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The Latest Medtech Insights from Archimedic.

Investigational Device Exemption (IDE) Trials: Burden or Asset? alex shaw clinical strategy regulatory strategy Jul 16, 2026

Are Investigational Device Exemption (IDE) trials a burden or asset?

Truth is, they can be either, depending on how they're designed.

Ask most device teams about IDE trials, and you'll hear about bu...

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Who's Responsible for Ensuring Single-Use? Everyone. design rightley mcconnell Jul 10, 2026

A Memphis gynecologist was sentenced to 20 years in federal prison for performing more than 15,000 hysteroscopy procedures on women using dirty, reused single-use devices.

He bought fewer than 200 ne...

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A $335M Lesson in Strategic Partnering for All MedTech Founders fundraising market driven innovation rightley mcconnell Jun 25, 2026

If you are an early-stage medtech founder who thinks a $335 million exit has nothing to teach you, this one is worth five minutes of your time.

In 2026, Artivion, Inc. paid $135 million upfront, with u...

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Crossing the Chasm from QSR to QMSR alex shaw quality management regulatory strategy Jun 23, 2026

Are you adapting an existing quality system from QSR to QMSR/ISO 13485?

If so, you're not alone, and you may be finding that the transition isn’t completely seamless.

To bring everyone up to speed, ...

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Is It a Medical Device? alex shaw product development regulatory strategy Jun 17, 2026

Is your product a medical device…or is it not?

It is a seemingly simple question. However, we often talk with innovators who are unsure about the answer.

The ramifications are real, and often existe...

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Good Enough for the Top 4%: The Go-to-Market Lesson Every Medtech Startup Needs design market driven innovation product development regulatory strategy rightley mcconnell Jun 10, 2026

MedTech Innovator announced its 2026 accelerator cohort. Congrats if you're one of the lucky few! 65 companies were selected from 1,835 applicants. MTI has a 93% ten-year survival rate among alumni, a...

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FDA Clearance is Not the Finish Line market driven innovation project management regulatory strategy rightley mcconnell Jun 04, 2026

FDA clearance is not the finish line.

Most founders know that. What fewer plan for is that it might not even be a pit stop with a defined length. As any F1 fan will tell you, an unexpected pit stop of ...

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The Importance of Core Values alex shaw team development May 28, 2026

Should a small BioTech or MedTech startup spend precious time and resources developing a corporate mission and core values? The answer is 100%, absolutely, unequivocally, YES.

A clearly stated missio...

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Acquirers Don't Buy Your Device, They Buy Your Market Position clinical strategy fundraising market driven innovation rightley mcconnell May 25, 2026

Olympus Corporation just agreed to pay $270 million for a balloon filled with saline… Take a moment with that.

At $14.5 million in sales, that’s more than an 18x on a times-revenue basis. For what is, ...

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Breaking Barriers in MedTech Fundraising fundraising Feb 21, 2025

Raising funds for a MedTech startup isn’t just about pitching investors—it’s about building relationships, gathering insights, and positioning your innovation for long-term success. In a recent Linked...

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A Peek into the Angel Due Diligence Process for MedTech fundraising Jan 30, 2025

It’s been just over a year since I joined Robin Hood Ventures as an angel investor. While many investors in the group are far more seasoned, I’ve gained invaluable insights by diving into the due dili...

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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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