When a project reaches clinical trials, I can imagine the morale of the project team being very high as they have created a working device that was proven to work and sent off for “testing”. Sometimes, as Dr. Simon mentioned, even when a device is in clinical trials, change requests must be issued.

How would the project team approach a DCR during the clinical trial as opposed to during the design process? What sort of changes can you expect and have any of you ever dealt such changes? Finally, how would a project team cope with changes that are implemented well in the product’s development?