Tuesday, March 2, 2010

The PEEK Wars, It's Time to Get It On!

Recently one of our readers solicited TSB's opinion about the monopoly that exists in the spine industry regarding PEEK (Poly-Ether-Ether- Keytone) material for manufacturing of ACDF, PLIF, TLIF, and ALIF interbody devices. At this stage I would think it appropriate to include PEEK rods and artificial discs. Could this be the beginning of a rebellion by the industry, similar to the movie Chocolate Wars? Rather than a young man rebelling against the ingrained heirarchy of an elite Catholic school, is the industry getting tired of Invibio's antics? I mean where's the competition?

So the question posed to our readers is when will Zeniva Peek be available? Zeniva is one of the most chemically resistant plastics available with high strength and stiffness, plus excellent toughness and fatigue resistance. Yet, it seems that Solviva has been giving the industry the same old run around when it comes to getting their material approved along with the time lines for commercial release? It was also mentioned that Modern Plastics is another innovator, when as of this posting it seems to be nothing more than an imitator.

How long will we keep paying "Infibio" the $225,000 -$250,000 for their licensing agreement?

Looks like Brother Leon has stacked the deck and that we need the FDA's ability to review the quality of Solviva's and Modern Plastic's material, along with some good old Catholic school boy rebellion? TSB wants to know what our readers think?

45 comments:

  1. I hope this all comes to a head shortly. We've heard the "our material will get FDA approval any day now" story for a while now. We decided to wait for such approval to avoid Invibio's huge up-front license. And, we've waited... and waited... and waited. Anybody know what's going on? Does Solvay really have a shot? What's the problem at the FDA?

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  2. The same problem the FDA has always had: Needing explanation of the terminally simple.

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  3. An added thought.....Westlake Plastics is in the process of releasing an implantable Peek...known as MediPeek. Appears that the monopoly may be over.

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  4. Modern Plastics is not an "imitator". We are the REAL DEAL and have a major Orthopedic implant company taking on our MediPEEK-IM Implantable PEEK product. We are actively selling MediPEEK-IM implantable PEEK for testing across North America and overseas. We are in fact an "innovator" and we also don't have all of the contractual obligations and minimum buys with our implantable PEEK products. It's traditional supply chain arrangments. We stock it, we'll ship it overnight. Full certifications, great pricing, complete bar-code traceability for 30 years minimum and most of all -hassle free purchasing. ISO 9001:2008 and currently working towards ISO 13485.

    Your prayers are being answered!

    Any questions contact Bing J Carbone, President, Modern Plastics or Vince Griffin, Medical Plastics Manager at 800.243.9696, Ext 215 or e-mail, vgriffin@modernplastics.com

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  5. Check out Modern Plastics on the MediPEEK-IM. www.modernplastics.com

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  6. Mr. Carbone:

    Do you have clients with spine devices in 510k application with the FDA? When would you expect to have your first spine implant approved? How has the FDA been in dealing with you as a "new PEEK material"? Why have we been hearing stories for months and months that "approval is just around the corner". I hear what you are saying, and I'm hoping you'll be a viable option soon, but something doesn't add up?

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  7. Another high performance thermoplastic of the PAEK family, which is superior to PEEK in terms of mechanical properties and processing advantages, is missing here in the list of PEEK Optima competitors: PEKK!
    PEKK is a copolymer, thus available in an amorphous and a crystalline grade! It is commercially available under the trade name OXPEKK from Oxford Performance Materials (OPM). OXPEKK-IG is ISO 10993 tested; it has been implanted for many years in the rest of the world and new material solutions made from OXPEKK material have recently been introduced to the market place (http://www.prweb.com/releases/OXPEKK_BioFlex/Quantum_Composite_Nail/prweb3454634.htm). Off course so far only outside of the US!

    OPM does have an extensive master file with the FDA though and doesn’t charge access/licensing fees!
    Is the FDA prohibiting innovation? Will we have to rely on Europe to benefit of the latest innovations?

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  8. Any surgeons out there reading this post? Why do you like PEEK vs. Titanium?

