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

04/15/2014

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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