Analytical Framework for Examining the Value of Antibacterial Products. 5.1.5 Phase Durations


There are no published studies that provide estimates of time to market for rapid POC diagnostics.  Based on discussions with industry experts, the time it takes to bring a new rapid POC diagnostic to market could range from 2 to 3 years if the diagnostic does not require the development of a new platform to around 5 years if a new platform is necessary along with the test.  For the model, we assume that it takes 4 years to get to the point of submitting a 510(k) application to FDA, with 2 years spent on R&D and the remaining two years on clinical research.  Further, we estimate that it takes 143 days (i.e., 0.39 year) for a complete review of the submitted application based on FDA data (U.S. Food and Drug Administration, 2012).

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