Shannon Hoste

 
 

Chief Scientific Officer

Hoste joins Pathway for Patient Health as the Chief Scientific Officer, who leads the development of scientific content and learning. Hoste is also the Pathway Associate Professor for all 3 Quality Science Education courses, and has over 26 years of experience in the medical device industry and FDA. Hoste was instrumental in the development of several classes in the Product Development and Validation course and Risk and Failure Analysis course. In addition to teaching the Pathway courses, Hoste is also the Senior Director of Human Factors and Regulatory Strategy at Agilis Consulting Group and is active on several international standards committees for medical devices.

Formerly, Hoste 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). At the FDA, she led reviews of Human Factors data for medical device premarket submissions through 510(k), PMA and De Novo pathways, combination products through NDA, BLA, ANDA pathways, as well as data to support IND and IDE requests.

Hoste also has industry experience, working for several global medical device, IVD and combination product companies as in R&D as a Quality Engineer, Manager and Director. Over this time she 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, requirements management, software validation, system verification/validation and the incorporation of human factors and usability into overall product development processes.

Hoste holds a B.S. in Mechanical Engineering from the University of Toledo; an M.S. in Management from Mount Vernon Nazarene University; and an M.S. in Cognitive Systems Engineering from the Ohio State University.