How to Develop Usable Surgical Devices-The View From a U.S. Research University

User-centered design (UCD) is a broad term used to describe design processes in which the end-users influence how a design takes shape (Abras, et al., 2004). It is both a philosophy and a process. It is a philosophy in that it puts the user in the center of the design process, and it is a process in that it focuses on the cognitive factors that come into play during the interaction of people with objects (C.S. Department of Health and Human Services, 2007). UCD is a comprehensive approach to product development that is based on two fundamental premises: that the design should be focused on users and that a scientific, data-driven or engineering approach to design must be taken. Most medical devices, including surgical and laparoscopic tools, have not been designed using UCD principles; in fact some appear not to have considered there was a user. In an effort to reduce the discomfort that surgeons experience, UCD principles were developed and employed in LJ”niversity design projects. These methodologies involve an integration of users’ needs and expectations in combination with the tasks performed. The methodologies followed include the Quality Function Deployment (Akao, 1999: Marsot, 2005; Ku\jt-Evers et al., 2009), Bobjer and Jansson’s (1997) "11-point program to design ergonomic tools, an adaption of Nielsen’s (1993) usability principles (Hall beck and Oleynikov, 2006), and a practical ergonomic product design process (lung et al., 2008). In addition, ISO, ANSI, and IEC standards as well as AAMI, AHRQ, FDA and IHI guidelines must be utilized. Teaching University students to combine these techniques with standard and guidelines for medical device design allows the students to approach the development process from a number of different angles and challenges them to think about the user and understand the socio-technical., cognitive and physical parameters, as well as the interactions of these parameters, with respect to the (re)design effort for task performance.