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How Do FDA Device Classifications Work?

Posted by Tyler Kiliszewski Content on 14 Oct, 2026

When someone develops a new medical device, one of the first questions they usually ask is, "How do I get FDA approval?"

Why Engineers Obsess Over Problems That Haven’t Happened Yet

Posted by Tyler Kiliszewski Content on 5 Oct, 2026

Engineers spend a surprising amount of time worrying about things that haven't happened.

The Hidden Engineering Behind Everyday Medical Devices

Posted by Tyler Kiliszewski Content on 16 Jun, 2026

When most people interact with a medical device, little thought is given to the engineering behind it. Whether it is a simple glucose monitor or a com...

From Sketch to Surgery: The Journey of a Medical Device

Posted by Abby Kiliszewski Content on 4 Jun, 2026

Every device begins with an idea

Whether that be a drawing on a napkin when a thought appears or an inspiration coming from a clinician voicing their ...