The Stryker Brouhaha: How the FDA demonstrates that it was never loved as a child...

If you have not heard about Stryker's (latest) legal problems, the FDA is charging Stryker and a random collection of expendable Stryker executives with off-the-label marketing.

I will link one of the many reporting stories available on the issue at the bottom, and you can read for yourself as to how, apparently, Stryker executives knowingly promoted a cement approved with stringent restrictions on marketing for humanitarian use, for off-label use. They even provided Doctors with highly suggestive recipes and concoctions on how to use the cements.

As with most of Orthopedic products that have been riddled with poor design, kickback scheme accusations and marketing attitudes, a lot of patients suffered.

So, the FDA finally jumped in!

The charges and the possible punishment

And it has accused a total of 8 Stryker folks, half of whom are classed as "former" and include, among others a former president and a sales executive.

At the outset, this all seems like "action". The charges include "wire fraud, conspiracy, misbranding, and making false statements."

Take a closer look. What does it entail as an eventual form of punishment?

Nothing, er, next to nothing in the following order: Something, Nothing, Next to Nothing.

If convicted, Stryker will face the following extremely debilitating actions taken against it:

1. As quoted: "fines for Stryker of at least $500,000 for each count"

2. "Exclusion from federal and state healthcare programs".

Okay, you read it, now say it loud with me, "Are you joking"?

Is the FDA Joking?

With you, one who is not charged by the FDA, yes.

How far does $500,000 go in 2009?

For large companies, $500,000 is chuck change. Heck, it is lesser than any of the following:

1. The amount such companies pay for their lawyers (which didn't work for Pepsi whose lazy lawyers missed a court date and are now scrambling to get a $1.2bn charge dismissed) to simply go out and harass, among others, federal agencies, smaller companies, individuals (Charles Riegel anyone?) and such.

2. The amount medical device and pharma companies pay in a quarter to lobby Congress to forget patients and pass laws that will make sure the right amounts of donations are made to individual campaign funds.

3. The amount these companies spend in a year using weak patents and other methods to harass smaller companies.

4. The amount these companies pay their executives in a month!

5. The amount that will be spent in lawyers fees defending the current charges by the FDA!!

6. The amount device companies are paying to lobby against healthcare reform of any kind!!!

And, of course I can go on and on...

This clearly demonstrates something. The FDA is obviously out of touch with reality, somewhat like a bad parent in need of love from their children at all costs.

What should be the punishment?

You may even wonder if punishment is necessary. See a lot of these brazen executives move from company to company and take their despicable attitudes with them. They do not change, because there is nothing that makes it necessary. They then proudly promulgate and breed more such "executives".

Punishment needs to be debilitating.

Punishment should invoke shame.

Large organizations thrive on corporate image across several industries. Not so in medical devices. Take Orthrocare or Stryker for example - such companies have been involved in all kinds of lawsuits. They pay cursory fines and get away with anything. Many such companies then turn around and lobby against healthcare reform!

Punishment should invoke the need for attitude change.

The punishment needs to be proportional to the crime. It is one thing for Hollywood to make disturbingly emotional movies where one soldier, one victim is important and a whole town, a whole army rallies around them.

It is another, for companies to be let go for a small fine when they kill and otherwise disable patients with obvious disregard for law and ethics.

Growing up to the times

The meter-maids, not FDA, are supposed to hand out parking tickets. Companies need to be punished proportional to their crime. Crime, among medical device companies is systemic:

1. The entire Orthopedic industry (well, the 4 companies controlling 95% of the industry) was implicated in wonderfully disgusting "kick-back schemes". Nothing came of it, except minor fines.

2. Companies like Stryker have been abhorrent at clinical research (read my squeaky hips post linked below) or at respecting patents, and systematically get involved in lawsuits. As a result of the fact that every federal agency, including the judiciary system is filled with ineptitude to mete out the right amount of judicial punishment, they keep on, keeping on.

Sending the wrong message

With the current listness and a lack of any form of seriousness, the FDA is sending the following message: As long as you hang back and reserve a few million dollars in lawyer fees and a few hundred thousand dollars in fines for the FDA, you can get away with anything you want - cooking data, promoting off-label use, anything.

At this rate, you should soon see the bigger device companies to sell 5-hour energy pills, phallic extension pills and fake weight-loss drugs.

Heck, why not? Right?

