Recently, one of our commentators asked if TSB would table a discussion regarding Tier 2 companies. In an attempt to understand the comment, MSM believes that this individual really meant Tier 3 companies. If one looks at the big picture, Tier 1's are comprised of Medtronic, DePuy/Synthes, Stryker, and Nuvasive. The Tier 2 are comprised of Globus Medical, K2M, AlphaWreck, Lanx No Thank, Orthofix, Biomet/EBI and Zimmer, and the last two get a nod based on their size rather than their respective portfolios. The majority of these companies have portfolios that allow them to compete on an even playing field, at least that illusion exists at Biomet and Zimmer. But who are the Tier 3 players and how do some of these companies survive considering their make-up? Which one of these players have brought innovation to the marketplace? The companies that embrace this category are Amedica (Si3Ni4), Allez Spine, LDR, SpineWave (StaXx), Integra Spine, Expanding Orthopedics, Spinal Elements, Medicrea, Pioneer, Choice Spine, X-Spine, Life Spine, Eminent Spine (Is George Thorogood the CEO?), Eden Spine, Custom Spine, aka Closet Spine, Paradigm Spine, Centinel Spine, Spine Frontier (Is William Shatner the CEO?), Trans1, Titan Spine, Wenzel Spine, SI Bone, Vertiflex, and VTI. Some of the newer entrants into this happy go lucky group is little known Zyga Technologies (what is a Zyga?) and OIC ( obviously an original acronym if their ever was one). For the obvious reason, TSB cannot include everyone. But for the vast majority of us in the industry, this scorecard makes up the vast majority of the players.
The impetus for this post comes not only from one of our readers, but it is also influenced by another commentator who attacked the readers by posting the following, "how many of you hotshots took a risk to develop an idea for a spinal fusion device or a nucleus replace devise (sic)?" Our reply would be, "how many of you can fail multiple times at the expense of the investors?" Let's be honest, how many of the Tier 3 companies were developed prior to, or at the time the market began to fold in 2008? The vast majority of these companies had an idea that if they positioned themselves properly they would be sold. Can you spell W-i-n-d-f-a-l-l? Yet, in response to our wounded CEO's comment on April 23rd, 2012, how many of the T3 companies have or had developed a product as a solution to a problem that doesn't exist? Is Silicon Nitride going to better the outcomes? Investors have pumped at least $100 million dollars into that company and TSB's guess is that they will never recoup their investment. Is a titanium alloy surface a game changer for inter body fusion? In reality, how big is the SI market, considering the hoopla and money that's recently been infused into Zyga? Don't 7.3mm cannulated screws work, considering they create compression across the SI Joint? TSB forgot, their not as sexy as a plasma sprayed fertilizer plug from Home Depot. There is some interesting technology in the Tier 3 group, but it probably comes out of one or two companies at most. As one engineer so eloquently put it, "in spine, people develop their idea first and then look for an indication." Don't shoot the messenger, just think about the message. How many different ways can the industry address fusing someone's back or alleviating pain? Innovation is important. It is what drives the human spirit. Yet, TSB has more respect for those Tier 3 companies that are purely driven by profit, no matter how they do it, rather than create the illusion that they are advancing spine technology. It's quite obvious that some of the companies that have reversed engineered products generate more revenue than those that tout their genius, and you know what, kudos to them. Years ago, we were creative. Unfortunately, as more and more companies have surfaced for the obvious reasons, we no longer innovate. We saturate. Think about it. It takes some of these T3 companies three years to bring out a new product. If a cannulated pedicle screw is all you have to offer, then fall in line. Thank the investing surgeons for being your slaves.
TSB wants to know what technologies do some of these companies have that would benefit the big boys? Who is primed for acquisition? Is anyone of these companies a contender? As hospitals create barriers for the smaller vendors, what strategy will you use to sustain your business model? Will the government step in to alleviate your angst in competing with POD's? Or are we heading to the complete destruction of the traditional business distribution model? It's here, whether you like it not.
"on the day I was born, all the nurses gathered 'round
and gazed in wide wonder, at the joy they had found
The head nurse spoke up and said, "leave this one alone"
she could tell right away that I was bad to the bone"
I just got back from SpineWeek and was surprised to see SpineArt had the largest booth with the most traffic. They seem to have good products but their largest innovation is sterile implants. They are small in the US but growing fast globally. I am not sure if it's an innovation but it seems to be working.
ReplyDeleteThey look like junk to me. The implant process is very disruptive and the disks offer no shock absorption and they over rotate. They are nothing more than a "Me Too" device.
DeleteWhat are you talking about? The disc market in the U.S is dead right now. Unless someone is going to invest 50 million in your idea it will never see the light of day.
DeleteNo one is investing in another disc. Stop the insanity. No one is buying another disc for some ridiculous F you money. Reimbursement and pricing is an issue.
