We examine all facets of how people will interact with a medical device or product including what they bring technically, physically, and emotionally. We customize our services to accommodate each client’s needs and specific challenges. Agilis has extensive experience with low literacy users to maximize first-time product success. Our proprietary human factors engineering methods seek to cost-effectively optimize device design while ensuring user satisfaction and regulatory requirements.

 

Human Factors Engineering

Our concept and early-stage design services improve usability, user satisfaction and product differentiation while changes are still easy and less costly.
 

Evidence-based Instructional labeling & Training

Agilis uses evidence-based methods to analyze user skill and performance requirements and provide an array of services for Instructions for Use and product training.

human factors regulatory guidance

Our risk-based analyses of user interactions help mitigate use errors, create a human factors plan and successfully gain regulatory clearance.
 

Post Market Surveillance

Post-market use problems can be a powerful resource in identifying use risks and design enhancements. Agilis employs innovative search techniques to mine use-related issues from complaint and MDR narratives.