PRODUCT UPDATE
Catheter Processing Equipment and Services
Benjamin Lichtman
The popularity of minimally invasive procedures drives growth in the catheter processing industry.
Minimally invasive surgical procedures continue to exert an influence on the device market, and catheters are being called on to play significant roles in clinical applications. Devices that allow surgeons to enter and exit access sites quickly and with limited complications hold the dual promises of improved patient recovery time and reduced costs.
"We are seeing a trend toward minimally invasive procedures, and this is certain to benefit catheter manufacturers," observes Dan Kasprzyk, president of Machine Solutions (Flagstaff, AZ, USA), which supplies catheter testing and stent-crimping equipment. Kaspryzk further predicts that as minimally invasive procedures become more established the market for access-site closure technology will grow.
In order to remain competitive, device companies must be able to innovate quickly and bring their products to market in a timely manner without sacrificing quality. A range of equipment and services is available to help manufacturers of catheters meet this challenge, from tube cutters and balloon forming machines to custom extrusion and contract manufacturing.
Balloon forming machines are popular with catheter manufacturers that seek not only to automate their production lines, but also to develop proprietary balloon designs for a variety of clinical applications. Josef Stupecky, president of Interface Associates (Aliso Viejo, CA, USA), points out that his company's clients include companies working on angioplasty, respiratory, drug delivery, and microcutting applications. The company, says Stupecky, is continually modifying its machines to fit the requirements of developing projects. "We introduce a new machine every four months," he says.
Ralph Joiner, vice president of sales at Farlow's Scientific Glassblowing (Grass Valley, CA, USA), also observes an emphasis on the development of new catheter applications. He notes that his company's clients will often present the firm with multiple projects simultaneously. "One project will be in development while another is just beginning production," he says. Joiner adds that the abundance of patents on nylons and polyethylenes has spurred an interest in catheter balloons formed from new material blends.
According to Monika Löffler, product manager at melab Medizintechnik und Labor GmbH (Leonberg, Germany), regulatory pressure in the disposables industry has placed a new emphasis on catheter testing. Löffler stresses that companies are looking for testing equipment that handles documentation automatically. "Simply put, such equipment minimizes failures and saves a lot of money," she says. Löffler points out that melab's catheter testing equipment includes interfaces to feed test data to computers for analysis, storage, and documentation.
After considering the substantial investment necessary to launch a new product, some companies find that outsourcing manufacturing services is the most cost-effective way of bringing a catheter-related product to market. Ravinder Gill, managing director of Maspac Ltd. (Galway, Ireland), explains that his company is developing "innovative ways of delivering finished devices that are more cost-effective—that's our challenge." Maspac specializes in the production of minimally invasive vascular catheters and provides a full range of contract manufacturing services including product design, laser welding, metal forming, heat treatment, assembly, sterilization, and shipping.
Indeed, industry observers agree that the most successful manufacturers of equipment also view themselves as providers of services. Henrik Søbygaard, president of Søbygaard Machine Design ApS (Naestved, Denmark) sees his company as a service provider, a role that augments its core activities as a supplier of catheter manufacturing equipment. "We take great care to involve customers in every aspect of a project, beginning at the design phase," he says, noting that his staff is often called on to evaluate clients' cleanrooms and personnel. "Our small size allows us to offer personalized attention to our customers," he adds.
Manufacturers seeking new sources of catheter processing equipment and services are encouraged to consult the following descriptions of some of the industry's leading suppliers.
NATec Medical
A manufacturer of high-performance PTCA catheters exclusively for OEMs, NATec Medical (Le Pian Médoc, France), specializes in balloon technology, producing balloons for both stent delivery systems and angioplasty applications. The company has invested 10 years of R&D efforts in its catheter line, and has developed a proprietary nylon balloon material that features flexibility and resistance to pressure. Polyamide balloons offer puncture resistance, low profiles, EtO compatibility, and shape-memory properties. They have an average burst pressure of 25 atm and a minimum rated burst pressure of 16 atm. Hypotubing shafts are produced in stainless steel, and PTFE coatings can be applied to enhance lubricity.
Business manager Vincent Lagarde comments that NATec's dedication to the OEM market makes the company more flexible in responding to customer needs. "We are not in competition with our clients," he says. "This allows us more freedom to exchange design data with companies while performing custom work for them."
NATec also has a manufacturing and R&D facility in Thompson, CT, USA, but is planning on transferring all of its production to its French facility over the next few months. According to Lagarde, the company is currently working on advanced catheter technology for applications such as drug delivery systems.
