P1.1: Consider and diagnose

Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for [...]

Each of these 3 stages is important — and has its experts. The middle stage, developing the core technology, involves proving the science is feasible before investing substantial resources on the [...]

It’s a consequential decision to hand over the responsibility of designing your medical device to an outside team — even if it’s only for part of the project. You need to have a lot of trust and [...]

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 [...]