This is under revision… please don’t forward this version. For a current version, please see my iteration on Linkedin. Early in 2018 I underwent surgery surrounded by medical devices that were made by companies for which I had consulted. As the staff connected to a device that would keep me breathing during surgery, I thought […]
6 minute read. In the 1980’s, the rock-band Van Halen caused $85,000 damage to their dressing room because they found brown M&M’s in their bowl of “munchies.” Van Halen’s story can help medical-device companies pass an FDA or ISO Quality-System audit. This article shows you how, but the conclusion may not be what you think. […]
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). There are only a few circumstances in which this deadline can be extended. If you’re familiar with MDSAP, […]
5 minute read. This article provides an overview of FDA design controls and lists resources to help understand and apply them. BACKGROUND Researchers in the 1980’s discovered that 44% of medical device recalls in the United States could have been prevented through design controls. Almost half of medical device recalls were preventable before a product […]
6 minute read. The Medical Device Single Audit Program (MDSAP) allows medical device companies to sell products in multiple countries with one audit. This article summarizes the MDSAP and helps your company prepare for it. If you’re confident in your knowledge of MDSAP, consider taking a quiz to see if you’re prepared for MDSAP. After […]
5 minute read. The Buddha was born in Lumbini, Nepal, 2,600 years ago. Today, Buddhism is the world’s 4th largest religion. I traveled to Lumbini to see what the Buddha’s life would have been like when he was known as Prince Siddhartha Gautama. Lumbini I arrived in Lumbini by bus after hiking over the Himalaya […]
6 minute read. When you walk through a jungle, remember four things: If you’re charged by a rhino, climb the nearest tree. If there are no trees, run in a zig-zag pattern and drop your backpack or a piece of clothing; rhinos have poor eyesight and use their sense of smell when charging.If you encounter […]
6 minute read. After hiking across the Himalaya Mountains, I entered the kingdom of Mustang. I had learned a few Nepali phrases; how to meditate effectively; and how to be mindful in each moment. I would spend the next two weeks hiking through Mustang and down another side of the Himalayas. The previous blog ended […]
11 minute read. It took 28-days to hike over the Himalaya Mountains. This blog describes people I met, life in the Himalayas, altitude sickness (and rescues), and methods I used to develop mindfulness. It began in the town of Besisahar and ended in Beni Bazar. Background This was part of a longer backpacking trip through […]
4 minute read. Two hours before arriving in Kathmandu, I opened a guidebook for the first time. I was flying into Nepal and would depart from India. My plan was to not have plans, adapting each day based on people I met and lessons I learned. I’ve traveled this way for 30 years: fly into […]