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Articles from 2003 In August


Hemocompatible Coatings for Blood-Contacting Devices

Originally Published MDDI August 2003

Coatings

Coating makers take many different paths to ensure the blood compatibility of medical products.

William Leventon

Digital micrograph of polyurethane catheter tubing coated with Medi-Coat on both the lumen and outside surface. The dyed coating was uniform with a measured polymer thickness of 11 µm.

Blood can leave a troublesome mark on a medical device. When blood contacts a device surface, the result can be clotting that impairs device performance and can harm a patient depending on the product. 

David E. Babcock, an associate research scientist with SurModics Inc. (Eden Prairie, MN), says “Materials used to fabricate medical devices can possess different surface chemistries that can influence how aggressively blood will respond to the surface of the device.” He explains that most synthetic polymers and metal substrates are thrombogenic. Even when the materials that comprise a device are all blood compatible, the finished product may not be. This can be the result of factors such as complex device geometry.

Many manufacturers are exploring ways to improve the blood compatibility of their devices. One option is to coat device surfaces with a hemocompatible material. In tests and in use, hemocompatible coatings have been shown to reduce surface clotting. Device manufacturers put off by the challenges of coating use, however, have been slow to adopt the products. Now coatings may be poised for a surge in popularity, thanks to several developments that could accentuate the positives and mitigate the negatives of surface-enhancing products. 

An Active Approach

The current crop of coatings use a number of methods to ensure blood compatibility. Some coatings rely on biologically active materials loaded into a polymer matrix or bonded to the device surface. These bioactive materials prevent clot formation by altering the physiological responses of blood.

In many coatings, the bioactive agent is heparin, a widely used drug that inhibits blood clot formation. Heparin plays a key role in the activity of Medi-Coat, a hemocompatible coating developed by STS Biopolymers Inc. (Henrietta, NY). Medi-Coat technology entraps heparin in hybrid polymer layers. The coating slowly releases heparin when exposed to blood. This creates an environment of high drug concentration near the surface of the medical device. To suit different applications, STS can vary the release rate by changing the polymer mix. In this way, the coating can be formulated to release heparin over time periods ranging from days to months.

Digital micrograph of polyurethane catheter tubing coated with Medi-Coat on both the lumen and outside surface. The dyed coating was uniform with a measured polymer thickness of 11 µm.

Polymers used in Medi-Coat formulations include cellulose esters, polyurethanes, methacrylates, and polyvinylpyrrolidone. The polymer layers serve as a reservoir capable of holding high heparin loads, which extends the time that effective drug concentrations can be maintained near the coated surface. 

A number of device companies have shown interest in Medi-Coat, says Richard Whitbourne, chairman and chief technology officer of STS. Next year, the bioactive coating will make its debut on catheters. Meanwhile, the coating is being evaluated for use on vascular stents.

Like Medi-Coat, a formulation from Surface Solutions Laboratories Inc. (Carlisle, MA) combines heparin and various plastics to produce bioactive coatings. The company's patented technology binds heparin and other bioactive agents to a matrix polymer. The coating can remain bioactive for more than a month while in contact with blood, according to Margaret Palmer Opolski, president of Surface Solutions.

The company's coatings also offer relatively hassle-free application, Opolski says. The formulations can be applied in a one- or two-step dip-coating process. This simplifies the job for device manufacturers that want to coat products in-house. 

Long-Lasting Effects

For long-lasting hemocompatibility, a number of device manufacturers have opted for a heparin-based treatment called Carmeda BioActive Surface (CBAS) from Carmeda Inc. (San Antonio, TX). CBAS was developed to boost the anticlotting effects of heparin molecules, which are chains of repeating sugar units. Each chain includes an active sequence of five sugar residues that bind to and accelerate the activity of antithrombin, a clot-preventing agent in the blood. If a coating process attaches this active sequence to a device surface, it will hamper the heparin molecules' ability to interact with the blood.

Therefore, CBAS features end-point attachment of heparin molecules. Fastened at their end points to a device surface, the molecules “sway in the bloodstream like seaweed in water,” according to Carmeda. This maximizes the interaction between the active sequence and the flowing blood, the company claims.

For greater durability, CBAS covalently bonds heparin to a device surface. Unlike heparin-release coatings, which are effective only as long as the drug supply lasts, the bonded heparin isn't depleted over time. Thus, a fixed amount of the drug can continue to fight clotting for as long as several months, according to Carmeda.

To prove the effectiveness of CBAS, the company points to studies showing that it reduces the amount of thrombus formation and various blood components on medical device surfaces. Like other surface-enhancement products, however, CBAS offers improvement—not perfection. “You're still going to have growth on a coated surface,” says Andrew Jacobson, Carmeda's director of business development. “What you want is less growth—and less-harmful growth—than what you'll get on an uncoated surface.” For example, he says, an effective surface-enhancement product might reduce the clot rate on a medical device from 25 to 15%.

Today, CBAS is reducing the clot rate on a number of commercial medical devices. One of these is Propaten, a vascular graft sold in Europe by W.L. Gore & Associates. CBAS combats clot formation on the inside surface of Propaten grafts. Such clots can cause blockage that reduces blood flow through the grafts, explains Robert Thomson, a product specialist at W.L. Gore's Flagstaff, AZ, facility.

To test CBAS, Gore conducted animal studies that compared the performance of treated and untreated versions of 3.0-mm Propaten grafts. In one study, thrombi covered the surface of an untreated graft within 2 hours of implantation. But the treated graft was “almost entirely clean” after a 2-hour implantation, according to Thomson. “The difference was very striking,” he recalls.

On the downside, CBAS carries a hefty price tag. In addition, “it's a difficult process,” Jacobson admits. Unlike dip-and-dry coating methods that can take minutes or even seconds, CBAS is applied to devices in a batch treatment process that lasts 4 hours. Normally, Carmeda performs the process at its facility in Sweden. So devices must be shipped to Sweden and back, a journey that can take 2 weeks for products made in the United States. 

Disguising a Device

There are other ways to boost hemocompatibility besides employing clot-fighting agents like heparin. One is to disguise the device surface so blood can't detect the presence of foreign material and trigger clot formation.

Such a passive approach to blood compatibility may offer device manufacturers a significant advantage over bioactive approaches: a shorter, simpler, and less-expensive journey to regulatory approval. “FDA is very conservative if you make a claim of some kind of bioactivity,” says Min-Shyan Sheu, vice president of research and development at AST Products Inc. (Billerica, MA). As a result, Sheu emphasizes, manufacturers that use bioactive coatings may have to undertake costly and time-consuming clinical studies to satisfy regulators.

