Assessing Ergonomics and Risk Awareness in the Initial Phases of Medical Device Design: A Critical Perspective

Abstract

In the realm of medical device design, ensuring ergonomic considerations and risk awareness in 
the initial phases is crucial for enhancing usability and safety. This critical perspective paper 
delves into the assessment of ergonomics and risk awareness in the early stages of medical 
device development. By scrutinizing existing methodologies and practices, it highlights the 
significance of integrating ergonomic principles and risk management strategies from the outset. 
Drawing upon interdisciplinary insights from human factors engineering, usability testing, and 
regulatory compliance, this paper advocates for a holistic approach that prioritizes usercentered design and proactive risk mitigation. Through case studies and theoretical analysis, it 
elucidates the complexities involved in balancing usability requirements with stringent safety 
standards. Furthermore, it underscores the necessity of fostering a culture of continuous 
improvement and collaboration among stakeholders to address evolving user needs and 
regulatory expectations. Ultimately, this critical perspective serves as a call to action for 
researchers, designers, and regulatory bodies to collectively prioritize ergonomics and risk 
awareness in the nascent stages of medical device design, thereby fostering innovation and 
enhancing patient outcomes.