MedTech Mindset Blog

Design Freeze is a significant milestone in MedTech. It's the point when you're ready to start the Verification & Validation (V&V) process. It implies maturity of your technical design and also your d...

Written by Eric Sugalski

Prototyping is an essential part of medical device development. But, the vast majority of companies get it all wrong. I've been in medical device design and development (w...

Written by Eric Sugalski

I hear it often -- "We need an MVP."

But most of the time it really means, we need a prototype on the cheap. Or, we need to get our first product launched and we're operatin...

Written by Eric Sugalski

In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between design, quality, and regula...