At Sloan we outsource the development so when we set up a Project plan we include a scope that clearly defines the deliverables, goals, and deadlines. Since it can be very expensive to develop a medical device we usually break it down into Phases (Phase 0, Phase Ia, Phase Ib, etc). Phase 0 is the planning phase where the scope is laid out for example the company will come up with various designs of the device and then Phase Ia will work with moving forward with the scope of only focusing on one design to move forward into a functional prototype for a clinical trial. So the Scope really lays out what deliverables are expected (which design will move forward) and the corresponding timeline with milestones/deadlines. The scope of the project is definitely important if you’re working with an external company you’re paying because if you decide to go with another design or to add other things that were not originally contemplated with the signed off plan (scope), the company will consider that to be out of the scope of the project and that means it will cost you, literally. So defining the scope is very important, because you don’t want to have to go back to the higher-level stakeholders to ask for more money.