Essential Questions to Uncover True User Needs in Medical Device Development

Defining user needs early helps keep the design and development of a medical device on track.

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Questions to help clarify user needs

1. What clinical task will the device address?
2. What do you want the device to do for the patient?
3. Who is the primary user? List every potential “end user” and note their experience or ability with similar devices.
4. When will the device be used? What else will the user be doing at that moment, and will conditions vary?
5. In what setting or context will the device be operated?
6. Which procedures or interventions will involve the device?
7. Can the user operate the device alone, or will assistance be required?
8. Will the device be rechargeable, reusable, or disposable?
9. How do its key features differ from those already on the market?
10. Will other devices or accessories interface with it?

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Add further questions as they arise, but answering these ten provides a solid foundation for understanding user needs.

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