If we talk about planning phase in a project of medical devices, according to me one of the important aspect is to find out user needs. Sometimes user needs are bit vague and ambigious but that is considerable. In planning phase some points that are needed to look are who is going to use that device, how will the user interact with that product, the clinical procedures involved, the environment where it will be used in, and other products that is going to interface with medical device.

So what other measures are important and how would this help?