Challenge icon

The Challenge

FDA mandated a change to the Instructions for Use (IFU) for a multi-step operation to reconstitute medication for self-injection due to medication errors. This mandate required IFU and use tasks updates that required subsequent Human Factors Validation Testing.

Due to previous successful Human Factors Programs, Improvita was selected to design and execute a Human Factors Validation Program.

Unique Challenges Included:

  • The product had not previously been subject to Human Factors Validation
  • Intended use population was a rare and vulnerable patient population
  • The first-generation product is currently on the market with FDA-established timeline for Human Factors Validation completion
Syringe being filled with liquid from a medicine vial
Solution icon

What We Did

  • Combined Human Factors, Device Development and Regulatory Subject Matter Experts (SMEs) to tailor project plan to unique project needs
  • Produced a comprehensive set of risk management documents
  • Redesigned IFU tailored to unique patient population (layout, organization, and balance of graphics to text)
  • Executed and reported on Formative and Summative Validation studies with 41 intended users
  • Recruited patients of a vulnerable population across the U.S. (people living with HIV using a combination product as a treatment)
Results icon

Results Delivered

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

Key Outcomes

  • HFE Summary Report and URRA supported a successful NDA submission
  • Developed an IFU what was well received by self-injecting home users