Validating instructions for use for high-risk patients
Industry: Pharmaceutical company seeking FDA approval
Goal: De-risk medication instructions for caregivers and self-administration of oncology drug
Methods: In-person observation interviews with instructions for use (IFU) prototypes
Problem
Comprehension Risks: A pharmaceutical manufacturer needed to ensure that patients and caregivers could safely and accurately prepare and administer a new oncology drug based on the Instructions for Use (IFU).
High-Stakes Environment: Given the complexity of oncology treatments, any misunderstanding in the clinical trial phase could lead to dosing errors or compromised trial data.
Impact
Instructional Optimization: Collaborated with design team to consolidate complex steps and develop improved copy and illustrations, significantly boosting user comprehension and the overall experience.
Regulatory Readiness: The refined IFU and supporting data were included in a formal report delivered to the FDA, ensuring the product was optimized for safety.
MY ROLE
In-Person Testing: Conducted 1-on-1 in-depth interviews (IDIs) where participants used common household materials to physically demonstrate their interpretation of the IFU steps.
Direct Observation: Systematically watched patients and caregivers execute the preparation process to identify specific points of confusion, physical hurdles, or instructional gaps.