B01-25-P-009928 AMM RFI-KO Review.docx

REQUEST FOR INFORMATION

ADVANCED MEDICAL MONITOR (AMM) DEVELOPMENT EFFORTS

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS

(RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

Disclaimer: The purpose of this RFI notice is to gain market knowledge. This notice does not obligate the Government to award a contract/order or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a re-solicitation synopsis and solicitation may be published in System for Award Management (SAM.gov), at a future date and time. However, responses to this notice will not be considered adequate responses to a solicitation.

1. RFI Number: HT9425-25-01-RFIJMC

2. RFI Issuing Office: United States Army Medical Research Acquisition Activity (USAMRAA)

3. RFI Issue Date: 6 March 2025

4. RFI Title: ADVANCED MEDICAL MONOITOR (AMM) DEVELOPMENTAL EFFORTS

5. Agency: U.S. Army Medical Materiel Development Activity (USAMMDA)

6. Office: Defense Health Agency (DHA) Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO)

7. Location: Frederick, MD located at Fort Detrick

8. Contract Type: Unknown

9 Synopsis: In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of the Defense Health Agency (DHA) Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO), or collaborative Department of Defense (DoD) activities.

This RFI is for information and planning purposes only and is neither to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents are solely responsible for all expenses associated with responding to this RFI. No evaluation letters and/or results will be issued to the respondents. Currently, no solicitation exists; therefore, lease do not request a co of the solicitation. NO PHONE CALLS PLEASE.

Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

10. Background: In contrast to recent Counter Insurgency (COIN) Operations, future Large-Scale Combat Operations (LSCO) conducted during Joint All Domain Operations (JADO) will generate casualties in numbers not seen since World War II. Medical provider to casualty ratios will become a significant challenge. Many of the casualties will present with occult injuries that cause internal hemorrhage or other injury or illness, which are not readily apparent to medical providers at the point of injury (POI) and throughout the roles of care. Regardless of severity, all casualties must be triaged. The AMM will give medical providers the information needed both to support triage decision-making and to inform treatment decisions.

· Injury or illness may result in urgency of immediate intervention, and adverse consequences if not readily recognized at the POI. Currently fielded equipment provides little to no diagnostic or decision support capability in far forward settings. To address this, the AMM project aims to field decision support capability as far forward as POI.

· As an example, uncontrolled occult hemorrhage would lead to rapid circulatory collapse which is invariably fatal if not immediately treated. Additionally, casualties might present with signs and symptoms that suggest potential occult hemorrhage when in fact this condition is not present. A predictive indication of presence or absence of occult hemorrhage will be a valuable tool for triage support, including both prioritization of the most critically wounded and support for return-to-duty decisions. Hemorrhage detection is a threshold-level decision support capability for AMM, for both the Next Generation Medical monitor (NGMM) and the EMM devices.

· Vital Signs (VS) data for all patients is important to medical treatment decision-making and important to retain as part of patients’ electronic health records (EHRs). AMM will provide potential to retain digital records of patient VS beginning at first response, thereby providing a comprehensive account of clinically relevant data as the patient progresses through the care continuum.

· Noninvasive medical monitoring capability to determine priorities for increased levels of care or evacuation will reduce decision overload on medical responders and improve macro level survivability.

· Evacuation to and treatment by a Role 2 facility with a surgical capability or to a Role 3 facility that has both a surgical and Computed Tomography (CT) capability will be enhanced by AMM’s generating and flagging key mortality indicators.

· Additionally, the AMM will seek to combine functionality of currently deployed monitors, as well as potentially adding capability to monitor more than one patient on a single device, thus allowing for optimization of the total number of medical monitors required at a given site.

The envisioned AMM capability is for use from POI to Role 3, including en route care.

11. Objective and Purpose/Scope AMM Capability Description

· Advanced physiological monitoring solutions will provide actionable information to enhance casualty triage, informing treatment and evacuation priorities, as well as monitoring vital signs of patients receiving medical care. Family of Systems (FoS) components will facilitate transfer of patient data through Roles of Care. The solutions could include individual sensors, monitors and/or decision support algorithms.

· FoS components: Next Generation Medical Monitor (NGMM), Expeditionary Medical Monitor (EMM)

· FDA approval required

NGMM

· Form factor similar to existing bedside monitors

· Interfaces with EMM, electronic health record (EHR) and other systems – via Battlefield Assisted Trauma Distributed Observation Kit (BATDOK) / Joint Operational Medicine Information Systems (JOMIS) / Operational Medicine Data Service (OMDS)

EMM

· Sensors/vital signs detectors in a wearable form factor

· May “mine data” from other sources, but still need end items for medics to use

· Interfaces with EMM, electronic health record (EHR) and other systems – via BATDOK / JOMIS / OMDS

12. North American Industry Classification System (NAICS) Code: 334510-Electromedical and Electrotherapeutic Apparatus Manufacturing

13. RFI Attachments: The following documents are attached to the RFI

14. Response Due Date: Interested parties shall submit the RFI response electronically by 100 pm Eastern 21 March 2025 via e-mail to:

Jeanette Collins Jeanette.m.collins4.civ@health.mil

Email subject/title: “RFI response for Advanced Medical Monitoring (AMM) Developmental Efforts”

15. SUBMISSION INSTRUCTIONS:

15.1 The Government appreciates responses from ALL capable and qualified sources.

15.2 Interested firms should submit a response that demonstrates the Respondent's ability to perform the scope of work identified in this RFI.

15.3 Format specifications include Arial 12-point font, single spaced, single sided, 8.5 by 11- inch paper with 1-inch margins. All submissions shall be made electronically (as described above) and be in one of the following formats: Microsoft Word or searchable Adobe PDF

Responses should adhere to the following formatting and outline instructions:

Cover Page (1 page)

· Title

· Organization

· Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

· Topic area: "ADVANCED MEDICAL MONITORING (AMM) DEVELOPMENTAL EFFORTS”

15.4 Completed Attachment 1 and Attachment 2. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in Attachment 2.

16.0 Confidentiality: All 'Proprietary', 'Classified', 'Confidential', or 'Sensitive' information shall be marked as such and will be treated accordingly. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

(End of RFI)