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Lessons from Recent FDA Recalls and What Device Teams Can Learn

Posted by Abby Kiliszewski Content on 29 Jan, 2026

FDA recalls are not typically due to a fundamentally bad product. More often than not, these recalls result in gaps in documentation, usability errors...

10 Things Every Inventor Should Know Before Prototyping a Medical Device

Posted by Tyler Kiliszewski Content on 11 Nov, 2025

Prototyping a medical device is exciting, but it’s also one of the riskiest parts of product development. A poorly thought-out prototype can cost time...

Plastics Assembly in Medical Devices

Posted by Arin Holecek Content on 22 Oct, 2020

Plastics can be assembled in a variety of ways: through mechanical means, through welding, and through bonding. Here we will talk about these methods ...

Plastics in Medical Devices

Posted by Arin Holecek Content on 14 Jul, 2020

There are a wide range of plastics that can be used in medical devices. Plastic selection depends on application as well as cost and manufacturability...

A Look at a Common Medical Device Design Challenge, Tolerance Stack-ups.

Posted by Arin Holecek Content on 3 Mar, 2020

“A common practice among engineers is to put together a prototype of an assembly with every part very close to the nominal or intended measured charac...