Takeda SOPH-A-PORT Administration Kit

Takeda was developing an implantable spinal access port for the epidural or intrathecal administration of chemotherapy or pain-relieving drugs to adults and children. This required detailed instructions for use (IFU) and quick reference guides for the surgeons performing the procedure, clinicians administering the drug, and the hospital pharmacists preparing the drug for administration. In addition to producing both print and video IFUs, we designed a solution for human factors testing that consisted of a color-coded package to house these materials and the necessary infusion and pharmaceutical components. The final product received FDA clearance after the first submission and required no further modification. This allowed Takeda to complete human factors testing under a tight deadline.