Notice ID: HT9425-23-R-0065
Description
The mission of the U.S. Army Medical Research and Development Command (USAMRDC) is to “Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter.” Accordingly, it is the mission of the U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO) to acquire Ultrasound Field Portable (USFP) systems.
SCOPE – The Government intends to procure a USFP system, potentially refine it to remove all network capabilities, field test it, down select to one (1) USFP system, conduct risk management framework (RMF) assessment(s)/evaluation(s), which may require further modification to ensure any cybersecurity risks are identified and mitigated, and then purchase a limited quantity for initial operational capability (IOC).
The objective ultrasound system is at a TRL 7 final prototype without the ability to connect to any networks. The threshold ultrasound system is at a TRL 6 with network capabilities, which may require the Performer to modify their current system to maintain functionality without connectivity to any network or cloud domain, to achieve the objective of TRL 7, which may also require notification to the FDA. Development efforts (if needed) shall ONLY BE FOR development of a TRL 6 device that has network connectivity to get it to a TRL 7 (final prototype) device that does not have the ability to connect to networks. NO OTHER DEVELOMENT EFFORTS WILL BE PREMITTED. NOTE: The Performer shall remain the FDA Sponsor for this effort.
The final USFP system shall be handheld, easily transportable (including transducer(s) and viewing platform), reliable, has minimal power requirements, and has no network connectivity (i.e. ability to function and perform software updates without connectivity to any network and cloud domain), with all required accessories. The handheld portable USFP system shall meet field environmental and operational testing conditions and provide imaging quality sufficient for diagnosis in the Focused Assessment with Sonography in Trauma (FAST), Extended FAST (eFAST) and Musculoskeletal Injury (MSKI) exams. The USFP shall enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult patients.
