Archimedic Blog

If you're building medical devices, there's an "AI" that will determine your time to market far more than the one in every headline right now. It's the Additional Information request, and understandin...

What Human Factors Actually Costs (and What Drives the Number)

If you've been searching the web for what a human factors program costs so you can plan a budget, you've probably come upon a lot of pag...

Most founders treat reimbursement like taxes: something to deal with once the real work is done. Build the device, get it cleared, then figure out how to get paid. That sequence is backwards, and it's...

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...

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...

The FDA published its mid-year device authorization numbers and the news is bittersweet.

More devices are getting approved in 2026 than at this point last year (good news), but the time it's taking to ...

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...

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, ...

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...

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...

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...

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 ...