Traditionally, human factors have not been a large part of FDA regulatory requirements. That’s all going to change in the fall of 2012, when FDA is anticipated to finalize its new guidance on human factors and human usability requirements. In the view of Stephen Wilcox, founder of human factors and usability design firm Design Science (Philadelphia) the new guidelines promise to add important steps to FDA’s approval process and could help to further clarify the process.

April 24, 2012

3 Min Read
Delivering What FDA Expects in Human Factors

Traditionally, human factors have not been a large part of FDA regulatory requirements. That’s all going to change in the fall of 2012, when FDA is anticipated to finalize its new guidance on human factors and human usability requirements. In the view of Stephen Wilcox, founder of human factors and usability design firm Design Science (Philadelphia) the new guidelines promise to add important steps to FDA’s approval process and could help to further clarify the process.

“It’s been a number of years since the original law, 21 CFR 820.30, came out that required validation research; it wasn’t consistently enforced and it wasn’t completely clear what was required,” Wilcox says. “It used to be that it was never clear what the rules were and [FDA] was relatively inconsistent in what it required.”

Wilcox believes that the new guidelines, currently in draft form, will alleviate these issues. “I think this new draft guidance has made it clearer that you really have to go through a process to obtain [FDA] approval. They’ve raised the bar in terms of eliminating user error, but at the same time they’ve made the whole thing much more transparent and predictable.”

It is because of these changes that Wilcox will be chairing a session, “Integrating Design in Human Factors to Meet Regulatory Requirements and User Needs,” as part of MD&M East. The session will cover general principles for addressing human factors with an emphasis on meeting FDA approval.

“The goal is to provide practical advice that has implications for improving products and also helping with regulatory requirements,” he says.

Human factors professionals working in device design, regulatory people looking to be brought up to speed on the new FDA regulations, and even those just looking to learn more about the usability side of device development will be able to immediately apply the information given in this session, Wilcox says.

Even with the new FDA guidance still in draft form, Wilcox stresses that what’s already in place is still of great value to professionals. “The draft was extremely explicit, and even though it’s not finalized, this represents the FDA’s current thinking,” explains Wilcox, who is in constant communication with FDA through Design Science. “I haven’t seen much or any real contradictions in what they say and what is in the draft. The feedback we’ve been getting is in keeping with draft guidance.”

Those in attendance will also benefit from having Ron Kaye on-hand. Kay leads the FDA Human Factors Pre-Market Evaluation Team, the group responsible for the new draft guidance.

“The primary author of the draft guidance is the first speaker,” Wilcox says. Kaye will provide an overview of the new draft guidelines and what companies can expect in the future. Following Kaye’s talk, William Muto, principal human factors engineer at Abbott, will build on Kaye’s discussion and examine ways companies can address the FDA requirements.

“Aidan Petrie of Ximedica is going to talk about putting standard operating procedures in place to address human factors issues,” Wilcox says. “Following that, Michael Wiklund [of Wiklund Research and Design] is going to talk about using technology to make products more usable.”

Speakers will take audience questions, and case studies will be presented to further attendees’ understanding of the process.

“Our plan is to have case studies from major corporations,” Wilcox explains. “We’ll have case studies in which corporate representatives will walk through examples of their work addressing human factors and integrating human factors into industrial design.” Ethicon, Phillips, and GE Healthcare representatives are among the presenters.

For Wilcox this all ties into the core of creating great products, and he hopes attendees will take from the session practical advice as well as a greater appreciation of human factors and design.

“There’s a kind of magic in the combination of human factors and industrial design. Human factors people come from a scientific perspective, and industrial designers are typically trained in art schools,” he says. “There’s a kind of yin-yang between the two, and the combination is what you need to build products that people like to use and to avoid mistakes.”

The session will take place Monday, May 21.

Chris Wiltz

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