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But hey, it's MVP... design mvp product development Apr 09, 2024

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...

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The 510(k) Fallacy clinical strategy market driven innovation product development regulatory strategy Mar 10, 2024

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...

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5 Reasons to NOT Outsource Medical Device Development market driven innovation product development research team development technology development Feb 19, 2023

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....

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Quality - The Secret Weapon to Accelerate Time-to-Market in Medtech product development quality management regulatory strategy Jul 06, 2022

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 –...

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Don’t listen to users (and 3 other human factors tips) human factors market driven innovation product development Jun 29, 2022

- 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...

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Can Scrum and Medtech Coexist? product development project management Jun 22, 2022

- 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...

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How to drive speed and quality with your product development process product development project management Jun 08, 2022

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...

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