Thursday, October 28, 2010

September 2010 FDA Clearances

Arthrocare Corp:        Parallax Contour Vertebral Augmentation Device

Centinel Spine:           Stalif Midline

LDR Spine:                  C-Plate, Anterior Cervical Plate

MSD:                             CD Horizon Spinal System
MSD:                             TSRH Spinal System

Novabone:                    Novabone Putty

Orthofix:                       Construx Mini PEEK Spacer System

Orthovita:                     Vitomatrix

Spine Smith:                 Cynch Spinal System - Visualif Interbody Fixation

Spine Wave:                 Staxx Xd System

Spinefrontier:               Vega Span Spinous Process Plate

Synthes LLC:                Norian Fast Set Putty

Theken Spine:              VuApod Intervertebral Body Fusion Device

Zimmer Spine:              Pathfinder II Minimally Invasive Pedicle Screw

Tuesday, October 26, 2010

POD's Legal or Illegal, You Be The Judge

Having spoken to many industry professionals on the national level, the prevalence of physician owned distributorships has picked-up momentum.  Times are very tough for those poor doctors.  They no longer can earn a respectable living being a physician or a surgeon, today they are compelled in becoming much more than a surgeon, they want to become distributors.  Yet, many people including the legacy companies believe that this is a conflict of interest.  TSB would like to provide a forum to have an intelligent discussion without calling each other names.  When you think of it, it does not serve any purpose.   So here are the questions fellow bloggers;

Do POD's create a conflict of interest that can distort medical decision making because it provides surgeons with an incentive to use implants that will benefit them financially?

How do we know that POD's are actually keeping costs down?

Are POD's negotiating and opting for the best possible product for their patients, or are they seeking the cheapest deal that allow them to maximize their profitability?

With the proliferation of POD's the potential exists for improper inducements.  Therefore, should these ventures be subject to intense scrutiny?

Like most business models, the POD could very well be a legitimate business model, yet, inherently POD's can give rise to a fundamental conflict of interest that places the physician's  financial interest ahead of the patient's best interest.  So what do you think?  Is this a legitimate business model, and will it obsolete the need for having a rep?  Or, will the industry eventually have some sort of hybrid?  You be the Judge, TSB wants to know what you think?

2011 Spine Outlook!

As the U.S. economy continues to churn and burn, it has become evident that double digit growth in spine is a thing of the past.  If you're willing to listen to the analysts' and other talking heads, the primary culprit is an unemployment landscape that has not been witnessed for many years.  Patients refuse to have surgery if it could mean losing one's job or having to incur additional out-of-pocket expenses.    The insurance industry continues to wreak havoc on procedural reimbursements as medical device companies attempt to roll out new and potentially emerging technologies.  Today, many companies, especially early-growth stage organizations, are re-evaluating their capital needs to launch new products,  while assessing their fiscal viability.   Finally we have come to our senses and accepted the fact that spine is no longer the "run and gun" industry it once was.

The industry is in the throes of a fiscal healthcare/spine environment that will be defined by cost containment.  If one cannot substantiate that the product will improve outcomes, it will be deemed another commodity product.  Yes, fellow bloggers, medical devices will continue to have high margins, yet, those 80-90% gross margins will be a thing of the past, spine will continue to be a lucrative investment only by adjusting the overall financial model to attract future investors.  This will mean lower commissions, even lower than what they are today, a proliferation of physician owned distributorships, fewer jobs,  and less hardware with a focus on stem cells and biologics.  Many of our readers are in denial if they continue to believe that things will remain status quo.

Hospitals are putting tremendous pressure on companies to make pricing concessions.  How can a company justify a premium if there are multiple options when choosing a product, especially me-too products?   Regardless of one's opinion, legacy companies will still have a hold on the market with their flexibility to adjust pricing, much more so than start-ups or early growth stage business models.  There will be a premium on convenience and conciliation.  The one-stop shopping mentality will prevail.  So whom do we blame?

Obviously, no one is willing to accept responsibility.    It is easier to deflect the blame on everyone else except ourselves.  For many years we have been warned, only to look into the eye of the storm and defy reality.  As an industry, we have spent time analyzing primary symptoms without looking at the secondary and tertiary drivers.  Maybe that's where we have gone astray?  Today, there has been a shift in how companies must manage themselves and their research and development in order to survive.    Many years ago, when the reconstruction and trauma markets were being reigned in, spine thumbed its nose at the hospitals and third party payers, laughing all the way to the bank.  Today the joke is on us.  The battle lines are being drawn in such a manner that it is pitting us against them.  A chasm that has never before existed.  So who will be hurt?  Unfortunately, only the patient.  Because in the end our arrogance and avarice will come back to haunt us.  TSB wants to know what our readers think?  Are we heading into the eye of the storm, or will we stare down the monster?

