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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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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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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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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