Case Studies

Post Market Analysis

The Client’s Problem:  Prioritize human factors efforts for next product generation based on post-market usability trends.

HCS conducted a post-market analysis by isolating FDA adverse event reports for the product line of interest. HCS then conducted a linguistic analysis of the reports focused on usability problems in order to provide the company’s human factors department with a list of high priority problems that should be addressed for their next generation products.

Usability Process Reviews

The Client’s Problem: Understand potential gaps in their usability engineering process.

A device manufacturer, who had received warning letters concerning adverse events caused by potential user interface problems, requested HCS to perform a process audit and gap analysis of their human factors and usability processes.  Usability study reports and use risk analyses methods were reviewed by HCS to identify areas of deficiency in usability engineering with regard to compliance with IEC 62366: 2007.  Findings pointed to a lack of systematic formative evaluations and missing or incomplete summative testing.  The company now has included these testing formats in design inputs and validation processes.

Human Factors Process Gap Analysis Using Post-Market Data

An insulin pump manufacturer was concerned with problems reported by users of the pump in a market acceptance test study.  Users wore the insulin pump for three months and recorded use problems during this trial period.  These problems and reported events were analyzed by HCS for root cause by classifying them into perception of information, cognitive processing of information, and physical actions.  Cognitive problems accounted for nearly 80% of all problems reported pointing to a lack of formative evaluations in product development.  The development team has now added a human factors group and incorporated a formal set of standard operating procedures that include formative testing of user interfaces.

Protocol Development Review

Client Problem:  Need to design and conduct a simulated use study with no previous usability testing experience.

The manufacturer received an FDA deficiency letter regarding a pre-market application because they had not conducted a simulated use validation study.  HCS developed a study protocol and advised the company regarding study methods and execution.  With HCS’s help, the study was conducted.  Because test results revealed a pattern of use error on a critical task, the company made modifications and conducted a supplemental study showing no problems.  With HCS guiding them through the human factors reporting process, study results were accepted by the FDA and the product was approved for market.