To make sure that your product meets user needs in an optimal way, it’s vitally important that your team maintain a focus on the end users throughout the product development process.
MindFlow Design offers stand-alone human factors engineering and usability engineering (HFE/UE) services to help you maintain that focus outside of a full medical product design engagement. We provide everything you need to successfully meet the requirements in the FDA guidance Applying Human Factors and Usability Engineering to Medical Devices and the IEC 62366 medical device standard Application of Usability Engineering to Medical Devices.
How We Support Your Usability and Human Factors Needs
1. Usability Engineering File planning or audits
Your Usability Engineering File is the best way to organize your human factors design effort and it’s required by the FDA. If you’re in the early stages of development, we can create a usability plan for you to include in your master project plan. It will assure that you employ human factors best practices and organize all the required information as the project proceeds rather than wait until the end to find gaps. If you’re further along in development, we can audit your usability engineering file for gaps and provide human factors support or testing to get you back on track for FDA submission.
2. Conducting formative usability evaluations throughout your project
Formative usability testing throughout the development process will help you make sure your proposed solutions are safe and that they meet the needs of your user groups. Not only is this the most effective way to develop a successful product, the FDA expects to see your supporting data. Simply showing potential users your prototypes and jotting down their feedback is not enough.
3.Conducting summative usability validation testing
It’s important to validate a complete or near-complete design under realistic conditions with the right test subjects to confirm that it meets specific performance and risk benchmarks. Summative usability testing is your last chance to catch any usability issues and subsequently fix your hardware or interface before proceeding to costly clinical trials or submitting to the FDA.
4. HFE/UE validation reporting
Our human factors team can assist with or write your HFE/UE Validation Report. It’s important to provide the information in exactly the way the FDA recommends in the guidance document Applying Human Factors and Usability Engineering to Medical Devices.
What Our Clients Say
Joe Calabro – Vice President, Sequal Technologies