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? […]
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. […]