The people's blog site where news, ideas, job opportunities and what's been heard on the street can be discussed in a professional manner.
Saturday, December 31, 2011
2012 New Years Day Readers Poll
Is Osseon the next company to fall? Word coming out of the New England area is that there is trouble in paradise, could this be the next company in financial trouble? Ultimatums are a terrible way to have a relationship, usually ends up in divorce court, and this ain't Judge Judy the Nudie that we are talking' 'bout. So, what's the buzz tell us what's a happening. Where's OTW when you need all that insight? TSB wants to know, and so does the market, do they have legs or are they running on borrowed time? Who's next?
Saturday, December 24, 2011
Merry Christmas to All
As the Silly Season is upon us, TSB would like to wish all our readers, including the Cheetah Nation, a peaceful and joyous holiday season. Liberate yourselves from the insanity that you subject oneself to for at least a few days, it will be therapeutic. Hug your kids, love your significant others, and keep things in perspective. Closing those PO's this week will only get you inches closer to $1 Billion, or your bonus. Contrary to a minority opinion, those that contribute to our blog love this industry, we even like Nuvasive, but when you're news, you're news. If you learn anything this coming year, keep "Da Noise" that exists in this crazy industry to a minimum. Some would call it balance. Some should actually try it, it works. Whatever you believe, TSB knows that our blog provides a heuristic venue to explore and investigate the many recesses that exist in this crazy industry.
So in the spirit of the holiday season, and yes my judaic friends that does include hanukkah, last year you whined about us not giving you a shout out. Have a healthy and happy 2012 (shhh! don't tell anyone that we're devout capitalists), and while we're at it, can someone remind the POTUS that the shamash is always the first candle lit, an amateur Jew at heart looking for votes. Until then, Merry Christmas to one all, Ho! Ho! Ho! Santa's got to go, he's got to deliver toys for all his spine girls and boys.
Team TSB
Come Dasher, Come Dancer, Come Prancer, Come Vixen, Come Comet, Come Cupid, Donner and Blitzen, lastly Rudy we're on our way.
So in the spirit of the holiday season, and yes my judaic friends that does include hanukkah, last year you whined about us not giving you a shout out. Have a healthy and happy 2012 (shhh! don't tell anyone that we're devout capitalists), and while we're at it, can someone remind the POTUS that the shamash is always the first candle lit, an amateur Jew at heart looking for votes. Until then, Merry Christmas to one all, Ho! Ho! Ho! Santa's got to go, he's got to deliver toys for all his spine girls and boys.
Team TSB
Come Dasher, Come Dancer, Come Prancer, Come Vixen, Come Comet, Come Cupid, Donner and Blitzen, lastly Rudy we're on our way.
Tuesday, December 20, 2011
The Culture Club
As the year winds down, the "2011 Year in Review" has brought to light many of the problems that continue to exist in the spine. What we have learned over the last few years is that our recidivistic nature supersedes our ability to execute. TSB loves to quote Einstein's definition of insanity for the obvious reasons. Management in spine companies are fused in a time warp. They have forgotten where they came from and how they got there, regardless of what you believe, money and power can have a way of obfuscating reality. Dilution or is it delusion occurs. The eventual outcome is that many of these leaders forget what it took to get out of the box, or never understood what out of the box really meant. Considering that out of the box means moving in diverging directions which could potentially result in novel or innovative ideas, the fact remains that when you become the Street's bitch, you eventually lose the eye of the tiger or sometimes the eye of the cheetah. Shareholder value, that becomes your focus, don't believe TSB, just sit in on a Stryker or NuVasive call. Just look at Steve Jobs, love him or envy him, he was a visionary, an outlier, albeit in a completely different industry. It was always about the product. Yet, whatever the inevitable, some of us will leave the industry in a wooden box, while some will leave in a gilded box. The difference is that a gilded box influences others to believe that you were successful, because money is still perceived as a sign of success and power, sometimes even anointing one to sainthood. Regardless, what the Street has predicted for our industry, many continue to live in the past. What worked at Medtronic, J&J, Zimmer, Synthes, or Stryker in the roaring eighties and nineties has outlived its usefulness. The battlefield terrain has changed. The rules of engagement have change and the question remains do the generals have the ability to adapt and survive? Getting your testi's handed to you can be a humbling experience, just look at Nuvasive's recent demise in the stock market. How long does Alex and his minions plan on riding XLiF and neuro-monitoring? As one of our commentators suggested, the stock for this company is a highly manipulated stock. Isn't that a barometer of the lack of confidence that investors have in a company that once touted their innovation and responsiveness as cheetah like? How quickly Lukianov forgets, but then again, isn't some of this about smoke and mirrors? One can only ride the propaganda machine that your public relations company spits out on your behalf so long and then, it's game time. Yes, there are isolated exceptions, whereby some companies are showing growth. But in the larger picture, they are small companies generating growth by shear will, while some do it by buying business a la POD's and POC's. But, as far as the big boys go, or those that want to grow up, let TSB quote one of our favorite philosopher's Paulie "Walnuts" Gualtieri, "fuggedaboutit." Organic development is something the food industry has learned to capitalize on, the spine industry has lost focus and direction with how it arrived at this fork in the road, vis-a-vis INNOVATION and CAPITALIZATION, and we have no one to blame except ourselves. Where are the emerging technologies? The readers are correct when they poke fun at and criticize the industry leaders. Many can thumb their smug noses, but time eventually catches up with you, just take a visit to the graveyard of spine. Stability, not volatility and movement have reigned over the years, and then for some reason a school of thought emerged that if you are not growing by leaps and bounds, a sudden change in direction will solve your growth problems. It would be interesting to identify when this mercenary attitude become prevalent. Just look at some of the companies within the industry, they are a revolving door. Are the expectations unrealistic? You be the judge.
Consolidation is not a thing of the past, it is the future. No fellow readers the days of start-ups will not disappear. But, it has become difficult to launch anything unless it is truly an emerging technology. Many smaller companies are finding this out the hard way. Access to capital as in the pre-2008 bubble burst is long gone, and with that, so are the excessive valuations. Not only are many of you attempting to figure out how to survive in the battlefield, you are also dealing with leaders that still want to fight in a conventional war. In today's market place, the sales representative or manager that has the ability to preserve and sustain your customer loyalty and revenue is much more valuable, than the gunslinger that rides into town and promises you the world, for the obvious reasons. There are no magic bullets. In addition, they are a hired hand, until the next deal comes along regardless whether its a distributor or surgeon. The tenured sales rep or manager at your company knows what the challenges are that must be addressed in order to maintain your business, the question is does anyone on your executive management team listen and have the cojones to execute, or, does it fall on deaf ears? Is your company listening and being responsive to your battlefield needs? Do you have the ability to be pro-active rather than reactive? But then this has been our point all along. Are you better off than you were two years ago? Maybe that's why we all laugh at the industry. How do you sell when you have no samples, no marketing collaterals, no bone models, an inadequate training program not just on the clinical issues, but on the environmental issues that you are challenged with on a day-to-day basis? Think how absurd it is when company executives claim that they don't want to be like the company that they previously worked for, yet surround themselves with the same people that they worked with at that other company? Create a new culture? Highly unlikely. More like an attempt to catch lightening in a bottle by copying that culture because you think you can do it better, and then one day you wake up and you realize that you are no different than the company that you claim you did not want to be like. You've become the 4,000 pound Gorilla that has an inability to innovate because everything becomes an exercise in accounting, you need to have meetings because everyone needs to cover their ass or wants to be heard, so all that execution that you once told the market you were capable of doing better and faster has come down to a grinding halt. The result is that you start losing customers. You know the people that will only tolerate your BS to a point and then shut you down by moving to another company or product. Surgeons are customers, and an unhappy customer means you're in trouble. So as Jethro Tull once sang,
Happy and I'm smiling walk a mile to drink you water
You know I'd love to love you and above you there's no other
We'll go walking out while others shout of war's disaster
Oh, we won't give in let's go living in the past
Once I use to join in every boy and girl was my friend
Now there's revolution, but they don't know what their fighting
Let us close our eyes outside our lives go on much faster
Oh, we won't give in let's go living in the past
TSB wants to know what you think.
Consolidation is not a thing of the past, it is the future. No fellow readers the days of start-ups will not disappear. But, it has become difficult to launch anything unless it is truly an emerging technology. Many smaller companies are finding this out the hard way. Access to capital as in the pre-2008 bubble burst is long gone, and with that, so are the excessive valuations. Not only are many of you attempting to figure out how to survive in the battlefield, you are also dealing with leaders that still want to fight in a conventional war. In today's market place, the sales representative or manager that has the ability to preserve and sustain your customer loyalty and revenue is much more valuable, than the gunslinger that rides into town and promises you the world, for the obvious reasons. There are no magic bullets. In addition, they are a hired hand, until the next deal comes along regardless whether its a distributor or surgeon. The tenured sales rep or manager at your company knows what the challenges are that must be addressed in order to maintain your business, the question is does anyone on your executive management team listen and have the cojones to execute, or, does it fall on deaf ears? Is your company listening and being responsive to your battlefield needs? Do you have the ability to be pro-active rather than reactive? But then this has been our point all along. Are you better off than you were two years ago? Maybe that's why we all laugh at the industry. How do you sell when you have no samples, no marketing collaterals, no bone models, an inadequate training program not just on the clinical issues, but on the environmental issues that you are challenged with on a day-to-day basis? Think how absurd it is when company executives claim that they don't want to be like the company that they previously worked for, yet surround themselves with the same people that they worked with at that other company? Create a new culture? Highly unlikely. More like an attempt to catch lightening in a bottle by copying that culture because you think you can do it better, and then one day you wake up and you realize that you are no different than the company that you claim you did not want to be like. You've become the 4,000 pound Gorilla that has an inability to innovate because everything becomes an exercise in accounting, you need to have meetings because everyone needs to cover their ass or wants to be heard, so all that execution that you once told the market you were capable of doing better and faster has come down to a grinding halt. The result is that you start losing customers. You know the people that will only tolerate your BS to a point and then shut you down by moving to another company or product. Surgeons are customers, and an unhappy customer means you're in trouble. So as Jethro Tull once sang,
Happy and I'm smiling walk a mile to drink you water
You know I'd love to love you and above you there's no other
We'll go walking out while others shout of war's disaster
Oh, we won't give in let's go living in the past
Once I use to join in every boy and girl was my friend
Now there's revolution, but they don't know what their fighting
Let us close our eyes outside our lives go on much faster
Oh, we won't give in let's go living in the past
TSB wants to know what you think.
Tuesday, December 13, 2011
2011 - A Year to Lick Your Chops or Lick Your Wounds
Yes fellow Spineophiles, its that time again, when Santa comes down the chimney with echoes of "Ho, Ho, Ho, Santa's got to go, he's got to bring toys for l'il girls and l'il boys." As we rapidly approach the end of another year in the wacky world of spine its time for TSB to look at the winners and losers for 2011.
January brought us a deep freeze, depending on where you were. Though these companies were use to warmer climates, revelry played out for Cardo Medical and Facet Solutions. Cardo couldn't get out of their own way, the blind leading the blind, attempting to capitalize on its acquisition of Vertebron, laid this dog to rest once and for all, while Facet Solutions was gobbled up by Globus Medical, aka, when will they go public, for pennies on the dollar.
February had Nuvasive cautioning analysts' that the winds of change were coming, inevitably experiencing a smack down by the marketplace and the Street. Even Bill Walton wasn't capable of posting up Lukianov considering that even with XliF, Walton is running on bad wheels. Thank goodness that Memphis is winning at the box office, considering that the stock has been a chihuahua lately, hey Yoquero where's the chalupa? Can I hear $11 dollars? By the way, for all of those drinking the kool-aid, it is purple isn't it, spare us the complaints of NuVa bashing, it is what it is, a one trick pony, is all that horse can do, it's a one trick only, it's the principal source of their revenue.
March came in like a lion when DMT better known as "no motion" experienced a capital crunch, along with Applied Spine being sold to Rachiotek for pennies on the dollar. Love Panjabi, but his advisors and investors should've been fired a long time ago. It was during the Ides that the first shot was really fired at INFUSE putting the holy grail of biologics under the electron microscope. March entered riding the lion, but left like a lamb.
April brought us headline news with Dr. Makker and Sundaresan making the cover of various media outlets with questionable practices, while Zimmer and Wright Medical made their own news announcing the hiring of Paul Graveline and the resignation of Gary Henley as CEO, but the big story in spine was the pending acquisition of Synthes by J&J. Will the arbeitsgemeinschaft osteosynthes fragen ever be the same? Synthes was always more Armani than Brooks Brothers, at least during yesteryear, today, they should fit in well considering that the company was and is run by a pharma dweeb who looks at salespeople as a necessary evil.
May had Larry Biegelsen, a Wells Fargo analyst touting that the acquisition of Synthes by J&J could benefit Zimmer, well Larry, don't want to disappoint you, but we're still waiting, and waiting, and waiting. Medtronic announced and initiated layoffs, while John Viscogliosi hit the road entering Centinel Spine in every Bar-B-Que contest East of the Mississippi. Wasn't he running a spine company? The NJ State Board of Medical Examiners levied civil penalties against Drs. Errico, Balderston and Goldstein for failing to disclose to their institution their financial interest in ProDisc using the widely held Jon Corzine defense, it was merely an oversight. But the big story in May was the resurgence and advocacy of POD's. It's truly a shame that surgeons can't earn a living being surgeons, they now insist on being salesmen, c'est la vie. The silicon chip inside Tony Koblish's head finally switched to overload and Orthovita was sold to Stryker for $316 mil in cash. You know what Henry Butler of The Three Kings sang, "let the good times roll." It
was in May that we poked fun at our favorite whipping boys, the stock analysts' of the device world. Where are those smart guys? As ATEC stock continues to plummet it's awfully quiet on the home front. In May we announced 20% is a thing of the past, unless you're a POD, and everyone was tightening their belts leading to a year of fiscal austerity in spine.
June had TSB announcing the departure of Mike Mogul from Stryker, and a Federal Appeals Court overruled that the trial judge from the First District Court in Boston had applied the False Claims Act and Anti-Kickback Statute too strictly in the Whistleblower case against Blackstone. Poor Orthofix, talk about being kicked in the nuts, they like paying their executives wonderful bonuses, maybe its time they settle this suit and move on to better things, just like Medtronic did this week. Ortho-fix should just clean up that dog of a spine division formerly known as Blackstone, SUCKERS!!!! Norian was sold to Kensey Nash and TSB announced that there would definitely be jail time after the verdict in the Trial of the West Chester Four. The Guyer Family experienced their own loss when Jeff Guyer passed away in June. Hopefully, the Guyer's will have a peaceful holiday season. POD's and attacks on sales people become the topic du jour and Ortho-fix announced the resignation of Alan Milanazzo whereby TSB provided the play by play of that stellar career.
