Understanding how intended 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. These can easily derail progress if not addressed early. That’s where formative usability studies make a difference. 

The Eurofins Medical Device Services network of laboratories is a trusted partner in designing and executing formative studies of all sizes, small to large, to provide meaningful user insights, not just data. Our formative usability studies with recruited, intended users help with shaping the safety and effectiveness of your product design before it is finalized and costly to modify. Beyond their intrinsic value, formative usability studies are a regulatory expectation throughout the development lifecycle of medical devices and combination products. 

We have extensive experience conducting formative simulated use studies of all types of medical devices, software, and combination products with thousands of participants. This foundation enables us to design and execute 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 a prototype of an autoinjector to 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. 

Strengthen your formative usability strategy.