Thursday, March 29, 2012

Time Has Come Today

As the Chambers Brothers once sang;

Time has come today, Globus is on their way
Can't put off that S-1 filing another day
I don't care what The Spine Blogger has to say
They won't listen anyway, Time has come today

Well Spine Nation, as old blue eyes once sang, .... now the end is near, but is it really near?  Word on the Street is that Globus has filed an S-1 Registration with the Securities and Exchange, the only caveat is that danger may be lurking in the bushes. Could there be an IED awaiting Paul and Demski, even Born Agains eventually meet their Maker.  Who knows?  Could there be another lawsuit, or surprise awaiting Globus at the eleventh hour?  TSB wonders if David Paul actually sleeps at home, or does he change dwelling each night?  In TSB's old neighborhood, he might have been taken to Satriales Pork Store by Johnny Boy Soprano.  Until then, let's party like it's 1999.  TSB wants to know can you spell D-I-L-U-T-I-O-N?

Could this be another Orthovita deal where the CEO, CFO, VP of Sales all cash out while the rest of PIGS are slaughtered?  So let TSB take one last jab at our infamous commentator  "Globus is going Public!"

Looking Through The Glass Onion

Lennon and McCarthy? Elton and Bernie? Bacharach and Sager? Jagger and Richards? Strummer and Jones (The Clash), Page and Plant? Lennox and Stewart? Hall and Oats? Ashford and Simpson? Spineophiles, one of our newest contributors penned this post, and let's give credit where credit is due.  As Bogart once said to Berman, Who knows maybe this is the start of something beautiful, here's looking at you kid!

I am he as you are he as you are me and we are all together
See how they run like pigs from a gun, see how they fly, I'm crying
Sitting on a cornflake, Waiting for the cement to come
Corporate T-shirt, stupid bloody extravasation
Man you've been a naughty boy, you let your face grow long

Goo goo g' joob spine bloggers!  Who knew that the immortal John Lennon, aka Public Enemy #1, was thinking about the Kyphoplasty market circa 2012 when he penned those lyrics?  Yes, friends, just when you thought the demand for new VCF products rivaled that of Singer Sewing Machines and IBM Typewriters, we have more new entrants than ever into the marketplace. Recupero’s child, aka Chuckie, has now spawned more imitators than a Las Vegas Elvis convention. Just when you thought it couldn’t get any more crowded, what with Stryker Interventional Spine, DFINE, Osseon, and CareFusion all having me-too products available, and with the medical world on the edge of their seats for AOI, CrossTrees, Benvenue, Soteira (Solyndra?) and Joimax to flood the market, TSB, aka Public Enemy #2, now knows that Globus (W.W.T.P.?) and Synthes are also entering the fold. What a surprise that the Lennon-McCartney songwriting duo of Hansjorg and David Paul would have simultaneous VCF products coming out? 

It seems that Globus’ entity, under the name Algea (What is an Algea) Therapies, is using the time-tested strategy of coercing Kyphon retreads into promises of large base salaries and high commission percentages to come on over to the dark side. We all know how well that strategy worked for DFINE, which went on to dental retreads and now imaging retreads to sell its cumbersome product. But then again, David Paul has been known to have Svengali like powers. TSB told me that they will buy a magic carpet for their office. Stryker IVS tried to go down the long and winding road, but was bitten on the ass, after an aroused Medtronic/Kyphon thought it a bit odd that its entire Southwest Region resigned the same day and showed up at work 2 weeks later all wearing Stryker nametags.  Does it surprise anyone, that Algea is headed by David Veino?,  The former Stryker IVS VP of Sales was terminated after Medtronic’s sued over the above fiasco. CareFusion, which was poised to challenge Medtronic with an identical balloon and Cardinal cash, imploded early under weak, indecisive leadership, unwilling to exploit holes left by Medtronic. Their newly hired National Sales Director smelled the dog shit early and headed back to the implant world.

Meanwhile, despite previous failed entrants into the market, and the pending merger with Depuy, our friends at Syn TES are at it again as well, and are said to be deploying an all new sales force. Of course, Depuy is still trying to figure out how to sell its acquired product the No-Confidence system (Is it a Kypho? Is it a Vertebro?). No word on whether SynPuy will co-market both systems or not.