Hope and Change

If Obama and Margaret Hamburg really want change, they need to start setting examples. As I stated above, the industry does have it's fair share of fearless, lying crooks. By cowering to the fact that these companies are large and fearless, the Government is doing no better than the previous administration, and is really not bringing about any form of measurable change.

When companies such as Stryker are brought to court based on real evidence of crime, they should be made to pay. There should be no room for such companies to express "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter".

They should instead be "ashamed", rue the day they decided that bending the law was "cool", and should be forced to gouge themselves of their present attitudes.

If this is not what the Obama administration wants to do, then there will be no change, and soon the hope will whither away.

Grandma will have no insurance because that was lobbied against.

Grandma will get a squeaky hip that won't work and embarass her to no end.

Grandma will also get dysfunctional cements, stents and ICDs in her body.

And, instead of looking forward to their one hour of daily exercise, such "executives" will keep popping champaigne bottles everywhere...

References:

1. On the charges against Stryker: Click here

2. On Stryker's squeaky hips:

http://chaaraka.blogspot.com/2008/12/okay-kids-squeaky-hips-are-in-again.html

3. On Acumed Vs Stryker:

http://chaaraka.blogspot.com/2009/01/unfortunately-but-we-infringed-only.html

4. On Stryker's previous kickback settlements:

http://www.saundersblog.com/2008/01/stryker_settles_kickback_schem.html

How many weird medical device stories did you read this week?

As a note, I was quite sick and I am finally back...to report two really weird medical device stories that I myself came across this week. To say the least, I have no idea what to make of them, so maybe you can help me out here.

Link1: Of Medtronic, Judges and their sons...

Link 2: Stryker's "amazing" tact to distance itself from it's own sales reps

Let's take the first story.

First, off sorry about the weird, expensive, unpopular anti-Obama Republican haven journal Wall Street Journal link. It is the only one reporting the story as far as I can tell....I learned this story myself first from the SmartBrief summaries. I dug up news.google and found nothing anywhere else. If you find another place reporting this, please let me know. It's not just the thin reporting that wins this story weird points...

Okay, so maybe Medtronic itself doesn't have much to do with it. I really suspect it though. For both the judge and the lawyer to not know their personal relationship and fiduciary compounded with judiciary relationships with Medtronic...well, gets slightly edgy, doesn't it?

The Judge can't have it both ways - this is not a Perry Mason "The Judge who did not know" story. This is "Either the Judge is stupid or dishonest" story.

Well, isn't this all just a ploy by the plaintiffs? Yeah, maybe..

Isn't it simply wrong then?

Do you think stealing consumers of their rightspre-emption is right?

Like I said, I don't care what Medtronic thinks or puts out in its vehement press releases. They probably have very little to do with this nonsense (other than, maybe paying some incredibly incompetent law firms).

I want someone to scrutinize this "Judge" Kyle. Because in the race to nominate people in public positions who lack self-awareness, he might have joined the likes of Merkel, Judd Gregg and the entire set of House Republicans....

And, now to move on to the second strange "medical device" "weird" story of the week.

Okay, so what was Stryker trying to do here? Play the harp or whatever as its sales reps burned in the courts?

Why is it so weird?

Well, for one, the name of the employer of the sales rep prosecuted is mysteriously missing. So is the "medical device" that was sold deceptively. (Until reporters had to do a lot of "court document" digging.) Why the secrecy?

What is the big idea?

So, they will convict the guy, but not disclose to the tax-paying public what medical device was misused and under the auspices of which employer?

Did we all undergo some weird time-space transformation into some middle eastern country in the 16th (or 21st, doesn't matter) century?

How is it possible that in this day and age, companies can wash their hands off employees they were supposed to discipline and regulate? How is it that even the medical device that was inappropriately marketed is not disclosed?

Am I the only one feeling a chill down the spine?

Talking of spines - can we rely on the devices designed by any one of the ............... er, orthopedic device makers out there?

Congratulations old people of the Supreme Court - your "get out of jail free card" called preemption is live and kicking....

[Click on Post Title for Link to External Article]

...patients where it really hurts!!!

We now have a perfect system to circumvent any need for accountability or justice. We can watch patients die or be put through unnecessary morbidity by firms without any need for worry, whatsoever.