Digital micrograph of polyurethane catheter tubing coated with Medi-Coat on both the lumen and outside surface. The dyed coating was uniform with a measured polymer thickness of 11 µm.

AST is working on a bioinert coating designed to provide blood compatibility without bioactive agents like heparin. Instead, the coating will include a substance that attracts and binds blood proteins to a device surface. The proteins will cover the coated surface, hiding it from the blood-stream and thereby preventing clot formation.

Development of the AST coating is still in the early stages, but another surface-disguising coating has already reached the market. Developed by Hemoteq GmbH (Würselen, Germany), the appropriately named Camouflage coating provides hemocompatibility by mimicking endothelial cells that line human blood vessels.

Hemoteq makes Camouflage using a patent-pending process to synthesize carbohydrates that mimic inert endothelial cell surfaces. By relying on synthetic carbohydrates rather than organic materials (which were the basis of a previous version of the coating), the new Camouflage should accelerate the regulatory approval process, according to product manager Ingolf Schult.

Camouflage consists of a single layer of molecules with a thickness measured in nanometers. To ensure durability, the coating is attached to a device by a covalent bonding process.

According to Schult, Camouflage isn't burdened with one limitation of heparin-based coatings. With their highly negative charge, heparin molecules actually attract blood protein to the device surface. The coating is quickly covered by a protein layer that can block the heparin's anticoagulant 
activity. Once that occurs, the hemocompatible coating “doesn't work anymore,” Schult asserts.

By contrast, Camouflage doesn't depend on bioactivity to make a device hemocompatible. “It's athrombogenic because it's passive,” says Schult.
So far, no device firms have marketed Camouflage-coated products but Schult notes that several are interested in the coating. He expects coronary stents to be the first commercial application, with other Camouflage-coated implants following soon after.

Like Camouflage, a coating from MC3 Inc. (Ann Arbor, MI) mimics human endothelial cells. But the MC3 coating takes a more active approach to mimicry. According to MC3, tests have shown that endothelial cells generate nitric oxide (NO), which prevents the platelet activation that causes clotting in blood vessels. To mimic this natural anticlotting action, the company is developing NO-releasing polymers that can be used to coat medical devices. In this effort, MC3 is collaborating with Mark Meyerhoff, professor of chemistry at the University of Michigan. Meyerhoff's group works with “donor molecules” that release NO when they contact aqueous solutions. Entrapped in a polymer coating on an implanted device, these donors will interact with blood, producing NO that inhibits platelet adhesion to the surface of the plastic.

In animal testing, polyvinylchloride with entrapped NO donors significantly reduced the incidence of thrombus formation and platelet activation, according to MC3. Other tests showed that the blood sensor performance improved when the sensors were coated with NO-releasing polymers.
MC3 is now looking for device-manufacturing partners willing to try the new coatings. In the meantime, Meyerhoff's group is attempting to determine precisely how much NO release is needed to produce the desired anticlotting effect. “We don't want [the coating] to produce too much, because NO is very toxic,” Meyerhoff adds.

In living organisms, he adds, the toxicity of small amounts of NO doesn't present a problem because the molecules quickly react with elements in the blood. “There's no systemic effect because [the NO] never makes it very far from the surface of the polymer,” he says.

MC3 is also trying to develop materials that can be used in high-temperature manufacturing processes. A number of NO donors decompose when exposed to excessive heat, making them unsuitable for some manufacturing operations. Although MC3 has identified some promising high-temperature candidates, more research is needed before these materials are ready for the market, says Scott Merz, president of MC3. Because NO and heparin work on different parts of the clotting process, Merz believes the most effective blood-compatibility approach would be to combine both anticlotting agents in a single coating. To that end, he says, MC3 is looking at ways to incorporate heparin into its NO coatings.
Like their heparin-based counterparts, NO-release coatings provide hemocompatibility only until the supply of anticlotting agent is depleted. So Meyerhoff's group is trying to develop a coating capable of generating NO from elements inside the body. These NO-generating polymers could provide sustained hemocompatiblity on the surfaces of permanent implants. In addition, they could be used on devices that require extremely thin coatings, which would provide very-low-capacity reservoirs of NO donors for release coatings.

The Next Step

Coatings can add many useful properties to medical device surfaces aside from hemocompatibility. Many coating makers believe their next logical step is to a single surface-enhancing product that combines two or more attributes. For example, a future coating might be lubricious and antimicrobial as well as hemocompatible. But developing these so-called combination coatings will entail much more than simply mixing a hemocompatible substance with an antimicrobial substance. “It's not like making soup,” says Jacobson, whose company plans to develop such coatings.

Coating experts are also looking at new factors that might enhance hemocompatibility. For example, antimicrobial additives may kill bacteria that cause thrombus formation, Opolski notes. Or a potentially troublesome blood substance may be less likely to adhere to a hydrophilic surface. “People are finding things that expand the definition of hemocompatibility and how you impact it,” she says.

According to Opolski, some of her colleagues in the coating field are also considering the use of genes that give hemocompatibility-enhancing instructions to the body. For instance, she says, genes in a coating “could signal the endothelium to get cranking real fast” or trigger the production of cells that mask an implanted device from the blood.

Opolski knows of no company close to introducing a hemocompatible product based on gene therapy, which she calls the “Star Wars” idea in the coating field. She believes such products may have been pushed even farther into the future by recent gene-therapy mishaps that resulted in patient deaths.

Wanted: Users

Though the makers of hemocompatible coatings sound hopeful about the future, current sales figures must be a disappointment to at least some of them. As Jacobson sees it, there are a number of reasons that device manufacturers have been slow to adopt coatings. For one thing, proprietary coatings offering long-term hemocompatibility can be very expensive. In addition, he says, device makers must spend large amounts of money—often millions of dollars—on studies showing that a coated device is better than an uncoated one. “And end-users often balk at this proof anyway,” he notes. “They say, ‘That's nice, but we like our low-cost device.'”

Another factor working against coating makers is that some of their products haven't lived up to claims made for them. Worse, Jacobson adds, the products have actually caused harm in some cases. As a result, he says, “people just don't believe in coatings.”

Then there's the issue of regulatory approval. Many device companies may not have a clear idea of how to get a coated device past regulators. “If you don't know the regulatory path for a coating, it creates a lot of anxiety and uncertainty,” Jacobson says.

Even manufacturers with a clear view of the regulatory path may find it an unnerving sight. Coatings can add considerable time and cost to the regulatory approval process for a device. Companies with coated devices can spend several years and millions of dollars gathering enough test data to satisfy U.S. and European regulatory bodies, says Thomson.

