User needs are the lifeblood of product development. Why? User needs help to define design inputs (what your product should be from a technical perspective), which leads down to your design outputs and verification. They also set the stage for validation activities towards the end of your project by defining what the product should do to in the user's hands. By having a clear understanding of user needs, developers can design devices that are not only effective but also user-friendly and intuitive. This ultimately leads to improved patient outcomes and satisfaction.

When determining user needs, it is important to consider factors such as the environment in which the device will be used, the demographics of the intended users, the expertise and perspective of end users, the desired clinical process and outcome, and any specific challenges or limitations users may face. This user-centered approach helps to create devices that address real-world problems and improve the overall quality of care, not just focusing on fancy new technology.