Thursday, April 16, 2009

AdvaMed: Hey if we reeeally want to scare them away we need to throw around the word "innovation"

Here is the article link:

Nothing outside this statement can be farther from the truth about pre-emption:

""Nothing chases away advanced medical device innovation like uncertainty" about whether a company is going to get sued for its product, said Stephen J. Ubl, AdvaMed's president."

What is innovation?

For one, it has nothing to do with the fear of being sued. That would be "AdvaMed-artifically-generated-phobia".

Here is what the paragon of truthisms, Wikipedia has to say on innovation:

"The term innovation means a new way of doing something. It may refer to incremental, radical, and revolutionary changes in thinking, products ..."


Innovation would be saying, "Let's not start another drug eluting stent company, only to lay off 111 out of 121 folks after a few years. Let's either prove that drug eluting stents work or let's find a new way to cure disease."

Innovation could also be innovation in cost restructuring, outside of keeping the devilishly under-performing CEO, handing him out bonuses and laying off 20% of your workforce (amounts to 4,300 employees. Very hard to find out which "innovative" company I am talking about).

Innovation could be steps taken in shorter time to establish Design Validation, better designs, better manufacturing, Design for Manufacturability and so on.

What else could innovation be?

Surprisingly, it could be some of this:

1. When patients die because of your device, report them, promptly! No "the dog ate my adverse reaction reports".

2. When patients' hips start squeaking and their ICD batteries die out, start investigating.

3. When your product is the result of some bad "fitting round pegs into square holes", apologize - no medical device company has done that before. It would count as one heck of an innovation!

4. Do post-market follow up, not because the FDA weakly grunts about it, but because it is something you ought to do!

5. Stop subscribing to AdvaMed and it's opinion pieces.

Are innovation and torts related?

Absolutely not. Here is how a typical medical device gets to market:

1. Doctor and couple of engineers get together in a garage. They sit on the device for a while, think of and do all kinds of crazy things. They then double mortgage their house and go present in West this conference and East that conference.

2. After several failures and crazy ideas, some random thing works. Then a couple of years down the line they get funding and muck about sleeplessly for a few more.

3. They start selling the first generation, possibly first-in-class device. They are about to hit the IPO.

4. Really fat company rolls (lumbers and sometimes huffs and puffs) in and purchases them. Wants to impose it's "culture". Brings strange looking aliens (managers, change agents, transfer managers and such are their taxonomic guises) who want to change everything from the coffee machine to the CAD program.

5. All the "good" folks leave or are kicked out. The people who are left are still well meaning people staring at designs they don't understand. New people replace yet another layer of skimmed off people. Eventually, no one knows what's going on where.

6. The second in class device based on "marketing driven product development" and other wonders of nature gets to market.

7. Hips squeak, leads break, stents fail, meters dole out improper readings and patients, of course, die or become otherwise greviously injured!

In this whole mess innovation can only possibly happen from step 1 to 3. Torts happen after step 7. The FDA is a thematic black comedy that spans all these steps, but really doesn't affect anything, at least positively.

So, are torts and innovation related? No!

But don't we still need pre-emption?


First of all, the Supreme Court Judges are acting like a bunch of txting teenagers. On the one hand they say that devices are subjected to pre-emption but on the other hand they say that the same iconic government agency (I mean the F, D and A) is ill-equipped to regulate drugs pre-emptively.

What gives?

Secondly, "the fear of lawsuits is the mother of many things". If these companies walked off on a permanent basis from responsibility (helped by the likes of the Federal Judge "Kyle" from Minnesota), then consumers, in this case patients, dead, dying or a loved one, have absolutely no respite.

A parting word for AdvaMed

So, let's not abuse the word innovation please. Let's start with listing your "donors" and "Corporate Members" somewhere easily accessible on the home page. That would make it so much easy for us to separate reality from Kool Aid and find out who really is going to be chased away from innovation and if that indeed is an ironic oxymoron...

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