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The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Other Transaction Agreement for prototype projects Request for Project Proposals (RPP) with... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Other Transaction Agreement for prototype projects Request for Project Proposals (RPP) with two Focus Areas. To meet the intent of this upcoming RPP, each enhanced white paper SHALL specifically address only ONE of the two Focus Areas: FOCUS AREA #1: Accelerating Medical Device Interoperability and Autonomy (MDIA) – This topic is focused on accelerating mechanical ventilator and/or infusion pump interoperability, remote control and integration into NETCCN (National Emergency Tele-Critical Care Network) platforms in support of tele-critical care of COVID-19 patients. FOCUS AREA #2: Technology in Disaster Environments (TiDE) Learning Accelerator (TLA) – This topic is focused on developing performance measures and accelerating the availability and application of insight for use in improving delivery of tele-critical care through NETCCN and to technology in civilian and military disaster and mass casualty environments more broadly ______________________________________________________________________________ Background In support of COVID-19 surge response, the Telemedicine & Advanced Technology Research Center (TATRC) has funded the development and deployment of the National Emergency Tele-Critical Care Network (NETCCN), a set of cloud-based, low-resource, stand-alone health information management systems for the creation and coordination of flexible and extendable “virtual critical care wards.” These high acuity, virtual wards bring high-quality critical care [expertise] capability to nearly every bedside, be it healthcare facility, field hospital, or gymnasium regardless of geographic location. Based on available communication networks, mobile technologies and cloud computing, NETCCN platforms support the extension of high-quality intensive care to locations that lack adequate critical care expertise or resources necessary for care of COVID-19 patients. Under a previously issued MTEC RPP (released in FY20) and through a competitive down-selection process, TATRC has supported the development and clinical deployment of NETCCN platforms from four clinical-technical teams including: Avera Health partnered with VitelNet, and DocBox Deloitte Consulting, LLP partnered with AWS GovCloud, Decisio Health, Elsevier, Qventus, T6 Health System, Verizon, and Zyter Expressions Network, LLC partnered with Mercy ACO Clinical Services, Active Innovations, and SDSE Networks The Geneva Foundation partnered with Omnicure, Society of Critical Care Medicine (SCCM) Discovery Network, DocBox, MD PnP Program at Massachusetts General Hospital, and Madigan Army Medical Center (MAMC)/Telemedical Research for Operational Support (TR4OS) In anticipation of scaled response to COVID-19, each of these teams has validated their individual platforms through simulation testing and, through the MTEC consortium, is presently delivering tele-critical care for COVID from their clinical networks through their NETCCN platforms (“apps”) to healthcare organizations. TATRC and the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) have established a Memorandum of Agreement (MOA) to incorporate NETCCN into broader COVID surge response systems and processes. This partnership will also support the addition of capabilities to the NETCCN platform and study its deployment on a local, regional and national basis for COVID and other disasters. TATRC has identified the addition of “virtual hospital” capabilities to NETCCN platforms as a key strategy to enhance the scope and impact of tele-critical care support to resource-limited environments. By adding these advanced capabilities through the NETCCN platforms, we can address resource limitations and increase capability and capacity of healthcare delivery during a disaster. By accelerating development and inclusion of medical devices that utilize interoperable, remote control, and autonomous technologies, we can augment the knowledge, skills, and abilities of local caregivers. Currently, tele-critical care providers (i.e., clinicians delivering critical care at a distance) have limited ability to monitor, assess, and control the operation of essential medical devices (e.g., monitors, intravenous (IV) pumps, ventilators) used in the care of COVID-19 patients due to proprietary interfaces, absence of remotely controllable functions, and the need for custom licensing agreements. TATRC has also identified the need to measure NETCCN performance and to identify and rapidly exploit improvement opportunities as vital to the scaling and impact of the initiative in the fight against COVID. And importantly, establishing a Technology in Disaster Environments (TiDE) continuous learning system for iteratively improving disaster healthcare support during this disaster can inform care in the civilian context for future disasters and in optimizing military healthcare during large scale combat operations (e.g., massive numbers of casualties). In addition to this RPP, TATRC is funding two important activities outside of the MTEC consortium in support of the two focus areas: 1. A Device