Core clinical engineering and protocols for IEC 62366 Usability Engineering.
Consumer mobile apps optimize for engagement and conversion. Mobile medical applications (such as automated insulin bolus calculators or digital therapeutics for psychiatric disorders) must optimize for safety and error prevention. A misunderstood icon or ambiguous button in a medical app can lead directly to patient overdose or missed therapy.
SaMDApp implements formal usability engineering: developing detailed User Profiles, Use Environments, and Task Analysis. We conduct rigorous summative usability trials with actual patients, recording task completion times, confusion points, and close calls to prove to regulatory bodies that the app cannot be operated erroneously.