Thursday, May 19, 2011

Anybody Hear????????

Recently, a few of our avid bloggers inquired whether TSB would cover some other areas of our industry besides POD's, and the state of the union in healthcare.   So in the spirit of debate, who are the companies that are doing something innovative?  And, why?  Are these products game changers?  Are they line extensions?  Who are the contenders?  Or, are there only pretenders?  The past two years have brought us a few technologies that would be considered innovative, but is there truly something out there that is going to change clinical outcomes?  And for you Nuvasive bashers, please, don't attempt to legitimize products like XLiF, it's been around for years and its shoulders are starting to get tired.  Like an old sage once espoused, Is it new, Is it true and Is it really making a difference?  Or, are we entering an era of downsizing and consolidation.  In closing, your answers to this post would be appreciated before you open up the bottle of Milagro Anejo.

72 comments:

  1. fat cells fuse bone, yeah baby!

    ReplyDelete
  2. PODs are innovative... he he he
    Globus going public is.....science fiction.

    ReplyDelete
  3. Looks like you have stumped the readers.

    ReplyDelete
  4. i just learned about an innovative way Blackstone funnels money to their referring surgeons. Since the surgeon consultant gig did not work out so well for them they have figured out it is harder to trace neuromonitoring $$ kicked back to them. Check out a website www.docholdingsllc.com (open the cache version). This is a slush fund that I believe all neuromonitoring money is funneled to from Blackstone referring docs. The way it works is the surgeon pushes out the existing monitoring company for the new, Blackstone endorsed IOM company....odd though that this company either doesn't show up for medicare surgeries???? hmmmmmmmmm, I wonder why? (tongue placed firmly in cheek) All this monitoring money gets deposited into a fat bank account in Nashville TN., and voila everybody gets paid!! Before I get inundated with criticisms of slander, let me reiterate this info is what I have found to be consistent from 3 different states (Maryland, Florida, and Texas) anybody else out there seen this going on?

    ReplyDelete
  5. The hospital that I do most of my cases has sent a letter to all independent distributors. The letter quotes the OIG as stating that they feel that PODs are illegal. There was a POD there but they temporarily dissolved. The hospital will not let them back....TSB tried to email you the letter, but I think you must have changed your email(?)

    ReplyDelete
  6. Alphatec is innovative with GLIF and Stem Cells.
    My distributor says that GLIF will be bigger than XLIF in a couple years. Also Puregen is really taking off. I have two new docs trying it and a few more interested. This seems to be the REAL DEAL!!!

    ReplyDelete
  7. If Puregen is "really taking off", then why did Alphatec remove any reference to it on their web page?

    ReplyDelete
  8. GLIF full launch was delayed again until late next year, Solus is a flop so far and Puregen is not their product, they license it. Nice try 5:41.

    ReplyDelete
  9. Yea but his Distributor "said", it must be so...

    ReplyDelete
  10. TSB's e-mail spineblogger@me.com, send it we'll post it

    ReplyDelete
  11. The FDA..aka...Obama...is making it nearly impossible (and financially irresponsible) to bring product/technology through 510k and to market. Lateral systems are not new technology...a new pedidle screw dydtem, standalones, cervical discs are not new technology. Biologics seem to come and go depending on the weather. There are no game changers

    You will continue to see the big fish gobble up the little fish to fill their portfolios ..its cheaper, and its faster...than developing, testing and submitting new product. With pricing pressures and insurance pressure affecting volumes, I'd say we are in a consolidation period. Sprinkle in the government sticking their dirty hands in everything and you've got yourself a lot of mediocrity for years to come

    ReplyDelete
  12. I was going to offer an under/over of 6 posts before some stooge mentioned POD - Globus going Public and/or Alphatec being the greatest spine company ever.

    GOOD JOB MM - seems our readers just want to bitch and moan.....just like my 3rd ex-wife.

    GO TRIBE!!!!

    ReplyDelete
  13. Don't know why it matters that Alphatec licenses the Puregen product, with exclusive license for indication,they would just pay royalties like many other company and it would essentially be THEIR product. I think the key question everyone has is who is Parcell Labs (licenser), what are their credentials and how are they going about marketing a "live donor" stem cell product thru "tissue regs"...hmmmm....sound suspicious????

    ReplyDelete
  14. Issues raised by 6:23 maybe why Puregen disappeared from the Alphatec Website?????

    ReplyDelete
  15. Wow! Another TSB post referencing NuVasive.

    SHOCKING!!

