Task and Use Error Analysis -- Human Centered Strategies has conducted task and use error analysis for a variety of devices including blood glucose meters, infusion pumps, finger stick devices for blood sampling, and insulin pumps. Each analysis has been based on collecting data from user experts, usability testing, MDRs, and customer service data to deliver a comprehensive picture of the range of anticipated or known use error sources.

Regulatory Responses -- Human Centered Strategies has recently helped several companies respond to questions and comments from FDA reviewers concerning usability evaluations and use error risk analysis.

Usability Test Plans -- We have developed Usability Engineering Plans for companies wishing to plan the gamut of usability activities across the life cycle of the device and all phases of the Quality System Regulation Design Controls Process. Often, these plans have been linked to the company's own internal process (i.e. Stage Gate, waterfall, etc.) but are synergistic with FDA expectations of documenting human factors activities and processes suitable during a QSIT Inspection.

Usability Evaluations -- We have designed and conducted a variety of usability evaluations suitable for different stages of product development. Often, these evaluations take place during critical design decision making concerning user interface features such as the formatting of information displays, layout of controls or evaluation of user manuals. For example, in early design stages, we have conducted "formative" evaluations, involving early mockups of the device and its interaction scheme, while later design stages include more rigorous assessment of use error frequency and time to perform tasks.