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On-Site Creation of Dialysate Fluid

Description:

TECHNOLOGY AREA(S): Bio Medical

OBJECTIVE: The objective of this Small Business Innovation Research topic is to develop a technology that can create dialysate fluid on-site using potable water, non-potable water, and salt water without a source of electrical power that weighs less than 1lb. and is FDA approved for its intended purpose.

DESCRIPTION: It is anticipated that future battlefield environments will have prolonged care scenarios in which critically injured patients will not be evacuated out of theater for extended periods of time, up to and beyond 72 hours.Based on these evacuation times, it is anticipated that patients will arrive at Field Hospitals in critical condition, leading to increased rates of acute kidney injury (AKI) ~19-40% of patients arriving to the Field Hospital, similar to those seen in civilian hospital emergency rooms1-2.Current technologies that provide support for AKI require large amounts of dialysate fluid to function, ~75L of fluid per patient per day.Shipping this amount of fluid into the battlefield environment is not logistically feasible in future battlefields that will be conducted using Multi-Domain Operations (MDO).Therefore, the DoD is seeking new and innovative technologies that are able to create dialysate fluid on the battlefield that don’t require power, are lightweight, and are rugged enough to withstand military environments.The technology should be able to create the dialysate fluid from any source of available water including, but not limited to potable, non-potable, and salt water.

PHASE I: The contractor should provide basic proof of concept that their selected technology has the ability to create dialysate fluid for use in extracorporeal life support of the kidneys.The basic principle that is demonstrated should be expandable for use with different water types with no or minimal modifications to the process.The technology should function without electrical power.Design drawings for the fully functional prototype device should be completed by the end of this phase.

PHASE II: :The contractor should develop and demonstrate their technology showing that it can create dialysate fluid for use in extracorporeal life support of the kidneys.The technology should function without electrical power and be able to use any source of available water to create the dialysate fluid, including, but not limited to potable water, non-potable water, and salt water.The contractor should then validate that the created dialysate fluid meets US standards for dialysate3.Finally, the contractor should conduct a Pre-Submission meeting with the FDA to validate their regulatory strategy and testing of the technology aligns with FDA requirements.Deliverables include 5 prototypes, validation test reports, the contractor’s proposed regulatory strategy, FDA pre-submission meeting minutes providing feedback on the contractor’s proposed regulatory strategy, and a technology commercialization strategy.

PHASE III: The contractor should refine and implement their regulatory strategy for obtaining FDA approval of their technology for use as dialysate fluid based off of their initial FDA feedback.This phase should culminate in submission to the FDA of the developed technology for approval.In conjunction with FDA submission, the contractor should develop scaled up manufacturing of the technology that follows FDA quality regulations.Work may result in technology transition to an Acquisition Program managed by the Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO) and/or commercialization of this technology capability. Contractor shall seek additional funding from other government sources and/or private sector investors to develop or transition the prototype into a viable product for sale to the military and private sector markets.The ability to create dialysate fluid on the battlefield will remove the logistical constraint for providing kidney support to critically injured soldiers on the battlefield, allowing kidney support to be provided in theater.This type of technology may also be of interest to large-scale dialysate manufacturing companies for further partnership and commercialization.

KEYWORDS: Dialysate, Kidney, Extracorporeal, Life Support, Renal Replacement Therapy, Fluid

References:

1. Haines et al. (2018). Acute Kidney Injury in Trauma Patients Admitted to Critical Care: Development and Validation of a Diagnostic Prediction Model. Nature Scientific Reports (8:3665) 1-9.;2. De Abreu et al. (2010). Acute Kidney Injury After Trauma: Prevalence, Clinical Characteristics, and RIFLE Classification. IJCCM, 14(3). 121-128.; 3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KPO

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