Thursday, February 13, 2014

Human Centric Design: How Pushback From the FDA Is Driving Innovation

WIRED by Reade Harpham of Battelle Humanic Centric Design 29 January 2014

The following exert from IEC 62366:2007 is being credited with driving improvement "The design of a usable Medical Device is a challenging endeavor, yet many organizations treat it as if it were just “common sense”. The design of the user interface to achieve adequate (safe) Usability requires a very different skill set than that of the technical implementation of that Interface."
– International Standards Organization: IEC:62366:2007, Application of usability engineering to medical devices, pg.6
(see complete standard here).

In the last 36 months medical devices have been tested, re-designed and re-tested with over 2,000 actual users.  These are people off the street, never seen the device before, don’t care how it looks/works/feels users; the people who open a needle, drop it on the dirty bathroom floor, blow it off and inject.
Users, who no matter how much you paid your design firm to develop a great “user experience,” rip open the box; toss the instructions in the trash and get down to business. The unhappy marketing and development teams behind the two-way glass are ever frustrated by how the users used it “wrong,” without really considering the very real possibility they designed “wrong.” Until now…

The FDA is becoming aggressive with their enforcement of good Human Factors, and rightfully so. In 1999, the Institute of Medicine released “to Err is Human,” which outlined the fact that up to 98,000 deaths resulted from medical error at a cost of $29 billion. Since then, they have been steadily beating the drum, releasing new guidance and tirelessly training companies on how to appropriately incorporate human factors. Developers are finally starting to respond, albeit mostly as a result of an application being rejected to lack of human factors.

They are adding “Human Centric Design” line items to their budgets, opening the door for user feedback from the beginning. They are recognizing that a small, well executed usability activity in the early stages of design will save ten times in time and money downstream, not to mention drastically increase the likelihood their device will be approved the first time around.

More importantly, device manufacturers are beginning to recognize the value of a human centric approach from the inception of the idea. Enabling users to have a voice beyond “I prefer this one” can drive design decisions across the entire develo

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