Regulatory approval hasn't come easy for Gore's CBAS-coated Propaten product — despite the fact that both the coating and the graft are well-established products. “It's been a protracted process,” says Thomson, whose company has won approval to sell the coated Propaten version in Europe but is still awaiting an FDA decision. “This isn't something any company is going to take on lightly.”

Dramatic Growth Ahead?

Despite these negatives, Jacobson predicts “dramatic” growth for the coating market in the next few years. He cites several reasons for his optimism:

• Investment in coatings. In the near future, increased supplier in R&D investment will result in attractive coating products. “You're going to see new technologies, and I think the supply will [stimulate] demand as these new technologies are developed and introduced,” he says.
• Better coatings, lower prices. Carmeda and other coating suppliers are working on ways to make their products more affordable. In time, he says, “I think people will come up with higher-quality coatings at lower coated-devices costs.”
• A boost from drug-eluting stents. The attention attracted by drug-eluting stents—and the high prices these stents will probably command—should benefit manufacturers of coatings that offer hemocompatibility and other properties. The reason is that coatings add value to products, “which is very attractive to mature markets,” he says. “When you have a mature product line, you're just fighting for market share. But with a coating, the whole pie expands.”
• Easier approval over time. As coated devices become more common, U.S. and European regulators will establish guidelines that clarify the approval process.
• Adoption leads to more adoption. For example, once stents and grafts with Carmeda coatings hit the market, other device manufacturers showed more interest in CBAS, Jacobson reports. At that point, adoption “required less of a leap of faith,” he says. “People said, ‘Wow, this stuff must really work. I don't have to be as big a risk taker.'”
• Competitive pressures. “If there are five players in a mature market and one of them gets a coating, the other four will have to jump on board to keep up,” he asserts.

Thomson seems to agree with the last point. In the medical device industry, he notes, people are starting to realize that coatings provide the best solutions to physiological problems like clotting. As a result, he says, executives at Gore and other device companies have two choices when considering whether or not to embrace coatings: “Either we play now and get our feet wet, or we get left behind.”

Processes to Consider

To improve hemocompatibility and performance with a coating, manufacturers must consider what processes will best integrate the material with the device. Use of such processes as plasma polymerization and surface characterization can help optimize functionality while potentially reducing the time to market.

Although using polymerized plasma to coat materials and devices is not new, it's steadily gaining usefulness and popularity in the medical field. The process is performed by pumping a monomer gas into a vacuum chamber, where plasma polymerizes the gas into a coating. The process is unique, according to Stephen Conover, CEO of Applied Membrane Technology (AMT; Minnetonka, MN), in that it “opens up and creates sites on the substrate—a piece of tubing for a pacemaker, for example—and you can attach to that site a layer of whatever it is you're trying to create.”  The result, Conover says, is an “intimately bonded” layer of coating, even if you're using materials that normally don't combine, such as Teflon, polypropylene, or polyethylene. “The plasma polymerization process creates free radicals, or free-radical active sites, on both the material you're going to coat and the coating. That creates the bonds,” and makes possible the combination of materials that are normally incompatible, he says. 
Conover's company uses plasma polymerization to coat implantables, such as sensors that are left inside the body, as well as tubing, catheters, and membranes. Additionally, AMT is currently coating fibrous membranes for firms that are developing artificial organs. In addition to their biocompatibility, Conover says, plasma polymerized coatings are flexible and resistant to radiation. 

But what about the cost? According to Conover, it's less than you might guess. “Plasma polymerization is not necessarily more expensive than some other coating processes,” he says. 

Surface modification has become an equally important process in coating devices. Klaus R. Wormuth, PhD, of SurModics, says the firm has “developed a PhotoLink surface-modification technology platform that improves medical device surface characteristics,” such as hemocompatibility. The method provides the basis for time-controlled elution of drugs from device surfaces—a development that has been critical to the current generation of coronary stents.

Conclusion

Hemocompatible coatings prevent the formation of harmful clots on medical device surfaces. Some of the coatings include bioactive agents that interfere with the clotting process; others attempt to prevent clots by concealing the device surface from the bloodstream. 

Nevertheless, device makers have been reluctant to adopt the coatings, despite their usefulness. This is due in part to the cost and complexity the coatings can add to the regulatory approval process. But competitive pressures, the commercial success of drug-eluting stents, and other factors may soon push hemocompatible coatings into the medical mainstream. 

Copyright ©2003 Medical Device & Diagnostic Industry

Keys to Growth of the Medical Device Market

Originally Published MDDI August 2003

R&D Roundtable

Research expenditures continue to grow steadily. But are the dynamics of medical device development shifting?

Gregg Nighswonger

“Medical R&D is 
partially insulated from normal business cycles, as the need for medical care and 
funding by insurance are relatively constant.” -Buckley 

The medical device industry has continued to enjoy generally healthy market growth despite the sluggishness of the national economy. Looking at industry in general, industy support of R&D efforts is expected to top $194 billion in 2003—roughly the same as 2002. Government priorities are likely to continue to be influenced by a focus on defense and biological sciences, according to many industry observers.

To examine some of the current trends in medical R&D, MD&DI invited five representatives from industry to discuss current funding levels and factors that are shaping R&D.

The selected participants were: William Buckley, Business Development Manager with Foster-Miller (Waltham, MA); Jules Duga, PhD, Senior Researcher at Battelle Memorial Institute (Columbus, OH); Bill Inman, Senior Chemist/Technical Service Representative at Dow Corning (Midland, MI); Gary Smith, Director of Marketing at Battelle; and Dean C. Winter, PhD, Director of the Bioengineering Department at Southwest Research Institute (San Antonio, TX).

MD&DI: Who is funding R&D today?

Inman: The government, at least here in the United States, supports the National Science Foundation (NSF), the National Institutes of Health (NIH), and through the university programs. That's where a lot of the new, cutting-edge research seems to be happening. 

Buckley: Government agencies and individual firms fund most current R&D. Other significant sources of R&D funding are industry consortiums. Our experience with industry consortiums has been primarily within energy production and distribution. 

Duga:
The government doesn't do a lot of work, as near as I can tell, directly funding device work. But they have provided an awful lot of the background from which industry then can pick up in terms of identification of diseases, and ways in which various medical treatments can be assisted with the development of appropriate diagnostic and therapeutic delivery systems. 

I think the government provides a platform from which others can launch various types of incentives. But the primary source for performance of medical device R&D is in the industry. 

Namely, government organizations such as the Veterans Administration have a very distinct interest in the welfare of their clientele and to the extent that specialty medical devices are required for people who come under the jurisdiction of the Veterans Administration, there would be a small amount of R&D that would go into that. Actually, the R&D budget for the Veterans Administration isn't particularly large—I think it's scheduled to be something on the order of $800 million, which is a real drop in the bucket—but, nevertheless, it is something that can act as a catalyst. 
I also get rumblings that representative organizations that have a significant clientele that may need various types of medical devices, such as AARP, would be a reasonable place from which to get either seed funds or influencing funds. That is, they go through such organizations as AARP to identify what the needs of their clientele are, and to use them as a lobbying force for either government or industry to help influence expenditures in R&D. 

