Wednesday, December 26, 2007

Medical Device Myth Busters: Can Linux meet the cut with FDA?

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Disclaimer: I am not a Linux hater. However, like Will Smith in iRobot, I am allergic to "BS".

The credit goes to slashdot for showing me where the original link is:

[This is an interesting project. Nothing against them either. Ah, to enter the magical world of incessant disclaimers..]

Linux users usually piss me off with something or the other. This time, it is by spreading this vague notion that the FDA would like to side with devices based on Microsoft (who else?) For all the brouhaha, Linux adoption has been slower than that of handicapped snails....not because Bill Gates and Steve Balmer double up as "thugs of the night" going around slashing electrical wires and smashing monitors wherever Linux is used....

It is mostly because people who work with Linux have this ad obnoxium problem with using Linux for what it is. Instead, they always have to somehow make it a Windows problem...always fighting the "man".

A very simple "Google" search produced "Merlin"

-a device that is used in CRM.

(That's a real medical device by the way. I am constantly nagged by people posting monitors as "medical devices just because they will be used in hospitals. I don't have a problem with someone marketing their product as strong and ready for use in hospital environments - but equipments and devices that directly aid a person's treatment are different...a helmet helps you keep your head working(class I device), a monitor helps the doctor(usually does not require approval). A doctor who drops a monitor is... here is a link to this ignominous monitor: )

'Tis the season to rant, but Merlin seems to have done fine with FDA approvals. And I am sure if I dug deeper, I would find enough software and OS based on Linux that are probably being routinely used in medical devices.

Validated Software and Operating Systems

It is not that there will be a witch-hunt when devices fail, but medical devices need to be "validated" to be "approved". So, a disciplined development approach is needed. While it may be great to think of downloading an entire operating system and making whatever the heck we want of it, a disciplined approach is needed for use in medical devices.

Imagine lying on the OR table while the OS or software springs a little "surprise". No one would like that now, would they?

Validated Linux OS, Software, and Unix Software are commonly used in medical devices. Here is another reinforcing link:

Here is a paragraph stolen directly from that link:

"In short terms, medical device manufacturers can usesoftware from third parties as long as they validatethat the software behave as intended in the medicaldevice. The degree of validation required for a packageis relative to the confidence that such package mayhave developed in the industry."

What will it take, anyway?

In short here are the ways in which Linux can see increased adoption in the medical devices industry:

1. No negative, Windows is the all consuming evil - marketing, please (and that's not just for medical devices). Thing is, it always feels great to think all corporations are out to get your goat, but so is every honest-to-salt business man. You have to compete. It's not Microsoft's fault that at some point they were really good at it. Linux developers, for the most part still haven't left their teenage rage behind..

Practicing physicians and surgeons do not care about your phantom wars.

2. Adoption breeds on adoption. There are Linux based devices out there. Use these as examples when you plan to design software for your medical devices and definitely reinforce these when seeking approvals from the FDA. Learn and understand how medical device validation works. It is not unlike software validation in general, its just more procedural. (After all, you don't want your CEO in prison for your coding or commenting shortcomings, now do you?)

That's it! Get set go! And don't blame the FDA for poor Linux adoption. (That note is for our anonymous friend at Slashdot who tries to peg the wrong reason for the "extremely rare" adoption of Linux for medical devices). There are several hundred other real problems among which you can pick and choose - to blame the FDA :).

Happy Developing!

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Tuesday, December 25, 2007

Can you teach your own doctor? Yes you can, if he or she slipped a little in medical school...

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So what were these guys doing in Medical School? We place medical doctors at a much higher level than fossil-brush doctors (paleantologists) or the other kind of doctors....

And in return, this is what we get!?

Well, bordering on the humorous, this indicates how little doctors seem to know about some of the most basic stuff, while they are overloaded with other stuff, which may be conventionally important.

This news comes this week, following some interesting revelations that most surgeons do not discuss reconstruction with their breast cancer patients:

Is this a marketing slip on the silicone peddlers? Have they failed in "inducing" patients to get reconstructive surgery because it belongs to another department - plastic surgery, and they won't get reimbursed for it?

Or, are they just plain insensitive? Apparently someone is guessing, it maybe because breast cancer surgeons think it may be a "hassle" to suggest so...

I agree, your patient might walk in the door just wanting to be rid of their cancer. While that may be their biggest bother at that point in time, they are definitely going to regret not thinking of life after cancer. Why? Because there is so much fear surrounding cancer - mostly realistic.

But it is a surgeon's great disservice in not sitting down and painting the whole picture for their patients?

I have heard other stories of how certain "gold standards" arose from a single, unverified opinion of one physician/surgeon!

And yes, before I leave, I am compelled to recollect my cliched rants about questionable dubious "innovations" such as drug eluting stents and rapid - exchange balloon angioplasty...

Are medical practitioners less compelled to initiate, read and follow scientific studies?

All this combined, makes me shudder at the thought of putting my life in the hands of a medico!

How about yourself?

Anyway, do read the article and find out if your doctor has been catching up with his/her reading. After that, double check your prescriptions.. :p

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Sunday, December 23, 2007

Want to feel like you are one of the idiots? - Mix it in .... and smoke marijuana?!

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Well, it was hopefully useful for atleast those who did the research - they got to spin the wheels once again.

College students smoke pot. Of course they think it helps them relax, they think it is against the "man" who is trying to stop them from experiment with the limits of their brain, it helps them perform better at..., okay, lets leave it at that.

So why do you need to do research to find that out? You think since Australia was "isolated" from the main land?

People who smoke marijuana - (unless they have cancer or AIDS, because it is a known domain where there is a real pain numbing effect) are just that - idiots!

Yes, you will learn what to do with folks like that - realize that all your efforts to teach them commonsense failed and you will move on.

Wonder whose research money got wasted into this effort in idiocy. I only thank my stars that I don't pay taxes in Australia. Otherwise, I will have to worry about their next research project....hmm, why do college students chug beer?

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Tuesday, December 18, 2007

Addendum to Provenge Label: Warning! Might expose FDA inefficiences..

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Okay, so the first two Congressmen started expressing their "Provenge" displeasure and I thought, oh well, what is two Congressmen. After all, under President Bush, most federal agencies have weathered an entire Congress!

And then one more added himself to the list and Three's Company of course, so I thought, might as well roll out my cynical red carpet...

The gist of the story is that the panel that reviewed Provenge had atleast one guy working for a competing company, Novacea. How did he get to sit on the panel anyway? Apart from violating fundamental ethics, was he also able to access sensitive data on Provenge? Is the FDA performing the dual function of being unethical and destroying competitiveness?

So, in the future everytime the FDA rejects a drug, are we to spend immense time and energy investigating and/or lamenting over whether or not the rejection was appropriate?

Heck, it atleast gets a few Congressmen to do something..anything!

However, now let's take a step back into this month's favorite cliche: Riegel (with all respect to the deceased).

So, the FDA, the attorney general and anyone who considers themselves an expert (including the lawyer who doesn't believe in juries) went in front of the Supreme Court or blogorama as they saw fit, to argue in favor of federal pre-emption.

But we go back to the age old question that Will Smith asked in that spy movie, "Who watches those who watch us?"

And if we claim that the FDA knows better than the jury because it employs a "panel of experts" who are somehow better than 12 high school educated folks, how would you explain all the hullaboo surrounding Provenge?

Even 12 year olds know thats not the right thing to do!

IMO, by taking up the Riegel case, the Supreme Court has snatched itself a nice little commonsense vacuum. With low funding, low morale and definitely lower ethics, the FDA is now an aging dinosaur - just refer back to my post on the "new" DES rules..

All our friendly, neighborhood Supreme Court Justices run the risk of stepping on some 'caca' for suggesting that the FDA is above "torts" and has its own "experts" who will keep us all safe....a very dubious and unbelievable statement indeed.

Meanwhile, do you have any hope for some good to come out of the potential Provenge investigation? Do Congressional investigations actually result in any good?

I have a suggestion: Try to make the panel immaculate (not religiously, and this is the season when Discovery Channel tries to show through reruns that nothing can happen immaculately! - sorry for the spoiler!!!). That is, there should not be folks with conflicts in the panel. If you had a prostate cancer panel of 14 guys, none of them should be working on ANY prostate cancer drugs, maybe even cancer drugs.

Am I suggesting that 14 such folks can be found among a population of 300 million (and counting)?


