Thursday, December 18, 2008

Okay kids, squeaky hips are in again - solving an unconsciousable mystery....

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It's always great to hear from an old friend, isn't it? Especially when they produce squeaky sounds as they approach you! In case, you missed my blog from earlier this year (because you were reading random pie charts and "nice" stuff written by bloggers placing ads of the companies they were writing about)...

http://chaaraka.blogspot.com/2008/05/stryker-now-with-squeaky-hipsoh-what.html

Anyway, in May we all found out that Stryker had been providing hip replacements with added functionality - total, unassailable, humiliation to it's customers (no, not the Doctors getting cushy payments, free breakfasts, golf games etc.) - the patients that had to walk around with them.

As you walked with your brand, spanking hips, they would jingle or squeak nicely. Well, around the holidays if you are dressing up as Santa, that must come in handy - or hippy?.

Long story short, thanks to George Bush the Supreme Court Riegel pre-emption, Stryker has walked away, let's say, without having to squeak.

What happened after the news article came out seems to be a total mystery. With a highly ineffective Congress and Judicial System failing to hold companies responsible for grave errors that have put patients through extreme trouble, this doesn't surprise me.

After all, not doing what you are supposed to, or get paid for is the hallmark of...

Oh well.

The Analysis

What is intriguing is, that Stephen B. Murphy, MD is hoping to acquit most hip implants minus one - and which one that is, is anyone's guess.

Back in May, I had alluded to the material properties of the implants and had urged some testing. In fact, I said that the displaced or replaced hips (about 7% of all hip implants had to be replaced thanks to the squeaky joy) and do some fatigue analysis on them.

It turns out the material is probably the culprit.

If you read the rather confusing article on orthosupersite.com, Dr. Murphy points to the specific stem material as the culprit.

If you want a good introductory article on hip replacements, go to:

http://www.orthop.washington.edu/uw/tabID__3376/ItemID__70/mid__10313/Articles/Default.aspx

If you want a good image, go to:

http://www.exac.com/patients-caregivers/images/img_patients_hip_components.jpg

(Thank you guys).

"ceramic components mounted on a beta titanium alloy stem causes the squeaks"

To briefly recap, hip replacements are not new, so please do not accept any feigned innocence on new products. This is a tried and tested product line.

Dr. Murphy's study (which I have not read and vetted yet - I will report back later) claims that when a specific type of alloy, known as the "beta titanium alloys" that contain molybdenum, zirconium and iron are used, alongside ceramic heads, you get this problem.

This should be a slam dunk.

The study looks more like a literature review, but I am sure it is sufficient to indicate probable cause. My theories on the failure still hold:

1. There is a new material. If the FDA where to actually act and examine if the implant material was appropriately tested, I am sure short-falls will be noticed. The very presence of the squeaking in 7% of the products, the apparent attempts to "silence" the patients, not the hips, and a continuing fogging of whatever happened after the news came out in May should be a clear indicator.

When a company endeavors to introduce a new product line with a new material, shouldn't the IDE contain extensive data on material testing and properties, rather than just biocompatability?

2. Take a look at this study:

http://www.ceramtec.com/pdf/8thSymp-5-8.pdf

It points to several factors including "component design and engineering", patient selection and other decisive factors. Like I said, not such a mystery - the science or engineering. I would bet that if you reviewed the squeaky hips, "marketing requirements" would stand out as winner.

Whenever you have "marketing" drive "innovation" and product design, this type of result should not be surprising. After all, ages ago, I almost worked for one, and then did work for another where "marketing" aka MBA jockeys with little to no knowledge or concern for medical device efficacy were driving design. Where those products went, how innovative they have been since that point would be a child's guess.

3. Prove it - A good finite element model can produce enough information on impingement, transcendental friction, long-term wear, fatigue, and so on.

A good motion analysis will produce data on what happens in inaccurate placement. It could also indicate how much error the surgeon is indeed allowed in placement. It's fundamental kinematics that I am sure is well within the analytical prowess of today's software applications.

