In 2004 I managed a medical device team. Our company developed products faster than competitors, rapidly grew sales, and earned twice the profit of similar products. A larger company bought us for $42 Million. That sounds like a success, but years later I learned that our product caused pain and suffering for some patients and […]
4 minute read. This article explains Risk / Benefit analysis and Risk Control methods using performances of Harry “The Hat” Anderson, a comedian, actor, and magician famous for visual humor.
7 minute read. 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 easily misunderstood. This law is best explained with an example from cars, comparing today’s state of the art with to the 1980’s television series Knight Rider, […]
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). If you’re familiar with MDSAP, this article quizzes your knowledge of key concepts. If it’s new to you, read […]
6 minute read. In the 1980’s, the rock-band Van Halen caused $85,000 damage to their dressing room after finding brown M&M’s in their bowl of “munchies” before a concert. The facts behind that story can help medical-device companies become more efficient and pass any FDA or ISO Quality-System audit. This article shows you how, with the […]
In 1987, the hip-hop group Public Enemy asked: “How low can you go?” In 2017, Europe responded, “As Far As Possible.” This article discusses how to reduce medical device risks as low as possible.
6 minute read. In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts. In this article, I travel back in time to reanalyze the Space Shuttle program using modern methods for Risk Management.
7 minute read. Any company that wants to sell medical devices in the European Union must follow new EU Medical Device Regulations. These new regulations were motivated by EU citizens demanding safer healthcare. This article is the EU-MDR big picture with links to learn more.
Sixty-three words that could change the world are:
3 minute read. Teams resist change because of biases, our tendency to form opinions based on incomplete or inaccurate information. This article explains the nature of our biases and why we resist new regulations in healthcare safety, but the concepts apply to all of us.