MTEC Pre-Announcement: Algorithm Development for Early Warning and Prediction of Chemical and Biological Threat Exposure Leveraging Artificial Intelligence and Machine Learning (AI/ML) Approaches

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) which will be focused on the development of a software prototype containing algorithm(s) for early warning of chemical and biological threats. The project will involve proof-of-concept algorithmic development for providing predictive values indicative of a potential exposure/infection to a chemical/biological threat prior to symptom onset by utilizing physiological data captured from wearable devices. ____________________________________________________________________________________ Background: Prior to the COVID-19 pandemic, the Defense Threat Reduction Agency's (DTRA) Digital Battlespace Management Division (RD-CBI) leveraged non-invasive physiological data to develop predictive algorithms capable of informing users of a potential exposure/infection to a chemical/biological threat prior to symptom onset. This capability was initially based on clinical hospital datasets that utilized hospital-grade monitoring devices. It was subsequently expanded to include multiple, large-scale, real-time datasets collected throughout the COVID-19 pandemic using commercial-off-the-shelf (COTS) devices. This capability illustrated the feasibility of an infection-based predictive algorithm built strictly from physiological data collected from wearable devices. The early warning capability is undergoing continued research and development (R&D), and has been refined to alert participating COTS device wearers and users to a potential COVID-19 exposure up to 48 hours in advance of symptom onset. Physiological data has been acquired from COTS devices such as the Garmin Fenix 6 smartwatch, Oura ring (Generation 2 and 3 versions), Dexcom patch (G6 Pro), Empatica E4 wristband, BioTel ePatch, among other devices and clinical ground truth data. Further R&D is underway to collect wearables-based, physiological data from over 10,000 participants for analysis and future algorithm development, including data verification and validation. The objective of this RPP is to implement artificial intelligence/machine learning (AI/ML) methods and analytics approaches that provide alerts to exposure to chemical and biological threats. Biological threats have been of interest due to the nature of incubation and transmission timelines; however, there is also interest in utilizing these methods to enhance capabilities for identifying chemical exposures through physiological-based data. Such improved capabilities would enhance the U.S. Department of Defense's (DoD) capacity to limit the spread of a contagious agent throughout the force and/or more rapidly implement mitigation measures (e.g., medical countermeasures, quarantine), thereby reducing overall morbidity and mortality and increasing force readiness. Solution Requirements: Under this upcoming RPP, DTRA RD-CBI is seeking a performer who can leverage existing wearable device-based datasets to develop algorithms that have the following attributes (not listed in order of importance): 1. Produce a higher confidence predictive model for a biological and chemical threat exposure at lower than a 15% false positive rate 2. Be optimized for data degradation: lowest capture of data or fewest number of viable physiological features to still achieve the optimal false negative and low false positive rate 3. Provide an earlier prediction (i.e., greater than 48 hours) before symptom onset 4. Be threat agnostic, with the ability to alert to any potential biological and chemical exposure 5. Differentiate and account for confounding factors including but not limited to: sleep deprivation, exercise, activities at rest, and other daily stressors Although Enhanced White Paper proposals (see the - Acquisition Approach section below for more details on the anticipated proposal submission requirements) that propose to meet all of the product attributes outlined above are preferred, the Government may consider responses demonstrating only a portion of the final product attributes if the Offeror's approach can address how the remaining requirements can be met over time. Therefore, it is expected that an Offeror's Enhanced White Paper will describe in detail what they plan to accomplish within the budget currently available. If the Enhanced White Paper proposal is not able to fully address the envisioned solution within the $1.47M of available funding, the Offeror is expected to describe and provide a roadmap to achieve the envisioned end state during the proposed Period of Performance (if more funding was available). Offerors are encouraged to bring forth proposals that include teaming arrangements with other organizations to try to address all or as many as the attributes as possible. Potential Follow-On Tasks: There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Awards (subject to change depending upon Government review of completed work and successful progression of milestones). Note that any potential follow-on work is expected to be awarded non-competitively to resultant project awardees. Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has up to $1.47 million (M) in Fiscal Year 2023 (FY23) for this upcoming program. The USG may apply additional dollars for follow-on efforts via post award modification to any resultant award(s) after the evaluation and acceptance of work and cost plan. Dependent on the results and deliverables, additional time may be added to the period of performance for non-competitive follow-on tasks. MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work. However, as part of the award recommendations, if a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the - MTEC Member Teaming section below for more details. The Period of Performance is expected to range from 12 to 36 months, dependent upon the maturity of the proposed solution. 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 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 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 (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. Lauren Palestrini, MTEC Director of Research Programs, contact@example.gov.