The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a 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.
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.
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
- 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 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 –
- 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.
- 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 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.
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 of this RPP). 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.
Enhanced White Papers are due no later than January 8, 2021 at 12:00pm Eastern Time. The RPP is posted to the MTEC website (mtec-sc.org) and a notice is posted on www.beta.SAM.gov to notify interested parties. 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/
URL for more information:
Filed Under: Funding Opportunities