Historically, medical products have been manufactured in batches or lots, with a sample of the devices subjected to destructive, visual or audit testing to evaluate quality.

More recently, however, a paradigm shift has begun to take hold in medical device manufacturing, enabled by advances in measurement and data management technologies. The result is a movement away from end-of-line sample testing and towards the adoption of in-process measurement strategies that ensure product quality in real-time, on a part-by-part basis. This in-process strategy is based on the principle that all manufacturing defects are the result of deviations in one or more process inputs, including variations in component characteristics, process station parameters or environmental factors. Therefore, by collecting and analysing data on all of the critical inputs throughout the manufacturing process, it becomes possible to control and ensure product quality far more effectively than with the traditional approach based on statistically applied sample testing.

Central to this new approach is the introduction of process signature analysis to all critical manufacturing steps. By analyzing the data gathered on all of the relevant process inputs, it is possible to develop a detailed understanding of the underlying physical processes, and how these process variables interact to affect product quality. This approach provides a number of key benefits to both the manufacturer and the consumer, many of which seem almost contradictory in nature: reduced product costs and improved manufacturing efficiency, while simultaneously generating significant improvements in product quality, traceability, and risk mitigation.