Here is a link to an article describing how four LVAD patients have died due to poor device instructions: http://www.qmed.com/news/thoratec-warns-hospitals-after-lvad-patients-deaths?cid=nl.qmed02. These incidents emphasize  the importance of the broad and careful considerations necessary to create safe and effective medical devices. In addition to “traditional” technical design issues, biomedical devices require careful consideration of everything from overall concept to packaging and labeling (including user instructions).