Enhancing Risk Awareness and Ergonomics Integration in Early Medical Device Conceptualization: A Critical Review

Abstract

Medical device design and development is a complex process that requires meticulous attention 
to both functionality and safety. This critical review explores the integration of risk awareness 
and ergonomics in the early conceptualization phase of medical device development. 
Recognizing the significance of these factors in mitigating hazards and enhancing user 
experience, this review highlights the current state of research, identifies gaps, and proposes 
strategies for improvement. Key findings suggest a need for greater emphasis on risk assessment 
methodologies and ergonomic considerations during the initial stages of device 
conceptualization. By fostering a proactive approach to risk management and ergonomics 
integration, manufacturers can streamline the development process, optimize device 
performance, and ultimately improve patient outcomes.