Medical Device Quality Initiatives: Grow the Carrot, Chop the Tree
The giant sequoia trees in the Pacific Coast are breath-taking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great in a forest isn’t always so great elsewhere. Let’s push the metaphor a bit more, and say there’s another huge tree growing out there that we shouldn’t be so happy about: the rising incidence of product failures in the medical device industry. And an excellent new report from Booz & Company identifies those root causes for the growing number of reported adverse events caused by medical devices. FDA says they rose from 7,839 in 2001 to 28,049 in 2009. That’s an average hike of 17 percent a year. Worse, that average was much faster than the overall industry average growth rate of nine percent over the same period.
According to Booz, the FDA says nearly 70 percent of device recalls were traced to failures in product design, supplied materials, or manufacturing processes. The financial hit is getting harder, too. “The average decline in a device manufacturer’s share price after a major quality event was 16.8 percent between 2006 and 2009, an increase from an average decline of 9.8 percent between 2000 and 2002.”
Three big roots feed into the growing sequoia-sized tree we call product failure in the medical device industry: a “siloed, reactive” approach to quality, a lack of focus on continuous improvement and the relentlessly growing complexity of medical devices.
At the risk of sounding too much like the fool/genius Chance the Gardner in the 1979 movie classic Being There, the image of big roots feeding into a growing tree is useful.
To prune back the weeds and keep the tree trimmed, Booz urges medical device manufacturers to develop quality management as an organizational capability. Keys to that are:
- Critical-to-quality (CTQ) management;
- Systems engineering; and
- Design for Six Sigma DFSS).
It’s not easy to do, but Booz offers a tantalizing carrot, “companies that successfully weave these three elements into an integrated, preventive quality capability can achieve a competitive advantage and a leadership position in their industry.”
Further, Booz analysts say an improved quality capability earn companies an average payoff of five-to-one in the first year alone.
So, the idea here is to grow that carrot, and cut down that tree.