Archimedic Blog

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...

Ever built the wrong medtech device? I’ve worked at a number of medical device companies and each one took a different approach to writing User Needs and Design Inputs. And it’s no wonder—FDA CFR and ...

You’ve probably heard of Proteus.  mAt one time it was the darling of digital health. But within a single year, Proteus went from a $1.5B valuation to a fire sale at $15m. Here's a recreation of event...

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...

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 ...

In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between Design, Quality, and Regulatory functions. Questions ...

Many organizations believe that the Q-Sub process should be completed after a design is relatively mature. The belief is that sufficient technical detail needs to be shared to gain substantive feedbac...

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...

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...

 Consider this analogy..  You are driving across the US, planning for a week to travel from coast to coast. With elevated gas prices you want to optimize for fuel consumption.  Without much thought or...

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...