Human factors engineering is often required for medical devices, but it can be costly. Here are eight strategies to make it more affordable.

Matt Gottschalk, Worrell, and Kimberly Fogel, Philips Respironics

HFE is the study of how people use a device in its intended environment—correctly or incorrectly—and incorporating that data into the design of your product. The goal of HFE is to ensure your device has been designed in a way that mitigates the risk of causing harm to its users to the furthest extent possible.  You can find elements of HFE in countless products you use every day—from a tool handle designed with a more substantial grip to prevent fatigue, to a safety guard shielding a sharpened blade, to the written instructions telling you what buttons to push and not to push.

For certain devices (mainly Class II and III), the FDA requires that you perform human factors testing on your device. The FDA recently published a list that further clarifies which devices are under the most scrutiny—however; it is not all encompassing.  If a risk analysis of your device indicates potential misuse, HFE data will need to be included within your submission.

There is no shortage of statistics backing the need for HFE considerations.  For example, in 1998 the Institute of Medicine (IOM) reported between 44,000 and 98,000 preventable deaths due to medical error. More recent studies project that these numbers could be as high as 250,000 annually—which would make it the third leading cause of death on the CDC’s official list behind heart disease and cancer.  Furthermore, these errors carry a tremendous price tag via the additional medical care that is needed to address them—an estimated $17 billion a year.

However, the benefits of HFE extend far beyond increasing safety.  When HFE is properly integrated into the product development process, products are often more effective, intuitive and inclusive of novel features that create competitive advantages, while improving the overall user experience.  Performing HFE tasks can also reduce the cost of development by uncovering and resolving serious usability issues early on in the design process.

The FDA and a number of standards organizations (IEC/ANSI/AAMI) have released guidance on how to properly perform your preliminary analyses and conduct formative and summative testing.

HFE does require an investment, though. Read on to discover eight powerful strategies recommended by industry experts to help avoid common pitfalls and get the most out of human factors engineering.

(Learn more about device design at MD&M East in New York City, June 13-15, 2017)

Matt Gottschalk is a product development consultant at Worrell (Minneapolis) and Kimberly Fogel is design quality engineer at Philips Respironics (Murrysville, PA).

[Image courtesy of Will van Wingerden on Unsplash]