Monday, October 25, 2010

Spineblogger's Hit Parade

TSB was cruising in the iron horse this afternoon, wondering was there anything of real interest going on in spine.  I guess if you're looking for a little bit of Sup-stance, is that the French spelling, or if you want some Pro-fessional Stim-ulation, it seems that its been a l'il quiet in spine.  So I leaned over to the IPhone and plugged it into the Beamer and turned on some Monte Montgomery.  This Austin based acoustic guitar virtuoso can pack more stimulation into one afternoon than a $3,500 piece of plastic.   His soulful vocals and blistering guitar playing skills make him a must between cases.  As for finishing the day, there's nothing like throwing in some Eli "Paperboy" Reed to get the juices flowin', so tune in and turn it up, TSB wants to know if you're bored and tired of the same ol' same ol.....what's going down in spine, have we hit a lull or are we still playing the blues?

Thursday, October 21, 2010

Slo Cooking Spine New York City Style

In September 2010, TSB posted a blog entitled; "Thrilla in Manilla, Is Centinel Spine on the Ropes?"  This post was in response to news that an English court's ruling in favor of Paradigm BioDevices had placed financial pressure on Centinel.  In the proceeding weeks, leading to today's blog, what we have learned from other industry platforms is that it's business as usual at Centinel, witnessed by the recent article dated October 18, 2010 in OTW.   TSB would not expect anything otherwise from that milquetoast publication.  But the question that needs to be asked is, is it business as usual, or, is something new being cooked up at Centinel?  So TSB called his good friend Tyler Florence and asked him if it was true that barbeque brisket, chicken and pulled porked was coming to the Ritz in New York City this weekend, and, was he going to be the Master of Ceremony?  Unfortunately, Tyler is tied up in Marin County and in San Francisco minding the store and cooking up his own storm on the West Coast.

Could there be an Iron Chef competition going on in New York City that TSB was unaware of?  So I called my friend Alton Brown at the Food Network.  Alton responded, that he was not aware of any cook off in the Food Network Studios.   Bobby Flay was my next phone call.  Bobby conveyed to TSB that he wasn't doing a Throw Down this weekend due to other obligations.  So out of desperation, TSB called the Neely's in Memphis.  Pat and Gina love to cook barbeque, and have a great show of their own, and after 22 years in the business told me that they would know if something was slo-cooking.

At some point in time TSB felt like he was looking for Waldo.  Usually I get an invitation to various Food TV ceremonies across the country.  So it was much to my chagrin that I found out that there will be an unveiling of a new Bar-B-Que Sauce this weekend in NYC.  No fellow bloggers, TSB is not softening up the spine industry's favorite blog site.  It seems that the V-Brothers are branching out of the spine industry and going into the food industry. Saturday, October 23rd is their maiden voyage into food, with John Viscogliosi being the master of ceremony in launching their new company and sauce called Purple Pork Eaters.  So the question that must be asked is, will it be North Carolina or Kansas City style bar-b-que, or will it be City Slicker Sauce?  TSB has usually had his slo-cooking pulled pork parties around his bar-b-que pit with plenty of 'slaw, a choice of homemade NC/KC sauce and plenty of cerveza.  But these guys are hilarious at the expense of their investors.  A bar-b-que at the Ritz in NYC?  Will y'all be dressed in your designer clothes?  Tony is probably going to play the character of Mitch Robbins,  John will proably be Phil Berquist and Mark will be Ed Furillo.  Could Mitch be having a mid-life crisis?   This is definitely right out of the movie City Slickers.

You know fellow readers, if you can't make it in spine with all the money that these boyz have raised, what other options can a man have?  Times must be bad at Centinel.  With a projected 60% decrease in revenue in 2010, a limited amount of available cash in the bank, and a ton of outstanding debt, could this be a going away party for the investors?  On many occasions, TSB has been criticized for speaking out on the irrational behavior that exists in spine, and rightfully so.   I guess the way to a man's wallet is through  his stomach.  So come on down all you big Wall Street, private equity investors and city boys and make sure you wear your Levi's and Cowboy Boots (no designer jeans at this party),  its time to grease your hands and open your wallets, sounds to me that there's more cooking on the bar-b-que than we know about.  TSB wants to know if there are any press passes available, I'll bring Waylon and Willie along for the ride.

Hopefully, the employees will get some left overs to take home and feed their families.

