Design of Experiments is a structured approach todetermining the relationship between different factors (or inputs) in a processand the output (or response) of interest. In simpler terms, it’s a systematicway to find out what really matters in a production process by testing variousconditions in a controlled, efficient manner. By doing so, we can identifywhich factors have the most significant impact on the final product quality andthen optimize those factors to achieve the best possible results.
In the context of medical device manufacturing—whereprecision, consistency, and compliance with industry standards areparamount—DOE becomes especially valuable. Let’s break down an examplescenario: