The FDA says conduct human factors studies, or else
From: Medical Design & Outsourcing - 08/03/2016
By: Rogene Evans

Patients and caregivers adapting to new equipment may use them in error. But
applying human factors principlas and conducting usability studies early
enough in a design can minimize mistakes.

Today, applying the principles of human-centric design to a bewildering array
of medical devices is one way to minimize errors in hospitals and homes.

"About a decade or so ago, the FDA began paying more attention to the
increasingly complexity of medical devices," says Debbie McConnell, human
factors lead at Battelle Laboratories. "In 2007, the FDA wrote guidance that
said, in effect, if a company wanted a successful submission, it had to
demonstrate its product was likely to be used as intended - and the medical
device manufacture could not use the justification that, 'The user did not
follow instructions.'"

Read the entire article at:
http://www.medicaldesignandoutsourcing.com/fda-says-conduct-human-factors-studies-else
https://issuu.com/wtwhmedia/docs/mdo_july_7-16_vs2 (page 41)

Links:
The FDA has a lot to say about Human Factors
https://issuu.com/wtwhmedia/docs/mdo_july_7-16_vs2 (page 45)

Ten Usability Guidelines for Designing a User Interface
https://issuu.com/wtwhmedia/docs/mdo_july_7-16_vs2 (page 47)

Ten Usability Heuristics for User Interface Design
https://www.nngroup.com/articles/ten-usability-heuristics

Debbie McConnell
https://www.linkedin.com/in/debmcconnell

Battelle Unveils User-Centric Simulation Lab to Accommodate Demand for
  Usability Studies
http://www.battelle.org/newsroom/press-releases/battelle-unveils-user-centric-simulation-lab-to-accommodate-demand-for-usability-studies