Human Factors and User Experience
Human Factors Integration is critical to ensure that your development process is focused on patient impact, use safety, and success.Human Factors Engineering/Usability Engineering
HFE/UE integration is critical to ensure that your development process is focused on the most important aspect of your efforts: patients.
Human Factors is important to get right, as regulatory authorities place significant emphasis on the safety and usability of your devices and software.
There are few things as frustrating as spending substantial time, money, and effort to design a combination product only to have regulators reject the submission, asking for more data, or more testing.
Regulatory pathways aren’t always clear, which can lead to guesswork—or overcomplicating a submission.
To help support your combination product development, we can work with you to get regulatory reporting right. Our extensive experience in performing HFE/UE activities includes:
- Requirements development (e.g., User needs, product UI requirements/specifications, etc.)
- Analyses (e.g., Contextual inquiry, Risk-based task analysis, Use FMEA, Day-in-the-Life, etc.)
- Design validation (e.g., Development of Design-to-Requirements, Heuristic/Expert Reviews, trade studies, development of mockups/models/prototypes, for both the device UI and for its associated labeling, etc.)
- Formative and Summative Testing (e.g., development of test protocols, conducting the HFE/UE studies, objective and subjective data analysis, root cause analyses, etc.)
- Drafting the Final HFE/UE Report required for submissions to the FDA
Our highly experienced HFE/UE specialists can help you develop an internal HFE/UE function, develop Standard Operating Procedures, and support the design and validation of your combination devices.
Your expertise is your product—ours is preforming HFE/UE activities to support product design and validation, and submittal to the FDA.
Our team has experience on more than 50 Human Factors Formative Studies and more than 30 Human Factors Summative Studies. All of our Human Factors Summative work was accepted by the Food and Drug Administration (FDA).
