Improving Device Human Factors Through Focus Groups

When designing medical devices it is important to identify use-related hazards as early in development as possible so that mitigations can be developed into user interface requirements, incorporated into the design, and then tested for effectiveness. The recently released draft FDA guidance entitled Applying Human Factors and Usability Engineering to Optimize Medical Device Design describes several examples of analytical approaches to hazard identification. The use of focus groups, one of the more popular approaches, is worth a closer look. When they are conducted early in development and centered on developing use scenarios and investigating foreseeable misuse, these meetings can be a useful forum for risk identification.

Focus groups are a common method for gathering input from users (usually industry experts) by medical device marketing and engineering design teams, particularly during early stages of development. Typically these groups meet and discuss the desired workflow for the device, which translates nicely into marketing requirements. Often these discussions center on business objectives, such as desired features or functional preferences based on this workflow.

Project stakeholders can use this forum to strengthen their device human factors by exploring use scenarios that could pose use-related safety risks. These discussions may be conducted using concepts or early prototypes. Once the risks are identified, corresponding mitigations can also be identified and included in design iterations earlier in the process when there is less impact to project schedules. An added bonus is the opportunity to evaluate the effectiveness of those mitigations sooner through formative evaluations, rather than waiting until Stage IV validation when it would be much more difficult and costly to change the design. Representative users who are members of the focus group may be ideal participants in these early evaluations.

One of the strengths of focus groups is their interactive nature. Participants may come from various backgrounds depending on the intended user population, but each one can bring a unique perspective to the table based on past experiences. If the group dynamic is such that everyone feels comfortable sharing their point of view, these discussions can be enlightening and valuable. On the other hand, even one extremely vocal or opinionated participant can bias the thoughts of others in the group, or at the very least make them feel uncomfortable sharing an opposing viewpoint. This can lead to a bias in the overall group “voice.” An effective moderator is influential in these meetings by fostering an attitude of open-minded interest among the group while guiding the discussion in the right direction. Respectful debates between group members with varying points of view can benefit the development team by prompting them to consider use scenarios they may never have thought of otherwise.

When planning a focus group, it is important to define an agenda up front. This will aid the moderator in keeping the discussion on track so that the project stakeholders will be able to gather the information they need most. Documenting the agenda, the discussion during the meeting and any resulting design decisions in the Design History File will facilitate clear traceability. A well-planned and well-documented focus group can be a powerful tool for improving device human factors.

Focus groups provide a valuable opportunity to involve representative device users in use-related risk identification. Keeping these sessions interactive and progressing toward pre-defined goals is beneficial because participants remain engaged and the development team is able to collect the information they need to make informed design decisions. Finally, thorough documentation of focus group proceedings and any impacts to the design is critical for traceability of device human factors considerations.

Kristen Berger


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