This article gives two steps your company can quickly take to prepare for the most confusing requirement of the new European Union Medical Device Regulation, reducing risk As Far As Possible. I use the Kaizen approach to continuous improvement of applying small steps that are likely to be understood rather than drastically new procedures that […]
This is an older version, kept on my site because other articles link to it. I recommend switching to the newer version. 7 minute read. Beginning in 2020 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 […]
7 minute read. The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by European citizens demanding safer healthcare; the United States is considering similar changes. This article is the EU-MDR big picture with links to learn more. WHY Almost 400,000 people received toxic implants […]
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 […]