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This post is a little different from my normal innovation related posts, but a few days ago I had the honour to interview Ronald D Kaye.

For those of you who don’t know who Ron is, allow me to enlighten you. Until late last year Ron worked at the FDA, where he was responsible for the pre-market assessment of medical device user interfaces within the FDA’s Office for Device Evaluation (ODE). In short, if you are a medical device manufacturer, and you want to sell your product in the largest healthcare market in the world, you need to convince Ron’s (former) team that the way your users (patients, healthcare professionals etc) interact with your product is safe and risk free for them. And just to be sure a user interface is not just the buttons your press on a blood pressure monitor, or similar, but also the instructions you write on your pack of aspirin or paracetamol.

Although Ron has now retired, the guidelines that he and a colleague wrote a few years ago are still being used by the FDA. In addition, the people currently working at the FDA in Human Factors assessment, were recruited and trained by Ron. In short, his opinion matters!

In a wide ranging discussion Ron talked about the development of Human Factors testing at the FDA, what the problems were and why they wanted to see manufacturers considering how users would actually use the product being developed. He also highlighted some of the common mistakes companies make in submissions. Things such as, measuring the wrong things, just because they can (measuring how long it takes a user to open the packaging was the best one for me!), providing irrelevant data, not completely understanding all the appropriate risks associated with the device, and most importantly not talking to users and understanding how and why they interact with a device in a certain way.

He also talked about seeing a body of evidence that you have done the work in your submission, understood and categorised the risk, understood the user interactions and designed out the problems that could cause issues with users.

This got me thinking about an analogy. 

If you have kids going through exams at the moment, especially maths, you will find that most kids know the answer to the question and will get it right, but more marks are given to candidates who showed how they got to the answer, demonstrating they understood the question being asked! Exactly the same principle applies to FDA Human Factors submissions!

My interview with Ron has been written up as a white pape. If you would like a copy, then contact us at Pure Insight on info@pure-insight.com (http://info@pure-insight.com), and we will happily send you one.