Winter: Well, I think there are a couple of major players. One is certainly the federal government and NIH. And I think a fair amount of that goes on through the SBIR program within NIH. And the other area that we see is really the small medical device companies that may be angel or venture funded. 

From our end, we see less and less being done by the larger established medical device companies. They're still a major component, but it's less and less. 

MD&DI: In what device sectors are the most active R&D efforts found?

Buckley: There is much R&D activity in the areas of minimally invasive surgical procedures, semi-invasive diagnostic procedures, and improved methods of blood glucose monitoring.

Inman: Right now, the ones that seem to be really hot are tissue engineering (that would include stem cell research and such), wound care and wound healing—how to promote ideal wound healing and minimize scarring and such. 

Drug delivery is another big one as well, trying to get focused drug delivery so that less and less of a drug can be used but still get to the site. Use of patches is getting to be really big. And they are looking to roll in more of the standard drugs that people would take orally and put them into patch forms. 

Smith: I think the big three are still cardiovascular, oncology, and orthopedic. And close behind that would be endocrinology driven primarily by diabetes management. 

Winter: I would mention drug delivery too. I think that's a big area. The technology that goes with drug development, which I guess peripherally relates to medical devices, is a really big area. 

And there's cardiovascular support—anything from electrophysiology, like defibrillators, to the vascular stents and things like that. We see a lot of activity in that area.

MD&DI: Is funding still available for medical R&D, or is it becoming harder to locate?

“There is an increasing move toward 
outsourcing, not only domestically but also on an international basis. This is going to be continuing.” -Duga 

Inman: I would think it's still available. The way I see it, if you want to go out there and get R&D dollars, you need to have some real, focused objectives in mind. You can't just say you want to go out there and see what you can find out. Nobody's really willing to support the kind of research that doesn't seem to be tied into some kind of viable end results anymore.

Buckley: There is a large amount of funding available for medical R&D. It is not necessarily easy to locate and never has been. The most effective way to locate R&D funding is direct contact with industry and agency decision makers. However, establishing and maintaining this direct contact can be challenging and time consuming. To qualify for funding from government agencies such as NIH, one must usually bring an innovative technology to the problem being addressed.

Duga: Looking at some of the areas we deal with here at Battelle—surgical and medical instrumentation and apparatus areas—the history suggests a relatively steady growth in R&D expenditures by industry. 

The projections are for about 4% per year in current-dollar expenditures, which is a pretty good growth rate considering that inflation is relatively small. 

There was a somewhat smaller growth rate in industries that deal with orthopedic and prosthetic devices, but it's generally still positive. I think the monies will continue to be there, and we're talking about 3 or 4% there as well. 

Now these data are based upon surveys and reports that have been put together by a company in Illinois. They take data that are available to the Securities & Exchange Commission, reports from publicly traded companies, and they extract the R&D data from these and do a variety of analyses on them. The data are always subject to question, especially when you're talking about individual companies. However, when you're looking at industry as a whole, things are reasonably accurate and the projections are fairly good. 

And I think that the industrial availability of money will continue to grow at about the same rate as it has in the past, outpacing inflation by two to three points per year for the foreseeable future. 

Smith: As a gross generalization, when we take a look at the healthcare sector in its broadest sense, we divide research from development in trying to analyze it. Again, as a simplification or generalization, government supports research, industry supports development. Government dollars, whether they are federal or state or local, will support research—disease research, diagnostic research, therapeutics research, health and life science research in the most nascent forms, including the funding going to national laboratories. It is this early research that industry is unwilling to sustain. It's too early, it's too unpredictable, and too risky. So industry then can afford to wait and see what happens with that government-funded research. At that point, the government dollars typically won't support it once product commercialization starts to take place. Once a product and commercial opportunity are identified by a researcher, they begin to look for funding from industry—and that industry funding can be corporate, venture, angel, family and friend, and so on.

Duga: And that applies not only to medical devices, but to almost every other area as well. It is somewhat of a fallacy to talk about industrial research when it is, in fact, much more a case of industrial development. To some extent, industry does do what they refer to as fairly basic research, but it is certainly directed basic research, not the kind of truly fundamental research that the universities are accustomed to, or that groups like NIH and NSF are accustomed to supporting.

Winter: I think the venture capital has tightened up quite a bit. I think that's pretty obvious. It seems, at least we hear, that it's loosening up a little bit in the biotechnology area, but not necessarily medical devices. So I think that is where the biggest economic impact that we've seen is. Smaller companies are finding it hard to get financial backing. 

MD&DI: What types of organizations are most involved in R&D? Small, large, multinational firms?

Buckley: All three general sizes of organizations are actively involved in R&D. The differences between them are in the scale of the R&D effort and funding. Small companies are often start-ups using private and/or government agency funding to commercialize new technology. Large firms often have permanent R&D staff and departments to generate new technologies and extend existing technologies. Multinational corporations do not necessarily do more or less R&D than large national firms. Large pharmaceutical companies sponsor large-magnitude R&D on an ongoing basis.
Inman: All three are really doing it—small, large, and the multinationals. As far as cutting-edge R&D, I think the smaller companies out there are doing a lot of the advanced research. It's mainly just to try and establish themselves in an industry that's pretty large. They are the ones that seem to be taking the most risks. 

With the larger companies and the multinationals, most of them now have risk programs where they actually meet, maybe in a boardroom, to see what inherent risks are associated with a type of research and whether they want to do it or not. They're considering whether it is worth potentially losing everything they have to lose. On the other hand, the small company can usually get things done relatively cheaper than the bigger companies. And, relatively speaking, they have less to lose.

I think the smaller companies are risk takers more so than the larger companies. And you know a lot of the larger companies, at least from what I've seen on the device side, they simply sit back and keep a close eye on these smaller companies. And if they see something they like or something that's likely to pan out, a lot of times they'll just purchase the company.

Smith: We see research as a continuum with different mechanisms and different “producers” along the curve. At the research end, there are national labs, academic and clinical research centers, and emerging companies—all funded by a variety of federal, grant, and private resources. 
Development is happening in more established firms where technology has been in-licensed or acquired from the aforementioned sources. These firms typically have strong sales and marketing capability and will often contract outsource development to ensure timely delivery of products to their market constituents (customers). I would say the trend continues toward small companies taking on the R&D risks. More so than ever in the past, the big companies are now realizing that they are sales and marketing and distribution organizations. 

