P1.1: Consider and diagnose

In the past, medical device design companies and consumer product companies didn’t often intersect. Medical product developers were almost exclusively concerned with FDA regulations, while [...]

Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason.

If you’re reading this, you probably have a viable idea for a new medical device — and that’s exciting. You’re ready to launch a startup and get your product into the hands of the users who need [...]

Human factors and usability activities play a vital role in medical product development. Not only do they help provide insight for development, they are also closely tied to risk management and [...]

If you’re planning to bring a new medical device to market, your first order of business is to determine how your product will be classified by the Food and Drug Administration.

As medical product developers, we observe design every day in what we see and interact with, learning from the problems of the past and using those insights to fuel our ideas for new products. So [...]