So, fellow bloggers, TSB wants to know your thoughts on all the excitement in the VCF market, especially in light of questionable clinical papers, reimbursement scrutiny, litigation, and declining physician interest. Is the future crystal clear, or are we looking through a Glass Onion.

I told you about strawberry fields
You know the place where nothing is real
Well here's another place you can go
Where everything flows
Looking through the bent backed tulips
To see how the other half live
Looking through a glass onion

I told you about the Globus and me, man
You know that we're as close as can be, man
Well here's another clue for you all
The walrus is Paul

Wednesday, March 28, 2012

The Soft Parade - Wednesday's Editorial


When I was back there in Seminary School, there was a person there who put forth the proposition that you can petition the Lord with Prayer, Petition the Lord with Prayer?  You cannot petition the lord with prayer.............can you give me Sanctuary I must find a place to hide, a place for me to hide.

Yes Spine Nation, TSB is a place to hide, and contrary to the one person that is continually calling out for the old TSB, TSB is still here.  Our Wednesday Editorial comes in response to the few comments that have called Alex Lukianov brilliant because Mitt "Vanilla Ice" Romney made a guest appearance at the Moscow of the West, NuVasive.  The accolades are just starting to roll in.  Does anyone actually believe that having Vanilla Ice appearing under a banner is a brilliant move?  I could just hear Alex turn around to Vanilla Ice and declare, "Yo VIP, Let's Kick It!" Brilliance is watching Yo-Yo Ma or  Slash play their instruments, let's not elevate people like Alex to Sainthood...... just yet. Besides, the Russian Orthodox Church frowns upon sainthood for mere mortals.

But what does it say about Alex if he promotes Vanilla Ice?  Maybe he isn't as out-of-the box as he was once perceived, that change is really not that good, especially if you have to adapt and change yourselves.  Corporate people hate to change, and unless someone truly has leadership and an open mind, they detest and eliminate anyone that threatens their mere existence, their way of doing things like Einstein's definition of insanity. Years ago this industry was innovative, then success and believing your own press clippings makes you and your company rigid and conservative, unlike a Cheetah.  Just ask Andy Cappuccino. One day you wake up in your Ralph Lauren pajamas in Rancho Sante Fe and realize that you have become everything that you detested, a big slow elephant, incapable of moving quickly anymore. Or is this nothing more than a charade at this juncture in someone's career?

Sure there will be backlash in response to this post because there are those poor souls that need to believe something rather than believing in themselves.  The Cheetahs are no different than the people that perished in November 1978 in Guyana drinking the kool-aid of the Mad Messiah.  So as our readers throw barbs at one another TSB could hear Vanilla Ice and the Bear singing,

Will it ever stop? (Mitt)  Yo I don't know? (Alex)
Turn off the lights, I will glow (Mitt)
To the XLiF extreme I rock a mic like a vandal (Alex)
Light up a stage and wax a chump like a candle (Mitt and Alex)

Hopefully for those of you that find the time between cases and sales call to read our posts, this evokes a smile and some levity in your day.  

"We need someone or something new, to get us through, yeah, c'mon.

Tuesday, March 27, 2012

Carnival in RIO

It couldn't have been more appropriate, only the timing was off.  Canival is a festive occasion held 46 days before Easter in Brazil, but let's have a Carnival of our own fellow spineophiles so follow the bouncing ball........ where's Kelly Key when we're ready to party?

When my baby, when my baby smiles at me I go to Rio De Janeiro, my-oh-me-oh
Biomet goes wild and does the Samba and La Bamba
Now I'm not that kind of company with a passionate persuasion for dancing'
Or romancin' but I give in to the rhythm and my feet follow the beatin'

No fellow bloggers, its not the late, late, late Peter Allen, its Jeff Binder having to do the Samba and La Bamba (now there's a vision) in response to yesterday's report in the Wall Street Journal regarding Biomet agreeing to pay more than $22 million in penalties to settle allegations (if they are allegations why are they paying) that it bribed surgeons in Brazil (No way Jose) and China (Kopy Kats) over a period of years.

It seems like the governments on-going investigation into violations related to the Foreign Corruptions Act is resulting in a windfall.  But let's get serious, if anyone has attempted to do business in Brazil, corruption runs rampant.  TSB knows that some Brazilian will take umbrage with TSB accusations, but if you haven't made an attempt to sell in the largest market in South America, you haven't tasted Salsa until you go to Rio.  The Chinese are no different.  As U.S. companies, surgeons, and businessmen kiss the ass of the Chinese, "it's a whole new market, etc., etc.," the Chinese are strategically planning our demise.  But back to the story.......

