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Archimedic Blog

The Latest MedtechĀ Insights from Archimedic.

Who's Responsible for Ensuring Single-Use? Everyone. design 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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Good Enough for the Top 4%: The Go-to-Market Lesson Every Medtech Startup Needs design market driven innovation product development regulatory strategy Jun 10, 2026

MedTech InnovatorĀ 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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AI Skipped Childhood design human factors Jun 04, 2026

AI has a massive blind spot that nobody is talking about.

LLMs lack physical intuition. The kind you and I started learning as infants.

When you dropped something onto the ground, you learned what would...

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DRG Framework design market driven innovation regulatory strategy Apr 28, 2026

Why do so many medical devices fail to make it to market? The market is there. The concept is novel. The technology is achievable. It can’t NOT work, right?

And yet, the vast majority of medical devi...

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5 Essential Checks Before Design Freeze in MedTech design manufacturing project management prototyping quality management v&v Jun 19, 2024

Design Freeze is a significant milestone in MedTech. It's the point when you're ready toĀ start the Verification & Validation (V&V) process.Ā It implies maturity ofĀ yourĀ technical design and also your d...

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5 Steps to Effective Prototyping in MedTech design product development project management prototyping technology development May 09, 2024

Prototyping is an essential part of medical device development. But, the vast majority of companies get it all wrong. I've been in medical device design and development (with a heavy dose of prototypi...

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But hey, it's MVP... design product development Apr 09, 2024

I hear it often -- "We need an MVP." But most of the time it really means, we need a prototype on the cheap. Or, we need to get our first product launched and we're operating on a shoestring.

Funds a...

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Dividing Lines Between Design, Quality, & Regulatory in MedTech design quality management regulatory strategy Dec 02, 2023

In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between Design, Quality, and Regulatory functions. Questions ...

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