10 Ways To Align Your Medical Device With Human Factors Industry Best Practices

Discover how human-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that their products align with user expectations.

Battelle, a leading company in medical device design, offers 10 tips to implement best practices in human factors and usability engineering. These include conducting user research, engaging stakeholders, implementing an iterative design process, and conducting rigorous usability testing. Manufacturers should also provide clear instructions and develop standardized training programs to assist users. Post-market surveillance is crucial to identify and address usability issues that may arise. Creating user-centered design documentation that captures the entire design process is essential for regulatory submissions and compliance. Conforming to international standards such as ISO 13485:2016, ISO 14971:2019, and IEC 62366:2015 ensures safety and quality.

Being open to change throughout the development process can reduce costs and improve regulatory approval. By prioritizing collaboration, communication, and empathy for end users, medical devices can meet industry requirements and enhance patient outcomes and user satisfaction. Learn more about how human-centric design principles can revolutionize medical device development.