Human Factors and Usability Engineering

For Medical Devices and MedTech

Better Products, Better Outcomes

When developing new products, most companies get laser-focused on the technology. When they want to avoid costly surprises and ensure people actually can and want to use their product, they call us.

We sit down with their team and implement human factors & usability methods throughout development to ensure products are safe, easy and enjoyable to use.

Contact us to learn more.

We have over 25 years experience in helping medical device manufacturers research, design & test new products. Our user-centered design process spans the development cycle to ensure that human factors & usability are baked-in from the beginning, not an afterthought.

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.