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5 Essential Checks before 'Design Freeze' design manufacturing project management prototyping quality management v&v Jun 19, 2024

Design Freeze is a significant milestone in MedTech. It's the point when you're ready to start the Verification & Validation (V&V) process. It implies maturity...

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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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Quality Managers | Moving from the Back Seat to the Driver's Seat in Medical Device Development project management quality management regulatory Dec 10, 2023

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,...

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EVT - It's like TSA precheck for Verification & Validation manufacturing project management quality management v&v May 02, 2023

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...

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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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How to Run Meetings that Don't Suck project management May 25, 2022

Written by Eric Sugalski

Meetings. When you hear the word, what comes to mind?

You're probably imagining a large assembly of colleagues listening to a self-promotor...

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3 Timeline Killers in Medical Device Development project management May 18, 2022

Written by Eric Sugalski

When developing a new medical product, have you ever heard a medtech investor or exec say, "Take your time. We'll get there when we get there.."?

Me neither.

There's...

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