Mitigating Risks in Medical Device Innovation: A Holistic Approach to Ergonomics and Human Factors
Keywords:
Medical device innovation, Ergonomics, Human factors, Usability, Risk mitigation, User-centered design, Patient safety, Early product development, Regulatory compliance, Design optimizationAbstract
In the realm of medical device innovation, ensuring safety and efficacy is imperative. This paper
advocates for a holistic approach to risk mitigation during the early stages of development by
integrating ergonomic principles and human factors considerations. By prioritizing the
interaction between users and devices, this approach aims to bolster usability, minimize errors,
and ultimately enhance patient outcomes. The significance of early development is underscored,
emphasizing its pivotal role in shaping the success and safety of medical devices. Understanding
user behavior, preferences, and limitations is foundational to this approach, facilitating a usercentered design process. Ergonomic principles are seamlessly integrated into the design phase,
focusing on optimizing device interfaces, controls, and overall usability to enrich the user
experience. Human factors considerations, including cognitive workload and error prevention
strategies, are paramount in medical device development. Rigorous usability testing involving
end-users at early stages allows for the identification of potential issues and the refinement of
design elements to enhance safety and performance.
