Originally Published EMDM September 2005
Market Watch
Catheters
To combat price erosion, manufacturers are finding novel ways to add value and reduce production costs.
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| Very thin layers of a diamond-like carbon coating, applied to stents and catheters in a plasma chamber, could prevent encrustation. |
Maturity may be a desirable quality in individuals, but it’s not always a positive attribute when it describes a technology. Manufacturers of a product that is approaching maturity often must plan for price erosion. To offset declining margins, they must compete either by finding more economical ways to make their product or by adding value that can command a higher price. That has been the scenario for catheter manufacturers.
“Angioplasty and angiography were introduced more than a decade ago,” says Vaishnavi Ananthanarayanan, industry manager and research analyst, North America, at Frost & Sullivan. Its clinical advantage over coronary artery bypass graft (CABG) procedures propelled its rapid growth. “But in the past two to three years, [off-pump] beating-heart surgery has gained in popularity,” she notes. “Consequently, the angioplasty catheter market is taking a back seat.” Annual growth will be minimal in this sector, she says. Compounding the difficulties for manufacturers of traditional cardiac catheters is the emergence of rapid-exchange catheters, which has driven growth in this field in 2003 and 2004, according to Ananthanarayanan.
The outlook for IV catheters is a bit better, but only marginally so. “It won’t grow substantially, because this is mainly a replacement-demand market,” says Kavitha Ravikumar, an analyst for Frost & Sullivan based in Europe. “I would say the annual growth rate is between 3 and 5%, at best.” There are some exceptions, however. Depending on a country’s reimbursement policies and its attitude toward safety, so-called safety catheters can buck this trend. In France, for example, growth has been above 10%. Embedding antimicrobial properties in catheters represents another means for manufacturers to add value to their devices.
The picture is also brighter in the urinary catheter field. An aging population, the spread of obesity, and a growing number of diabetics, accompanied by a changing mindset, has contributed to sustained growth, says Ananthanarayanan. “More-advanced surgical procedures—even those involving drainage bags—have led to some dramatic increases.” She estimates that annual growth in urinary catheters will reach nearly 10% in the United States and Europe.
Adding Value
A shift toward the use of silicone and Teflon in lieu of latex is described by Ananthanarayanan as a major trend in catheter manufacturing. “This will make a big difference, and not just for people suffering from latex allergies,” she says. “These materials are more comfortable for everyone.” The raw materials are more expensive than latex, and will lead to justifiable price increases. “This won’t affect the market right away,” she adds. “It will take time to educate users on what is available, but you will see a noticeable difference in the market within a couple of years.” Patient comfort is also driving the use of silicone for IV and even urinary catheters, adds Ravikumar. In addition, the material is compatible with certain antimicrobial coatings.
One promising coating technology under development in Germany applies very thin coatings of carbon to indwelling urinary tract catheters. Despite state-of-the-art sterilization methods used in hospitals, catheterization remains a common cause for urinary tract infections. “Up to now, there has not been any effective way of preventing bacteria from entering the urinary tract via the catheter and thereby triggering a urinary tract infection,” says Norbert Laube of the University of Bonn. Also involved in the research are the Institute of Thin Film Technology (Kaiserslautern, Germany; www.uni-bonn.de) and New Technologies in Thin Films GmbH (Rheinbreitbach, Germany; www.nttf.de).
The researchers used an extremely thin layer of diamond-like carbon (DLC) coating, applied in a plasma chamber, on urinary stents and catheters. After three months in the body, the devices showed virtually no encrustation. In addition, the coated catheters were easier to insert and remove than uncoated ones.
Because of their high thermal conductivity and dielectric properties, DLC films have been used in laser diodes and microwave electronics. With the advent of mass production capabilities, DLC coatings are now being used in other sectors, including protective coatings for medical devices.
Reducing Manufacturing Costs
Providing better, safer products is one way of resisting price erosion. Another is to cut production costs. As in so many other market sectors, manufacturers are turning to outsourcing. Not surprisingly, China is on the radar of many OEMs.
“A lot of catheters are being produced in China,” says Ananthanarayanan. The confidence level is higher than you might think, she adds, because Chinese suppliers are able to provide a satisfactory level of quality assurance. “They do not need to spend as much on resources [as US and European firms do], so more personal attention is provided at every stage of the production process.” Typically, the material processing and basic fabrication of device components is done in China, while the assembly, final sterilization, and packaging is managed by the OEM.
Ravikumar adds that Chinese and Indian manufacturers have penetrated the markets of Eastern and Central Europe. “They went into those countries because market access was simpler than in the European Union.” Now that those countries have joined the European Union, market access in other EU countries is within reach. “They may not be the best available products,” says Ravikumar, “but they are good enough. They have the CE mark, and they are cheaper than competing products.”
