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Archimedic Blog

The Latest Medtech Insights from Archimedic.

 
Medical Device Design Meets Value Analysis clinical strategy healthcare economics market driven innovation Oct 31, 2024

I had the privilege of interviewing the Value Analysis Whisperer himself, Mark Copeland, who cracked open the black box of Value Analysis Committees and shared the secrets that MedTech companies need ...

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The Rise and Fall of Proteus Digital Health clinical strategy fundraising healthcare economics Mar 26, 2024

You’ve probably heard of Proteus.  mAt one time it was the darling of digital health. But within a single year, Proteus went from a $1.5B valuation to a fire sale at $15m. Here's a recreation of event...

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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 in the chart below. The data is a bit dated. But the push for the quick 510(k) happens just as much today as it did back when...

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

 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 to optimize for fuel consumption.  Without much thought or...

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

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


If you are growing a medical device business, a big part of your mission is to impro...

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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 initia...

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

True story. A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device was intended to be a bridge – worn for approxima...

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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 bumps and subseque...

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

“You need to show clinical evidence that your medical device provides a benefit.” It's a common request that early medical device innovators hear after they gain regulatory clearance. It’s rational, e...

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