Interoperability and Autonomy Coordinating Center: In collaboration with ASPR, TATRC has already funded MITRE (www.mitre.org) to establish a Device Interoperability and Autonomy Coordinating Center (DIACC). Work through DIACC will be performed in collaboration with Agency partners – the U.S. Food and Drug Administration (FDA) and ASPR. Through this DIACC, TATRC has engaged the Medical Device Plug and Play Interoperability & Cybersecurity Program (MD PnP) at Massachusetts General Hospital, the Johns Hopkins University Applied Physics Lab (JHU-APL), the Society of Critical Care Medicine (SCCM), civilian and military tele-critical care experts and other key stakeholders to identify and prioritize specific projects related to device interoperability, remote monitoring/control, and autonomy that would: a. Enhance the quality and impact of tele-critical care for COVID patients managed within the NETCCN; b. Conform to regulatory pathways, including but not limited to Emergency Use Authorization (EUA) or utilizing COVID specific enforcement discretion. Note: The FDA recently released “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus; c. Be available for deployment and use as part of NETCCN platforms within 3-12 months. 2. A TATRC Data Commons to collect research data from NETCCN performers, surveys and other data collection conducted through NETCCN platforms, and additional data sets, as available, to supplement QI and research efforts. The prototype TATRC Data Commons and associated research portal is currently hosted at the Johns Hopkins University Applied Physics Lab; Technical Requirement – FOCUS AREA #1: Medical Device Interoperability and autonomy (MDIA) TATRC’s NETCCN platform aims to support the extension of high-quality, “anywhere to anywhere” intensive care to locations that lack adequate critical care expertise and resources necessary for care of COVID-19-related illnesses. TATRC believes that giving critical care providers and response teams the ability to deploy, monitor, and control devices (or networks of devices) remotely using “light” hardware solutions (e.g., mobile devices or inexpensive computing platforms), will allow remote experts to improve the delivery of advanced critical care, optimize resource utilization, and increase the safety of both patients and staff. The addition of remote monitoring, remote control, and more advanced capabilities, such as closed loop and autonomous algorithms, may further enhance care delivery to more patients during surge conditions, especially when network resources are fragile. Adding these “hospital”-type capabilities to NETCCN virtual wards represents an important step in advancing the overall NETCCN goal. The NETCCN delivers point of need telemedicine solutions that allow remote experts to provide advice to patients or local caregivers anywhere and at any time. NETCCN platforms will be able to collect data about these encounters, as well as survey data and medical device, wearable, or passive sensor data to better understand care needs in context (i.e., what patients and local caregivers need from remote experts and how best to provide it), casualty problems, and medical system resources. Under the upcoming multi-topic RPP, the MDIA topic area will focus on the acceleration of the availability of remotely controlled ventilators and/or IV pumps for use by clinicians delivering tele-critical care through NETCCN platforms to COVID patients. Specifically, this program aims to accelerate the availability and integration into NETCCN platforms of “hardware and/or software modifications implementing the capability for remote monitoring and remote adjustment of parameters (i.e., adjustment of parameters by trained health care providers from outside an isolation unit to avoid unnecessary exposures)” (https://www.fda.gov/media/136318/download). Multiple MTEC members (currently anticipated as up to four) to include commercial manufacturers of ventilators and infusion pumps may be selected to work with the DIACC and NETCCN performers to: Add or enhance remote control capabilities; Establish project plans to modify devices to achieve the desired interoperability and autonomy capabilities and obtain regulatory clearance of the modified devices; Provide data from ventilators and/or IV pumps to enable use by the NETCCN ecosystem for remote monitoring of these devices; Utilize standards to enable harmonization of data from the device(s) developed in this program with data available from other devices modified as part of the NETCCN project; Test and validate modified devices and capabilities; Demonstrate device capabilities, including risk-management strategies, in a pre-clinical testbed environment; Integrate and incorporate devices into NETCCN platforms; and Participate in the evaluation of devices and capabilities in the delivery of tele-critical care to COVID patients through NETCCN platforms for real-patient care. Technical Requirement – FOCUS AREA #2: TiDE Learning Accelerator (TLA) The goal of the TiDE Learning Accelerator (TLA) is to bring together the TLA performer(s) to be awarded under this upcoming RPP with NETCCN performers, TATRC and key stakeholders to identify and prioritize QI and research needs to improve tele-critical care for COVID through NETCCN and to provide recommendations