The Federal Corruptions Act of 1977 prohibits improper payments to foreign officials in exchange for business.  It's cut and dry.  The Art of the Spine Deal has been made famous by companies like Orthofix J&J, SNN, and now Biomet, but we all know that this has been going on for years. Orthofix for those that may need a memory jolt recently settled with the U.S. DOJ as reported in their press release dated February 6, 2012, so cool your jets down in Lewisville.

But here's a question for our readers, why does the U.S. Government continue to pander to corporations that violate and break laws without throwing anyone into jail?  If companies are people, then someone is obviously responsible for these actions, and should be held accountable.  You have to love legal "pretzel logic," the government finds wrongdoing, but the company doesn't admit any wrong doing. LMAOL.  To quote Jeff Binder, "Over the past several years,  we have significantly enhanced our global compliance procedures and financial controls......" Yeah sure, been there, done that.

In April 2011, Johnson & Johnson agreed to pay $70 million for bribes to Greek doctors (love them Greeks, not only don't they pay taxes, they love taking handouts, suckers), last month Smith & Nephew agreed to pay $22 million for improper inducements to Greek healthcare providers, who knows if the Greeks are smart they could potentially pay down their debt by using the medical device companies.  Stryker and have also disclosed FCPA investigations.

So as the hits keep coming...... TSB is on his way to Rio where the beaches are hot, hot, hot

Monday, March 26, 2012

Truth or Dare? Or Is It Liar, Liar Pants on Fire

Good day Spine Nation, it's time to play truth or dare. What do Trent Northcutt, Brent Johnston, Thomas Gardner, Robert Smart, Kyle Webb, Lance Cochran, Kiki Steinberg and Lazlo Garamszegi have in common?  As Richard Dawson use to say, "the answer is......................"  It seems that once again the Usual Suspects have enacted a drama that will either play out in a court of law, or with a mediator, regardless, could this be a game of liar, liar, pants on fire?

On March 12th, 2012 a complaint was served in the Superior Court for the State of California Orange County, Santa Ana on behalf of Trent Northcutt and Brent Johnson against Phygen, LLC, Allez Spine, LLC, Thomas Gardner, Robert Smart and 50 Does. That's like Does as in John and Jane Doe of the famous Doe family. The complaint alleges that in or about 2008, Northcutt and Johnston designed a Dynamic Interspinous Implant Design applying for a provisional patent on the ISP product and design including their proprietary dynamic ratcheting locking system., never before seen or used in the Spine Industry, as opposed to the standard grommet nut locking system.

For those of you that do not know the industry, prior to sharing the ISP design under the protection of IP Agreements, the Plaintiffs had consulted for Phygen and Allez Spine. That could have been their first mistake. It was during this period that Northcutt and Johnston told Gardner, the CEO of shell companies, Phygen, aka Physician Generated, Allez Spine and Athernova about their ISP idea.  Gardner assured (wink, wink) the Plaintiffs that he would be interested in the ISP product based on their experience and success at LANX No Thanx, the US market leader for ISP fusions.

On May 28th, 2009 the parties signed the IP/ISP protection agreement, specifically, a three year Non-Circumvent and Non-Disclosure Agreement. The documents were scanned and e-mailed to all parties.  The plaintiffs signed on behalf of Apogee Dynamics and Mssr. Lazlo Garamszegi (love that name, Could it be Lazlo from Casablanca).  Under the IS/ISP Agreement the other Defendants were shown the Plaintiffs design. At the time the Plaintiffs presented their design Gardner, Garmszegi and Dr. John Brown indicated that they were "impressed and expressed an interest to acquire or develop the product." After a few months the product was not acquired or developed.  Mssr. Northcutt went on to work for SpineArt as a VP in North America, and Johnston stayed on with Phygen/Allez (gotta love these shell companies) until his departure in early 2011.

