Feb 15, 2022

It’s a new year (2022) and a good time to reflect on the state of human factors engineering (HFE) and its application in the medical technology realm. In short, HFE is booming. The medical device and pharmaceutical combination product industry appears to be “loading up” on HFE specialists, thereby creating a bit of a labor shortage. Fortunately, HFE also appears to be a booming field of study, as illustrated by the significant increase in students majoring in human factors where I teach (Tufts University) and many other programs within the US and abroad. So, the labor shortage might lessen in the near future.

In-house HFE teams within medical technology companies were unusual even in the recent past. By recent, I mean very recent, as in just three to five years ago. However, in-house HFE teams are quickly multiplying among large, medium, and even small companies, which is to say all-size companies.

It’s a sign that HFE is now viewed by many companies as an essential, core competency. So, where does this leave HFE consultancies like Emergo by UL?

I am confident that HFE consultancies will continue to play a critical and even pivotal role in the application of HFE to medical technology. Also, and quite importantly, they will continue to be great places to work. I know that sounds like I am promoting Emergo by UL’s services and employment, but my viewpoint applies equally to other, strong HFE consultancies.

In the case of Emergo by UL, we are proud to have the largest, fully integrated team of human factors engineers working in the medical technology domain with specialists based in the US, EU, UK, Japan, and China. Consultancies like ours, as well as several other strong ones, offer human factors engineers the advantage of working on many different technologies and supporting many regulatory applications per year.

This variety of HFE applications affords a perspective that can be quite helpful when deciding the type and scale of various HFE initiatives and especially how to report results to regulatory bodies (e.g., the US Food and Drug Administration) in a complete, correct, and compelling manner. That is why HFE teams embedded in manufacturing companies continue to seek our support to complement their own work as they find themselves stretched thin on an intermittent or chronic basis. It results in a nice symbiosis. Internal team members apply expertise they derive from a “deep dive” into the technical aspects of the products their company develops. In parallel, HFE consultants apply expertise they derive from a perhaps “shallower dive” into the technical aspects of the various products their multiple customers develop.

Wrapping up this commentary, I’ll say it’s great to see that HFE is now a mainstream discipline operating within a significant proportion of medical technology companies. The 25-year period of adoption, tracing back to when FDA raised expectations in 1996 by publishing draft HFE guidance to the industry, is arguably over, and benefits will be mounting. Also, speaking from the perspective of a consulting team leader, it is great to see ever-increasing demand for advisory services. This is truly a boom time for HFE professionals working in the medical technology space. We practitioners can be pleased by this development and, at the same time, must deliver great results with the ultimate goal of making medical technology increasingly safe, effective, and satisfying to use.

Michael Wiklund is General Manager and Director, Human Factors Research & Design (HFR&D) at Emergo by UL.

Learn more about HFE and usability for medical devices and combination products at Emergo by UL:

  • HFE user research for medical devices, IVDs and combination products
  • Human factors design and prototype development support
  • Whitepaper: Usability testing of medical technology

Author

  • Michael Wiklund

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