DeleteTheir largest innovation is sterile implants. That's impressive....
DeleteMaybe you will be impressed when your company is forced to provide sterile implants. Keep your disgusting implants away from me and my family. I will pass on anything you keep in your car and garage being implanted into my body. You and your company are a bunch of pigs putting patients at risk. Think about it......if it was you would you prefer brand new implants opened 30 seconds before implanted or your implants that travel the county getting contaminatind and cleaned over and over again. If you choose the latter you are an idiot.
DeleteWhere do you think those sterile implants are gonna be stored and transported? In somebodys trunk!! So how sterile is your sterile packaged implant? It's not perfect either but at least one that was autoclaved. Don't get me wrong, sterile implants are a good idea, but not the only way to provide safe implants
DeleteIt makes no difference as the liability falls on the implant manufacturer. Your company puts the liability on the hospital to sterilize the implants.
DeleteYour argument makes no sense as the implants are sterile unless the packaging is damaged. So which implants would you prefer? There is no question that sterile implants are a huge advantage. I assure you the hospitals feel the same way.
What if the package is not damaged but has exceeded the allowable temperature range or has been stored in a high humidity environment, unbeknownst to the hospital? As I said, I think it's a good idea but cannot be executed perfectly. I would prefer that the hospital accepts liability for the sterility of the implants because they actually follow the SOP unlike reps carrying trunk stock. The ideal would be sterile packaged implants that never leave the hospital but the main benefit to manufacturers of having sterile implants is that they can have fewer total implants covering more cases if sterile implants are portable. So we are back to the question of being able to validate the storage conditions under which sterile packaging must reside in order to guarantee sterility. It's more complicated than simply identifying a damaged package. Sterile packaging is good but not a panacea. Steam sterilization has been the standard of care for decades and it has a damn good track record so I wouldn't bet the moon on that single feature making or breaking any product.
DeleteHah! 8:19 here. I wasn't even commenting as to the sterile implants vs non-sterile implants. I was merely repeating your quote of "their largest innovation is sterile implants" and thinking that was pretty funny. The largest innovation is not the implants, according to you, but the fact that Spine Art sterilizes the implants. C'mon, that's just funny!
DeleteIt's called improving the user experience. The iPhone is just a phone right? It does the same thing as every other phone does so I guess it's not innovative. SpineArt has several products currently being studied in Europe that are completely new ideas and materials. Keep doing what your doing though I am sure the people above you will make everything alright.
DeleteDon't back tread now. You said their biggest innovation was that they sterilized their own implants. You said it, not me. "Spine Art. Our biggest innovation is that we sterilize our own products." Funny.
DeleteSpinal USA?
ReplyDeletehttp://www.spinalusa.com/solutions.html
DeleteSpinal USA is another Me Too company making junk.
A couple of goobers at a local hardware store could come up with a safe, flexible, durable and shock absorbing disk spacer is a couple of hours. Disk implants were used successfully in the 1950's. This is the 21st century. I have contacted all the major device manufactures about my disk design. None of them have contacted me.
ReplyDeleteI have a superior design that does everything that the M6 and NeoDisk can do and more. My design is infinitely adjustable in both ROM, height and flexibility. It can also distract adjacent disks. No keel is required and it only requires two small carbon fiber screws. A monkey and most American surgeons could implant one.
Does it come with reimbursement and will it prove to be better than a fusion? If you don't have the reimbursement issue licked, as no one does, this is why the biggies, no pun intended, aren't interested. There is no return on investment for the IDE. If these devices ever become 510kable then hang onto your IP and at that time you may be able to generate some interest, even if it something one of the biggies may want to just shelf.
DeleteDear Fat Bastard, why do you refer to surgeons as monkeys..can you expand? Why are you so upset with surgeons (who are so greedy according to you) , companies (who won't buy your implant) and the world in general. - A concerned-for-your-health reader and occasional contributor.
DeleteIt's pretty obvious what Fat Bastard means. The highest paid doctors are American and 20% of the US GDP is medical.
DeleteWhat you morons forget is that there are more than just the US market. India, Japan and China has some damn good engineers and doctors and a hell of a lot more people. They can come to the US an set up shop on Indian land and tell the medical industry and the FDA to have aeronautical intercourse with rotating pastry.
Fat Bastard your idea sounds very interesting and you sound like a sharp guy. Are you located in the US?
ReplyDeleteLooks like Spinal USA is considered Tier4...junk is junk my friends! Even TSB does not have you Surgeon owners on its radar...lol!!
ReplyDeletespinal usa has concealed any information on how many of their implants require a 2nd surgery and cost to remove the defective hardware that breaks and the screws backing out----I am now wondering since TITAN SPINE AS OF SEPT. 8 ,2014 is giving a warranty on their hardware will the FDA make all of them now give guarantees since the others are not similar in that respect. I actually feel betrayed by our govt. to have allow these makers of the screws implanted not to be responsible for breaking and backing out----especially when you are charged over a 1000 dollars for them----its not right.
