Legislation

By Josh Kerst, CPE, CIE

Early last week the U.S. Food and Drug Administration proposed the Innovation Pathway, which is a priority review program for new breakthrough medical devices.  This system will help expedite the delivery of vital technology to users. Acceptance into the FDA fast-track program will require manufacturers collect usability data using sound ergonomics protocols.  Usability information is gathered during the product’s development and clinical testing stages to ensure each device is optimized to meet the end user’s needs while minimizing the risk of errors with the device’ s use.

An accelerated FDA approval program for drugs has been in place for nearly twenty years, but the United States medical device manufacturers have long complained that the agency’s review time for their products is much longer than that of other countries.  In fact, the Associated Press reported that “The United States is the seventh slowest nation in terms of device approvals”. The AP also reported that new FDA program aims to review first-of-a-kind devices within five months; about half the time it currently takes.

Ergonomics is a central element in the Innovation Pathway program and the agency has released guideline documents that address new usability expectations.  In addition, more comprehensive information is provided through ANSI in the HE 75, “Human Factors Engineering – Design of Medical Devices” best practice guidelines.  This 400+ page document describes general Human Factors design principles for accommodating user characteristics, capabilities and preferences, as well as managing and controlling risk of use and errors, protocols for usability testing and documentation, and even includes packaging design guidelines for device applications.

Due to the sheer volume of these guidelines, manufacturers face a potentially daunting task of sifting through the information to demonstrate and document that their device has been strategically designed to meet human needs and capabilities.  Product design teams can no longer test their potential design with a few in-house “subjects”.  Instead they are more often turning to third-party organizations like Humantech that have the capability and track record of producing effective results in a tight time-frame.