Base jumper or fell runner?

International standards such as ISO 62366, ISO 14971 compliance gurus and journals all talk about taking a risk based approach to elements of your development…

The train at platform 9 and 3/4

We’ve been on a road trip recently, sharing a way of encapsulating the key steps of device development that has been attracting “rave reviews”. I’d…

4 steps to (device) heaven

After I wrote about the MDA’s approach to device development (here’s the post), several people emailed me to find out more. Perhaps, like them, you’re…

Road testing the big picture

Get the right people together, in the right place, at the right time, with a shared idea and a similar outlook. It’s amazing how quickly…