Wednesday, June 13, 2012

Where Will the Next New Innovation Come From in Spine

As someone who spends time following the industry from a product and business development perspective, TSB must ask our readers, "where will the next new innovation come from in spine?" If you evaluate the current state of affairs, there are more spine companies than ever before. The market is still dominated by Medtronic (35%), DePuy/Synthes (26%), Stryker (9%), Nuvasive (6%), Globus (3%), and Zimmer (3%), with the rest of the world at 18%. It would be fair to say that outside of the major players there are at least 100 plus companies out there vying for a piece of the proverbial pie, and that pie is shrinking faster than expected. K2M is the only other company that TSB would consider grouping with the Big 5.  The last few years has seen an influx of inter body devices in all shapes and sizes creating a traffic jam of "me too" cage products. The disc space has never been so crowded. It is a wonder that surgeons heads don't spin like Regan MacNeil's in the Exorcist, and then we wonder why it's so difficult to sell anymore. If anyone has a hold on the marketplace it has to be Invibio. That $225,000 three year agreement at $75,000 per annum looks prettier as companies line up to enter this marketplace. Occasionally, the market gets a titan of a product that makes one wonder if some are just grasping at straws, or if some of these companies are developing products for a problem that does not exist?  I mean come on, even Monty Python found the Holy Grail faster than some of these start-ups.  

Just for the sake of argument, let's say that the medical device tax is repealed, regardless whether its effected by a SCOTUS decision to overturn Obamacare, or Congressional legislation repeals the tax, where will the next new technology or innovation come from?  If you speak to surgeons, many believe that the evolution of biologics will eventually lead the market to gene therapy as a modality of treatment to remodel the disc space, but that is still a long way off. If that is a viable observation, what would then happen to all these interbody impersonators? Maybe it's time to start building a Spine Museum, now there's something constructive for NASS to endeavor. What would happen to the artificial disc market, considering there are at least 25-30 companies competing in both the  cervical and lumbar arenas?  Whether there is a change in government administration or not, the days of organic innovation at the Stryker's, Medtronic's, DePuy's, Nuvasive and even Globus' are gone. If some of the start-ups were smart they would strategically align themselves with one of the bigger players with the option for big brother to buy whatever technology or IP's that the little guy has. Of course if you are nothing more than a shell company for a POD, POC or whatever it is that you call yourself, that's okay, because there's a place in this space for everyone. Very few companies will be touting double digit growth in spine over the next few years, until the delivery of healthcare is completely overhauled in this country. As TSB has countlessly stated, we are not going back to the glory days. The U.S. healthcare industry is getting its dose of reality.  Old habits may die hard. Adapt and you will survive, don't, you will perish. Those that grow by double digits will have to pump more capital into consultancies than ever before (Nuvasive and Globus) just to sustain their growth and predictions for the Street.  Just look at what Lanx did with Cappuccino.  Capital investments are at a minimum for the spine world because investors are no longer enamored with spine, especially the hardware end of the business.  There  are plenty of surgeons that have pumped enough of money into some of these companies that at times all they are doing is propping up the inevitable. It reminds one of Greece and Spain. As one investment banker stated, "no one is going to make any long-term commitment in some of these companies, especially if one looks at their strategic plan, lack of leadership and expectations that these entities exhibit." Ever wonder why some companies cannot raise any capital, beside overstaying their welcome with the investment community? Some have even resorted to looking for foreign investment. One American company has even been talking about an infusion of Chinese capital for over a year to no avail.  What does that tell you?  Even if there is a change in the administration,   a mandate for more austerity will  lead to more uncertainty, and uncertainty will lead to things coming to a grind. Or, if there is a change, will the opposition come back into power and then effect the same policies and lack of regulations which will lead to more of the same insanity.  Why would any patient take any time off for surgery if it meant losing one's job? As one patient so poignantly stated, "I'll live with the pain if it means keeping my job." What we fail to understand is that there must be a balance in order for everyone to benefit.  Wealth does not have to be shared on an equal basis, but if you want a prosperous society, everyone must have an opportunity to earn a living commensurate with their abilities. Think about it and don't be reactive. 

The numerous companies that have failed over the last few years have left a bad taste in the mouth of many investors. TSB is sure that there will be some more hearts broken over the next few years.  As consolidation continues, the traditional business model that we have become accustomed to will evolve. Don't believe it?  Just read the recent debate between Dr. Steinmann and Pat Miles from Nuvasive regarding PODS and how they are affecting the way you were use to doing business.  TSB believes that this is the future of spine, let alone the device industry.  Many of our bloggers just don't get . They are perceived as a commodity, as replaceable, and as highly overpaid cover reps in a crowded marketplace. What value do you truly bring to the your job? Why does a surgeon need you in the operating room? I mean they are highly trained individuals, aren't they? You are perceived as one of the many factors that have contributed to the escalating cost of healthcare, yet, since you are low man on the totem pole its easy to point fingers at you first. If you think that its only surgeons like the Dr. Steinmann's that have this opinion of you, you're in for a surprise.  Steinmann does make a great point that his POD saves money, as to making the world a better place, well, let's just say that's debatable.  Patients are sheep, they have no clue what goes on in our industry.  Just the facts, Dr. Steinmann, just the facts. Patients are more concerned about spending their money on BS, rather than taking care of themselves.  Don't believe  it?  Look at America the next time you are at an airport, you are looking at a mirror image of yourselves.  Companies should be concerned that the business model that Steinmann espouses is the future, but then again, rather than stand their ground, companies are at fault for creating the circus atmosphere that exists because profits have always taken precedence over people.  Price pressure?  Who's attempting to fool the public?  We have been under assault from U.S. hospitals for the past five years in spine. Everyone is attempting to squeeze every penny out of the system. Even the Dr. Steinmann's of the world.  And if its not the Dr. Steinmann's it's some BS consulting firm that is extracting every penny that they can from a poorly run hospital system. Everyone is profiting from it.  No one is giving it back, are they?  But then don't we have ourselves to blame?  The level of professionalism in our craft is mediocre at best and it goes up the ladder. We take no pride in ourselves. Many of the start-ups and early growth stage companies cannot even develop a training or education platform for its employees, and TSB means a real one, not some BS rag tag "I don't know what I am doing program." And why wouldn't a Nuvasive, Stryker, DePuy, Globus or K2M not play to this model?  By eliminating the sheep, they will streamline their business model, surely their margins will go down, but then, they will not have as much overhead. They will hire new sheep (the young and poor generation), they won't have to innovate, they won't have to invest that 5% into R&D (that is pretty funny Dr. Steinmann that in itself shows how clueless you are about certain things), they won't have to pay exorbitant consulting fees, and we will have solved all of our healthcare problems.  But then again we don't need innovation because "conventional products are generally our best and safest products, but then again, profitability is a result of innovation."  But then again has current innovation really led to improved outcomes? Maybe twenty years ago, but it can be debated that better carpentry would lead to better outcomes, considering TSB has never met a surgeon who wasn't in a rush to finish their case with the few exceptions.