July brought us the Spirit of Edgar Dawson and the ghost of Marshall Urist and many of our readers responded with passion regarding BMP's. Synthes and Globus entered into the ring for another suit. Could this have been Wyss' parting shot at David Paul? The FDA issued a warning label to AlphaWreck for PureGen resulting in pink slips in the Biologics Division at d'Wreck. July was quiet as it usually is.
August had us asking the question whether technology was distracting the Art of Surgery. Even Jack White formerly of the Raconteurs and White Stripes commented that technology may make things easier, but, does it takes away from man's creativity? Once again, it takes an artist to shed some reality on the facts of life. Are we training a generation of surgeons that will lack the necessary skills to know how to operate? That was the six million dollar question that a veteran of surgery posed. Once again, the market for spine was down graded. Rachiotek and Yale University filed suit against everyone's whipping boy, Globus when it comes to law suits. Synthes, Medtronic, Rachiotek? TSB could hear Sonny and Cher in the background, "and the beat goes on, and the beat goes on, the drum keep pounding a rhythm to his brain."
September brought us memories of the Ali-Wepner fight when Medtronic and Nuva geared up for the Rope-a-Dope, while Sharp's and Scripp's hospital systems issued a storm warning on POD's claiming that they were unwelcome at their facilities. Did anything really happen? NuVa took it on the chin and their stock plummeted to 18.65, leaving TSB to ask the question, will they ever see 18.65 again? By the looks of their recent performance, even the analysts' aren't drinking the kool-aid.
October brought us boot camp for the Spine Technology Awards as everyone was polishing their silver and putting out their fine China in preparation for that venue. Spinal USA made the Wall Street Journal claiming that they were a legitimate company invoking Jim Pastena to claim, well, that they are a real company, duh! TSB did ask the six million dollar question, where is the innovation? Pedicle Screws, Cervical Plates, Interbody Devices, Biologics, as Clara Peller use to say, "where's the beef?' Then we wonder why hospitals are capping pedicle screws at $500 like Medstar is in Ohio. Olympus made headlines by some nefarious activities that have now garnered the attention of multiple federal enforcement agencies in Japan and the U.S. resulting in the V Brothers getting some unwanted publicity. By the way, what were they doing in the Olympus Booth at the Chinese Orthopedic Associations trade show? Can someone say $14 +$22?
November brought Nuvasive more bad news as its market cap continue to fall faster than a speeding bullet. Where was Superman? Did anyone see him? Word on the Street was the NuVa was taking it from all sides, including losing one its biggest hitters Dr. Cappucino. NASS was another humdrum meeting, David Paul was spotted walking the floor with his bodyguard Tatoo or was that a human troll?
So as we wrap up another year Santa is looking out for those that are naughty and those that are nice. It will be interesting to see where stocks like Nuvasive and AlphaWreck end up. Will they rebound and make those soothsayers, the analysts look brilliant, or will they never rebound? Never rebound? Never rebound? Considering that the market has been over hyped and inflated much of the industry's destiny will rely on the Asia markets. With Europe in a state of flux, there is no telling whether some of us will ever rebound. Could this be the year of the small company, and who will be gobbled up as we wonder who will fall to the way side? So as we wind down the year the question to our readers is, was this a year to lick your chops or lick your wounds? You be the boss.
January brought us a deep freeze, depending on where you were. Though these companies were use to warmer climates, revelry played out for Cardo Medical and Facet Solutions. Cardo couldn't get out of their own way, the blind leading the blind, attempting to capitalize on its acquisition of Vertebron, laid this dog to rest once and for all, while Facet Solutions was gobbled up by Globus Medical, aka, when will they go public, for pennies on the dollar.
February had Nuvasive cautioning analysts' that the winds of change were coming, inevitably experiencing a smack down by the marketplace and the Street. Even Bill Walton wasn't capable of posting up Lukianov considering that even with XliF, Walton is running on bad wheels. Thank goodness that Memphis is winning at the box office, considering that the stock has been a chihuahua lately, hey Yoquero where's the chalupa? Can I hear $11 dollars? By the way, for all of those drinking the kool-aid, it is purple isn't it, spare us the complaints of NuVa bashing, it is what it is, a one trick pony, is all that horse can do, it's a one trick only, it's the principal source of their revenue.
March came in like a lion when DMT better known as "no motion" experienced a capital crunch, along with Applied Spine being sold to Rachiotek for pennies on the dollar. Love Panjabi, but his advisors and investors should've been fired a long time ago. It was during the Ides that the first shot was really fired at INFUSE putting the holy grail of biologics under the electron microscope. March entered riding the lion, but left like a lamb.
April brought us headline news with Dr. Makker and Sundaresan making the cover of various media outlets with questionable practices, while Zimmer and Wright Medical made their own news announcing the hiring of Paul Graveline and the resignation of Gary Henley as CEO, but the big story in spine was the pending acquisition of Synthes by J&J. Will the arbeitsgemeinschaft osteosynthes fragen ever be the same? Synthes was always more Armani than Brooks Brothers, at least during yesteryear, today, they should fit in well considering that the company was and is run by a pharma dweeb who looks at salespeople as a necessary evil.
May had Larry Biegelsen, a Wells Fargo analyst touting that the acquisition of Synthes by J&J could benefit Zimmer, well Larry, don't want to disappoint you, but we're still waiting, and waiting, and waiting. Medtronic announced and initiated layoffs, while John Viscogliosi hit the road entering Centinel Spine in every Bar-B-Que contest East of the Mississippi. Wasn't he running a spine company? The NJ State Board of Medical Examiners levied civil penalties against Drs. Errico, Balderston and Goldstein for failing to disclose to their institution their financial interest in ProDisc using the widely held Jon Corzine defense, it was merely an oversight. But the big story in May was the resurgence and advocacy of POD's. It's truly a shame that surgeons can't earn a living being surgeons, they now insist on being salesmen, c'est la vie. The silicon chip inside Tony Koblish's head finally switched to overload and Orthovita was sold to Stryker for $316 mil in cash. You know what Henry Butler of The Three Kings sang, "let the good times roll." It
was in May that we poked fun at our favorite whipping boys, the stock analysts' of the device world. Where are those smart guys? As ATEC stock continues to plummet it's awfully quiet on the home front. In May we announced 20% is a thing of the past, unless you're a POD, and everyone was tightening their belts leading to a year of fiscal austerity in spine.
June had TSB announcing the departure of Mike Mogul from Stryker, and a Federal Appeals Court overruled that the trial judge from the First District Court in Boston had applied the False Claims Act and Anti-Kickback Statute too strictly in the Whistleblower case against Blackstone. Poor Orthofix, talk about being kicked in the nuts, they like paying their executives wonderful bonuses, maybe its time they settle this suit and move on to better things, just like Medtronic did this week. Ortho-fix should just clean up that dog of a spine division formerly known as Blackstone, SUCKERS!!!! Norian was sold to Kensey Nash and TSB announced that there would definitely be jail time after the verdict in the Trial of the West Chester Four. The Guyer Family experienced their own loss when Jeff Guyer passed away in June. Hopefully, the Guyer's will have a peaceful holiday season. POD's and attacks on sales people become the topic du jour and Ortho-fix announced the resignation of Alan Milanazzo whereby TSB provided the play by play of that stellar career.
July brought us the Spirit of Edgar Dawson and the ghost of Marshall Urist and many of our readers responded with passion regarding BMP's. Synthes and Globus entered into the ring for another suit. Could this have been Wyss' parting shot at David Paul? The FDA issued a warning label to AlphaWreck for PureGen resulting in pink slips in the Biologics Division at d'Wreck. July was quiet as it usually is.
August had us asking the question whether technology was distracting the Art of Surgery. Even Jack White formerly of the Raconteurs and White Stripes commented that technology may make things easier, but, does it takes away from man's creativity? Once again, it takes an artist to shed some reality on the facts of life. Are we training a generation of surgeons that will lack the necessary skills to know how to operate? That was the six million dollar question that a veteran of surgery posed. Once again, the market for spine was down graded. Rachiotek and Yale University filed suit against everyone's whipping boy, Globus when it comes to law suits. Synthes, Medtronic, Rachiotek? TSB could hear Sonny and Cher in the background, "and the beat goes on, and the beat goes on, the drum keep pounding a rhythm to his brain."
September brought us memories of the Ali-Wepner fight when Medtronic and Nuva geared up for the Rope-a-Dope, while Sharp's and Scripp's hospital systems issued a storm warning on POD's claiming that they were unwelcome at their facilities. Did anything really happen? NuVa took it on the chin and their stock plummeted to 18.65, leaving TSB to ask the question, will they ever see 18.65 again? By the looks of their recent performance, even the analysts' aren't drinking the kool-aid.
October brought us boot camp for the Spine Technology Awards as everyone was polishing their silver and putting out their fine China in preparation for that venue. Spinal USA made the Wall Street Journal claiming that they were a legitimate company invoking Jim Pastena to claim, well, that they are a real company, duh! TSB did ask the six million dollar question, where is the innovation? Pedicle Screws, Cervical Plates, Interbody Devices, Biologics, as Clara Peller use to say, "where's the beef?' Then we wonder why hospitals are capping pedicle screws at $500 like Medstar is in Ohio. Olympus made headlines by some nefarious activities that have now garnered the attention of multiple federal enforcement agencies in Japan and the U.S. resulting in the V Brothers getting some unwanted publicity. By the way, what were they doing in the Olympus Booth at the Chinese Orthopedic Associations trade show? Can someone say $14 +$22?
November brought Nuvasive more bad news as its market cap continue to fall faster than a speeding bullet. Where was Superman? Did anyone see him? Word on the Street was the NuVa was taking it from all sides, including losing one its biggest hitters Dr. Cappucino. NASS was another humdrum meeting, David Paul was spotted walking the floor with his bodyguard Tatoo or was that a human troll?
So as we wrap up another year Santa is looking out for those that are naughty and those that are nice. It will be interesting to see where stocks like Nuvasive and AlphaWreck end up. Will they rebound and make those soothsayers, the analysts look brilliant, or will they never rebound? Never rebound? Never rebound? Considering that the market has been over hyped and inflated much of the industry's destiny will rely on the Asia markets. With Europe in a state of flux, there is no telling whether some of us will ever rebound. Could this be the year of the small company, and who will be gobbled up as we wonder who will fall to the way side? So as we wind down the year the question to our readers is, was this a year to lick your chops or lick your wounds? You be the boss.
Tuesday, December 6, 2011
NEIN X NINE = NEIN
No spine nation, it's not the Godfather of Soul (may he rest in peace), neither is it that other Godfather, you know the one that ran a pizza company who basically was taken to the woodshed by his wife Gloria last weekend, neither is it memories of Adolf Hitler who liked to scream, "Nein, Nein, Nein." What Nein X Nine = Nein amounts to is the answer that the Supreme Court issued to Blackstone Medical and Orthofix with regard to their Petition for a Writ of Certiorari. The Cert Petition is a legal request to the SCOTUS whereby a defendant, in this case Blackstone and Orthofix, asks the Court to review a decision by the a lower court, in this case, Blackstone Medical Incorporated v. U.S. ex rel. Hutcheson. But before we go any further let's understand the issue at hand.
The issue in Blackstone Medical was whether a device company THAT PAID ILLEGAL KICKBACKS to prescribing physicians (we know who you are) could be liable under the False Claims Act for causing false claims to be submitted to MEDICARE. The basis for the law is that anyone submitting claims for federal monies cannot submit false or fraudulent claims. If so, the Federalis can recover large fines for each submission as well as treble damages. Treble damages is a term that indicates that a Statute permits a court to triple the amount of the actual/compensatory damages (are you listening boys). In addition to the treble damages, the whistleblower shares in the bounty. Blackstone, Orthofix and its cadre of attorneys were hoping to argue that another law for which the filer had certified compliance was being violated.
Considering that this Writ of Cert came in front of the Robert's Court and was denied is BIG. It seems that Blackstone's/Orthofix attorneys were hoping for a "Hail Mary"considering that the Roberts Court has decided five FCA cases in five terms. In addition, for those that applauded the effort of the Writ and the law firm for throwing the kitchen sink at the plaintiff, let us remember a few facts.
It is estimated that the SCOTUS usually hears 40-50 cases per term
Legally, 99% of the time, a Writ like the one filed by Blackstone/Orthofix is denied
Why? Because the SCOTUS adjudicates issues that affect and effect Constitutional Law or disputes between Circuit Courts of Appeals with the intent to create uniformity in the law. So the question is asked, will this establish a new precedent, whereby any company that knowingly and willfully is involved in kickbacks (PODS?) think twice about its business model? Will the BOYZ and Orthofix be ready to ante up more than that $50 million in escrow that has been reserved for this rainy day? Or, will their arrogance and money let them believe that they could crush the whistleblower acting like the two thousand pound gorilla that they like to think they are? The end result is that not even Darth Vader will right the ship. So like TSB likes to say, "it's game time BOYZ." This is an opportunity for the DOJ to set an example once and for all. Stop acting like the paper lion that you are perceived to be by those of us in the industry that attempt to do the right thing. Bitch slap the parties involved with the MAXIMUM, don't negotiate. Let them come to you asking for forgiveness and show them no mercy. Considering that they thumbed their noses at everyone, pay back can be a bitch. So you know what Jackson Browne use to sing;
I'm sitting down by the highway, down by the highway side
Everybody's going somewhere, riding just as fast as they can ride
I guess they have a lot to do, before they can rest assured
Their lives are justified, pray to God for me baby, He can let me slide
Cause I've been up and down this highway, far as my eyes can see
No matter how fast I run, I can never seem to get away from me
No matter where I am, I can't help feeling I'm just a day away from where I want to be
Now I'm running home baby, like a river to the see.
Seems like Blackstone and Orthofix have them Bright Baby Blues. Who knows, maybe OTW will write something in defense of the industry? The bigger question that remains is whether or when will the government proceed with criminal charges?
The issue in Blackstone Medical was whether a device company THAT PAID ILLEGAL KICKBACKS to prescribing physicians (we know who you are) could be liable under the False Claims Act for causing false claims to be submitted to MEDICARE. The basis for the law is that anyone submitting claims for federal monies cannot submit false or fraudulent claims. If so, the Federalis can recover large fines for each submission as well as treble damages. Treble damages is a term that indicates that a Statute permits a court to triple the amount of the actual/compensatory damages (are you listening boys). In addition to the treble damages, the whistleblower shares in the bounty. Blackstone, Orthofix and its cadre of attorneys were hoping to argue that another law for which the filer had certified compliance was being violated.
Considering that this Writ of Cert came in front of the Robert's Court and was denied is BIG. It seems that Blackstone's/Orthofix attorneys were hoping for a "Hail Mary"considering that the Roberts Court has decided five FCA cases in five terms. In addition, for those that applauded the effort of the Writ and the law firm for throwing the kitchen sink at the plaintiff, let us remember a few facts.
