Join the conversation
Drop your email in the form below, and you will receive our medtech articles as soon as they're published.
Quick 510(k) = Quick exit
Right?
Not quite.
Here's some interesting data:
SVB: 2019 Trends in Healthcare Investments and Exits
Ok, the data is a bit dated. But the push...
Written by Eric Sugalski
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...
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 –...
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...
Written by Eric Sugalski and Ulrich Herken
True story.
A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device...
Written by Eric Sugalski
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...
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....
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...