Once you get a new medical device project, the first two things you should do is find out what the user needs are and establish a design plan. When going about user needs, what kind of questions do you ask to determine what the user needs are based on your experience in industry or academic settings? Also, how has your company/research institute established a design plan as it is more than just a project schedule.

In the company I work for, some considerations we look into include how the device will be used by patients, implanted by the physician, budget, other devices that may interfere with our given device, and regulations the device must go through. Then we develop the design plan with a high level schedule that also includes roles and responsibilities. Each role has varying schedules but all of them come together to meet the high level schedule. Throughout the process of developing the device, we also have routine design reviews to make sure things are on track and if not, how to get back on track. Once the device is developed, we go back to the user needs to confirm whether or not they are met.