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The Fundamentals of a Human Factors Program

Edmond-Israelski-web Rob-Ngungu-web Eric-Schaffer web
Ed Israelski Rob Ngungu Eric Schaffer
Convener of IEC and ISO Joint Working Groups on Usability Engineering Standards

Director Regulatory Affairs and Product Development Strategy, Austen BioInnovation Institute

CEO and Head of Human Factors International Laboratories

Device manufacturers with a weak approach to human factors and usability engineering will need to increase their focus on this function, as regulatory bodies place a greater emphasis on product design safety and effectiveness and the orthopaedic industry becomes more competitive.

Human factors/usability engineering intentions, risk and testing are part of FDA’s premarket approval process and are sometimes required for a 510(k). Following stricter protocols—and recalls—in the U.S., the European Union, Japan and China are raising regulatory expectations surrounding this function. Experts note that the release of new guidelines and the greater attention placed on human factors internationally should drive manufacturers to implement practices that demonstrate the value of human factors to the entire organization.

Prudent manufacturers already know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can leverage their programs to cut costs, mitigate risks and understand how they stack up to competition in the market.

“A lot of manufacturers that haven’t incorporated human factors as part of their culture are doing so now because it’s required by regulators,” says Ed Israelski, Ph.D., Convener of IEC and ISO Joint Working Groups on Usability Engineering Standards. “They think they can do the bare minimum, and that’s a mistake. There are great business reasons for doing good human factors. Your product will sell better; will be more competitive; will have less costs associated with supporting it; you’ll have fewer complaints, returns, recalls and fewer field actions. Also, you’ll spend less time training people if it’s a good, easy to use product.”

Rob Ngungu, Director Regulatory Affairs and Product Development Strategy, Austen BioInnovation Institute, illustrated this point in his OMTEC 2015 presentation, Applying Human Factors to Usability Engineering.

 How are Human Factors Defined?

Human factors:

“… the application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems,
environments, and organizations…”
(ANSI/AAMI HE75:2009)


“Characteristics of the user interface that establishes effectiveness, efficiency, ease of
user learning and user satisfaction.”
(ISO/IEC 62366”2007)


“It’s useful to conduct some type of comparable usability study with a protocol and three or four competing devices that you put a series of users through,” Ngungu says.

When Austen BioInnovation brought in nurses and physicians from local hospitals to test different brands of a similar product, they learned that stakeholders gravitated to the easiest brand to use and ignored the other devices, which then sat unused. When manufacturers compare failure data from the field or FDA, the number of adverse events might mean that the product does indeed have a serious flaw—or it might mean that one product is being used more than the other, and therefore has a greater probability for adverse events.

Hospitals will restock the product that is more highly used; therefore, manufacturers should consider marketing and sales data when understanding the usability of a device. “In some cases, you may not have complaints; however, you’re losing market share,” Ngungu says.


Manufacturers need to implement a holistic approach to their human factors programs. This outlook often falls short in proper planning for people, design and testing.

People Requirements
When it comes to people, first, there is a lack of commitment from leadership to understand human factors and how the function should be incorporated into the company culture.

“Executives are starting to get behind human factors engineering efforts, which is great,” says Eric Schaffer, CEO and Head of Human Factors International Laboratories. “The problem is that they don’t know what it means. They know the word—whether it’s user experience, customer experience or patient experience—but they don’t know what it takes to do it, and they don’t understand that it’s a profession like any other.”