Use design controls for innovation

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In the movie Wolf of Wall Street, Leonardo DeCaprio challenged his team to “sell me this pen,” implying that a good salesperson could sell anything.

This article helps teams “design a pen” using design controls in a way that sparks innovation. I wrote it for the biotech or medical device industries but the concepts apply to any company that must share work among a team. We go from defining user needs to transferring design into manufacturing.

Medical Device Design Controls

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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

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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

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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

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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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You get what you give in Varanasi India

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7 minute read if you skip the bad stuff.

The Lonely Planet guide to India, the gold-standard of travel guides, a bible for budget backpackers, and usually a kind voice encouraging you to travel without judgement, said this about Varanasi India:

Brace yourself. You’re about to enter one of the most blindingly colorful, unrelentingly chaotic and unapologetically indiscreet places on earth. Varanasi takes no prisoners.

Varanasi tested my patience, humor, and immune system more than anywhere in the world, yet remains one of my favorite memories of a trip across Nepal and India.

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Mindful meditation for pain relief

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7 minute read.

Meditation and mindfulness reduce suffering from pain. The United States Veterans Administration advocates mindful awareness, a process each person must follow until finding what works for their unique situation. Many books and online resources are available to help your process; here’s what worked for me, I hope it helps you. Read more

Meditate on the Buddha’s final words

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This article shares what I learned while meditating on the Buddha’s final words, while backpacking the route of his life from birth to death, from Nepal to India.
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Medical Devices: learn from my mistakes

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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

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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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