    ReplyDelete
  16. Actually, the most impressive innovation in spine really is and will continue to be aquisition/consolidation in the industry. Corporate boards, CEO's,IB's, are finally using their influence to take control of a wild industry. Creation of compatable corporate partners, the $$ deal, integration and yes distribution transition when well planned and executed is really special. This trend will not only affect our livelyhoods but also products offered, sales and marketing protocall and ultimatly patient outcomes.

    ReplyDelete
  17. i made 245k last year after taxes. things are good here.

    ReplyDelete
  18. AxiaLIF is innovative.

    ReplyDelete
  19. 8:45 If the shoe fits........boy can I specifically play you like a violin, sweet music listening to you whine.....

    ReplyDelete
  20. The ASSLIF might be innovative but it fails miserably if not done perfectly on the perfect patient. The surgeon will not be paid and Trans1 management is pathetic!!!

    ReplyDelete
  21. LOL!! I am usually on the Medtronic aimed end of TSB's stick but I have to stick up for him here. I can remember MANY posts he made asking, even pleading with bloggers to share innovative technologies with the tribe... to no avail. For all those bitching about POD talk, its whats relevant currently and the post numbers reflect it. Judging by the number of posts here relevant to TSB's topic I would say there are not many things to talk about besides consolidation and POD's.

    signed,
    smooth as eggs

    ReplyDelete
  22. Time to spout my pie hole:
    Don't work for NUVA, good company, tech getting old but won't bash em.
    Globus going public? Don't give a shit.
    Alphatec Bashers, even MM calling them Alphawreck. Get over it. Do carry their line why? Meets product needs. Not consulting deals. Not in POD. And futures proving in europe osseoscrew, osseofix. Puregen going well for me too. Their bio specialist not cutting into my pie and helpful establishing the story. Don't know about GLIF, my docs not ideal targets, but do know not taking end of 2012. Really wish bashers would check the facts. My take, positioned well, growing, developing, hungry, responsive. It's not if FDA clears osseofix and osseoscrew. It's WHEN. and when happens. GAME ON! Did my trench time with Danek, synthes, and JJ learn/honed my skills. Like I said, ATEC has been good for me and my docs without said commentary threading this post. So ATEC, great job, keep the development, keep the faith, do little better getting your next to market, and thanks for stock bump last week. Also, VP Lube never never mentions playing in NFL. Those know him, know truth, he's more proud of national championship ring from Boston College.

    ReplyDelete
  23. 7:35 - Keep drinking the Kool-aid. Call the GLIF product manager and ask when the full GLIF release is planned.........2012. Osseofix cannot enroll patients in the study so approval won't be for years, Osseoscrew will require an IDE so again years. Their internal employees are miserable causing tremendous turnover. Their execution on product development and launch is the worst in the industry. Their only hope is for NUVA to buy them.

    ReplyDelete
  24. and735 who calls themselves Lube? WTF

    ReplyDelete
  25. 7:35

    Your out of the loop internally. They are doing consulting deals now.
    7:54 Is on point!

    ReplyDelete
  26. if osseoscrew requires IDE they won't have any problem enrolling-proceeding. Osseofix parameters being changed. My point is they're doing it in europe with new stuff and i expect to take time here. no big deal.
    TSB...
    So in the spirit of debate, who are the companies that are doing something innovative? And, why? Are these products game changers? Are they line extensions? Who are the contenders? Or, are there only pretenders? The past two years have brought us a few technologies that would be considered innovative, but is there truly something out there that is going to change clinical outcomes?
    I'm saying ATEC has game changers, not line extensions. True they licensed the tech, who cares. They did it and are making a run outside USA which one day will stick here. Remember what happened to Kyphon? If NUVA or WHOEVA acquires em, good for em, good for my stock.

    ReplyDelete
  27. Better yet, who are the visionary & influencers of this industry that will take it to the next level? Its developing now.

    ReplyDelete
  28. If there is a game changing product it is in an IDE study right now. Anything truly innovative will not pass the 510k process. Putting a cage in through a different incision on the body (i.e GLIF) is not game changing, it still fuses the spine.

    ReplyDelete
  29. 8:39 makes good point ATEC doing changers and true to them have broadened their lines/extensions.

    8:46 if I knew, wouldn't want to say and spoil the IP. But think vision/influence comes from not only from surgeons.

    ReplyDelete
  30. I would say endoscopic spine until motion preservation actually works. The coding/reimbursement is keeping the technology from going mainstream.

    ReplyDelete
  31. VTI uplif pretty innovative. 48 mm wide implant through a 9mm unilateral plif approach.

