Three Key Steps to Successfully Integrate Human Factors & Usability into Medical Device

June 24, 2018

The terms “usability” and “human factors engineering” have recently gained much attention in the medical device design community but the principles behind them are historically established and proven for good device development. Since October 2009 when the Association for the Advancement of Medical Instrumentation (AAMI) published its recommendation for human factors standard HE 75, [1, 2] the FDA has expected medical device manufacturers to identify, understand, assess and mitigate use error in the design of new products and, perhaps most importantly, document their risk management efforts throughout the development process.

The authors here believe that it is becoming increasingly important to demystify the process of understanding and incorporating the user’s perspective and context into medical device design and to share best practices in order to raise industry standards.