Human factors formative and validation testing have become a part of the regulatory submission process for new medical devices in the U.S. and Europe. However, there are additional design research methods that manufacturers should consider implementing before and during development to ensure their products are safe, usable and desirable. Many manufacturers avoid conducting design research due to regulatory requirements to document adverse events. This paper discusses contextual research and participatory design performed to gather user needs for a new Total Artificial Heart TAH-t) user interface as well as strategies for conducting research with current users to comply with regulatory constraints.
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