Monday, October 18, 2010

To Be or Not To Be?

Seems like a few of our readers are struggling with insomnia and have become a bit antagonistic over this entire vertebroplasty/kyphoplasty issue.  Insomnia is not suffering.  Many industry professionals have come to recognized that your identity is imposed upon you by your job, and by your possessions, finally you realize that you are not in control  of your life.  Unfortunately, proponents of VCFx have had to defend the efficacy of these procedures the last year.  It was reported on 10/18 that a growing number of third party payers are reconsidering their coverage of VCFx procedures.    Dr. Christopher Bono reported that at least three insurers have issued draft policies that would end reimbursement payments for VCFx procedures, and in some cases kyphoplasty.

Noridian Administrative Services, LLC manages Medicare payments for 11 Western states.  An LCD, aka a local coverage decision was issued in May of this year, and physicians and companies had through September 6 to submit comments to the coverage decision.  Noridian is now writing its final policy which should be ready sometime around the first quarter in 2011.  This coverage could be terminated, or Noridian may adopt provisions on when it thinks the procedures are appropriate and worth covering.

Dr. Bono believes that Noridian's decision carries a lot of weight with other insurers, so, this could potentially have a cascading effect with other carriers.  Surgeons and companies are concerned that this decision could impact the number of procedures, as the majority of these patients are the elderly.    The recently published AAOS guidelines, and, the study in the NEJM have set off a maelstrom effect in the industry whereas proponents of vertebral augmentation (kyphoplasty) have distanced themselves from vertebroplasty procedures.  But the question must be posed to our readers, does augmentation actually restore the height of the fractures vertebral body?  Or, is this procedure designed to eliminate pain, restore some functionality, and potentially lower the cost of care?  Noridian's argument is that there is an absence in the literature that demonstrates the efficacy of either vertebroplasty or kyphoplasty.

The question must be asked, is there a pattern of overuse and misuse of this procedure?  Are IR's and surgeons injecting cement into too many levels  resulting in a disturbing amount of post-op complications?  Many surgeons and IR have risen to the defense of these procedures, yet, they concede that there must be stricter guidelines.  Interestingly enough the two groups commented that they take the misuse of these procedures seriously, yet, the question must then be asked, how do you police yourselves?

A touchy subject?  Of course it is.  Considering that companies like CareFusion, Stryker and ArthroCare are in the process of releasing new lines, no wonder some of our readers are struggling with insomnia and are a bit antagonistic.   One must consider William Shakepeare's opening line of the soliloquy in Hamlet; "To be or not to be, that is the question, Whether 'tis nobler in the mind to suffer the slings and arrows of outrageous fortune, or to take arms against a sea of trouble, And by opposing, end them.  TSB wants to know what will be the outcome?

Sunday, October 17, 2010


TSB is not writing about the second book of the Torah and the Christian Bible, nor, is this about the Exodus of the Israelites from Egypt.  No fellow spineophiles, word on the Street is that in the year 2010, Otto Preminger's major blockbuster movie may be life imitating art, where the departure of several key figures are or have left Kyphon Medtronic for Stryker Interventional.  No fellow bloggers, this isn't a new company, it's a new division at the Fatherland.  Unlike the movie where holocaust survivors sit on a cargo ship in anticipation of returning to the homeland, liberation in the modern world occurs at the speed of light.  Does anyone believe that Kyphon/Medtronic would behave like the British and take legal action against some of these refugees?  If there is any truth to these rumors, will the refugees stage a hunger strike?

The bigger question is, what is going on at Kyphon/Medtronic?  Word is that they are mired in a leadership vacuum.  If so, this does not bode well for KM sustaining marketshare with Kyphoplasty.  Could Stryker be looking to establish and define their infrastructure and business distribution model prior to making an acquisition or launching a new Kypho/Vertebroplasty product?  It seems possible, considering that they have been cementing people for many years.  Is there any truth to this rumor, considering that the Almighty Stryker has been known as a corporate raider in addition to being called the Fox in the Henhouse when it comes to enticing employees from other companies.  Just remember what TSB always says;  Sometimes a man meets his destiny on the Road he took to avoid it. So in closing is there truth to the word that something is brewing on the good ship exodus, or, is this an isolated situation?  TSB wants to know what our readers think?

