Presenter

Denise Forkey is Director of Human Factors Strategy - Advisory at UserWise, a ClariMed company. ClariMed is a best-in-class consultancy focused on integrating human factors engineering and user experience design into medical product development to optimize devices and therapies for patient usability and safety.

In her role at ClariMed, Denise helps medical device and combination product manufacturers and startups design safe, easy-to-use products that improve patient outcomes. With over 25 years of experience in the medical products industry, she is an expert in implementing usability engineering processes. Her background spans conducting use-related risk analyses, formative evaluations, and validation testing for a wide range of medical technologies, from home-use devices to complex robotic surgery systems.

Denise develops human factors submission strategies and documentation for FDA and international regulatory compliance. She has successfully guided numerous clients through FDA human factors submissions, created usability materials for international device approvals, and managed audits from notified bodies and test labs. Overall, Denise leverages her deep expertise in human factors and usability engineering and product development to help clients bring innovative medical technologies to market that are safe, effective, and easy for patients to use.