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Actionable medtech articles, weekly.

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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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Proof-of-Concept Pitfalls in Medtech market driven innovation technology development Feb 23, 2022

The phrase “proof-of-concept” (POC) is widely used and engrained in the accepted formula of innovation. Engineers, scientists, researchers, and instructors operate under this mantra...

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Who Pays and Why? market driven innovation Feb 16, 2022

It’s a critical decision that defines your commercial strategy – one that affects your market time horizon, pricing, marketing claims, distribution strategy, and more. Who pays and why?...

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How to build your healthcare economic story market driven innovation Feb 09, 2022

Whether you are an established OEM or a medtech startup, clearly understanding and articulating your healthcare economic story is a vital part of your go-to-market strategy. With healthcare...

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5 Secrets to Actionable User Needs in Medtech market driven innovation regulatory strategy Feb 02, 2022

User Needs (UNs) are the foundational component of your Design History File (DHF). This single document should be the one that feeds design requirements, risk management, and the V&V process....

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