Archimedic Blog

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...

 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...

The prospect of obtaining a new reimbursement code and corresponding coverage for a new medical device is daunting. So much so that many investors simply refuse to pursue medical device opportunities ...

True story. A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device was intended to be a bridge – worn for approxima...

Many medtech leaders are pressured by investors and others to rapidly achieve regulatory clearance with a product design that is not intended for the market. This is sometimes referred to as a “paper ...

User Needs (UNs) are the foundational component of your Design History File (DHF). This single document should be the one that feeds design requirements, risk management, and the V&V process. It’s the...

When you are developing a new medical device, it is tempting to start by brainstorming, developing prototypes, and running demos for investors and others. But this approach will often lead you to a so...