Testing & Evaluation
Does your product meet the needs of your end users and comply with safety and usability regulatory requirements? Let Battelle help you ensure your final product is ready for market release or FDA submission. We offer comprehensive testing and evaluation services under a rigorous quality system that meets all requirements for the FDA submission process.
The Battelle human centric design (HCD) team brings together experts in cognitive and behavioral psychology, usability engineering, human factors and a broad range of engineering disciplines to provide reliable, trusted results for human factors studies. We can solve complex problems and evaluate all kinds of products, from software applications to highly technical medical devices. We have special expertise in medical device development, and our testing and evaluation services can also be applied to consumer, industrial and military products.
Let us help you solve your product design challenges.
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We offer a full range of testing and evaluation services, from formative user research to summative studies. Our services include:
- Formative user research: Our experienced user research teams know how to ask the right questions to illuminate the needs, desires and challenges of your users and the context in which they operate, and translate that understanding into meaningful recommendations
- Heuristic evaluation: We conduct expert review of your product using recognized standards and guidelines. Heuristic evaluation helps manufacturers identify potential safety or usability risks before design validation. A cross-functional team of experts analyzes each product and scores it against dozens of human factors guidelines, from device responsiveness to linguistic clarity. The final gap analysis provides clear explanations of how the product does or does not meet each recommended guideline.
- Summative human factors studies: We have extensive experience and a proven track record of success in conducting human factors summative studies that meet all FDA submission criteria that help our pharmaceutical and medical device customers achieve FDA approval. We conduct summative studies using strict quality processes that meet all FDA submission criteria.
The 4,500-square-foot Battelle uLAB is located at our headquarters in Columbus, Ohio, steps away from our Consumer, Industrial & Medical Products development lab. The facility has been specially designed to facilitate the observation and evaluation of human behavior as participants demonstrate their use of various medical devices, consumer products or software systems.
- Five rooms configured to test everything from hardware and software to full-scale interiors for office and home environments.
- Private intake rooms and a medical exam table for clinical consultations (for studies that have a focus on medical devices).
- Available remote access for software usability testing, which opens up recruiting to long distance and international participants.
In addition to our on-site user research lab, Battelle has on-demand access to user labs and simulation sites across the nation.
At Battelle, you can count on us to take care of everything, from participant recruiting to creation of the final submission packet. Our turnkey services take the burden off of your development team while providing a fresh set of eyes to ensure that your product is ready to go.