Nearly any change to FDA regulated manufacturing processes requires FDA approvals. Because of this, improvement efforts for already validated processes can prove time consuming, costly and risk filled. This in turn can cause pharmaceutical and medical device manufacturers to procrastinate on improvement effort investments aimed at underperforming, approved processes.

What is often overlooked however, is that substantial improvement potential is readily available via an enhanced understanding of how combinations of raw material and processing variable settings impact product and process performance outcomes as they vary within their already approved ranges. Knowledge regarding the millions, billions and more combinations of presently `approved` process settings is at our fingertips, through the use of very large scale, statistically designed experimentation; experimentation where `shippable goods` can perform double duty as `experimental units.`

In this paper, this unique approach is critiqued through its use on an underperforming `implantable medical device` manufacturing process. In this case, the impact of over two million combinations of readily implementable process settings become clarified, resulting in the immediate implementation of the best of them. The newly uncovered combination of refined settings produces an immediate and sustained double digit yield increase, accomplished quickly without the time, costs and risks typically associated with improvement efforts requiring revalidation.