CIMIT Forum: Representativeness versus Generalizability: How to Get the Most Out of Simulation for Medical Device Development

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Representativeness versus Generalizability: How to Get the Most Out of Simulation for Medical Device Development

12.07.2010

PRESENTER:
Andrea Cassano-Piché, MASc, PEng, Human Factors Engineer, Health Technology Safety Research Team, University Health Network, Ontario

MODERATOR:
Jeffrey B. Cooper, PhD, Founder and Executive Director, Center for Medical Simulation; Professor of Anaesthesia, Harvard Medical School, Department of Anesthesia and Critical Care, Massachusetts General Hospital

Forum Abstract

Using simulation as a tool for identifying human factors issues throughout the medical device design process is a growing trend. This is, in part, due to new FDA draft regulations requiring human factors data as part of the 510(k) submission process. Human factors specialists at the Centre for Global eHealth in Toronto, Canada, have participated in many simulation-based design, procurement and research evaluations using a wide range of approaches.

This presentation will describe the capabilities of simulation for evaluating human factors issues as part of the device design process using examples from real simulation evaluations conducted at the Centre for Global eHealth Innovation. The benefits of using different levels of representativeness in the simulation, and the relative merits of simulation versus clinical evaluation will be discussed.