I am not talking only of Medtronic mind you - this article refers to their cases that were dismissed. Very recently, Stryker also walked away from any responsibility from similar cases filed in Colorado.

The FDA is dead and useless for all practical purposes, and the only lawmaker who even seems to know anything about all this is of course, Grassley, but that is almost plain hypocrisy since it is the Republicans who appointed the Supreme Court Justices and cheered the industry on to weaken regulation on any and every kind.

We do have only God (who created us 6,000 years ago alongside the dinosaurs by the way) to thank for the continued existence of the FDA - given President Bush's propensity to allow "free" markets and deregulation even when everything fails.

However, I do not trust the Democrats to stand up for, against or with anything. Even with 39 senators, Republicans can hold the Senate to ransom because Democrats are chronically weak, aimless and never in charge. Moreover, their focus is to bring in their grandchildren to inaugural ceremonies of every sort, and Obama is focused on "diversities of opinion" at the expense of the people who voted for him and stood by him.

Meanwhile, in other parts of the galaxy - companies do recalls, fail to sell products of any remarkable quality and are now well protected!!!

Apparently, the FDA is thrilled that there were "fewer" clinical trial rule violations in 2007 (that may be because they are all waiting 6 months to a few years before feigning knowledge of breaking the law!)

Read about it here:
http://www.smartbrief.com/news/advamed/storyDetails.jsp?issueid=7AAC37B8-F2E5-438D-82C6-FCA5A7DF75F9©id=F24E6520-7502-4050-9A02-DDC0053774B5

Sigh! Watch this space for continue sad and bleak revelations on the fruits that preemption will bear.

Meanwhile, an infamous stent manufacturing "power house" medical device company whose stock is worth less than fodder, just acquired a company in Ireland - this after laying off hundreds of well meaning employees and unloading assets over the last month.

Irresponsibility, seems to be the backbone of 21st century medical device manufacturing...

Oh, happy new year, by the way.

Okay kids, squeaky hips are in again - solving an unconscionable 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 Bushthe Supreme CourtRiegelpre-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.

Irressistable to post: Hollywood Meets Riegel, Drugmakers and FDA: uninformed and uncompensated lab rats

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I don't care what you think of me, I don't know who Dennis Quaid is. But, I like his Hollywood style. Though brazen and "filmy", I completely agree. There is a problem with pre-emption. The FDA becomes judge and jury. In any democratic legal system that is a debacle.

We all know the effects of that. One has to only look at how the USPTO "regulates" or until recently tried to "regulate" itself and all of its customers, leaving a very bad taste in the mouths of several lifescience companies.

However, some of them are now trying to hide behind an anologous federal agency pre-emption situation.

Why wouldn't pre-emption benefit all of the industry? Very simple. Let's say your competitor is really selling a terrible product. And, unlike the present times when the FDA is displaying unparalleled levels of leadership, if said leadership were to degrade in quality at a future point in time!, neither you nor said company's unhappy customers have a reprieve.

All that needs to happen is, the FDA can take a look at boiling hearts and squeaking hips and say, "Bah, that was expected. It was not the manufacturer's fault. That is our decision. Of course, the investigation is closed and we won't tell you what happened". While this disastrous drooping of levels in the FDA is next to impossible, this is not just an unhappy customer's headache.

On the other end of the stick, is a problem where this happy state of squeaky hips, burned catheters and other quirks pile up for a while and then an appalled Congress picks up from there and over-regulates the industry. Getting a 510 (k) approval is tough enough, who wants new headaches?

Doubt it will happen? Tell that to the folks trying to end Sarbanes-Oxley.

From these two perspectives it becomes very important that Riegel should not have gone down the way it did. And it did. So now we are in trouble!

It is binding on any society that expects quality in service to create and maintain a system of checks and balances. Otherwise trust, efficiency, creativity and all other elegances will disappear into nothingness...

In face of this, it is important that Congress listen AND understand AND exercise an appropriate system of checks and balances.

Lets see if we succeed or wait till other Hollywood, YouTube, FaceBook and "Can you act stupider and sillier than a 2nd grade child" stars also show up screaming at Capitol Hill....

Stryker - Now, with squeaky hips....oh what a mess

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While the hip jokes roll on, I apologize to anyone that may be offended.

I am sure you awoke yesterday morning to squeaky hips. From NY Times to thousands of bloggers, including yours truly (who could not but give in to coming out of his cave for this) have been waxing eloquent about the squeaky hips issue.

