Human error is one of the predominant factors in adverse events experienced in healthcare. It is well established that ‘human error ‘is inevitable’. You just cannot prevent users from making mistakes due to fatigue, ignorance, training decay or over-tasking.  But  you can anticipate the use error, and design a product that is safe and effective in preventing harm to the patient. 

The Standards and Guidelines for applying Human Factors Engineering (also ‘Usability Engineering,’) to medical device development processes, are clear. Medical Device manufacturers are expected to identify use error as part of the overall device risks and eliminate or reduce, by design, flaws that allow a likely use error to result in possible harm to the patient.  To verify that you did just that, pre-market submission reviewers expect testing and data that addresses any known, expected, or unanticipated use problems.  Applying the principles and processes of Human Factors Engineering will help you predict , detect and mitigate those use problems.  

So, regardless of whether you are a startup company, redesigning an existing product or in the early, middle or late stage of your product development,  enable your team to detect the BIG OOPSES early by embedding a few simple, good Human Factors Engineering principles. It will protect you from having to deal with late design changes, delayed market introductions or, even worse, product recalls .