What to Ask in Order to Define the User Needs for a Medical Device?

Defining your user needs is crucial to get on the right track before diving into design and development of your medical device. So...

What are the questions you can use to help define the user needs?
  1. What is the clinical job to be done your device is going to solve?
  2. What do you want the device to do in the customer?
  3. Which is the user persona for the device? Remember to consider all persons who could be an “enduser” and their level of ability or savvy with the device.
  4. When the customer is going to use the device? What are the activities the customer will be doing around that time? Will it be under certain circumstances, or all of the time?
  5. Under what context will the device be used?
  6. What types of procedures will the device be used for?
  7. Can the user interact directly with the device or needs help/support?
  8. Will the device chargeable or disposable?
  9. How are your features of your device different from what is already in the market?
  10. Other devices or products that will interact with the device?

Of course, the more questions you add, the better. At least, you should cover these 10 questions in order to have a better idea of the needs of your user regarding their medical device.