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  9. Any surgeons out there reading this post? Why do you like PEEK vs. Titanium?

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  10. Modern Plastics has supplied MediPEEK-IM rod to several Spine Manufacturers. Currently these companies are conducting their own biocompatibility testing and are in the process of internally approving MediPEEK-IM for implant use.

    Once the devices and prototypes are completed they will be submitted to the FDA for 510K approval.

    We expect to have the first MediPEEK-IM device approved by the FDA in June 2010. We do not deal with the FDA directly but our material is considered an equivalent to the implantable PEEK on the market and the FDA Master File number can back that statement up. There have been several companies over the years claiming to have an "equivalent implantable PEEK product" with a reliable supply chain in place.

    Modern Plastics offers:

    Reasonable price to medical device manufacturers

    No buy-in fees, royalties or inventory tracking

    No language barrier in business transaction and customer support

    Pre-and-post sale customer support and technical consulting

    Willingness and capability to work with customers on product development and OEM production

    A variety of forms –resin, compounds, stock shapes, compression molding, injection molding, near-net shapes

    Perhaps that does not answer all of your questions, but I’m giving it to you straight..!

    Thanks.

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  11. Cages from Amedica: They use a silicate with a roughened surface vs. plastic (PEEK). I believe these factors allow for a better healing response for bone to form in and onto...I can also see it on xray as well as assess fusion post-operative.
    PEEK has a body of evidence mounting against it for migration and fiberous response.

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  12. This comment has been removed by a blog administrator.

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  13. I would not trust anyone except Invibio for my PEEK. How many recalls? None. The cost of Invibio PEEK vs. the sales prices is nothing. What will be the cost of a recall? Substantial. The manufacture of a polymer is highly complex. Why do you think the FDA has such a hard time approving another material? Why risk it? For a point or 2? We will not be risking it.

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  14. Someone asked why PEEK is preferred over titanium for cages. The answer is twofold. First, PEEK has a modulus of elsticity similar to bone and is less likely to subside under axial loading. The other is radiolucency- PEEK cages are transparent on X-ray. This allows for assessment of the bone growth inside the cage. Titanium cages are rarely used anymore.

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  15. Dear Anonymous 5:41

    Sounds like a advertisement for Invibio. Considering that everyone loves to cry out "free market enterprise," wouldn't a little competition be great for the industry? I find it hard to believe that the FDA is truly concerned about a point or two. But like I say, you're entitled to your opinion, even if its contrary to the dissenting opinion within the industry.

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  16. Shawn Shorrock - Solvay Advanced PolymersMarch 3, 2010 at 7:42 AM

    It is certainly time for Solvay Advanced Polymers to weigh in on this. I am the Global Medical Market Manager for Solvay Advanced Polymers - Solviva is our family of biomaterials offered for use in implantable medical devices. Zeniva PEEK is our PEEK product and we empathize with how the industry feels we’ve been providing “the run around” regarding the availability of this material. Zeniva PEEK has been approved in one device, albeit not a spine device, via the 510(k) process. With respect to spine, we are working closely with our customers and the FDA to address the FDA’s requests and concerns regarding Zeniva PEEK in spinal applications. I do have to laugh at one of the postings regarding the FDA requests – yes, we are struggling to understand the relevancy of their requests. However, as I am sure the readers of these blogs know far better than us, the FDA’s expectations don’t always align with those of the manufacturers or the raw material suppliers. I can assure you all that we are working diligently to address the questions posed by the FDA. I can also assure you that we will sing loudly from the rooftops once even one of our customers receives 510(k) approval for a spine device. As you well know, we can’t guarantee a date as to when this will occur but we are optimistic that it will be soon.

    So, to address some of the other comments, what does make us different? We don’t just sell Zeniva PEEK. We have three other products available in the Solviva family of biomaterials – Veriva PPSU, Eviva PSU and Proniva SRP. We have well developed MAF’s for each of these products and ongoing developments in all three. This broad product offering gives designers more design options for their implantable devices.