The Johnson & Johnson models, the Medtronics, and the Guidants clearly have a strategy where they would rather wait and acquire a company that is either past some key milestones, such as FDA approval, or well beyond feasibility. They're comfortable with seeding a small dollar volume into the research company at a point where they know they can garner equity later on, even total ownership. But rather than risk their own dollars in that front end, I see them seeding lots of companies, building strong franchise development organizations—organizations that are responsible in core technology organizations for surveying the market and looking for start-ups that have certain capabilities that will fit their pipeline. Sprinkling the infield, so to speak, to be able to pick the best flowers later on.

So, would that cause a decrease in their R&D expenditures? I don't know that it has. But it shifts dollars into business development.

Duga: I would add that the larger companies in general over the past decade have gone through a very significant restructuring of their internal R&D activities and the extent to which they maintain laboratories that are necessary to deliver services for their customers. A lot of their R&D has been outsourced and has been going down through the supply chain. So they've let their suppliers undertake the kind of R&D that's necessary to get a finished product. Now in the long run, this shifts the R&D budget from the major corporation down to the next level. 
That doesn't necessarily mean that the major corporations are saving a lot of money because they are now buying it from their suppliers with a higher value added to it. But they have reduced some of the risk, and they have a lot more flexibility when it comes to outsourcing to that supply chain. 

MD&DI: How much R&D is still handled in-house versus outsourced programs, collaborations, and others?

“I think the smaller companies out there are doing a lot of the advanced research. They are the ones 
that seem to be taking the most risks.” -Inman 

Buckley: This is a difficult question to answer because most in-house R&D is proprietary to the organizations that perform it. Our perception is that the great majority of commercial R&D is performed in-house. Government-sponsored R&D often involves collaboration between multiple research organizations, academic consultants, and the sponsoring agency.

Inman: There's more outsourcing, very much so. It's quite a paradigm shift for Dow Corning because, in the past, we've always thought we had to build our own expertise. It's taken a lot of time and a lot of money. 

And there are some instances where that doesn't necessarily pan out. So what we have done is started to look outside to see if there is a product that we would like to bring to market. And if there isn't, and it's not within our own core capabilities, who could we work with to bring it to market? 

An example of that would be where we've had customers come to us and ask for reinforced tubing. Now that's not something we typically have done, and we don't really have a true core competency in that area. But we partnered with a fabricator to bring a new line of reinforced tubing into the marketplace. 

I think you're seeing that everywhere really. People are finally realizing that from an economic standpoint, they can't do everything. It just doesn't make sense if there's somebody out there that's already skilled and has the capability to help a company as a partner to do what they want. Ideally, it's a win-win situation for both sides of the partnership. 

Duga: That depends a lot upon the particular industry. For what I know about the medical device area, it would appear to me that there would be less outsourcing within the device industry because of the highly proprietary nature of the eventual product. However, there is an increasing move toward outsourcing, not only domestically but also on an international basis. And I think this is something that is going to be continuing. Again, this would be at different levels for different types of industries. 

Smith: I would add that in the past 18 to 24 months, there's been a moderate contraction in the outsourcing trend due to the economic conditions. Companies have had to defend their own staffs, as dollars dried up for them both in the public markets as well as in venture and angel funding. So they were forced to drop some programs to focus on recurrent engineering needs and problem-solving within their own organizations. 

I think when the market comes back around to a healthy state, we'll see a reestablishment of a trend that we started to see clearly in the 1997–98 time-frame, which was, “My commitment to Wall Street and my investors is larger than I can handle alone, and so I'm willing to outsource some key programs.” 

Winter: This may reflect the economic situation, but we find that companies are more risk averse when it comes to developing R&D programs. First of all, they are not reluctant to outsource manufacturing, for example. 

And they're not reluctant to outsource things that don't necessarily involve the development of an actual product. They tend to want to keep that in-house for a couple of reasons. One, they don't want to share the intellectual property (IP), which you can understand. But, secondly, they want to have the people inside who develop the IP. 

I've heard one of our consultants describe this medical device industry as, in this sense, an immature industry compared to the automobile industry, or some long-established industry that had learned to deal with this and to outsource their R&D in certain areas. Medical device companies don't know how to do this. 

MD&DI: What impact is global outsourcing having on R&D programs?

Buckley: Global outsourcing has resulted in a significant amount of R&D now being done outside of the United States and Western Europe. For example, a large amount of software development is being done in India.

Inman: I don't really think so yet—at least on a really wide scale. But there is huge potential. You look at countries in Asia. In countries like China and India, for example, you have a very highly skilled, intelligent population that is more than capable of doing a lot of this R&D. And the price is right. So I see a lot of that shifting now. We've seen it from a manufacturing standpoint already with many OEMs going down to Mexico to get their assembly done. I think it's just a matter of time now before they look to shift the R&D over to some of the Asian countries.

Duga: I see this as a very significant factor in various sectors. I don't know the extent to which it's a factor in the medical device industry. However, there has been a very strong increase in the amount of outsourcing, both to captive laboratories—those that are subsidiaries of U.S. companies—as well as to noncaptive ones. 

But before anyone gets terribly excited about this, you need to take a look at the total statistics on it. U.S. industry does spend several tens of billions of dollars in supporting R&D programs overseas. 

But for every dollar we spend supporting their R&D, foreign companies spend a dollar and half to two dollars supporting R&D performed in the United States. So we have a positive balance of trade relative to the performance of R&D.

I think that the globalization of R&D efforts is something that probably will continue when companies are attempting to establish themselves in those markets. They have to undertake R&D that is going to be more specific to the regulatory and cultural environment in which they want to market their goods. So there's every good reason to undertake R&D in places like India and Bulgaria, Mexico, or wherever else they choose to expand their business. 

Smith: I would add that the medical industry interestingly lags behind the consumer product industry in product development and R&D. Product lifecycles are typically longer in the healthcare industry, and costs have not been that much of an issue traditionally. Only recently have we seen interest from the medical device industry in looking overseas for outsourcing resources. Typical interest includes software development and manufacturing.

Winter: We see a couple of things. One is software, say run-of-the-mill software, that is outsourced overseas. And we've been seeing more and more things like rapid prototyping and packaging going to places like China. 

Certainly it's all driven by cost.
 
Again, this goes back to what I said before, to the companies that are willing to outsource things that are not IP related—and packaging tends not to be, and run-of-the-mill software tends not to be. And it's driven a lot by bottom-line cost.

MD&DI: What factors are influencing R&D?