    ReplyDelete
  32. Any new biologics worth talking about? Don't say Puregen because it is sh*t. Let's be real people. Bacterin is me too, as is all the CaP products out there. Any new growth factors worth talking about?

    ReplyDelete
  33. RTI Biologics' Multipotent Adult Progenitor Cell (MAPC) Technology licensed from Athersys....holds promise to FINALLY show real clinical efficacy in the biologic implant area for adult stem cells in orthopedic market.

    ReplyDelete
  34. This is an interesting collection of responses, in that they don't list anything new. I personally know of a few things but most of its stealth aka keeping a low profile (not to be confused with another awesome cervical plate).

    What do you think about Spinal Restoration? At least its a different approach and it just might help some people.

    I just saw the press release on Impliant being sold, after burning through the better part of $50M in investor money. Was that "smart money." Hopefully some lessons have been learned.

    ReplyDelete
  35. LDR has come out with some innovative products. Their screw-less plating platform is intuitive... Definitely not "me too". They also have the Mobi-C cervical disc which is the better than any approved or anticipated discs out there

    ReplyDelete
  36. Has any one heard of a company by the name of OIC (Orthopaedic Implant Company). Their tag line is as follows: The Orthopaedic Implant Company Pledges Health Care Savings of $1.2 Billion by 2015. A low cost implant company out of Las Vegas, 45% ownership by surgeons.

    ReplyDelete
  37. What happened to the SiN material from Amedica? I rememeber a thread where everyone was saying this was the future for bony ongrowth interbody devices. Haven't heard much about it since. Did the stiffness of the material hinder adoption? Are the implants breaking on insertion? Did they ever produce human clinical data?

    I think the next "low barrier to entry" technology will be interbody devices that allow for bony ingrowth/ongrowth. Lots of activity going on in that area.

    Don't expect to see too many more PMAs due to the hurdles the FDA is putting out in the PMA approval process. Too risky of an investment.

    Class 2 devices with iterative changes will be the future.

    ReplyDelete
  38. Baxano's iO-Flex is gaining traction and receiving very positive surgeon feedback. Certainly unique in the space as it isn't an implant, but certainly highly effective in addressing stenosis the patient population that it's intended for treating.

    ReplyDelete
  39. - SI Bone is niche-y but the guys who use it rave about it.
    - LDR's 2-lvl superiority to fusion with Mobi-C is finally the holy grail that payers will be unable to deny payment for, and their stand-alones are simply the easiest/fastest (whoever is saying you have to do a corpectomy to remove is displaying their ignorance).
    - If somebody can come up with a simpler/cheaper navigation system, that would change practices/outcomes.
    - Arthroscopic discectomy is a game-changer if it doesn't add too much to the cost of a surgery.
    Thoughts?

    ReplyDelete
  40. How large is the market for SI-Bone, just the facts, not the hype.

    ReplyDelete
  41. Not that large. Spoke to one of their reps the other day, he said this "This is the hardest sell I've ever faced in my career."

    ReplyDelete
  42. How much hype has this product received? Let's be honest, this is another venture that is a pump and dump, nothing more, nothing less

    ReplyDelete
  43. MM,, Can't disagree. Not sure they've received all that much hype,,

    Bottom line, I'm not really sure who'd be interested in buying SI since I don't think they're doing all that well?

    ReplyDelete
  44. To the guy/gal who cleared $245k after taxes... I loathe you. You do not deserve what you are paid.

    You say what you are told to say by Compliance and Regulatory departments (though you may think it comes from Sales), spend company money wining/dining your surgeons while pretending it's your own (how much of a big shot are you without your expense account), sell products whose development you had nothing to do with, and likely do not put in an honest work-week.

    What you also do is sit on this site and bitch about threats to you (like anyone should care), spread lies and rumor, and beg for the government to play the role of your Mommy and prevent any new developments in sales models that threaten your house of cards.

    How many of you will go back to selling cars or big screen TVs at BestBuy when market forces strip you of your outrageous commissions and salaries? Go get me a coffee monkey!

    ReplyDelete
  45. Here's a snapshot of what's wrong w/ this industry today:

    I was in a case earlier this week where as part of the case, the surgeon had to do a Kyphoplasty at L4/5. Having been his original rep about 8 yrs. ago, he asked if I'd simply help the scrub tech prep eveything as she was new. I said no problem as he is a good friend & customer.

    After the case I asked why the actual rep hadn't shown up for the case, the surgeon responded, "He hardly ever shows up, seems like he only does when he needs to have the shelf stocked."