    All of these products are manufactured in Alpharetta, GA on dedicated assets under the relevant aspects of cGMP and ISO 13485. We perform process validation on all of the Solviva manufacturing processes and have full product traceability in place. The Solviva products are available in resin form and Zeniva PEEK and Proniva SRP are also available in a variety of stock shape sizes.

    If you are interested in learning more about the Solviva family of biomaterials or just want to be put on our contact list to be contacted once the FDA has approved a spine device using our Zeniva PEEK, please email me at shawn.shorrock@solvay.com or visit our website at www.solvayadvancedpolymers.com.

    I will also check back to this site regularly to address any further questions that come up regarding our Solviva products.

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  17. Does someone have a quick and easy explanation of why the source of PEEK material is an issue? My understanding of other materials, i.e. Titanium, is that as long as the material conforms the the appropriate ASTM standard, it does not matter who it comes from. As long as the vendor is ISTM certified, it can be reasonably assumed by the manufacturer that they will conform to the ASTM standards.

    Why is it a double-standard for medical PEEK?


    Also, just a note on MARCH 3, 2010 5:41 AM, there is NO WAY this is not someone from Invibio. At best, everyone that buys from them resents their monopoly, at worst it would be hatred.

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  18. To amplify Anon 02MAR10 1359:
    I am fairly certain that I have seen CE mark certs for spinal devices (cages, likely) in the OXPEKK material (not a PEEK, but a closely related material) dating back some years. I have also NOT seen any reports of recalls of those devices, granted that I have not searched deeply, but recalls tend to have some visible profile. I also understand that OPM has a masterfile with some heft. Seems to put them in a position to challenge the US monopoly if/when the FDA emerges from their current visit to detox.
    Come to think - harsh language also seems lacking when discussing this OPM company. Noteworthy.
    Anon 02MAR10 1057 - Yes, it seems the blindingly obvious has, in fact, blinded the FDA outright. The EU seems not to have an issue, at least not with this OXPEKK stuff - maybe they ate more carrots as children?

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  19. I totally agree with 7:48.... resent & hate don't fully capture the disdane I've had for their attitude over the years.... what a bunch of smug gougers. The Spine industry can't wait for a viabale competitor and I for 1 (and perhaps all spine engineers globally) am/are cheering the competition on.

    Viva la PEEK competitor

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  20. Invibio has been arrogrant for years!!! Bring on the competition. Hatred is too kind of a word!!! My company is in talks with their NEW competition and we are switching as fast as we possibly can. Good riddence Invibio!

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  21. John Devine PhD - InvibioMarch 3, 2010 at 10:03 AM

    TSB has raised an interesting debate on the cost of PEEK and Invibio have observed rather than participated –until now.

    What represents value for money in selecting a supplier of biomaterials in today’s regulatory environment? Is it solely the cost of materials or the value creation through innovating with those materials (TSB has discussed the merits of the innovative VTI device from PEEK and it has been stated that $300M of PEEK devices were sold last year by one industry leader).

    Invibio has had competition for a number of years and believe that value relates to quality, safety, biocompatibility and security of supply and most importantly meeting and investing in the regulatory demands placed on medical device companies. Those familiar with the polymer industry would agree that monomer purity, polymer purification, synthetic route and post production processing can all impact on not only the biocompatibility but the mechanical properties. Therefore these values should be investigated and demonstrated rather than assumed. We also understand that these values need to be provided for a relatively small fraction of the device selling price.

    This is only one piece of the jigsaw however, and there will be many views on how much involvement and investment biomaterials companies can make in medical device development. Our view has always been that we want to and need to know how the material works in the actual device and this is why, for example, we have been contributors to the research of our materials in spinal arthroplasty devices and fatigue performance in PDS systems.

    For those interested in learning more about our approach please contact me direct through the usual channels.

    John Devine PhD.

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  22. How about MedShape Solutions. They have figured out how to apply shape memory to PEEK and have just released a suture anchor. I do not believe they are getting their source material from Invibio. It will be interesting to see what spinal applications they come up with.

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  23. "Considering that everyone loves to cry out "free market enterprise," wouldn't a little competition be great for the industry?"