Open your eyes and look in, Are you satisfied with the life you're livin'
We know where we're going, we know where we're from
We're leaving Babylon, We're going to our Fatherland
Exodus alright, movement of the People

Saturday, October 16, 2010

Week End Hit Parade

TSB is introducing a new segment to the blog, whereby every so often we will feature an exceptional artist, or band, to add to your listening pleasure.   Considering that TSB loves music, especially sweet soul music, and that many of us spend an inordinate time behind the wheel, or in the operating room, it's time to turn it up and turn you on, especially some of the younger whipper snappers, to some great music.  Our inaugural recommendation is an LA based soul/indie band by the the name of Fitz and the Tantrums.   Considering that music has been overrun nowadays by many a light-weights, TSB can guarantee our readers will find this band to be the real deal. The Schizz!!!!!!! So fasten your seat belts, open your wallet and slip in the disc, or hook up your IPhone, I can guarantee you that this is a "Money Grabber

So "Pickin' Up the Pieces" is easy, on October 23rd, Fitz & the Tantrums will be at the North Park Oktoberfest in San Diego, be there or be square.

Wednesday, October 13, 2010

The Great Debate: Whose Is Bigger and Better?

The recent guidelines that were published by the AAOS on the use of vertebroplasty or kyphoplasty for spinal compression fractures (SCFx) has raised many questions as to efficacy and cost.  Sources estimate that $17 billion is spent annually on the universal treatment of SCFx .   Those figures probably reflect universal treatment.  Annually, 1.5 million fractures are diagnosed with an estimated 200 to 300 thousand patients undergoing some type of vertebro/kypho procedure.  The cost per procedure can be as low as $2,400 and as high as $4,000.  In order to minimize cost per procedure, it may behoove the industry to have this procedure performed in an ambulatory surgery center.  Yet, the biggest question that is being debated is whether surgical intervention should take precedents over conservative care?  And, what is the rationale behind the AAOS' findings?

To recap the players, we have Kyphoplasty (MSD), Osseoplasty (Osseon w/DePuy Distribution), No Confidence (DePuy), RF Kyphoplasty (DFINE Be Fine), Parallex EZ Flow (Arthrocare), CDV/LP2 (Biomet), Stryker, and  Cortoss (Orthovita).  TSB apologizes if there have been any omissions.  Considering that many of these systems have their own features and benefits, TSB though it would be interesting to table these products and offer the industry a unique forum to discuss the pro's and con's of each system.  Some of the questions that we have heard include the following;

Do surgeons choose cost over retrospective data, intra-operative performance and post-op results?

Why one system over another?

Which system has provided the industry with a revolutionary or evolutionary advancement and why?

Which cement has the best workability, viscosity, and settling characteristics?

Is an articulating tip for unipedicular access an advantage or disadvantage, and why?

Is mimicking the physiological properties of bone important, if so then who has the best material?

Can one product legitimately minimize the potential for adjacent vertebral body fracture (ALFx), and does a lack of interdigitation contribute to ALFx?

Is thermal necrosis of nerve endings in the affected level a bad thing?

Is there a mechanical and chemical advantage of Cortoss over PMMA?

Considering that this is a hot market and that there has been some serious capital invested into some of these companies, TSB wants to know what our readers think?

Tuesday, October 12, 2010

Dissension Amongst the Ranks

On September 24, 2010 the American Academy of Orthopaedic Surgeons Board of Directors approved a new clinical guideline on osteoporotic spinal compression fractures.  Immediately a poll was taken, asking industry professionals, are these guidelines a political ploy or valid information?  These new guidelines had 11 recommendations.  1 guideline was supported by good evidence.  1 guideline was supported by fair quality evidence, and in most areas the evidence was insufficient or conflicting, not enabling the work group to make recommendations for or against intervention.

The treatment of spinal compression fractures has become big business.  There are over 750,000 spinal compression fractures treated annually.  25% of adults will experience some sort of spinal compression fracture in their lifetime, and as of 2005 figures, $17 billion plus is spent treating these fractures on an annual basis.

So the question must be asked, why do we treat spinal compression fractures, and is there a cost benefit to this modality of treatment?   Considering that baby boomers are not aging gracefully, it is estimated that within the next ten years 33% of the US population will be over 65 years of age.  Osteoporosis is a disease of the aging.  People with osteoporosis are quite susceptible to vertebral compression fractures.  VCFx are very painful, and the possibility of long-term disability is a major concern.   Over the years the treatment options have included, preventive medicine such as estrogen and calcium replacements, weight bearing exercises, analgesics, bracing, and surgical intervention.  

Based on the AAOS guidelines and two Level II studies, quality of evidence was critical in supporting practice guidelines.  It seems that they found that there was not enough of high quality evidence to support or oppose non-surgical and holistic treatments.  Yet, they supported treating VCFx with signs and symptoms suggesting acute injury within 5 days of onset and the patient being neurologically intact with calcitonin.  Calcitonin is indicated for elderly patients with low bone mass.  The use of calcitonin may result in increased bone density particularly in the spine with a plateau effect in 18 months.

