Stage 1

 

Identifying a need for a new or improved device

Medical device development is extremely expensive.Therefore it is essential to carry out the necessary pre-development work, before the process begins to ensure that the correct device is developed, i.e. a device that will provide a useful function to individual users, patients or healthcare professionals.

The aim of user requirements research at this stage is to establish first of all whether there is a need for a device. This need may be in terms of improved patient care, making a task quicker, easier, more-cost effective or safer, or replacing an existing device that is performing unsatisfactorily or sub-optimally.

This work will normally be small-scale involving a relatively small number of users. This stage may vary according to how focused it is: when identifying ideas for an entirely new product (sometimes called horizon scanning) then the research should be open-ended in nature. This may involve studying:

  • An entire work environment including multiple users (e.g. an operating theatre)
  • The working pattern of particular clinicians (e.g. shadowing particular groups throughout their working day)
  • The experiences of a particular patient group as they progress through the healthcare system.

If some information is already known about the potential device then a more focused study may be appropriate. For example, a surgeon may have reported a problem with a particular procedure and identified a need for a device to solve it. In this case a detailed study of that procedure would be required, ideally including a range of different users.

A variety of different research methods can be used during this stage of development (figure 1). For example, ethnography may be used for scoping, open-ended research, task analysis and usability tests for more focused study, whereas contextual inquiry and focus groups may be used in both types of study (see glossary for a discussion of these research methods). As with all user requirements research, ideally more than one method should be used in order to gather different types of data. For example, an observational technique such as contextual inquiry may identify a number of issues which can then be investigated further, validated and refined by a discussion method such as a focus group.

The intended outcome of user requirements research at this stage is to identify an area which is currently problematic and where a new or improved device could make a positive contribution to the healthcare system. For example, a clinical procedure that is currently very time-consuming or has been identified as a high-risk with potential impacts on patient safety.

Appropriate Methods:

Methods that are particularly useful for identifying areas where a new device could benefit users include:

  • Focus groups
  • Ethnography
  • Contextual Inquiry
  • Task Analysis
  • Surveys
  • Interviews

The choice of which method(s) to use when examining an area for an un-met or ill-met need will depend mainly on whether you would like the users to report their opinions, experiences and needs (Focus groups, surveys, interviews), or whether you would like to observe the task or procedure yourself (ethnography, task analysis). Contextual inquiry is a method that tries to combine the two approaches; the researcher observes the user and prompts them to describe what they are doing, why they’re doing it and the problems that they encounter (see the glossary for a description of these methods).

Example: Identifying a Need for New or Improved Device: An Example of Good Practice