What it comes down to is that there are no winners and losers because we still haven't come to grips that the system must be overhauled, and until then, there are no solutions.  Steinmann is correct that our healthcare system is twice as expensive as it should be, but then again, who is effecting this?  Is it the sales rep?  Is it the surgeon consultant? Is it the Fee-for-Service System? Is it the CEO who is unaccountable for how he manages the company? Is it the incompetent hospital administrator? Contrary to what some people believe, Dr. Steinmann and TSB agree on one thing, we have commoditized ourselves to the point where its difficult to justify charging $6,000 for a piece of PEEK.  So TSB wants to know "Where Will the Next Innovation Come From in Spine?"

61 comments:

  1. PRODISC & ARTHROPLASTY . . . We need to see more approvals for this great technology

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    1. Oh yes, more ProDisc Metal-on-Metal devices so we can all end up in the looney bin with cobalt, chromium, nickel, titanium poisoning. I just love living with necrotic bone tumors and kidney pain on a daily basis. Chechen out this data about the ProDisc study: http:// www.ProDisc-study.info/ and if you are just another bio- medical greed head sociopath, show this myelogram image to your surgeons in re metal on metal motion preservation that is guaranteed to cause Beyer topic ossification of posterior longitudinal ligament, osteolysis, vasculitis, facet joint degeneration at every level from content motion. Check out these tumors and synovial cysts compressing on the facet joint. Myelogram image taken two years post implant: http://CerviCoreSpine.com. Best viewing is on a high resolution monitor. For more information about the destructive kinematics of Motion Preservation cervical devices go to SpineSupport.org - most neurosurgeons won't touch these devices and all insurance companies will make you fight them for approval, because the insurance companies have no intention of throwing good money down Medtronics motion preservation rat hole.

      Necessity is the Mother of Invention. Biomedical engineers should be focusing on developing a line of custom plates and cages that will support revision surgeries for all the spines that will have to have their metal on metal devise removed and replaced with a fusion - using a plate or cage that does NOT have the metal that the individual is highly allergic too. Plus absolutely no more nickel in spine devices. Perhaps biodegradable plastic plates or cage to stabilize the cervical while the new bone is fusing. Plaster of Paris is another option. Metal motion devices leach metal into spinal cord, and wreck absolute havoc once metal ions start circulating and accumulating in the vital organs.

      A pox on you for touting metal on metal arthoplasty. The trend is dead in the water and if you saw the results I have seen in the corrupted studies ( Stryker's CerviCore & FlexiCore) were never fully approved with an IDE. They had to be registered in the FDA black lock box back in 2007 for all ki nds of non compliance issues - the most criminal one being " Not disclosing and prescreening the research subjects for metal allergies and sensitivities"!

      Nickel sheds toxic metal ions when static and is a nightmare for articulating devices. Stryker knew this, but wanted to show off and state they manufactured a device with a 50 year life cycle. As it turned out, if they don't subside within a month ( which ironically will save your life, because you will have to have it removed), it will cause every kind of spinal adverse event known to man, in spades. The fusion is the gold standard - no point in redesigning the wheel. What is important is to now custom design non metal spinal support plates and cages for all of the upcoming revisions when these MoM devices fail and need to be removed to save the patient's life.

      Do a google search on these devices - everything about them came to a screeching halt in 2010 when the Neuro surgeons did a comparative study and found thst they are nothing more than an over priced piece of crap, requiring 2 or 3 surgeries post implant to restore the spine lordosis, etc,

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    2. http://journals.lww.com/spinejournal/pages/articleviewer.aspx?year=2005&issue=06010&article=00028&type=abstract

      ProDisc - instant paralysis immediately post implant. Now that is scary!

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    3. Are you kidding? 1. Prodisc is not metal on metal. Get your facts straight please. 2. Your second shot is incorrect as well. According to the article quoted, it describes a complication of pedicle fracture due to abnormal load which was revised with an ALIF. Where does it say anything about instant paralysis?

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    4. Pro Disc may not be classic metal on metal like CerviCore, but it has enough metal in it to cause serious metal hypersensitivity. As for the paralysis, the abstract stated that the patient was immediately paralyzed upon implantation of the Pro Disc.

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    5. Cervical Myelopathy Following Cervical Total Disc Arthroplasty: Case Report and Literature Review

      http://journals.lww.com/spinejournal/Abstract/publishahead/Cervical_Myelopathy_Following_Cervical_Total_Disc.98478.aspx

      Objective. This paper reports two cases in which the patients accepted revision surgery following CTDA due to iatrogenic neurological injury.

