Design-phase-specific selection of user research methods

For increasing the usability of a medical device the usability engineering standards IEC 60601-1-6 and IEC 62366 suggest incorporating user information in the design and development process. However, practice shows that integrating user information and the related investigation of users, called user research, is difficult in the field of medical devices. In particular, identifying the most appropriate user research methods is a difficult process. This difficulty results from the complexity of the medical device industry, especially with respect to regulations and standards, the characteristics of this market and the broad range of potential user research methods available from various research disciplines. Against this background, this study aimed at guiding designers and engineers in selecting effective user research methods according to their stage in the design process. Two approaches are described which reduce the complexity of method selection by summarizing the high number of methods into homogenous method classes. These approaches are closely connected to the medical device industry characteristic design phases and therefore provide the possibility of selecting design-phase- specific user research methods. In the first approach potential user research methods are classified after their characteristics in the design process. The second approach suggests a method summarization according to their similarity in the data collection techniques and provides an additional linkage to design phase characteristics. Both approaches have been tested in practice and the results show that both approaches facilitate user research method selection. © 2009 Springer-Verlag