The problem is, this is not just about squeaky hips. Its about:

1. Stryker (and we will revisit this, I am certain)
2. The FDA
3. Preemption!
4. Post Market Follow Up (a surprisingly new concept for medical device companies with large market caps)
5. General Company Goodwill to customers, the lack thereof, idi...wasn't I supposed to revisit something? :)

Well, so where do we begin?

I think I will go for the letter writing contests called "warning letters" and the hard won "preemption" guilt-relief that the FDA afforded for medical device businesses everywhere.

So, hmmm...let's see. Avandia, Vytorin, Dr. Jarvik with his very helpfully misleading qualifications, medical practice (the lack thereof, rather) and ads, catheters burning inside people, the dude selling medical devices from Hungary in case anyone recognizes him, the fake-heparin touting, mysterious, unnameable (well, go find out! Its true. The FDA won't name them!) Chinese salesmen of lore and now this...

Apparently, Stryker was sent a "Warning Letter" (which itself is now under review after a company pointed to a rather surprised FDA that the letters were so detatched from their purpose as to be 100% gobbledygock) last year.

True, they sent out a letter, but the funny thing is it doesn't actually allude to the real number of patients who have complained of the squeaking.

Plus, who will trust a letter with impertinent references to the Finnish. What? Do I not make sense? Well, here goes:

http://www.fda.gov/foi/warning_letters/s6627c.htm

"However, your finn has not prevented the recurrence of poor fixation of the hip implant component or prevented the failure to function which has resulted in revision surgeries"

Unless the FDA has been secretly requiring all medical device companies (or just Stryker) to employ a finn (Finn, more respectfully) to solve their problems, this demonstrates the level of competence these letters bear.

Of all the people writing about the Squeaky Hip Phenomenon (and that is not a reincarnation of the Flower Children's (carefully sidestepping the childrens joke created by the super-chief of all Federal Organizations)endavors of 1969), the most silent one is the FDA.

It is now clear through several examples that another 1300 or 13000 employees will fail to make a difference, if the FDA does not reign in some of these fundamental issues.

While semantically federal preemption sounds great, a letter and an NY Times Article is not going to push some of our friendly, neighborhood device manufacturers into post-market follow ups and complaint handling.

The orthopedic industry, previously famous for its chivalrous bribery and other favorable forms of nepotism, now dragged this to its own house.

Anyway, I digress (you say, "You think!?")...

Why is the squeaky ceramic hip replacement a "mystery"?

It is really not a mystery. Its either a fixable problem, or Stryker should have stopped selling those.

"Defects in the product's performance arise due to improper usage by surgeons and patiens" - is not the answer. The only point where I agree with the FDA's "letter".

The very premise in cGMP is and if not, should be, that the product should not be prey to the whims and fancies of those fast and loose surgeons that seem to never learn how to use any of the FDA approved products. Hmm..how I wish we could do something so that companies are required to train surgeons...wait a minute, aren't they supposed to do that anyway? Oh well...

If this were a smaller firm, they wouldn't try to push the blame that way, boosted by the paucity of grandeur and a need for good publicity.

Also, it is a warning to people wanting to walk around with Stryker's hip replacements that their surgeons and they alone (also fondly described as "patient variables") should currently face the blame for all the unintended Herman Munster impersonations...

"failure to achieve initial biological fixation" (from the letter)

Here is a somewhat non-fundamental definition of fixation:

http://mrw.interscience.wiley.com/emdi/articles/emd194/frame.html

Well, really, how much does patient variability come into this?

Alright, if it does, how so?

Then, why weren't new instructions created so that the surgeons would then contact their patients and let them know of ways to reduce their own variability in this? (Well, its impossible, so let's move on..)

What did the surgeons receive in terms of new instructions to modify their surgical techniues so that a desirable initial fixation can be achieved?

The rest of it is garbled in the letter, but you don't need invaluable degrees in engineering to realize under what circumstances two bodies rub against each other so as to squeak. Lets do a little bit of Engineering 101 brainstorming:

1. Two bodies rub against one another in unexpected manners when the interluminal lubricant is missing, or is lost due to other causes.

2. The body is not strong, is corrosive and otherwise subject to loss of material, that changes its interaction with surrounding objects, in this case, a counterpart composed of the same material.

