Archimedic Blog

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...

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 operating on a shoestring.

Funds a...

Quick 510(k) = Quick exit. Right? Not quite.

Here's some interesting data in the chart below. The data is a bit dated. But the push for the quick 510(k) happens just as much today as it did back when...

I know what you're thinking - this is a sales pitch in disguise. Not the case. The intention of this article is to help you understand when to steer clear of outsourcing. And there are plenty of those...

Most of the time, quality (as in “quality management”) is only considered after a design concept is mature, if not finalized. Design control, document control, risk management – they are considered ch...

Defining the right use case, ensuring a positive user experience, and mitigating user related risks are critical parts of the medical device design process. Interfacing with users (often) is a smart t...

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...