Medical device the rule of thumb seems to be luck over science

KEY IDEA:  Seventy million Americans have a medical device implanted within their body. “When it comes to medical devices, we built a system that doesn’t work,” David Kessler, the former FDA commissioner, said in The Bleeding Edge.  The disturbing truth is that, despite so many people relying on such implants, the medical device industry is very weakly regulated. Continue reading

Healthcare: the availability of unlimited profits is a powerful motivating force

KEY TAKEAWAY: Healthcare is now the single biggest sector of the US economy. It is bigger than big oil, bigger than big banking, and bigger even than the famous military-industrial complex that President Dwight Eisenhower warned about in his farewell speech. In 2013, the most generous estimate pegged the price of the military-industrial complex at $ 1.3 trillion, while healthcare expenditures in 2015 were $ 3.2 trillion, consuming nearly one of every five dollars spent in the US. Continue reading

Medical Device companies need more oversight, not less

KEY TAKEAWAY: Via the NY Times “makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress”.  This is not the way to ensure medical device companies stay compliant. Continue reading