Session Full Program · Contributors · Organizations · Search Program · Flagged · Happening NowMore…Search ProgramFlaggedHappening NowOral Presentations: Rethinking the Rules: A Critical Look at HF Regulations (MDD1)Session ChairShannon HalgrenSage Research & DesignEvent TypeOral PresentationsTracksMedical and Drug Delivery Devices (MDD)TimeMonday, March 3110:30am - 12:00pm EDTLocationHarbour A/BPresentations10:30am - 11:00am EDTCounterarguments to Controversial Perspectives in Medical Device Human FactorsAuthorAnders Orn11:00am - 11:30am EDTHow Many Users Do We Really Need? Analyzing the Impact of Key Characteristics on Usability Test Performance and Sample Size Selection of HF Validation for Combination ProductsAuthorsMaeve O'SullivanBriana RawsonHasan AliLimor HochbergClara VamvulescuBihua Yu11:30am - 12:00pm EDTWhen is Enough, Enough? How Many Times Do We Have to Demonstrate a Commercially Available Platform Device is Safe for the Public?AuthorsChristina MendatLiz Mauer