The AAOS made strong recommendations against the use of vertebroplasty in patients that are neurologically intact.  The question must be asked, was there enough of data in these studies to substantiate their report?   If these findings are inconsistent, why did they even bother to publish this information?  It is difficult to comprehend the motivation of the AAOS.  What we do know is that the ideal vertebral body for augmentation is one that has collapsed less than 50%.   So the question must be asked was this a political ploy, or was this valid information?

If you experienced a VCFx wouldn't you want to Relieve the Pain,  Restore Mobility and Resume Functioning?  TSB wants to know what our readers think, and is there an underlying motivation behind the AAOS throwing this out into the public domain?

Saturday, October 9, 2010

Weekend Op-Ed Piece

Cardo Medical Incorporated, a Beverly Hills (that always makes me laugh) based orthopedic and medical device company, regretfully announced on Friday that it terminated 15 of its 30 employees in varying functions, and that its CEO Andrew Brooks, M.D., and President and COO Michael Kvinitsky have agreed to forgo their salaries for the foreseeable future.   As most of you know, dedicating any time to writing a blog about a company that doesn't come up as a blip on the radar screen, or, as a fly on someone else's ass,  isn't worth the time.  Yet, TSB is compelled to eulogize another company that attempted to get into the spine industry.  Over the last few months, there have been numerous attacks by surgeons complaining about sales people,  justifying their expansion into POD's, and waxing poetically about what smart business people they really are.  In many respects, they think of themselves as Captains of Industry that walk the canyons of the spine world.

Cardo, as you many of you know, is the company that acquired the troubled balance sheet, and me-too products that our friends the Three Stooges at Vertebron had developed.  Word on the Street was that Vertebron was offered an estimated $10 million, and some sources claim that there also had been an offer for $30 million.  If true, why were those offers rejected?   Simple: the Three Stooges as they have become affectionately known, graduated from the PT Barnum school of business.  Only to find out that the joke was on them  The bankruptcy courts auctioned off the company and its assets to Cardo.  Old news is old news.  So why is TSB dedicated time to rehashing history?  Because there are lessons to be learned.

The first mistake that they made was not bringing in an experienced industry veteran,  qualified to assess the existing portfolio,  the value of the intellectual property,  the business distribution model, the surgeons that were committed to this product (LOL) and address the issues that this company had, and would face if they were to successfully integrate a spine portfolio (not even mediocre) into a reconstruction company.   Remember, you can't make Beef Wellington out of Bull Shit.

If there was any truth to the rumor that commissions were owed to distributors that were contracted to Vertebron prior to the sale, they should have been paid, even if Cardo found that a bitter pill to swallow.  Why?   It's bad enough when Moe, Larry and Curley were willing to perform their infamous now you see it, now you don't, it's a double whammy when the new owners reject their responsibility in acquiring the company.  That's right fellow bloggers, when Cardo acquired Vertebron, they just didn't buy the portfolio, they bought a company. 

Maybe there are lessons to be learned, and hopefully, some people will look in the mirror and understand that being a surgeon doesn't qualify you to run a company.  That being an engineer with a background in recon doesn't make you a great spine engineer.  There is a difference between driving a train and being the conductor.  Why does this continue to happen in our industry?  Fool's Gold?  Ego?  Stupidity? Whenever you use someone else's money, you lack discipline and accountability.  How many of these fly by night companies have come and gone?   How many companies exist where the CEO has asked its management team, or employees, to forego their salaries until they raise more capital?  How many spend money without being held accountable by its investors?   How ridiculous do the banksters and private investors feel that they continue to piss money into the wind?  The future is in front of you, open your eyes.  Attempting to execute a reverse merger vis-a-vis a PIPE in this economy was and is insanity.  Not when you have absolutely nothing to offer.

So in closing, our heartfelt condolences go out to those fifteen people that lost their jobs this week.  It sucks to be out of work in this economy, hopefully, someone will see your value and offer you a job.  As for Abbott and Costello, the show goes on.

Friday, October 8, 2010

NASS' Revelry!

Good Morning

What a night for a dance, you know I'm a dancing machine, with fire in my bones and the sweet smell of kerosene, I got lost in the night so high, I didn't want to come down, to face the loss of the good thing that I once found.

