RFP - Burn Wound Imaging Technology   4

Background
The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support development of a novel burn wound imaging technology (BWIT). This technology is envisioned as a non-invasive imaging device to rapidly assess the wound size and severity and assist emergency physicians on triage decisions to more specialized burn centers. It would also be designed to provide information useful for clinical decision by burn care specialists on the wound areas in need of interventional treatment to achieve definitive healing. Furthermore, adoption will be expanded through placement of these devices into both initial and definitive burn care settings with end-user training.

Work Details
This RFP focuses on supporting late-stage development leading to the Offeror achieving marketing clearance for a non-invasive burn wound imaging device from the FDA. Critical attributes of the device shall include the capability to provide guidance on estimating size as well as its healing potential (based on characteristics such as depth severity and data driven prognosis). The work includes advanced development work, clinical studies, manufacturing readiness, health economic studies, execution of post-marketing requirements, capability development for manufacturing at commercial scale, additional functionalities of injury/disease condition evaluations, and approval of human and animal protocols.

Period of Performance
The anticipated period of performance is from September 29, 2023, to September 24, 2030.

Place of Performance
The geographic locations where the contract will be performed are not explicitly provided in the solicitation.