Medmarc Webinar: How Human Factors is a key component of your product risk management process and why regulatory agencies are paying attention

October 27, 2021

Attendees to this webinar will learn more about the following:

  • What is Human Factors/Usability Engineering (HF/UE) for medical products?
  • What are the regulatory bodies asking for around HF/UE?
  • How does HF/UE factor into other development processes such as risk management, design controls and software development?

Shannon Hoste, MSM, MSSE 

President Agilis Consulting Group 

Assistant Professor, Pathway for Patient Health  

 

Shannon is the President of Agilis Consulting Group, 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). 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.

 

Outside of Shannon's work for the FDA, she continues to build on her 25+ year career where she has worked in the medical device, IVD and combination product industry as a R&D and Quality Engineer, Manager and Director. 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, requirements management, software validation, system verification/validation and the incorporation of human factors and usability into overall product development processes. 

 

Shannon has a earned a B.S. Mechanical Engineering from the University of Toledo, a M.S. in Management from Mount Vernon Nazarene University, and a M.S. in Cognitive Systems Engineering from the Ohio State University.