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AI Will Bring Back the Builder-Engineer

Posted by Abby Kiliszewski Content on 20 Feb, 2026

The Smartest Engineer in the Room is Changing

For most of engineering history, the “smartest” person in the room wasn’t the one who could produce the ...

Why Some Brilliant Devices Never Get Adopted

Posted by Abby Kiliszewski Content on 13 Feb, 2026

It’s Not FDA. It’s Workflow Politics.

In Medtech, we like to believe that good technology wins. If a device is safe, fast, and effective, adoption of ...

MedTech Isn’t Just STEM, It’s Negotiation

Posted by Abby Kiliszewski Content on 6 Feb, 2026

Why great devices are built through alignment, not just engineering

When majority of people imagine medical device development, they picture engineeri...

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...

The Year-End MedTech Checklist: What to Close Out Before January

Posted by Abby Kiliszewski Content on 30 Dec, 2025

As the year comes to a close, many medical device teams are eager to look ahead to what new goals and roadmaps come next for the new year. However, be...