DeleteLifevSpine has an expandable ISP. Anyone ever use it?
ReplyDeleteUlrich Medical has the best cages on the market. Can't believe they haven't been gobbled up by one of the big boys..
ReplyDeleteTheir expandable metal cage is nice, but the PEEK expendables/buildables are better for obvious reasons.
DeleteThere are much better cages, both PEEK and Ti on the market. XCore Mini is a game changer and with any luck will own the market. Ulrich is a very small fish without much innovation.
DeleteSpinal USA LOL!!!! Joker, Jugglers and Clowns.
ReplyDeletemy friend had their screw latches break and then the screw back out and a 2nd surgery needed
DeleteUlrich Medical? A one trick pony and that pony is tiny and outdated
ReplyDelete6:50 Outdated??? Then why doesn't anybody have a better cage? Especially the small one
ReplyDeleteYou obviously haven't seen the new Nuvasive corpectomy implant. It will finish off Ulrich when it's released.
DeleteYa good thinking on this post! Theken had great products. We should still be selling that! No inovation in cervical plating at all!
ReplyDeleteSpinewave is next to go out of business. They carry more debt than their company is worth. We looked at them a few years ago and walked away because of the debt load. Plus, all of their business is from consulting surgeons.
ReplyDeleteMore debt than the company's worth LoGuidice is running the American dream machine, lol
DeletePlus, every doc using them is on their payroll.
DeleteAs a distr who has sold SW for 9 months I can say they do not pay all docs and seem to have their stuff together. Atleast more together then the other 2 tier 3 companies I represent. The Sniper perc system is one of the best on the market. Give them a little credit. Out!
DeleteI've heard paradigm Coflex getting pma and starting process to sell before distribution
ReplyDeleteSell to whom?
DeleteOf course they would rather sell than distribute. They have no money for inventory to support any agents. I wouldn't doubt that they will try setting up stocking dealers. Words to the wise unless you have money to burn, if they want to set anyone up as a stocking dealer DO NOT BUY INVENTORY TO FUND THIS COMPANY OR YOU WILL MOST PROBABLY LOSE IT. Just my opinion since more than once all the executives for any V company have been asked to go without pay for a few months one or more times.
Deletev bros employees make more than any other company's except maybe the most senior employees at top 5 companies.
Delete1:51 That is part of the problem then, considering they don't sell as much as the top five companies.
DeleteI actually think it means vb hires people with a heart as oppose to 99 percent of stupid management decision makers. That's how you persevere and get IDE studies to pma approval by thinking long term.
DeleteMarc is about as smart as they come in this industry or any other. Of course the V Bros are contentious, but certainly not in the way David Paul and the G Group. People here may not agree with how they do business sometimes and yes they are not the easiest to work for, but please raise your hand if you have been screwed over by them...that's what I thought almost no one. Its pretty much limited to Mike O'Neil, and according to Mike who hasn't tried to screw him over. Has there ever been a start up that the executives didn't have to hold their salary at some point? Maybe not if you are funded by Sand Hill Road, but otherwise that has been pretty commonplace during the last 4 lean years around spine. Coflex will get PMA at some point the data has been seen enough of late, but the secret sauce is the reimbursement work was already done for the study and insurance co's are prepped and ready to go. Seeing how many other PMAs have died of late this could be the last PMA non-disc in spine for 10 years. Someone with deep pockets will find value in having control of that market using the PMA and the IP to push some others out. Just my opinion for what its worth. Not a VB apologist by any stretch, just familiar with the industry and thought someone who wasn't jaded by it should chime in. Happy Selling.
DeleteLook at VTI, another company run by a two time loser (disc dynamics and ABS), champagne dreams with caviar wishes, can't manage its own finances, desperate for cash, without consultant business this company is toast
ReplyDeleteDisc Dynamics never went anywhere and they burned thru how many millions, what is an ABS?
DeleteI would bet no one wants to invest in VTI because of some peoples track record
DeleteShip in a bootle? Sinking Ship in the bottle. Is the Captain of the Costa Concordia at the helm or is he in his dingy?
DeleteSpine Art has interbody prep instruments (rotating cutters/paddle scrapers) where the handle is in the shape of a big butterfly. Not very ergonomic. I've seen surgeons complain and other reps laugh. They laughed even harder after the docs quit using Spine Art products. What a silly little company.
ReplyDeleteThat little company just took the 4th spot in procedure volume in Europe. The Butterfly handles havn't been in the sytem for a year.
DeleteAfter Northcutt gets his $25 million from Phygen, he'll probably buy Spine Art.
Delete4th spot in euro procedure volume? Reference or bs!
