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5 Steps to Effective Prototyping in MedTech design product development project management prototyping technology development May 09, 2024

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...

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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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