      Summary of Background Data. Cervical total disc arthroplasty (CTDA) has been increasingly investigated to treat cervical degenerative disc disease. However, there are limited reports focused on its complications, especially the neurological complications following the procedure.

      Method. A 52-year-old male underwent total disc arthroplasty for C5-C6, but immediately after surgery, he was suffering from paralysis of his upper and lower limbs. Radiographic images indicated residual compression to the spinal cord in the level of C5-C6. Another patient, a 60-year-old male, underwent total disc arthroplasty for C4-C5. Afterwards, he suffered severe neck pain, and paralysis of upper and lower limbs. He was unresponsive to conservative treatments, thus, a laminectomy was performed 3 months later. However, little improvement was observed. Radiographic images indicated kyphosis and spinal cord compression at the level of C4-C5. Furthermore, both cases showed a high signal in the spinal cord by T2-weighted MR image, suggestive of spinal cord injuries.

      Results. Revision surgeries were performed in both cases. Cervical implants were first removed by the anterior approach, and fusion was then performed after a complete decompression. Motor exam of patient in case one showed Grade 3 strength in both his hands and feet 6 months after revision surgery. In case two, the patient's severe neck pain was resolved at the early postoperative stage. Motor exam showed Grade 1 strength in both his both hands and feet 3 months after revision surgery.

      Conclusion. Based on presented cases and other reports, the surgical goals in these patients were prioritized as follows: 1) safe and adequate neurologic decompression, 2) establishment and maintenance of cervical sagittal balance. Moreover, a criterion for selecting patients undergoing CTDA needs to be established in order to reduce the occurrence of neurologic complications associated with the procedure.

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    6. What companies' disks were used? Let me guess, Depuy and Medtonic?

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    7. Had to be F B - Synthes Pro Disc or Medtronic were the only two corporations that had CTD on the market. These motion preservation spinal devices are lethal death traps. I have documented stories about the CerviCore TDR study (with with photos, X-rays, Myeolgram imaging and Bone Scan) that prove how dangerous these devices are. I think the disc that caused the paralysis was the Pro Disc. The fact that the disc is NOT revealed called into question the entire Motion Preservation theory. The concept is dead in the water and a total fad that caused serious blowback injury. Note how the trend is to blame the surgeon, instead of the device. This will end up alienating ortho surgeons (which is good) and perhaps these midieval metal motion preservation scams will finally fade like the Ford Edsel. Most surgeons I have spoken too say they are no longer doing spinal implants. Now with SunShine Law kicking in soon, surgeons will not risk getting caught implanting devices that 9 times out of ten, FAIL, and risk being sued for corrupt medical mal practice. There are plenty of surgeons out there who will testify against a surgeon who went ahead and coerced a patient into consenting to an implant with all the evidence out there about the dangers of these discs. I was told by a neurosurgeon that the Prestige failed in the best candidates. Spinal Motion Preservation devices requires enert material. To date, there is no material that will not release particulates into bloodstream. This particulate release in combination with HO ( hetero topic ossification) are two issues that will automatically cause numerous other issues or adverse events to the list of causes of clinical trial failure. Most disastrous is the fact that the data in the clinical trials for the devices already on the market is beyond questionable and biased (bought and paid for statistics). Everyone knows how corrupt the medical device industry is and if anyone is interested in a good laugh, check out who MacMillan's new pay master is? And the division he will be heading up - the defunct Synthes Spine division. I fell out of my chair laughing. If J&J believes MacMillian can breathe life onto the spinal implant division they will be in for a huge surprise. Motion Preservation Spinal Disc using metal is DEAD in the water with way too many casualties. As times goes on, more and more casualties from metal motion preservation devices will be surfacing. Books for the public will be on the market explaining the dangers of these devices in laymen terms and will soon turn this snake oil device industry on it's head. Books exposing about physicians and surgeons selling out their patients for feeder fees will soon be best sellers on Amazon dot com. Within ten years, the public will be educated about the medical con game and how these corporations are acting from the same level of medical fascism that was being practiced in Nazi Germany. England is now leading the world in creating registries for reporting defunct mal- metalware. You can't teach old dogs new tricks. These huge corporations are moribund and unteachable. They don't learn from their own mistakes. So fate steps in and puts down the old dogs so new puppies can be given new homes. A strange analogy, but the point is, old untrainable dogs who refuse to learn new and harmless ways of doing business that impacts the health care of billions of people will get put down as a useless crippled snarly smelly old dog. Humanity will strike back and con artists CEOs will soon eat humble pie, as in being used to head up a division that has no future what so ever. MacMillian was starting to believe his own bullshit and that is how a con man gets conned by his own BS. A decent human being couldn't get a good nights sleep knowing that his executive action caused foreseeable severe harm/ death to hundreds of patients, but a sociopath can and does.

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  2. MM, Do you really think the surgeons want innovation, or even better outcomes?? Seriously, innovation means Dr. cutter will have to use another product that won't necessarily pay him (or her) like the existing company does. Better outcomes means Dr. fuse won't necessarily get to bring the patient back for a revision or pseudoarthrosis for God's Sake!

    What are you thinking???

