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Written by Eric Sugalski
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...
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...
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
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....
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...
- Written by Sam Menasha & Eric Sugalski
Most medical device companies operate using the waterfall method. But most medical device companies don’t operate as quickly as they could or...
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...