Minneapolis, MN — Kablooe Design Inc., a leading medical device design consultancy, has achieved certification to ISO 13485:2016, the internationally recognized standard for quality management systems (QMS) in the medical device industry.…
Once upon a time, a little girl named Goldilocks wandered into the woods and entered a house that didn’t belong to her. Inside, she found three bowls of porridge.
One was too hot.
One was too cold.
And one—just one—was just…
Failure has a branding problem.
In product development, especially in medical technology, failure can sound like the thing everyone is trying to avoid. Failed tests. Failed launches. Failed assumptions. Failed investments.
But when…
Those of us who are in the design industry typically spend a lot of our time thinking about the person who is going to use our fabulous invention, and what the situation is like when they will be using it...
Welcome to today’s lesson on Medical Device Classification 101. Don’t worry—there won’t be a pop quiz at the end. But by the time the bell rings, you’ll walk away with a clear understanding of how Class I, Class II, and Class III…
“We’re not just designing devices—we’re designing dignity.”
That sentiment, shared by Kablooe CEO Fred Sklenar during his MD&M Midwest presentation, perfectly captures the mission behind today’s most impactful healthcare…
Prepare to boldly go where no engineer has gone before!
In the world of embedded software engineering, chaos lurks in the void between hardware and software. Signals misfire. Timelines collapse. And sometimes, even the most promising…
Diving into product development concept work too early is one of the most common mistakes teams make. And while it’s tempting to chase the fun stuff right away, skipping the all-important groundwork often leads to bigger problems down the road. In fact, resisting early ideation is often the smartest move you can make.
5 Hidden Potholes of Medical Product Development
Is Your MedTech Design Revolutionary or Evolutionary?
Kablooe Design Achieves ISO 13485:2016 Certification, Strengthening Its Commitment to Quality in Medical Device Development
The Goldilocks Principle of Usability: Not Too Complex, Not Too Simple
Fail Early, Fail Often, Fail Smart: The Power of Iterative Design
How to Design a Better Medical Device User Interface
Class is in Session: How Kablooe Excels in Class I, II, & III Medical Devices
Aging-in-Place Technology: How Innovation and Empathy Are Redefining Home-Based Healthcare
Resistance Is Futile: How Embedded Software Engineering Assimilates Hardware and Software
5 Reasons to Hold Off on Concepting and Ideation in Product Development