A decade ago, Europe was arguably lagging the USA regarding the application of human factors in medical device design. While European medical device manufacturers paid close attention to industrial design and associated ergonomic concerns, they focused less attention on overall usability, particularly the interactive quality of embedded software applications. Today, their approach to user interface design is evolving rapidly.

European companies now tend to focus intensely on the usability of medical devices as it relates to patient safety. They are driven by an International Electrotechnical Commission standard (IEC 60601-1-6, soon to be replaced by IEC 62366) and EU directives to do so. Failure to do so can deny a company product approvals (e.g., a CE mark). Since the late 1990s, American companies have felt the same pressure to focus on use-safety as a result of changes to FDA’s Quality System Regulation and associated standards (e.g. AAMI HE74:2001).

Accordingly, our firm is routinely engaged to test the usability of prototype medical devices in multiple USA and European sites. For example, one recent client funded tests in Germany, Denmark, Italy, Sweden, and France, in addition to the USA and Canada. We’re sure that our colleagues in other human factors firms are experiencing similar demand to collect international feedback on evolving medical device designs that are intended for worldwide sale.

The long-term challenge for Europe is to develop local sources of human factors expertise, noting that there are just a few human factors education programs “across the pond.” Until then, European companies are going to be doing a lot of importing.