Pre-Announcement: Navy Multi-Topic - Advanced Biomedical Product Development for Naval Operations

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for multiple Requests for Project Proposals (RPPs) focused on the advancement of engineering and medical prototypes and knowledge products related to a broad range of medical technological needs identified below. Relevance to the enhanced readiness and resilience of Navy and Marine Corps health and performance is a key feature of these upcoming RPPs (a total of two RPPs are anticipated). Problem Statement Due to the Navy and Marine Corps diverse warfighting capabilities, Sailors and Marines operate in a vast array of challenging and austere environments. Combination of physical and mental stress from extreme conditions compromise human performance capability, increasing risk and possible failure of mission objectives. In addition, operating environments cause complications and challenges in medical logistics and casualty management, both vital elements to ensuring survivability of combat casualties. To maintain warfighter lethality and operational effectiveness in challenging environments, next generation biomedical products are required. Technology Focus Areas The upcoming multiple topic area (multi-topic) RPPs will require white paper submissions that describe projects that are based on logical reasoning and sound scientific rationale. Projects shall not be exploratory in nature and do require a foundation of preliminary data. Note that MTEC-sponsored projects must result in - prototype research deliverables that transition medical solutions to industry. Proposed prototypes shall be at a minimum of a Technology Readiness Level (TRL) of 5 at the time of white paper submission. [Note: TRL definitions can be found here: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf] Subsequent to the completion of performance under the prototype awards resulting from the upcoming RPPs, the Government reserves the right to award follow-on work. Any follow-on work for the continuation of the prototype development is contingent upon availability of future funding and the successful completion/progression of milestones. Proposed prototypes considered for further development should be at a TRL of 6 or 7 at the conclusion of the prototype award. A TRL of 6 or 7 means that the prototype solutions are ready, currently going through, or completed the Technology Maturation and Risk Reduction phase of the Defense Acquisition System framework or equivalent. Proposed prototype solutions shall address at least one of the following Technology Focus Areas. These areas of interest are not listed in order of importance. Specific areas of interest within each overall focus area will be included in the upcoming RPPs. TECHNOLOGY FOCUS AREA #1: CASUALTY CARE - This area focuses on patient and personnel recovery, remote health monitoring, wound (combat-injury) care, and immersion injuries. TECHNOLOGY FOCUS AREA #2: MEDICAL LOGISTICS ENHANCEMENT - This area focuses on resupply efficiencies and medical product stability or other enhancements for medical logistics support in austere or disaggregated operations. TECHNOLOGY FOCUS AREA #3: HUMAN PERFORMANCE - This area focuses on the prediction of health status and outcomes from various sources of combat related stressors and advanced biomedical devices and components such as sensors and advanced electronics miniaturization. TECHNOLOGY FOCUS AREA #4: PROLONGED AND EN ROUTE CARE - This area focuses on patient care at and through the continuum of care as well as products and services that sustain patient health in austere environments such as expeditionary, littoral, and deep water. TECHNOLOGY FOCUS AREA #5: OPERATIONAL READINESS - This area focuses on preventive measures against dental disease and optimization of baseline warfighter performance and resilience. Proposed prototype solutions must be either - engineering and medical prototypes or - knowledge products. See below for the definition of each. Engineering and medical prototypes: System, subsystem, component, or material directly or indirectly delivering or supporting a biomedical product or critical capability. These are physical, in-hand products which can be examined, tested, and demonstrated. This may also include products that require approval by the U.S. Food and Drug Administration (FDA). Knowledge products: Non-materiel solutions that include methodology, technology, or technical process directly or indirectly supporting a biomedical product or critical capability. This may also include products such as technical reports or manuals impacting training and/or operations. Potential Funding Availability The U.S. Government (USG) currently has available a total of approximately $20-30 million (M) of Fiscal Year (FY) 2019 and 2020 Research, Development, Test, and Evaluation (RDT&E) funds for anticipated awards to be made during FY2020 and FY2021. The estimated total available funding per Technology Focus Area is: TECHNOLOGY FOCUS AREA #1: CASUALTY CARE ~ $10M TECHNOLOGY FOCUS AREA #2: MEDICAL LOGISTICS ENHANCEMENT ~ $2.5M TECHNOLOGY FOCUS AREA #3: HUMAN PERFORMANCE ~ $5M TECHNOLOGY FOCUS AREA #4: PROLONGED AND EN ROUTE CARE ~ $3M TECHNOLOGY FOCUS AREA #5: OPERATIONAL READINESS ~ $10M MTEC anticipates that multiple awards may be made under each Technology Focus Area with average budgets ranging from $500,000 to $2,000,000 for the base period of performance (exclusive of any proposed options), with a maximum award amount of ~$15,000,000, inclusive of optional tasks/years options for selected topic areas. The base Periods of Performance (POP) may range from 12 to 36 months, dependent upon product type and level of maturation required. Note that projects may be phased, as appropriate, with contract options to enable the exercise of additional milestones to allow maximum flexibility in terms of the progression of work, availability of funding, and duration of the awarded project(s). 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. Acquisition Approach As the Government will solicit five Technology Focus Areas, multiple RPPs are anticipated (a total of two RPPs are anticipated as reflected in the table below). The anticipated schedule for the RPP release dates and due dates is as follows (subject to change): 1. Anticipated RPP Solicitation #: MTEC-20-02-NavyMulti Anticipated RPP Release Date: early January 2020 Anticipated White Paper Due Date: early February 2020 Technology Focus Areas: Technology Focus Area #1 - CASUALTY CARE Technology Focus Area #2 - MEDICAL LOGISTICS ENHANCEMENT Technology Focus Area #3 - HUMAN PERFORMANCE 2. Anticipated RPP Solicitation #: MTEC-20-03-NavyMulti Anticipated RPP Release Date: early March, 2020 Anticipated White Paper Due Date: late April, 2020 Technology Focus Areas: Technology Focus Area #3 - HUMAN PERFORMANCE Technology Focus Area #4 - PROLONGED AND EN ROUTE CARE Technology Focus Area #5 - OPERATIONAL READINESS These upcoming RPPs will be conducted using a two-staged approach for proposal submission. 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 Focus Areas 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 Stage 2 process may vary, for example, some Stage 2 processes may require a solution pitch (i.e., oral presentation) or submission of a full proposal using the MTEC Proposal Preparation Guidelines (PPG). The RPPs will be posted to the MTEC website (mtec-sc.org) and the Contract Opportunities website (beta.SAM.gov) to notify interested parties. MTEC membership is required for the submission of a white paper in response to these upcoming MTEC RPPs. 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 government 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. Points of Contact For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts: Technical and membership questions - Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov Programmatic questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov MTEC Member Collaboration Database Tool - Ms. Melissa Sanchez, MTEC Program Administrator, contact@example.gov