Case study
Evaluating safe and effective use of an on-body delivery system
Challenge
A pharmaceutical manufacturer needed to determine whether healthcare providers could safely and effectively prepare and administer a subcutaneous injection using an on-body delivery system (OBDS). The objective was to identify potential use-related risks and inform protocol adjustments prior to human factors validation testing.
Solution
We conducted a formative human factors study with oncology healthcare professionals. Participants followed the device’s instructions for use (IFU) to prepare and administer medication to a manikin in a simulated-use environment. All observed use difficulties and errors were documented, and follow-up probing questions captured root causes and knowledge gaps.
Impact
The study identified specific steps in the preparation and administration process that posed potential use-related risks. Root cause analysis provided actionable insights to improve clarity of instructional materials and refine study protocols ahead of validation.
Bold Outcomes
- Documented observed use difficulties and associated root causes
- Identified steps with potential for user error during device preparation and administration
- Informed refinements to IFU content and study protocol
- Provided evidence to support validation readiness and regulatory strategy
Result
The manufacturer received a comprehensive report to guide IFU refinements and protocol adjustments, supporting safe and effective use of the OBDS in preparation for validation and FDA submission.