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Live from HealthPack: Human Factors and Packaging Usability

The same methods that apply to device development can also be applied to packaging development. A product design research expert talks about fitting packages to the people who use them.

Stephen Wilcox, Principal and Founder at Design Science.
Stephen Wilcox, Principal and Founder at Design Science.

Human factors are studied extensively in product development, but these principles should also be studied in healthcare packaging. The discipline—which can apply to anything from consumer products to industrial machinery, software interfaces and more—seeks to ensure that the “item” being studied is safe and easy to use in the real world.

In terms of healthcare, the FDA made human factors and usability engineering a regulatory requirement in 1990 when it created the Design Controls Requirements (21 CFR 820.30), and published a guidance document, Applying Human Factors and Usability Engineering to Medical Devices, in February 2016.

According to Stephen Wilcox, Principal and Founder at Design Science, a contextual inquiry is a real-world study of what people do, including observation and interview while people do their jobs. As Wilcox explained at HealthPack 2017 in Denver, it’s rooted in cultural anthropology, combining both psychology and engineering, and examines the interaction between the “person” and the “thing” being studied.

To start, you must answer three key questions about the user and the product:

  • Who is the user?

  • What is it that they do?

  • What is the environment of use?

In terms of packaging, a contextual inquiry will show, for example, how a medical device kit is actually used in the surgical suite, which will help guide how the kit should be configured. In his work with medical packaging, he noted that he’s found numerous opportunities for improvement. In fact, with one vascular access insertion system, the Arrow ErgoPack System, the ease of use of the packaging became a main selling point.

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