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 […]
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.
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. […]
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.
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.
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 […]
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.
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.
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 […]
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.