Wednesday, November 08, 2006

Resurrecting Confidence

I visited Boston Scientific corporate headquarters yesterday trying to understand what they’re going to do to resurrect their business in the Cardiac Disease Management section of their company -- the Guidant portion of their business.

I met with a number of individuals: Mark Bartell, Senior VP, Global Sales and Marketing (tough job #1), a few of the heart failure marketing folks, Randy Ban, VP Marketing in charge of Corporate Communication Strategy, a fellow Dukie (go Blue Devils!) John Russell, who is in charge of the Latitude Patient Management System, and perhaps the most impressive person recruited to salvage the quality mess: Bill Young, VP of Reliability and Quality, a former Baxter quality professional with friends in high places at the FDA. This was a good pick as far as I can tell.

And why do you think I saw these particular individuals? Because they knew I am a skeptic. I have bright patients who read the newspapers and press reports. I have patients who say, “You can implant any device, except a Guidant device” when I tell them they need a defibrillator.

So what did I learn today?

In short: they’ve gotten the message.

They understand that a 99.2% or 99.3% device reliability is not good enough for the public and doctors, especially when you implant tens of thousands of these devices that must work years after they are implanted, charge hospitals and patients big bucks for them, and are withholding when problems with their devices surface. Like the airplane industry that has learned that it's not okay to have 1 in 1000 planes crash, I think they've made a good-faith effort to re-establish the importance of quality and long-term reliability in their products.

They also have learned that reporting failures TOO early can unnecessarily frighten patients, that doctors and the FDA can be helpful, that they’ve got more to do. All engines are geared right now to clearing their FDA 483 warning letter. They say they’re ready for their inspection, due any day. We’ll see. But they have changed personnel, recruited like crazy to shore up their quality and reliability shortcomings, and changed their corporate quality reporting structure to avoid internal conflicts of interest. Time will tell.

One of the best new standards they have implemented that can tangently be identified, was their online product performance reports. (Unfortunately it's still on their Guidant website - they really need to bury that name! But I digress.) Reportedly, this report is updated every three months. This, my friends, is impressive and welcomed. Now if a patient wonders about the reliability of a proposed implant, the information is quickly available on-line. This should be an industry standard.

And their marketing strategy? Lay low. Keep the old bad experiences out of the press. Look for plenty of “feel-good” pieces on Latitude, but also look for behind the scenes settling of their litigation burdens, which are considerable. Slowly. Quietly. Carefully.

Seems like a good plan. But all of this aside, it will mean nothing if they don't execute - and the raising of their FDA Warning Letter will be their first test.


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