User’s needs is indeed an important topic to be discussed in the planning phase of a medical device project. A question that should be answered is: what questions should be considered when talking about user’s needs? I will list three main questions. The first one is who will use the medical device? The next one is how will users/patients interact with the product? The third is what kind of clinical procedures are involved? These are some questions that should be asked to determine user’s needs. Once the user’s needs has been finalized, the next step would be design input which is followed by design process. Then design output which will lead back to verification of the design input. And finally you have the medical device and the validation process.