Understanding how real users interact with your product is invaluable when developing a medical device. Misunderstood instructions, unanticipated use errors, or vague design elements can compromise patient safety, increase development costs, and delay market entry. It can easily derail progress if not addressed early. That’s where formative usability studies make a difference. 

Eurofins Medical Device Services network of laboratories is a trusted partner in designing and executing formative studies to provide meaningful insight, not just data. Our formative usability studies help with shaping the safety and effectiveness of your product design. Beyond their intrinsic value, they are a regulatory expectation throughout the development lifecycle of medical devices and combination products. 

We have extensive experience delivering formative evaluations across all stages of product development. Our work enhances usability and supports compliance by applying proven methodologies, including early-stage generative research such as interviews, focus groups, and cognitive walkthroughs. This foundation enables us to conduct targeted formative studies that produce actionable insights and support better design decisions. These evaluations are flexible in scope and can be tailored to your specific development objectives. Whether assessing a single element of the user interface, such as instructional documentation or a subset of software screens, or examining the complete end-to-end user experience, formative studies identify usability challenges before they escalate. From concept development to near-final designs, we  uncover what works, what doesn’t, and how to make it better with: 

• Exploratory Studies: We recruit participants to evaluate multiple designs in development, identify opportunities for improvement, and seek subjective feedback and recommendations on how to improve usability. These studies reveal rich insights on what may hinder usability, helping you refine critical elements early on.
• Rapid Iteration Studies: Working with small participant groups, we test, gather feedback, revise, and re-test based on new insights. This agile process accelerates design confidence and keeps development timelines on track.
• Human Factors Pre-Validation Studies: Entering a human factors validation test with confidence in both your product and protocol is essential. We recommend conducting a small-scale study using the methodology defined in your human factors validation protocol to ensure both are fully prepared for formal testing.

Our services cover the full medical device lifecycle: protocol development, participant recruitment, moderation, data analysis, and report delivery. You’ll receive not just observations, but actionable insights. We also define how each study fits within your broader human factors strategy to maximise the usability and safety of your product.