As part of ongoing support of a pharmaceutical client’s new product submission, Kymanox® assisted in the development of the Human Factors Engineering and Usability Engineering (HFE/UE) Report using the expertise from Kymanox Human Factors subject matter experts (SMEs) and device and design engineers to ensure FDA guidelines and requirements were met.

Challenge

Ensuring data was both robust enough and formatted properly to support FDA approval

Solution

Kymanox developed an evidence-based recommendation to conduct an additional validation study to ensure the most comprehensive data

Results

Kymanox analyzed whether the results of the Validation Study conducted by the client could support a conclusion of safe and effective use. Ultimately, the team generated an evidence-based recommendation to perform another Human Factors validation study with strategic input from Kymanox. With data from both studies, Kymanox developed a robust HFE/UE report, restructuring the data into an industry standard format to support the new product submission and minimize regulatory risks. In the end, Kymanox was able to enhance the client’s confidence in their own work and ensured their satisfaction to continue working with Kymanox in the future.