3. The material has non-linear properties such as fatigue, creep and other behaviors that were not realized through veritably appropriate, but accelerated (and thus, eventually inaccurate and unnatural) aging studies.

4. The material, composition, design, tolerances and lubricants all accounted for, there may be defective manufacturing and/or quality processes in play, leading to a loss of properties.

Alright, how many more can we grab if we go down the brainstorm. You are right - we could be here, all day long.

But is this really a problem?

Most likely, yes. First, it is psychologically demeaning. If I were wearing one and it squeaked merry, I don't give a damn as to whether or not this outlasts the supposedly inferior plastic and metal ones. Who the hell wants to drive around a rattling Bimmer?

What is the solution?

1. Well, some if not many of the 7% of defectively squeaky replaced hips have been replaced, I am certain. If not, I am sure at least a few more are on the verge of being surgically replaced. Stryker should get their hands around some of these. Grab 'em, and test them.

2. These patients must also have had extensive radioloical exams during the post-operative process. Get them and test them. I am sure you have to wade through HIPAA and other issues but the summary un-squeaking of replacement hips is a much more urgent desire than any other...

3. Even for the patients in whom, the culprits still reside, it is possible to perform appropriate radiological exams to examine what's going on.

4. Play with ones that have never been implanted, accelerate them, age them, but try to find out what's wrong with them.

And yes, we could play this game till the moon sets as well.

What is the main message anyway - the real root causes?

1. Post-Market Follow Up. It is almost criminal that such low quantity of follow up exists in our industry. If the company that makes them cares less for them, fine. But what about the competitors? The FDA? Someone should be looking at Old Squeaky Sarah and find out what's up!

2. It is clear that the preemption is acting as an inducement for certain companies in the industry to do as less as they please about the problems that crop up in their devices. It is not that anyone wants to welcome a slew of lawsuits based on misplaced commonsense. However, it is important to realize that in some cases, unnecessary delays, careless designs and such can be reigned in by juries.

3. It is clear that the lengthy approval processes (which hurt the good devices from being approved rather than improve upon bad designs) and very un-threatening warning letters are not working. Some device and drug companies exhibit an unabated degree of insolence and irreverence to the FDA and the US Congress. The regulatory environment, to the detriment of the innovative many, feeds to the whims of the careless few. I do not fail to recognize that the FDA has the world's best regulatory process. However, it is still not enough and absent the FDA this world would be a chilly place for patients...

"Overblown" (see the NYT article)

“It is important to keep this in perspective,” said Aaron R. Kwittken, a spokesman for Stryker. “Published research shows squeaking is rare compared with other total-hip-related risks like infection, dislocation and leaving patients with uneven leg length.”

Overblown you say?

Here is something NYT would like to share with the rest of us:

One study in the Journal of Arthroplasty found that 10 patients of 143 who received ceramic hips from 2003 to 2005, or 7 percent, developed squeaking. Meanwhile, no squeaks occurred among a control group of 48 patients who received hips made of metal and plastic.

So, what he is really saying is:

"Come on...(with a Peter Griffin accent). What's sheven percent eh, Louis? A little squeak in the legs should scare the kids into eating their breakfast cereal and never done no one no harm..."

Well, I am sure, apart from the 143 lucky hip recipients examined, in an aim to achieve and sustain profitability, these ceramic jingles were sold to several more. Amidst laughing wives and mocking colleagues, they might not have yet mustered the courage to reveal that the original hips that they came packaged with have been replaced with noisy toys.

Really, it never ceases to amaze me, the source of PR messages of these companies...

A Note

These enchantingly rare squeaks are not serving the hip-bearers and their wives anymore. These squeaks can be heard on NYT, thousands of blogs, this blog, YouTube, other tubes and in several other places. The squeak is now shrill! It may come as a surprise, but this might actually be classified as a problem now.

Next Edition: D'Antonio Vs. Orozco (see NYT, page 2)

Which one is the better surgeon? Who is telling the truth?

Conclusion - Opportunities

As I have lamented in the past, it is the mistake of the few that cause harm to all, in this case other medical device designers and patients in general. This is a great opportunity for young, innovative companies to learn to perform extensive pre-design and post-design analyses, testing and some more testing.

Keep a watch on what happens once the product gets released in the market and never, I pray and repeat, never, say "It's overblown" because that, is how, you blow it....