Description

A biopharmaceutical company required support on multiple activities related to human factors studies for its new microneedle patch drug delivery system to ensure smooth execution and approval by the FDA. Support for the development of the packaging components for the microneedle patch drug delivery system was also required.

Challenge

Needed a comprehensive human factors strategy with the goal of avoiding FDA mandated training that would delay the project

Solution

Kymanox Human Factors experts, including former FDA staff, and packaging team members were brought in to ensure successful completion of the project

Results

The Kymanox HURAS team provided input on human factors strategy including review of formative study results to inform our expert recommendations on the layout and wording and diagrams of specific instructions and to ensure that the Instructions for Use (IFU) is designed with the intended user’s needs in mind. In addition, Kymanox HURAS team also provided strategies on integrating the quick reference guide as part of the IFU so that all the user instructions are located in one physical document. Furthermore, Kymanox HURAS provided recommendations to strengthen the use Failure Modes and Effects Analysis (uFMEA) documentation on risk mitigation strategies and to ensure compliance to regulatory requirements and ISO 14971, Application of Risk Management to Medical Devices.

Our Packaging Technology and Engineering subject matter experts were also brought in and provided support for the development of the packaging components for the microneedle patch drug delivery system as well as the graphics needed to support the human factors studies. They evaluated packaging and labeling designs with emphasis on usability and human factors aspects to inform their final recommendation.

The input provided by the Kymanox team helped the client successfully complete formative evaluations, with the goal of avoiding FDA mandated training that would delay the overall project as well as impact budget.