
The forgotten twin?
January 27 2016
Human Factors and Usability are “hot topics” in the medical device world (and increasingly for drug/device combination products too), yet the concept and the disciplines…
Human Factors and Usability are “hot topics” in the medical device world (and increasingly for drug/device combination products too), yet the concept and the disciplines…
So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have…
The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016. In…
During 2015 we dipped our toe in the water, posting thoughts and tips both on our website and LinkedIn Pulse. At the close of the…
UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious…
Whilst visiting a local pharmacy recently, I came across a notice that free flu jabs were available for qualifying NHS patients. This seemed like a…
Developing medical devices that really meet users’ needs will give you a distinct competitive advantage. Following a robust development process that is focused upon the…
A team from Three Circles recently completed a 2 week long formative usability study for a medical device in Europe. The study was typical of…
Medical device manufacturers can have a tough time gaining approval of new devices in the US, due to the increased scrutiny of the usability aspects…
A little over a year ago, I was fortunate to be involved in the AAMI/FDA summit on healthcare technology in the home setting, in Washington…