Here’s where the plot thickens.  Unknown to the Plaintiffs at the time, allegedly Gardner and Smart directed the employees to create a “secret” ISP folder and began developing the stolen IP design.  In or about February of 2012, metal prototypes were received by the Defendants, who began showing the metal prototypes in San Francisco during the AAOS trade show.  The question TSB must ask is, why didn’t Mr. Gardner submit the product to the Spine Technology Awards, bet Robin Young would have given Phygen a prize for the effort alone, if any of this is true.  Could have named the award something like, well let's just call it the Paul Award for old time sakes.

On February 8, 2012 as the lights went down on the city, and the sun shined on the bay, Mssr. Gardner invited Northcutt to attend the Allez/Phygen cadaver lab.  Awaiting were some former oldies but goodies from Blackstone Medical, Kyle Webb,  Lance “I took it on the chin" Cochran, Kiki “I gotta mouth” Steinberg, and Lazlo. The  Our Gang of the Spine Industry offered Northcutt some wine and cheese , how gauche, but he declined.  As the Plaintiff toured the lab much to his surprise he noticed a familiar ISP implant that was attached to the cadaver.  Can one image that even the dead are being dragged into this suit? Yet, although the shape of the implant was different , it had the exact locking mechanism. Obviously at this point Northcutt realized that something did not smell right.  Words were exchange, and Gardner swiftly escorted Northcutt out the front door.  Here’s where this complaint gets funny, Gardner and Smart are attempting to sell Allez/Phygen to a financial suitor for an estimated $15-25 million.  You know what PT Barnum once said……  The Plaintiffs believe that the stolen device could exceed $25 million in the open market.  So what do our readers think, is this truly a game of truth of dare?  Or, is this a game of he says, she says.  Whatever the consensus, once again, it seems like old habits die hard in the Spine Industry.   You know what they say,

Got those highway blues can't you hear my motor running
Flyin' down the road with my foot on the floor
All the way in town they can hear me comin'
Fords about to drop she won't do no more  
And I smell my motor burnin' 
Underneath the hood is smoke
Can't stop and I can't stop got to keep movin' or I'll lose my mind

Wednesday, March 21, 2012

Rust Never Sleeps

Fellow Spineophiles;

Upon taking a few mental health days from blogging, it is great to get to the keyboard and share a few thoughts about the industry and some of the comments that have been posted referring to this blog dying a slow death, that TSB sold out to another TSB, that there were grammatical errors, that the creative juices are gone by asking you a simple question in our post, "where has all the innovation gone?" This is your forum, isn't it?  It has always been about the people, it has never been a PR platform for any one individual.  TSB is not Robin Young shopping his OTW around to other publications, a gadfly, an industry oracle, no we would never be that full of ourselves. TSB stopped hanging onto mommies apron a long time ago.  But before I continue to blog, let me make an observation about some of our readers.  For the most part, the majority of you contribute in a positive manner, many with surgical like precision contrary to the naysayers.  Unfortunately, there is a minority, if not a few individuals that truly believe that they are entitled to dictate what we should write about, how often should we post, and what we should say, let alone how we should say it. They continue to espouse their non-sense. With that said, let me quote Samuel Langhorne Clemens,  Mark Twain for some of gnomes that surf this site, "the reports of TSB's death are greatly exaggerated."  How ridiculous do some of you sound?  You would think that TSB was working for our readers.  Guess what?  We're not.  Not any one individual that contributes to our weekly posts works for any of you.  In all likelihood we will never work for anyone, nor will we ever pander to anyone's desires.  Our objective was and will always be to be honest and truthful about this industry and some of the cartoon characters that make up the usual suspects.

Upon attending some recent industry related meetings the one thing that truly jumps out is that this industry is as toxic as it has ever been.  Many of you and your companies have gone so far off course that the question must be posed, will you ever get back on track?  Upon visiting some of your booths, it became apparent that the delusional have never left the building. Building is a thing of the past, and maybe this is a by product of the kind of leaders some of your companies are putting in place.  As for culture, that is nothing more than a charade.  TSB and his Band of Gypsies walk around some of these meetings and do not see anything that resembles an industry that took great pride in itself. The reason this industry has reached this crossroad is because we lack an ethic and moral that once made us a proud industry.  How pathetic is it watching some of you run around kissing some KOL's ass?  They laugh at most of you, and mock you behind your backs.  As for leadership, it's a joke at best.  Leadership was about doing the right thing, today it is nothing more than a distant memory.  It's all about making money.  Yet, before anyone dare illicit a response, look at the tactics and strategies that have been implemented.  Today, leadership is not about leading, its about beating your managers and sales force over the head with unrealistic expectations.  Where do some of these people come up with their hallucinations?  Could it be that they are the people doing the drugs?  Hey, why not read another book or attend another leadership seminar only to leave those tools at the door when you leave.  Today very few dollars are directed at education for the direct and independent sales rep.  Part of the problem is that many claim to understand leadership and management, yet, few understand sales.  You actually need to be a magician to succeed in this business.  But then again, there are a few Mr. Magic's that are in sales leadership positions.

