Consider the cost of lost opportunity for the devices and specialized medicines that won't be around to prove their worth. An example of one that made it:

How many people suffer life-long stomach ulcers today?

Not many people, thanks to the discovery of H. pylori bacteria about 1982 and the brave people who persisted against huge odds. It took almost 20 years for the simple antibiotic cure to become standard-of-care. There was no huge ROI for anyone - only savings for the patients and payers. Yet, billions of dollars of infrastructure had to be re-purposed to other chronic conditions before acceptance could be allowed to occur.

Could such a discovery get to standard-of-care today?

Will a killed innovation prevent YOU, or a loved one, from obtaining a solution for a devastating condition?

Having been in the medical device industry for close to twenty years, I am truly ashamed of the PR campaign being put forth by the medical device industry to fight this legislation. We all know that there are potential problems with a tiny number of devices, even with Six Sigma, so if anyone is harmed by something truly defective, that person deserves recourse. Wouldn't you want that if it happened to you?

Some companies simply do not wish to be responsible for their inadequacies. Back in the day, when Medtronic was sued by unsatisfied customers, most often when the implanting physician messed up, their legal teams fought vigorously, and almost always won.

No life-saving medical devices will be shelved or prevented from going forth. Period. Please, we are all smarter than that. This entire discussion is an embarassment.

This attempt at regulation is a result of these companies cavalerely endangering peoples lives with products that have not been properly tested for applications they are being marketed for overtly or covertly, to do things they were never intended to be used for.

I say its about time

Medical device safety is everyone's concern--from manufacturers to clinicians to patients. Mishaps and situations that are indistinguishable from them unfortunately will occur despite the best of intentions and efforts. The medical practicioners, their institutions, and the manufacturers have an ethical responsiblity to financially help with the consequences. Pharma and medical device makers are attractive because of their perceived deep pockets.

I don't think we should argue for a "free pass" to manufacturers based on meeting FDA approval criteria. As Epstein points out, the resulting litigation sometimes pits the medical staff against the manufacturer since after all "someone is to blame". I do think passing a meaningful FDA review process should entitle both clinicians and manufacturers to a presumption of delivery of standard practice and not willful or gross misconduct. Plaintiff attorneys may be expected to argue the opposite and should they assemble a preponderance of evidence, I suggest justice requires more than a prompt apology and modest coverage of expenses.

Reform, yes. Denial of responsibility, no.

The act would seem to go counter to the latest internationally recognized methods of detecting and preventing risks in medical devices and products. The latest change from the previous risk standard is a demand that the risk be viewed in light of the medical benefits. The standard, (IEC 14971:2007 for you development management types) states: "For risks that are demonstrated to be outweighed by the benefits, the manufacturer shall decide which
information for safety is necessary to disclose the residual risk."

In other words, the entire world community (including the United States) is adamant that before even thinking about development, the overall risk must be reviewed, documented and if too high, find something else to invent. The change in the latest edition is that if the medical benefits far outweigh the risk left over after trying to prevent it, they may decide to proceed, but specifically tell everyone.

The "Device Safety" act will certainly prevent drugs and devices that could help millions of lives from coming to market because there will no longer be a standard to be measured against. And that is not patient safety.

Hey, we could go back to leeches and hanging garlic around our necks.