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Written by Eric Sugalski
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...
Written by Christopher Scholl
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...
You’ve probably heard of Proteus.
At 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.
...
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
In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations,...
Written by Eric Sugalski
In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between design, quality, and...
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...
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...
Written by Eric Sugalski
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....
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 –...
- Written by Aidan Hyde & Eric Sugalski
Defining the right use case, ensuring a positive user experience, and mitigating user related risks are critical parts of the medical device design...