Topical Combination Product for At-Home Use by Children

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

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

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

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

The Challenge

What We Did

Results Delivered

Key Outcomes

Human Factors Case Study: Topical Combination Product for At-Home Use by Children

The Challenge

What We Did

Results Delivered

Key Outcomes