Buckley: Medical R&D is partially insulated from normal business cycles, as the need for medical care and its funding by insurance (for most patients) are relatively constant. The major factors that have influenced R&D over the recent past are the need for cost reductions in devices, procedures, and care related to procedures; minimally invasive surgery technologies as a way to reduce patient trauma, discomfort, and the cost of care; increased concern about contamination and infection for both patients and medical professionals; and increased use of disposable devices and components in response to cost (of disinfection or sterilization procedures) and contamination concerns.

These factors influence the selection of medical procedures and associated device technologies to be developed. The need to reduce trauma during medical procedures, and therefore save costs and improve the patient's comfort, has spawned a variety of new devices.

Inman: Right now, on the spot, I'd have to say it is economics. Companies are really still doing some of that long-term research, but they're looking for shorter-term opportunities—maybe two to four a year—where they can really get some bang for their buck, and relatively quickly. They're looking at customer-focused opportunities where they're trying to listen more to their customer to bring to market faster what the 
customer needs. 

With development of our Class VI high-consistency silicone rubber (HCR) elastomers and liquid silicone rubber (LSR) elastomers, you have a good example of customers telling us that they needed these more-cost-effective materials and that they needed them quickly. Within a year, we had HCRs on the market, and we had LSRs within two years. And they've really taken off since then.

It's really customer-driven development. There's still some core research that's happening, but right now it seems to have been cut back quite 
a bit. I think companies are still doing it. But, again, it's more focused and they have certain goals in mind. For example, we're looking at things such as photonics, and we're trying to focus our efforts and deliver some long-term gains in those areas. 

Copyright ©2003 Medical Device & Diagnostic Industry

Device Development: Investing in the Long-Term

Originally Published MDDI August 2003

FROM THE EDITORS

Mergers and acquisitions can be used to gain market share quickly. But for the device industry, the focus should remain on acquiring R&D potential.

There have been two dominant models for mergers and acquisitions (M&A) in the healthcare industry. In one, acquisitions are driven by the need to maintain double-digit growth to satisfy investors. In the other, acquisitions represent long-term investments in new product development. For the most part, the device industry has followed the second strategy with great success. But will pressure from investors change this?

There is evidence that the pharmaceutical industry has already succumbed. So suggests a white paper published last year by IBM. In it, author Jeffrey Jung noted that M&A activity in the drug sector has been focused largely on “boosting sagging earnings,” and that strategies have targeted “short-term gains instead of long-term cures.” 

Under pressure to fill product gaps and gain instant market share, these companies have favored mergers with established firms that offer immediate returns rather than those with many new products in the pipeline. The end result of this approach is that companies end up suffering from bloat while struggling to reach growth rates that are difficult to sustain. 

Jung's view is buttressed by a recent report from Datamonitor suggesting that “the pharmaceutical sector's prevalent business model is flawed with strategies focusing on growth.” The report asserts that drug firms will “continue to sacrifice return on investment to hit investors' growth targets, although this is an unsustainable strategy.”

In the device industry, by contrast, acquisition strategies more often have looked beyond short-term gains. Their M&A efforts are, in essence, long-term investments in R&D. 

This link between R&D and M&A in the device sector is noted in a recent report from Irving Levin Associates. In 2001 and 2002, device-industry M&A increased by 45%, versus a 20% decline in the overall M&A market. Of the top five deals of 2002, three involved acquisitions of firms with strong R&D programs. 

This relationship between acquisition and product development is reflected in this issue's R&D Roundtable, beginning on p. 52. In it, several of the participants emphasize the importance of smaller firms to the R&D efforts of larger ones. 

As Battelle's Gary Smith observes, the larger OEMs often invest in small startups, essentially seeding innovation, motivated by the potential for eventual ownership. For the start-up device company, the OEM offers a potential source of vital capital as well as the promise of considerable gain if its research is successful. 

The OEM, on the other hand, can benefit from such R&D investment by strengthening its ability to extend product lines, deepen market penetration, control development risks, and reduce costs by eliminating resource duplication.

The perennial strength of the device industry has been its commitment to R&D. In the minds of many, it is a market sector defined by a steady stream of breakthrough technologies. Thanks to this perception, analysts and the public have generally viewed the device industry as an R&D juggernaut. 

More often than not, larger device companies have looked beyond acquisition for short-term gains. Instead, they have focused on investing in product development, not just through internal R&D efforts, but through acquisition as well. 

It is in the interests of the device industry to resist the types of pressures that have affected mergers and acquisitions in the pharmaceutical industry. New product development is the engine that drives the long-term success of this industry. Slowing that engine down will, in the long run, benefit no one. 

The Editors

Copyright ©2003 Medical Device & Diagnostic Industry

SARS Containment Aided by Computing Grid Technology

Originally Published MDDI August 2003

R&D DIGEST

This screen image of the SARS research portal illustrates the information exchange tools that aid diagnostic collaboration among Taiwanese physicians.
(click to enlarge)

The availability of data and links for effective communication is often critical to fighting the spread of disease. A current example is the research at the University of California, San Diego, which may help in the diagnosis and treatment of severe acute respiratory syndrome (SARS). 

More than 8000 cases of SARS and 600 deaths have been reported since February to the World Health Organization. Taiwan has been one of the regions hardest hit by the disease. In their efforts to control the spread of SARS in the region, healthcare providers in Taiwan recognized the potential value of telescience technologies. Developed by affiliates of the University of California, San Diego's National Center for Microscopy and Imaging Research (NCMIR), telescience essentially provides a computing grid to aid in sharing data and other information.

Taiwan's National Center for High-Performance Computing (NCHC) is integrating hardware and software to aid physicians. The NCHC is also a participant in the Pacific Rim Applications and Grid Middleware Assembly (PRAGMA). The Taiwanese group has asked NCMIR for help in setting up a system that would allow real-time exchange of diagnostic information. The data to be traded includes numerical instrument readings, high-resolution x-rays, and audio/video discussions. 

The system also has to protect medical professionals from SARS exposure. Several hospitals already had been quarantined because of SARS outbreaks. The result was a gap in healthcare services that could have allowed the further spread of the virus. 

Mark H. Ellisman, PhD, PRAGMA affiliate and NCMIR director, perceived the situation as a beneficial application for NCMIR's telescience technologies, especially the telescience portal. He believes that the portal can provide an effective, reliable system for exchanging data within the medical community. 

Says Ellisman, “In conjunction with NSF's National Partnership for Advanced Computational Infrastructure [NPACI], NCMIR scientists are building an integrated environment, accessible through a Web interface—the telescience portal—where remote instrument control, grid computing, visualization software, and federated digital-image databases converge and are seamlessly orchestrated to provide a high-performance analysis environment for complex applications like electron tomography.” He adds, “We are pleased that we could extend our leading-edge research technologies to quickly assist with this critical health issue.” 