It is estimated that the SCOTUS usually hears 40-50 cases per term
Legally, 99% of the time, a Writ like the one filed by Blackstone/Orthofix is denied
Why? Because the SCOTUS adjudicates issues that affect and effect Constitutional Law or disputes between Circuit Courts of Appeals with the intent to create uniformity in the law. So the question is asked, will this establish a new precedent, whereby any company that knowingly and willfully is involved in kickbacks (PODS?) think twice about its business model? Will the BOYZ and Orthofix be ready to ante up more than that $50 million in escrow that has been reserved for this rainy day? Or, will their arrogance and money let them believe that they could crush the whistleblower acting like the two thousand pound gorilla that they like to think they are? The end result is that not even Darth Vader will right the ship. So like TSB likes to say, "it's game time BOYZ." This is an opportunity for the DOJ to set an example once and for all. Stop acting like the paper lion that you are perceived to be by those of us in the industry that attempt to do the right thing. Bitch slap the parties involved with the MAXIMUM, don't negotiate. Let them come to you asking for forgiveness and show them no mercy. Considering that they thumbed their noses at everyone, pay back can be a bitch. So you know what Jackson Browne use to sing;
I'm sitting down by the highway, down by the highway side
Everybody's going somewhere, riding just as fast as they can ride
I guess they have a lot to do, before they can rest assured
Their lives are justified, pray to God for me baby, He can let me slide
Cause I've been up and down this highway, far as my eyes can see
No matter how fast I run, I can never seem to get away from me
No matter where I am, I can't help feeling I'm just a day away from where I want to be
Now I'm running home baby, like a river to the see.
Seems like Blackstone and Orthofix have them Bright Baby Blues. Who knows, maybe OTW will write something in defense of the industry? The bigger question that remains is whether or when will the government proceed with criminal charges?
Thursday, December 1, 2011
The Rainmaker or Is It the Rainman Is Gone
As Yogi Berra use to say, "it ain't over t'ill it's over." Word coming out of Amedica is that the Rainmaker, aka Ben Shappley is no longer the CEO of Amedica. An inside source has informed TSB that Ben Shappley was greeted by two BOD members and the CFO resulting in Custard's Last Stand at Little Big Horn. No scalps were taken, but Ben was last seen being escorted from the building in a heated confrontation. As the company went on to announce Mr. Shappley's termination via a conference call, the company erupted in simultaneous cheers and applause. Free at last, Free at last, thank God Almighty, Free at last.
Could this termination be a by product of Ben's inability to take the company public? Could this termination be the result of an acquisition, US Spine, gone awry? It will be interesting to see who will take the helm of this industry darling. TSB knows that there will be plenty of candidates lining up to take a shot at the title. You know what John Lennon use to say, "instant karma is going to get you, gonna knock you off your feet, better recognize your brother, everyone you meet." TSB wants to know what are readers think?
Could this termination be a by product of Ben's inability to take the company public? Could this termination be the result of an acquisition, US Spine, gone awry? It will be interesting to see who will take the helm of this industry darling. TSB knows that there will be plenty of candidates lining up to take a shot at the title. You know what John Lennon use to say, "instant karma is going to get you, gonna knock you off your feet, better recognize your brother, everyone you meet." TSB wants to know what are readers think?
Monday, November 21, 2011
Nine Months: A Lifetime
High drama? No fellow bloggers, this wasn't Judge Judy's courtroom. Today at around 2:45 p.m. Judge Lagrome D. Davis sentenced Michael Huggins and Tom Higgins to nine months in prison with three months probation and a $100,000 fine for their roles in Synthes illegal promotion and clinical tests by spine surgeons resulting in the deaths of three patients.
Judge Davis said that Michael Huggins showed a "knowing disregard" for the safety of the patients. But one must ask the $21.3 billion dollar question, why didn't prosecutors seek any charges against one Hansjoerg Wyss? Huggins and Higgins must share responsibility for their conduct, yet, how is it that one individual named in the original legal documents as Person #7, not be held responsible for the actions of those that were employed by Sin-thes. A miscarriage of justice? Is this another case where the minions pay the price while the man pulling all the levers rides off into Big Sky country counting his billions.
Obviously there will be no joy in the Huggins or Higgins household this holiday season, but then what about the deceased families? Hopefully Wyss will have done the right thing and paid for everyone's legal fees, a small token for keeping his raggedy Swiss ass out of jail. So fellow bloggers the next time someone asks you to do anything that potentially threatens your freedom, remember that at the end of the day, it's your ass that's on the line. As for the three deceased patients, may you rest in peace, all for the love of the almighty dollar.
Judge Davis said that Michael Huggins showed a "knowing disregard" for the safety of the patients. But one must ask the $21.3 billion dollar question, why didn't prosecutors seek any charges against one Hansjoerg Wyss? Huggins and Higgins must share responsibility for their conduct, yet, how is it that one individual named in the original legal documents as Person #7, not be held responsible for the actions of those that were employed by Sin-thes. A miscarriage of justice? Is this another case where the minions pay the price while the man pulling all the levers rides off into Big Sky country counting his billions.
Obviously there will be no joy in the Huggins or Higgins household this holiday season, but then what about the deceased families? Hopefully Wyss will have done the right thing and paid for everyone's legal fees, a small token for keeping his raggedy Swiss ass out of jail. So fellow bloggers the next time someone asks you to do anything that potentially threatens your freedom, remember that at the end of the day, it's your ass that's on the line. As for the three deceased patients, may you rest in peace, all for the love of the almighty dollar.
Spine Art?
With the recent barrage of comments regarding Spine Art, TSB decided to send some of our investigative reporters into the Street to identify who is this clandestine operation. But before we could do any due diligence on this company, it was important to get security clearances for our roving eyes and ears from the CIA. We started by looking at their website, figuring that a company touting its technology as innovative would be more than happy to let the world see what this innovation is all about. What we have learned is the Spine Art is developing highly classified stealth like technology that fly's under the radar or under the C-arm. Holding a top-secret security clearance, even TSB was not able to accomplish the task at hand. What we have learned is that Spine Art has classified information that pertains to technology that will affect the national security of both Switzerland, the United States, and potentially the rest of the world. Having presence in thirty-four countries, it is obvious that this maybe more of a movement than a company, or could it be both? Actually, our reporters saw them setting up distribution networks in Zucotti Park and Berkeley. One must question motive when there are no products on display, could this be nothing more than a ruse? So we followed the bouncing ball to the K-wireless website and found a product that was an MIS system that can be utilized wireless we think, or with a wire. At one point we were wondering were we involved in a game of Where's Waldo, when in reality we were involved in a game of Where is Yoda?
So TSB must ask our readers is this a legitimate company? Do they actually have revenue? Or is this an organization that is run by a masked man, bunkered down in an Atomic Bomb shelter in the foothills of West Virginia? Could it be that the Lone Ranger rides again, Hi-O Silver!
So TSB must ask our readers is this a legitimate company? Do they actually have revenue? Or is this an organization that is run by a masked man, bunkered down in an Atomic Bomb shelter in the foothills of West Virginia? Could it be that the Lone Ranger rides again, Hi-O Silver!
Monday, November 14, 2011
Supersize? How about Downsize
Stryker is going to focus on quality by laying off ............................1,000 people
Stryker is going to innovate by laying off........................................1,000 people
Stryker is going to control cost by laying off...................................1,000 people
Stryker is going to drive growth by laying off...................................1,000 people
As consolidation becomes the noun du jour, it is interesting to read many of our your reactions especially as companies continue to use the upcoming 2.3% medical device tax as their rationale for laying off more employees, or moving manufacturing overseas. A point in fact is the announcement by the Almighty Stryker that they will "downsize" their workforce by 5% "as part of Stryker's ongoing focus on quality, innovation, and cost, and position the company to provide strong consistent growth in a changing environment."
If you analyze the anatomy of MacMillan's quote, it reflects a perverse corporate mentality that has been prevalent for years, whereas publicly traded companies rationalize their decision to downsize its workforce to preserve growth for its shareholders. Has there ever been a CEO who had the chutzpah to tell its shareholders that they will have to tighten their belts for the sake of innovation? Now that would be out of the box, Stevie. Have you ever heard a CEO at one of these giant companies announce that they were taking a pay cut, or foregoing their stock options or bonus, because their company really isn't providing quality, innovation, or even growing the business at double digits, let alone being profitable after years in the marketplace? Let's be honest many of these companies take advantage of modified accounting rules as much as they attempt to increase revenue by buying marketshare or even occasionally launching a not so innovative, but new product. It never has anything to do with their lack of vision, it always comes down to some external force or the current boogeyman that is causing lack of growth. C'mon Stevie Wonder where is all that innovation coming from at Stryker? If the acquisition of Orthovita is innovation, I guess Stryker is really innovating. Stryker is no different than a company like Covidien, in that it is a "bean counter" driven company. Their foray into the recon medical device market was driven by their acquisition of HA technology, their jump into trauma was a by product of their acquisition of Osteo, and they acquired DIMSO to enter spine. Where is the innovation Stryker? So, here is how Stryker is going to bring quality, innovation and cost to its shareholders, by downsizing the workforce by 5%.
TSB is sure that Stevie Wonder goes to bed at night tossing and turning that he has to let 1,000 people go, but at the end of the day, its all about the shareholder, isn't it? We are sure that when the time comes to hand out those pink slips, he will send them a message on behalf of all of those at Stryker telling them how valuable their contributions have been and that Stryker will be providing outplacement service to help them find employment in an economy that is built around downsizing to begin with, but isn't that the same propaganda that has been Stryker's modus operandi for all these years? TSB could hear Stevie Wonder in the background,
I just called to say I love you, I just called to say how much I care, I just called to say I love you, and I mean it from the bottom of my heart.
TSB is sure that Stevie Wonder goes to bed at night tossing and turning that he has to let 1,000 people go, but at the end of the day, its all about the shareholder, isn't it? We are sure that when the time comes to hand out those pink slips, he will send them a message on behalf of all of those at Stryker telling them how valuable their contributions have been and that Stryker will be providing outplacement service to help them find employment in an economy that is built around downsizing to begin with, but isn't that the same propaganda that has been Stryker's modus operandi for all these years? TSB could hear Stevie Wonder in the background,
I just called to say I love you, I just called to say how much I care, I just called to say I love you, and I mean it from the bottom of my heart.
Wednesday, November 9, 2011
One Million and Counting
Spine Nation:
Those of us at TSB, would like to thank each and everyone of you for supporting our blog site. As the ticker keeps ticking, TSB has reached a new milestone. The month of November has graced us with our one millionth viewer for 2011. That's right, 1,000,000 and counting, in addition we are averaging over 60,000 unique visitors per month. Last year we had 750,000 readers, meaning that contrary to what visionary industry analysts like Mike Matson, Joanne Wuensch, or Raj Denhoy may profess, and you all know that those boys and girls never pump up the volume, TSB may just be the fastest growing spine platform in the industry, growing with laser like precision, avoiding Japanese companies at all costs, avoiding hiring relatives to write stories on behalf of our personal interests. Yes indeed, we are humbled to provide those of you in the trenches with a forum. Whether you are a sales rep, marketing director, engineer, nurse, hospital administrator, patient, surgeon, owner of a POD, delusional CEO, or had some bad plastic surgery, we love you all. You are what makes us get up in the morning and keep a watchful eye on the industry. We keep many of you entertained, get some of you angry, and keep some of you on your toes. No fellow bloggers, TSB will not be erecting any Golden Arches, there will be no Spine Technology Awards, neither will we be investing in a stem cell company, there will be no analyst luncheons, no Taj Mahals being erected to honor the Spine Gods, we'll just keep on keeping' on. You know what Billy Squier once sang,
You crave attention, you can never say no, Throw your affections any way the wind blows
You always make it, you're on top of the scene, You sell the copy like the cover of a magazine
Puttin' on the eyes, 'til there's nobody else, You never realize what you do to yourself
The things we see make the daily reviews, You never get free, Everybody wants you
So in closing, there's no need to write a review on NASS. Based on your many comments, we still feel that NASS rips off the attendees, charging, say what, how much? Whoa Baby! A G note to walk around in a drug induced stupor? Listen to Karl Rove? Is that where our money goes, shame on you NASS. Boring! It would have been more interesting listening to a crash survivor from the Uruguayan Rugby Team than another political bloviator. As one of our roving reporters stated, the model in the silver outfit with the headlamp was lame, the girl with the low cut top had fame, and walking the McCormick Center caused foot pain. The Baxano and SI-Bone booth had activity, but maybe that was more of a reflection of how boring many companies have become, rather than how innovative some of those technologies really are. It was nice to see David Paul and his sidekick Tatoo walking the floor. TSB wants to know who had the best new technology? Cervical? Lumbar? MIS? Interbody? Pain Management? Biologics? We want to know what our readers think? Did anyone had technology that was ripe for the pickings? You be the judge. Is there one company that really stands out? Who is ripe for an acquisition? Who will be subjected to an inquisition? As another year winds down, it will be interesting to see who is left standing when the dust settles. Once again, TSB wants to thank you for your support, now let's finish the year on a strong note.
Tuesday, November 1, 2011
NASS: A Harbinger of Things to Come
Well Spine Nation, tomorrow marks the beginning of the 26th Annual North American Spine Society meeting in the Second City for exhibitors. Are there any words to express the euphoria you all must be feeling? NASS was kind enough to send TSB an invitation to drop by for some Halloween Candy, and you know what Jack Torrance said in Stanley Kubrick's infamous 1980 psychological thriller, "all work and no play makes Jack a dull boy," so maybe Wendy when least expected We may stop by and tickle your fancy.
This will be an interesting meeting, to say the least. The theme of the meeting should be called "The ShinIng." In all likelihood there will be various national media outlets attending the 2011 lovefest as a result of many stories that have found their way onto front page news for the American public to read. Yes, fellow bloggers, TSB is sure NASS will be monitoring attendance. This will amount to a mere side show in comparison to what will be going on down on the exhibition floor. The recent Medtronic Round 1 TKO over NuVasive will definitely be worth watching, in addition, many will be monitoring how the V Brothers behave in response to being named as a party to the Olympus scandal that is unfolding on a much larger scale. Will they continue to party on, or will they be less flamboyant, even Marshall Mathers from Deutsche Bank says that this deal has nothing on the real Slim Shady,"may I have your attention please."
