Ensuring suitable quality of clinical measurements through design.

To design and deliver high quality, safe and effective products, manufacturers of in vitro diagnostic (IVD) products follow a structured, traceable process for controlling the uncertainty of results reported from their measurement systems. This process and its results however, are not often shared in detail with those outside of the manufacturing company. The objective of this paper is to facilitate discussion by describing some of the best practices used during the IVD design and development process, highlighting some design challenges manufacturers face, and to offer ideas for how IVD manufacturers and laboratories could work together to drive further improvement to public health.