    Actually, protecting innovation and intellectual property is the foundation of the US Medical Device Industry - I can't believe you are advocating that someone else copy Invibio's product. If someone wants to make a device out a novel material let them, if they want to get to market fast they will probably choose something that has a Master file at FDA like Bionate or PEEK... Its the company's choice, but nobody has the right to say that another company shouldn't be able to benefit from its IP.

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  24. Dr. Devine,

    The issue is not whether InVibio is delivering value (most believe they are or we wouldn't buy the stuff), the issue the relative worth of the value and the manner with which InVibio treats it's customers.

    This blog should act as a wake up call to your Management. I assure you, there is broad support for a competitor among your customer base. As soon as the Regulatory risk of using an alternative PEEK is resolved, your business will likely drop.

    Other premiumly priced technologies have learned to treat their customers right while still extracting a premium price.... you should look to a few (Apple) and take the leason.

    Anyway.... good luck with your current approach... have a good AAOS and enjoy it while it lasts.

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  25. To March 4th 8:48am..... (IP Dude)

    Ain't no patent on PEEK.

    .... just FYI.

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  26. (IP Dude)

    Ain't no patent on PEEK.

    ---

    There WAS, otherwise this discussion wouldn't be happening.

    The point is that people who are so upset that there was only one source could have chosen another material; apparently there were reasons to work with Invibio and it seems like those reasons are being lost in this discussion.... IMO

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  27. Anon 0945:
    The reasons continued (until recently) to come down to lack of choice. In the US Invibio (for reasons comprehensible only to the FDA) enjoys a monopoly. In EU, OPM's OXPEKK-IG materials have several CE approvals awarded these last few years - prior to which Invibio also had monopoly. The current regulatory environment in the US is such that no one seems able to penetrate with a polyketone (even OPM's apparently demonstrated good & safe PEKK)- it is unclear whether Invibio would be able to do so now themselves.
    Oft times, choice is an illusion. Stage magicians have been fooling the public into thinking they made free choices for centuries...

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  28. I'm always amazed when Bing "I inherited everything from my Dad" Carbone makes a statement. They haven't shipped any pc of MediPEEK to date.Fact. They don't make the material. Fact. And there recent attempt to buy support at a manufacturer fell through. Fact. So take what this guy says whith a huge grain of salt.

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  29. Solvay's Zeneva PEEK (made into stock shapes by Drake Plastics)and Evonik's VEATKEEP I ( made into shapes by Westlake) are 2 very good, pure alternatives to Optima. If everyone reads the the memo, K97-1 you will see that the need for new 510K tests is and may not be necessary when going from one PEEK to another PEEK. They do however tell the OEM in strong words to basically do your due diligence and "use logic when making a change".New 510K tests are required, in my understanding when there is a change to the geometry of a device, a process to make the device or a "significant" material change to a device. The OEM doesn't currently submit for new 510K test when they go from using the same Titainium or Cobalt Chrome supplied by someone else do they. Nope. They do their homework on the new supplier as they should. Let's face it when and if this Obama care goes through all of these Spine OEM's & PEEK users will be looking to cut costs and take evrything overseas so these new products will find a quick fit

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  30. Someone has made another novel biomaterial, a small Swiss company, coLigne AG has a long fiber carbon reinforced polymer (ostaPek) that has already received 2 market clearances via 510(k) on spinal devices. Carbon composites are stronger than pure plastics and therefore much less material is needed for the structure of a device optimizing the biologic potential of the graft. They also have greater cellular adhesion which could promote earlier fusion mass (Note the 'halos that are sometimes present in post-op diagnostic images of PEEK devices.

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  31. Anon 0447:
    You have never done it, have you? Attempted to ply the FDA with that logic? Go try and let us all know how you get on. I suspect that some large part of the fusion cage manufacturing world will be grateful and thankful if you can manage the feat.
    I, for one, will not wait up for you. I would, however, be happy to greet you with fresh coffee if/when you DO stumble in...