Since the Taiwanese request in June, NCMIR's computer scientists have been able to use the telescience portal architecture to build a preliminary SARS equivalent that will begin to address the needs of Taiwan's medical establishment. 

The telescience team is collaborating with scientists in Taiwan to install the custom portal on machines that will be used in the NCHC environment. This adapted SARS research portal provides users with access to NPACI's Storage Resource Broker, which is used for managing data between locations, and standard image-processing software for manipulating common radiology images. These resources will help the Taiwanese medical sector manage distributed patient data.

Copyright ©2003 Medical Device & Diagnostic Industry

Nanoscale Sensor Has Potential Medical Applications

Originally Published MDDI August 2003

R&D DIGEST

 

A single DNA molecule attached to a micron-sized bead forms the sensing element of this mechanical nanodevice. When the target molecule binds, the conformational change of the sensor molecule causes a nanometer displacement of the head, which is detected optically.

Physicists have created a first-of-its-kind nanoscale sensor using a single molecule less than 20 nm in length. Uses for the nano molecular sensor could encompass early diagnosis of genetic diseases. Other applications in medicine and biotechnology are also possible, says Giovanni Zocchi, assistant professor of physics at the University of California at Los Angeles (UCLA) and member of the California NanoSystems Institute. Zocchi is the leader of the research team developing the sensor. 

“This nanoscale single-molecule method could lead to significant improvements in early diagnosis of genetic diseases, including the growing number of cancer forms for which genetic markers are known,” Zocchi says. “The largest potential applications for this sensor may be in the drug discovery process, where the possibility of quickly gauging the gene expression response of cells to prospective drugs is crucial.” 

The nanoscale sensor uses a single molecule to detect the presence of a specific short sequence in a mixture of DNA or RNA molecules. According to Zocchi, “Traditional assays use an averaged procedure that detects a minimum amount of molecules, but our method can detect a single one. When a target molecule binds to the probe in the sensor, the probe molecule changes shape, and in its new conformation, pulls on the sensor. It is remarkable that a single molecule can actually move the sensor, because the relative sizes are comparable to one person trying to move a mountain, but mass is of no consequence at these minuscule scales.” 

The sensor motion is detected by an optical technique called evanescent wave scattering, which analyzes light that leaks out behind a reflecting mirror. This evanescent wave can be used to sense precisely the position of an object “beyond” the mirror. “Instead of detecting the presence of the target, we detect the changing conformation of the probe when the target binds to it,” Zocchi explains. 

The UCLA team is the first to report measurements of conformational changes in a single DNA molecule at the nanometer scale. “This single-molecule sensor could be an important component of a ‘lab on a chip' technology for doing chemical analysis on a chip,” Zocchi says. 
He adds that the team plans to use the nanoscale sensor for experimental leukemia research. The goal will be to determine whether the sensor's high sensitivity can detect a recurrence of cancer at an earlier stage than is now possible. “If we can increase the sensitivity of the detector, then it may be possible to detect genetic diseases at an earlier stage,” Zocchi adds. “It may become possible to diagnose the presence of an abnormality in DNA at an early stage, or the expression of a certain gene that should not be expressed.”

Zocchi believes that research to develop the nanomolecular sensor could also benefit basic research efforts. 

Zocchi explains that “a single-molecule sensor has, in principle, extraordinary sensitivity. Unlike previous single-molecule experiments, which were impractically complicated for large-scale applications, the simplicity of this design lends itself to many applications.”

The researcher speculates that having an efficient high-sensitivity method would be an important tool for testing how cells react to a new drug. He adds, “The nanosensor could also be a useful tool for stem cell research. A nanosensor based on this technology could potentially 
detect minute traces of biological weapons, based on a characteristic genetic signature. These are the first steps down a path toward devices that we expect will be really useful.” 

In addition to the proposed applications, Zocchi believes that the research could offer benefits in basic science. He also speculates that “the future will undoubtedly see nano-bio composite devices applied to perform molecular tasks. Ultimately these efforts will lay the groundwork for creating artificial systems with more and more of the characteristics that have been unique to living things.” Zocchi adds that “economy of scale allows nature to pack the most elaborate laboratory on Earth in the volume of a single bacterial cell; in the future, artificial systems may approach similar complexity.”

Copyright ©2003 Medical Device & Diagnostic Industry

Reducing Medical Errors with Benign Failures

Originally Published MDDI August 2003

NEWSTRENDS

Gregg Nighswonger

John Grout suggests using intentional failures to reduce medical errors.

The potential for adverse events in hospitals, whether caused by device malfunction or human error, has been the focus of increased public and industry concern. 

The costs associated with such events—in the form of lost income, disability payments, and healthcare expenses—are estimated at as much as $29 billion annually. Medical errors often have consequences that are more severe than those in other industries, prompting the healthcare industry to consider a range of possible remedies. Recently, a professor at Berry College (Rome, GA) proposed that one way to reduce or eliminate adverse events is to intentionally design targeted failures into medical systems.

John Grout, David C. Garrett Jr. associate professor of business administration at Berry College, admits that purposefully designing failure into healthcare processes might be the surprising answer to preventing medical errors. Nevertheless, he proposes that taking such an approach could make healthcare processes more resistant to the tendencies of human beings to make mistakes. Specifically, he suggests that medical processes be designed to fail benignly before patient injuries occur—rather than building in additional, often costly, checks and redundancies.

According to Grout, “Medical mistakes, which kill tens of thousands of Americans each year, too often are caused by healthcare workers simply being human. They make mistakes that cause failures in the processes used for patient care. Research has shown that no amount of punishment, berating, finger-pointing, or guilt will eliminate human error. Regardless of good intentions and extensive training, people will make mistakes—and some of them will be deadly.”

Grout believes that it is more sensible “to design medical systems that make human error irrelevant to outcomes than to create more checks and redundancies for already over-burdened nursing personnel and other healthcare providers.” Staff workloads are a principal consideration. He adds, “Increasing nurses' work load or the need for more nurses isn't practical or affordable. Designing processes that fail before a patient is injured may well be both.”

Grout uses the example of scalding a patient with too-hot bath water as a harmful process failure that can be caused by human error and prevented by a planned, benign process failure. “Even if there are checks and redundancies built into the system, it is possible for caregivers to make a variety of errors that lead to scalding,” he explained. “It can be as simple as misreading a temperature gauge.” 

While no water coming from the tap at bath time also is a process failure, he continued, it is inconvenient but not dangerous. In medical terminology, it is benign. Grout suggests that this type of benign failure can be designed into processes, thus preventing patient injury. “A scald valve could be installed that restricts flow from the tap if the water temperature exceeds a certain level,” he stated, “causing the system to fail before the patient is injured even if the caregiver makes a mistake.”

