In the development of a new laboratory test, the design of experiment is important in determining the optimal conditions (of multiple variables) for a test against predetermined specifications. Through proper DOE, the research and development team can control specific input factors (concentrations of reagents, temperature of testing cycles, incubation times, etc.) while also monitoring the uncontrollable input factors (temperature of the lab) to review the outputs/measurements of the test against marketing’s specifications (sensitivity/specificity) for synthetic control samples tested during initial development. Discuss briefly what challenges they may have and how they can go through them?