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. Everything you need to successfully meet the requirements in the final FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

How We Support Your Usability Services

1. At the beginning: user needs assessment and opportunity identification

User needs provide the basis for your product strategy and requirements. Gaining a full understanding of user needs and behaviors is the single most important task to be accomplished at the beginning of a design project to assure that it will not veer off track, wasting both time and money. The user experience for a medical device is super-complex and there are many factors to consider.

The user research we conduct and the recommendations we make will help you design for real people in real situations. It can also lead to identification of entirely new product or business opportunities.

2. In the middle: formative usability testing throughout your project

Formative usability testing throughout the development process will help you make sure your proposed solutions are safe and that they satisfy 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. Toward the end: summative usability 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. This is your last chance to catch any usability issues and subsequently fix your hardware or interface before proceeding to costly clinical trials.

What Our Clients Say

The MindFlow engineers act with a sense of urgency and sensitivity to our production schedule. Their thoroughness in analysis and testing processes mean that I can trust that they are delivering accurate results and a quality prototype.

Harel Hakakha – Senior Engineering Manager – Life Technologies

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