Whenever that's not possible: Pick rotating panels of experts from the FDA. Let them keep serving their commercial masters. But come time for applications (which the FDA can set starting from 3 - 6 months prior to the actual review date), the FDA should set a period where it decrees that the panelists should stop any conflicting work which might include accruing current benefits (like salary, bonuses etc). They can pick up conflicting businesses once the decision is made. Given the potential "upping" to the resume that serving on FDA panels brings, I doubt if many will protest this with vigor.

Then again, don't blame it entirely on the panel. This is where the irony of the FDA's argument in Riegel sets in. The Provenge panel did recommend an approval. The panel is support to be the expert..and a 13-4 vote is not contentious. So, who then got to decide to screw Provenge over?

What would be the point of arguing that panels know better than juries and then not listening to panels? We might as well do a TV program where out-of-work parttime bartenders could review drug applications...

So, is an investigation necessary? Yes.

Is there a better way for the FDA to function? Yes

Transparency somehow appears to be a potential keyword in this does commonsense!

But hey, why listen to me..after all the FDA has its own experts!!!

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Saturday, December 15, 2007

Update: Stent Startup facing difficulty with IPO..

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Here is my post from yesterday:

So, I talked about the FDA and their much delayed, yet knee-jerk reaction on DES. I also talked about how stent companies do keep popping up, regardless of several issues with perception. To sum it up, I defined how the major stent players are more worried about litigation on defective products than in actually trying to understand (I am pretty sure - no one has a clue) if stents are actually effective and proving it medically and scientifically.

Referring back to the article on VentureBeat, it is a little bothersome to me that they didn't react quickly. What is it that they were doing from May all the way through December? Yes, and what is with all the secrecy?

Well, it maybe that Devax has other issues to deal with. But they are venture funded. So aren't their investors interested in making sure Devax doesn't raise unwanted suspicions?

Maybe we will hear from them soon....

It is interesting though that Venture Capitalists do continue to fund stent companies. Only time will tell if these "new" stent companies will revive the market or if the whole thing will unravel. One thing we would not expect to see as much is the kind of mania that surrounded DES when they were first introduced.

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Friday, December 14, 2007

Drug Eluting Stents - what a very proactive, caring FDA has decided to do

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It seems like dinosaurs were converted to fuel faster. How long drawn out is the drug eluting stent story going to be? Are DES actually effective? If they are, what is happening with all those deaths and increases in mortality risk?

Is the problem with the drugs? Because stents work don't they? Or do stents work either?

While you may think these don't fall under the gamut of the FDA....they do have a responsibility to patients, companies and stock holders of publicly traded medical device companies.

The essential problem is that the device industry has not always paid a lot of attention to thorough analysis. To date, effective analysis has not been performed on what stents actually do.

Wasn't it one hell of a shocker to find out that angioplasty for all the hue and cry it created and made rich folks out of a handful few is actually not that effective when you compare it to drugs?

So, expert one day, lucky guy one is an expert anymore.

Our only way to find out whether or not something works is to build it, build a hype around it, bring the FDA into the hype-building exercise and then when patients die...overreact!

Indeed, it is the stone ages of medical devices today. We hit something over the head and if it works!

Trying out unproven treatments on a whole lot of people based on a slim history to pass judgements is veritably not the right way to device use.

Where lies the solution? Definitely not with the FDA. The FDA has proven itself quite ineffective and gullible to industry pressure.

The solution lies in smart companies and in University laboratories. Instead of "teaching" people how to make devices, some of these schools would benefit from spending research effort and energy on building appropriate models of the human body, with respect to both anatomy and physiology and then study the interaction of the device with the body, and the long term effects of the device. The NIH will also benefit the industry by jumping in with grants..

Of course, data generated from devices should still not be ignored. It is a very critical source for further analysis wherever the models would become inaccurate.

Will it slow down product development? Not really. The current model for developing devices and bringing them to the market is fairly successful. No one is asking for an "overhaul" of the very basics of the industry. (Imagine suggesting that - boy would the bubble burst!)

A sound analytical background should be built around the device development process. That is already being done by the really good companies that spare no expense to ensure that they are actually building effective devices. But two things have to happen:

1. Extend the analysis, way into the post-market process without any slow down.

2. Bring more companies in-line with these efforts and make long-term device and device-body interaction studies an industry standard. After all, this is one heck of an industry where rituals and ritualistic folks make constant hay....

Will it be expensive? I ask you to spend a few seconds imagining your company, the company you built with your very hands on a stock market free does it sound expensive?

As to the FDA? Instead of restating the obvious, the organization would benefit from learning to act responsibly and instilling a sense of responsibility in device companies.

Didn't we all know that stricter guidelines and more studies were needed for drug eluting stents? Did we ever hear of any efforts by the companies involved to design appropriate research projects to understand drug eluting stents and their effect on the body?

No, instead they are merrily carrying on over a patent tussle on a product that doesn't work!

And more stent companies are popping up...everywhere!

Who do you think is responsible for all this?

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Thursday, December 13, 2007

Commonsense and/or a fear of dead patients prevails in China..

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I don't know what ticked off the Chinese initially - that they required a "near 100% inspection of ALL imported medical devices". Maybe it was the fact that they were packing toys with lead...yes it did happen, but enough with it already....

Maybe it was global ex gratias such as Lou Dobbs who have the genius of converting minor issues into apparent major disasters.

Maybe it was the fact that the US and folks around the world in general over-reacted to production quality of Chinese goods.

Well whatever it is, both parties are guilty. If production coming out of China was truly off quality, it was not just the factories that needed to share the blame - atleast not always. Many US and other international organizations have subsidiaries in China. Wouldn't it be a shared responsibility then, to reassure everyone of product quality?

Would it hurt Walmart and other toy stores if they checked products for lead or other mishaps before loading them on stores? Apparently, it would! They are unwilling to play their part - then their yellow smiley cannot keep smiling as the prices would go up. So they blame it on China...and a guy hangs himself...truly nasty!

And, recently China seized toys and products coming into their country from elsewhere that had product only proves one thing. Many of these companies and countries share a common attitude when dealing with China, "Do as I say and not as I do...."

Would it really work?



Simple: China is an emerging superpower. Keep ticking them off and lose any percentage of 1.3 billion (and counting) customers. Same would go for China.

The equations and dynamics are changing. The difference between the "old" world and the "new" world is shrinking..helped by a dollar that is on a downward sliding scale. Even when the dollar picks up, if it does, as predicted in 2009, the world would have changed by then....

Companies and countries should realize this, and learn to present a picture of equanimity and commonsense when criticizing...and of course make sure they don't have glass doors before they throw stones at anyone else! So can someone shut up Lou Dobbs already?

But China, how naughty of you?! Did you really think you could do a 100% incoming inspection....And Thank God for the patients who really need those medical devices!

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Saturday, December 08, 2007

Forget Genetic Planning and all that - Good, old style self-torture is alive and kicking!

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The big argument that certain religious groups and paranoia-professors is that once genetics and cloning advance enough, people will be able to choose the eye color, height, weight and other characteristics. After placing this argument, they also aptly display shock to try and drive home the message.

I wonder how they would respond to this new surgical technique that helps you grow your limbs - quite painfully. So, orthopedic surgeons took a surgery they only use to perform for people recovering from traumatic injuries or from congenital defects to ... well, anyone who has the money and a story to go with why they would have this surgery done on themselves.

Shouldn't there be a review of ethical issues on braking someone's legs on purpose? Being short is bad now? I am 5'5". Should I go into bouts of depression over this "defect" as opposed to the many other, more easily corrected problems in my life?

Wouldn't it be easier to counsel someone on how they would really appear to people if it were to be revealed that they had their legs fractured so that they wouldn't feel bad?

Oh well, for all you "cloning" and "genetic cleansing" naysayers out there, manicure, pedicure and "limb elongation" are all symptoms of a desire to misuse tools that are meant to heal that precede inventions and tools that are supposed to help those suffering through trauma or from congenital defects.

So, please, think twice before you kill the messenger...

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Thursday, December 06, 2007

Healthcare: Just what were you thinking?

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In a quest for some justice, Californians have struck gold...again! Las Vegas is not the gambler's haven...California is. You know I read a blog yesterday: they were trying to enlist which CEOs should go back to Business School here:

There seems to be a special B. school that CEOs of all companies doing business in California should go to: The "Don't be stupid enough to fight the State of California" Business School..

Kaiser and Blue Cross should have really spent some time looking at how bad their previous experience has been, and tried to fix things before they blew up so much.

Instead, they gambled with the law in the most populous and, veritably one of the most activist states in the US. Now, all insurance companies that have used dubious insurance schemes will have to deny insurance to Californians will see a spurt in class action lawsuits.

This is another representative example of how poor practices will simply not go down with health insurance and the law will catch up sooner or later

Wednesday, December 05, 2007

Update: Its Riegel, Riegel and more Riegel at the Supreme Court, on blogs and everywhere else...

[Click on Post Title for Link to External Article]

[According to the WSJ, The Drug And Device Law Blog is the best. I will let you make your own conclusions :), but it is a true blog, in that they posted a written report by a third party and their comments on the proceedings]

So Riegel is everywhere. Everybody who thinks they are some kind of a journalist, a legal expert or a medical devices expert is writing about it, no matter how little they are adding in terms of new information or value. How, but how could I leave myself out of this? I want to feel important way of some n'th association...

Anyway, coming back to reality, it appears that Medtronic, not surprisingly, is set to win this one. Federal pre-emption is set to win anyway. I am guessing this will be my pre-final update on the Riegel case..

All said, I would hope this doesn't open a bleeding wound whereby, jury trials become harder and harder to obtain against drug and device makers, societally speaking.

More or less folklore, it is not uncommon that State Regulations tend to be stricter than Federal Regulations, atleast in some of the "activist" states. This has led to better regulations at the Federal level and the Federal Justice System should not become "a path of least resistance" for the real wrongdoers [Medtronic, not being one of them] to "get away with it".

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Sunday, December 02, 2007

OT: For Fellow Bloggers: Know your rights..!

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Thanks to Tim Oey [ ] for the link to the story.

This post is Off-Topic only in one sense. As bloggers, we often tend to write about companies and sometimes if not all times in negative light. I have very little respect for "Professional Bloggers", especially in Medical Devices who just rehash news articles and try to write nice things about everyone - a true betrayal to journalism.

We all have our right to our opinions and our ability to express them. As such, I have not written anything overtly controversial yet, and have not been harmed in any way, but should such a time arise, I would like to see my rights protected. Wouldn't you?!

Anyway, just go to the link and read about how BidZirk tried to harass Philip J. Smith, a blogger and lost.

This should be lasting proof to any of those in doubt. Remember to defend your rights, otherwise they will be taken away from you, one way or the other!

Good Luck Bloggin'!

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Riegel Update, Can States Regulate Medical Devices?, Are Devices and Drugs related? and how "stupid" juries are...

[Click on Post Title for Link to External Article]

Typically, struggles in a field ensue because a bubble burst...morbidly, in this case a balloon burst. That is how Medtronic's struggles started with Charles Riegel and his family. Thence followed a series of "interesting" events -

1. Charles Riegel himself did not die from the incident. However, he did manage to sue Medtronic for "alleging design and manufacturing defects and inadequate labeling with the device."

2. He then passed on and his wife continued the lawsuit. At one point in the recent past the case was in the danger of being dismissed based on a technicality - the lawyer acting on behalf of the Riegels displayed the maturity of a 5 year old.
[ ]

3. Somehow the case seems to have survived, and will be heard by the Supreme Court this month. Against this backdrop, here are some interesting things that have come to view...

a. The basic argument by medical device makers is that they are already regulated by the FDA, a federal agency, which supersedes any state regulation and thus should not have to answer to a state. Fair enough, after all, we do need to invoke the constitution whenever it benefits us. Only, the FDA regulates how a manufacturer makes and labels a device - it does not punish the manufacturer for causing harms to patients by awarding penalties. This is one of the essentials of the legal system.

The "national standards" argument is very weak - given how several states have time and again demonstrated the ability to exceed politically motivated federal standards that are generally lower.

b. Here is the Soliciter General's Office expressing their "expert" opinion:
"Subjecting a manufacturer to liability for not departing from an FDA-approved design or label would interfere with FDA's ability to protect public health by balancing the risks and benefits of a particular design or label," the brief states.

- Call me naive, but doesn't the statement sound like "Bring it on"? It is almost asking the people to sue the FDA instead. Exactly how does a lawsuit in a state interfere with the public's duty? The suit will follow the approval usually, not precede it. They seem to be claiming an extraordinary amount of defense, almost as if saying they are infallible.

c. Here is the clincher:

"I think you should put this in the hands of an expert federal agency, which sets up one set of standards that applies nationally," said Mark Herrmann, a partner at the law firm Jones Day, who has followed the Riegel case closely. "Having a jury of 12 people, with an average of a high school education and in the presence of an injured person in the courtroom, decide whether or not the medical device company did things that were right or wrong is a bad situation for society," he said.

- If you are thinking, "Geez, are they handing out law degrees at the county fair?", you are not alone. Sometimes, they suggest, if you cannot say something nice, just say nothing. This guy could have done himself the favor.

Let's extend his argument. What do a bunch of lawyers who read books for three years to get a degree know about medical devices? All they do is argue, "He says, she says".

Juries of 12 people have gone on for a few hundred years around the world, making judgement calls on hundreds of thousands of cases. Yes, they do make mistakes, but so do the "experts". And that is what is being argued out in the Riegel case, that is if it gets past the point of State Vs. Federal statutes.

Who would have known insulting the intelligence of juries, high school education and the general practice of law is considered a cogent argument by some? I am thanking my stars I am not a lawyer. To believe this guy would be a peer just makes me shudder...

Believe me I have nothing against Medtronic or other device makers. The Riegel case makes an important judgement call on the volume of legal troubles device makers will see in the future. It is a very serious situation, and what happens to Medtronic will reflect on the entire industry.

So, for their own good, and for the rest of the device makers, lets hope Medtronic has a better argument (they seem to have a good lawyer, who won a case based on thin air) than that of the Solicitor General and the genius lawyer who didn't believe in juries.

On a slightly different note, here is something Howard Brody raises, "Are devices different from drugs?". Read the blog here:

Now, visualize if the Riegel case is part of a rather larger, more troublesome issue of coercion than basic legality and ethics. Because, if device makers are indeed dodging the law in Minnesota and elsewhere based on influence, it is bound to run out one day and bring what would seem like a house of cards down. One would hope, they decide to take the high road... so that the rest of us in the devices industry stay safe and employed!

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Saturday, December 01, 2007

It is World AIDS Day Today. How can you contribute?

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This is not a question I am trying to answer for you. This is a question I am trying to answer for myself. On the outside, it would seem that the biggest benefit we can derive for AIDS is by going out and finding some cure.

However, if you have paid the slightest amount of attention on the problem of AIDS and the HIV virus, you know that a cure is not very forthcoming any time soon, and that even the most successful therapies, resemble a finger placed on a dam wall to save Holland..

So what is it that I as a single unit do to contribute to the cause of fighting HIV/AIDS?

For starters: Remove I. Think Team. Yes, as the cliche goes, there is no I in team. And, this is one more of those situations where cliches don't hurt.

There are several small and large steps that have been identified and recommended for people in the fight against AIDS. I did a quick brainstorm and came up with these:

1. Advocate the practice of safe sex, and where possible abstinence.

2. The article on the link [Click on the title of this post] recommends proper nutrition for HIV+ individuals, especially in those that have the onset of AIDS already. If you know someone who has AIDS, make sure they are on a proper diet. If you don't know someone personally, donate to the cause.

3. Donate whatever you can to the cause for a cure for AIDS

4. Be responsible. Always demand that blood gets checked before any transfusion.

5. Do not under any circumstances share needles with another person.

6. Do not reuse your needles, if you are taking medicines for legitimate purposes. While this has nothing to do with HIV, it is important to follow good hygenic practices.

7. Ensure that you dispose of any needles you may personally use appropriately, so that no one will be able to retrieve and reuse them. This is a major problem in several regions around the world.

8. Educate yourself. Educate those around you. Join HIV advocacy groups when and where possible and volunteer your time, energy and, if you have the luxury to do so, your money.

Are there other things a person can do? I am sure there are. If so, do write in. I would like to hear them, and so would several people, I am sure!

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Friday, November 30, 2007

Update: Disgrace of Indian Medicine breaches new heights...

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Rarely do I get the opportunity to update my displeasure with more displeasure, but now would be a good time to do so. Thanks to comments by a "Lone Crusader", I now know that the President of India, a women who guilelessly accepted a cosmetic position handed to her to prove that the Government could put a woman "up there", has signed a veritably unconstitutional but definitely unethical modification to an act that has ousted the troubled director of AIIMS.

Not withstanding the fact that the move by the Government is illegal in the face of the fact that a lower court had specifically ordered the Government to seek its permission before getting rid of Dr. Venugopal, this case is now going to court soon, with the Supreme Court gunning to examine the act on Monday.

So, this wont be the final update on this issue. But, I reiterate that this demonstrates how weak India's position is in the world of medicine, biotechnology and medical devices. The industry has very little independence from the Government, the chances of India's Government being populated by people with base levels of commonsense are quite low and the Indian populace barely wants to pay attention.

To sum it up, this is a lingering (a bit too long) moment of disgrace to India, and the practice of medicine in this great country of mine....

[For the original post, read the blog immediately below this one..]

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Thursday, November 22, 2007

Dr. Anbumani Ramadoss's contribution to Indian medicine: Eternal Shame

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For all those people blindly tolling the bells of progress in my country, Ramadoss serves as the "duh" reminder.

A very inept man, he represents everything that is a political stumbling block that hinders rapid progress of India. Not only does his existence have nothing positive to contribute to the nation, but he has also taken on a personal enmity with the Director of AIIMS, one of India's premier institutions to prove how low, demeaning and cheap his existence can be, and how much damage he could continually cause in a "democracy".

He has the full backing of Manmohan Singh, a man who, surprisingly enough, continues to fall in stature. Singh is only interested in keeping his party in power, which has naturally translated into an unabated freedom for Ramadoss to act like the veritable Bull in a China Shop.

This incident that appears more like a long drawn out battle in idiocy is a good example that highlights the weaknesses in India's democracy:

1. Just like the US Constitution, the Indian Constitution is weak in that parties in power can pass legislation that is fundamentally wrong - ethically, morally and legally. In India, the situation is worse, and continues to unravel despite an active Judiciary.

2. The caste systems that the British took advantage of have now become a weapon in the Indian Government's hands. This is something that can only contribute to some of the darkest pages of contemporary Indian History.

3. The Indian Press, and the force of public opinion is more or less a joke. While AIIMS continues to suffer through multiple strikes and government interventions, patients continue to suffer. The public has not taken a stand and has not represented its grievances against the situation.

4. Healthcare continues to be a very low priority issue in India.

5. Autonomy of institutions is also of very little concern to the Indian Government, the opposition, the press and the general public.

Given all these facts, and the very untenable situation created by parasitic ministers like Ramadoss, progress has a dim outlook in the Healthcare education and administration in India.

These facts are not factored in multiple assessments of the Indian Healthcare, Pharmaceutical and Medical Devices Industries.

It is indeed easy to fix a dollar amount X to any product/service unit, multiply it by a billion or a fraction thereof to come up with juicy numbers. This, however, does not represent the true market size of any industry in India.

Here are some very damaging scenarios that could play out in the presence of someone with as minimal intellectual capabilities as Ramadoss:

1. The quality of medical education can be diluted to the extent that Indian Doctors and Medical Institutions will lose their credibility and competitiveness in the world. This will severely hamper the future ability of India to fight off China and other emerging nations in terms of clinical trials, clinical research and related industries.

2. Irresponsible Healthcare Ministers can suspend or permanently stop clinical trials and research without logical reasons or explanations. It is very obvious where this will lead to.

3. Both 1 and 2, individually or collectively will also affect patient healthcare, both local and those coming in through medical tourism.

What India needs is responsible, educated ministers who need to be qualified for their portfolios. In the absence of such leadership, and in the presence of cretins like Ramadoss, all new and existing companies doing business in India within the healthcare or other frameworks will have to be very cautious and conservative in their approach and outlook.

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Professional Stupid: Do not attempt at home or airports

[Click on Post Title for Link to External Article]

Why does the practice of medicine have to be more like "Grey's Anatomy" and less like "Scrubs"?

We have all watched Scrubs, and besides the promiscuity, we are apalled by some of the activities "J.D." and the rest of the Archies-Scrubs gang get involved in.

But Dr. Chiu here has proven that Scrubs is not that far from reality.

Please read the rest of the article posted as the Link for details on how crazy this "Doctor" is. Hope he has his licensed taken away from him...

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Monday, November 19, 2007

Of Eyelashes and how the overgrown eye brows blinded the organization to commonsense...

[Click on Post Title for Link to External Article]

The hottest market for drug or device development is : brain growth for governments worldwide.

Unfortunately this largely untapped market looks like it will remain so...forever!

Here is the latest proof that determines this urgent clinical need:

>FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."<

Why does this seemingly innocent policy bother me? Well for starters, apart from being an engineer in the field that FDA breathes down, I am, fundamentally a consumer. I am glad they went ahead and "siezed" a product that they had already "banned" from sales before I could dunk it by the pound to grow giant eyelashes, a lifelong wierd dream of mine.

But, what seems like a cliched protest from a hithero unknown Jan Marini Skin Research, Inc, did raise a few red flags(lifted verbatim from the Reuters Article):

1. Jan Marini, the company's president and chief executive, said the product at issue had been in its warehouse since September 2006, when California public health authorities "embargoed" it at FDA request.

2. The company added in a statement it had offered to destroy the product, "but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure."

3. "We have been unfairly singled out," Marini said in a telephone interview. "Other companies use the same ingredient and we're not aware of any action that has been taken against them."

And, going back to the very beginning of this post,

4. FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."

Here is why all these 4 statements mother me....

1. Okay, September 2006 subtracted from October (I am sure it took the FDA two weeks to prepare for a one page, cryptic, zero value press release) 2007 equals 1 year and a month. Why on Earth did it take the FDA 13 months to make some sort of a final decision, however small its incremental value was? Is this the average, lower end or higher end of the timeline for the (in)activity of FDA? Will we ever be blessed with the opportunity to find out what happens in Wonderland that takes them soo long to arrive at simple endpoints?

2. "so that it could issue a press release announcing the seizure." In all fairness, I don't know if this is true, but this is what got quoted on the company's behalf on the Reuter's Article, and I didn't see the FDA protest this statement anywhere. So have we been treated to a classic dog and pony show? Moreover, what irks me is why do they need to "seize" these products? How much money was spent into this "seizure"? Why would it be harder to let the company destroy the product on its own?

3. This is what ticks me off the most. Maybe the company was wrong in making and marketing this product, but not only did the FDA hold them in a state of limbo for over a year, they won't even reveal if other companies do make products with the same chemical "bimatoprost" or similar eyelash products are under investigation. Why is that so? It almost makes one think that JMSR is being singled out! This may very well not be the case, but 4, the statement by an FDA spokesman makes one very suspicious...

4. This is a "company friendly" policy that just seems to be wrong in every possible way, except that it probably thrills the companies under investigation. While we all would love for the stock prices of healthcare companies to perform as well as all other companies, we love living and not getting killed by devices and pharmaceuticals even more. This seems to be one of the worst policies a government agencies could have.

It also means the FDA is uncomfortable with the appropriateness of its own investigations. It seems to indicate they don't trust themselves. And, it is definitely not a good starting point. If at all Congress is interested in changing the way devices and drugs are developed and delivered to customers, this little "policy" needs to be wringed out of the FDA's day to day activities....

In effect, points 1 - 4 and my doubts relating to this issue seem to leave open some holes that would challenge the ozone layer's own holes in terms of graveness, urgency and the ability of the FDA to act as an effective policing agency..

If you have it in you, you may choose to shock yourself more, relating to the regulation of devices here:

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Thursday, November 15, 2007

Autodesk: Not just engineering, now bringing new suicidal techniques to a courtroom near you...

[Click on Post Title for Link to External Article]

Okay, what is the connection between a medical devices blog and Autodesk? Well not much, but to be fair, AutoCAD was the first modeling package I used as an engineering student. Suffice it to say there is no love lost here. And then, they do this to bring joy and happiness....

The premise of copyright is to protect your work, not to further your illegal plans to build huge corporate empires based on CAD package sales. It is almost shameful to honest engineering that companies would lose sight of fundamental ethics and go off on the left field to commit what could veritably be proved a crime in court.

Exactly where commonsense disappears and insanity begins seems to be a greying deadline. You know, I was always wondering, with the advent of Pro/Engineer and later, SolidWorks, what AutoCAD's marketing and sales strategies where...well now we know!

It is hard as it is, for engineering students, small firms and entrepreneurial individuals to afford software, but AutoCAD has done grave injustice to all these classes of people for years, as it now becomes apparent.

I wonder what this one person achieves by earning $10 million from AutoCAD, but one would hope that if the court sees this activity as purely illegal, it should set an example for other large companies trying to "cut corners".

And, as to the California Bar Association's investigation of the lawyer, one would hope this is quick and effective. My cliched suggestion to them is "put legal back into the practice of law".

Hopefully this case results in more of a lesson to companies donning the fraud coat than, say, what a very large, two letter-name bearing IT firm got for its "creative listening" activities...

My advice to young engineers?

- Based on my understanding of the "best practices" at Autodesk, gain skills in modeling packages that you may afford.

My advice to other modeling companies?

- Before you plan to mire your future customers with "network licensing" and other dubious "lock ins" .... watch out. The customer is not for yours to imprison, but win over.

How is it that I repeatedly see companies missing out on the "Duh" facts of life? Why do I find myself repeatedly asking these questions?

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Thursday, November 08, 2007

Of PFO Closures and the MIST Trial: Troubling times for Alice in Wonderland

[Click below for link to external article]

[Another update has been added at the bottom]

In case, you have a problem with blogs, here is the "original" article that reported it:

It is your choice to read either article or the blog. Both read like the Oh-la-la of a Hollywood movie, er..the Fugitive. Okay, maybe it is not so dramatic, but our main characters are Dr. Wilmshurst and Dr. Dowson. The playground was TCT 2007 and the (you thought I was going to use the e-prefix, huh?) Corporation is NMT.

Several not-so-mysterious mysteries surround the issue:

Now if everything is both hunky and dory in PFO land, why not show Dr. Wilmshurst the data and shut him up? What is wrong with letting him see the data?

Or what is wrong with proving to him that the echocardiogram data was independently verified?

In fact, why not publicize the entire data set?

Why not conclusively prove and delineate the purported "protocol" violations of Dr. Wilmshurst?

What about Dr. Dowson's seemingly troubled past?

It seems cliched enough, but the silence of NMT (on these questions only) is deafening. See, not answering these questions, to the simple mind, seems to be very troubling.

Essentially, it seems like the MIST Trial seems to be well on its way to becoming a prime example for the "10 Things to avoid", "How to turn your device Trials into publicity nightmares", "It is fun to try and fool all of the people some, most and all of the times" case studies that business schools and a variety of other graduate schools could hand over to avid students worldwide...

I am constantly surprised at how companies with so many "experts" fail to take the easy, simple, honest way out with things. Who knows if the MIST Trial was even wrong in the first place? But things have escalated to a level where that is not even the issue anymore...

Remember, this is only ONE of the several foul-smelling issues raking up in the "increasingly, well-funded, rapidly growing" medical devices industry. For hints look up defibrillators (going back to more than a year, if you please) and Orthopedic devices for other "issues".

Well, if this trend continues, our entire industry is going to look like a bunch of quacks trying to sell sham wands in the place of sham potions..

What this industry needs is people with strong, actually very strong ethics, not blind "several years of experience conceiving, designing, redesigning, launching, manufacturing and hand deliverying devices to patients and surgeons for very, very low pay". Effective leadership in the medical devices industry seems to be its very own holy grail...

By the way, coming back to our friendly, neighborhood PFO-closure mania, this is not the first time I have posted on the subject either. Here is another archive:


Bad coincidence. Just after I published this post, another of my Google Alerts turned this one up:

If that doesn't send a chill down your spine, I wonder what will..

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A cryptic one: They call it "money talking". I call it "Dinosaurs Rising"...

[Click on Post Title for Link to External Article]

(I feel like the Oracle today. You are going to have to visit the link and some of my archives to get the full purport of what I am trying to post here)

It has taken them so long. This letter, that has come up with the alacrity of a brontosaur from the Triassic Period, very much reminds me of the cow like portrayal that Spielberg did in Jurassic Park.

I am still not happy. Is this letter going to do anything? Where did the number 31 VCs come from? Does it take them SO LONG to come up with one measly letter? And the end-result of their co-operation is a letter? Is that the show of the strength? I seem to have more respect for the TV show writers..! Is anyone paying attention anymore...?

Oh well, one would hope so! If I am wrong, and if this is indeed "money talking" and not "Dinosaur Rising", then it might help us to get rid of H.R. 1908, the maniacal child of a miscarried intellect...

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Thursday, November 01, 2007

The Cliched Post: Patent Rules blocked in cinematic fashion....

[Click on Post Title for Link to External Article]

Okay, this is becoming all too familiar. Why am I commenting on these things so late, after everyone? Look at the Exubra thing, and now this..

Well, first I thought, regardless of the last minute courtroom drama typification, it was bound to happen anyway, so where is the surprise. And then I read another law blog. And another, and yet another.

At one point my only thoughts where, "God, I wish Nancy Grace was covering this..."

And then, slow as I am, I got to thinking...

Here are some of the salient features of the whole brouhaha:

1. The pharma industry is the largest user of continuations. Only one of them filed against the new rules. What were the other companies smok doing?

2. Why did it take so long to get a district court to block the final rules?

3. Why was there not much effort put into the public commenting period?

Now, comes my most important worry:

4. The USPTO spent over a year to get to the rules. They were announced in August 2007 and this mania went into November, scintillated by webinars and other gala activities arranged for the public benefit (or the opposite effect thereof) by the USPTO.

Who, other than me is worried about holding someone accountable for all the public money and time spent in framing and trying to implement illegal rules, the illegality being as clear as it would be in broad daylight?

If government agencies are using public money, which is what they are using every minute they are functioning, shouldn't they be held accountable to spending the money in a sensible manner? Can they just act like irresponsible kids blowing away their grandpa's inheritance? How is it that the USPTO thought that this very anti-competitive, anti-inventive, anti-public-service measure would actually survive? How low has their ethical nature stooped that regardless of the answer to the previous question, they went ahead and tried to impose these measures anyway?

Given the amount of "public" interest in bringing the USPTO to its heels on the rules themselves, I don't think point 4 will be addressed...ever!

Atleast, as an inventor, the injunction makes me happy. Thank You, random Judge in Virginia...

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Saturday, October 20, 2007

Pfizer & Dell get down with online social networks & blogging?

[Click on Post Title for Link to External Article]

Also read this one for Dell:

Another blog on Pfizer and Exubra you might say?! What can I do? Everyone's doin' it, so I had to too.. ;). I will try to make this interesting though...

Okay, so we all learned (learnt) about Pfizer's earnings this past week.

There was a slightly heavy write-off on the failure of Exubra (about $2.8 bn you might say). And some of us also probably read about Nektar's CEO steaming about how Pfizer didn't even let them know about the fact that they were dropping Exubra and they had to learn about it from Pfizer's earnings call...

Come on, what are press releases for, eh, Howard Robin? You should be reading them, and Pfizer was testing you...

If you ignore this dark side of Pfizer where they blindside their own collaborators, you can begin to look at their "positive" side. And that is this:

They realized the problem with Exubra's sales was "marketing".

I see. So, it had nothing to do with 'inhalable insulin' being one of biotech's biggest challenges or that Nektar seemingly modified a supersized birdfeeder (read the "bizjournals" reference to a blogger saying so..wasn't me!) to cause the delivery of Exubra.

Oh I am sure Exubra's failure had to do with marketing. Why wouldn't it? Just look at how well Pfizer handled its PR with Nektar...through a press release. Its like breaking up over the phone...

Anyhow, now that the really long premise has been set for the whole post, lets look at Pfizer's next move to mitigate their "marketing" goof up. They are going "facebook" on physicians.

They are now going to walk the online landmine that is "Sermo". Sermo, apparently Latin for conversation (because latin is very relevant) is a take on the erstwhile "stitch n' bitch" approach that doctors usually take to advance their practice.

Apparently Sermo doesn't regulate what the doctors post after it verifies that in fact they are MDs. (In other issues I found this FAQ badly in need of grammatical touch-up, "How will Sermo paying clients use information from the Sermo community?"). Plus, rightfully enough, the MDs don't need to reveal who they are when they post...

Could all this mean more PR problems for Pfizer in the future? Potentially! Maybe they should merge the PR and Marketing departments to "strategically" "leverage" their "operational advantages" to "maximize" something or the other.

I can totally understand why they would use an "innovative" technique to solve a fundamental problem. After all "old-school" techniques such as plain talk with doctors won't lead to good marketing results now, would they?

Meanwhile, I think Dell has actually done something meaningful with online collaborations to try and improve its stature among its customers. Mostly because they make a consumer product, and they cannot reach out to thousands of customers on a personal basis.

As for me, I hope Sermo's execs read Pfizer's press releases closely (A Google Alert might help). And, if this trend continues, eHarmony and might have another "vertical" "channel" to explore.

PS: Just feeling very sarcastic today. Most of the double quotes refer to "corporate speak" that you could download onto flash cards and spend many a lazy afternoon making up meaningless gibber...for fun! It could land you a job with PR, Marketing, Cross Department Collaboration, Business Development or Executive Management!!!

PS2 (not to be confused with Sony's suffering product line): I was looking for the "birdfeeder" reference and came up with:

Oh, so much fun...

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Monday, October 15, 2007

Medical Device Blogging: J n' J by the way, is down wit bloggin' & other emerging paradigms....

[Click on Post Title for Link to External Article]

If you have paid any attention to the blogosphere at all, there are only a handful of medical device professionals blogging. I don't blog exclusively on medical devices, so I may not count. However here is my micro-analysis on this issue...

There are probably four categories of blogs on medical devices:

1. Blogs by medical device professionals - designers, engineers (R&D, manufacturing, quality), consultants, regulatory professionals, marketing professionals etc. This also includes physicians blogging with a focus on medical devices.

2. Blogs by medical device publications, newsletters, magazines etc.

3. Blogs by medical device companies, company leaders and company-sanctioned blogs

4. Blogs by investors and investment trackers on medical device companies.

We have discussed category 1 before. Mine may qualify as one. is definitely another. This and some of the blogs by professionals are of quite high quality.

Now, to category 2.

Most of the blogs so far that have come outside the realm of individual professionals have come from magazines and other publication sources. To be honest, though I even list many of them, I don't think they are truly "blogs". Many of these are what I call "creative paraphrisations" of articles and press releases.

These blogs tend to walk clear of any controversy, the bloggers and companies not wanting to piss off current and future supporters I guess. Not a bad idea, if you want to stay in business...

My take on blogging - or web blogging is completely different. Armed with the duality of the 1st amendment and the expressive freedom donated by the internet, it should be a venue for people to express their opinions freely, especially when companies do things wrong. Respectfully pointing out these mistakes should not be a problem.

However, with television, in blogging too, I have noticed it is the controversial ones that become famous. That may not be all too bad if these controversy creators are responsible and are not doing it just to gain more hits.

Whatever be the case, I would not categorize blogs of group 2 as very valuable unless they tend to offer an opinion, a critique, an analysis or some other tool or output that professionals, observers and investors can use or discuss.

As to category 3, J&J's attempt seems to be the first of it kind from a large medical device company, definitely not the first of its kind in medical devices. There are probably a few blogs by smaller companies - I don't know yet.

The blog seems tame enough and even the blog roll is well, "whitewashed". And the comment policy seems to come from a scared PR department...

This will be a good observation opportunity for blogs in this category. Will it just be lip service to the company's PR line? Or will it be more frank and open? Will it do anything to create a pathway for other companies to follow? Or will it just disappear in ether?

Category 4 is from investors, investment analysts and VCs, etc. These blogs provide valuable information on how Wall Street views the field from outside - something that does get lost in the noise. With all the "bigwigs"-to-be of the industry doing really bad - in the stock market, with the FDA and elsewhere; and oodles of companies getting funded, these blogs should provide some interesting perspectives.

I dont know if there is a category 5, but there are blogs by individuals, groups, foundations, companies, individuals suffering or surviving special diseases etc. These blogs provide a pivotal support role on the perspective or the more hackneyed "big picture".

In my opinion categories 1 and probably 5 provide the most value for professionals to use in the future. Category 2 needs a lot of work. Categories 3 and 4 provide us all with the most entertainment and for us emerging "device geeks", new stories to throw out in our discussions...

So, blogging is growing in our field. Let us see where it takes us. Wonder who will be the first to get fired for "blogging"? I hope its not me ... lol!

In my opinion medical device professionals should blog more. This will help standardize issues and opinions across the board. After all, we are the least organized and recognized professionals across several engineering and scientific fields.

I think blogging has been a primary driver especially for industries such as IT. That has yet to catch up here. Let us wait and watch....

I do have one problem with J&J's blog: "Why am I not on your blogroll?" :p

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Saturday, October 13, 2007

GSK to rescue us from USPTO final rules or the "Work Reduction Program"?

[Click on Post Title for Link to External Article]

So the public comment period for the USPTO final rules ended around the second week of October and I was a little surprised to see so little action. And then I came across this post on "The Patent Prospector" Blog. GSK is apparently trying to get the courts to take a look at the final rules and how inventors will be unfairly affected by the final rules.

All of this is based on, what is atleast obscure to me, "The Patent Act confines the PTO's powers to regulating internal procedures in practice before the agency." (lifted verbatim from The Patent Prospector Blog)

If you feel adventurous enough, try to read "35 U.S.C. § 2(b)(2). Section 2(b)(2) " and the blog post to understand more of this. Apparently the federal courts have ruled that "Section 2(b)(2) does not confer on the PTO the power to issue substantive rulemakings".

In effect, I am hoping this means, the USPTO simply cannot "do this". That is good enough for me. Thank you GSK! (like someone posted on the comments). However, what I don't get is this: I think in totality there was just one other case filed by an "inventor dude". Other than that, none of these deep - pocketed companies that "believe in product innovation to maximize the value to our customers" make even a half-hearted attempt to fight the USPTO. How not so surprising! Nor were the omnipresent ACLU or any of their frat bros interested.

Well, I hope the courts rule that the USPTO "final rules" are fit for the trash can. Good Enough!!

It must have been quite a party the day they announced their big "work reduction program". Keep your pay checks and have very little to do. Must have sounded great. Next they would have issued rules to say "Claims should fit on one side of an A4 sheet typed in size 12 font and with no less than 2 drawings". Ah, well, those would have been the days...

But is anyone going to do anything to prevent the USPTO from being naughty again in the future? Who is going to tell Santa Claus that while people work hard to make progress in their lives and society, the USPTO decided to distract public money, time and attention to make seemingly illegal "rulemakings" ?

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Saturday, September 29, 2007

New and Ironic twist in Riegel case....

[Click on Post Title for Link to External Article]

So, I was out all day and come back to read a long list of interesting medical device articles. And, hidden deep inside, I find this.

Read the blog and some very unsympathetic comments at the end of the article.

As some commentor on that blog pointed out, no one seems to care about the actual issue at hand, and everyone wants to pounce on the plaintiff's lawyer. Well, she does need pouncing on, but why are people stopping there?

It would be interesting to see if this case goes anywhere. Oh well, that's that, till some other case with lawyers atleast more competent than 4 year olds makes its way upto the Supreme Court again...

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PFO closures, Cryptogenic Stroke and Migraines - Advancing Voodo Science well into the 21st century (and one more medical device design lesson)

[Click on Post Title for Link to External Article]
[Article may need registration with]

For those of you who don't know, PFO refers to Patency of Foramen Ovale, or simply put, the inability of the inter-atrial septum to close. Very important for fetal blood exchange, the PFO is supposed to close itself during the first year of a child's natural life. In about 20 - 25% (even this statistic is not clear) of the human population, this fails to happen.

Taking advantage of this anatomical "defect", something I would prefer to as "condition", a handful of medical device companies popped up all over the place. Some even boast fat VC wallets. [If you are looking for proof that VCs aren't always so clairvoyant, you could use these companies as examples to twist statistics your way - after all that is what some of these companies are purportedly doing to PFO statistics.]

There are two conjenctures [inconclusive correlations through studies that look at diseases retrospectively] available to help promote the closure of PFOs:

1. Cryptogenic Stroke assumed to arise from PFOs. The idea here is that there is a shunt, that is a passage of flow available for blood to flow from the left atrium to the right atrium. It is presumed that a small blood clot could flow via this route (as if there is no other route available, especially, looking at 6th grade anatomy, the left ventricle, aorta and hundreds of arteries in the body?!!) into some small artery in the brain causing cerebral stroke.

2. Migraine with Visual Aura. This idea is quite enigmatic and about 200 years from now could show up as one of the "mistaken tribal practices" of the 21st century on National Geographic. Using retrospective trials, it has been shown that for this specific subtype of migraine, relief may become possible if you have the PFO closed.

Here is the problem with both conjectures. Neither has been studied from an etiological cause-effect perspective. The cardiologists that support this procedure have "a feeling" "anecdotal evidence" and other imaginative reasons to support it. Maybe, for them, "Imagination is more important than knowledge".