on disaster medical support system improvements after a disaster response or disaster simulation event. TATRC expects to adapt NETCCN platforms and capabilities for military operational and garrison medicine in support of both disaster and large-scale combat operations and subsequent combat casualty care. In anticipation, TATRC has established an overall strategy to collect data and bring together key experts to optimize clinical outcomes and resource utilization in response to disasters, public health emergencies, and large scale combat. Components of this strategy include: A TATRC Data Commons to collect research data from the NETCCN performers, surveys and other data collection conducted through NETCCN platforms, and additional data sets, as available, to supplement QI and research efforts. The prototype TATRC Data Commons is currently hosted at the Johns Hopkins University Applied Physics Lab; A Research Portal (currently under development) to provide access to data (and tools for QI, research and data science) in the TATRC data commons for use by the TiDE Learning Accelerator performers and partners; Funding for NETCCN performers to contribute data, share insights and challenges regarding delivery of tele-critical care for COVID and other disasters with TATRC and TLA performers; Funding for NETCCN performers to collaborate with TLA performers to prioritize and conduct QI, research and data science projects and findings / outputs; and Funding for NETCCN performers to collaborate with TLA performers to prioritize and conduct research to develop algorithms, analytics and AI for incorporation into NETCCN platforms, the CPAM or elsewhere; Funding for NETCCN performers to participate in local, regional and national-level tele-critical care simulation events. Therefore, as detailed above, TATRC has identified two focus areas for funding under the TiDE Program. To meet the intent of this upcoming RPP, each enhanced white paper SHALL specifically address only ONE of the two Focus Areas described below. Offerors are not limited to a single enhanced white paper submission. Projects not aligned to only ONE of these Focus Areas will not be considered for funding under the upcoming RPP. FOCUS AREA #1 – Accelerating Medical Device Interoperability and Autonomy (“MDIA”) Add additional hospital-like capabilities to the NETCCN “virtual hospital” platform that will enhance the scope and impact of tele-critical care support to resource-limited environments. By adding these advanced capabilities through the connected telemedicine base platform, resource limitations can be addressed to increase capability and capacity of healthcare delivery during a disaster. By accelerating development and inclusion of medical devices that utilize interoperable, remote control, and autonomous technologies, we can augment the knowledge, skills, and abilities of local caregivers. 2. FOCUS AREA #2 – Technology in Disaster Environments Learning Accelerator (“TLA”) Using real-time data obtained from the NETCCN – from system resource information, health records, ecologic momentary assessments, real-time vital signs monitoring of patients at home and in the hospital – as well as other federal, state, academic, and open source (e.g. internet) information sources, the Government is seeking to establish a continuous learning system for iteratively improving disaster healthcare support and to identify lessons learned in the civilian context for use in optimizing military healthcare during large scale combat operations (e.g., massive numbers of casualties). Scope of Work FOCUS AREA #1 – MDIA In order to be responsive to this focus area, Offerors shall propose modification of existing devices to incorporate new functions related to: Device interoperability (i.e., the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems – https://www.fda.gov/medical-devices/digital-health-center-excellence/medical-device-interoperability) Visualization of device data through NETCCN platforms; Remote control of devices; and Base interfaces on standardized and/or fully disclosed specifications to the extent possible so that devices can be used with vendor-agnostic information displays and control interfaces. The DIACC will develop a set of materials necessary to facilitate and assist device manufacturers in developing, testing, validating and achieving applicable regulatory clearance of devices. In addition, the DIACC will coordinate work with NETCCN performersto integrate devices into NETCCN platforms. Anticipated activities to be proposed by Offerors include, but are not limited to: Identification of candidate devices; Participation in project planning and project roadmap development for device interoperability, autonomy, regulatory submission and review; Collaborate with other vendors, DIAC, FDA, and MD PnP on identifying medical device interface data specifications (MDIDS), using existing standards terminology where possible, to provide safe remote control; Collaborate with other vendors, DIAC, FDA, and MD PnP on identifying exemplar remote control use cases, NETCCN platform common user interface, and safety assurance cases for remote device control; Development of materials necessary to adapt interoperability and device control standards and frameworks such as ICE (ANSI/AAMI 2700-1: 2019), AAMI Consensus Report: Emergency Use Guidance for Remote Control of Medical Devices (AAMI/CR511:202) and Medical Device Interoperability Reference Architecture (MDIRA); Preparation of regulatory submissions, reviews and other activities; Participation in simulation and real-world testing of modified devices, as applicable; and Collaboration with the DIACC, NETCCN performers and other TATRC performers to integrate devices into NETCCN platforms. 