4. I said this before, and I will say it again - get those replaced, squeaky hips. Study them. It is so easy to do fundamental image comparison and analysis to reproduce the "altered" states of the failing hips thoroughly.

5. Be honest, for heaven's sake. When you print those brochures about saving people's lives - mean it! If you can't stand by one word of your "mission" or "vision" statement, why bother?

Well, this hip story is not over. I am going to try and access the paper, and find out more about the study itself. If you come across this blog and know something about other studies, please let me know.

Saturday, December 13, 2008

Blogging for fun: - The science of Dr. House..."ataxia"

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The premise: I watch way too much House, M.D. - I mean waaaay too much. More than the pills Hugh Laurie scores on the show.

And they keep throwing Kawasaki's Disease, Sarcoidosis, Ataxia, Leukemias, Lymphomas and what not.

And epithets like

"Idiopathic is a term used by idiots who cannot figure out what's going on"

"These procedures would be much simpler if we could perform them on healthy people."

"Relative to its size, the Gorilla has the smallest penis size of any animal."

"Relative to its size, the barnacle has the largest penis size of any animal."

So, I thought why not get something out of it, rather than just watch the show to Kingdom come...

Ataxia

Ataxia is the inability of the Brain to control the patient's muscles during voluntary movement.

Ataxia is usually caused by diseases in the Cerebellum.

The symptoms present themselves as the inability to conduct basic voluntary movements, inability to walk straight, staggering and so on.

So, until the next obsessive House, M.D. Episode...

Thursday, December 11, 2008

China: Now converting no-brainers into "medical mysteries" in an extremely polluted village near you...

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You must think I am such a brazen ass from the title. Except, I am not. I have a lot of sympathy for the poor folk in the Chinese village. Some of what perplexes me includes:

1. I have spoken to many people from China. They all seem to have this weird, controverted line of thought that the complete lack of even strands of democracy is totally "cool". This is in a very small (very, very small compared to China) way, similar to my experiences talking to my friends and neighbors back home in India.

Having been sold on the Kool-Aid of Democracy, I find it quite hard to believe it is possible for a state to not be a democracy and think for the common good of it's people.

I know, I know Singapore has this "Democracy that the Government enforces" - weird, but it is such a microcosm of a heavily progressive society where at least a member of your family is directly or indirectly in Government that it works.

However, when you take China, where protesting affords you a visit to a mental institution, it is not surprising that environmental battles would meet with no victories.

I mean come on, President Bush almost got away with all of our Clean Air Regulations in a supposedly, highly vigilant and proactive society...

2. Why would a country's Government, for whom pride and a public face of ascendance is such a priority, not bother to do anything about it's amazingly dismal environmental and health record?

Mind you, this village is all but a sampling, and we already know about baby food, Heparin, Lead, and the Olympics, the Earth Quake response ( and no, no one is forgetting Katrina. One sad Government failure at a time)....so much just piles up.

In the wake of all this, the lack of even rudiments of a revolution is just flabbergasting!

3. Why does China strongly believe that a positive attitude towards environmental and health concerns would necessarily be a bad thing for it's economy? This is a stupid concept sold solely on shall we say, people grouped with the letter "R" as the first of a word?

Why does everybody have to be sold on it?

I mean, imagine. The economy has slowed down. China is seeing fewer orders. Instead of simply pumping random shards of cash, which has proven highly effective anyway, why can't they jump into modernization?

Wouldn't that re-hash their economy, self-image and dignity without all the contortions, distortions, laughably transparent deceptions and so on?

Why is it that the entire human society is divided into little pockets called "nations" and "economies" - each one of which seem to be missing the blindingly obvious?

4. You know what is the worst part? I have not met a single person from China who would find it hard to understand the urgency or the obviousness of this problem!

And mind you, what is happening in China, is happening in India - and I just don't know what to say. It is probably not at the same level or is poorly reported.

So democracy or communism is not the answer, and I have the sobering feeling that I am leaving this post with fewer answers and more questions....

Do any of you have some answers for me?

Saturday, December 06, 2008

An exciting new vaccination technology to write home about...

