The FDA recognizes the importance of human factors engineering in the design and development of medical devices, including clinical support software. Designing clinical tools around human factors takes into account human capabilities, limitations, and characteristics to protect the wellbeing of people and to minimize the risk of design-induced human performance issues. The regulatory pathway for clinical support software can vary based on intended use, risk level, and complexity of the software. Within these pathways, Human Factors data is an integral part of your product development and data to support your regulatory submission.
Discussion will include:
- Regulatory landscape for clinical software solutions
- Using a human factors approach in clinical software development
- Challenges and considerations
- Case studies
Shannon Hoste is the Vice President at Human Factors 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 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. 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.
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