SWIFT ANTIDOTE


to evacuate to a higher echelon of care. Te program team achieved the rapid development and fielding of a 10-milligram (mg) naloxone autoinjector using these novel approaches: Public Law 115-92, which “authorize[s] additional emergency uses for medical products to reduce deaths and severity of injuries” resulting from CBRN exposure, as well as the middle-tier of acquisition pathway and other-transaction authority agreements, both of which provide for rapid prototyping.


A FIRST FOR JPEO-CBRND Industry-average medical development timelines can exceed a decade and cost upward of a billion dollars to mature a product from discovery through Food and Drug Administration (FDA) approval and commercialization. To combat this, the program team spearheaded a $36 million program to deliver a military medical capability using the middle-tier of acquisition pathway,


the first DOD medical program to do so. Te middle-tier path- way is used to fill a capability gap with a technology that has a level of maturity that allows for rapid prototyping within five years of program start. Middle-tier acquisition programs are not subject to conventional Federal Acquisition Regulation; instead, the pathway is intended for prototyping and rapid development and fielding.


For developing the autoinjector capability, the middle-tier acqui- sition pathway was determined to be the most expedient. Tis allowed the use of a draft capability-development document that served as the requirements document for the program and did not require validation from the Joint Requirements Oversight Coun- cil before obtaining approval from the Protection Functional Capability Board. It’s estimated that by using this pathway, the overall acquisition process was accelerated by at least 18 months.


TO THE BATTLEFIELD


A test player prepares to use a naloxone autoinjector during a training exercise in June 2021 at Camp Bullis. The naloxone autoinjector is a rescue treatment that will counteract the adverse effects from exposure to opioids. (Photo by Jose Rodriguez, U.S. Army Medical Center of Excellence)


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Army AL&T Magazine Winter 2023


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