What does Human Factors and Usability actually mean?

Human factors and Usability focus on the synergy of human operators, or users with systems, and their UIs by applying knowledge of human capabilities and limitations and performing tests and evaluations of user/system performance. Human factors also apply known principles and best practices in the design of displays, controls, and other UI aspects to optimize the use and eliminate or limit use-related risks.

Usability should align with your Product Requirements Specification (PRS) which defines everything about your product. When the PRS is not defined keeping the usability in mind it can become the top cause of project delays, so getting it right, getting it agreed across the business, and sticking to it, will allow for a smoother and faster development process and a commercially successful product.

What are the benefits of applying Human Factors and Usability as inputs to my development project?

The benefits of applying human factors/usability engineering to your development projects are:

• Easier-to-use products,
• Safer connections between device components and accessories (e.g., power cords, leads, tubing, cartridges),
• Easier-to-read controls and displays,
• Better user understanding of the product’s status and operation,
• More effective alarm signals,
• Easier product maintenance and repair,
• Reduced user reliance on user manuals,
• Reduced need for user training and retraining,
• Reduced risk of use error,
• Reduced risk of adverse events, and
• Reduced risk of product recalls.

Product development always involves some level of compromise. To make the most successful product possible, it is essential to define the Usability or ‘Ideal User Experience’. However, owing to technical or commercial limitations the ideal user experience may not be achievable, but by defining the ideal, the project team can understand the elements which negatively impact the user experience and ensure that they can get the best possible user experience within the constraints of manufacturing processes, technology, cost, and regulations. 

There are some long term benefits too. Technologies always develop and become cheaper over time. Even hugely successful devices get replaced by newer, better versions. By keeping a picture of what the best possible product might look like allows you to identify the opportunities created by new technologies, materials, or processes and apply them to your product, driving the next wave of innovation in the market.

Key take-aways

• Usability and human factors should be a vital part of the product development process especially concerning medical device ease and safety of use.
• The FDA and other regulatory bodies' pre-market device review process now routinely includes human factors risk assessment and validation testing of the device UI with intended users.
• Innovation, HF, and UE activities should be conducted throughout all phases of design and development including preliminary task and risk analysis, UI design and evaluation, not just at the final validation testing point.
• Every design change should warrent the question: How does this affect the user? How does this make the user feel? What is the user's perception of the product now? Does this align with our PRS?
• You can use HF and UE to create new products in the future as new technology develops around you. Revisit them periodically.