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Reading this article took me back to the first time I read about the genius that Louis Pasteur applied to come up with the world's first vaccine. The concepts of vaccination have been building on the same basic principle - create an opportunity for the body to fend off the disease by vaccination and watch the body fight away the disease when it attacks later.

Read about the mechanism in the medicalnewstoday.com brief:

An "incapacitated" version of the flu-virus A is used as the train bearing a string of amino acids attached to a gene of the virus B and inserted into the body. This apparently (and I get it!) sets off an automatic and aggressive response, and what follows is similar to the antibody-antigen mechanism.

Next time the virus attacks, the body is ready!

The Novo Nordisk Foundation and Novo A/S are set to make a fortune I presume, if all of this succeeds!

But, there is more - there are two key aspects of the technology's effectiveness that the medicalnewstoday.com article refers to that deserve a plagiaristic re-mention:

1. The technology, InVacc proffers a rapid response - and, without expanding we are also informed that the vaccination will be effective even against rapidly evolving and mutating bacteria and viruses. I would like to know what mechanism dictates this second aspect.

2. The technology also instigates the activity of the CD4+ cells (in case you are wondering - CD stands for Cluster of Differentiation, a type of grouping of immune cells) that control the body's immune response. They lead to the active production of CD8+ cells - cells that form the body's defense mechanism.

It appears that the technology has already worked quite well in mice. I wonder how long it will be, before we see the first vaccine to come out of the this technology. More on this as it evolves!

Blog Brief: How to run a company - medical devices or otherwise...

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Two years ago, in the first year of his "professional" career in medical devices, a friend of mine, "not me", came to know that his plant was being shut down to "cut costs" and was being moved from where it was to another state that was offering "tax incentives". (This said state is no longer offering any incentives, its own economy having been..).

In all, a healthy, profit producing part of the organization was shut down. Not only that, it was rumored that the "executive" responsible for this received a healthy "bonus" for all this, to a tune of millions of dollars, not too far south of what this generous family offered up as a bonus to all their employees.

Can you imagine the same amount of money as this family offered to dozens of workers to one guy for firing north of a 100 folks?

Now, I will name no parties and trust that as a reader of this blog you will never try to find out who my friend is, what company he worked for and who this "executive" was by going to LinkedIn or Google or anything.

But why talk about that dumbass "executive" any way?

Immediately after that, my friend happened to work for another medical device company that also laid off 20% off its workforce minus the CEO who is almost singularly responsible for the company's ongoing miserable performance for the last 3 years.

This CEO was also laughably seen giving entrepreneurs advice in Ohio about a month or so ago - himself having never done anything worthwhile in his career, other than of course...

Anyway, let's look past all this.

Do you want to "start-up"? Do you want to "promote the rapid growth of your stellar organization"?

Then stop "seamlessly integrating" anything, or "fitting round holes into square pegs" or "streamline operations" or "initiate a painful, yet necessary set of "cost-cutting" measures" (yes, that was air-quotes in air-quotes)...

Fire your "C" level executives practicing "CYA" management.

Yes, stop the BS. And no, true advice never sounds pretty.

Be honest to your employees. Maybe you don't have to be like the Illinois Family who were caring for their employees even after they sold the company..

Maybe, just maybe, you will treat your own employees - the ones actually producing something other than Excel Spreadsheets and Powerpoint slides - with a little bit more dignity and respect.

Maybe, just maybe.

And, lo! you will have yourself a great organization - whether you are making medical devices, software or bath tissue...

Friday, December 05, 2008

Teach-Yourself Brief: Best practices for part numbering

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I have been quite busy and have found it hard to do any blogging. I was intrigued by a question on LinkedIn about "best part numbering practices" and a brief search on the web brought to attention this excellent link! :

http://www.bpic.co.uk/faq/part_nos.htm

I am sure there is more information out there, but this a good start. The next time I run across this issue again, I will update the page with more information.

I am sure others will be answering the LinkedIn Question. So, if you want to follow the thread:

http://www.linkedin.com/answers/business-operations/project-management/OPS_PRJ/378322-19515337