This trend can only amplify as the European Union expands. Larger companies may not have a cause for immediate concern regarding an influx of lower-cost products into Western Europe, notes Ravikumar, because brand recognition is very important. “But I do see it having an impact in the years ahead,” she adds.
Suppliers in Western Europe have not given up the struggle to help OEMs compete. One such company is Heinz-Schade GmbH (Reutlingen, Germany; www.heinz-schade.de), which has developed a PTCA and PTA catheter fabrication process that reduces production time by as much as 30%, compared with prevailing methods.
The so-called MODUL technology relies on optimized machine fittings, resulting in a reduction in the amount of required cleanroom space, and a specially designed infrared (IR) heating process for balloon forming.
“The IR heating process that is integrated into the system deviates by less than 0.3°C,” says company founder and director Heinz Schade. “It results in a more efficient and consistent production process that can be used in two ways. Constant balloon manufacturing can be performed at temperatures exceeding 200°C. In addition, welding can be achieved at accelerated rates without affecting product safety,” he explains.
The manufacturing system meets all European and US FDA norms, he adds.
“Minimally invasive devices such as PTCA and PTA catheters represent a huge market,” says Schade. “But OEMs such as Boston Scientific, Johnson & Johnson, and Medtronic are diligently looking for ways to reduce production costs.” By developing a more streamlined and cost-efficent processing system, Schade hopes that their gaze will turn to Reutlingen rather than China or Eastern Europe.
Heather Thompson contributed to this article.
Supplier Profiles
Benefits of Microabrasive Blasting Rub Off on Catheters
In microabrasive blasting, an abrasive media is mixed with air and propelled out of a small nozzle tip at high velocity. The technique is designed to clean, texture, deburr, or otherwise process very small parts and hard-to-reach areas with extreme accuracy. The variety of abrasive media that are available and the capability to adjust the blast pressure offer users a great degree of process control. Some manufacturers are using microblasting equipment designed by Comco Inc. (Burbank, CA, USA) to process catheters.
One application involves the use of sodium bicarbonate to remove polymer coverings from small selected areas of tubing and to remove PTFE coatings from catheter guidewires. Other abrasive media can be used to prepare surfaces for bonding and coating adhesion. Microabrasive blasting is also suited for deburring tubing and texturing or lightly abrading surfaces.
Contract Catheter Manufacturer Offers Range of Balloon Sizes
A company located in Mauritius has more than 12 years of experience producing PTCA catheters for medical device OEMs. The Tamarin family of coronary catheters, manufactured by Natec Medical Ltd. (Reduit, Mauritius), features a low profile and rapid exchange in a 0.036-mm-guidewire format. A hypotube design ensures pushability. Balloons can be specified 8 to 40 mm long and 1.5 to 5 mm in diameter. Customer-specific marker configurations and custom connectors can be accommodated.
The firm is certified to ISO 9001 and ISO 13485, and its products are made in accordance with CE marking and US FDA requirements. New Class 10,000 cleanrooms are on-site; sterilization and packaging services are provided.
Catheter Production, Testing, and Packaging Equipment Available under One Roof
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To assist engineers involved in the manufacture and quality control of catheters and medical tubing, a company offers relevant production, testing, and packaging equipment. In particular, Medical Engineering Technologies (Folkestone, Kent, UK) highlights a catheter-processing machine.
The equipment relies on induction heating, or induced electrical currents within the material, to process the material. Target temperatures can be reached in less than 1 second. The system is suitable for tip forming, welding, and eye cutting as well as permanent bending and shaping. The company offers free trial runs to potential customers.
Other products of interest to catheter manufacturers include cyanoacrylate and UV-cure adhesives, including a range of formulations that change colour when exposed to UV light to facilitate validation; single- and multilumen catheter leak-and-flow testers; pouch-packing machines; and blister tray sealers. The firm can provide biocompatibility, material, and functionality testing services.
Precision Machining Firm Houses Well-Equipped Inspection Lab
A company with expertise in micromachining services for the medical device and biotechnology industries manufactures balloon moulds, mandrels, inserts, and nitinol formers. Caragh Meditech (Galway, Ireland) cites among its capabilities CNC Swiss-type turning, CNC wire and plunge EDM, five-axis machining, grinding, lapping, polishing, finishing, cleaning, and packaging. Assembly is available in a cleanroom environment, and laser welding and laser marking services can be provided.
A climate-controlled inspection laboratory includes coordinate-measuring equipment with a surface-scanning module and roundness tester. The firm’s engineering department employs SolidWorks solid modeling and sundry CAD/CAM processes.
