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.

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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Risk Control & Risk-Benefit

4 minute read.

This article explains Risk / Benefit analysis and Risk Control methods using performances of Harry “The Hat” Anderson, a comedian, actor, and magician famous for visual humor.

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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.

The MDR Big Picture

The MDR big picture

7 minute read.

Any company that wants to sell medical devices in the European Union must follow new EU Medical Device Regulations. These new regulations were motivated by EU citizens demanding safer healthcare. This article is the EU-MDR big picture with links to learn more. Read more

The risk of being biased

3 minute read.
Teams resist change because of biases, our tendency to form opinions based on incomplete or inaccurate information. This article explains the nature of our biases and why we resist new regulations in healthcare safety, but the concepts apply to all of us.

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