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.