Why incorporate human factors early in medical device design?
By Adam R Shames A common reason for a medical device company to call us for the first time is that they have received a response letter from the Food and Drug Administration (FDA) requiring them to run a human factors study . They are usually surprised because they have never had to consider human factors before. Why should a company incorporate human factors early on in their medical device design process, and not just as a reaction to an FDA letter? It is simple, because it will create a better, more effective device and save them time and money. Many designers claim their device is intuitive and people will be able to use it with common sense. Unfortunately, you cannot assume a person can use a medical device until you see a person actually using it safely in real-life or a simulated-use environment. The reality is that people are fallible. Highly educated healthcare professionals make medical mistakes that result in far too many deaths than we should find acceptable. The D