BRIDGING STUDIES

Human factors bridging studies are conducted when manufacturers want to “bridge” the information gathered from the development program to support another program and/or application. The draft guidance, “Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry” (2019) provides an example of the following:

“...if a stand-alone device proposed to be used as a device constituent part of a combination product has been previously approved or cleared, the applicant may be able to leverage relevant existing device-related data, provided that the data has been bridged (i.e., shown to be scientifically relevant), for the development of a new combination product.” 

A human factors bridging study is conducted to ensure that the bridged product remains user-friendly, safe, and effective. This approach helps maintain user satisfaction and minimizes any potential risks or issues resulting from the change. These studies are built upon the same premise of a human factors validation test as they are typically simulated use, but they are often much smaller than the human factors validation test for the original or referenced product. 

Key to any bridging effort, however, is to reference and update the relevant documentation to reflect any updates so that they are considered when developing the protocol. Some examples include:

• Impact assessment: This assessment involves analyzing the changes in design, functionality, or features and predicting how they may influence user behavior and perceptions.

• Training and instructional materials: If the minor change affects the product's instructions or training materials, the study should validate clarity, understandability, and effectiveness of the revised instructions to ensure that users can properly comprehend and follow them.

• Risk assessment: Update the risk assessment to identify any potential hazards or risks associated with the minor change. 

How We Can Help

Our staff have planned, conducted, and reported on several bridging studies. We will leverage the documentation, developed by either your organization or ours, to craft the appropriate human factors bridging test protocol. Once the study is completed, we will analyze the data and generate a human factors bridging test report for your company’s needs. 

 
Contact Us

If you think a human factors bridging study might meet your needs, reach out so our highly experienced staff can help you develop a personalized solution that best fits your organization’s needs.