Challenge icon

The Challenge

A novel topical product, intended to treat a common skin condition previously treated by cryotherapy or curettage, required Human Factors Validation. This product was intended for use among children under the age of 18 and required a Dosing Card for mixing two topical components.

Improvita was selected to design and execute this Human Factors Program due to our expertise in early-stage Formative Testing and Summative Validation.

Unique Challenges Included:

  • Dosing card required to properly mix two topical components to create active medication
  • The design of the instructions needed to be clear for self-administration by children under the age of 18
Child giving a doctor a high five
Solution icon

What We Did

  • Combined Human Factors, Device Development and Regulatory Subject Matter Experts (SMEs) to tailor project plan to unique project needs
  • Collaborated with the FDA to gain concurrence on Human Factors Validation protocol prior to execution
  • Designed and validated the Instructions for Use (IFU)
  • Recruited participants of vulnerable population (children ages 3 – 17 years old)
  • Executed and reported on Formative and Summative Validation Testing with 42 participants (children with caregivers & adolescents)
  • Collaborated on Residual Risk Analysis and Risk Benefit Analysis to provide with NDA submission
Results icon

Results Delivered

  • Produced a comprehensive set of Human risk management documents:
    • Known use problems analysis
    • Task analysis
    • Use Failure Modes and Effects Analysis (uFMEA)
    • Use Related Risk Analysis (URRA)
  • Produced a Human Factors Engineering (HFE) Summary Report
Key outcomes icon

Key Outcomes

  • HFE Summary Report and URRA supported a successful NDA submission
  • Developed an IFU that was well received by the intended users, including children and their caregivers