DeleteThe Spine Fart rep in my area carries around this dirty beat-up cardboard box (in his trunk) that contains his sterile implants. Or, I mean, he used to when he had cases here. So long.
Delete3 legacy companies have already made offers to buy SpineArt but the owners do not want to sell. They have several new technologies that will be released over the next few years. Their engineers have developed 2 new materials never used in the medical field before which is why the big boys want them.
DeleteNever has such lies and misinfomation been said as with SpineArt. The company is all show and no substance. Number 4 in Europe? Prime big three acquisition target? They will say anything to make the market believe they are a real player. They scrape up sales like all bottom tier companies do - low pricing and relationships.
DeleteThe truth hurts, they have great products and the world is pushing for sterile implants. They are also the first company to comply with UDI standards. They are a global company growing fast. No surgeon ownership, no POD affiliations.
DeleteYeah, and did you hear that their biggest innovation is that they sterilize their own implants?!!? Wow... They are for real!
DeleteProvidence Medical Technology / DTRAX. Approach is appealing - posterior/percutaneous cervical, innovative concept - indirect decompression & fusion, clinical evidence - 60 patients w/ 1 yr follow up. I attended a seminar at Spineweek re DTRAX. European surgeons having good experience and gaining momentum.
ReplyDeleteOne of my docs wants to use DTRAX. I emailed the company about distributor openings and am waiting to hear back. Anyone worked with the Providence guys before?
DeleteIs this not just another version of the run of dowels which are hammered into the facet joint and billing for a "fusion".
DeleteNo more like hammered/screwed into the SI joint like SI Bone
Deleteyou know why they are pushing this product, its sexier than a cannulated screw(s) and the reimbursement is higher, another scam by the man
DeleteThe SIJ market is most likely quite large (2x per every person undergoing significant loads). Seemingly, Zyga is entering the market with the instrumentation as their edge and not simply the cannulated screws. vs Globus and SIBone they attempt to prepare the joint by removing the cartilage and additionally can add bone grafting. I got the info from their site: http://www.zygatech.com/simmetry.php and found more info regarding the prep instruments here: http://sijpain.com/news/ see Dec. 14th 2010 entry and click on the patent application link. Additionally, here are some people discussing (what they think) are SIJ issues: https://www.facebook.com/groups/69991252216/
ReplyDeleteZyga has the old engineers from TranS1 and are using the same "disc prep" instruments for the SI joint. The system is essential the AxiaLIF for the SI joint. Innovation...perhaps not, clever....maybe.
DeleteSeems like most of these companies lose sight of what they were initially funded for and fail. Look at Amedica. Started off as a bearing surface company, and yet that is not their focus today. These companies need to stay focused at developing technologies that address a market need. Not the other way around (technology looking for a market). If all you have is a hammer, everything starts to look like a nail.
ReplyDeleteSpine Art as #4 in Europe? What a crock of s#*t
ReplyDeleteSpine Art popped up in my territory about a year ago. The sterile implants thing is unfortunately gaining momentum with a lot of the docs and hospital staff. Its my understanding that Stryker and DePuy are already working on similarly packaged implants to sell by 2018. If this standardizes it is going to shut out a lot of companies unfortunately. So much for let the good times roll...
ReplyDeleteSterile Packaging costs $5 to $10 per implant max. What world are you living in thinking this is a unique technology? All across the rest of the world sterile packaging is the norm.
DeleteExactly. Where has this guy been? Been in a hip case in the last 10 years?
DeleteIt is not unique, the fact that you sell your implants loose makes you and your company pigs. Would you allow a hip to be implanted in your body if it was loose in a tray and sterilized dozens of times? Our entire industry will move to sterile implants and SpineArt has a jump on everyone. You better hope hospitals don't demand sterile implants before your company is ready.
DeleteThe best part is the hospital supports SpineArt's sterile implants and become an advocate.
DePuy already has their sterile implant "machines" already in alpha launch. 2018 is way off, 2013.
DeleteSorry, 2018 until it actually works. The "vending machines" are pieces of shit. DePuy should have just put a bunch of implants in a glass case and had the OR staff use the claw to get them out.
DeleteIt will shut out a lot of companies?! If it becomes required, won't every company just start doing it? There, problem solved. Do you really think they'll make the effective date before the non-sterilizing companies can effectively comply? You, Mr Spine Art, are a moron and your company's biggest innovation, according to you, is that they sterilize their own implants.
DeleteHeard a rumor that Phygen is coming out with a new cannulated screw called the Hollow Tip. Anyone heard about this?
ReplyDeleteLeave it to some corporate gangster to make a disparaging remark about spine patients who are suffering for their greed.
ReplyDeleteTITAN SPINE now gives a warranty on their hardware----now will the FDA require all of them to do the same because they now are not similar in that respect.
ReplyDelete