On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss:
- FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP)
- Human Factors vs. Usability Engineering vs. Design Validation
- Risk Management and User Risk
- Summative HF Evaluation and Sampling
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).