This section identifies the key design decisions to be made during the process of planning a user requirements study at any point in the development of a medical device. Working through the following list of questions can also help (a checklist of these questions can be found on page 39).


1. WHAT do we want to find out?


2. WHY do we want to know this information? e.g.

  • To identify an unmet need
  • To find out whether there is a need for the proposed device (and if so, what that need is)?
  • To identify the target users and/or patients of the proposed device
  • To evaluate a prototype device and feedback to the designers
  • To demonstrate the value of a device to purchasers (different purchasers will require different types of information and may require that the research is done independently.
  • To feed into a health economic model
  • For marketing purposes


3. WHO are the best people to provide this information?

  • If they are not available then who are the next best?
  • Are there any patient or professional groups that could collaborate in this study?
  • Is any of this information available already (e.g. from within the NHS, from published literature or from anthropometric/ergonomic guidelines).


4. WHEN is the information needed?

  • If the next step of development has to begin in 12 months then it will not be possible to conduct the research in the NHS.


5. HOW much money is available to conduct this research?


6. WHERE should the research be performed?

  • Does it have to be performed in the clinical environment?
  • Or outside, in the community, a simulated environment, over the internet.


7. HOW?

  • The answers to the above questions can then be used to pick the most appropriate methods and users.


Decide Aims of Study                                 Identify Users                              Ethical Approval