Insights From Our Team

If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and resubmit it for another chance at FDA approval. Learn how to make certain it’s the right time for your human factors study.

To shape a positive medical device user experience, you should focus on product information design throughout your medical device development process. For instance, developers too frequently procrastinate their Information for Use (IFU) documentation.In doing so, you’ll set your product on a smoother path to FDA approval and subsequent market success.

You're not tearing down to reverse engineer something but rather to spring toward innovation. Tearing it down will give you a great foundation of needed knowledge. Engineers tend to just worry about this, and this is the solution to avoiding that. Consider and identify a clear purpose. Who should be present? Who has input?

As you develop a medical device, there will be moments it becomes apparent you need outside assistance. No matter the crossroads you’re facing on your medical device design and development journey, MindFlow Design can help. Our service areas cover every aspect of medical device design and development — all the way from a nebulous idea to a distributed product. What’s more, each of our engagements is customized to meet you where you are.

The most successful medical devices aren’t just safe and effective. They also make their end users’ lives easier. Unfortunately, an excellent user experience (UX) is far from inevitable. In fact, a great UX sets medical devices apart precisely because designing a truly user-centric experience is so challenging.

Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of medical devices, this study is not simply “nice to have.” It’s a critical component of your FDA submission. So, how can you conduct a successful human factors validation study?