Medical Device Design Controls

This article provides an overview of FDA design controls and lists resources to help understand and apply them.
This is in a “dry” format, necessary for repeating definitions. See my blog for versions that use case-studies or are related to pop culture.

5 minute read.

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Design Control: learn from my mistakes

Innovation, efficiency, and safety can coexist when a team uses effective design controls. In this article, I apply modern design controls to a product I co-invented and commercialized in 2004 using lessons learned in 15 years.
I describe that product in another article. This article helps you learn from my mistakes.

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Medical Devices: learn from my mistakes

In 2004 I managed a medical device team. Our company developed products faster than competitors, rapidly grew sales, and earned twice the profit of similar products. A larger company bought us for $42 Million.

That sounds like a success, but years later I learned that our product caused pain and suffering for some patients and added useless healthcare costs to everyone.

In this article you can choose your adventure, choosing which you’d like to see addressed after 15 more years of experience in:

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Van Halen, Brown M&Ms, and Quality Assurance

6 minute read.

In the 1980’s, the rock-band Van Halen caused $85,000 damage to their dressing room after finding brown M&M’s in their bowl of “munchies” before a concert. The facts behind that story can help medical-device companies become more efficient and pass any FDA or ISO Quality-System audit. This article shows you how, with the lead singer of Van Halen, David Lee Roth, as your guide.

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