Duration of Development Stages
It is impossible to present a standard benchmark for the amount of time it takes to develop diagnostics products. While the evolution of some products takes more than 10 years, other IVDs fly through development and hit the market in less than three years.

These large variations are present in the data collected for this study, as shown in Figure 2.4 [data figures appear in complete report, but not online]. Total development time from concept to market launch range from Brand 1’s 15 years to Brand 4’s 14 months. The average development time across surveyed companies is slightly more than four years from concept to launch.

IVD development time depends largely on where companies “jump off” with their new products. While some companies’ products are brand new technologies, other diagnostics are conjugations of existing products and technologies. Usually, developing an entirely new diagnostic requires significantly more time than improving on an existing product line. Engineering, regulatory, and marketing hurdles are all lower for IVD conjugations.