In 1987 Chuck D, frontman of the hip-hop group Public Enemy, asked: “How low can you go?” In 2017 Europe responded: “As Far As Possible.” The new European Union Medical Device Regulation entered into effect in 2017 and will require devices to reduce risk As Far As Possible by 2020. Noncomplying devices will be removed […]
I hiked over one of the world’s highest mountain passes in a four-week journey, offline, without plans. This blog describes people I met, life in the Himalayas, altitude sickness (and rescues), and methods I used to develop mindfulness that allowed me to overcome a decade of suffering from chronic pain. It began in the town […]
7 minute read if you skip the bad stuff. Varanasi tested my patience, humor, and immune system more than anywhere in the world. 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: Brace yourself. You’re about […]
6 minute read. In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts. The explosion originated near an O-ring gasket that sealed rocket fuel. The gasket protected a known design flaw that could expose fuel to fire. NASA’s purchasing department had bought the O-ring based […]
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.
8 minute read (4 if you ignore one part). This article is to help anyone who would like to improve their electronic search skills. Over the past couple of years, I’ve noticed a wider range of people unsure of, or unaware of, search techniques I take for granted. To cut to the chase, read these […]
In 1993, the rock musician Prince changed his name to an unpronounceable symbol, confusing record companies, concert venues, and even fans. It turned out to be one of the most productive times of Prince’s esteemed career, releasing two albums each year during this transition. In 2020, the European Union is changing their Medical Device Directive […]
Harry Anderson passed away last month; my thoughts are with his wife, son, daughter, and family. The following is unusual, but truthful. It’s how Harry “The Hat” Anderson helped me learn, and teach, design, entrepreneurship, and risk management. 7 minute read. Harry Anderson was a television star on Cheers, Night Court, Dave’s World, It, and […]
I grouped celebrities who share a common medical treatment and ask you to classify the device using the new European Union Medical Device Regulation rules. I give the answers, you respond in the form of a question. If you need to see it in action, watch the video of Saturday Night Live’s Celebrity Jeopardy spoof. […]
Three of my skills in this world include medical device development, teaching, and 1980’s pop culture. This article combines all three, using pop culture to illustrate concepts behind medical device quality system regulations that require a “process-based approach.” It’s starts with this, which will either confuse you or make you chuckle: Was that a process? […]