Calling BS on the link between tax increases and medical device innovation...

I know I haven't posted here in months. Things have been quite busy and I am unable to write as much as I would like. That said, I wanted to leave 2011 with a "I told you so" post, so that I can come back and harp on this later.

Is money the problem with innovation?

How does more money equate innovation? Is it the same expectation as throwing many monkeys in a room with a bunch of keyboards and expect them to produce great literature? It probably is. Has it ever worked? Maybe you will get a couplet out of it, but can you expect a sonnet?

Is laying people off the most innovative solution to increased taxes?

I am not at all for increasing taxes. However, how else would you expect incomes to come in to pay to allow more Americans to access health. One "large" organization is claiming that it will lay off 1000 employees to pay for the taxes. Now, is this really the way to innovation? They can't cut other costs? 

When costs increase, do you skip meals, or skip the movie outings? Every lay-off is grounds to believe that the CEO and management has probably failed TWICE. Why twice? First, they probably did some very inefficient hiring, and secondly they chafe responsibility. 

Well, you have to ask yourself this. Why did they hire a 1000 employees too many? First of all, it never happens to be that much, and secondly, yes, it happens - employee functions disappear and such, but more or less, this is just because the "management" in most of these organizations is an old boys (and girls) club and they want to get rid of well meaning employees, rather than cut from a management.

Shouldn't a performance failure directly mean management failure?

The Cisco Example

Look at the CEO of Cisco. The company was in dire straits in 2011 directly because of his narrow mindset, heck, his inability to produce results. Why mince words? Yet, he got to lay off thousands of jobs and keep his. Ask yourself...

The HP Example

HP had it going for a while. They bought worthless companies, hired duds and kept sending them off with golden parachutes. When things got hot though, what was their solution? Well, they brought Meg Whitman, of the "I took the eBay stock and rubbed it in kaka" fame, and "I hired an illegal immigrant and decided to run for a Governor on behalf of the people opposed to that" fame as well in as the CEO. Here is the kicker - she was on the board that made all the poor decisions in the first place!!!!

What are the real roadblocks to innovation?

A 2.3% tax increase is not the reason why innovation in medical device design is going to retroactively die, as John Kartch and Stephen MacMillan would like to misinform you. Let us look at some real issues:

1. The mid-life crisis - monkey see, monkey want

There were some innovations in the industry, and then for the most part, they tend to poke out their head out of the vast desert stands of the medical device industry every so often. Why so? 

This was a problem in 2007, it is very much a problem even now. One stent succeeds marginally, of course the success is called phenomenal at first, and everyone wants to build a stent company. A catheter company succeeds and of course everyone wants to build...well, you get the point, monkey see, monkey want, monkey try, body not agree, monkey blames taxes, the FDA, the Mayan calendar, everything except self...

There is no attempt at real innovation here, just a need to create copycats. You can see it in the companies, their names and even their job advertisements - Wanted: Someone who has designed 233 catheters and wishes to design their 234th; slavery a must, peanuts optional...

Innovative, no?

2. Crash and Burn - VC style..


The Venture Capitalists who got there with almost nothing but sheer luck and no nothing about devices have their own plan. Under-fund a company on crappy me-too ideas, going after diseases and devices just before they get to the "also-ran" point, and demand quick results that lead you to King Solomon's mines...

The companies that are lucky enough to get this money go after said diseases and devices in a rushed manner, fail and then give the whole thing a bad name, making it bad for anyone trying to go after this a second time around.

And then of course the VCs bandy together and blame regulations for the failures of their minion companies...

3. Taking the wrong risks and avoiding the right ones


Innovation is risky business. By treading the familiar path, you will never innovate. You have to branch off, go against the flow and all that to actually change the way something happens. You really, really cannot do anything but micro-innovate your way to success.

The easy way out, is to blame Obama, the tax man, the regulations, heck even the Mayans and their calendars...and this, is what I am calling BS on...

Medical Device Innovation! : Arthrocare is now rebranding to Art-no-care!

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Innovations in medical devices have been happening at hitherto unknown magnitudes of time and quality. The time for medical devices to join the banking sector in defrauding the American Public seems to have finally arrived! How, you say?

