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It's all about the User Interface

posted Nov 2, 2013, 4:55 AM by Frank O'Brien   [ updated Nov 2, 2013, 5:20 AM ]
Improvements in your medical device user interface will result in real improvements in safety.  This was Frank O'Brien's message during his talk at MedTech, Ireland in October.  The presentation starts with actual field data on adverse events/incidents.  The data justifies the new emphasis FDA and EU are placing on a human factor/usability engineering process.  The presentation summarizes the FDA guidance documents, and EU EN/IEC 62366 standard to support this important process.  

Manufacturer's risk management process sees that hazards are adequately mitigated to acceptable levels of risk.  As use error/reasonably foreseeable misuse is a hazard, the risk process should adequately deal with these use hazards.  However the human factor/usability engineering process places emphasis that:
  • identifying use error hazards can necessarily require user input and observation; and
  • validation of the effectiveness of use error mitigations necessarily requires a plan for use study, with methodology and compliance criteria.

Designers are reminded that the user interface their device presents to users invokes behavior.  It's important this behavior not result in harm.  Users are motivated by effectiveness, efficiency, ease, and satisfaction.  Users are the experts.  This new mindset will result in safer devices.  

A copy of the presentation can be seen here.