User Needs

What are User Needs (UN)?

User Needs in medical device development are the critical capabilities or deliverables that a medical device provides to its users.

Tips on Writing User Needs (UN):

It requires deep thinking to properly capture User Needs. Word choice and sentence structure are very impactful. Below are four actionable steps to help you make progress in the right direction.

Use the perspective of the user: Formulate UNs from the perspective of the end user. A good sentence structure is “The <user> needs to accomplish <something specific> with the <device>”. At the same time, consider how the team will validate that the final product meets every UN.

Don’t confuse User Needs with Design Input Requirements: Design Input Requirements (DIR) are derivatives of User Needs; they define the capabilities the device needs to have to deliver the UNs. For example, DIRs can look like this: “The <device> shall deliver <functionality>”.

Establishing Preliminary UNs early helps: Early in the project, it is helpful to document the key UNs so all involved parties can review and optimize them to create common understanding and a focused target for the product deliverables.

UNs should be kept evergreen: As the development of a new product progresses, the UNs should be revisited to improve and re-confirm they are appropriate.

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