For a globally leading manufacturer of laboratory equipment, a new digitally controlled microcentrifuge was developed. The product combines high performance with modern interaction concepts and is designed for professional use in laboratory environments.
To enter the European and U.S. markets, a formal usability validation in accordance with IEC 62366-1 was required.
Consulteer took full responsibility for the planning, execution, and documentation of the summative usability evaluation - from pilot phase to fully audit-ready final study.
Two Studies. Two Continents.
For approval in Europe and the United States, a comprehensive usability validation was required. Safety-critical use scenarios related to installation, operation, and maintenance had to be evaluated under realistic conditions.
Key challenges included:
Coordination of two international study phases (Germany & USA)
Tight timelines combined with high regulatory complexity
Recruitment of representative target users via market research agencies
Securing test infrastructure and device operation in Boston and New York
Fully compliant documentation in line with MDR, FDA, IEC 62366-1, and ISO 14971
Two-Stage Usability Evaluation.
The evaluation followed a two-stage approach. First, a pilot study was conducted in Germany with eight experienced laboratory users to validate the study design and identify potential usability risks at an early stage.
This was followed by the summative certification study in the United States with eighteen professional users. The study took place in dedicated test facilities in Boston and New York, with Regulatory, Engineering, and Quality Assurance teams observing remotely.
The following tasks were evaluated:
Device setup and commissioning
Rotor insertion and loading
Operation and programming
Maintenance procedures
Methodology & Analysis.
The evaluation was based on a structured, standards-compliant study design with clearly defined success criteria and risk-oriented analysis. All tests were moderated by experienced usability professionals and documented using a four-eyes principle supported by standardized protocols.
Established usability metrics were applied, including:
User ratings per use scenario
User performance based on success rate
User performance based on time-on-task
User performance based on error-free rate
System Usability Scale (SUS) as a final overall assessment
Error-Free Validation. Actionable Insights.
The study successfully delivered the key proof: all safety-critical use steps were completed under realistic conditions in a traceable, error-free, and risk-free manner.
The results fully met regulatory requirements and were incorporated directly into MDR- and FDA-compliant documentation without the need for iteration. In addition, the findings provided valuable input for the targeted improvement of user experience and usability throughout the product lifecycle.
Key outcomes:
Error-free execution of all safety-relevant use scenarios
No risk events and no rework required
Seamless integration into MDR- and FDA-compliant documentation
Beyond regulatory validation, the project generated meaningful insights that supported continuous optimization of the product’s usability and user experience.
More than a Study.
Consulteer supported the project as a full-service partner - from protocol development and study execution to final regulatory documentation. Our combination of regulatory expertise, human-centered design, and methodological rigor makes us a reliable partner for user-centered medical technology.