    A typical example of what this industry has become which is a bunch of lazy, spoiled brats who don't want to work & who walk into situations where they've done NOTHING to build the business, but expect to earn $250K/ yr. There are many great reps in this industry who've spent yrs. building tremendous books of business for companies, only to watch as much of it is split & taken away, then given to some upproven, lazy, irresponsible rep who does nothing but piss the business away over time.

    Thank good for the mergers that are occurring as in additon to cleaning up much of the dreck & redundant technology in the marketplace, it will also help rid the sales environment of much of the good for nothing, unproven, overpaid reps who've been earning way too much for contributing very little to nothing at all.

    ReplyDelete
  46. 747am. Amen to that!

    ReplyDelete
  47. Hey 7:47, I'll take the flip side. Did you ask yourself why we (the insurance premium paying community) should be paying a rep to stand in a room for the docs' umpteenth Kyphoplasty? I hope he was out selling something or supporting a case by a doc using a product for the first time, or otherwise making himself useful for the money he gets paid. Sure, you did the right thing by helping out. I would expect nothing less from anyone. I also would expect you had a good reason to be there too, unlike the Kyphoplasty rep who for the most part would simply have been there wasting my money.

    ReplyDelete
  48. May 19, 2011 7:35 PM

    When did Boston College win a national championship in football?

    May 20, 2011 7:30 AM

    Agree with you about "Mr. $245K After Taxes", but why sooooooo angry? Life is short.

    ReplyDelete
  49. 7:47 How do you perform a kyphoplasty at L4/5? Shouldn't it be at L4 and/or L5? Are those that common?

    Does a surgeon and hospital that's been using this technology for 8 years really need a rep in the room to "set up" a case? At some point the Surgery staff has to take over.

    Also, I highly doubt that any current Kyphon rep is pulling in $250K. I realize there are unique one time situations, but that job doesn't require near the expertise it did 8 years ago.

    ReplyDelete
  50. @ 10:29 & 10:51 Laughing at your responses,, Which one of you is the rep who was the no show for the case?

    As for your comments,, "Why are we paying a rep to stand in the room for the doc's upteenth Kypho" & "Does a surgeon and hospital that's been using this technology for 8 years really need a rep in the room to "set up" a case? At some point the Surgery staff has to take over".

    Couldn't the same be said for an ACDF, PLIF, TLIF, etc?? Really,, how hard is it to pull an implant from a tray & load it on an inserter or to load a pedicle screw on a driver? Hell, many scrub techs know more about the sets & instruments than some of the reps who are there to provide support.

    You're probably both reps who are bitching about PODs when the very point is IF YOU PROVIDE A HIGH LEVEL OF SERVICE TO YOUR CUSTOMER & BRING VALUE, YOU WON'T BECOME IRRELEVANT.

    Once again, thank to both posters for emphasizing my earlier point of how lazy & complacent so many reps in this business have become.

    ReplyDelete
  51. @6:28: Re. "Arthroscopic discectomy is a game-changer if it doesn't add too much to the cost of a surgery."

    How exactly will it change the game? Decompressing the nerve/root/dura by removing the herniation won't change. Will reducing the scar from 3 cm to 2cm, or reducing the hospital stay from 23 hours to 22 hours really make a difference?

    Now if it could prevent reherniation and disc height loss....

    ReplyDelete
  52. Don't reps get paid the commission whether they are in the room or not? How is not being there saving the "insurance premium paying community"?

    ReplyDelete
  53. 12:18
    Not having a rep in the room does not save any money nor does it cost the insurance companies, patients, or hospitals any less. The John Steinmann model for a POD is to simply add a middleman to siphon cash from the system by only implanting devices sold through them first. It has never been about saving money for the hospital. Why do the surgeons who join PODs, not use a lower priced implant, prior to joining the POD, when they didn't get compensated for the implant choice?

    ReplyDelete
  54. 7:30/Karl Marx.
    Why would you loathe someone for how much money he/she makes. I could loathe every spine surgeon for making $500 to $3million/yr but I don't. Granted the guy is a complete d-bag for the post but his pay is not the norm in this industry....which I am sure makes you really happy. You are obviously a bitter insecure looser that needs to worry more about himself and not other people. You should get into therapy and deal with your issues so you can be a happier person. I can't tell if you are a bitter surgeon or a socialist that found this blog.

    ReplyDelete
  55. 11:18 - wow someone hurt your feelings. So how did you cover a Kyphoplasty at L4/5? Fact is you have no idea what you're talking about.

