Evaluation & Regulatory Services

Our team is equipped to help you navigate the full human factors/usability engineering process as part of your FDA submission, CE marking plans, or other global regulatory submissions. We are experts on the FDA Human Factors Guidance and we are active members of the ISO/IEC joint working group on usability, responsible for the ISO 62366: Application of usability engineering to medical devices standard. We are also members of the AAMI Human Factors Engineering Committee and are experts on the HE75 standard on the design of medical devices. We can assist by reviewing the current state of your usability documentation and usability engineering file. We also regularly support our clients in developing use specifications, use-related risk analyses, defining critical tasks and assisting with developing the final HFE/UE Report (Usability Engineering Summary).

Our team is skilled in discovery techniques and user research that lead to design insights, a deep understanding of user needs and their interaction with products, systems, and services. We employ methods including ethnographic research, contextual inquiry, interviews, focus groups, participatory design, and workshops to help you understand the needs of your users and their use environments to help you innovate and deliver safer solutions.

Human factors and usability engineering methods should be incorporated throughout the design process. Early stage formative evaluation will make your product more competitive, and reveal opportunities for next generation prototypes. We have the capacity to conduct low and high-fidelity formative evaluations in an environment appropriate for your product’s use. Our team will assist in developing a formative test plan, recruit the appropriate users, conduct the evaluation, and prepare a comprehensive report outlining potential usability issues and recommended design changes in order to improve the product.

Prior to receiving regulatory approval, device manufacturers must conduct human factors validation (summative) testing in order to prove that their product is safe and effective for the intended users, uses, and use environments. With extensive experience evaluating medical devices and combination products, we can provide test support in accordance with the appropriate FDA Human Factors Guidance and International standards, such as ISO 62366.

Comparative evaluations can uniquely assess a medical device or system against competitors for usability, learnability, efficiency, user satisfaction, and use safety. Our team of researchers, affiliated with an academic hospital system, can provide an objective and independent study to support healthcare organizations make evidence-based procurement decisions. We can also assist our clients in collecting and using comparative usability data to develop better products, or to publish whitepapers and peer-reviewed articles that demonstrate the competitive advantages of their solutions.