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  3. "Investment in Innovation (IN3) Medical Device 360 degrees Boston" strategic partnering and investment conference, June 27-29, 2012, at the Hyatt Regency Boston in downtown Boston, Massachusetts.

    http://www.marketwatch.com/story/elsevier-business-intelligences-in3-medical-device-360-degrees-boston-conference-to-feature-exceptional-line-up-of-start-up-presenters-and-top-tier-investors-2012-06-12

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  4. Nothing will change until people are willing to pay out of pocket for their healthcare. It always amazes me that someone will spend 4k on a purse but gets mad if they have to pay $80 for a prescription. We need to pay for our doctor visits, meds, etc. and leave the insurance for catastrophic needs. When people have skin in game the free market takes over. For Example: if you have Blue Cross PPO and go to get an MRI you will pay $1500 towards your deductible. If you offer the MRI center cash they will ask for $500. That is a 66% price reduction for actually paying for a service you receive. Giving our implants away for free will do NOTHING to save the system. No one can save this system until patients become accountable for their health.

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    1. You couldn't give away your implants even if you wanted to! And it does not even matter what brand of implant it is because the hospital requires at least a minimum amount because if it is not enough they won't get their multiple when upcharging for the implant.
      Now if you are going up against the big blue that is an entirely different story....
      To all of you expert spine sellers out there, this question is directed toward you:
      If you go into a facility that has gotten "a free O- arm" and into bed with Medtronic because the surgeons all trained at Barrows, and the hospital is too afraid to use your implants because then Medtronic will not pay them their juicy rebates at the end of the year, what do you do?

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    2. @9:02 I call on a hospital that is one of the major Medtronic accounts, including a large high profile fellowship. The O-Arm at this particular hospital is rarely used, as it is more of a hindrance (These guys are very competent at pedicle screw placement- I am sure your guys are too). The Medtronic Sales Representatives, one in particular, is a very good rep with a high level of service and support. I have no doubt this particular guy has earned his place at the account and every time I am there he is around. His support staff, are solid case coverage reps too. The way in which, I believe, you have to tackle this (if the Surgeons will even give you a chance) is to look for nitche products that you can show a exceptional level of competence with and go from there. The chance of walking in there and taking the business that Medtronic has, quite possibly, earned over years of great service is low. However the chance that you can walk in and provide the same or quite possibly better service level and competence with a nitche bag of products, is much greater. I just got off the phone with a area manager from a tier 1.5-2 company that has been cracking his head on the door of this account. His failure, he believes, is that his check book is not big enough to "buy" some exposure. My counsel to him was this, every company comes into these guys with a gimmick and most with an open check book for consultancy/design team etc... Take a good hard look at your competition and understand but do not focus on all the deals the other companies do, instead be different and come in with competence, confidence and exceptional service as your tools. Interesting concept, huh? I will say, that I am well aware of all the "deals" that we deal with everyday with our call lists, but that is something we can not change. As I have seen, every company has these deals from Medtronic-Joe Blow Spine. I am definitely not an expert and every scenario is different. Good luck!

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  5. To Anon 8:27 am. I agree with your statement. I am in my 60s and lived during the time ( briefly) when we got by with only catastrophic health insurance. The rest of the services were paid out of pocket during office visit. These were the days that as a consummer, you got what you paid for. Then Nixon turned that upside down with the HMO scam - the rest is history. We are now trapped in our own medical services nightmare. We are treated like junkies by our health care providers. They give us what they see is the medication or surgeries that we will come back for over and over. There is nothing about prevention - unless you are on Medicaid.

    The medical game is rigged! Let's face it, nothing will change until the medical industry is held accountable for their deviant and greedy behavior. That will not happen in our lifetime. Dr. Weliby was assassinated and replaced with Dr. Mengale. Medicine is layered with institutional corruption that works with an unspoken efficiency for screwing thenpatients and wiping clean all prints of who is responsiblenfor the debacle. Sales reps are who are really treating us behind a screen - physicians have no idea what to do with a really sick patient. They do know how to treat patients who are moderately healthy - by manufacturing a disease that requires life long prescription and call it conservative treatment.

    In a healthy society, we wouldn't need to see a physician except in an emergency or the onset of a critical condition. Americans are obsessed with their doctors, pills and surgeries. So in light of that fact, we use doctors to fill a deep emotional need to be cared for - and by this, we invent ourself sick and believe every commercial on TV. Now Obamacare will see to our needs and legally require us to be maintained from cradle to grave with a national prescription for hypochondria.

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  6. When do we start holding the surgeons and their societies responsible for insurance companies no longer supporting innovation? Why would NASS decide who should use a tracking code or an unlisted code on new technology that helps patients? How can small innovative companies survive if their very own societies prevent innovation? Wake up Spine Surgeons and be more vocal in supporting life changing technology that helps your patients.
    Regarding POD's and Reps in the OR....It scares me as a patient to NOT have an experienced rep in the room. I have seen a great deal of mishaps by surgeons where the rep was able to step in to improve outcomes. There are so many procedures that neurosurgeons and orthopedic surgeons perform, they cannot be expected to know proper sequence, tips and tricks, that a rep who has seen hundreds of case may be able help with. If the rep does not have that level of experience, use another product with a rep who does.
    Spine Surgeons....speak up against insurance denials and do not support unlisted codes or tracking codes or you won't be doing Spine Surgery in the future..... TAKE SOME RESPONSIBILITY for what is happening in your industry.

