P1.1: Consider and diagnose

You're not tearing down to reverse engineer something but rather to spring toward innovation. Tearing it down will give you a great foundation of needed knowledge. Engineers tend to just worry [...]

As you develop a medical device, there will be moments it becomes apparent you need outside assistance. No matter the crossroads you’re facing on your medical device design and development [...]

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 [...]