The biggest story in the medical devices industry in the last decade has been the launch of drug-coated stents and the subsequent growth of that market, which totaled approximately $5 billion in 2005. Specialized coatings have been used on medical devices for decades, but the launch of drug-coated stents has awoken device manufacturers and coating developers to the potential that these technologies have in providing clinical benefits and sizeable market opportunities. While there has been a rush of new coating developers into the field in response to this shift, many of these companies come without the same advantages as the leading established competitors. The market for medical device coatings is intensely competitive. Major companies, such as Carmeda, SurModics and Angiotech, are well funded, have been in the market for decades and have established client relationships and significant amounts of data illustrating the benefits of their coatings. Most major medical device companies that license coatings also have their own internal research programs working on coatings as well, although this varies from company to company. Figure 1 shows the names of coating developers targeting medical device applications.
Companies Competing in the Medical Devices Surface Modification Market,(2005):
BioChrom Labs, Inc.
Biocompatibles Int. (UK)
Surface Solutions Labs
Coating developers agree that the market potential for medical devices is huge. Many of these companies believe that less than ten percent of all medical devices that could benefit from a biocompatible coating currently have one, which indicates significant room for growth in the market. Developers speculate that in ten years, thirty to forty percent of all medical devices are likely to be coated in some way.
The interventional cardiology marketplace continues to hold the greatest potential for coating developers. The three leading coating development companies have all targeted that space as one of significant interest to them. While coatings designed for drug delivery have captured the most attention, coatings that reduce surface friction, prevent infection, and reduce blood clotting have all been developed and commercialized. Other coatings designed to encourage tissue growth or encourage a specific gene expression or particular physiological responses are also in development.
Coating developers point out a number of reasons for why the medical devices coating market is expected to grow rapidly. First, clinicians have finally been able to see the benefits that coated devices can confer to their patients, and that encourages them to favor purchasing the devices and paying the premium prices manufacturers are charging for them. Along with drug-coated stents that reduce restenosis, coated extracorporeal blood circuits can reduce the risk of stroke and heart attack, and coated catheters can help reduce the rate of infection. While this growing history of positive experiences with coated devices continues to be the major driver of the industry, more work is also being done on the underlying science behind coating technologies and how the body responds to them. Researchers are beginning to better understand the biological signaling pathways and events that occur in blood, what drugs can be used to impact those pathways, and finally how to attach those drugs to the surfaces of devices. The markets for many coated devices have seen the launch of second or third generation products at higher price points because of the better demonstrated clinical benefits they offer compared to the first products launched. Prices have been lower for these products for competitive reasons, but also because regulatory costs were lower. The launch of these new products and the related increase in the number of new coating companies entering the market has grown the industry. Many medical device manufacturers initially skeptical of coating technology are now rushing to apply it to their products in order to preserve their market share and expand their positions in the industry.
Weighing the Cost of Coatings Versus their Benefits
The value that clinicians see in coatings and surface modification varies significantly by what type of device they are applied to. The challenge to developers is that many coatings have proven to be clinically effective, but not cost effective, and that difference is critical in today’s healthcare environment. The reason why Cordis and Boston Scientific were able to win support from insurers for use of their drug-coated stents was because they were able to illustrate that the additional $1,000 spent on a drug coated stent instead of a bare metal stent was worth it to reduce costs associated with treating restonsis, which might involve another angioplasty/stenting procedure or surgery.
Device manufacturers, clinicians and coating developers recognize the value of a coating depends on whether it is used short-term (blood circuits, central venous catheters, etc.) or long-term (stents, ventricular assist devices, etc.). Currently, most devices used in the short-term are considered commodity disposables and priced at very low levels. Consequently, not many short-term devices are priced high enough to allow for extra coating costs. The pricing that coating developers are able to charge is heavily dependant on the clinical benefit the coating is able to demonstrate over a particular period of time. The medical device companies that license coating technologies are often able to command a premium of between five and 25 percent for coated devices; however, sometimes that premium can be even higher, as in the case with drug-coated stents. Yet in some markets, coated devices are priced at nearly the same level as uncoated devices because manufacturers use the products merely as a means to gain market share from competitors.
Clinicians Unable to Differentiate Among Competing Coatings
Coating developers acknowledge that it is difficult for clinicians to pinpoint clear differences among competing coatings since it is too expensive to run head-to-head trials. In addition, running trials to prove that coatings offer specific clinical benefits is also very expensive. The device companies that license coatings are usually not willing to sponsor those types of studies unless the stakes in the market are large. This lack of data has limited market penetration for coated devices and made it difficult to convince users that coatings are clinically necessary and worth the cost.
A panel of interventionalists, intensivists and cardiothoracic surgeons surveyed by Frost & Sullivan stated there was insufficient clinical data available from manufacturers or published sources to compare one anti-thrombogenic coating to another. This same panel however stated that clinical data was very important to them in determining whether they were going to use a coated device or not. Physicians are currently purchasing many coated devices not because of the abundance of data supporting their benefits, but because the coatings are being applied to products from manufacturers they already trust or because they have heard favorable anecdotal reports about coated devices.
