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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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Dividing Lines between Design, Quality, and Regulatory Functions in MedTech design quality management regulatory Dec 02, 2023

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...

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5 Steps to Prepare for an Early and Informative Q-Sub with FDA regulatory May 18, 2023

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...

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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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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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Top-Down and Bottom-Up Modes in Medtech clinical strategy market driven innovation regulatory strategy Aug 31, 2022

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...

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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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Speed versus Scale in Contract Manufacturing manufacturing Jun 15, 2022

What is your manufacturing strategy? There are several options to consider. Sometimes it makes sense to engage a large CMO early, whereas other times it makes sense to launch manufacturing with a...

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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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Should your Medtech Team Bulk Up or Stay Lean? team development Jun 01, 2022

Medtech teams have a critical decision to make at the early stages. Should the strategy be to build a robust in-house team or leverage outsourced experts to achieve medtech milestones. Here's...

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