1. The FDA:

The Bush administration, in well measured tactical moves has rendered the FDA a nearly useless joke (except of course it's the dead Chimpanzee cartoon kinda joke - the kind that no sane person would laugh at). Want to know more?

Read This!

Now, regulations both necessary and otherwise don't exist. You know what happens when there is less regulation?

More "innovation" in medical devices!

2. The Supreme Court:

Give a bunch of extremely old people with outdated ideas and extremely untalented people John Roberts the chance to do what they please and say what they please for life and you have reduced "Democracy" to "Ironic Drivel".

Last year, this was very helpful in creating something so entertaining that Tyler Perry, Stephen Colbert and their like have to kiss it's ass - this was called "Pre-emption".

With this tad bit of innovation, now you the patient cannot sue a company for a medical device that the FDA has already "approved". Yes, you are right, the very same FDA that is totally weak, engages in all kinds of unethical duty dodging...

Yes, you cannot sue if in fact the device malfunctioned, did not do what the labeling suggested it was going to do, or if in fact, the device killed you or a "loved one".

Who else laughed so hard that their stomachs hurt?

Careful there, your stomach ache medication may have side effects including death, permanent disability, loss of self esteem, feelings of suicide...

3. The Slapstick Entertainment Commission, er., SEC:

If you thought the FDA was a joke, wait till the SEC comes to investigate. You know, how in Hollywood movies the cops and the army always show up after the trouble is over (unless they caused it of course!), and the hero has tackled all the thieves, alien monsters and so on....who told you that was fiction?

4. More Tools to help innovation? - Democrat Nominees for HHS, FDA or any government position you can name

Let's see. There is this certain subspecies among humans. They love taxing you. Any excuse is enough. Are you rich? Are you wealthy? Are you a business? Are you none of the above?

Doesn't matter. They will tax you!

Except...they won't pay.

Come on, whoever followed what they preached?

Won't believe me? Go look up "Daschle", "Geithner", "The husband of a labor secretary nominee" on the Googles and see for yourself!

With friends like these in Government, who needs the GOP and their fear of comparative studies? (Yes, they don't like the idea!)

Meanwhile, if you are a medical device company looking to "innovate" alongside the aegis of "Art-No-Care" and others, here are a few tips:

1. Don't worry about the FDA. As long as you fill paper work, you will get a 510(k) - heck you might even get a PMA approval.

2. Tell your sales folks to ignore "approved uses". Tell them to sell the medical device for any use that pleases them. If convicted, only the sales guys go to prison. You can even take your company name out of the mention in court papers!

3. Hire lawyers whose dads work in the federal judiciary system. This way, you can use the son to get the dad to dismiss any cases, pre-emption or otherwise. The dad can always deny even knowing his son had a job!!

(See my previous blog post, if you can't believe your eyes and ears about 2 and 3).

4. When in doubt, be assured that pre-emption will protect you! Do you fear that the Obama administration will ever do something about it? Fear not!

How come you say? Well, for one, they are not very different from the Bush Administration - they just sided with them (and against your right to know) on White House emails. How different do you think they are going to be? Change is only for Washington - not much else.

For another, Obama will never appoint a HHS secretary. Or he may, and it would be too late anyway. Heck he hasn't responded to FDA scientists who lamented about the FDA and later pleaded that they were being persecuted.

5. Ignore audits, the SEC and other regulations. If anything, it will be years before the SEC investigates. By the time the agency would be busy with one of two possibilities - either the administration (and the party that administers said administration) would have changed, or the SEC itself would be re-branding, because the last name did not work out! And you would be far away.

Who cares if you have to re-state revenue figures for a whole decade in the past? As long as you can cook up the numbers for the next 90 days, it's good enough! Be practical.

Meanwhile - Yay! Innovation. Enjoy! There are absolutely no barriers or regulations or rules of law that will stand in your way.

Art-No-Care just proved it.....

The USPTO: Killing innovation, 5 claims at a time...

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So, too many patents are being filed. Yes, maybe there are not too many people innovating, but just folks trying to protect everything under and above the sun...

It is becoming harder to review patents...

Too many companies are fighting over them...

And, of late, the work has started becoming strenous...

