Shannon Hoste Agilis

Shannon Hoste is the president of Agilis Consulting by Kymanox and an associate professor in Pathway for Patient Heath's Quality Science Education program. Formerly, Shannon worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as reviewer within the Center for Drug Evaluation and Research (CDER/OSE/DMEPA). Prior to the FDA, and since leaving the FDA, she continues to build on her 25+ year career in the medical device, IVD and combination product industry. Over this time, she has worked within and directed project teams in all phases of product development from front end research to post-market support, as well as architecting process improvements for design controls, risk management, and the incorporation of human factors and usability into overall product development processes.