Lately, it seems that some of the luster has been knocked off the billion dollar baby. At close yesterday, NuVasive was rapidly approaching its 52 week low of 14.81, by closing at 14.82. It will be interesting to attend NuVa's Investor luncheon on the 3rd to hear the company's strategic plan and see whom the loyalista's are that will sit on the surgeon panel. If there is any truth to Key surgeons jumping ship to the competition, could this be a sign of some fatigue beginning to set in at NUVA? For those that have criticized our reporting on NuVasive, could they have ridden XLiF into the ground? Pioneering a surgical approach is formidable, building upon these advancements is where the challenges lie. So,who will bail next? If there is any truth to surgeons jumping ship, could investors be next? If NuVa's public relations firm is ever going to earn its keep, this meeting will be a telltale sign, considering NuVa's market cap has plummeted faster than a speeding bullet. If today's market (14.03) is a barometer of things to come as Keith Jackson use to say, "whoa nelly," As for some of our fellow bloggers whom attack TSB for NuVa bashing, get over it, the company's on the hot seat and in the news, what would you write about, the Spine Technology Awards? Sometimes it's better to be humble and stealth like, rather than roar like an engine on a 757. Panache is a double edge sword.
Another company to keep one's eyes on is Zimmer. Are they poised to do something in spine,or is spine truly the bastard step child? Let's be honest, when Zimmer acquired Spine Tech, they had no clue as to what they were getting into, and neither did their then savior Ray Elliott, the acquisition was well a Clusterf#*k from the get go. Abbott Spine just exacerbated the management deficiencies that exist at this company. Dvorak massages the analysts' by telling them the patients will come back when they are no longer afraid of losing their jobs, and they are investing in their sales infrastructure. So where will the growth come from in a zero-sum market? By raiding other companies distributors? For some the lure of a signing bonus or additional commissions will be attractive, but in reality, aren't you jumping out of the Frying pan and into the fire? And, how long before your hospitals declare you persona non grata? There has to be some innovation, if not, some type of product acquisition to jump start this Edsel.
And what about the North America Spine Society, aren't they coming into this meeting with a battered and bruised reputation based on the recent publicity some of its members have received in the press. How many more front page headlines can you withstand before the organization's governing body has to assess its policies and procedures, again. It really doesn't bode well when class warfare between surgeon and sales people becomes the rule rather than the exception, considering that we are all in this together. Thanks to some well known surgeons that believe that with the advent of Skype sales people will be replaceable, your organization does nothing more than throw gasoline on a burning fire. So fellow bloggers it's another year, and it will be your turn to judge who has the best booth, who is offering the best new technology, and how much traffic you get at your booth will be dictated by how late we all stay out, hopefully we can thank each other for making it thru another year without killing each other. PS, and don't be surprised if one of our TSB models stop by your booth and give you a squeeze.
This will be an interesting meeting, to say the least. The theme of the meeting should be called "The ShinIng." In all likelihood there will be various national media outlets attending the 2011 lovefest as a result of many stories that have found their way onto front page news for the American public to read. Yes, fellow bloggers, TSB is sure NASS will be monitoring attendance. This will amount to a mere side show in comparison to what will be going on down on the exhibition floor. The recent Medtronic Round 1 TKO over NuVasive will definitely be worth watching, in addition, many will be monitoring how the V Brothers behave in response to being named as a party to the Olympus scandal that is unfolding on a much larger scale. Will they continue to party on, or will they be less flamboyant, even Marshall Mathers from Deutsche Bank says that this deal has nothing on the real Slim Shady,"may I have your attention please."
Lately, it seems that some of the luster has been knocked off the billion dollar baby. At close yesterday, NuVasive was rapidly approaching its 52 week low of 14.81, by closing at 14.82. It will be interesting to attend NuVa's Investor luncheon on the 3rd to hear the company's strategic plan and see whom the loyalista's are that will sit on the surgeon panel. If there is any truth to Key surgeons jumping ship to the competition, could this be a sign of some fatigue beginning to set in at NUVA? For those that have criticized our reporting on NuVasive, could they have ridden XLiF into the ground? Pioneering a surgical approach is formidable, building upon these advancements is where the challenges lie. So,who will bail next? If there is any truth to surgeons jumping ship, could investors be next? If NuVa's public relations firm is ever going to earn its keep, this meeting will be a telltale sign, considering NuVa's market cap has plummeted faster than a speeding bullet. If today's market (14.03) is a barometer of things to come as Keith Jackson use to say, "whoa nelly," As for some of our fellow bloggers whom attack TSB for NuVa bashing, get over it, the company's on the hot seat and in the news, what would you write about, the Spine Technology Awards? Sometimes it's better to be humble and stealth like, rather than roar like an engine on a 757. Panache is a double edge sword.
Another company to keep one's eyes on is Zimmer. Are they poised to do something in spine,or is spine truly the bastard step child? Let's be honest, when Zimmer acquired Spine Tech, they had no clue as to what they were getting into, and neither did their then savior Ray Elliott, the acquisition was well a Clusterf#*k from the get go. Abbott Spine just exacerbated the management deficiencies that exist at this company. Dvorak massages the analysts' by telling them the patients will come back when they are no longer afraid of losing their jobs, and they are investing in their sales infrastructure. So where will the growth come from in a zero-sum market? By raiding other companies distributors? For some the lure of a signing bonus or additional commissions will be attractive, but in reality, aren't you jumping out of the Frying pan and into the fire? And, how long before your hospitals declare you persona non grata? There has to be some innovation, if not, some type of product acquisition to jump start this Edsel.
And what about the North America Spine Society, aren't they coming into this meeting with a battered and bruised reputation based on the recent publicity some of its members have received in the press. How many more front page headlines can you withstand before the organization's governing body has to assess its policies and procedures, again. It really doesn't bode well when class warfare between surgeon and sales people becomes the rule rather than the exception, considering that we are all in this together. Thanks to some well known surgeons that believe that with the advent of Skype sales people will be replaceable, your organization does nothing more than throw gasoline on a burning fire. So fellow bloggers it's another year, and it will be your turn to judge who has the best booth, who is offering the best new technology, and how much traffic you get at your booth will be dictated by how late we all stay out, hopefully we can thank each other for making it thru another year without killing each other. PS, and don't be surprised if one of our TSB models stop by your booth and give you a squeeze.
Thursday, October 27, 2011
The Forecast Calls for Pain
Hari Kari is defined as a ritual suicide by disembowelment practiced by the Japanese Samurai. The Samurai is looked upon as a high ranking noble, if ever there were nobles that believe they have entitlement in the upper ranks of society, this may be the story. The October 26th headline news in Reuters presents an intriguing plot for readers as to an acquisition that smells afoul.. The cast for this drama includes Stryker (the seller), Olympus (the buyer), the Viscogliosi Brothers (the original buyers and advisors), a disgraced CEO (Kikukawa), a fired CEO (Woodford) and a Japanese company that may have been sold futures when it came to their acquisition of OP-1 by a business partner/advisor.
But before we go any further, one must ask the question, what is Olympus doing in making investments and acquisitions into ventures that are totally out of the realm of their business model and expertise? Portfolio diversification? Just for historical purposes, many years ago the Almighty Stryker acquired the licensing rights to BMP-7 from a company named Curis Biomolecules for $200 plus million. After years of dumping, that's dumping, not pumping capital into this black hole of a product, the best that they could get was an HDE (human device exemption) and a delicate ass whooping from the DOJ for some company related improprieties, advocating off-label use. So why do you think Stryker was selling you OP-1 for $60 million, regardless that the original price that the VBrothers were offering was $50 million? Could it be that Stryker was looking to get rid of the proverbial Albatross from around their neck, an obvious fitting metaphor, for a product that was sucking capital and placing them under scrutiny with the USDOJ? Could this deal have evolved into an age old act of protective agreements and political marriages in order to accumulate power eventually surpassing tradition, of course that being the traditional way of doing business in the Japanese culture? Were the Japanese involved in this deal following the bushido, the moral principles to live honorably?
The plot thickens when Reuters reports that the deal may have cost Olympus 50% more, thanks to payments made to its advisors, the V Brothers. The V Brothers and Olympus are bound by a confidentiality agreement, therefore, the basis for the story is centered around a $25 million dollar loan that Olympus made to the V Brothers that carries an eight year term, with a 7% interest rate, and would be collateralized by the Viscogliosis' interest in Small Bone Innovations (SBI), and Paradigm Spine (how diluted are those companies). But here is where the deal between both parties gets interesting, the V Brothers utilized the proceeds from the loan to pay back a $30 million debt facility (loan) from Fortress Investment Group of NYC., and under the terms of their agreement Olympus agreed to forgive $2 million of the loan every year, starting in January of 2012 which would leave a balance of $22.8 million and accrued interest if the product received certain approvals by 2015 or 2018. Yet, in August, Olympus Biotech expressed concerns about the value of the collateral (surprise), it has with the V Brothers, and former CEO Michael Woodford who challenged Olympus' acquisitions and was fired in a coup by the BOD, was told that Olympus would need to write off the loan.
Reuters reports that the FBI are investigating the massive advisory fee and Woodruff himself has called upon authorities in Japan and Britain to launch investigations of their own. TSB wants to know what our readers think, is this a House of Cards, or is this a House of Blues? As Robert Cray sang,
Coffee for my breakfast, shot of whiskey on the side
It's a dark and dreary morning, with the clouds covering up the sky
The forecast calls for pain, I can hear approaching thunder
I can feel the chills run up my spine, I've seen love freeze before
And I know I'm on borrowed time, the forecast calls for pain
But before we go any further, one must ask the question, what is Olympus doing in making investments and acquisitions into ventures that are totally out of the realm of their business model and expertise? Portfolio diversification? Just for historical purposes, many years ago the Almighty Stryker acquired the licensing rights to BMP-7 from a company named Curis Biomolecules for $200 plus million. After years of dumping, that's dumping, not pumping capital into this black hole of a product, the best that they could get was an HDE (human device exemption) and a delicate ass whooping from the DOJ for some company related improprieties, advocating off-label use. So why do you think Stryker was selling you OP-1 for $60 million, regardless that the original price that the VBrothers were offering was $50 million? Could it be that Stryker was looking to get rid of the proverbial Albatross from around their neck, an obvious fitting metaphor, for a product that was sucking capital and placing them under scrutiny with the USDOJ? Could this deal have evolved into an age old act of protective agreements and political marriages in order to accumulate power eventually surpassing tradition, of course that being the traditional way of doing business in the Japanese culture? Were the Japanese involved in this deal following the bushido, the moral principles to live honorably?
The plot thickens when Reuters reports that the deal may have cost Olympus 50% more, thanks to payments made to its advisors, the V Brothers. The V Brothers and Olympus are bound by a confidentiality agreement, therefore, the basis for the story is centered around a $25 million dollar loan that Olympus made to the V Brothers that carries an eight year term, with a 7% interest rate, and would be collateralized by the Viscogliosis' interest in Small Bone Innovations (SBI), and Paradigm Spine (how diluted are those companies). But here is where the deal between both parties gets interesting, the V Brothers utilized the proceeds from the loan to pay back a $30 million debt facility (loan) from Fortress Investment Group of NYC., and under the terms of their agreement Olympus agreed to forgive $2 million of the loan every year, starting in January of 2012 which would leave a balance of $22.8 million and accrued interest if the product received certain approvals by 2015 or 2018. Yet, in August, Olympus Biotech expressed concerns about the value of the collateral (surprise), it has with the V Brothers, and former CEO Michael Woodford who challenged Olympus' acquisitions and was fired in a coup by the BOD, was told that Olympus would need to write off the loan.
Reuters reports that the FBI are investigating the massive advisory fee and Woodruff himself has called upon authorities in Japan and Britain to launch investigations of their own. TSB wants to know what our readers think, is this a House of Cards, or is this a House of Blues? As Robert Cray sang,
Coffee for my breakfast, shot of whiskey on the side
It's a dark and dreary morning, with the clouds covering up the sky
The forecast calls for pain, I can hear approaching thunder
I can feel the chills run up my spine, I've seen love freeze before
And I know I'm on borrowed time, the forecast calls for pain
Monday, October 24, 2011
Crossfire
Day by day, night after night
Blinded by the Neon light
Hurry here, hustlin' there
No one's got the time to spare
Money's tight and nothin's free
Won't somebody come and rescue me
I'm stranded, caught in the crossfire
Well fellow bloggers, it seems like the Spinal USA debacle won't come to rest. No it's not Carville and Buchanan, neither is it Begala or Kingsley, some individuals have taken it upon themselves to question the credibility of the Wall Street Journal, calling the article, well...... tabloid sensationalism. A sophomoric attack on the bastion of capitalist publications, you know what Tommy DeVito would say, WTF? Spinal USA's CEO, compares SUSA (no offense Synthes) to K2M and Kyphon. C'mon Jim, you can't be serious? As Clara Peller use to say, "Where's the Beef?" Granted, we all know that K2M and Kyphon had surgeon investors, but those surgeons were, well....actually designers of systems that have either set a precedent for managing VCFx's, paving the way for investment capital into other companies with VCFx technologies, or arguably, the MESA can be called the best deformity system in the industry. What is it that SUSA has in its IP pipeline that will actually make it a legitimate player in the industry? Another pedicle screw? Another cervical plate? Here is your chance to set the record straight. Prior to the this story making headline news, one must ask, where was the transparency? Today, SUSA attempts to perform damage control. After talking to various people in the industry, there were some people that didn't know this company even existed. Hmmmmm? It gets even funnier when a surgeon's wife defends the organization in the WSJ, going to the extent of defending the surgeons decision making without identifying herself as the surgeons wife, deflecting the impetus of the story on some disgruntled rep. As usual, its the reps fault, but isn't this class warfare at its best? Carreyou and McGinty must be shaking in their boots, when their credibility is questioned by the Jimmy Olsen's of the world. But let's be frank with one another, does anyone believe that the WSJ would run a story for the sake of tabloid sensationalism, unlike some other platforms that sensationalize anything and everything in the industry? Somewhere between those words a bigger story prevails as to what's been going on for years in this industry, as some people jump from one venture to another in hopes of hitting a financial windfall without any consideration as to how it effects the industry, the investors, the employees, the patients, and one's own decision making prowess. As for emerging technology or innovation, maybe SUSA will be a new entrant for the Spine Technology Awards to solicit, they could even have a new category called "best me too products." Considering that Pastena brought up K2M, TSB must ask the six million dollar question, is that company on the move?
Over the last few weeks, there has been much activity down in Leesburg,Virginia. Considering that K2M launched two new products at CNS, which were line extensions for their cervical portfolio, the Pyrennes, translational cervical plate and the Chesapeake zero-profile device now provides K2M distributors with a complimentary armamentarium. This past weekend at the Society for Minimally Invasive Spine Surgery in Viva Las Wages, K2M debuted the RAVINE lateral access system along with the ALEUTIAN lateral inter body system. The dual flat blade system should be a less invasive system for splitting the trasnspsoas. Some people will wonder why TSB is writing about K2M? Well....... considering that Spinal USA attempted to compare themselves to a company that continues to increase its product portfolio and market share on a national level attaining critical mass, let's see what new and innovative technology will come out of Jackson, MS? TSB wants to know is Spinal USA a nationally based company, or are they nothing more than a physician owned company? TSB wants to know what the court of public opinion believes?