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  7. TSB - Your reference Dr. Steinmann and his opinion that sales representatives represent a useless added cost to the industry that can easily be removed in order to cut costs. You also mentioned that people need the ability to earn a living commiserate with their abilities, which I certainly agree with. Who on this blog including the spine surgeons think spine surgeons ought to make 2-3 million a year. An internal medicine physician is lucky to clear 200k. Talk about obscene money, profits and margins and who thinks making that kind of money doesn't cloud their judgement. Forget if it is right or wrong that they make money off their practice, surgery, imaging, bracing rehabilitation, their surgery center or hospital and now implants, is that sustainable to the taxpayer as I am guessing in each case the usage goes up dramatically and unnecessarily. Add on all those profits and the surgeons are still looking for consultancy and royalty agreements to subsidize their woe as me incomes. The type of money most spine surgeons make is reserved for business owners or CEOs of much larger corporations than the revenues they sometimes fraudulently bring in. All I hear about is declining reimbursements but am I incorrect in saying the medicare "doc" fix has been suspended every year and many of those years they have actually gotten a increase in reimbursement. This whole subject is like trickle down economics, which doesn't work. If you want to get a hold of healthcare costs in the US I would start with bloated hospital administrations and income doctors are pulling out of the taxpayers or at least include them in the discussions. Industry is not the only negative influence in this equation. In fact the ethics, morality and legality of industry practices are well above many surgeons and healthcare facilities. It takes two to tango and for most fraudulent, illegal or overudilization healthcare transactions you can bet, there is a physician involved, a healthcare facility involved or both.

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    1. Interesting post, with some good points. The medical industry is definitely in a dance with Physicians/Hospitals/Industry and everyone wants to be on the floor doing the cha-cha. I would not pay to much attention to Dr. Steinmann, as his motives for POD's are very easy to figure out. If he was truly just interested in saving money for the patients, it would be much easier to use capitated pricing at his hospitals/surgery centers. Instead, he points fingers at everyone and everything to keep the focus off the simple solution of the aforementioned pricing. Physicians will not feel the squeeze until the rest of the industry has been bled dry. At some point. pricing will be at the floor and the all powerful Oz at the hospital will look for more ways to improve profit margins from surgery. At which point, the decision will be Surgeon salaries or Administrative salaries (which one will win). I will however concede that Sales Representatives for some spine surgeries are questionably needed, depending on the environment and Surgeons. Most of the Surgeons that I call on can do a ACDF or PSF without the Sales Representative in the room. The more complicated cases, in some cases a surgeon can make an ACDF complicated, we are most definitely needed. The small percentage that we make 6-12% is insignificant for the level of service which we should all be providing. It is often overlooked that when we are not in the OR we are not making money. All of the running around, sales calls, meetings, travel, labs and for distributors expenses including health/retirement/rapetrax etc. ad nasuem are on our dime. It still is a great industry and I thank my lucky stars that I can be in it. I feel lucky to be working with some good guys that are, for the most part, in it for the patient. I appreciate your post.
      thx

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  8. Reimbursement for each patient not each device, e.g. screw, rod, interbody, ect. Maybe, just maybe I would be in favor with Physician-Owned Distributors (PODS).

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  9. New Innovation will come from Spineweek. Just kidding, that was for a previous post, aka Spineart man.

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    1. What are you talking about? SpineWeek is the biggest global meeting in Spine. The meeting is far superior to NASS which has become an awful meeting. Hopefully you are joking, or you are too green and know nothing about your industry. These type of comments are why I rarely read this blog anymore. It simply highlights the dumbest in our industry.

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  10. Medtronic doesn't giva away the O-Arm...they sell it to you and then give you a year's worth of free neuromonitoring in exchange.

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  11. Eleven years ago in San Antonio, Texas a major hospital system determined that they could get abreak on their liability insurance if they kicked out all of the Reps out of the OR.

    It lasted a week.

    Surgeons and Scrub Techs were begging to have us back.

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  12. Once again, Steinmann comes across as one of the smartest guys in the room. His motivation is purely financial, isn't it? He's not doing it for the love of his patients, is he? As for Pat Miles, nice guy but its obvious that his boss the infamous AL threw him to the wolves. Innovation Pat? Nuvasive hasn't done anything innovative since XLIF. Carnival Barkers

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  13. Isn't there a hospital in Austin Texas that has a vending implant kiosk?

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    1. Yes, at Westlake Medical Center. I hear that it never gets used and is in the process of being removed.

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  14. Pat Miles: "Spine is not a mature market." Pat whose chain are you and your fellow cheetahs yanking? That like pissing on my shoes and telling me its raining. Get serious. Are you people taking LSD in LaJolla

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  15. The next innovation will come from Asia. Here is what it will be. It will be in the field of regenerative medicine. They will grow a biological disk bone complex implant using stem cells. The FDA will disallow it and the US will remain in the medical third world.

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  16. Si-bone, globus and zyga. Wave of the future? What do you guys think? Your reasoning...any better ideas? Are the top tier players missing the boat on this one (except globus of course)? Hips can cause pain and L5-S1 too...can the si-joint hurt as well? The company I rep hasn't been talking about this space, should I push them to look more into this?? Thanks in advance for your insight!

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  17. Yes, too bad the FDA would likely "disallow" it. What roles would you consider you play in the FDA's decision on this matter when you envoke hyperbolic negative rhetoric regarding the current state of medicine, bio science and industry? I imagine there are positive and potential negative consequences of what you exclaim: a regard for safety, morality and efficacy yet, e.g., an environment of fear among companies bringing new and revolutionary products to market from potential litigation due to the unfortunate reality that there are very real risks any patient takes when receiving medical/surgical care to balance the fragile and complex system that is the human body and pyche (whether by drug, device or otherwise) and fear among the good people of the FDA that they could have prevented a bad occurence simply by not allowing a product which they don't fully understand because of its revolutionary properties or capabilities. There is a fine line, I agree, but patients should be allowed access to such technologies accompanied with honest discloure of risks, realities and experimental nature. Many patients are in situations that others should not judge the risk/benifit ratio for them and subsequently deny its availability. Compare the EU system, I'm curious as to what other readers think as well.

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  18. Sounds like the author of this post (remember folks, TSB is not just one person...it's a group of contributors) (A) works for one of the industry behemoths--like Medtronic or Deputhes--that have forgotten how to innovate or (B) is involved on the investment side of the industry without any real understanding as to what a rep even does on a daily basis. He (or she?) clearly believes that all companies have the exact same products, and that reps have no value in this industry. The first assumption may be true for certain companies, but the latter couldn't be further from the truth. Start betting against the rep with the relationship, and you're going to lose 9 times out of 10. I'm not much of a gambler, but those are some pretty terrible odds no matter how you slice it.

