By Thomas Klein
In a government-sponsored workshop on usability in 2011, the FDA’s 510(k) team leader regarding human factors presented a brief and relevant history of human factors for medical devices.1 The history included incidents resulting in patient deaths, with root cause attributed to poor designs of medical device user interfaces. Also in that presentation, a qualitative chart claimed an increasing activity over the years regarding usability and human factors, by both FDA and industry. The author of this article examined factual data available through FDA, in an attempt to quantify this increased activity.
By searching documents available on the FDA website related to devices cleared within the past ten years, it can be seen that the terms “usability” and “human factors” have indeed been gaining more prevalence. Figure 1 below shows the number of unique 510(k) Summary documents that contain these terms, regarding the activities described to FDA by companies seeking medical device clearance for the US market. The year axis shown in Figure 1 represents the year in which the relevant 510(k)s were submitted to FDA, not the year in which the devices were cleared.
Readers must be cautioned that not every company describes all details of actual device development and testing activities in the 510(k) Summary to be published on the FDA website. Therefore, Figure 1 does not represent all 510(k) applications where the companies conducted specific usability and human factors activities for their new and modified devices. However, the quantitative FDA data used to generate Figure 1 does indeed validate the qualitative claim by FDA that more companies with successful 510(k) applications have been discussing usability and human factors during the FDA review process.
