Human Factors Engineering

A products users are often an untapped resource for obtaining ideas and defining requirements. To become familiar with users and their goals and uncover potential obstacles to using a new product we employ several different research techniques during such as, contextual inquiry, ethnography, workflow analysis, and ergonomics research. We seek to know users’ interaction with a product and their environment from a 360-degree perspective to ensure our designs are compatible and innovative.

To guide the innovation process, we conduct formal, generative research with prospective users to obtain their reactions to early design artifacts and interactive prototypes. We direct them to walk through typical use scenarios to validate our designs’ intuitiveness, speed-of-use, efficiency, and safety and to learn any opportunities for enhancement. We refine our designs and establish a preferred direction based on our informed insights and users’ needs and preferences. Compelling product concepts emerge from users’ feedback and clever design iterations.

Refined user testing with higher fidelity prototypes is essential for reducing residual risks in the product design. As the prototype more closely resembles the final device in form and function, it allows users to interact with it in a realistic and meaningful way. This enables the identification of subtle usability issues that may not have been evident in earlier, lower fidelity versions. By observing how intended users perform tasks, make decisions, and respond to the device in simulated use scenarios, the development team can uncover potential use errors, confusion, or inefficiencies. Addressing these findings through iterative design improvements helps ensure that the product is safe, effective, intuitive to use, and ultimately supporting compliance with regulatory expectations and improving patient outcomes.

Human factors validation testing is a critical step in medical device development because it confirms that the final design can be used safely and effectively by the intended users, under expected conditions, without causing harm or use-related errors. This testing simulates real-world use scenarios to evaluate whether users can perform critical tasks correctly and consistently. It ensures that the design adequately supports user needs and mitigates risks identified throughout development. By validating that the device aligns with human capabilities and limitations, this process not only enhances safety and usability but also fulfills regulatory requirements from agencies like the FDA and EMA.