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  19. SI type implants are a solution looking for a problem that does not exist...forget it. Not the next great innovation.

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    1. Ok doc, thanks for the insight!

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  20. It sounds like there are a bunch salesmen here. They keep you guys in the dark. They are worried that some of you may develop a conscious. I was in sales and I dealt with a lot of hospitals and clinics. I also knew the game and I got good at doing end runs around department heads.

    I sold a service. I knew who was on the take and I used a method for bribe and kickbacks that was totally untraceable. It was pretty much what the drug reps do. I didn't feel bad about it because we had a superior service and they were taking bribes anyway.

    My company was on the up & up. We could have scammed but the money was so good we didn't have to and our industry was fairly clean at the time. The crooks were our clients.

    The FDA decides very little. The industry tells the FDA what to do. It's a revolving door and you guys should know that.

    Here's the problem. Medicine is monetized Medicine should not be monetized. Good medicine is serving the patient as per the Hippocratic Oath. Today medicine is the exploitation of disease and suffering.

    I will ask a question that I doubt will get an answer. What diseases has the medical industry cured in the past 50 years?
    Make a list.

    Now that you can't make a list, make excuses. Point the blame as you defend said industry.

    Corporations have no fear of law suits. They know there will be lawsuits. They figure that in their risk management. Take J&J's hip implant. They knew it was junk. They knew it should never have gone to clinical trial and so did their friends at the FDA.
    They knew failure rates and they knew the revision rates.

    J&J/Depuy, Medtronics ect.. know there will be lawsuits. They get fined and a judge sets that money aside to pay victims in class action lawsuits. When the money runs out the company is off the hook and free of anymore liability. Corporations are above the law.

    I know why it was submitted and approved but I would like to hear your theory.

    Medtronics made a fortune on Infuse in spite of the lawsuits.

    Let's take disk disease. If medical ozone, Discogel and the 3 good American made ADRs were in us in the US the spine industry would lose BILLIONS.

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    1. "I knew who was on the take and I used a method for bribe and kickbacks that was totally untraceable"
      "I didn't feel bad about it because we had a superior service and they were taking bribes anyway"
      "My company was on the up & up. We could have scammed but the money was so good we didn't have to and our industry was fairly clean at the time"

      So your company was on the "up and up" but you used a untraceable way to bribe and deliver kickbacks to your clients? It appears we have an oxymoron here, FB.

      You are however right, in my opinion on the legal law suits. From my understanding of the medical device industry, possible legal costs are calculated into the pricing of the widget. As is most other industries, including childrens toys, vehicles, etc...

      Delete
    2. Okay, here is a list just off the top of my head, Fat Bastard: ALL (acute lymphocytic leukemia); peptic ulcer disease caused by H. Pylori; stage I prostate CA; significant improvement in M&M (morbidity and mortality related to MI and stroke); polio eradicated; smallpox eradicated; HIV/AIDS is now survivable (progress in just 20 years, from universal fatality); Rheumatoid diseases & AS (ankylosing spondylitis) nicely managed with alpha-TNF...now, if only we we could cure obesity and out-of-wedlock procreation, so that you would go "poof".

      Delete
    3. The way we bribed was simple. We offered the institution "premiums". If the department head wanted it to go to the hospital he could fill out the paper work and have it sent to the hospital or have it sent some place else. It was up to them whether to be dishonest or not.

      We were completely above board.

      This works with all sorts of crooks. It has been used on purchasing agents for years. Today you little weasels don't have to be so subtle.

      H-Pylori is cured with bismuth and penicillin. This has been known since the 60's.

      Polio and small pox were eradicated in the 50's.

      Everything else is "managed" HIV and cancer and RA are big money makers.

      Alpha-TNF was discovered in 1968 by Dr. Gale A Granger from the University of California, Irvine.

      Compared to what was spent in medicine then and now it's disgusting.

      The answer to what has been cured in the past 50 years is little and nothing.

      Your list is very unimpressive.

      Delete
    4. Your company instituted a system that offered "premiums" to hospitals and you facilitated these agreements and your pontificating to us on how the medical industry is corrupt? Wow! You are a idiot of the highest order.
      Instituting a policy, in which, you are well aware is incentivising an institution or the members of that institution is the exact same thing, you are preaching, is wrong with the medical industry.
      It appears that when the medical world was paying your check, personal ethics and morals did not matter. Now that the medical world has stepped on your toe, or more probably denied your incredibly ADR, your ethical standards are so high you can criticize the same system that you participated in, willingly.
      When and if you ever have a patient come to your office and thank you for restoring their quality of life, you may speak to Surgeons motives. Oops, I must have forgotten that your mothers basement does not have a office.

      Delete
  21. Does innovation have to be a device?
    Many think "process" innovation will dominate the next 5 years navigating rules and restrictions and cleaning up balance sheets.

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  22. Thank you 7:06 you're the winner of this post, someone actually can figure out what is written

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  23. What Process innovation are referring to?

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  24. PODs are illegal.

    What patients want is a device that is safe and works right the first time and that is why the leave the US. I would like to see MSM tailor some of his posts to patients and go onto some of the spine surgery forums and listen to what patients are saying.

    Is the patient the customer or is the patient merely the end user? The patient clearly is the cash vending machine.

    Want an innovation process? Get rid of the companies and get some real engineers and scientists and come up with solutions. Marketing drives R&D if you can call what the industry does R&D. The industry is not looking for solutions. A solution would cost them market share.

