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.
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, […]
3 minute read, or a 12 minute quiz, if you’re ready. By January 2019, the Canadian government will require all companies selling medical devices in Canada to be certified under the Medical Device Single Audit Program (MDSAP). If you’re familiar with MDSAP, this article quizzes your knowledge of key concepts. If it’s new to you, read […]
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 […]