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? […]
6 minute read. This article uses 1980’s pop culture to describe purchasing requirements in ISO 13485 and the Medical Device Single Audit Program, MDSAP. In the 1986 film “Crocodile Dundee,” a gang in New York attempted to rob a crocodile-hunter visiting from Australia. They flashed a knife, and he replied with a line that’s been […]
2 minute read. I define addiction as: Acknowledging an action has consequences harmful to yourself or othersAcknowledging that you’d like to stop an action, then repeating the action I took this photo in 2010 while laughing with friends after I had surgery and was diagnosed with medical conditions associated with chronic pain. By 2017 the […]
6 minute read, unless you’re dyslexic, then it’s 9 19% of us have it, and so do 55% of prisoners and many celebrities. Dyslexia has many forms, and many levels, and we may not even realize we have it. What’s saddening is the correlation between dyslexia, school dropouts, and prison. 5-19% of people exhibit dyslexia35% […]
4 minute read. Sitting longer than 30-60 minutes at a time increases your risk of back pain, diabetes, and cardiovascular disease. It also decreases your learning ability and mental alertness. You can take steps every 30 minutes to increase your physical health and mental clarity; literally, take steps every 30 minutes, at a minimum. For […]
5 minute read. This is the history of hope, happiness, and politics. It starts with the caste system in Nepal and ends with how to recognize truthful hope. The caste system I arrived Kathmandu and learned that Nepal was recovering from a ten-year civil war, had a new democracy, and would be voting for the […]
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 […]