The Advanced Medical Monitor Request for Information (RFI) seeks industry input for the Next Generation Medical Monitor (NGMM) and the Expeditionary Medical Monitor (EMM). The document outlines the response format for interested companies, which includes sections for company information, anticipated bidding intentions, and requests for clarification on the RFI content. Companies are prompted to provide insights on existing FDA-approved products and their intellectual property rights, as well as their capabilities concerning government contracts. Key areas for potential bidders include clarification of specific references within the document, the timeline for FDA approval, and any access issues related to embedded links in the RFI. The form also allows for additional feedback about company qualifications and expertise to align responses with the federal objectives. This RFI serves as a foundational step in gathering information to inform future procurement strategies for advanced medical monitoring technologies as part of government operations and initiatives.

The Defense Health Agency (DHA) has released the Medical Device and Equipment Risk Assessment (MDERA) Version 6 to ensure compliance with cybersecurity standards set by the United States Federal Government and Department of Defense. Vendors are required to complete a comprehensive questionnaire detailing the technical characteristics, security posture, and compliance of medical devices being offered for procurement. The submissions will be evaluated to support the Risk Management Framework (RMF) Authorization process. Key elements of the assessment include system identification, data processing capabilities, software, and hardware specifications, and network configurations. Vendors must provide information regarding data security measures, vulnerability management, and the adherence to standards such as NIST. The assessment will help determine necessary cybersecurity efforts prior to RMF assessments. Failure to report accurate information may result in exclusion from procurement opportunities or contract breaches. This document is vital for maintaining the security and integrity of medical systems within the DHA framework while addressing the risks associated with medical devices in healthcare settings.

The document outlines the specifications for the Advanced Medical Monitor (AMM) systems, aimed at providing non-invasive physiological monitoring in military medical care from the Point of Injury (POI) through comprehensive hospital treatment. It details critical and desired performance parameters essential for the Next Generation Medical Monitor (NGMM) and Expeditionary Medical Monitor (EMM) devices. Key critical parameters include FDA approval, net readiness, and airworthiness, while desired characteristics encompass compatibility, exportability, and open architecture. The NGMM parameters include monitoring physiological metrics such as heart rate and blood pressure and stipulate compliance with cyber survivability standards. Desired NGMM traits focus on compatibility with electronic health records, decision support for medical conditions, and the ability to monitor multiple patients. For the EMM, critical specifications involve measuring vital signs, whereas desired features include device interoperability, monitoring capabilities for up to 20 patients, and extended data storage. Overall, this document serves as a guiding framework for RFPs relating to military medical technology, ensuring developed devices enhance patient care through advanced monitoring capabilities in various combat conditions.

The Advanced Medical Monitor (AMM) project aims to develop a Family of Systems (FoS) comprising next-generation and expeditionary medical monitors (NGMM and EMM) supporting non-invasive patient monitoring for military medical providers. The Defense Health Agency (DHA) seeks devices that enhance situational awareness, data-sharing during patient transfer, and mitigate cognitive overload in decision-making. The development unfolds in two phases: Phase I focuses on prototyping, environmental testing, and FDA submission planning, while Phase II aims for full-scale development, including regulatory approval and manufacturing readiness. Success is critical as future combat operations may generate unprecedented casualty rates, necessitating advanced monitoring to detect life-threatening conditions like occult hemorrhage. Deliverables include device prototypes, user manuals, cybersecurity compliance reports, and training materials. The project emphasizes compliance with FDA regulations, cybersecurity standards, and logistical support for effective field operations. The anticipated timeline for completion spans from September 2025 to June 2029, reflecting the importance of ensuring safe and effective medical support in all operational environments.

The document outlines a Request for Information (RFI) from the U.S. Army Medical Research Acquisition Activity (USAMRAA) focused on the development of an Advanced Medical Monitor (AMM). This RFI, issued on March 6, 2025, seeks market insights to enhance medical monitoring capabilities for future large-scale combat operations, addressing the anticipated increase in casualties and the complexity of injuries in the field. The AMM aims to provide real-time vital sign data and decision support to improve triage, treatment, and evacuation priorities, thereby facilitating better patient outcomes in combat zones. The system is envisioned to support noninvasive monitoring and integration with existing medical record systems. Respondents are invited to submit detailed information showcasing their capabilities, ensuring compliance with submission guidelines, including formatting and content specifications. The RFI emphasizes that it does not constitute a solicitation for proposals or contracts, but invites a comprehensive understanding of potential solutions for advanced medical monitoring in military medicine. The document highlights confidentiality expectations for proprietary information and outlines submission deadlines and requirements.