Ultrasonic Punching Takes Edge off Catheter Tubing
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Mechanical punching of tubing for catheter use may leave sharp edges around the “eyes” of the device. A maker of automation equipment for medical technology companies has developed an ultrasonic punching process that forms a smooth radius on eye edges. The process is suitable for use with drainage and suction catheters, according to Kahle Europea S.p.A. (Caravaggio, BG, Italy). In addition to eliminating sharp edges that may cause patient discomfort, the ultrasound technique produces accurate ellipses to eliminate turbulent flow through the eyelets. The press can be integrated with the firm’s 100% on-line inspection and tip-forming equipment. The company will send samples of tubing processed using its equipment upon request.
Thermal Shrinking Systems Provide Uniform Treatment
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Thermal shrinking systems are used during processing to apply heat to a variety of delivery devices such as guiding, diagnostic, and urinary catheters; stent-delivery devices; and other braided or coiled catheter products. The MSI Vertical Shrinker VS 1000 product line was recently introduced by Machine Solutions Inc. (Flagstaff, AZ, USA).
The PC-controlled machines feature a 360° thermal nozzle that uniformly applies heat, thus reducing the incidence of hot and cold spots during the shrinking process. They have a four-station design with programmable product-specific speed settings and heat zones that feature accuracy to within 1 mm. The profiles can be saved and recalled, easing setup and ensuring repeatability.
The thermal shrinking systems product group is the latest addition to the company’s line of catheter-processing equipment. It offers several products that partially or fully automate a number of catheter-manufacturing tasks that have traditionally been done manually.
Grinding, Coating, and Assembly Expertise Are Applied to Guidewire Fabrication
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Advanced grinding, coating, and assembly technologies enable a company to manufacture guidewires that combine different materials. Epflex Feinwerktechnik GmbH (Dettingen, Germany) prides itself on its ability to meet a range of unique customer requirements.
To eliminate flaking, the firm offers guidewires with precoated hydrophilic ends. They are available in a range of stiffnesses and in different flexible lengths. The middle portion of each device is coated with PTFE to improve control. Guidewires can also be manufactured with stainless steel and a nonkinking nitinol core.
Contract Heat Shrinking Performed in Class 10,000 Cleanroom
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Custom heat-shrink services are offered in a Class 10,000 cleanroom. TexMed (Fort Worth, TX, USA) develops, designs, and recovers heat-shrink tubing in partnership with customers. By outsourcing these processes, medical device OEMs can reduce development time and costs, and forego investments in capital equipment, says the firm. In addition, there is no need for the OEM to stock inventory, as the firm offers just-in-time delivery.
The firm defines a typical project as a combination of application engineering and precision manufacturing. Acting as an extension of the customer’s engineering department, the firm’s engineers provide guidance in material selection. The USP Class VI–compliant heat-shrink material is applied to catheters, surgical instruments, and related medical devices. Radiopaque products are also available, and heat-shrink products can be supplied marked, scored, drilled, and packaged to suit customer requirements.
Firm Offers CE Marked Silicone Catheters
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A firm with more than 20 years’ experience supplying finished products and services to medical device OEMs considers the fabrication of silicone catheters to be a core competency. Degania Silicone (Regensburg, Germany) offers a one-stop service, from product development to delivery of sterile CE-marked silicone catheters.
Foley and suprapubic catheters, as well as products in customer-specific configurations, are routinely produced. The firm processes long-term-implant-grade materials, and provides balloon moulding, extrusion, and dipping services. Two-layer balloons can be mounted on PVC shafts. The company also has expertise in embedding antimicrobial and other protective agents into the catheters.
All quality systems are certified to ISO 9001 and ISO 13485.
Catheter Tubing Designed and Manufactured on Contract Basis
A company that combines extrusion expertise and in-house wire-processing capabilities designs and manufactures a range of custom catheter tubing for device OEMs. Braid-reinforced tubing, lubricious catheter shafts, and tubing with conductors or linear strength members are routinely produced by New England Catheter Corp. (Lisbon, NH, USA).
The firm’s key competencies include the design and manufacture of tight-tolerance thin-wall extruded products, multilumen braided tubing, and tubing made of thermoplastic resins bonded to layers of fluoropolymer resins. Extensive braiding and wire-handling capabilities enable the use of round or flat stainless-steel wire, high-strength fibres, plastic monofilaments, and other materials as braided reinforcements. Carrier braiders and stainless-steel wires, either flat or in a range of diameters and hard or soft tempers, are always in stock.
The company offers a mix-and-match option that allows different braids or materials to be used within a prototype run.
Copyright ©2005 European Medical Device Manufacturer
