• Out With The Old, In With The New: Considering Legacy Systems Early In The Design Process

    As a medical device innovator, you may be positioning your product to replace a legacy system. If you ignore how your device will affect an established workflow, you could negatively impact user experience and safety with your new design. This article will discuss these negative consequences and show the importance of understanding the legacy system workflow early in your design process — to help reduce use errors and achieve higher acceptance/retention rates.

  • An Introduction To Human Factors Engineering For Medical Device Development

    I hope by now the overwhelming majority of medical device manufacturers have at least heard of human factors. If you are reading this and are unfamiliar with human factors or usability, I fear that you may learn about it the hard way — a "wakeup call" from the FDA in response to your 510(k) submission requiring human factors and usability testing to be performed. But this type of testing, when executed correctly, will usually identify areas for design improvements to reduce use errors, leading to a better and more lucrative product.

Andy Schaudt, MedStar Health

Andy Schaudt

Andy Schaudt is the director of usability services for the National Center for Human Factors in Healthcare at the MedStar Institute for Innovation. In this role he plans, coordinates, and manages the projects, programs, and daily operations for the usability division, which is chartered to conduct medical device and health IT usability evaluations, both for the industry and for MedStar Health (a 10-hospital healthcare system in the Washington, DC / Maryland region). The author can be contacted through