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Cognitive-Behavioral Testing With User-Centered Design

in Significant Risk Devices Prior to FDA Review

Expert Consultation

Our unique blend of education, training, professional experience across disciplines allows us to provide you the highest level of service to meet your needs.  We have experience conducting global clinical trials and human factors testing across a variety of disciplines.


Contextual inquiry

When we perform contextual inquiry, it is generally done by one interviewer talking one to one with the person being interviewed and with the aim of gathering as much raw data as possible from the interview for later analysis.

Interviewees are interviewed in their environment, when doing their tasks, with as little interference from the interviewer as possible.  In healthcare, we can do this wherever care is provided or work is performed.  That can be in a field setting, an office, clinic, hospital, laboratory, or even operating room.

Formative and Summative Evaluation

When we perform usability testing in simulated environments, we generally perform it in a usability laboratory where we can create simulated environments and test a device or product using a scenario much like it would be used in the workplace.  For healthcare, that means that we recruit real patients, real healthcare workers, lay healthcare providers, lab technicians, etc.  Our aim is to create a situation that tests the limits of the device/product using real users.  We can conduct usability testing in any major city in the United States and abroad. 


Our team is dedicated to providing you a robust research program and a formal HFE/UE report using FDA Guidance and ISO standards.  Our team has more than 15 years experience writing research protocols, statistical analysis, and reports that will inform product development in compliance with regulatory requirements for safe and effective medicines, devices and healthcare products.