ANALYSIS OF MEDICAL DEVICES DESIGN REQUIREMENTS

Article type: Research Article

Authors: Chen, Mingbin | Chen, Zhenyu | Kong, Lan | Zeng, Yong

Affiliations: Concordia Institute for Information Systems Engineering, Concordia University, Montreal, Canada

Abstract: The design and functional complexity of medical devices have increased during the past 50 years. As device functionality is becoming complex, safety, reliability, and comfort are becoming increasingly critical in the medical devices design. Case studies show that the majority of failures of medical devices come from the ignorance of important design requirements in the design stage. Based on the environment-based design model, this paper studies the sources of medical devices design requirements and proposes a systematic approach to guiding the gathering and collection of these requirements.

Keywords: medical devices, design requirements, human factors

Journal: Journal of Integrated Design & Process Science, vol. 9, no. 4, pp. 61-70, 2005