In the dark of the night, I could hear you calling out my name (NASS, NASS, NASS) With the hardest of hearts I still feel your pain, So I drink and I smoke, and I ask if you're ever around, even though it was you who drove us into the ground.  See the time we shared, it was precious to me, But all the while I was dreaming revelry.

Fellow bloggers, do you remember the days when each and everyone of you were excited about making that arduous trek to the industry's annual pilgrimage, the mecca of the spine industry, NASS?  A necessary evil, but always a worthwhile experience?  Not only did you get the opportunity to spend time with surgeon/customers, and fellow spineophiles,  people actually enjoyed each others company.  Somewhere along the journey, something happened.  At times you almost feel like you are a character in the Book of Eli.  Based on many accounts by viable sources, NASS is on the verge of having to re-invent itself, or lose the interest of its patrons. This meeting is no longer the darling of the industry.   It makes going to the dentist a welcome respite.  You know what Linda Richmond use to say on SNL, can we talk?   We are no longer the visionary industry that use to amaze people with our creativity and talent.  As one of your own peers opined, "All the presenters are bought and paid for, and there are no new toys to exhibit."  Today, the industry has become a by product of Wall Street.  Rather than questioning social utility, we should be asking ourselves whether we are providing any clinical utility to the patient public?  We are resting on our laurels.  The leaders of NASS and its slavish followers, the spine company CEO's, the analysts, and people like the Robin Young's and Viscogliosi's of this world,  dominate over who can show the least innovation and vision, show the least concern about the future of spine, with a willingness to pander to short-term narrow minded selfishness.  It's all about enhancing one's portfolio.   It's all about smoke and mirrors.  It is all about the Benjamin's.  Yet, our bloggers are crying out for something new, and something breakthrough.  But when will that happen, and how will that happen?  Part of the challenge will be to re-focus and understand that the industry needs to stop worrying about politics, and reinvest in its future. That's what made this industry great.  You know what they say, you have to spend money (sometimes some of your own) to make money.  This industry needs to wake up and realize that they need to stop behaving like they are part of Wall Street, and start spending more time worrying about long-term viability.  Stop pontificating about Obama care.

Many of you have blogged that you love your job, the fact that you are part of the O.R. team that plays an integral role in caring for people, even if that role is peripheral.  Please continue to believe.   Many people in this industry do not share that vision.  Yet, don't be discouraged.  Some people will blame you, and your right to earn a living as the reason for an out-of-control healthcare economy, don't despair, this is the new entitlement generation that is not accountable for anything.  As you walk around today, ask yourself this question, is there anything really innovative at this meeting?

As for consultancies, all one has to do is attend a scientific or clinical presentation to understand the absurdity of the industry.  Everyone is a consultant.  If surgeons believe that reps are driving up the cost of healthcare, whom do you think absorbs the cost of paying consultants?   Many of you have had the same out of body experience listening to a surgeon on the dais pontificate about their clinical experience with a product, only to walk away thinking, either I'm an idiot, or  did that person say anything new?  The surgeons have become corporate lackeys, bought and paid for.  Lobbyists at best.  As the legacy companies complain about the "ankle biters" creating a pernicious business environment, you have only yourselves to blame. Today, you all hide behind AdvaMed, while flagellating yourselves, crying out Mea Culpa, Mea Culpa!  Do you hear us Medtronic, Stryker?  Biomet? DePuy? Zimmer?  Synthes?   As the teachers, you taught your students well.

So in closing, maybe its time the people that work in the trenches and on the street take back this industry.  If the CEO's aren't willing to do it, then it's time for us to throw the garbage can through the pizzeria window, and  say DO THE RIGHT THING.  If you really believe that we need change, don't plan on going to NASS next year.  Don't attend the Spine Technology Awards.  Besides, the cost of these meetings are criminal.  Bacon and Baker should be embarrassed.   Hurt the powers that run NASS where it hurts, in their pocketbook.  They have become complacent and fat.  Don't pander to a surgeon's demands for a consulting agreement.   The next time you get your quota, don't be afraid to ask the Regional Manager, the VP of Sales or even the CEO "where is the innovation" to justify such an increase in quota.   TSB wants to know what you think?  Will you run, or will you fight?

Thursday, October 7, 2010

Stryker and The Viscogliosi Brothers: What Strange Bed Fellows

Hollywood has had its unusual set of bed fellows.  Clark Gabel with Vivien Leigh, Joan Crawford, Myrna Loy, Jean Harlow, and Lana Turner.  For those bloggers under the age of 35, this would be the equivalent of Brad Pitt with Juliette Lewis, Gwyneth Paltrow, Jennifer Aniston and Angie.  But Steve MacMillan and Tony Viscogliosi?  No fellow bloggers this is probably more like a Gabel movie.  Could it be Run Silent Run Deep?  Not on your life.  Could it be It Happened One Night?  Possibly.  Yet, it probably is more like The Misfits.

