Formative Usability Studies

Formative usability studies are invaluable to your product’s design, not to mention there is a regulatory expectation that they are conducted throughout the product development effort. 

Depending on your goals and objectives, formative usability studies may take many forms. Additionally, formative studies may focus on an element of the user interface, such as instructional documentation or a subset of software screens, or they may evaluate the complete, end-to-end user interface. 

Our team has extensive experience conducting all sorts of formative evaluations – with products at all stages of development – to maximize the usability and safety of medical devices and combination products. In addition to early-stage generative research such as interviews, focus groups, and cognitive walkthroughs, we place great value on conducting the following types of formative usability studies:

• Exploratory studies: In exploratory studies, we recruit participants to evaluate one or more designs in development, identify opportunities for improvement, and seek participants’ subjective feedback and recommendations on how to improve usability. By conducting these studies, we can generate rich insights and actionable design modifications to improve the product’s usability and mitigate use issues early on in development. 

• Rapid iteration studies: For years, our team has worked with medical device and combination product manufacturers to conduct rapid iteration studies to make and evaluate changes, fast. We structure these studies to evaluate the user interface with a subset of participants (e.g., n=5-6), make (feasible) changes based on the insights gleaned during these sessions, and then evaluate the revised UI with new participants the next day, repeating the process as needed. Conducting rapid iteration studies has enabled us to rapidly provide our clients with confidence that the design is headed in the right direction. 

• Human factors pre-validation studies. Going into a human factors validation test with confidence in both your product and protocol is of the utmost importance. We advocate for conducting a small-scale study, following the methodology outlined in your human factors validation protocol, to ensure your product and protocol are ready for primetime. 

Regardless of whether you are working with low-fidelity prototypes or near-production-equivalent designs, our team can conduct a full formative usability study on your behalf. This includes developing the protocol, recruiting test participants, moderating the study, analyzing the data, and writing a concise and effective study report that gives you actionable recommendations to move forward, instead of just a regurgitation of data. Additionally, our team can help you determine how this formative study fits into your overall product development effort, as well as help define your human factors strategy to maximize the usability and safety of your product. 

Contact Us

If you have a medical device, combination product, or instructional documentation in development that could benefit from a formative usability study, send us an email or give us a call so our highly experienced staff can help you conduct a study that best fits your organization’s needs