Dear Dr Letter

BSX over reports???????? You can't be serious!!!!!!! Were you not around a few short years ago???????

 

Hello . yes its 2013..and you have a recall on the generation of product that replaced the one that had 33 recalls.

 

Did a 13 year old girl post this?

 

What a whiny bitch. And I'm so sure you swapped a BSX device with early battery depletion because that happens soooooo often in your territory. Which device was it? Just link a to the PPR for that device and provide us the link to your equivalent. RIFF coming to BSX? Laughable.

 

How is that quality iniative Aurora or whatever the hell you called it...

Headers, battery depletions, etc

 

Your list would be more impactful if you listed more than two things before busting out the etc. which company do you work for? the one where like a quarter of the defib leads fall apart inside of people or the one where 5% fractured?

The current buzz in Arden Hills is to roll back the things that were implemented during Aurora to reduce cost. Too much money, too little benefit.

 

the point was that you implemented project aurora and released a new product and you had headers fall off.

but I'm glad you OK with 2 manufacturing issues on a device that supposed to save a life...

2 issues are no biggie

 

If you actually look at the extent of the issues BSC had after aurora they really aren't big problems and to pretend otherwise is idiotic.

At the volume that these devices are built and at the cost in which they must be built, there are going to be problems. As cost pressures drive down margins, there are going to be more problems. That's going to happen no matter which company you work for.

BSC, MDT, and STJ all build medical devices that save lives. Unfortunately, problems with these devices result in people dying or not being converted sometime. That's an unfortunate reality. While none of these three companies are putting out a device that they know is bad, there are going to be escapes due to bad design decisions, manufacturing errors, and supplier problems. People are going to die, and the devices are going to be responsible. Based on the preponderance of the risk that is, in fact, okay given the alternative (no device). The best the companies can do is maximize the benefit and minimize the risk within the cost constraints that they must operate.

The ICD, CRM, and pacer maker devices from the big three are already good enough in terms of therapy. As we as an industry move towards more of a commodity, there will be less innovation in CRM. Less change will result in lower risk, lower cost, and lower margin.

Pull your head out of your ass and quit pretending like your company is better or your shit doesn't stink. While your products might look better this week, I've been around long enough to know that's fleeting.

If your a physician, pick two manufacturers and hedge your risk in implants. That way when something goes seriously wrong with one of them, you'll only have half your patients to deal with at a time.

 

I agree with everything you have said here, but my take on how it plays out is a little different.

Your point about docs choosing 2 companies for risk diversification has always been a wise choice, but many failed to exercise it....even during the days when there was innovation in technology AND the doctors had the power to choose...they still chose to use one company 80% of the time with a smattering for the rest IF they bought in to the concept of risk diversification.

Fast forward to today...you are right that this is becoming a commodity market marked by lack of innovation, questionable reimbursement and sp forth....doctors no longer call the shots (nor do the ultimately care)...contracting rules the day in a commodity market, and CONTRACTORS don't give much weight to arguments about RISK DIVERSIFICATION...they want the lowest bidder, and if committing to a 100% volume commitment is the way to get to the best number...then so be it. If the one vendor that wins the contract happens to be one the doctor likes, thats just a fortunate happenstance...

 

device shorted when it tried to shock the 21 yr old hypertroph out of vf. Very different than the device "killing the child". 9 years ago.

 

WASHINGTON, Oct 17 (Reuters) - Boston Scientific Corp agreed to pay $30 million to settle allegations that the Guidant unit it acquired in 2006 knowingly sold defective heart devices implanted in Medicare patients, the U.S. Justice Department said on Thursday.

Guidant from 2002 to 2005 sold the implantable defibrillators even though it knew they could short-circuit and become ineffective at correcting heartbeat rhythms, the department said in a statement.

In 2010, similar allegations led Boston Scientific to plead guilty to two misdemeanor charges of withholding information from the U.S. Food and Drug Administration (FDA) and agree to pay $296 million in fines.

The latest settlement resolves a civil lawsuit the Justice Department brought in 2011 under a law designed to recover money defrauded from government programs such as Medicare.

Boston Scientific spokesman Peter Lucht said: "While the company continues to deny the allegations made in the complaint, it felt it was in the best interests of all parties to settle this matter and avoid further protracted litigation."

Boston Scientific bought Guidant for $27 billion in 2006.

Guidant did not fully disclose to doctors and the FDA the problems with its heart devices until May 2005 after it was contacted by a New York Times reporter, according to the government's suit.

James Allen, a patient who received one of the devices and who initially brought the civil suit under the anti-fraud False Claims Act, will receive $2.25 million as a whistleblower, the department said.

..

 

Now now. No sense in judging.

 

You can point the finger anywhere you want, but it doesn't change 2 key facts plaguing ALL battery powered medical devices:
1. Available battery technology has not achieved an acceptable level of reliability for devices on which human lives depend.
2. Electronic components such as capacitors are such commodity high volume items that no company wants to do what it takes to "play" in the medical device world-- volumes are just way too low compared to the consumer demand for electronics. Consumer electronics are largely "throw away" devices that don't need to last more than a couple of years and the components are accordingly LOW QUALITY.

To keep costs low, components are purchased off-shore where quality is highly varible and sometimes nonexistent.

Personally, I don't want any of my loved ones to depend on ANY electronic devices to stay alive. At some point though, I'll take the risk because life outweighs the alternative.

KEEP UP THE FIGHT FOR BETTER MEDICAL DEVICES!!!