Medical Device Manufacturer: Formative Human Factors Research

C​hallenge

The manufacturer of a pediatric vial kit was in the process of testing the kit formatively to improve the design and related instructions for use (IFU). The kit was to be used by home caregivers to administer medication to children diagnosed with Juvenile Idiopathic Arthritis (JIA). For a variety of reasons, the medication administration process was complicated for home caregivers compared to, for example, a single use prefilled syringe. As such, it was unclear whether or not home caregivers would be able to carry out the process without making errors.

Prior to conducting a human factors validation study, the manufacturer wished to better understand difficulties that may be encountered by caregivers when attempting to assemble and use the syringe in the kit. After these difficulties were made clear, the goal was to improve the device and the IFU to ensure that a clear step-by-step process was conveyed to the caregivers.

User Centric was asked to propose an approach to assess what difficulties caregivers might have when attempting to assemble the kit and administer medication, so that improvements to the IFU could be made and changes to the kit itself could be recommended prior to carrying out a human factors validation study.  

User Centric Approach

User Centric proposed an iterative approach that would allow IFU changes to be informally validated during the first phase of the formative human factors research, and recommendations for the kit itself to be proposed at the conclusion of the second phase of the test.

In individual sessions, caregivers of children diagnosed with chronic conditions were asked to follow the instructions included in the IFU in order to prepare and administer a faux injection. Participants were asked to think out loud and were probed by moderators on difficulties as they occurred to gather rich feedback on each point of confusion to inform recommendations for improvement.

Based on the trends and issues observed during the first phase, the User Centric team restructured the IFU and developed new illustrations to better communicate key steps of the assembly and administration process. Participants in the second phase of the formative human factors research then used the revised IFU to attempt the same tasks so that the effect of the updated IFU on performance measures could be assessed.

Results

As a result of User Centric’s changes to the IFU, success rates for proper assembly of the pediatric vial kit and administration of medication increased. The final IFU design was easier to understand at a glance, allowing a greater number of participants to confidently administer the medication. Several minor modifications to the components of the kit were also recommended, as changes to the IFU alone were not sufficient to eliminate participants’ confusion.

The iterative approach taken in the formative human factors research of the pediatric vial kit allowed for early designs to be updated and usability issues to be addressed prior to any human factors validation.

User Centric delivered the formative human factors research report to the manufacturer for inclusion in their 510(k) submission to the FDA.