Synthes And Bioresorbable Internal Fixation Devices

Synthes’ roots are based in the non-profit Swiss research group, Association for the study of Internal Fixation or, AO, as it is referred to by the Swiss. The AO was formed by a group of medical professionals including orthopaedic surgeons, metallurgists and other scientists, whose goal was to find other means repairing complex fractures because the methods used around the time, the 1950’s, was either left patients suffering months of rehabilitation or with permanent disabilities. AO was built around three basic principles research, education and development, the building blocks for any R&D company. With regards to the education aspect of the organisation AO, would frequently offer multi-courses for other orthopaedic surgeons to enlighten them on the new internal fixation techniques.

AO began to work with other non-profit organisations, distributing implants to “a particular region” in the world, with exclusive rights. Synthes was given exclusive rights to North America, and its counterparts Stratec and Mathys were given exclusive rights to Western Europe and Eastern Europe Asia and Africa respectively. Synthes Itself was split into four different companies, Orthopaedics, Spine, Maxillofacial and Canada. For the purpose of this report the main focus will be Synthes Orthopaedic; they are the leader in US orthopaedic trauma implant market with a domestic market share of approximately 50%.

The question posed is whether or not Synthes should invest in bioresorbable devices, these are pins or screws or other fixation devices that degrade over time and are absorbed by the body instead of being removed manually. The obvious advantage is to the patients, because they will a smoother recovery process, the major problem that companies face however is finding the formula to maintain the fixation devices for a long enough period of time to ensure full recovery.

One of the main reasons why Synthes should get into bioresorbable devices is the fact that they are a R&D company and developing new products is their core function, it is one of the major values of the company. There is also the fact that any lapse in the R&D of the company may lead to their competitors producing a like product, obtaining a patent and gaining market share and recognition at the expense of Synthes. With companies such as Johnson and Johnson and Boimet competing to achieve the same goal Synthes needs to always be one step ahead. In most cases it is best to be the first mover in an industry, for example when Phizer created the Viagra pill, albeit accidentally, they maintained a patent on the drug for several years and the exclusive production rights allowed them to corner the market. First movers sometimes even create an industry standard, such is the case for Microsoft. Many people still believe that Windows is the best and only operating system, even though there are many other, much better OS’s in the world. Furthermore Johnson & Johnson have already crept ahead by producing the second generation of polymers for the industry, even though the success is still not as great as it could be, they still have that expertise. Synthes can use that knowledge to continue the research and possibly produce the third generation of polymers, the “game changer”, the one that works as well as they industry hopes. A key function that is required is not only research or develop the product, but also to sell it and another reason why Synthes should consider the bioresorbable market is because they have a hugely competent sales force, the case says they are the most experienced in the industry.

There are reasons however why Synthes should not go in this market. Key among these is the fact that the market is growing very slowly and is still highly unstable according to the case. The research into stable polymers is going at a snail’s pace, it can be argued however that slow growth is better than no growth. Take the example of Apple who suffered in the shadows of Microsoft for many years, but one break with the launch of the iPod and the iPhone is helping to push them to the top of the technology market, their persistence paid off. The other main reason can be seen in the case of Johnson and Johnson in the case, although they were one of the first movers into the bioresorbable market, they failure of the product to perform on par with the metallic fixation devices has left them behind Synthes in that respect.

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The four options discussed by the Synthes managers were to either ignore the bioresorbables completely while focusing on the improvement of their metallic implants or to “wait-and-see”, where-by they would monitor the progress of the other manufacturers and learn from them as they perform tests. During this stage Synthes will still invest heavily into the production of bioresorbables, that way they can quickly enter the market if they it started become a sounder means of income. The Third method was to develop and market their own line of bioresorbables with the current polymers on the market first developing plates and screws for hand, feet, wrists and ankle fractures and then they plan move to paediatric fractures. The final option is to continue research and development into the 3rd generation of bioresorbables implants, to improve the polymers in an effort to strengthen them and increase their reliability. The industry believes that progress can be made in the development of these polymers but is not quite sure exactly how much progress can actually be made. As with any corporate level decisions there are many advantages and or disadvantages connected.

If Synthes chose to completely ignore the bioresorbables market their major advantage is that they will be able to focus more closely on their core competence, the development of metallic implants and improve it faster than their competitors as all of their focus will be on that aspect of the market. Ignoring the market completely is also a means of lowering the risks involved, because this is already their core function and because that sector of the market is far more stable than that of the bioresorbables market they are assured sustainable short term success. However this short term success is not conducive to growth.

Synthes will, in effect, be limiting their growth prospects by not even attempting to develop their bioresorbables sector. As risky as it may be they if they were to take part and it became successful the rewards would heavily out-weigh the risks. They are in essence a research and development company and as previously mentioned R&D is one of their core values, not even attempting to research the potential of bioresorbables would be undermining the nature of the company itself. Their scientists and researchers may potentially become frustrated if they are not allowed to even touch what to them could be the future of fracture repair.