Blinded by the Neon light
Hurry here, hustlin' there
No one's got the time to spare
Money's tight and nothin's free
Won't somebody come and rescue me
I'm stranded, caught in the crossfire
Well fellow bloggers, it seems like the Spinal USA debacle won't come to rest. No it's not Carville and Buchanan, neither is it Begala or Kingsley, some individuals have taken it upon themselves to question the credibility of the Wall Street Journal, calling the article, well...... tabloid sensationalism. A sophomoric attack on the bastion of capitalist publications, you know what Tommy DeVito would say, WTF? Spinal USA's CEO, compares SUSA (no offense Synthes) to K2M and Kyphon. C'mon Jim, you can't be serious? As Clara Peller use to say, "Where's the Beef?" Granted, we all know that K2M and Kyphon had surgeon investors, but those surgeons were, well....actually designers of systems that have either set a precedent for managing VCFx's, paving the way for investment capital into other companies with VCFx technologies, or arguably, the MESA can be called the best deformity system in the industry. What is it that SUSA has in its IP pipeline that will actually make it a legitimate player in the industry? Another pedicle screw? Another cervical plate? Here is your chance to set the record straight. Prior to the this story making headline news, one must ask, where was the transparency? Today, SUSA attempts to perform damage control. After talking to various people in the industry, there were some people that didn't know this company even existed. Hmmmmm? It gets even funnier when a surgeon's wife defends the organization in the WSJ, going to the extent of defending the surgeons decision making without identifying herself as the surgeons wife, deflecting the impetus of the story on some disgruntled rep. As usual, its the reps fault, but isn't this class warfare at its best? Carreyou and McGinty must be shaking in their boots, when their credibility is questioned by the Jimmy Olsen's of the world. But let's be frank with one another, does anyone believe that the WSJ would run a story for the sake of tabloid sensationalism, unlike some other platforms that sensationalize anything and everything in the industry? Somewhere between those words a bigger story prevails as to what's been going on for years in this industry, as some people jump from one venture to another in hopes of hitting a financial windfall without any consideration as to how it effects the industry, the investors, the employees, the patients, and one's own decision making prowess. As for emerging technology or innovation, maybe SUSA will be a new entrant for the Spine Technology Awards to solicit, they could even have a new category called "best me too products." Considering that Pastena brought up K2M, TSB must ask the six million dollar question, is that company on the move?
Over the last few weeks, there has been much activity down in Leesburg,Virginia. Considering that K2M launched two new products at CNS, which were line extensions for their cervical portfolio, the Pyrennes, translational cervical plate and the Chesapeake zero-profile device now provides K2M distributors with a complimentary armamentarium. This past weekend at the Society for Minimally Invasive Spine Surgery in Viva Las Wages, K2M debuted the RAVINE lateral access system along with the ALEUTIAN lateral inter body system. The dual flat blade system should be a less invasive system for splitting the trasnspsoas. Some people will wonder why TSB is writing about K2M? Well....... considering that Spinal USA attempted to compare themselves to a company that continues to increase its product portfolio and market share on a national level attaining critical mass, let's see what new and innovative technology will come out of Jackson, MS? TSB wants to know is Spinal USA a nationally based company, or are they nothing more than a physician owned company? TSB wants to know what the court of public opinion believes?
Monday, October 17, 2011
The Silly Season
Fellow bloggers, as the last vestiges of summer leave us, and we enter the spine silly season, CNS, NASS and of course the Spine Technology Awards, TSB must ask the $10 billion dollar question, where is the innovation and emerging technologies that we have been waiting for? Our correspondents that attended CNS and roamed the conference room, excuse us they meant, the exhibit hall in Washington, DC, reported that CNS must be concerned with the legitimacy of a meeting whereby attendance may have been at an all time low. With the exception of K2M, which launched some new cervical products, was there anything that truly was a game changer? The perception was that some companies hardly had any traffic. As usual, CNS strategically placed the "big boys" in the center of the exhibit hall where they erected their temples (small one's at least) so neurosurgeons would pay homage to them as they walked to the back to listen to the speakers and papers that were presented.
Interestingly, NuVasive, aka the Billion Dollar Baby, was missing from the festivities. Could they have been licking their wounds, or, was NuVasive one of the smarter companies not wasting their time and money considering that NASS is right around the corner? So what is truly happening in spine? Have we "out innovative" ourselves? The Spine Technology Awards will be a barometer of where the industry is truly headed. Who will present in the various categories for OTW? Will the judges be comprised of the "usual suspects?" Will there be anything different, or, will this be another humdrum performance? Every now and then our readers provide us with their words of wisdom regarding the state of the industry, but how does one keep their motivation and eye on the ball when some of the companies that you work for have done NADA to create that 6 degrees of separation for you to continue to grow your business and meet sales expectations? So here is your opportunity for your voice to be heard. What is it that your company is launching or selling that will provide you with the necessary ammunition to take out the competition? If anyone knows what's going down, it is always those in the infantry, regardless whether the generals admit it. Is spine the last frontier for medical devices, and has time caught up with this well insulated industry. As hospitals continue to drive down pricing, and insurance companies deny procedures, how is this affecting your ability to grow?
It will be interesting regardless whether Obama gets re-elected or not, because as more companies focus their efforts into foreign markets, they are behaving like the rest of America's titans of industry seeking new markets. The backlash from all of this will be more and more foreign made implants glutting the U.S. market, driving down the actual selling price. So TSB wants to know where is the technology and does your company have it?
Interestingly, NuVasive, aka the Billion Dollar Baby, was missing from the festivities. Could they have been licking their wounds, or, was NuVasive one of the smarter companies not wasting their time and money considering that NASS is right around the corner? So what is truly happening in spine? Have we "out innovative" ourselves? The Spine Technology Awards will be a barometer of where the industry is truly headed. Who will present in the various categories for OTW? Will the judges be comprised of the "usual suspects?" Will there be anything different, or, will this be another humdrum performance? Every now and then our readers provide us with their words of wisdom regarding the state of the industry, but how does one keep their motivation and eye on the ball when some of the companies that you work for have done NADA to create that 6 degrees of separation for you to continue to grow your business and meet sales expectations? So here is your opportunity for your voice to be heard. What is it that your company is launching or selling that will provide you with the necessary ammunition to take out the competition? If anyone knows what's going down, it is always those in the infantry, regardless whether the generals admit it. Is spine the last frontier for medical devices, and has time caught up with this well insulated industry. As hospitals continue to drive down pricing, and insurance companies deny procedures, how is this affecting your ability to grow?
It will be interesting regardless whether Obama gets re-elected or not, because as more companies focus their efforts into foreign markets, they are behaving like the rest of America's titans of industry seeking new markets. The backlash from all of this will be more and more foreign made implants glutting the U.S. market, driving down the actual selling price. So TSB wants to know where is the technology and does your company have it?
Thursday, October 13, 2011
Thursday Op-Ed
Today, one of our surgeon readers opined about how this blog has "regressed into a dark place where former allies, reps and surgeons, hide in cloaked veils of anonymity to routinely lash out at one another. Before we elaborate on this post and the state of our industry, one must remember that it is absurd to discuss how one hides behind an anonymous post, when the individual opining is writing anonymously themselves. But let's be honest with one another, whether you like it or not, this blog has never regressed, it has always been a referendum on the state of our industry. As TSB has stated, "for years it was our dirty little secret," and contrary to what anyone thinks, it has taken some courage from some individuals, god bless you whistleblowers because sometimes it takes a woman to show a man that it takes balls to step up and call out the nefarious arrangements and greed that slowly has become the norm rather than the exception. Thank you Blackstone, you set a great example.
Contrary to our commentator's opinion, surgeons and reps have always had a mutual respect for one another, at least our generation did, unfortunately somewhere in the journey, there was a change in personal and industry related dynamics. "If my mentor could do it, why can't I? I'm just as smart, I'm just as talented. If they could start a company why can't I? Some investment bank told me my company or IP is worth gazillions." Could these individuals be part of the entitlement generation, could some people be delusional, maybe some of them are nothing more than dreamers? It is difficult to place one's hand on the pulse of how a once respected industry has become so scrutinized in the public arena (thank you Mr. Carreyou), considering that there are many hard working young sales people and surgeons that do their job in a professional manner respectful of one another everyday. Unfortunately, the current state of the industry may sadly be a reflection of what our society has become, greedy. There's just never enough. Just like Democracy is for sale, spine has taken on the persona of its masters. There is never enough, because what were once vices have now become habits. And contrary to what Gordon Gecko has said, greed is not good when there is no balance in your lives. TSB believes in capitalism, but one must understand life's priorities. Today, company's still have unrealistic expectations when it comes to growth and market penetration. 20% is a thing of the past, of course unless you are dealing in a POD or POC. Zero-sum means zero-sum, unless you have breakthrough or emerging technology, the question becomes where are you getting your growth from? Your competition? It's difficult to understand the present or the future, if you are stuck in the past.
Yes doctor, the industry is truly in a sad state, and you are correct that life can go on without a rep, just like life will go on without your existence, but before you cast light on the reps, one should look at one's own profession and accept the fact that the patient has a malignancy that has never before been seen in this industry. Maybe what some people need is a good old fashion whipple? Chemo will not cure this malaise. So, who's fault is it? Is it the sales rep who earns on average $120-$175K, covers their own expenses, has a mortgage and family to feed, just like you and your peers? Free-markets means free-markets, not a specific set of rules that only benefit me and screw everyone else. Is it the surgeons fault, who has spent countless hours educating and honing their craft with the expectation of being compensated commensurate with their expertise, only to find out that enough is not enough? The reason this insanity exists is because of the lifestyle you choose, the personal decisions you make, and that you believe that you are the straw that stirs the drink. There's only so many LeBron James' or Kobe Bryant's and then the rest of you are bench warmers. But in the end, there's no special dispensation for you just because you are a doctor. When the world suffers, you too suffer. We have become so consumed with money, that it has led people in both our profession and yours to conjure up more schemes and business models in order to make that almighty dollar.
So before you make an off the record statement, Doctor Anonymous, maybe you should look at your peers and wonder what in God's name are they doing? Believe it or not, there are many sales people that are as disgusted as you are about the current state of affairs, the question is who and how are we going to do something about it before we get back to doing the things that made us all proud to be affiliated with this industry. TSB wants to know, what will you do?
Contrary to our commentator's opinion, surgeons and reps have always had a mutual respect for one another, at least our generation did, unfortunately somewhere in the journey, there was a change in personal and industry related dynamics. "If my mentor could do it, why can't I? I'm just as smart, I'm just as talented. If they could start a company why can't I? Some investment bank told me my company or IP is worth gazillions." Could these individuals be part of the entitlement generation, could some people be delusional, maybe some of them are nothing more than dreamers? It is difficult to place one's hand on the pulse of how a once respected industry has become so scrutinized in the public arena (thank you Mr. Carreyou), considering that there are many hard working young sales people and surgeons that do their job in a professional manner respectful of one another everyday. Unfortunately, the current state of the industry may sadly be a reflection of what our society has become, greedy. There's just never enough. Just like Democracy is for sale, spine has taken on the persona of its masters. There is never enough, because what were once vices have now become habits. And contrary to what Gordon Gecko has said, greed is not good when there is no balance in your lives. TSB believes in capitalism, but one must understand life's priorities. Today, company's still have unrealistic expectations when it comes to growth and market penetration. 20% is a thing of the past, of course unless you are dealing in a POD or POC. Zero-sum means zero-sum, unless you have breakthrough or emerging technology, the question becomes where are you getting your growth from? Your competition? It's difficult to understand the present or the future, if you are stuck in the past.
Yes doctor, the industry is truly in a sad state, and you are correct that life can go on without a rep, just like life will go on without your existence, but before you cast light on the reps, one should look at one's own profession and accept the fact that the patient has a malignancy that has never before been seen in this industry. Maybe what some people need is a good old fashion whipple? Chemo will not cure this malaise. So, who's fault is it? Is it the sales rep who earns on average $120-$175K, covers their own expenses, has a mortgage and family to feed, just like you and your peers? Free-markets means free-markets, not a specific set of rules that only benefit me and screw everyone else. Is it the surgeons fault, who has spent countless hours educating and honing their craft with the expectation of being compensated commensurate with their expertise, only to find out that enough is not enough? The reason this insanity exists is because of the lifestyle you choose, the personal decisions you make, and that you believe that you are the straw that stirs the drink. There's only so many LeBron James' or Kobe Bryant's and then the rest of you are bench warmers. But in the end, there's no special dispensation for you just because you are a doctor. When the world suffers, you too suffer. We have become so consumed with money, that it has led people in both our profession and yours to conjure up more schemes and business models in order to make that almighty dollar.
So before you make an off the record statement, Doctor Anonymous, maybe you should look at your peers and wonder what in God's name are they doing? Believe it or not, there are many sales people that are as disgusted as you are about the current state of affairs, the question is who and how are we going to do something about it before we get back to doing the things that made us all proud to be affiliated with this industry. TSB wants to know, what will you do?
Saturday, October 8, 2011
Mississippi Burning
TSB can see the Wall Street Journal's John Carreyou and Tom McGinty playing the investigative role of Rupert Anderson and Alan Ward (played by Gene Hackman and Willem Dafoe) roaming the back roads of Jackson, Mississippi looking for answers to serious questions regarding a virus that has spread to epidemic proportions in the spine industry. Carreyou and McGinty can Duke it out (No pun intended John) at the Journal's office as to who plays the leading role. In the current climate, at times it still feels like 1964, a country divided with anger, finger pointing, and reckless abandon. On October 8, 2011, Messieurs Carreyou and McGinty published an article regarding their ongoing investigation into surgeons taking a double cut by manufacturing and implanting their own devices.
