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Actionable medtech articles, weekly.

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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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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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How to Turn Conflicting Feedback into Market Clarity market driven innovation research May 11, 2022

Most companies avoid primary market research. They believe that in-house tribal knowledge is enough to make the key product and business decisions. Research would just tell the team...

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FDA's Early Payor Feedback Program (EPFP) payor strategy regulatory strategy May 04, 2022

The prospect of obtaining a new reimbursement code and corresponding coverage for a new medical device is daunting. So much so that many investors simply refuse to pursue medical device...

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The #1 Thing that Prevents Medtech Companies from Raising Funds fundraising Apr 27, 2022

Hey - Eric here.

Happy Wednesday to 602 motivated medtech business leaders.

Here's one short tip on how to refine your medtech strategy.

Today's Medtech Mindset issue takes about 4...

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