Instructions for Use (IFU) testing

Location: UK
Application: Auto-injector pens for the treatment of rheumatoid arthritis
Project scope: Formative handling study to assess the efficacy of the Instructions for Use (IFU)

Our client was in the process of launching an update to one of their auto-injector pens for the treatment of rheumatoid arthritis. In preparation for submission in the EU and the rest of the world (excluding the USA) our client commissioned us to conduct a formative handling study to assess the efficacy of the Instructions for Use (IFU).

The primary aim of the study was to identify aspects of the IFU that could be improved to ensure correct operation of the device. The formative study was a precursor to a larger summative study. The findings from the formative study will be used to update the IFU prior to testing in the summative study.

We conducted the formative study in London (UK), carrying out one-on-one usability trials with a total of 16 patients, including pen experienced and naïve users, and users with visual and dexterity impairments. Data was analysed and use errors classified as Critical (severe safety implications), Essential (errors that impact, correct use of the device) and Nonessential (minor usability issues).

Verbatim was also captured to fully explore reasons for use errors made. The findings were used to suggest improvements to the IFU with a view to mitigating the use errors observed.

Benefits to the client

The study allowed our client to get a clear understanding of the performance of the IFU at an early stage in the assurance process, putting them in a stronger position going into the more comprehensive summative usability trials. The study also served as an effective pilot for the summative study.

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