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The 510(k) Fallacy clinical strategy market driven innovation product development regulatory strategy Mar 10, 2024

Quick 510(k) = Quick exit 

Right?

Not quite.

 

Here's some interesting data: 

SVB: 2019 Trends in Healthcare Investments and Exits

 

Ok, the data is a bit dated. But the push...

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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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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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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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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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