Shannon Hoste, M.S.
Vice President
Shannon is the Vice President of Agilis by Kymanox, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products.
Formerly, Shannon worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as human factors reviewer within the Center for Drug Evaluation and Research (CDER), Division of Medication Error Prevention and Analysis (DMEPA).
Overview:
20+ years in the medical device, IVD, and combination products industry
Served as Human Factors Team Lead within the FDA
Optimized product development, risk management, and human factors processes for multiple companies from start-up to Fortune 100
Areas Of Specialty:
Human factors and regulatory strategies
Medical device product development process
Systems Engineering with focus on Requirements, Risk Management, Verification and Validation