    There should not be a implant device industry that goes around cutting each other's throat at the expense of the patient. It looks to me like the low level whores post here.

    We put a man on the moon in July of 1969 but spine care is not much better than it was then. The industry into selling hardware and not solution. If the patient was also the customer the industry would have to sell solutions but the game is rigged and the patient is seen as an opportunity. The entire industry is a sham and you all know it.

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    1. You are dead on the money FB. Do not allow these sales reps twist the facts. They are in the biz to pay their bills, not to save lives or protect their practice. They will sell a cart of horse manure to any surgeon dumb enough to think horse manure was FDA approved for spine surgeons. Necessity is the mother of all innovation - motion preservation spine devices are a fad that surgeons are discovering cause way more harm than the theoretical benefit. Fusions are the Gold Standard - why reinvent the wheel? Physicians knew as far back as the early 60s that metal on metal was NOT doable or scientifically sound. Then comes Medtronics with their European knock off and suddenly the race is on! The race is NOT for the patient to win - the race is for the stockholders to hold cheer leading rallies for the CEO that makes them richer. And here is where the physician should make him self invisible if he or she is ethical and takes the Oathn seriously. We expect CEOs and sales reps to be a bit jaded and in it for the bucks, but the surgeon must have "clean hands", otherwise there is no firewall protection for the patient and it is what it is - a very lucrative medical device racket. Good for you FB. We are both on the same page

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    2. Philomena you are soooo correct. After all, that quack motion preserving total hip and knee surgery is just a fad. I can't for the life of me understand why patients would not want to get a girdle stone procedure instead of a faulty, likely to fail total hip that allows you to get back to normal function. And how about those crazy total knees. A good old fashion knee arthrodesis never had to deal with poly wear or the surgeon having to go back in and replace the poly after 14 years. People used to just gimp along and make do. Crazy times we live in.
      What stupid statement. The spine is made up of motion segments, and it only makes sense to try and restore/maintain motion in the spine while addressing abnormal pathology. Your buddy Fat Bastard sure thinks its a good idea or he wouldn't keep talking about his great, unknown super top secret TDR.
      J

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    3. Anonymous June 14, 2012 5:59 PM lied and said

      Philomena you are soooo correct. After all, that quack motion preserving total hip and knee surgery is just a fad. I can't for the life of me understand why patients would not want to get a girdle stone procedure instead of a faulty, likely to fail total hip that allows you to get back to normal function. And how about those crazy total knees. A good old fashion knee arthrodesis never had to deal with poly wear or the surgeon having to go back in and replace the poly after 14 years. People used to just gimp along and make do. Crazy times we live in.
      What stupid statement. The spine is made up of motion segments, and it only makes sense to try and restore/maintain motion in the spine while addressing abnormal pathology. Your buddy Fat Bastard sure thinks its a good idea or he wouldn't keep talking about his great, unknown super top secret TDR."

      ---------------------------------------------------------

      Neither Philomena not I am against TDR or AJRs. We are against junk and engineering done my idiots/doctors.

      Medronic's junk and Depuy's junk are mechanically unsound. They are not motion constrained so the only thing that stops the segment is what? It's the facet you moron.

      There are no valid reasons for why the DCI, NeoDisc and and M6 are not available to Americans.

      A moron can design an ADR and the morons at Depuy and Medtronic designed 2 of them and they suck.

      Delete
    4. Philemonas words not mine that - "motion preservation spine devices are a fad".
      I see you left out ProDisc which is a similar-constrained TDR.
      Show me any data for a TDR that is constrained and has a shock absorbing capability that has been tested for 1 million plus cycles (approximately 10 years of motion). Let us all know at what point the mechanical bond between the gel type material and the endplates failed.
      If you or anyone else can overcome the stresses of sheer, tensile and torsional loads which can get a patient out further than five years then you will have a winner.
      FB, if you design and are able to prove out the efficacy of your device then I and a lot of others will personally congratulate you. But please do not continue your absurd remarks of any two hardware store employees can design a TDR. All you do is expose yourself to be a simpleton who loves to make derisive statements and little knowledge to back it up.
      J

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    5. J - motion preservation in the spine involves a natural organic kinematic. Metal devices cannot mimic this organic kinematic design - plus the shock of the metal replacing soft tissue causes osteoprogenerator bone to signal new bone growth, ergo HO. Note that all metal motion preservation devices cause HO. This does not happen with fusion because the new bone caused by the shock of the metal replacing soft tissue and bone can be ReAbsorbed. This is just one of the reasons for choosing fusion over metal implant. I am not against innovation, otherwise I never would have volunteered for a clinical trial, which at the time I did not know was already in the FDA Black Box for trial device not approved or cleared for any use by FDA. I am against the medical device industry rushing dangerous fad devices to market based on corrupted research.

      Delete
  25. One more thing... most doctors are just as greedy and immoral as the industry. An ethical doctor would sever all relations with companies like Medtronic, Globus, J&J, ect... I tell patients that if their surgeon is using products from a scumbag company to avoid that surgeon.

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    1. Just when I start thinking some of your posts have 10% rational thought, you go and prove me wrong again. Things are not always black and white, no matter how many ding dongs you eat. The good comes with the bad and that goes for any industry. Unfortunately, I do agree that patients should be more educated on who they go to see and for what.
      As a Sales Representative in this industry, I do whatever I can to avoid situations that I feel would compromise my personal ethics. Believe it or not, plenty of the guys that view this forum are in this industry for the right reasons.
      Being a fanatic is no way to go through life son...

      Delete
    2. Good point fat bastard 11:46. Tbat's why Cappuccino.signing with Lanx was so huge.. Signing om a reputable ethical surgeon like him really boosted their company.

