ABSTRACT
Cross-cultural or cross-national design of medical devices refers to the design of medical devices for international markets. These designs consider culturally speci c differences that may in uence the safety of medical devices in other countries. The terms “culture” and “nation” both describe the nature of the international market. Although culture is usually associated with national boundaries, a nation may contain more than one culture (e.g., the province of Quebec in Canada, where French is spoken instead of English), while different nations may exhibit similar cultures (e.g., Austria and Germany). This chapter identi- es design issues that are in uenced by culture-or nation-speci c factors and provides information to assist in the design of medical devices for use in international markets. A process that considers the unique requirements of cross-national and cross-cultural design in the analysis, design, and evaluation phases is proposed and discussed. When this process results in speci c solutions for a market segment, this is called localization. If it results in a solution suitable for all targeted market segments, this is called globalization. Globalized technology (e.g., computers) may have fewer cultural differences than do devices intended for use by the population as a whole.