Grout explains that this approach is based upon a conclusion reached long ago in such fields as psychology, engineering, and quality management: If you want to reduce errors, you have to stop processes from proceeding when they go awry. 

Grout's approach is based on the use of graphic fault trees to map processes and identify their potential areas of both dangerous and benign breakdown. “A careful analysis of the fault trees enables an analyst to anticipate how the process will behave after a change is made,” Grout explains. “Process failures that cause harm can be converted into the causes of benign failures.”

Grout first presented his approach for eliminating medical errors at the Partnership for Patient Safety's international symposium held October 2002 in Washington, DC. More recently, he described his proposal in the July 2003 issue of the Joint Commission Journal of Quality and Safety, published by the Joint Commission on Accreditation of Health Care Organizations.

Copyright ©2003 Medical Device & Diagnostic Industry

GMP Actions Could Affect Part 11 Enforcement

Originally Published MDDI August 2003

NEWSTRENDS

Erik Swain

FDA's effort to revamp good manufacturing practices (GMPs) for drugs could have effects on the device industry, an agency official says.

Steven M. Niedelman, FDA's associate commissioner for regulatory affairs, told a device industry audience that 
certain drug-GMP initiatives, such as revamped rules on electronic records and signatures (21 CFR Part 11), will cover medical devices and other FDA-regulated industries as well. He spoke at the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington, DC) in June. 

The agency began reevaluating drug GMPs in August 2002. Goals include incorporating more state-of-the-art science into the review and inspection processes, encouraging the adoption of new technology, improving agency coordination, and providing incentives for firms to implement better quality-management practices. 

There is no specific effort to restructure medical device GMPs, but device manufacturers should be aware of upcoming changes whose reach might extend beyond the pharmaceutical industry, Niedelman said.

One area is part 11, which covers how drug, device, and biologics companies must maintain electronic records and produce electronic signatures. Industry has long complained that the regulation is too confusing and burdensome. FDA has agreed to reevaluate it, and earlier this year withdrew a number of guidances pending that outcome. It also agreed to enforce it less aggressively for now—especially for systems in place before August 20, 1997, the effective date of Part 11. This will extend beyond pharmaceuticals, Niedelman said.

“Part 11 applies to all facets of the agency, and that means devices as well as drugs, biologics, etc.,” he said. “The device industry will need to keep up with the work going on in that area.”

Another development in the drug-GMP initiative is a clarification of precisely what a form 483 citation means. There had been a perception among financial analysts and others who evaluate the industry that a form 483 citation indicated that the firm was not in compliance with GMPs. So 
the agency is adding language to those documents to clarify that that is not the case. The language has also been added to every FDA Web 
site where 483s and warning letters are posted. 

The explanation reads as follows: “This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.”

This statement applies to device 483s as well, Niedelman said. “It applies to any industry that receives a 483.”

Device manufacturers should also pay attention to any changes that affect internal quality-system programs, Niedelman said.

More relevant developments could be on the way, he said. “We are doing a gap analysis of GMPs across the different regulated industries to compare how the GMP systems are enforced,” Niedelman added. “Ultimately, I can't say whether it will or will not have an effect on the device industry. But certainly CDRH is a player in this effort.”

Copyright ©2003 Medical Device & Diagnostic Industry

HEI and Cerner to Collaborate

Originally Published MDDI August 2003

NEWSTRENDS

Two leading medical software firms have agreed to develop and supply bedside-healthcare integration products for handheld patient-data devices. HEI Inc. (Victoria, MN) and Cerner Corp. (Kansas City, MO) are collaborating on integration products for the latter's CareGuard, a device that combines clinical documentation, error prevention, and bedside-device integration. CareGuard will use HEI's Link-iT technology to enhance real-time data collection in various Cerner Millennium products.

According to HEI, Link-iT enables OEMs and vendors to quickly add both wired and wireless connectivity and distributed-software applications to their products.

Copyright ©2003 Medical Device & Diagnostic Industry

FDA Approves First Cobalt-Chromium Stent

Originally Published MDDI August 2003

NEWSTRENDS

Maureen Kingsley

The cobalt-chromium alloy design of the Multi-Link Vision makes for a thinner strut design and lower profile.

Guidant Corp. (Indianapolis) has received FDA approval to market its unprecedented cobalt-chromium stent for cardiovascular applications. According to the company, the use of the cobalt-chromium alloy makes for a thinner strut design and lower profile. These features enable physicians to access more-difficult coronary blockages. 

Guidant plans to use the new technology in such treatments as drug-eluting stents and vulnerable-plaque therapies. The specific product receiving approval—the Multi-Link Vision—will be offered in diameters of 3.0–4.0 mm, and lengths of 8.0–28.0 mm. 

In clinical trials, the device achieved a six-month, clinically driven target-lesion revascularization (TLR) rate of 1.9%. TLR is defined as a repeat procedure at the original site during the follow-up period.  The company also plans to introduce its Multi-Link Mini-Vision product, a small-vessel cobalt-chromium stent, in Europe later this year. 

Guidant also announced recently that it has received market approval for its Vitality DS implantable cardioverter defibrillator (ICD) system. The company reports that this dual-chamber ICD is the smallest in the world. 

The Vitality DS is designed to treat patients with life-threatening rhythms in the lower ventricles of the heart—a common cause of sudden cardiac death. The Vitality ICD is implanted near the collarbone and continuously monitors heart rhythms. It delivers electrical therapy when required to protect against abrupt loss of cardiac function.

The new ICD incorporates Guidant's proprietary AV search hysteresis. According to the company, results from recent studies suggest that unnecessary pacing in the right ventricle may have a harmful effect on the heart. Guidant's AV search hysteresis is intended specifically to reduce unnecessary pacing of the right ventricle by periodically searching for the heart's intrinsic rhythm.

Copyright ©2003 Medical Device & Diagnostic Industry

New Name for B. Braun Unit

Originally Published MDDI August 2003

NEWSTRENDS

In June, B. Braun OEM/Industrial Division became the new name for the Burron OEM Division of B. Braun Medical Inc. (Bethlehem, PA). The change, announced during the MD&M East conference and exposition in New York City, was intended to reflect the unit's global presence and emphasis on expanded capabilities.

The firm's global OEM/industrial business will be directed by Ron Earle, group senior vice president of the B. Braun OEM/Industrial Division. Earle has had 24 years' of experience with B. Braun Medical Inc. According to the company, Earle will focus on “optimizing B. Braun's ‘Centers of Excellence,' the personnel and equipment at more than 40 worldwide locations.”

Copyright ©2003 Medical Device & Diagnostic Industry