    So keep covering the cases for your senior rep and don't forget your cart in SPD. You'll need it to haul those totes to fedex.

    Have no fear ... you'll get a territory soon (cough cough).

    ReplyDelete
  56. will that be one lump or two?

    ReplyDelete
  57. Ourobouros, anyone?

    ReplyDelete
  58. Wow...Ourobouros. That's a blast from the past.

    ReplyDelete
  59. 7:54 You are so right. Everytime I hear about GLIF, it's some new date. Always 6 months away. I m guessing the PM has no clue

    ReplyDelete
  60. Hey 11:18, the key word you said is provide a "high level" of service. But it's not just to the customer, but also the premium-paying public as a whole. I agree with you, being highly paid for standing around opening packages or stacking trays for routine ACDF cases is also arguably not money well spent from the public's perspective.

    In fact, one of the worst evolutions in our healthcare system was when we changed responsibility for prepping implant trays, etc. from a circulating nurse with a $60k per year salary to a rep with a $120k plus salary.

    Why it happened is obvious - at the time the cost of the implants - no matter how high - was passed on to the insurer, so the implant company providing the service was providing it essentially free to the hospital. They were happy for it, because it was one less job their overworked nursing staff had to worry about. But that trend is reversing, and now either the hospital is saying "we'll pay our staff to handle the sets if you give us a discount", or the companies are providing junior or service reps to do the job at a lower salary, and thus also are able to charge the lower price. Either way, the balance of the payment level for the service provided is getting back into alignment.

    And 12:18, to effectively manage costs anywhere in the system, we have to reduce the wasteful, redundant or unnecessary services that go with it. In the above instance, if the kyphoplasty rep is hanging out in the room being redundant, then he's not providing a valuable service for us all elsewhere. And if as you suggest, if he is working elsewhere and he's making too much money because he gets paid commissions on both the cases he's at and the cases he's not, then there will soon be someone else stepping in who will do the same for less.

    signed 10:29

    ReplyDelete
  61. 12:15,
    Let me be more clear: Athroscopic discectomies with HD video of perfectly prepared endplates, then perfect insertion and placement of the allograft/peek etc. Stryker and a couple of small scope co's are working on this now.
    Thoughts?

    ReplyDelete
  62. What do you all think about the increase of the interventional pain dr performing more complex spine surgeries. IMO I think many of the new emerging spine technologies are going to be target at that group. Thoughts?

    ReplyDelete
  63. 5:39,
    When you said 'discectomy', I thought you meant 'disectomy' not 'fusion'. A better prep of the fusion bed will not substantially impact fusion rate or more importantly, outcomes. Discectomy on the other hand needs to be improved, with 25% of patients ending up with a smptomatic recurrence and/or disc height loss and fusion, within a few years.

    ReplyDelete
  64. Anyone seen a line on this OsteoFab stuff? seems the PEKK guys have figured out how to sinter their polymer into useful shapes with real strength. You have to like the idea - make whatever is required from a scan, modified or no. Shoot- make a whole vertebra just like the original. Better than OEM, maybe...

    ReplyDelete
  65. What about the re-launch of Chymopapain? Could that fit into the innovative category? Maybe not, it's an old story, but it may rear it's head once again. I understand the usual suspects,... Hochshuler, Yuan and even Yeung are involved in this venture back to the future? Any insights on this or thoughts about its potential impact to the market?

    ReplyDelete
  66. In my review of the hundreds of little companies out there, there are only four with innovative solutions:

    VTI - huge implant through tiny hole

    Trinity Ortho - a screw system that restores lordosis (yes, an innovative pedicle screw!)

    SpineSelect - TLIF done on an outpatient basis

    Wenzell Spine - an expandable interbody that won't fail like the rest of them...

    ReplyDelete
  67. 8:00,

    You left off ISTO Technologies. They have the first cell based platform for disc regeneration. They also have a product in human trials called Denovo ET. They are growing cartilage outside the body. They also have a novel synthetic bone graft extender called InQu. It happens to be the fastest growing synthetic in the U.S.

    This is a company that is flying under the radar, but they have two game changing technologies in the pipeline. The future of spine will come from the Biologics arena.

    ReplyDelete
  68. I want to hear more about Blackstone funneling money through Intra-Op monitoring... got a feeling it's happening in a couple of my accounts

    ReplyDelete
  69. Does anyone know any more detail about docholdingsllc and neuromonitoring?

    ReplyDelete