Success Story: IVD Labeling

The Challenge

• The manufacturer of an in vitro diagnostic cancer screening device consulted with Agilis after a failed validation study. The results of the study were largely attributed to instructional materials which did not support performance of the intended lay users over the age of 50, including a low literate sub-group.

• The instructional interface included a user manual, a label sheet to identify the samples, and shipping instructions to send the samples to the laboratory.

What We Did

• The instructions were redesigned and tested through two formative evaluations and optimized after each formative evaluation based on the study data. Revisions to the materials were comprehensive and included redesign of illustrations, optimization of illustrations-to-text, reorganization of information in the user manual, revising instructions into sequential lists rather than prose text blocks, and revised language to suit low literate users.

• During formative evaluations, we implemented rapid prototyping of a critical task which had use errors in throughout the formative evaluations. The rapid prototyping allowed Agilis to gather feedback to finalize a successful design subsequently used in the validation study.

The Results

• The device cleared and is on the market (on-time submission and clearance)

• While use errors for the critical task were not completely eliminated, the residual risk assessment showed the iteration of the instructional materials and determined no further optimization could be made to the instructional materials.