For those of you that think TSB is dead, we are just catching our second wind.  Over the next few days and weeks we will entertain you with our take on the complaint files against Phygen for IP infringement and some other oldies but goodies.  To those that think TSB is dead, remember what the great Neil Young once said, "rust never sleeps."

Hey, Hey, my, my , TSB will never die, there's more to the picture than meets the eye, hey, hey, my, my. So keep your eyes out for over the days TSB will have arisen from the dead.

Keep On Rockin' Spineophiles

Thursday, March 8, 2012

Where Has All the Innovation Gone

Talk about a steady decline, how about an overall decay.  It's the last vestiges of Pompeii.  The spine industry is its own Mount Vesuvius blowing out ash and fire.  Who knows maybe one day when they unearth this industry with an archeological dig, we will all learn what happens when one self-immolates.

If we step back and evaluate some of the emerging technologies that have graced the spine industry, we can observe in shear astonishment how some of these products ever reached the marketplace, let alone generated revenue for the inventor and investors. TSB believes that many of you would agree that organic innovation, something that truly was a game changer, no longer exists at the big companies. A game changing technology, something that enhances the clinical outcomes and overall patient's quality of life.  If life is movement, and movement is life, then there isn't much movement or life coming out of the spine industry. As more start-ups continue to dump me-too products into the marketplace, the only outcome is lower pricing, lower commissions, lower profit margins, and less focus.  The emerging technologies are not coming out of the Medtronics, the Zimmers, the Biomets, the DePuy's, Orthofix, Synthes, or for that matter NuVasive. Is it the people running these companies? Is it our educational system when one looks at the quality of candidates coming out of engineering schools?  The smart guys are going to the Street. Could it be cheaper to acquire a product than develop it? Why do people continue to give some of these clowns capital only to find out that they have been played for fools?  The spine gravy train has left the station and isn't coming back.  Elvis has left the building. Could it be that even the small companies have become myopic?  Is the current business model in spine built on selling or brokering?

Look at some of the small companies, once looked upon as incubators for innovation, stagnation has taken over innovation. What is it about inventors, entrepreneurs or investors that inhibits them from bringing a game changer in today's marketplace?  Could hope spring eternal?  Where are the market-makers, or game-breakers? Every time you assess one of these start-ups you have to question whether the have the stamina to go the distance. The first couple of years, everything is usually status quo until personality flaws start to surface intra-operatively, or one of the big boys figures out a better mouse trap for your own product. Terrible two's suck. How many of you have worked for a company that had a great implant but mediocre instruments? Or, the instruments were beautiful but the implant sucked?  Or that the inventor believed that there wasn't anything wrong with the system, and that the surgeon(s) didn't know how to use the instruments or implants or weren't properly trained? FOOL GOLD my fellow bloggers. Based on some of your comments many of these people along with the people that manage these ventures are living in a fantasy world deluded by too many hallucinogens. TSB bets that there are many of you out there that have plenty of stories to share with one another.

Recently some of our sources were in the OR and reported that if one saw the quality of what is being offered as new and innovative technology is...... well......crap at best.  Mediocre instruments. Mediocre implants.  If you were a surgeon would you want to subject yourself to intra-operative torture?  So why have we stooped to this level?  Poor management?  Financial ineptness?  No experience? Bullheadedness?  Who wants to wallow in mediocrity, when suicide is painless.  So TSB wants to know has anything here seen my old friend Jurgen Harms, can you tell me where he's gone,  he designed some interesting things and now I look around and its all gone?

Money has always been important, but maybe there's a lesson to be learned that if you focus on the basics, we can return to some semblance of yesteryear, but then again, as long as human nature plays a role in outcomes, maybe not.  TSB can hear that the wind cries help me and wants to know what will it take?