Medical device usability testing with Smart Omix

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What are device usability studies?

Bringing medical devices to market is a long, rigorous process. One component of this process is usability testing. Usability testing essentially looks at how a user interacts with your product and helps validate that it is safe and effective. Usability testing is required by regulatory bodies like the FDA for certain classes of medical devices, but is a process undertaken by researchers developing a variety of products across the life sciences industry.

Why are device usability studies growing in importance?

Usability testing early and often keeps researchers within budget and de-risks the development process.

Regulatory standards are becoming more structured. The FDA’s higher expectations for well-defined methods, implementation, security and documentation beget a stronger focus on conducting rigorous usability studies.




Devices are used in many more different ways than before: in the home, in clinical settings, in trial settings.

This has led to a greater need to understand how different user characteristics and settings affect usability. As more products are digital, or digital-adjacent, it’s never been more important to think of the user interface when it comes to collecting meaningful usability data.


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Smart Omix is a smartphone-based solution to accelerate decentralized real-world research, built for researchers, by researchers.


Collect rich feedback using standard surveys participant-initiated reporting in your usability testing


Collect rich data to inform your testing efforts, like photos, videos or voice recordings


Access usability testing data in a compliant, environment for regulatory submissions


Effectively measure safety and efficacy across a diverse population using our smartphone-based, decentralized study methods


Easily enroll participants in multiple studies simultaneously, from 15 to 150 participants


Give your personnel an effective, intuitive environment to design and run multiple usability studies simultaneously.

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See how you can gather rich real world data for device usability testing.

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