The word on the Street is that something is in the works between the Almighty Stryker (always say that with reverence) and the Viscogliosi Brothers.  Stryker it seems, is looking to cell off OP-1, you know the bone morphogenic substance that they acquired from Creative Biomaterials that turned into Curis for $220 million dollars a few dog years ago.   I guess Stryker has learned that it is easier to sell hardware than it is to sell pharmaceuticals.  Supposedly, Stryker is looking to sell their manufacturing facilities and V3 will take over the company with Stryker continuing as a minority partner.  So in all likelihood, V1 (Tony) will probably be on the road to Malaysia to attempt to raise more capital.  Has this guy ever used money of his own to acquire anything?   If there's any truth to the rumor, you know what TSB says, what strange bedfellows they are?  TSB wants to know what you think?

For Whom The Bell Tolls: The Spine Technology Awards

The modern version of this classic is quite different than what Hemingway intended when he wrote For Whom The Bell Tolls.   No this isn't about Robert Jordan attached to a republican guerilla unit during the Spanish Civil War.  It's about another expert in the use of deception.  Looks like Hollywood is going to have to modify the The Spine Technology Awards.  The other nights lack luster performance by Robin Young starring as Robert Jordan, left many of the attendees exasperated with many unanswered questions.  Based on the people's opinions,  the STA is in dire need of a new leading man, and an independent voting panel like Deloitte and Touche.

Robin Young's vision of this red carpet extravaganza is in serious trouble.  One can rationalize that the lack of interest in attending may be attributed to a struggling economy, based on reports that the powers to be at OTW were hounding people to buy tickets up until the night of the event.   Where's Cameron Diaz when you need her?  You know what they say in the real estate market, location, location, location.  Many complained of the nice hike through Sea World.  Hopefully, the party goers stopped and paid an obligatory visit to Shamu.  Oscar was downsized.  What a shame even the trophy is having to tighten its belt during this double dip recession.

The President's Award, (by the way who is the President), was presented to two stem-cell based products, NuCell and PureGen.  TSB must ask our bloggers, is there no honor amongst thieves?  Is this a self-serving venue with the intent of benefitting one's agenda to be known as a market-maker in the stem cell market?   One would think that  the analysts' and investors are smarter than that.  Unfortunately, TSB doesn't believe that. Yet, watching Robin on the dais, is like watching Commodus the Emperor in Gladiator exclaim, Republic! Republic! Republic! The only difference is that he is crying out, Stem Cells, Stem Cells, Stem Cells.  Oh yes, Stem Cells are the second coming, but the second coming of what?  Is this really new technology?  Or, is this old technology with a new spin?   Even Muhammed Ali knew when he overstayed his welcome with the rope-a-dope.   So in closing, TSB wants to know, is it time to pull the plug on this event?  Is this a self-serving venue?  Does the industry really need a Spine Technology Award show, especially if there is no real value or entertainment.  You be the judge, TSB wants to know what the people think?

Wednesday, October 6, 2010

Is The Art of Selling Extinct?

Extinction:  The act or process of becoming extinct.  Coming to an end, dying.  Suppression, abolition, annihilation. 

Based on the recent attacks on sales people and distributors by the medical industrial complex, TSB thought that it would be interesting to ask our fellow spineophiles;  Has the Art of Selling become extinct?  In recent months,  sales people have been excoriated by various factions asserting that sales people have become a necessary evil, driving up the cost of the products, and bringing no value to the industry.   In many respects are we responsible for  bringing this upon ourselves?  As you walk around the convention center today, look around and absorb how many early-growth stage companies are selling commodity products competing in a zero-sum market.  Distributors have become Target or Wal-Mart, carrying multiple lines of the same product.   In many respects we are no different than the foreign merchants that sell knock off Louis Vitton bags, or fake Rolex's in the back alleys of Milan, Italy.   Do I have a deal for you Doctor.

So in the spirit of debate, are we to blame for euthanizing ourselves and becoming extinct in a profession that once respected the value that we brought to the game?  TSB wants to know what you think?

Tuesday, October 5, 2010

NuVasive and Globus: Let's Get Ready to Rumble?

