Pre-Announcement: "Advanced Medical Monitor"

Purpose

The Medical Technology Enterprise Consortium (MTEC), in support of the Defense Health Agency (DHA) Operational Medical Systems (OPMED), is excited to announce this upcoming Request for Project Proposals (RPP) focused on developing Advanced Medical Monitor (AMM) Family of systems (FoS) components, including the Next Generation Medical Monitor (NGMM) and the Expeditionary Medical Monitor (EMM), which continuously track vital signs and other relevant data. Both devices must be designed for expeditionary medical use and easy to maintain. The desired prototypes, by their final design, will need to be capable of advanced noninvasive physiological monitoring to provide actional information for enhanced military patient triage, to reduce cognitive workload, to inform treatment and evacuation priorities, as well as monitor vital signs of patients under medical care.

Funding Availability: The U.S. Government (USG) currently has up to $13.07 million (M) in current and planned funding for initial PoP of this effort, for direct and indirect costs.

Number of anticipated awards: The government anticipates making multiple awards for the NGMM and multiple awards for the EMM to qualified Offerors to accomplish the scope of work. These awards are expected to total between $3M and $4M each.

Period of performance: The PoP for the initial scope of work is not to exceed 24 months, with shorter timelines being preferred.

To view the full-length version of this Pre-Announcement, please download using the link on this page.

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BACKGROUND: In contrast to recent Counter Insurgency Operations, future Large-Scale Combat Operations are expected to generate casualties in numbers not seen since World War II. The ratio of medical provider to casualty is expected to present a significant challenge. It is anticipated that many patients will present with occult injuries which are not readily apparent to medical providers, such as internal hemorrhage or other injuries or illnesses. Regardless of severity, all patients must be triaged. The use of AMM will give medical providers the information needed both to support triage decision-making and to inform treatment, evacuation, and return-to-duty decisions.

Reliable medical monitoring as close to the Point of Injury as possible and continuing through all Roles of Care would enable medical providers to intervene early and allow for longer-term trend analysis to inform and improve upon the patient treatment and intervention. The current fielded equipment provides little to no diagnostic or decision support capability in far-forward settings.

Scope of Work

FOCUS AREA #1 - Next Generation Medical Monitor (NGMM)

The following are required characteristics for an ideal solution to this focus area. Offerors should note that additional required characteristics are described below.

• Device must be appropriate for use at Role of Care 2, Role of Care 3, and during en route care.
• Device must be capable of capturing robust vital sign information.
• Device must be capable of displaying information from other NGMM devices, EMM devices, or other sensors, either on the proposed NGMM or a centralized display.
• Device should support manual defibrillation (either through integrated capability or separate attachment).
• Device weight, including defibrillation, must not exceed 14 lbs.

FOCUS AREA #2 - Expeditionary Medical Monitor (EMM)

The following are required characteristics for an ideal solution to this focus area. Offerors should note that additional required characteristics are described below.

• Device must be appropriate for use at Point of Injury, Role of Care 1, and during en route care.
• Device should be a sensor with display, sensor paired to an End User Device (e.g., smartphone, tablet, etc.) for display, or other novel solution.
• Device must be able to noninvasively gather basic vital sign data.
• Primary vital sign data collection sites must be from the patient’s head, neck, and torso.
• Device must be capable of monitoring multiple patients via multiple EMM placed on patients connected to a central end-user device display.
• Device size, including battery, must not exceed 25 cubic inches, with no single device dimension exceeding 12 inches.

Additional requirements for both focus areas (NGMM & EMM)

The following requirements elaborate on additional ideal characteristics for both NGMM and EMM solutions. These requirements are in addition to and cumulative with the above, focus area-specific requirements. Offerors are expected to propose strategies for meeting all requirements during initial or future periods of performance.

• Provide advanced decision support to include ability to provide early indication of patient decompensation. Hemorrhage decompensation prediction should be highest priority, but alerts for other life-threatening events also add value.
• Transferring patient data via interface with Joint Operational Medical Information System (JOMIS) Healthcare Delivery tools.
• Devices must meet MIL-STD-810 standards for vibration, temperature, humidity, altitude, and shock, as well as Ingress Protection rating IP65 dust and water compliant.
• Devices must capture, retain, and transfer vital sign data to be displayed locally and/or on separate End User Device.
• Devices must include a modular open system architecture (MOSA) and be designed for interoperability. Devices should be capable of interfacing with external decision support tools and be able to communicate to and from the military electronic health record systems.
• Devices must support the ability to simultaneously monitor multiple patients via a centralized end-user display. Battlefield Assisted Trauma Distributed Observation Kit-Joint (BATDOK-J) and Operational Medicine Care Delivery Platform (OpMed CDP) software tools may be leveraged as a display functionality.
• Devices must be able to toggle any wireless communications/connectivity and remain capable of storing data and maintaining minimum critical functions, while not connected, to be updated once connectivity is reestablished.
• Solutions must be capable of using new/updated Decision Support algorithm(s) as they become available and are installed.
• Solutions must have user agnostic accessibility (i.e. no individual user log-in credentials required).
• AMM FoS devices must be reliable in all climates (including extreme temperatures and weather conditions) and in all operating environments.

Additionally, proposed solutions are expected to achieve Food and Drug Administration (FDA) clearance or approval, as appropriate, with indications for use in trauma environments on military populations. Offerors are encouraged to indicate their FDA strategy and reasoning within their proposal. While FDA clearance/approval is not required within the initial period of performance (PoP), the Government may make a down-select decision based upon successful performance and award additional tasks to progress effort(s) towards FDA clearance/approval and achieving program parameters.

Potential Funding Availability and Period of Performance:

The U.S. Government (USG) currently has up to $13.07 million (M) in current and planned funding for initial PoP of this effort, for direct and indirect costs. Dependent on the results and deliverables under any resultant award(s), the USG may, non-competitively, award additional dollars and/or allow for additional time for scope increases and/or follow-on efforts with appropriate modification of the award.

The government anticipates making multiple awards for the NGMM and multiple awards for the EMM to qualified Offerors to accomplish the scope of work. These awards are expected to total between $3M and $4M each.

The PoP for the initial scope of work is not to exceed 24 months, with shorter timelines being preferred.

Points of Contact

For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Chief Science Officer, lauren.palestrini@mtec-sc.org.