What the industry, our readers, and the general public have found out is that there has always been a fine line between medical ethics, surgical treatment, and financial interests. Shhhhh! Let's fly under the radar, and just maybe, no one will notice us. To use a broad stroke and categorize all spine surgeons as unethical is reckless at best. TSB has always been a surgeon advocate, unlike those outsiders that have ingratiated themselves and continue to suck on the teat of the industry. Our credo has always been that as long as surgeons are truly working on a product development, and not getting paid for redesigning a screwdriver in return for VOLUME, more power to them, and make as much money as you can. If they're willing to pay for your expertise, all we ask is that you be transparent. Yet, one must raise one's eyebrows as you read the WSJ's expose. As Carreyou and McGinty continue to lift the sheets, kick the tires, and look under the rug of our industry, they are learning and educating the American public on just how tainted this industry has become. Three Mile Island didn't radiate with as much toxicity. Surely, there will be an outcry regarding this story. Whatever happened to the Wall Street Journal, that bastion of capitalism? The unfortunate scenario for the surgeon in question, Dr. Lewis, is that this publicity will surely tarnish his reputation in the Jackson community, considering that those of us that have been in this industry for years, know very well that having any past affiliation with Blackstone raises everyone's eyebrows. Can you say, "VOLUME, VOLUME, VOLUME." If the DOJ is out there reading our blog, and we know that you are, many of us in the industry are waiting for you to deliver the blow that shakes up the industry, especially when it comes to Blackstone. If Orthofix was smart, and it is apparent that they aren't, they would put a reasonable proposal on the table and get the DOJ off their back, because the more you piss off the DOJ or the FBI, they will dig in their heels and play hardball, just ask Geoff Yielding. TSB would love to be a fly on the wall during those board meetings, but back to the story at hand.
Spinal USA would be a great case study for the Harvard Business Review, along with some of the other illustrious fly by night distributorships that masquerade as legitimate companies. The financial cost of entry into our industry is low, especially if one reverse engineers other companies products, and finds a manufacturer who is willing to get into cahoots with you. Innovation? Emerging Technologies? Beauty is truly in the eye of the beholder. Yet, the reader must question the credibility and acumen of surgeons that take to their soap box and espouse their business skills, especially after reading this story. In the spring of 2007, the FDA assessed Spinal USA with 14 violations, including failing to maintain master records for its devices, to having no system in place to track and label them. As a spokesperson for Spinal USA stated, ahem, "rapid growth caused Spinal USA to run afoul of the FDA." You must be kidding, right? Talk about on the job training, or is this another example of the Rudy Giuliani defense, "I had no recollection or knowledge as to how that happened." Anyone running an implant company understands FDA policy and procedure, especially if they have been in this business or have ever donned a gown and gloves. TSB hasn't met a single CEO, VP of R&D, Regulatory Director (especially the nervous regulatory guy), or Operations person that welcomes that dreaded phone call from the FDA, informing them that they will be on site on Monday, leaving you 72 hours to dot your "i's" and cross your "t's."
But here's a question for our readers, if Spinal USA was looking to contain cost by eliminating salespeople and marketing cost, why were they recruiting surgeons from other states? Obviously to increase revenue, resulting in more profits. You're not going to tell us that you were doing it for the love of spine surgery. TSB can guarantee that this venture wasn't an exercise in fiscal austerity. And how about expanding into other markets? I guess people in Mississippi must be concerned in sharing the cost savings with those in Alabama. There is a fine line between fact and fiction, contrary to what some attorney will tell you. But then again, isn't it the same people that take an oath to uphold the law, the same people that tell you how you can circumvent the legal system to make a profit? As one surgeon in the article states, "I know some people in the profession don't think its ethical, but I just don't see." Of course you wouldn't see it if you are making money off of it, neither were the people that were doctoring mortgage applications for people that couldn't afford paying for them. Though the OIG has issued regulatory guidance for complying with federal anti-kickback statutes, a thorough investigation into some of these business models could uncover some interesting ways of laundering profits. Oh, and by the way TSB would like to know how many reps are making $26,000 per month, such as the good doctor who filed for personal bankruptcy in this story. By the way, Dr. Famous, how does one file for personal bankruptcy making $26,000 per month on top of what one earns from the practice of medicine?
But here is the bigger question that lies in store for the people that run NASS, AANS and CNS, what's the point of subsidizing your meetings when you can't even keep your own house in order? How many more black eyes does the industry need before someone delivers the knock out punch? If you don't think its going to happen you are in for a surprise. Maybe that's what the doctor ordered, some CEO's, or former CEO's and surgeons serving time being Bubba's Bitch, dropping the soap in some Federal penitentiary. How many times do we have to hear these stories only to be reminded that our industry has run amok? TSB wants to know what our readers think?
But here is the bigger question that lies in store for the people that run NASS, AANS and CNS, what's the point of subsidizing your meetings when you can't even keep your own house in order? How many more black eyes does the industry need before someone delivers the knock out punch? If you don't think its going to happen you are in for a surprise. Maybe that's what the doctor ordered, some CEO's, or former CEO's and surgeons serving time being Bubba's Bitch, dropping the soap in some Federal penitentiary. How many times do we have to hear these stories only to be reminded that our industry has run amok? TSB wants to know what our readers think?
Tuesday, October 4, 2011
Tommy Can You Hear Me? I Can Hear Your Wind Blow
Welcome to the camp, I guess you all know why we're here, my name is Tommy, and I became aware this year, if you want to follow me you've got to play pin ball, so put in your ear plugs, put on your eye shades, you know where to put the caulk. Unfortunately fellow bloggers, the Tommy that TSB is writing about is not the Tommy that we know and love, that deaf dumb and blind kid that sure can play a mean pinball. Kudos go out to one of our commentators that has posted the link to the Becker's Orthopedic and Spine Company article on Ortho Direct USA. If you haven’t read this article or watched the You Tube video with Tommy, you’re missing out on the latest and greatest business model to take the healthcare industry by storm.
“Reducing Selling Cost? Skyrocketing implant costs? Driving down the cost of Marketing? Retool Sales People? Taking Back the Operating Room? Virtuous Cycle? Hospitals having difficulty in negotiating better pricing? More reps equal higher implant prices? Redefine the culture in the operating room? Medicare broke? Hospital having to figure out how to make profits? Take the salesman out of the equation? Helping hospitals take back responsibility for managing their implant business? Hospitals taking ownership, versus being a renter of our services? Changing the dynamics of organizational behavior? Seasoned, experienced and tenured individuals standing next to their ORDT candidates?” How many times have we heard the continuous harangue of these echoes of love directed at sales people in the industry?
Sounds a bit like a Jim Jones and Charlie Manson cocktail, a little social engineering mixed in with a bit of the ole Aztec Two-Step. Tommy, TSB doesn't know if you have been in a hospital lately, or whatever it is that their putting in your tap water, but if you have had the opportunity to visit the OR at your local hospital, there are more barriers and cost controls than ever before. And before you go any further with that wonderful Fort Wayne marketing spiel about outsourcing your own Orthopedic Device Technicians, or that cookie cutter program that you claim that you don't offer, you need to stop urinating on our shoes and telling us its raining. It's been raining so long, that we are being deluged out in the field. Where do you get your data that substantiates irresponsible information that sales reps are making more than surgeons? We haven’t seen any surgeons jumping ship to become salespeople lately, Tommy. The current climate in the industry is pernicious at best, such that hospital administrators and their staffs view sales reps as an adversary rather than an ally. Tommy…..Tommy……Tommy, can you hear me? Tommy, so let us get this straight, the hospital is going to contract you so that you can audit their process by recruiting sales people or distributors to turn over their accounts to be part of your so-called revolution. Black Belts in Six Sigma, why Tommy you may be the next coming of Jack Welch. In addition, if you're talking about driving up the cost of delivering great products at affordable prices, let's begin with Vendomate, Status Blue, and Rep Trax that suck dollars out of companies, distributors, sales people, and other allied healthcare professionals that attempt to do their jobs on a day to day basis? We actually have to pay to play, $100 here, $150 there, $400 here, $39 over there and after a while you have a “purdy” good scam hidden behind the guise that all someone is attempt to do is protect the patient. What all the PT Barnums in the industry are attempting to do is take money out of the pockets of hard working sales people who are obviously driving up the cost of healthcare, right Tommy, it’s those God awful salespeople that have caused healthcare to become 25% of the GDP by 2012.
But Tommy, maybe you are the wake up call that many people in this industry need, and that is that salespeople must understand that they have become the enemy within, that it is always easier to pick on the weakest link in the chain, than it is to go after the Big Boys. So before we end this blog TSB must send one message to his followers and tweeters of spine nation, raise your level of professionalism, learn as much as you can so you are viewed as an asset rather than a liability, increase your clinical knowledge and commitment, and the Tommy's of the world will become extinct rather than you yourselves. TSB wants to know what our readers think?
You feel me coming, a new vibration, from afar you'll see me, Tommy's a sensation.
But Tommy, maybe you are the wake up call that many people in this industry need, and that is that salespeople must understand that they have become the enemy within, that it is always easier to pick on the weakest link in the chain, than it is to go after the Big Boys. So before we end this blog TSB must send one message to his followers and tweeters of spine nation, raise your level of professionalism, learn as much as you can so you are viewed as an asset rather than a liability, increase your clinical knowledge and commitment, and the Tommy's of the world will become extinct rather than you yourselves. TSB wants to know what our readers think?
You feel me coming, a new vibration, from afar you'll see me, Tommy's a sensation.
Thursday, September 29, 2011
Take the Money Out of D.C. and Bring it Back to Main Street
Spine Nation,
The word on the Street is that you as a Nation are feeling the pain of an anemic economy. Based on the your input, it is becoming evidently clear that the future is not quite as sunny as some soothsayers like to predict. Whether you are the Big Kahuna, eating that Big Kahuna Burger, or a little fish, you are being battered by your companies (lack of innovation), the surgeons (not all, but you have key detractors), the hospitals (what ever happened to free markets), its administrators and staff (let's face it they view us as the enemy), the BS companies like Vendor Rape, Status Blow, and Rep Craps, that make you jump through hoops and fire in order to earn a living. As for eating the Big Kahuna Burger, TSB's only caveat is, be wary of what happens to those that opt to eat the BKB, you are susceptible to getting a visit from Vincent Vega and Jules Winnfield. Oh yes, spine nation, we feel your angst, and things are not about to get easier.
As yesterday's news unfolded in the NY Times, that bastion of socialist and radical news reported that health insurance companies are charging "sharply" higher premiums this year, outstripping any growth in your wages and creating more uncertainty, as the government and corporations struggle to drive down the unrelenting increase in the cost to delivering quality, yet affordable care. As the economy struggles, needing a desperate InFuseon of Geritol ( a dietary supplement from yesteryear before HGH become a cocktail of choice), as the real unemployment rate hovers around 15-16%, an increase in insurance premiums is as welcomed as a case of herpes, or a visit by the DOJ to Mississippi (was that Gene Hackman and Willem DaFoe). Interestingly, both political parties are mum when it comes to attacking or criticizing their benefactors, because contrary to what some of readers believe, both Houses of Congress are bought and paid for by Big Insurance. The BS that Aetna, United Healthcare and Oxford espouse is despicable, claiming that their rate increases are simply keeping pace with increases from physicians, hospitals, and pharmacies. What increases? What they fail to tell you is that what is billed and what is reimbursed paint a highly different scenario. Of course, everyone will blame Obamacare, aka Romney Care, (you know the same guy that calls Obama an elitist, while he himself graduated from Harvard Law School), because as TSB has said in the past, Obama is the boogeyman in the room, but those of you that understand how the game is played know that the insurance industry has never decreased your premium regardless of whomever was in office? As my good friend Alex Lukianov would say, nyet, nada, nein.
What is striking about this news, is that many of you have communicated that due to the poor economy, surgeries are down. Now whether this is affecting some locally, or nationally for the long term is still playing itself out. But one thing we do know is that people are putting off surgery and visiting their doctor in order to avoid co-payments and high deductibles, or until they meet their deductibles. The fact remains that the longer one puts off an office visit, or a surgery, the higher the cost in taking care of that patient. Despite a decrease in numbers, insurance companies are defending their record profits, increase in premiums, payouts to shareholders and bonuses paid to these Greedy Bastards (yes Dylan Ratigan you are not alone in your observations). As Benjamin M. Lawsky is quoted as saying, "these increases are often hitting people who just can't afford it. But, on the other hand, we have to ensure in keeping these insurance companies healthy." How much healthy can they get? Spoken like the Superintendent whom oversees NY State's Insurance Department, and probably was once associated in some form or fashion with a Big Insurance company.
Let's face it, this is a game, whereby the only people that are benefitting from the rules are the people making the rules, or find new and creative ways to circumvent the rules. So this is your opportunity to stand up and be heard, its time to take all the money out of politics, whether you believe it or not, special interest are killing each and everyone of you, its killing your ability to earn an honest living, its BRUTALLY divided a country that calls itself the "United" States. We are no longer tolerant of one another, nor our we a compassionate society, especially when it comes to our own citizens. We have been deluged with more scams, and business models that do nothing more than tear down the moral fiber of a society and industry that once was respected. Just because Wall Street does it, doesn't mean its legal, nor is it right. The irony is that for all the people that espouse free-market principles, the only free markets that exist are the ones that specific people benefit from individually. Take the example of the commentary on our previous post that dresses down sales people, calling you spoiled, overpaid, and sucking ass, TSB would bet that was a surgeon. Here's a typical scenario, whereby someone is critiquing what market forces allow you to earn. But what is Dr. Famous' position when his earning power is threatened? How does he know whether or not his earning has been over inflated, and what outcry do we hear every time the topic of decreasing Medicare reimbursements are tabled, or Big Insurance does not increase their reimbursements? Rather than coalescing and attempting to stand up and fight, but then again, it is always easier picking on, and beating up the weakest link in any chain of events. So when you get an opportunity our good friends Dylan Ratigan and Jimmy Williams are proposing legislation to get all the money out of politics, here's your chance. TSB wants to know what you think?
The word on the Street is that you as a Nation are feeling the pain of an anemic economy. Based on the your input, it is becoming evidently clear that the future is not quite as sunny as some soothsayers like to predict. Whether you are the Big Kahuna, eating that Big Kahuna Burger, or a little fish, you are being battered by your companies (lack of innovation), the surgeons (not all, but you have key detractors), the hospitals (what ever happened to free markets), its administrators and staff (let's face it they view us as the enemy), the BS companies like Vendor Rape, Status Blow, and Rep Craps, that make you jump through hoops and fire in order to earn a living. As for eating the Big Kahuna Burger, TSB's only caveat is, be wary of what happens to those that opt to eat the BKB, you are susceptible to getting a visit from Vincent Vega and Jules Winnfield. Oh yes, spine nation, we feel your angst, and things are not about to get easier.
As yesterday's news unfolded in the NY Times, that bastion of socialist and radical news reported that health insurance companies are charging "sharply" higher premiums this year, outstripping any growth in your wages and creating more uncertainty, as the government and corporations struggle to drive down the unrelenting increase in the cost to delivering quality, yet affordable care. As the economy struggles, needing a desperate InFuseon of Geritol ( a dietary supplement from yesteryear before HGH become a cocktail of choice), as the real unemployment rate hovers around 15-16%, an increase in insurance premiums is as welcomed as a case of herpes, or a visit by the DOJ to Mississippi (was that Gene Hackman and Willem DaFoe). Interestingly, both political parties are mum when it comes to attacking or criticizing their benefactors, because contrary to what some of readers believe, both Houses of Congress are bought and paid for by Big Insurance. The BS that Aetna, United Healthcare and Oxford espouse is despicable, claiming that their rate increases are simply keeping pace with increases from physicians, hospitals, and pharmacies. What increases? What they fail to tell you is that what is billed and what is reimbursed paint a highly different scenario. Of course, everyone will blame Obamacare, aka Romney Care, (you know the same guy that calls Obama an elitist, while he himself graduated from Harvard Law School), because as TSB has said in the past, Obama is the boogeyman in the room, but those of you that understand how the game is played know that the insurance industry has never decreased your premium regardless of whomever was in office? As my good friend Alex Lukianov would say, nyet, nada, nein.
