Archimedic 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...

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 (with a heavy dose of prototypi...

In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations, quality managers primarily focus on identifying and ...

Picture this -- you've raced to the airport and found yourself at the end of a massive security line. You do the truffle shuffle with shoes off, belt off, keys out, laptop out, while the security agen...

Most medical device companies operate using the waterfall method. But most medical device companies don’t operate as quickly as they could or should.

The waterfall goes like this:

1. Write down your
...

Most companies run product development under the Hero model. This is where a highly experienced medical device developer gives play-by-play direction on product development activities. This can work s...

Meetings. When you hear the word, what comes to mind? You're probably imagining a large assembly of colleagues listening to a self-promotor monologue on some irrelevant topic. It's long and tedious. E...

When developing a new medical product, have you ever heard a medtech investor or exec say, "Take your time. We'll get there when we get there.."? Us either.

There's always urgency. And for good reaso...