UX Blog

Navigating the regulatory landscape of medical devices can be a challenging endeavor. For companies aiming to bring innovative solutions to market, meeting FDA regulatory requirements is a critical milestone. But as anyone in the industry knows, even a minor misstep can lead to delays, increased costs, or even product rejection.  One of the most effective ways to avoid these setbacks? Incorporate usability testing into your development process. Usability testing not only ensures that your device meets user needs but also helps identify and mitigate risks that could raise red flags during FDA reviews. Here’s why usability testing is essential and how it can safeguard your path to approval.

Discover the top 5 UX research methods to enhance your ecommerce site. Learn how user interviews, usability testing, heatmaps, and more can increase sales and improve customer experience.

Explore the essentials of human factors validation for medical devices. Learn how understanding users, testing usability, and minimizing errors improves safety and ensures FDA compliance.

Learn how startups can conduct effective UX research on a budget. Discover affordable tools, remote testing tips, and creative strategies to improve user experience without overspending.

What Is human factors validation? Human factors validation focuses on assessing how intended users interact with a medical device under expected conditions in simulated use. The FDA requires this process to confirm that the device can be used safely and effectively by the intended users without causing harm or errors. It’s not about making assumptions—validation involves carefully designed usability tests where actual users perform critical tasks with the device. Their performance and any issues that arise form the basis for confirming that the device can be used safely and effectively by the intended users or if improvements are needed to the product’s design. If an iterative process has been used leading up to summative human factors validation testing, the results are more likely to confirm that users can safely use the device.

Discover how usability testing can improve your product development process by identifying user pain points, refining design, reducing costs, and boosting engagement. Learn about the key steps and benefits of usability testing here.

Discover 2025 top trends in medical device usability testing. Learn about early testing, AI tools, regulatory updates, and inclusivity strategies to enhance user experience, ensure compliance, and stay competitive.

Discover the essentials of usability testing with UX Firm's guide. Enhance your product's user experience through iterative design and testing. Start now!

A getting started guide to medical device usability testing for FDA submission. Contact us to learn more about our human factors validation testing services.

This primer gives you tips and techniques for conducting remote moderated usability testing so that you can put this technique into action to build user experience into your development cycle.

Learn the history & background of Microsoft's product reaction cards as part of the Microsoft Desirability Toolkit in usability testing. Contact UX Firm for a free consultation.

Use A/B testing to get quick answers to design questions while products are in development. New tools make it fast, easy, and inexpensive. Contact UX Firm to help you set it up.

Usability testing, expert review, diary studies, ethnography. Contact UX Firm to select the right tool for you.

The first rule of persona creation in UX is “use real data.” We actually created personas from the unusual position of starting out with no data. Contact UX Firm to learn more.

Learn what a user experience company does and what a UX designer and UX researcher does. Contact UX Firm to support your UX research needs!

A successful portal design is based on a remote moderated usability test of competitors' sites. Contact us to learn more!

Moderation styles vary widely in usability testing. Read our best practices for moderating usability tests. Contact us to learn more!

UserZoom Survey finds CEOs are aware of the value of user experience and UX Research, yet funding remains a challenge for many companies.

UX Firm coordinated and conducted human factors formative and summative evaluations for successful FDA 510(k) submission. Contact us to learn more!

All participants in usability testing need special handling, but participants in medical device usability testing may need extra consideration.

Customer journey mapping is a story-telling technique to gain insight into user experience at all touch points. Contact UX Firm to learn more!

User experience is more than designing a great product. Make sure your product documentation, manuals & instructions guide them through a good experience.