pilot site, including laboratories, intensive care units, x-rays, staffing, and services. It is expected that Offerors will propose an initial program plan and schedule, including an integrated master schedule and plan of actions and milestones, estimated funding needed for planning, design, testing, transition to implementation, and sustainment of a full-scale prototype medical surge capability. An initial program plan will be developed during the Period of Performance (PoP) and should include draft design(s) and drawings, inventory of equipment/devices/supplies required to support prototyping, and an initial testing plan. During the PoP, the program will be updated, a training plan for activation of the surge facility will be developed, and development of recommendations for how the modular surge materiel solution could potentially be integrated into a Joint Center for Emergency Medical Training, Readiness, and Coordination in partnership with the Department of Health and Human Services. Additional requirements of the award will include finalizing the design, development of the initial protype(s), development of initial training to support the modular surge facility, and testing the initial prototype(s) of the modular and/or convertible surge facility. PROJECT SCOPE AND NON-COMPETITIVE FOLLOW-ON WORK: The USG and MTEC expect that the scope of proposed projects will be based on the initial maturity of each Offeror's proposed prototype and the ability to meet the solution requirements summarized above. Therefore, USG decisions regarding both the rolling down-select (as further detailed below) 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) work listed below during any period (i.e., period of performance (PoP) 1, PoP2 - see the section below titled - 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): Update the plan for transition to implementation and sustainment of the full-scale capability Development of the full-scale prototype Sustainment of the full-scale prototype Potential Funding Availability and Period of Performance: The USG currently has available $12,815,730 for Fiscal Year (FY) 2022 for PoP1 work. The proposed budget should be commensurate with the nature, scope and complexity of the proposed research and development; however, it is highly encouraged that the maximum budget requested by each Offeror is $6,000,000. Offerors are encouraged to scope out their budgets in alignment with major deliverables of the proposed work so that large budgets are easier to evaluate, and the USG can more easily allocate available funding. The USG reserves the right to request adjustments to proposed budgets as a condition of award. Additional FY23 funding of approximately $18M is planned for PoP2 work. Additionally, there is the potential for funding in the outyears. The funding estimated for this RPP is approximate and subject to realignment. Awards and funding from the upcoming RPP are contingent upon the availability of federal funds for this program. Pending successful completion of the total effort, the USG may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC - 4022 section f. MTEC anticipates that one or more awards will be made. PoP1 is expected to begin in September 2023 and is not to exceed 12 months. Depending on the results of the anticipated rolling downselection (which will occur during performance of the project(s)), any resulting award(s) may continue into a PoP2 stage and beyond and add additional work to further support the overall goal of this program. Acquisition Approach and Rolling Downselection: This upcoming RPP will be conducted using the Enhanced White Paper proposal 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 and select those that best meet its current priorities using the evaluation criteria that will be detailed 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. Offerors are hereby notified that the USG 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 (or more) 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 at approximately 6 months into PoP1. Additional details will be provided in the upcoming RPP regarding the Go/No-go Decision Point, the estimated timeframe of the IPR, etc. This upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a summary version will be available on 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 (21 days or less). 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. 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. Lauren Palestrini, MTEC Chief Science Officer, contact@example.gov.