What is striking about this news, is that many of you have communicated that due to the poor economy, surgeries are down. Now whether this is affecting some locally, or nationally for the long term is still playing itself out. But one thing we do know is that people are putting off surgery and visiting their doctor in order to avoid co-payments and high deductibles, or until they meet their deductibles. The fact remains that the longer one puts off an office visit, or a surgery, the higher the cost in taking care of that patient. Despite a decrease in numbers, insurance companies are defending their record profits, increase in premiums, payouts to shareholders and bonuses paid to these Greedy Bastards (yes Dylan Ratigan you are not alone in your observations). As Benjamin M. Lawsky is quoted as saying, "these increases are often hitting people who just can't afford it. But, on the other hand, we have to ensure in keeping these insurance companies healthy." How much healthy can they get? Spoken like the Superintendent whom oversees NY State's Insurance Department, and probably was once associated in some form or fashion with a Big Insurance company.
Let's face it, this is a game, whereby the only people that are benefitting from the rules are the people making the rules, or find new and creative ways to circumvent the rules. So this is your opportunity to stand up and be heard, its time to take all the money out of politics, whether you believe it or not, special interest are killing each and everyone of you, its killing your ability to earn an honest living, its BRUTALLY divided a country that calls itself the "United" States. We are no longer tolerant of one another, nor our we a compassionate society, especially when it comes to our own citizens. We have been deluged with more scams, and business models that do nothing more than tear down the moral fiber of a society and industry that once was respected. Just because Wall Street does it, doesn't mean its legal, nor is it right. The irony is that for all the people that espouse free-market principles, the only free markets that exist are the ones that specific people benefit from individually. Take the example of the commentary on our previous post that dresses down sales people, calling you spoiled, overpaid, and sucking ass, TSB would bet that was a surgeon. Here's a typical scenario, whereby someone is critiquing what market forces allow you to earn. But what is Dr. Famous' position when his earning power is threatened? How does he know whether or not his earning has been over inflated, and what outcry do we hear every time the topic of decreasing Medicare reimbursements are tabled, or Big Insurance does not increase their reimbursements? Rather than coalescing and attempting to stand up and fight, but then again, it is always easier picking on, and beating up the weakest link in any chain of events. So when you get an opportunity our good friends Dylan Ratigan and Jimmy Williams are proposing legislation to get all the money out of politics, here's your chance. TSB wants to know what you think?
Thursday, September 22, 2011
1865
Fellow bloggers, the last forty-eight hours have been interesting to say the least. The title of our post "1865" signifies the one day damage that Nuvasive has incurred by dropping 12% in share price upon the market's and investors reactions to losing the verdict to Big Blue for infringing upon patents that are "owned" by Medtronic. 1865 is not about the year Abraham Lincoln was assassinated, nor about the year that we as a nation abolished and prohibited slavery. Depending upon the next phase of litigation, it might be a price, that one day, investors yearn for. For those executives or other platforms that deny this blogs credibility, this is the year of living dangerously. Thank you. The reaction from those in the industry, including Alex Lukianov and his minions of analysts' was predictable. Would any of our bloggers expect otherwise? Your vigorous comments say it all. Even Dr. Gary Michelson, a blast from both the plaintiff's and defendant's past, was thrust into this melee, and was quoted as saying, "people have to be respectful of intellectual property." And if there is one individual that knows about burning the midnight oil with his cadre of IP lawyers, it is Dr. Michelson. Whether one agrees with his past, one must be respectful of his legacy.
What does this say about Nuvasive, a company that has built its reputation and mystique on the XLiF and neuro-monitoring? What does it say about Alex? Has he lost his panache? Highly unlikely. What does it say about investors? Are they gullible, believing the "hype" that analysts' profess about their favorite spine stock du jour? Where is that guy that predicted on September 2, 2011 that the stock will go up 40% over the next weeks and months? And what does it say about the analysts'? "Painful, but manageable, bloodied, but still standing." Is that all there is? How does a company predict on becoming a billion dollar baby, when they are spending tens of millions on legal fees battling an assault on their very existence? If anything this litigation is far from over, and unfortunately for Nuvasive, it is going to take a little longer than predicted on becoming that Billion Dollar Baby. This verdict was more than a bump in the road, it is a set back. Alex will tell you otherwise because his job is to be the spinemeister and he can play with house money. The verdict will be appealed with vigor, while Nuvasive anxiously awaits Medtronic's next move. TSB knows that some will respond that this is the cost of doing business in a highly competitive environment. But, does this bode well for NuVa?
A company of Nuvasive's size can be sold. But now, any buyer will have reservation until this litigation plays out. The fact is that until this litigation is resolved, why would anyone risk buying a portfolio that potentially will have royalties tied to Medtronic? Realistically, at this phase of litigation, it looks like Medtronic is in the drivers seat, at least for the time being. How long will the shareholders and investors continue to provide a vote of confidence for the leadership team at this company? These are legitimate questions. In retrospect, many have raised questions regarding Nuvasive's quest, back in June 2011, to raise $325 million through the issuance of Senior Convertible Notes. Yes fellow bloggers there is much to speculate about, but the reality is that the sun will rise and set today, and NUVA will not shut its doors, let's be realistic. But what this verdict does is create a dynamic to how this company will proceed, and whether the leadership team here has the longevity to sustain multiple blows as Phase 2 and 3 develop in MDT's quest to utilize the patent laws to its advantage. Regardless of your love or disdain for the Big Blue, let's be honest, if you were in their place what would you do? In closing, Nuvasive is lucky that there wasn't an injunction placed on the sale of the products in question. This brings back memories of the old days when a company named U.S. Surgical laid down the gauntlet and challenged J&J/Ethicon's market presence, only to be repelled like a fly on someone's ass. Sometimes, history has a way of repeating itself. So what's Alex's exit strategy if all else fails? You know, TSB once had the pleasure of meeting Lauren Hutton, and her motto was, "don't ever let them see you sweat." Good Luck and Good Night.
Tuesday, September 20, 2011
Copy! Copy! Copy!
It's Game 7 of the Championship Series and NuVasive has the home court advantage, the anticipation is that this should be a blow out, considering that their opponent Medtronic hasn't won a game in many years. Medtronic has taken their blows. Some industry insiders began to wonder would they ever rebound, could they make the right pass, was their offense turning into an impenetrable defense. After the Michelson debacle, it seemed that Big Blue has been staggering. Even with a home crowd and the potential of some home calls, it was announced today that the NuVasive has taken it on the chin. No fellow bloggers it wasn't a Floyd Mayweather sucker punch. NuVa saw it coming.
It was announced earlier in the day, that a San Diego Jury with "laser like focus" awarded Medtronic $ 101.2 million in damages related to patent infringements by Nuvasive. Of course other publications in the industry will come to NuVa's defense claiming a wash since the jury also found that Big Blue owes NuVasive $660 thousand for infringing upon one of NuVa's patents. NuVa will now have to regroup and consider its legal option as to how to proceed with the verdict. To quote NuVa's attorney, "Nuvasive copied nothing!" A San Diego jury thought otherwise.
But some questions must be asked. How do investors continue to pour money into a company that has already lost a $60 plus million dollar trademark suit? And now, $101.2 million? It will be interesting to hear the "spin" on how "laser like" the Purple People Eaters will become as they continue their quest and journey to be a $1 Billion Dollar Company. There's no joy in Rancho Santa Fe tonight, nor do we think that anyone is drinking any Petrus. It will be interesting to see how OTW reacts and spins this verdict, considering that our boy, the oracle of the industry, loves the Big Bear. TSB wants to know how much will the markets react tomorrow to this decision?
It was announced earlier in the day, that a San Diego Jury with "laser like focus" awarded Medtronic $ 101.2 million in damages related to patent infringements by Nuvasive. Of course other publications in the industry will come to NuVa's defense claiming a wash since the jury also found that Big Blue owes NuVasive $660 thousand for infringing upon one of NuVa's patents. NuVa will now have to regroup and consider its legal option as to how to proceed with the verdict. To quote NuVa's attorney, "Nuvasive copied nothing!" A San Diego jury thought otherwise.
But some questions must be asked. How do investors continue to pour money into a company that has already lost a $60 plus million dollar trademark suit? And now, $101.2 million? It will be interesting to hear the "spin" on how "laser like" the Purple People Eaters will become as they continue their quest and journey to be a $1 Billion Dollar Company. There's no joy in Rancho Santa Fe tonight, nor do we think that anyone is drinking any Petrus. It will be interesting to see how OTW reacts and spins this verdict, considering that our boy, the oracle of the industry, loves the Big Bear. TSB wants to know how much will the markets react tomorrow to this decision?
Caveat Emptor
Greetings fellow bloggers. Based on your response to our last post regarding the Scripps decision to ban PODS from their hospital system, many questions have been raised regarding the OIG's response to U.S. Senators Grassley, Hatch, and Kohl's Senate Investigation. At best, the response still has those involved looking over their shoulder, as the OIG's intent is to methodically answer many questions that need clarification.
What we have learned is that the OIG has major concerns regarding the proliferation of PODS and whether the mere existence of these entities has or will have an adverse effect on Medicare and other Federal programs. Obviously, those that have leveraged their earnings and futures on the legitimacy of PODS, are keeping a watchful eye on the OIG along with the ongoing investigation by the Wall Street Journal into Mississippi and Alabama. Some readers accuse TSB bashing PODS. Contrary to some beliefs, our position has been that until there is legislation that clearly defines this business model, PODS will run rampant without any boundaries. Whether they are ethical is another issue.
Due to the lack of legal guidance, the OIG challenge will be to identify if the behavior, structure, and practices that PODS present violate any Federal Anti-Kickback Statutes? TSB's observation is that if they look deep enough, they will probably unearth more schemes than one can imagine. As PODS continue to to increase, the OIG's position is that guidance, legislation, and enforcement will be required. As the government continues it's investigation, their intent is to identify the financial arrangements that have been initiated between physicians and third parties acting as an intermediary between the POD and the hospital, the transparency between these parties and the hospitals, and the services that PODS offer in addition to the type of cost saving that these entities provide.
A major focus will be on how many of these PODS are operating on Medicare patients, and is the impetus for these business model merely for profit, by driving up revisions and increasing surgical procedures. One could not expect anything less than a backlash from those that have leveraged their current and future earnings on PODS, but if recent history has taught us anything, it is that as long as it is legal, everything goes, regardless whether it threatens the mere existence and livelihood of thousands of industry professionals. An observer of PODS has even raised the potential of these PODS backfiring on the same individuals that are brokering these deals. In the long run, if some of these POD surgeons have such disdain for sales reps, accusing them of driving up the cost of delivering quality healthcare, who is to say that with one fell swoop they could eliminate their brokers, whom they view as less than partners, but more like necessary evils?
What TSB has heard is that PODS are running rampant in the deep south and California, threatening the mere existence of a free markets. So the question must be asked, how is it that some of our readers cry out for free markets, only to game the system? Isn't there a conflict of interest when profits are driven by self-referral? And whom are some of the companies have gone from pretenders to contenders? What will be interesting to watch will be how hospitals, its administrators, and its compliance officers respond? TSB wants to know what you think?
Thursday, September 15, 2011
Ride The Lightening
As Metallica rings in the background, one must ask the question, for whom does the bell toll? Screw one of our readers who constantly bitches and complains about the use of lyrics and metaphors on our blog. As James Hetfield of Metallica belts out;
For a hill men would kill, why? They do not know, stiffened wounds test their pride
Men of five still alive through the raging glow gone insane from the pain that they surely know
For whom the bell tolls, marches on....................
Well fellow bloggers, could this be the beginning of the end for POD's? As Hemingway wrote in his masterpiece "For Whom the Bell Tolls, the Scripps and Sharp's Hospital Systems have ordered the demolition of a bridge that links POD guerillas to the our own very existence? Contrary to some madman's insinuations, TSB's sense of duty clashes with those whom call out their free market principles only to contradict themselves when it comes to their own survival.
Today, it was announced at the Sharp's Hospital Systems that no longer, yes fellow bloggers, no longer will Sharp's allow anyone involved in a POD to do business with their hospitals. Just like Scripps the gauntlet has been laid down. In addition to laying out this mandate, the word on the Street is that Phygen is Persona Non Grata.
As for the Scripps and Sharps Hospital mandate, you know what Jim Morrision once said, "This is the End my Friend, Beautiful Friend."
For a hill men would kill, why? They do not know, stiffened wounds test their pride
Men of five still alive through the raging glow gone insane from the pain that they surely know
For whom the bell tolls, marches on....................
Well fellow bloggers, could this be the beginning of the end for POD's? As Hemingway wrote in his masterpiece "For Whom the Bell Tolls, the Scripps and Sharp's Hospital Systems have ordered the demolition of a bridge that links POD guerillas to the our own very existence? Contrary to some madman's insinuations, TSB's sense of duty clashes with those whom call out their free market principles only to contradict themselves when it comes to their own survival.
Today, it was announced at the Sharp's Hospital Systems that no longer, yes fellow bloggers, no longer will Sharp's allow anyone involved in a POD to do business with their hospitals. Just like Scripps the gauntlet has been laid down. In addition to laying out this mandate, the word on the Street is that Phygen is Persona Non Grata.
As for the Scripps and Sharps Hospital mandate, you know what Jim Morrision once said, "This is the End my Friend, Beautiful Friend."
Sunday, September 11, 2011
Double Indemnity
"We're both rotten!"
"Yeah, only you're a little more rotten!"
Fellow bloggers, Barbara Stanwyck's and Fred MacMurray's dialogue in the American film noir co-written by Billy Wilder and Raymond Chandler can be an appropriate description of the spine world that we live in. Life can imitate art. Potentially our moment will play itself out beginning in November of 2011. If life does imitate art, then Senator Chuck Grassley (R-IA) and Herbert Kohl (D-WI) will play the dual role of Barton Keys (Edward G. Robinson), whose job it was to find phony claims in the movie Double Indemnity.
