Posts

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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The European MDR: learn from my mistakes

The European Union Medical Device Regulation protects patient safety and encourages medical device innovation. Companies that embrace the opportunity will succeed; companies that complain will not. Either way, society benefits.

This article is to help you learn the MDR using a product I co-invented and commercialized in 2004, demonstrating how to apply modern MDR regulations. I describe that product in another article. This article helps you learn from my mistakes.

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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Risk Management: learn from my mistakes

This article is about Risk Management applied to a medical device I co-invented and commercialized in 2004. I followed it’s history after our company was acquired, and am re-analyzing our 2004 work 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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Make state of the art medical devices

7 minute read.

The new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s easily misunderstood. This law is best explained with an example from cars,  comparing today’s state of the art with to the 1980’s television series Knight Rider, where David Hasselhoff fought crime in a talking, self-driving car.

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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Reduce Risk As Far As Possible

In 1987, the hip-hop group Public Enemy asked: “How low can you go?” In 2017, Europe responded, “As Far As Possible.” This article discusses how to reduce medical device risks as low as possible.

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How to apply Risk Management

6 minute read.

In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts. In this article, I travel back in time to reanalyze the Space Shuttle program using modern methods for Risk Management.

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