The first step is identifying the type of change being requested. It can be to the BOM, Labeling, paperwork, testing procedures, storing procedures, sterilization procedures, disposing procedure, packaging, etc. Depending on the type of change requested the factors to consider will obviously change. some of the changes may come from revised standards, in which case its not a matter of whether to change or not but how to best incorporate the new requirements into the project at hand(if possible or the project may be shut down).
In terms of changes that can affect the patient end, it will never get to that point because any major changes to the approved device need to be reported to the FDA and only after they say that the changes are acceptable can you go through with it. You may even have to start a new project and have a “new” product with a 510k comparing it to your old product if the changes are that huge ie. adding collagen to the tissue part of a bandage would make it a new product even though they are both bandages.
With how severe the repercussions of releasing a faulty product, shut down of all distribution and potential recall within 24 or 48 hours of discovery, any changes that could potentially affect the products reliability will either directly be shot down or go through serious testing.
Depending on the actual content of the change and how that change is related to the project you are working on, the change may be rejected or accepted but assigned as a task to someone outside of the project you are working on as it is outside the scope of the project.