November 2011 and the subsequent date of March 31, 2013 will usher in a new era of compliance. The Secretary of Health and Human Services shall establish policies and procedures to ensure compliance with the requirements authored into provisions within the Sunshine Act, aka the Patient Protection and Affordable Care Act of 2009, passed by the Senate on December 24, 2009, and the House on March 21, 2010. On November 1, 2011 the Secretary will begin conducting audits to determine that hospitals are also under compliance. No longer will some of our highly esteemed hospital administrators be able to look the other way when it comes to questioning some of the current concepts in spine. Hospital compliance officers will actually have to start being accountable.
If there ever was a time to accelerate the arrival of March 31, 2013, the time is now. TSB can hear the outcry, especially, from our celebrated commentator whose constant derision of our blog includes labeling us a socialist and liberal forum. Our only response is that some people wouldn't know the boogeyman if he jumped out and bit one in the derriere. If your personal freedom's are so threatened, please do not read our blog, your utter non-sense will not be missed, but then we do believe in free speech, therefore, rant on. Whether one agrees with our opinions, the reality is that once again our society needs to find balance in the individual roles we play in our lives, in our financial expectations, and the fact that maybe the illusion that we have created can no longer be translated into reality. Dr. Leary, where are you when you are needed? Change will be good, and everyone will learn how to adapt or perish. The recent outcry for less government is theater at its best. TSB can hear all those phony teabaggers, only to be contradicted by the recent events of Hurricane Irene whom invited herself into many of your lives and showered you with the wrath of Mother Nature. And you know what Michelle Bachmann says, "it's not nice to full Mother Nature." Ironically, the cry from Democratic and Republican bureaucrats on the state level in the East has been for more federal intervention, blaming the federal government for the mismanagement of their finances, and lack of action when it came to addressing the damns, rivers and streams that were never fortified in the event of a major disaster. Whatever happened to personal accountability and less government? But this isn't what this post is about.
On March 31st, 2013 and the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient shall submit the following to the Secretary,
Name of that individual
Business Address
Amount of Payment
Date of Payment
Description of Payment
Cash or Cash Equivalent
In Kind Items or Services
Stock or Stock Options
Any Other Form of Payment or Transfer (POD)
Description
Consulting Fees
Compensation for Services other than Consulting (POD)
Honoraria
Gifts
Entertainment
Food/Travel
Education
Research
Charitable Contributions
Royalty or Licensing Fee
Current or Prospective Ownership or Investment Interest (POD)
Direct Compensation for Serving as Faculty or Speaker for Medical Education
Grants
Any Other Nature of Payment or Other Transfer of Value,
These are just a few of the guidelines that will be enforced. Hopefully the DOJ will look at every company excluding no one, especially some of the smaller companies that attempt to fly under the radar. There are plenty of lawyers, surgeons and distributors burning the midnight oil in anticipation of how to circumvent the law. Whether the law will reign in the terror that we have inflicted upon ourselves will be determined by time. Will this legislation dampen the endless schemes that are hatched by individuals in our industry whom condemn the law, yet rely on the law to find new and creative ways to circumvent the very laws that they decry? Will we see a return to innovation? Will we see the demise of POD's, and phony consulting agreements? Regardless of your role in the industry, the stench that many of you smell is the infestation of corporate dollars in buying business rather then developing newer and innovative modalities of treatment. By leveling the playing field, we can separate the contenders from the pretenders, and stop the insanity that many of us are consumed with on a day to day basis. Who knows? So in closing TSB wants to know, is the Moon in the seventh house and will Jupiter align itself within Mars, is this the dawning of the Age of Aquarius?
Let the sunshine, let the sunshine in, the Sunshine in...........................................................
"Yeah, only you're a little more rotten!"
Fellow bloggers, Barbara Stanwyck's and Fred MacMurray's dialogue in the American film noir co-written by Billy Wilder and Raymond Chandler can be an appropriate description of the spine world that we live in. Life can imitate art. Potentially our moment will play itself out beginning in November of 2011. If life does imitate art, then Senator Chuck Grassley (R-IA) and Herbert Kohl (D-WI) will play the dual role of Barton Keys (Edward G. Robinson), whose job it was to find phony claims in the movie Double Indemnity.
November 2011 and the subsequent date of March 31, 2013 will usher in a new era of compliance. The Secretary of Health and Human Services shall establish policies and procedures to ensure compliance with the requirements authored into provisions within the Sunshine Act, aka the Patient Protection and Affordable Care Act of 2009, passed by the Senate on December 24, 2009, and the House on March 21, 2010. On November 1, 2011 the Secretary will begin conducting audits to determine that hospitals are also under compliance. No longer will some of our highly esteemed hospital administrators be able to look the other way when it comes to questioning some of the current concepts in spine. Hospital compliance officers will actually have to start being accountable.
If there ever was a time to accelerate the arrival of March 31, 2013, the time is now. TSB can hear the outcry, especially, from our celebrated commentator whose constant derision of our blog includes labeling us a socialist and liberal forum. Our only response is that some people wouldn't know the boogeyman if he jumped out and bit one in the derriere. If your personal freedom's are so threatened, please do not read our blog, your utter non-sense will not be missed, but then we do believe in free speech, therefore, rant on. Whether one agrees with our opinions, the reality is that once again our society needs to find balance in the individual roles we play in our lives, in our financial expectations, and the fact that maybe the illusion that we have created can no longer be translated into reality. Dr. Leary, where are you when you are needed? Change will be good, and everyone will learn how to adapt or perish. The recent outcry for less government is theater at its best. TSB can hear all those phony teabaggers, only to be contradicted by the recent events of Hurricane Irene whom invited herself into many of your lives and showered you with the wrath of Mother Nature. And you know what Michelle Bachmann says, "it's not nice to full Mother Nature." Ironically, the cry from Democratic and Republican bureaucrats on the state level in the East has been for more federal intervention, blaming the federal government for the mismanagement of their finances, and lack of action when it came to addressing the damns, rivers and streams that were never fortified in the event of a major disaster. Whatever happened to personal accountability and less government? But this isn't what this post is about.
On March 31st, 2013 and the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient shall submit the following to the Secretary,
Name of that individual
Business Address
Amount of Payment
Date of Payment
Description of Payment
Cash or Cash Equivalent
In Kind Items or Services
Stock or Stock Options
Any Other Form of Payment or Transfer (POD)
Description
Consulting Fees
Compensation for Services other than Consulting (POD)
Honoraria
Gifts
Entertainment
Food/Travel
Education
Research
Charitable Contributions
Royalty or Licensing Fee
Current or Prospective Ownership or Investment Interest (POD)
Direct Compensation for Serving as Faculty or Speaker for Medical Education
Grants
Any Other Nature of Payment or Other Transfer of Value,
These are just a few of the guidelines that will be enforced. Hopefully the DOJ will look at every company excluding no one, especially some of the smaller companies that attempt to fly under the radar. There are plenty of lawyers, surgeons and distributors burning the midnight oil in anticipation of how to circumvent the law. Whether the law will reign in the terror that we have inflicted upon ourselves will be determined by time. Will this legislation dampen the endless schemes that are hatched by individuals in our industry whom condemn the law, yet rely on the law to find new and creative ways to circumvent the very laws that they decry? Will we see a return to innovation? Will we see the demise of POD's, and phony consulting agreements? Regardless of your role in the industry, the stench that many of you smell is the infestation of corporate dollars in buying business rather then developing newer and innovative modalities of treatment. By leveling the playing field, we can separate the contenders from the pretenders, and stop the insanity that many of us are consumed with on a day to day basis. Who knows? So in closing TSB wants to know, is the Moon in the seventh house and will Jupiter align itself within Mars, is this the dawning of the Age of Aquarius?
Let the sunshine, let the sunshine in, the Sunshine in...........................................................
Tuesday, September 6, 2011
Ali v. Wepner, Bring Back the Old Days
This isn't the Fight of the Century, neither would one consider it the Rumble in the Jungle, one wouldn't even classify it as the Thrilla in Manilla. This lawsuit is a heavyweight going after a middle weight in a sanctioned bout reserved for a San Diego federal jury. The heavyweight is Medtronic and the middle weight is NuVasive . Could this be a Muhammed Ali/Chuck Wepner bout? The Bear is originally from NJ even though TSB highly doubts that he had Bayonne roots.
Warsaw Orthopedics, Inc., a unit of Medtronic has accused LaJolla based NuVasive of infringing three patents for implants that are capable of being inserted translaterally, a plate and screw system that can be used to stabilize vertebrae, I believe the attorneys meant "fuse" in the cervical spine, and a tissue retractor. Medtronic's attorney orated in his opening statement to the jury, that Medtronic's damages are substantial and that a financial expert will present one option for calculating lost profits at $200 million (ouch), and another that is estimated much higher. NuVasive on the other hand, contends that Medtronic infringed on its patent for a nerve monitoring system for lateral surgery. NuVa's attorney is quite eloquent in his defense of NuVa when he told the jury, "Nuvasive didn't copy nothin'."
It will be interesting to see how this bout develops, could a local jury affect the final outcome with some home cooking? Boxing fans know that scoring points is quite subjective with jabs and body shots, unless one delivers a knockout punch, or a lethal kidney punch. But what happens to NuVa if they lose this fight? And, how many more fights can they lose before the can't get off the mat? TSB wants to know whether our readers are rooting for the boys in the Blue Trunks, or the Purple Tights? TSB is taking even odds that the judges will score a homegrown decision, gotta love our industry, Rome burns while the attorneys make all the money. No wonder we can't get anything done. You know what they say, "sooner or later love is gonna getcha, TSB wants to know what our readers think?
Warsaw Orthopedics, Inc., a unit of Medtronic has accused LaJolla based NuVasive of infringing three patents for implants that are capable of being inserted translaterally, a plate and screw system that can be used to stabilize vertebrae, I believe the attorneys meant "fuse" in the cervical spine, and a tissue retractor. Medtronic's attorney orated in his opening statement to the jury, that Medtronic's damages are substantial and that a financial expert will present one option for calculating lost profits at $200 million (ouch), and another that is estimated much higher. NuVasive on the other hand, contends that Medtronic infringed on its patent for a nerve monitoring system for lateral surgery. NuVa's attorney is quite eloquent in his defense of NuVa when he told the jury, "Nuvasive didn't copy nothin'."
It will be interesting to see how this bout develops, could a local jury affect the final outcome with some home cooking? Boxing fans know that scoring points is quite subjective with jabs and body shots, unless one delivers a knockout punch, or a lethal kidney punch. But what happens to NuVa if they lose this fight? And, how many more fights can they lose before the can't get off the mat? TSB wants to know whether our readers are rooting for the boys in the Blue Trunks, or the Purple Tights? TSB is taking even odds that the judges will score a homegrown decision, gotta love our industry, Rome burns while the attorneys make all the money. No wonder we can't get anything done. You know what they say, "sooner or later love is gonna getcha, TSB wants to know what our readers think?
Monday, September 5, 2011
Are We Ready to Self-Implode? Yet?
As Mark Twain once said, "the reports of my death have been greatly exaggerated." As an author and humorist who grew up in Hannibal, Missouri, TSB can relate to Twain. As the summer comes to an end, and we enter the autumnal season there's only one question to ask our fellow readers, "are you ready for football?" Contrary to some observations, TSB does have a second, third, fourth, and fifth in line to succeed in the event of an attempt to subvert our organization, and contrary to a few industry platforms that would like to see our demise, the party goes on.
The past week's comments by our readers have exhibited the insanity that has come to rule the Spine World, your lives, and let alone the U.S. healthcare delivery system. In addition to our readers comments, NBC Nightly News reported that the U.S. ranks 41st globally in infant mortality, and that we spend more per capita for healthcare in the US, than any other country in the world. We would like to think that the majority of our readers are rational, we hope, and that this in itself is disconcerting, considering that five years ago we were ranked 29th, based on those facts TSB believes that we are moving in the right direction. NOT. Maybe it is time for a real Spine Summit, and not the BS Spine Technology Summit that has become a self-serving commercial venue for individual special interests, especially the person that runs it. The definition of a Summit is a meeting or conference of heads of state, conducting diplomatic negotiations or an easing of tensions. If there ever was tension in our industry, all one has to do is scroll down and read the comments on our blog site. The only easing of tension at the Spine Summit is the hand massage each one of these individuals give one another. You have a choice, patronize or boycott, and boycott seems to be more apropos.
The past week's comments by our readers have exhibited the insanity that has come to rule the Spine World, your lives, and let alone the U.S. healthcare delivery system. In addition to our readers comments, NBC Nightly News reported that the U.S. ranks 41st globally in infant mortality, and that we spend more per capita for healthcare in the US, than any other country in the world. We would like to think that the majority of our readers are rational, we hope, and that this in itself is disconcerting, considering that five years ago we were ranked 29th, based on those facts TSB believes that we are moving in the right direction. NOT. Maybe it is time for a real Spine Summit, and not the BS Spine Technology Summit that has become a self-serving commercial venue for individual special interests, especially the person that runs it. The definition of a Summit is a meeting or conference of heads of state, conducting diplomatic negotiations or an easing of tensions. If there ever was tension in our industry, all one has to do is scroll down and read the comments on our blog site. The only easing of tension at the Spine Summit is the hand massage each one of these individuals give one another. You have a choice, patronize or boycott, and boycott seems to be more apropos.
How is it that we initiate a blog on a specific company, technology, a rare happening, or an individual observation, and it becomes a cry for help? Don't believe it, just read the comments posted in the DTRAX blog. A.D.D., hopefully not, but then again, maybe so. The hilarious comments about the guy with $2,000 cowboy boots, Versace glasses, and canary sports jacket, we didn't know cowboys wore Versace, made us wonder what would the Duke would think if he was alive? Now there's a new definition for the rhinestone cowboy. If anyone delivered a fitting reality check for the industry, TSB can only thank Mr. August 31, 2:37 p.m.. Yet, contrary to a minority of executives and surgeons opinions, this is our industry and many of you have made it what it is with your passion, commitment, and dedication to a job well done. But getting back to our point, if our illustrious leaders happen to log on to our website, and we know you do, has it dawned upon you that you lack the leadership, the respect, verve and vision that it takes to make a difference. You have become greedy and useless as well, our readers can fill that in. You have become lackeys to your shareholders and the suck on the teat of The Street. Your arrogance belies most of our imaginations. You lack the guts to do the right thing. As one of our eyes and ears on the street reported this week, where are the IDE's, where is the investment capital, what are the CEO's doing to drive progress and innovations? Blame the R&D departments, blame marketing, blame sales. If y'all spent as much time focusing on innovation as you do on suing one another the world may be a better place.
Well the fact is that if there ever was a time to have our so-called spine "heads of state" conduct a meeting and face the music, the time is now. Our industry is a microcosm of a greater disease that afflicts the American Healthcare System. GREED. TSB wants to know are you willing to fight, or are you going to lie down? Stay tuned for our report on the NuVasive and Medtronic as they go toe to toe battling one another in the courts. Now that everyone has had their batteries recharged with a great vacation, it's time to get back to the spine world.
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