2. FOCUS AREA #2 – TLA In order to be responsive to this focus area, Offerors shall propose against one, some, or all of the tasks outlined below, however, all Enhanced White Papers shall include Task 4 as part of the proposed scope of work: Task 1: Work with TATRC and NETCCN performers, key civilian stakeholders like ASPR, Federal Emergency Management Agency (FEMA) and Society of Critical Care Medicine (SCCM), and military stakeholders like the Virtual Medical Center, Joint Tele-Critical Care Network, the Medical Capabilities and Integration Division (MedCDID) and Combatant Commands (COCOMS), to establish structural, process and outcome performance measures for technology support of healthcare during COVID, other disasters and large-scale combat operations (LSCO). The goal is to establish a core set of measures that can be tracked and improved upon from disaster to disaster; and from disaster care to LSCO; Task 2: Work with TATRC and NETCCN performers to identify, prioritize, conduct and implement QI projects to address challenges and opportunities to improve the efficiency, effectiveness and impact of NETCCN, other technologies, and their application for civilian disaster care and/or military operational medicine; Task 3: Work with TATRC and NETCCN performers to identify, prioritize, conduct and execute research activities, including development (and submission) of abstracts for publications; Task 4 (Required): In partnership with TATRC and NETCCN performers, share QI & research outputs and provide recommendations on disaster medical support system improvements after a disaster response or disaster simulation event. TLA performers will be expected to structure and perform QI, research and data science projects in such a way as to deliver insight to TATRC, NETCCN performers, and key stakeholders within 6-12 months. In addition to the TATRC data commons (and associated tools) and data available from NETCCN performers, TLA performers may – as part of this project – identify and use additional sources of public and private data and develop or use data infrastructures and associated analytic and data science environments necessary to deliver measurable improvements to NETCCN care delivery and operations. Potential Funding Availability and Period of Performance (PoP) The U.S. Government (USG) Department of Defense (DoD) currently has available approximately the following funding for this upcoming program. FOCUS AREA #1 – MDIA: $3.304 Million FOCUS AREA #2 – TLA: $2.832 Million The USG may apply additional dollars for follow-on efforts via post award modification to any resultant awards 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 follow-on tasks. Cost sharing, including cash and in kind (e.g., personnel or product), contributions are strongly encouraged and have no limit, and are in addition to the total $6.136M in Government funding to be provided under the resultant award(s). MTEC expects to make up to six awards for Focus Area #1 and up to four awards for Focus Area #2 to accomplish the proposed scope of work. If proposed projects are unable to sufficiently address the entire scope of work under a given Focus Area, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details. The anticipated Period of Performance for both FOCUS AREAS is up to 2 years. Acquisition Approach MTEC will implement the “Enhanced White Paper” contracting methodology for this RPP. This streamlined approach is anticipated to be a better means to highlight an organization’s methodologies and skills required to address the technical requirements described above. The Offeror(s) whose technology solution is selected for further consideration based on the Enhanced White Paper evaluation may be invited to submit a detailed cost proposal in Stage 2. Notification letters will contain specific Stage 2 cost proposal and submission requirements. The RPP will be posted to the MTEC website (mtec-sc.org) and beta.SAM.gov to notify interested parties. MTEC membership will NOT be required for the submission of an enhanced white paper in response to this upcoming MTEC RPP (but will be required to be eligible for award). To join MTEC, please visit http://mtec-sc.org/how-to-join/ MTEC plans to host a Proposers Conference (which is anticipated as a webinar) after release of the full RPP. The purpose of this conference is to provide an overview of the RPP details and allow the Government sponsor to address questions from interested Offerors. Additional details will be included in the forthcoming RPP. MTEC Member Teaming While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal 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. 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 (http://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 Director of Research, lauren.palestrini@officer.mtec-sc.org