Building a Foundation of Safety: The Crucial Role of Ergonomics and Human Factors in Early Medical Device Development

Abstract

This paper underscores the pivotal role of integrating ergonomics and human factors into the 
early stages of medical device development to establish a robust foundation of safety. By 
prioritizing these elements from the outset, manufacturers can enhance usability, mitigate risks, 
and ultimately improve patient outcomes. Ergonomics and human factors are essential 
considerations in designing medical devices that meet the needs and capabilities of users. 
Addressing these factors early in the development process is crucial to maximizing their impact 
on product design and safety. Failure to do so can lead to increased risks, including user error, 
device misuse, and adverse patient outcomes. Incorporating ergonomic principles into medical 
device design enhances usability and user experience, contributing to improved satisfaction and 
adherence among healthcare professionals and patients. Regulatory standards and guidelines 
emphasize the integration of ergonomics and human factors to ensure the safety and efficacy of 
medical devices. Interdisciplinary collaboration among engineers, designers, healthcare 
professionals, and end-users is essential to address ergonomic and human factors considerations 
effectively. An iterative design process allows for continuous refinement based on user feedback 
and usability testing throughout the development lifecycle