The FDA’s increased emphasis on the application of human factors as a risk management activity has led to a substantial increase in the number of organizations looking to include human factors (a.k.a. ergonomics) as a critical activity in their design and development process. This is the shared opinion of Battelle’s Reade Harpham and David Wourms as expressed in this month’s issue of Medical Design.

The FDA does not dictate how to implement human factors into the development process; it is interested only in whether a company can provide documented evidence of human factors science and methods being applied to address user error and safety considerations. For more on what human factors engineering is and is not, and why it matters, see Harpham’s and Wourms’s article, “Engineering human factors is critical.”