Medical devices are justifiably highly regulated. Whether the device must comply with FDA regulations or the newer EUMDR requirements, everything from the original design to production must be planned, validated and controlled to ensure that a device that is implanted in the patient is exactly what was designed. In some cases, this thorough regulatory oversight can seem restrictive because, by design, it limits the ability to adjust and improve a process mid-lifecycle. However, the consequences of making a well-meaning, but poorly thought-through change can be serious. In this case study, we discuss not only the consequences of such an action, but also the analytical methods used to determine the root-cause and source of the device failures.