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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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4 Steps to Defining Your Clinical Outcome clinical strategy market driven innovation technology development Apr 20, 2022

Hey – Eric here.

Here are 4 steps on how to clearly define the clinical outcome that compels adoption of your new medical device.

Today’s issue of Medtech Mindset takes about 3 minutes...

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Why Starting with Small Markets Provides Superior Financial Returns clinical strategy market driven innovation Apr 13, 2022

Consider a medical device startup, facing a critical market decision:

Should the company go big, aiming for the $1B market out of the gate? Or should the company go small, proving value with an...

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3 Secrets to Capturing Reliable Clinical Data at Home clinical strategy market driven innovation regulatory strategy Apr 06, 2022

Written by Eric Sugalski and Ulrich Herken

True story.

A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device...

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Why Fast-Tracking Clinical Use can Slow your Medical Device Progress clinical strategy market driven innovation Mar 30, 2022

Clinical use is a significant milestone for most medical device companies. Investors often see this milestone as a significant de-risking activity – one that can come with valuation...

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Which Path to Take – Consumer Product or Medical Device? market driven innovation technology development Mar 23, 2022

Written by Eric Sugalski

It’s a critical decision that defines your commercial strategy – but it’s one that is often taken without carefully weighing the pros and cons of each...

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The IP Anchor Effect intellectual property market driven innovation technology development Mar 16, 2022

New technology is one of the primary drivers of growth in the medical device industry. Developing new tech can be long, iterative, and expensive -- so it is understandable that...

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Is Clinical Data Enough to Drive Market Adoption? clinical strategy market driven innovation Mar 09, 2022

Written by Eric Sugalski and Ulrich Herken

“You need to show clinical evidence that your medical device provides a benefit.”

It's a common request that early medical...

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The Paper 510(k) Strategy regulatory strategy Mar 02, 2022

Written by Eric Sugalski

Many medtech leaders are pressured by investors and others to rapidly achieve regulatory clearance with a product design that is not intended for the market. This...

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