Technology in Disaster Environments (TiDE) Multi-Topic

****The purse of this amendment is to provide information related to two separate Proposers Conferences scheduled for each topic area. See below for these details and refer to MTEC's website for additional information at: https://mtec-sc.org/solicitations/ **** The Proposers Conference is a virtual webinar format that provides potential Offerors the opportunity to interact directly with both MTEC and the Military Sponsor related to this specific funding opportunity/Request for Project Proposals (RPP). The flow of the Proposers Conference is as follows. First, MTEC provides an administrative overview of the solicitation. Second, the Military Sponsor provides an overview of the technical requirements of the solicitation. Finally, all attendees are invited to anonymously type in questions into the webinar's chat function, which are answered verbally and live by the appropriate presenter from MTEC or the Military. We highly encourage anyone interested in this funding opportunity/RPP to listen in and/or ask questions. The Proposers Conference typically lasts between 1 and 2 hours. Since the 21-04-TiDE has two different focus areas with potentially different audiences, MTEC will host a proposers conference for each focus area. 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. Please register for the MTEC 21-04-TiDE Focus Area #1 Proposers Conference to be held on Monday, December 21, 2020 at 11:30 AM ET at: https://register.gotowebinar.com/register/7682050660446920462 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. Please register for the MTEC 21-04-TiDE Focus Area #2 Proposers Conference to be held on Monday, December 21, 2020 at 3:00 PM ET at: https://attendee.gotowebinar.com/register/9008119957661287691 In addition to the information details above, the original RPP description below has been updated to add the anticipate period of performance for any resultant OTA awards (The anticipated Period of Performance for both FOCUS AREAS is up to 2 years). See section "POTENTIAL FUNDING AVAILABILITY AND POP" below for more details. (End of Amendment 01 to MTEC 21-04-TiDE) ============================================== The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for an Other Transaction Agreement for prototype projects multiple topic area Request for Project Proposals (RPP) focused on the following two focus areas: 1) 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. 2) 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. See the attachment included in this Beta.SAM posting for the full text version of the MTEC Request for Project Proposals (RPP). This RPP can also be located on MTEC's website at: https://www.mtec-sc.org/solicitations/ --------------------------------------------------------------------------------------------------------- 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 (20-10- COVID-19_NETCCN_TATRC, 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. The ultimate objective of a virtual hospital would be to have remote control access to all bedside devices and availability to all data from bedside devices. 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., physiologic 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). FOCUS AREAS OF INTEREST TATRC has identified two focus areas for funding under the TiDE Program. To meet the intent of this 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 may be removed from the preliminary screening stage, determined ineligible for award, and may not receive a full technical evaluation. 1. Focus Area #1 - Accelerating Medical Device Interoperability and Autonomy (MDIA) Add additional hospital-like medical device 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. Refer to the full RPP (attached) for specific technical requirements. 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 Device Interoperability and Autonomy Coordinating Center (DIACC, already separately funded by TATRC) 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 performers to 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, remote control, future autonomy, and regulatory submission and review; Collaborate with other vendors, DIACC, the U.S. Food and Drug Administration (FDA), and Medical Device Plug and Play Interoperability & Cybersecurity Program (MD PnP) on identifying medical device interface data sheets (MDIDS), using existing standards terminology where possible, to provide safe remote control; Collaborate with other vendors on identifying disaster medicine exemplar remote control use cases, NETCCN platform common user interface, and safety assurance cases for remote device control. Offerors shall have a plan to obtain an Emergency Use Authorization (EUA) status from the U.S. Food and Drug Administration (FDA) in a disaster setting where expert resources are diminished and/or not available; Development of materials necessary to adapt interoperability and device control standards and frameworks such as Integrated Clinical Environment (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 - 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). Refer to the full RPP (attached) for specific technical requirements. 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 3 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 Development 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 research projects/activities that seek to understand the challenges and opportunities that technology like the NETCCN have to improve the efficiency, effectiveness and impact outcomes in civilian disaster care and/or military operational medicine. Deliverables may include the development (and submission) of abstracts for publication as appropriate; Task 3 (Required): In partnership with TATRC and NETCCN performers, share research outputs and provide recommendations on disaster medical support system improvements after a disaster response or disaster simulation event, which may be used to later inform and/or refine prototypes currently in use or under development. 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 work completed). Note that any potential follow on work is expected to be awarded non-competitively to resultant project awardees. Such follow-on work may include (but is not limited to) the following: To use the knowledge product(s) generated by this program to inform and/or refine prototypes currently in use or under development for additional or broader civilian use cases; and Activities related to the transition of this work to operational military environments. POTENTIAL FUNDING AVAILABILITY AND POP The U.S. Government (USG) Department of Defense (DoD) currently has available the following approximate funding amounts for this upcoming program: 1. FOCUS AREA #1 - MDIA: $3.304 Million 2. FOCUS AREA #2 - TLA: $2.832 Million Award and funding from the Government of Enhanced White Papers received in response to this RPP is expected to be limited to the funding specified above and is contingent upon the availability of federal funds for this program. Awards resulting from this RPP are expected to be made in Fiscal Year 2021 under the authority of 10 U.S.C. - 2371b. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant awards. It is expected that MTEC will make up to four awards for Focus Area #1 and up to two awards for Focus Area #2 to qualified Offerors to accomplish the statement of work. The anticipated Period of Performance for both FOCUS AREAS is up to 2 years. ACQUISITION STRATEGY This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in this RPP (see Section 8 within the attached RPP document). The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria in Section 5 of this RPP. An Offeror(s) 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. For more information regarding the requirements of the Enhanced White Paper process and template, refer to the attached RPP. You may also access the full version of the RPP by accessing MTEC's website at: https://www.mtec-sc.org/solicitations/ 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. ADMINISTRATIVE INFORMATION Enhanced White Papers are due no later than January 8, 2021 at 12:00pm Eastern Time. MTEC membership is not required for the submission of an Enhanced White Paper in response to this MTEC RPP. However, membership will be required for Offerors recommended for funding in order to be eligible for award. To join MTEC, please visit http://mtec-sc.org/how-to-join/ POINTS OF CONTACT Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at contact@example.gov Technical and membership questions - Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov Administrative questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov