Saturday, September 29, 2007

New and Ironic twist in Riegel case....

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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)

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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?

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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....

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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?

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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..

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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?

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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

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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

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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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