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Product Testing – It Can Really Hurt

Imagine a pioneering surgeon inventor and entrepreneur dedicated to proving that his latest medical device is safe by implanting it within the muscle of his own rib cage… by himself. Then, months later, removing it… again, by himself. The surgeon told me that it was a lot more difficult taking the device out than it […]

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Can You Reduce Device Risk Just By Informing the User?

Over 20 years ago, a doctor phones a medical device company’s technical service group from nearly half a world away, and is in a panic. He’s performing his first implant of the newly available AICD [automated implantable cardioverter defibrillator] technology, and his patient is sedated, on the table and there is a problem. “I’ve implanted […]

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Risk, FMECA and an Engineer’s Creativity

My wife walked in the door with a big sigh years ago after taking our young son to Toys ‘R Us. She realized he was going to take after his engineer father when, after picking an interesting toy off the shelf, he turned it over to see how it worked instead of just playing with […]

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