Interface Design as a Life or Death Proposition
http://www.cooper.com/content/insights/newsletters/2002_11/interface_design_as_a_life_or_death_proposition.asp

LeMoine, Doug
Cooper Interaction Design
2002

Abstract:

While the FDA has always required thorough documentation of product development, recent initiatives have instituted a more prescriptive, design-focused procedure encouraging extensive user research at the beginning of the development process.