On the afternoon of 13th January 2016, I spent a very enjoyable and insightful 90 minutes on the phone with Ron Kaye. Until late last year, Ron was the leader of the Human Factors PreMarket Evaluation Team within the FDA’s Office of Device...

From its’ inception in 2000, I led the establishment of the FDA/CDRH Human Factors program and then saw it flourish in its efforts to improve the safety and efficacy of medical devices. That initiative was then extended to FDA/CDER, as they began their Human Factors...

Without doubt the technology is advancing at an unbelievable rate, and technology can do more and more for us, making our lives simpler, giving us more time to do the things we like to do, and, dare I say it, removing human error from the equation. Nowhere is this...

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...