Voila! The new rules of USPTO ensure that not only will all these problems go away but they will also ensure that ALL logic will be defied!!! After all, isn't it the first duty of the government to ensure that over time its services become limited, confounded, expensive and anti - public?

Why would I only have five independent claims to a patent? Why is 5 the magic number? Why cannot I have more than 2 reviews to extend my patent? And why did this just become more expensive for me ? (In case you didn't notice, the person(s) filing the patent now have to do some of the USPTO's work...)

If there is any glimmer of hope to save us from deliverance by the USPTO, it would be the public comment period ending October 9. Hopefully, this doesn't promote other branches of the government to adopt the USPTO philosophy. After all, there has been all this talk about free speech and how everybody wants it.....

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New Strategies Galore - Using emotional appeal to kill innovation in medical devices

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Warning: This is an unusually long post..

Here are a couple of paragraphs I have stolen verbatim from the article:

"Dragseth cited the recent case of Dr. Gary Michelson, who in 2005 received a $1.35 billion settlement after suing a medical device company over his patented spinal surgical technique that speeds recovery. Medtronic v. Michelson, No. 01cv2373 (W.D. Tenn.)."

"Last month, a veterinarian who sued a surgical instrument maker over his patented technique for declawing a cat also won his case when the U.S. Court of Appeals for the Federal Circuit upheld his patent. Young v. Lumenis, No. 06-1455 (S.D. Ohio). "

Now let me first acknowledge the article lest, ironically, law.com sues me for freely using parts of their article (which was published after earnest research, and editorial skill for the common good I suppose)

Okay. Let us only look at these two examples. First Medtronic is not the small kid off the block who is being crushed by the Goliath Dr. Gray Michelson. Their positions in fact, would be switched if that were the case...

So what's actually going on? Medtronic, being the big company that it is, picked a problem area, saw a giant market opportunity and developed a product. Dr. Gray Michelson who had done the same thing, except a while ago - and had patented it, decided to sue. Its pure capitalism.

Now, lets imagine if the positions were switched. Let us say, Medtronic contrived of the whole thing, a few scores and some years ago (has to be less than a score for the patent to be valid, so lets say it was no scores and just a few years ago). Then comes Dr. Michelson who wants to perform the same procedure as "Michelson's special procedure". Do you think Medtronic would have said, "Oh, he looks like a poor enough doctor. And he is saving lives. So, let's not go after him..."

If you truly think Medtronic would have said that, I should say you need your head examined (some would say you need a head).

With quite a bit of further ado, let us look at our friendly Vet. Now, are we trying to say that just because a few people are overly taken by the love of their cats (which they buy mostly, thus promoting animal trade) would like to have them treated for cheap, the guy who actually invents the cat-life saving procedure (okay, cat de-clawing doesn't save lives, unless he/she plans to maul your other cats) should not expect to earn a little extra?

See the problem. This world is riddled with idiots. Simply put, their philosophy is "Don't live and most definitely, don't let live".

Innovation equates to and promotes progress. Innovation is needed for us to obtain new treatments. This innovation can grow only if rewarded. Patents are a very good business reward. In both examples above, the companies would have probably had good lawyers scoping the IP field before launching their products.

Don't even think they didn't....

So, in all probability, they decided to deliberately infringe on the patents, though on their life they would never admit it. They probably thought, "Its us, Megabucks Inc. versus single inventor dude. We are sure to win!" Again, not a bad strategy, business - wise. That is what companies do. They try not to own up for their costs as a strategy to reduce costs (thus increasing the miniscule possibilities of their executives paying a much needed visit to prison).

In neither case, would either company have entertained the idea of someone else infringing their patents or even coming close to it...no matter how many lives, cat or human it could have saved. (Kyphon and Medtronic play the merry-go-round of suing each other)

More importantly, if individuals and companies are not allowed to protect and gain monetarily from their hardwork, they would have no motivation beyond their self. And we know how that would go....

Plus, doctors cannot be sued for using procedures, patented or otherwise (unless of course the doctors are not medical, or they are doing it to intentionally cause harm).

Summary: We have now reviewed a very poorly written article, that very poorly through its examples, fails to stand up to a very poor cause.

But who cares? Now "politicians" are looking at "patent reform". And we all know how that story will end...


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