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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...

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...

Dr. Bon Ku's Solutions to Healthcare Challenges

Posted by Arin Holecek Content on 30 Mar, 2020

As developers of medical devices, it’s our job to focus on the details required to take a design from concept to clinical readiness. There is a tremen...

New World Order - Working from home during COVID-19

Posted by Arin Holecek Content on 30 Mar, 2020

The Decision to Move

Zewski Corp. is located in Texas and I live in Colorado, so I was already working from home when COVID-19 hit, but as early news ...

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...