It was reported today that NuVasive will be presenting clinical evidence this week at NASS to substantiate support of its XLIF procedure.  XLIF will be the subject of numerous podium presentations and E-posters.But the bigger news is that today, NuVasive announced that it has initiated patent infringement lawsuit against Globus Medical.  The lawsuits contends that Globus' lateral fusion offering instruments, implants and surgical technique sold under the trademarks TransContinental (how original), MARS (it must be out of this world), and LLIF (another stab at originality), infringes on NuVasives XLIF IP.

Come on down shoppers, and stop by Booth # 859, not only will there be a series of interesting presentations on XLIF, but Alex will be serving PETRUS with some goose liver pate, a variety of French cheeses and crackers.   Hopefully, someone will finally kick Globus' ass for allegedly stealing another company's IP.  Maybe Tony Soprano will pay David Paul a visit.

Monday, October 4, 2010

This Must Be Synthes Lucky Day

Hansjoerg Wyss is a Swiss National.    But today, he must feel like he hit the Irish Sweepstakes.  Just like the European Ryder Cup Team, the Weezer averted disaster today, Wyss and his beloved "Syntes" ( can you hear his lisp) dodged another bullet.  It was reported in the LA Times that Syntes will pay a $23 million dollar fine for illegally testing Norian in 200 spinal patients, resulting in three deaths.  In addition, Norian and Syntes pleaded guilty to criminal charges.

What remains to be seen is what type of sentencing awaits four Syntes executives who are to be sentenced sooner or later.   By Wyss' standards, this is a spit in the bucket for one of the richest men in the world.   I guess it goes to show you that money does buy you the best attorneys, whom cut the best deals.  As for the four former and present executives, time will tell.   

Friday, October 1, 2010

Weekend Op-Ed Piece

Since the inception of TSB, on numerous occasions fellow bloggers have questioned and opined as to the decaying state that has become a standard within our industry.  To many of our readers' surprise, this standard is a by product of something much larger that has infected our society.  Our country has evolved from an agrarian society, into the industrial revolution, to Silicon Valley, and today, we live in a predatory environment.  If man behaves rationally, and markets can be contested, information  sufficient, corporations or man's conduct would be honorable.    The industry like the world is ruled by a monied elite.   Retrospectively, history has, and will prove that regulated capitalism yielded prosperity for everyone.  Today, the signature of our industry is not competition but predation.  Essentially, we work in an industry where one organism captures and feeds on another, the equivalent of a zero-sum market.  Those companies that are willing to bend  the rules by featuring consultancies, setting up physician owned distributorships, or being outright unethical, are complicit in contributing to a decaying industry.  These are the defining features of the spine industry, if not the leading force.  The aforementioned features are what we deliver to our customers.

In a predatory environment, nothing is done to benefit the public or the patient.  In a predatory environment, the rules of economics and law do not apply.  There is no discipline.  Predators compete by not following the rules but by breaking them at every opportunity that presents itself.  If it's okay for the Street to be predatory, why can't we behave that way?    Rules are not designed to guide our behavior, they exist to define the limits of unpunished conduct.  A good example would be fake consultancies.  It becomes easy to step over the line, once you get near it.  We foster and reward bad behavior.  So who is responsible for this type of behavior?  It is the CEO's and executive management teams at every company, whether you are  a legacy or a start-up company.  Yet, there is a consequence for this type of behavior, invariably, you fail.  Predators suck the life out of any business.  So in closing, how do we re-establish some normalcy in spine?  How do we establish some checks and balances, that lead us back to some purpose beyond cutting the deal, and making millions of dollars.  As we approach NASS, maybe it would behoove the governing body to sit down and perform some due diligence on the current state of spine, before it's too late.  TSB wants to know what our readers think?

Friday Morning Question for Our Readers

Whom do you think are the best CEO's in the spine industry, and who are the worst?   Let's face it, there are a few charlatans in our industry.  TSB was speaking with one of our colleagues and we were wondering why do some people keep getting hired over and over, even after they have failed miserably in previous ventures.  Isn't that Einstein's definition of insanity?   What does it say about BOD's and investors.  Recently, it was reported to TSB that a top notch Regional Manager was fired who had achieved 100% of quota in his territory for the past two years, only to be replaced by another Medtronic lackey.  Is this leadership?  Are these people networked with the investment community?  Have some of these people ever sold in this industry?  How incestuous have we become?   One of our bloggers made a great point, there has to be someone out there that really knows what they are doing.  So in the spirit of a good debate, identify that individual and provide us with your rationale.  Does that individual possess integrity.  Does that person bring business and clinical knowledge of the industry.   The same rules apply for the individual that you would name as the worst.  It could even be someone that no longer holds this position.  With the 2010 People's Choice Awards around the corner, TSB wants to know what our bloggers think.