A pharmaceutical manufacturer was interested in obtaining empirical data and user feedback regarding the usability of a medication delivery system, including the devices, labeling, and IFU.
Assess feasibility of multi-fixed dose device for the treatment of Type 2 diabetes
Challenge
A pharmaceutical manufacturer was interested in conducting a formative study to assess the feasibility of converting the design of their predicate device for the treatment of Type 2 diabetes. The company sought to evaluate the usability of two device prototypes and their related materials and to gather participant feedback to inform ongoing device design.
Approach
We conducted 90-minute individual interviews that incorporated differentiation, simulated-use tasks, and knowledge assessment tasks. Participants were patients with type 2 diabetes across a range of body mass indexes (BMIs) and nurses who administer insulin regularly. The instructions for use (IFU) was assessed and updated iteratively during week 1, and one final version of the IFU for each prototype was used during week 2.
Outcome
Participants struggled performing injections with both prototypes of the device, and as a result, design changes were made to both the physical device and its accompanying instructions. An additional formative test was planned to determine the effectiveness of the changes.