The second choice that Synthes managers discussed was to “wait-and-see” what the other manufactures are doing, letting the others do the main research and make the major mistakes, while Synthes learns from them and develops their own line of bioresorbables but doesn’t market them until market conditions are favourable. In this method Synthes limits their risks significantly by not committing fully to either the development or marketing of their bioresorbables. They will only market if conditions are favourable, if conditions remain as unstable as they currently are then Synthes can simply pull out of the race. However the intend to invest $20 million into the development of their own bioresorbables; this is a very large and substantial investment. If it so happens that the market conditions remain unstable and Synthes decides not to go to market, they will incur a $20 million loss. They also face less risk in the development aspect because they will be leaving most of the work to their competitors; this also limits the amount of developmental failures they would incur if they were undertaking this task on their own.

This may seem like the ideal choice for Synthes, however if their competitors do manage to develop more stable polymers and crack the secrets of bioresorbable internal fixation devices, then Synthes runs a patent blockage risk. If for example J & J develop a perfectly functioning polymer and get their formula patented then they may have sole production rights for that particular formula for approximately 10 years. In those years they can create such a foothold in the market as the first movers that it could not only hinder the growth of Synthes, but in the worst case scenario, drive them out of the internal fixation device market completely. In the pharmaceutical industry, companies that have first mover advantage tend to retain that advantage for a very long period of time, as their products are more trusted than their competitors. The other drawback for Synthes is that even if a patent does not completely block them out of the industry, then they still run the risk of losing major market share to their many competitors. In the scenario where all of the competitors develop at the same pace and launch their products at the same time, the market pie will be divided among more players than is actually necessary thus limiting the potential market share for Synthes.

The third option of developing and marketing their own bioresorbables is by far the most risky option that Synthes can take. However they may gain from the “first-mover” advantage mentioned above, they also have the ability to patent their formulas, block out competition and secure their place in the market for an extended period of time. This option also gives Synthes the opportunity to recuperate their investment into the development of their bioresorbables with the potential returns from marketing with the current polymers. These advantages however depend heavily on the success of the development phase. Therein lays the risk. If Synthes scientists and researchers get it wrong, the results could be disastrous for the company. The investment on development is $20 million, no mention was made of how much it would cost to actually market the product as well, this will push costs even higher, and to have a product fail with those additionally costs could be potentially fatal for Synthes. This is especially true for the paediatric fracture sector that Synthes is hoping to enter, failed products are bad enough, but failed products for children is almost irreversible damage for Synthes. No company wants to be branded as unsafe for children; something like this will lead to permanent scarring for Synthes.

The final option of continued research and development into 3rd generation polymers, this once again is highly advantageous to Synthes as it returns them to their core competence of R&D. This method will please their researchers and scientists greatly. It is a more balanced option because it is less risky than developing their bioresorbables with the current unstable polymers available and is far more proactive than ignoring the market completely or letting waiting for their competitors to do the research and testing. The costs involved however will be greater than most, if not all of the other methods, but the rewards if they get this one right will be even greater than all the previous methods put together. There are other downsides however, for example even though researchers and other scientists will be pleased to be working on ground breaking new technology, many failures will occur in the interim and this can lead to a large amount of frustration for them, which can be demotivating. Synthes still run the risk of their competitors developing better polymers before they do which would leave them in far greater debt than the other methods.

The risks and benefits are great no matter what choice Synthes make, but the fact remains that they are essentially an R&D company and should stick to their core competence of research development and education. They are industry leaders and need to maintain the high calibre performance they have been demonstrating over the years of their existence. Ignoring a new development, or waiting for their competitors to develop first should not even be an option for such a company. However at the same time jumping into developing and marketing an unstable product in an unstable market is very fool hardy and far too risky to undertake. Continuing to develop a new and safer means of internal fixation with bioresorbables is the best option for Synthes, the creation of the 3rd generation of polymers should be their priority.

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In the debate of whether or not Synthes will have an impact on the bioresorbables industry, it is the opinion of the author that they can have a huge impact on the progress of the research and development aspect of the industry. Synthes have been a major player in the metallic fixation devices sector, they therefore have the knowledge on how the well the devices need to hold bones together, and also how they need to be shaped or designed to ensure maximum effectiveness. They are currently researching the effectiveness of the second generation polymers and can also begin to develop the third generation of polymers to catapult the industry into the future. The sheer size and capabilities of Synthes allow for them to exert a large amount of influence unto the market.

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There are many ways for Synthes to introduce resorbables into the market. They are very innovative, with large amount of resources, capable management and therefore are capable of avoiding “the valley of death” where many innovations end up with poor management. Synthes can fund their own launch and therefore do not need the aid of venture capitalists as such. Great care needs to be used when introducing resorbables; and it is the belief of the author that Synthes should introduce their resorbables in the form of small screws or pins for smaller fractures and breaks first before they commit. This way they can be used on less complex injuries to test just how long they last, smaller fractures need less time to heal. If Synthes finds that their products are functioning properly then and only then, should they consider to manufacture for larger more complex injuries. This is far less risky but at the same time means that Synthes can still be proactive in their research and development.

Use for small fractures only, not major complex broken bones. To ensure that they are stable enough and do no degrade in a short period of time.

Merge to compete with other two heavyweights.