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  32. Where is Boom Bada Bing when you need him. Probalbly crying over spilled milk again

    VESTAKEEP I >>>MEDIPEEK IM are here to stay and so are we. You will hear about us bery soon in the market

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  33. We have purchased MediPEEK-IM. Fact. We are going to be purchasing a lot of MediPEEK. Fact.

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  34. Now that the entire marketplace has gathered virtually to discuss Invibio's monopolistic position in the US market at this point of time and since the majority of you are CLEARLY WELCOMING THE COMPETITION, it is time for Oxford Performance Materials (OPM) to contribute to this very interesting blog!
    I am the Biomedical Marketing Manager of OPM and OXPEKK® is our branded PEKK (PolyEtherKetoneKetone) which has undergone extensive biocompatibility testing per ISO 10993. As somebody mentioned already earlier in this blog, I'd like to confirm that multiple devices made from OXPEKK-IG have been implanted for many years outside of the US.
    Our business model consists of charging for the material only - no royalties, no access fees to our extensive masterfile at the FDA!

    Unlike a few others who have spoken up in this blog, OPM is vertically integrated in the supply chain with its parent company Arkema who is responding to the demand of the fast-growing polyketone marketplace, in particular in the medical sector, by bringing on European and US production capabilities. Arkema reported sales of 5.6 billion euros in 2008, has 15,000 employees across 40 countries and six research centers with broad analytical capacities in France, the US and Japan.
    In short: OPM is not anymore this small player we used to be but has grown into a much bigger competitor.

    OPM is committed to the marketplace not only to bring on products like bar stock, but innovative products like mono- and multi-filament, radio-opaque compounds, OXPEKK Permetta film, as well as OXPEKK BioFlex, our fully implantable continuous carbon fiber composite offering which is radiolucent and can be anisotropic, thus enabling highly selective mechanical performance.

    Also worth mentioning is the fact that OXPEKK is not a "me too" product. In comparison to PEEK PEKK demonstrates higher mechanical properties (80% greater compressive strength than PEEK for example), as well as processing advantages through optimal flow and crystallization kinetics.

    OPM is offering you a unique supply chain solution: not only can we supply you with bar stock and pellets but also offer molding services of near net shapes in our ISO class 8 clean room!

    Finally, a word regarding regulatory situation of OXPEKK-IG in the US: though it is true that we have worked diligently and long with the FDA we are sympathetic with their plight as they have extensive mandates and limited resources. Given these pressures we remain confident that the FDA will in the end approve 510(k)’s with OXPEKK-IG based upon the extensive data we have presented and clinically relevant data from our many customers outside of the US.

    If you would like to learn more about our biomedical OXPEKK offering, please don’t hesitate to email me at sobrien@oxfordpm.com!

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  35. Further competition is available from Orthoplastics. I am the David Brooks, President of Orthoplastics. We are s dedicated manufacturer of implantable grade plastics. We ONLY make implantable grade plastics and would be VERY happy to assist anyone looking for an alternative to BOTH Invibio and Solvay. Try emailing brooks@orthoplastics.com

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  36. I would like to thank you for sharing your thoughts and time into the stuff you post!! Thumbs up plastic injection molding

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  37. Can someone explain what Invibio charges. I get the idea there are upfront fees but what is the $/lb and are there royalites based on the value of the devices? How much cheaper is Solvay, Evonik or OPM?

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  38. Good question! I am also waiting an answer... Maybe from one of Invibio's customers...

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  39. This comment has been removed by a blog administrator.

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  40. For all those Invibio lovers here on TSB, Solvay just got clearance for Zeniva PEEK in the spine. Check out this press release:
    http://www.chempoint.com/News/Pages/NewsItem-5.html?ItemID=2068&NewsType=Industry%20News

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  41. community members who go through the auditing process–which can be anxiety inducing–but you make a great point about how strong systems and dedication to continuous improvement are what management systems are all about. Thanks for sharing.
    iso 9000

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  44. Thanks for this post.Its useful for us. I would like to share related post.
    Peek Plastic Manufacturer

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  45. Contact Modern Plastics for EVONIK VESTAKEEP permanent implantable PEEK - Bing J Carbone, bcarbone@modernplastics.com

    ReplyDelete