Manufacturability of lab on a chip devices: tolerance analysis and requirements establishment

Abstract

Decisions made during the first stages of the design process can have an impact on the cost, quality and performance of a product. Variation in assemblies, if not managed correctly during the design stage, can have a negative impact on the success of the product. This work analyzes the Daktari CD4+ Cell Counter System's capability of meeting its requirements. A Variation Simulation Model was employed to anticipate any failure modes caused by manufacturing variation and to test the robustness of the design. The design was shown to be largely successful in its ability to deliver function but unexpected failure mechanisms were found. Design considerations in the system KCs were suggested in order to minimize the effect of variation and reduce the risk of failure.