What this guide contains

This guide will help you to understand the issues involved in studying user needs, what factors to consider when designing studies to capture user requirements and how to interpret the results of these studies.

Who should read it?

This guide is aimed at anyone who is involved with medical device development including designers, developers and marketing personnel. It is likely that you will be familiar with at least some of the concepts that are discussed in this guide, however the glossary provides a definition of the terms in bold.

When you have read this guide you should be able to:

  • Identify the issues relevant to your specific device.
  • Plan a user requirements study.
  • Make decisions on which users to include and which methods to use.
  • Make decisions on what compromises may be necessary. A trade-off will usually have to be made between the benefits of extra user needs work and the time and resources available.
  • Complete ethical and R&D Applications.
  • Collect necessary data to meet usability regulations and standards.

What it does not do

This guide does not provide prescriptive guidance on how to evaluate specific devices. Rather, it provides generic advice that is applicable to a wide range of medical devices and which developers can customise to fit their particular device.