Thankfully enough, for once, the FDA doesn't think so! Read this for details on what the FDA concluded at a panel earlier this year:

Basically, there were two things the FDA did:

1. They removed the "Humanitarian Device Exemption (HDE)" provided to two manufacturers of PFO occlusion devices. Without going into too much detail of HDE, it is some kind of a short cut that allows devices to proceed down a simpler regluatory path if there is enough evidence to show that these devices provide urgent relief for a group of patients not exceeding 4000 in number, suffering from a particular condition.

2. They have concluded that a randomized clinical trial (RCT) will be required of all PFO occlusion devices.

Here is an interesting quote I picked up from the second article, "this is a device trying to make the anatomical defect a part of the disease process and in fact in should be just the reverse." [If you are doing market research to develop medical devices, print the quote in really large fonts and paste it in poster size on your wall]

This is the main problem with the closure of PFOs for either migraines or for cryptogenic stroke. This is also another important "medical device design" lesson to learn:

1. Recognize a real need. Make sure you are designing a procedure, implant or device that is actually solving that need. It is amazing to me that VC firms and small and large medical device companies decided to jump headlong into a problem area with little to no proof of concept.

2. Secondly, they had years to design clinical trials to prove the relationship of PFOs with the conditions they are trying to treat (apparently the FDA panel met 3 times in the past decade to come to the same conclusions).

What we see however is posturing and pointless clinical trials that don't actually help provide the answers to the actual questions that will decide the future of these companies.

At the least, they should be answering important questions of whether or not the procedures are needed after the first stroke, or multiple strokes; or in patients with a given severity of migraines. Trust me, I suffer from migraine myself, but I won't have someone meddling with my heart when I can pop a pill...

Then, there is the whole "off-label" use, which could become another (or many) really long blog post by itself.

And, that is why, unless these medical device companies get their act together, PFO closure might remain one more "Voodo" procedure whether or not it is actually effective....

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Friday, September 28, 2007

Are Medtronic and Pfizer bringing home new trouble for medical device and biotech companies?

[Click on Post Title for Link to External Article]

Follow the link for the law blog that details in a simple way what the supreme court has agreed to review for Medtronic and Pfizer. There are two separate lawsuits that aim to hold Medtronic and Pfizer responsible for damages arising out of their products. Both lawsuits were filed at the state level and both companies probably have legal teams that think Civics 101 is enough to get rid of the lawsuits.

Well, maybe, maybe not.

If it is, good for both companies. And maybe for other medical device companies, some, which may also use it tactfully to abdicate responsibility.

What if it is not?

What if the federal pre-emption is narrowed down by the Supreme Court?

What if the Supreme Court says that the FDA is not equipped to deal with such lawsuits?

That would be fun now, wouldn't it?

The premise here is that it is tough enough to innovate and make something work, and work ever so safely in the human body. Medical Device companies and Biotech companies have it hard enough with this challenge (yes, its a beaten, dead horse, but it still needs to be beaten over and over to get it into some people's heads).

I am not at all suggesting that victims should not sue companies anymore. They will continue to do so and sooner or later they will prevail. It would behoove companies like Medtronic and Pfizer to settle such cases instead of trying to pull a "Law and Order: Corporate Intent" on the rest of us.

I have nothing against either firm, but I think they might be risking passing on their bad luck to smaller medical device firms who may soon need to be looking for deeper pockets to keep paying their legal fees.

Would federal regulations work? I don't think so. It only seems to be a way to avoid lawsuits at the state level without actually framing a legal network that avails victims of what they deserve. Plus the FDA is barely functional, trying to live up to its current mandates. 100 years of existance have still not prepared the organization to run smoothly.

And, oh well, even if the Supreme Court favors Medtronic and Pfizer it doesn't look pretty for the victims. And, that again, is why, huge corporate firms "that put their customers first" should really try to do that...

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Monday, September 24, 2007

IntraOp Medical: Your mystery medical (device) company....

[Click on Post Title for Link to External Article]

I dug this out of SJ Mercury News, who seem to have dug it out of SEC Filings. IntraOp is right down the road in Sunnyvale. I have really not heard of them before!

That said, they don't seem to be all that secretive. Mayo Clinic has discussed them, and so have a few others. The company seems to have been around since 1993. They also seem to have recently sold equipment to the Netherlands and China. And the story seems to be a classic take on the "entrepreneur's" struggle.

So what has been going on? First off, an IORT system is not a medical device in the colloquial sense of the word. It is medical capital equipment. Plus, given a spate of these systems , looks like IntraOp is suffering just about what every start up in the capital equipment industry is suffering from...stiff competition from the very market it serves.

Intra Operative RT never really took off, and it will continue to suffer due to competition from External Beam RT systems, PET, and the several variations of IGRT, IMRT and so on produced by companies like Nucleotron, Varian, etc. Plus there is the CyberKnife that Accuray makes. Throw Brachytherapy in the midst and ....

Plus, it makes one wonder, how far will $5mn take a company in this market? They will have to fight it out with several radiation therapy strategies, find acceptable study results, physicist buy-in and so on before they can really break in.

The physicist angle here is important... Medical Physicists like the elegance of planning, not all of them like to hang around in the OR while radiation and/or surgery is in progress. This is a problem even for established Brachytherapy systems.

So what is the angle IntraOp is playing here? True, it is great to see a management team that is totally sold on the concept to the extent that they even made huge loans to the organization. But how long will they hold out? Or will they emerge as one more unexpected Silicon Valley darling from the left field?

Too many questions that only time can answer...just remember, CyberKnife itself is quite the success story (this could become another blog post, and some day it will..)

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Sunday, September 23, 2007

Should medical device companies advertise (more) on television?

[Click on Post Title for Link to External Article]

Among many other problems that could be listed about the Twin Cities article referenced for this post, here is one that took me aback,

" As for the future, Kamp said it was "inevitable" there would be more TV ads for devices because of "the cultural change of (patients) being expected to be partners in the decision-making process with our doctors." "

This is apparently a quote from John Kamp, who is apparently the executive director of the New York-based Coalition for Healthcare Communication.

Now, I don't know about this organization, but I am appalled at the suggestion that patients should now become "partners". Well maybe it works for a few doctors who would like to have lesser liability on malpractice suits, but if we as patients made decisions, why would there be a need for doctors in the first place?

Don't doctors face enough trouble with overtly ambitious patients who come back loaded with misleading information from the internet? Remember the study that showed that only 52% of information you find on the internet is accurate? Statistical techniques themselves have only a certain degree of accuracy. So, maybe information found on the internet is only 40% accurate, maybe it is 60%, but the danger still rests.

Medical Device companies and sales teams may already be pressuring doctors. If patients also join the mayhem, how are they to make independent decisions? And then we blame them of malpractice..

Also, how are medical device companies going to differentiate themselves from the late-night morphological "enhancements" and "proven weight loss" advertisements?

Medtronic may have succeeded, though I doubt it. I don't remember seeing the ad, and being in the profession, if it doesn't stick in my head, I really doubt the strength of the message. I say this, because the blood glucose meter ads do stay fresh in my mind [I did work on blood glucose monitors extensively in the past and may be biased].

What will happen when companies with devices awaiting FDA approval start advertising? (You know the size -1 font disclaimer at the bottom of the "enhancement" ads?) How about companies making off - label claims on national television? The FDA has enough headache trying to deal with drug company ads. Is this new "inevitable" venue for marketing healthy?

I don't think so. Especially not for life - altering implantable devices and the like. Blood Glucose Meters *may* be okay, because they are carry-ons and semi-consumer devices compared to the Lap Band, ICDs and so on.

Raising patient hopes unnecessarily only to have their doctors later tell them they are not eligible for a device is very cruel.

So, am I just going to pose problems and not provide solutions?


Here is the alternative: Pick a disease. There are hundreds of non - profits (in some cases, atleast 1) dealing with various health conditions. These non profit websites and materials try to do full justice to various treatment options that are available. Please support them. Again don't dump money on them and try to coerce them. Stay within the ethical bounds.

And of course, differentiate your products from shady sleep medicine ads that air at 3AM. That is not "placement". It is just "plain disgusting".

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Friday, September 21, 2007

Patent Law reform struggles shows disunity and ignorance of start ups and VCs alike..

[Click on Post Title for Link to External Article]

Here is what is so interesting. CNET picks a guy off the street, and now I don't even remember if he is a VC or an inventor (you will see why no one needs to remember him soon enough) and he says he did not even know about the patent reform bill till it had passed in Congress.

