OM in the News: When New Medical Products Fail

In Chapter 5, we discuss both the importance of new products in a firm’s success (see Fig. 5.2) and the product development system (Fig. 5.3). One  industry whose lifeblood is new and improved products is medicine– where high product demand and the need to gain a competitive edge results in a constant churning of new drugs, devices, and procedures. But the promise of innovation can also prove a trap, according to The New York Times (June 25, 2011), a situation now playing out with dire consequences for 10,000’s of people who received artificial hips in the last decade.  “I don’t understand it, but there is a phenomenon in the U.S., for the latest and the greatest”, says a Swedish orthopedic surgeon.

The issue is metal-on-metal hip implants, designed by device makers as a supposedly major advance over a 50 year-old previous design  that used metal and plastic. The older, relatively simple model consists of a metal “ball” that replaces the thigh bone, while  a plastic “cup” serves as an artificial hip socket. This device is highly effective, with a 95% success rate a decade after surgery.

“The vast majority of the innovations with respect to orthopedics over the past 2 decades have not resulted in improved patient outcomes”, says one UC prof. But companies began promoting the new implants as “the next big step”. Patients, intrigued by ads featuring celebrity athletes doing strenuous physical activities, also wanted the metal-on-metal devices. All- metal implants now account for a 1/3 of the 250,000 hip replacements in the U.S..

Unfortunately FDA simulations to test the new product were based on idealized conditions, not real-world wear and tear. Now, debris from the grinding of the metal parts is causing crippling tissue and muscle damage, and even neurological problems. Of the half-million all-metal implants inserted, there is a likelihood that tens of thousands of patients will require painful replacements.

Discussion questions:

1. Why are metal implants failing at a high rate?

2. What other major drugs and medical products have imploded shortly after introduction?

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