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 (not just the customer, but those individuals who actually interact with the product). Now, 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”.
Your “Customer Centered” approach gets to the very heart of what we are trying to achieve with our FDA approved products.
Joe Calabro – Vice President, Sequal Technologies
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.
Human factors expertise is critical in understanding this complex situation and environment. This requires a deep understanding of all stakeholders’ cognitive and physical needs.
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.
The three components to a successful formative usability test are planning and recruiting test subjects, facilitation, and presenting findings and recommendations.
Our human factors experts can jump in and test your product or user interface concepts at any point during your project. We produce a persuasive findings report that can become the major substance of your FDA-required design history file. The recommendations we provide will help assure your project stays on track in meeting or exceeding the needs of your target demographic.
A report will be formatted in accordance with sections 2-7 of the HFE/UE report outlined in the FDA’s final guidance, appendix A, entitled “Applying Human Factors and Usability Engineering to to Medical Devices.”
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.
You will want to learn about any safety or usability problems before your costly clinical trials begin, not while they are in progress. As you know, the consequences of moving forward with an unnoticed design flaw can be catastrophic.
A report will be formatted in accordance with section 8 of the HFE/UE report outlined in the FDA’s final guidance, appendix A, entitled “Applying Human Factors and Usability Engineering to Medical Devices”.