Applications for Biocompatible or Anti-Thrombogenic Coatings
Any foreign material placed in the heart or bloodstream, whether it is plastic or metal, has the potential to cause blood to clot and form a thrombosis or embolism. As the name suggests, anti-thrombogenic coatings are designed to prevent the blood that comes in contact with a device from clotting or being damaged which could in turn lead to stroke, heart attack, anemia or other complications. Many coating developers use more broad terms for these types of coatings, such as “biocompatible” or “biomimetic,” pointing to the goal that these coatings have in replicating, as close as possible, the normal interaction between blood and the vessels it travels through while in the body. The primary benefit of the coatings is to improve patient safety and clinical outcomes by reducing the adherence of blood components to the surface of the device. Yet, the coatings can also help to improve the performance of the device itself, for example by maintaining smooth blood flow through a circuit or preventing fibrous encapsulation around a diagnostic catheter. The coatings can also help keep the device clean and extend the lifetime of the product by reducing the proteins and other components that stick to it. Figure 2 lists medical devices that already feature anti-thrombogenic or biocompatible coatings or hold the potential for being coated.
Applications for Anti-Thrombogenic / Biocompatible Coatings, (2005)
The following devices have already had anti-thrombogenic/biocompatible coatings applied to them or they are areas of research for these coatings:
Coronary and peripheral stents
Distal protection devices
Central venous catheters
Dialysis catheters and bloodlines
Extracorporeal blood circuits
Vascular grafts and surgical patches
Mechanical heart valves
VADs and artificial hearts
Defibrillator and pacemaker leads
Blood collection kits
Orthopedic and dental implants
Pulmonary artery catheters and introducers
Intra-aortic balloon pumps
Vena cava filters
In 2001, the FDA approved Cordis’ Bx Velocity Coronary Stent with Hepacoat, which was an end-point attached heparin coating from Carmeda. The stent was designed to reduce the risk of clotting in the stent, and it was well received when it was introduced. However, the market for that stent shrank considerably when the Cypher was launched a few years later and redirected the attention of physicians and the media. Carmeda has since run tests and published data showing the capability of combining Hepacoat with the Sirolimus-eluting coating of the Cypher so patients can reduce their risk of thrombosis and restenosis simultaneously. This potential application and many others illustrates how anti-thrombogenic coatings could provide clinical benefits and generate revenues for coating developers and device manufacturers.
Carmeda states it is looking to deploy biocompatible coatings on virtually any implanted medical device, such as hip implants or pacemakers. Some of its research also suggests heparin may promote cell growth, which could have therapeutic benefits beyond just preventing thromboses from occurring. But heparin-coated devices hold the risk of giving patients heparin-induced thrombocytopenia, which is a serious immune-mediated drug reaction that can lead to stroke, heart attack, organ failure, pulmonary embolism, limb loss, or death. According to one interventional cardiologist interviewed by Frost & Sullivan: “[With] heparin bonded catheters, there is a problem with heparin induced thrombocytopenia. CVP, Swanz-Gans, and dialysis [catheters] can be heparin bonded. However, there is a fair risk of thrombosis with catheters, and all invasive catheters might be helped by anti-thrombogenic coatings.”
Consequently, some coating developers, such as SurModics and others, have developed synthetic, non-heparinized biocompatible coatings to address this issue and others which limit the application of biological molecules like heparin to medical devices. The company believes these synthetic coatings might be better suited for devices with more complex geometries and also be less apt to degrade in the patient compared to biological coatings. Also, synthetic coatings are expected to allow for faster regulatory approval and time-to-market for customers licensing the technology.
SurModics has done research in applying anti-thrombogenic coatings to electrophysiology (EP) catheters so that clinicians are able to reduce the amount of systemic anti-coagulants they need to administer to the patient. The coatings might help to reduce the amount of clotting that occurs on EP catheters during studies. The company also believes there is potential for growth in applying hemocompatible coatings to blood collection kit components because while the margin on the kits may be low, the volume is very high which could make the market profitable. SurModics also sees room for growth in pro-thrombogenic coatings that could be applied to aneurysm coils or other devices that would encourage site-specific clotting.
SurModics also envisions a future where coatings are used to promote healing, such as coatings that encourage the growth of a protective layer of endothelial cells on devices as opposed to coatings that simply prevent thrombosis or elute drugs. The company believes the future of coatings will be more toward biological approaches like this. The prediction points to an overall business vision of SurModics which is that coatings must not simply be “nice to have” features, but rather be integral to the device because of the significant clinical value they provide. The company focuses its efforts on development areas that lend themselves well to this model.
Key Attributes of Successful Coating Developers
SurModics and Carmeda are the leaders in the medical device surface modification market because of their established reputations, wide array of coating technologies, and also their ability to covalently bond coatings to devices. Carmeda and SurModics both have unique technology backed by their own science. The companies also have the skill and experience to work with clients in product development.
The most successful surface modification companies targeting the medical devices industry are able to provide their customers important advantages:
Established reputation and successful client history. Well-known clients.
Wide range of proprietary surface modification technologies backed up with solid science
Ease of applying coating to client’s devices - flexible technologies that allow application to a variety of materials and geometries
Ease of integration with client’s existing manufacturing processes – ability to do coating on-site or tech transfer to OEM
Low-cost of coating application
Development, manufacturing, and ongoing technical support
Scientific support (testing of coatings or expertise in blood compatibility or other areas)
Ability to offer blood-compatible coatings in combination with other surface features, such as hydrophilic lubricity, anti-infective properties, and local drug delivery
Ability of coating, once applied, to be sterilized using conventional methods
Broad range of applications among many different market sectors in order to mitigate against risk
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