Medical Devices

We have over 25 years experience in helping medical device manufacturers design new products. Our user-centered design process spans the development cycle to help ensure new products have user interfaces that are safe, effective and enjoyable to use.

We don’t do focus groups. We believe that real understanding of user needs comes from observing people’s behaviors, interactions and use patterns. We go to OR’s, clinics, labs & homes to understand the use environment and observe how products are really used.

Research & Analysis

We work alongside internal development teams to conceptualize and develop new hardware and software user interfaces. We continually advocate for the user throughout the process and make sure their needs are not forgotten when trade-offs are made.

Design

Evaluation

We conduct formative and summative usability evaluations for medical devices and preparing the usability file and human factors report for FDA review. We know exactly what the FDA expects and help de-risk the submission.