Based on what we have learned so far, one could say that the execution process is rather one of the more simpler phases of the design cycle (assuming one has a competent project team). This is the phase where all the planning has already been done, the standard operating procedures have already been written and just need to be carried out. This can definitely be difficult if a project team is working with a high-end Class III device where not much is known going in (in which case the difficulty of the planning phase will still likely outweigh that of the execution phase). The real challenge of avoiding any delays during execution is ensuring that management has direct exposure to the activities that make up the execution phase to give them a sense of what is feasible and what isn’t. Allowing management to dictate the planning and execution phase without such knowledge can result in an impractical time expectancy for testing/experimentation. The more mistakes that are made early on in the design process, the more of a chance they will propagate later on, thereby increasing the project’s risk and diminishing its quality.

A primary aspect of the execution phase is ensuring that everything runs smoothly, which is highlighted by maintaining team development and vendor/supplier connections. Team development requires keeping track with individual matters such as team member absences, vacations, relocation, terminations, etc. Establishing and maintaining vendor relations involves soliciting quotes and prices for the supplies needed, carrying out an audit of the vendor’s facility, and keeping track of contract duration to prevent preemptive expiration. Is emotional intelligence used more in the execution phase than the other phases since communication and interpersonal relations seem vital? How do departments such as regulatory, manufacturing, and R&D operate differently when transitioning into or away from the execution phase? Which departments regulate handling changes in protocol during execution?