Now, isn't that great. If all entrepreneurs and VCs ensure that they stay this disinformed, and ensure that they do too little to late, we can see more such bizzare anti - startup laws show up at every turn.

Contrast this to the larger, corporate organizations. They seem to be at each other's throats all the time, and when the time comes they are all singing the same song on Capitol Hill. The whole "at your throat" thing soon looks like it was part of some mating ritual!

It is imperative that start ups, their founders and other stake holders decide to do something about this lack of unity soon. This is especially so for companies in the biotechnology and medical device realm. Otherwise, before they realize it, making their companies barely functional itself might seem so much harder....
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Tuesday, September 18, 2007

Bloodless surgery, Knifeless surgery...could it also be pointless surgery?

[Click on Post Title for Link to External Article]

I am not too sorry for the moribund title. While we would all love to see surgery performed minimally invasively, or not performed at all, where does the need stop and the want begin?

I am all for NOTES - a seemingly mundane acronym for Natural Orifice Transluminal Endoscopic Surgery and other options for patients, as long as the need is justified.

We seem to be slipping into a scary society where we don't even want to reveal the fact that we have been injured and are healing. It gets scarier when physicians perform and justify difficult operations for that.

As an engineer, I cannot stop to marvel at innovative surgical techniques and medical devices. I had a major surgery performed on myself. My surgeon worked really hard on an iliac crest bone transplant surgery to save one of my arms. I have a great respect for that man. I start losing respect for people who support high risk procedures for purely cosmetic reasons.

But, it looks like we will be seeing more and more of these...

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Thursday, September 13, 2007

How important is research in medical device development? - A good introduction!

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This is the article we have all been waiting to read, and write! If you have been around medical devices long enough, this seems more like a historic refresh.

If you are new, it is a great introduction for you. Recently when I blogged about Radiant Medical, I brought up some of the challenges that face medical device companies.

This very good article by Richard Halpern gives you a very good perspective of the promised land of medical devices. Happy reading, research and product development!

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Monday, September 10, 2007

Patent Reform Act, H.R. 1908: The [infringer] friendly patent reform

[Click on Post Title for Link to External Article]

So, I was thinking of all kinds of titles for this one. Let me first get a few of them out of the way,

"I said we need to 'reform' not 'deform' stupid!"

"Infringing a patent? Now Congress is with you"

"So you think we cannot travel back in time? Just look at where Congress and the USPTO are taking innovation..."

"Surely you jest, Congress!"

"Real men don't innovate"

And then, I saw this by the leader of BIO (short for Biotechnology Industry Organization)

"much more friendly for [patent] infringers"

Seems to be a better title. So, the BIO is opposed to these reforms, big deal you say...wait, even the generics guys are opposed to it. So are several legal beagles (just look online for lawyer blogs), and people from every walk of life, including the Bush administration.

We have all been worried about the need for patent reforms, haven't we? After a long vacation in the summer heat, Congress came back to session and decide to speed things up.

No use in wasting time thinking, strategizing and preventing a downward spiral of capitalism, eh.

After all the USPTO is doing its part (with a flawless final rule that will limit the number of claims and requests for application reviews) to cut down on this maverick innovation, why should other branches of government hold back?

When you are proposing a law, and no one in particular seems to like it , and everyone in general hates it, you may want to take a hint, or two, or three....

Since you may have read some well written articles ridiculing the various badly thought out propositions made by these reforms, I wanted to highlight the one I have the most beef with.

One of the crazy provisions of the new reforms requires that the victim (or the infringee, if you want to be cynical that way) has to prove that the infringer has violated all aspects of a patent to claim compensation.

Also, here is the big laugh, the amounts paid out on the claims will be directly proportional to the impact the infringement has on the product sold through such infringement. If this becomes law, courts will, in future be limited in terms of how much they can hand out by way of judgement.

This is not a reform. This is some Neandarthal attempt at dividing the spoils.

So now there are two motivating energies at work:

Positive - The infringers now have a lot of incentive to go ahead and walk all over your patents. First off, the burden of proof that all of your patent was infringed on, leans a little more heavily on you. Secondly, you will now have to run around with a calculator, trying to work out how much "impact" your patents' infringement had on the infringers' profits....

[If you remember the story of the poor guy who invented and patented wind shield wipers and nearly, literally lost his mind spending the rest of his life trying to get all the big automakers pay, you will understand why this just got a whole lot worse...]

Negative - Well, if you are a small time guy or gal, it is now going to cost more to patent anything, courtesy the new final rule laid down by your friendly neighborhood USPTO. And if you do get one through, it will cost you an arm and leg to defend it. So, you might as well give up...

But see, in the great ying-yang, Congress solved our problems. If patents go away, infringement goes away, ethical issues go away, patent infringement lawsuits go what if innovation also goes away. Innovation is the root cause of all patent evil, anyway.

Some great thinking went into this. And to think, this "reform" was sponsored by someone from California...

Potentially Horrifying Footnote: The above highlighted problems are not the only ones with these reforms....

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Tuesday, September 04, 2007

Women's Health: Sterilization Devices' War Heats Up...slowly

[Click on Post Title for Link to External Article]

I have already blogged about Essure from Conceptus. I saw this interesting article about "Ovion", acquired by American Medical Systems that enlisted the various players in the female permanent sterilization market and I thought it presented an interesting fight to wait and watch.

[Note: For those who don't know, Conceptus and Ovion were in a "first right of refusal" tussle that also arose from a previous dispute on Intellectual Property. However, AMS did finally close the acquisition following court intervention. The details of the settlements reached at various stages are murky and complicated. That could become a blog of its own...]

Now, Ovion and Conceptus will compete alongside Cytyc (which acquired Adiana) and IUD (Intra Uterine Devices). Actually, but for the IUD angle, this story would be a little dull.

Now that I have laid out the confusing matrix of players, let's dig in.

Tubal Ligation is the current gold standard for women who would like permanent sterilization. As is usual in many women's health issues, this is far from an elegant solution, requiring a hospital stay and provides very few options for reversal.

Essure from Conceptus is the first-in-class player, approved since 2002, but has made very little headway in an upscale fight against tubal ligation. This is not surprising, as is mostly the case with first-in-class devices. But, now that people know it works, Cytyc and AMS are banking on their acquisitions across the board.

Essure uses a metal implant, while Adiana uses radiofrequency energy and a polymer matrix implant to achieve occlusion. Adiana does claim opportunities to continue enabling endometrial ablation following the procedure and also in-vitro fertilization if the person changes her mind later. Exactly what Ovion not clear though.

To match their clinical performance to this point, Essure placement never resulted in pregnancies. Adiana did have one pregnancy directly related to the placement, as reported. Ovion - I have not been able to find anything beyond the fact that AMS suspended trials for about 4 months. The whys and hows are up for grabs, as of now...

Given this situation, it seems like no clear leader is about to emerge among the three. And throw in IUD placement in the midst, and more confusion ensues... IUDs are very simple devices, allowing for easy placement, and office procedure times of just a few minutes.

Compared to this, Essure, Adiana and Ovion require hysteroscopic or other equipment which may not be available with many OB/GYN practitioners, require training, are time consuming, require analgesics and/or anesthesia and most importantly, a follow - up exam for confirmation, leading up to which the woman has to continue contraceptive pills.

IUDs also provide the best and simplest opportunity for a woman who changes her mind suddenly. IUDs are very easy to remove and this procedure is also pain-free, effective and consumes very little time.

If you are still reading, I would say, none of the three players show much promise to be a run-away success. This does not mean they will not sell, it just means the field is wide open for another player to come in and knock their socks Cytyc's NovaSure did to about 3 or 4 major players in the endometrial ablation market, also effectively changing the practice of menorrhagia treatment and management.

Personally, I believe IUDs may not survive the onslaught of higher reimbursements, and will also fall prey to creative marketing solutions for women's health problems, such as the marriage of J&J's Gynecare Thermachoice and Essure as a combined, one-off solution to two headaches - endometrial ablation and female sterilization.

So knowing what may be in store for a new player, will there be one?

- There better be one!

The Women's Health market is large and growing, and can provide a nice addition to the bottom line of any growing medical device company. Moreover, replacing barbaric procedures with novel solutions should get Doctors and Engineers excited!

Also, given how medical device companies are getting handed funds and are being acquired left, right and center(which is a good thing), I am sure there will be interest generated in this area! Well, more may not necessarily be merrier...but hey, look at the prospect: atleast we could simplify the pain of aging procedures such as tubal ligation!

Note 2: Here is a generic list of various permanent sterilization options for women:

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