      Delete
    3. AnonymousJune 14, 2012 2:02 PM

      Just when I start thinking some of your posts have 10% rational thought, you go and prove me wrong again. Things are not always black and white, no matter how many ding dongs you eat. The good comes with the bad and that goes for any industry. Unfortunately, I do agree that patients should be more educated on who they go to see and for what.
      As a Sales Representative in this industry, I do whatever I can to avoid situations that I feel would compromise my personal ethics. Believe it or not, plenty of the guys that view this forum are in this industry for the right reasons.
      Being a fanatic is no way to go through life son...

      ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

      Here is what is Black & White:

      J&J/Depuy has been fined billions. They repeatedly break the law and all they get is fined.

      It is the 21st century and Americans still do not have a shock absorbing motion constrained ADR.

      It sounds to me like you've been drinking a lot of industry koolade. The sales literature is fiction and you believe it.

      The medical industry is corrupt. No gray area there either.

      Delete
  26. Can someone, who knows what they are talking about, give me the reimbursement scenario for SI joint fusion.

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  27. How many truly innovative products have there been in spine surgery? You could say pedicle screws for segmental fixation, Infuse for de novo bone growth, artificial disc replacements,and what else? Hasn't most everything else been line extensions of current 510 K products calling them new product launches? Except for the PMAs for cages, Infuse, and artificial discs where is the data? Payers are pushing back even for 510 K products because there is no evidence. With the FDA and regulatory hurdles, the reimbursement requirements for evidence (little in spine surgery because companies refuse to invest in now commaditized 510 K products), where is the next truly innovative product coming from? The days of 15 new product launches each year saying this is "innovation" are over. The is no ASP traction like the past (spine grew 15% a year from product line extensions until 2005 when payers learned to not pay for Charite). Company marketing teams desparately try to define product attributes that do not make any clinical difference in outcomes (because there is no data)and call their products "innovative." So with pricing pressures, a market flooded with "me too" products, no evidence to push back with payers to continue coverage, and only a hand full of PMAs in the near future...might I suggest the company that learns to navigate in this changing market will win market share. Let's face it, evidence and comparative effectiveness will rule in the near future, and companys that understand this process and joint ventures with payers will define "innovation" of the future. This is the essence of "process innovation."

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    1. ADRs have been around since the late 1950's. Infuse has been a disaster and Medrontic furthered that disaster by selling it off label in spite of numerous FDA warning letters.

      Screws are an innovation? LOL! The only screwing that is an innovation is how the patients get screwed. That has become quite novel.

      Here's the innovation. Medicine went from a profession guided by doctors and the Oath to an industry run by corporatists who managed to commercialize and monetize disease. In doing so that took America, the true leader in health care and took it from number one to 37th in the world.

      Corporate funded research sucks. Profit motivated health care sucks! The industry/FDA revolving door sucks!!

      Delete
    2. There is no profit in innovation. Let's say the industry had devices that fixed the problem right the first time, shortened recovery times and less revisions the industry would lose a large part of the market.

      I have to agree with you Fat Bastard. The products they offer are laughable. I had a friend do to Germany for a disk replacement procedure and a revision surgery for some butchering he got in the states. He's doing great now. We totaled up all his expenses related to his botched surgery and over the years it was probably $40K. If he had had a revision here it would have been another $40K and they probably would have botched that too.

      It's shameful greed.

      Delete
  28. There is no data that suggests Zimmer Spine has 3% market share. They haven't reported quarterly growth in almost 4 years. They are barely a $200M sales worldwide. Globus reported $330M.

    Z spine is dead. It's thrift store junk.

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  29. Spine surgery is an invasive pain management procedure in which a specially trained doctor (the surgeon) uses instruments to make incisions to repair damaged spinal tissues. Or in other words Spine surgery whether back or neck surgery, can be sum up as an advanced treatment option for pain and disability caused by an identifiable lesion in the patient’s anatomy that has not adequately improved with non-surgical treatments. Although spinal arthritis tends to be chronic, the symptoms are rarely progressive and rarely require surgery on the painful spinal joints.

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  30. What will the next big thing be in spine as reimbursement declines for all besides the hospital?

    Not seeing a whole lot around here.

    Most products a minor modifications of eachother. Screws, rods, cages, tubular retractors, this and that.

    Biologics? Maybe, but not biologics for fusion. Arguably, the biggest and best biologic of recent and perhaps soon to be near exctinct is bmp. We can all get the spine to fuse with time tested good technique and and the patients own bone and cells.

    I think the biggest innovations will be in biologics, but biologics for disc regeneration, nuclear replacement. That is the holy grail.

    I also think that unless a company is thinking about how they can save money for the hospital, that company will not survive. Relatively large innovation and sought after innovation will be in the form of cost savings and time savings method that producers and distributors can provide to the hospitals and to the patients in terms or less risk, less time in the o.r. etc.

    These big companies that keep rolling out the latest version of a goddam screw with a new label and expect higher prices of the hospitals are completely ignorant and will fail. How many ways can we cut a thread or cut a piece of plastic and call that innovative....and then demand a premium. That is quickly becoming a thing of the past. At this point a screw is a screw and a piece of plastic is a piece of plastic and the differences are subtle and will soon not be recognised as differences worthy of even the current decreased prices demanded by hospitals.

    As many of you know, boxano has a new,' innovative' device used to dental floss the foramen. While even that device does represent some level of innovation, why would a hospital pay the 3000 in extra cost when that device is not reimbursable and alternative standard techniques and old school tools can be used?

    Real innovation will be in regeneration to prevent salvage procedures like fusion for patients and cost savings to the system, mainly the hospitals and insurance carriers.

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    ReplyDelete
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  33. when a screw cost the patient 1000 dollars I would think it should perform as used or use a 10 cent screw .

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