Machine Solutions
The Interventional Device Track Equipment (IDTE) testing system quantitatively analyzes catheter tactile performance through the use of a motorized roller drive assembly that simulates catheter advancement through a tortuous arterial path. Tests include trackability, pushability, guidewire movement, crossability, deliverability, and retention. The machine has applications in both R&D and quality control.
A 300-MHz personal computer with a Windows 95 operating system simplifies the system interface and offers a touch screen. The screen displays water bath temperature, elapsed time, and test results. Adjustable test parameters include traverse speed, track length, catheter length, force range, and sample rate. Dan Kasprzyk, president of Machine Solutions (Flagstaff, AZ, USA), explains that the IDTE offers "quantitative analysis of the tactile components of interventional device development. The machine provides quantitative measurements for the type of subjective evaluations that a clinician makes in monitoring catheter performance. We've found that most firms have crude techniques for getting this info, but nothing that can provide this type of data."
The company also provides custom services and can design equipment to aid manufacturers with automated processes in the production of interventional devices.
Medi-Line S.A.
A manufacturer of disposable products offers a full range of contract services, from research and design to injection moulding, product finishing, and packaging. Specialties include single- and multilumen catheters, bubble tubing, and moulded components formed to customer specifications. Medi-Line S.A. (Angleur, Belgium) has its own tooling facilities, extrusion lines, injection moulding machines, and thermoforming equipment. All operations are conducted in the company's Class 10,000 cleanroom or Class 100 laminar-flow facilities. Products can be supplied in semifinished or finished form. Finishing operations include hole punching, tip finishing, flaring, welding, and bonding. The firm can also produce customized finishing equipment for customer-specific needs.
The company, which consists of 10 employees, was founded in 1994. The company's managing director explains that the firm's small size gives it a degree of flexibility in responding to customer demands. "Because we provide so many services in-house, we can offer clients continuity and very fast reaction times," he says, adding that Medi-Line can also accommodate smaller production runs than most large companies.
Farlow's Scientific Glassblowing
A new computerized model of a company's balloon forming machine allows for rapid assembly and quick delivery. The BBM3100 features touch screen programming, wireless mouse operation, and remote viewing. According to Ralph Joiner, vice president of sales at Farlow's Scientific Glassblowing (Grass Valley, CA, USA), the machine's modular design allows manufacturers to "pick up a section of the machine and replace it with another one in a matter of minutes." Temperature, pressure, and stretch parameters are all controlled digitally, so no mechanical adjustments are necessary. Service, inspection, and programme interfacing can be completed over the Internet, saving downtime and improving the efficiency of multilocation companies.
"This machine eliminates the need for programming," says Joiner, noting that the BBM3100 allows manufacturers to enter balloon dimensions directly using touch screen controls. The machine will see its commercial launch on 18 January at the Medical Design & Manufacturing West 2000 exhibition in Anaheim, CA, USA.
The company began work in the medical sector in 1981 while developing glass moulds for angioplasty balloons. The company is reportedly the world's only supplier of this technology. Farlow's also manufactures glass capture tubes, taper tubes, and tipping dies.
Søbygaard Machine Design ApS
Custom equipment for the production of disposable catheters is supplied in automated, semiautomated, and manual models by Søbygaard Machine Design ApS (Naestved, Denmark). A fully automated unit includes an integrated form-fill-seal machine for in-line production and packaging. The machine can produce up to 3000 packaged catheters per hour in sizes ranging from 8 to 18 French and in lengths ranging from 200 to 650 mm. Tubing is fed directly into the machine from the extruder. "Our customers can also purchase separate equipment for packaging, but they find that this is an economical alternative," says company president Henrik Søbygaard.
The company's automated manufacturing equipment is designed to operate continuously in cleanroom environments and is suited for high-volume applications. A special troubleshooting feature allows operators to diagnose production problems on a computer monitor in case of machine failure.
Doyen Medipharm Ltd.
Engineers at Doyen Medipharm Ltd. (Barton, Cambs, UK) have doubled the output of a four-side-seal machine using a twin-lane design. They achieved this by mounting one of the company's side-seal modules at the machine's datum, along the centre line. This allows a full size change to take place in minutes without corrupting validated settings. The machine is well suited for high-speed production lines or for long products like catheters.
Noel Blake, sales manager at Doyen, says, "This is the first time that manufacturers running more than one lane on their sealing machine can do so while achieving validated parameters." He notes that the machine will be particularly attractive to low-volume producers, since its fast changeover times allow it to be used on a variety of products.
Doyen is also working on moist packaging solutions for catheters for the home healthcare market. "Our customers are finding that it's not always desirable for products to look like a medical device," he says, adding, "We're working on machines that can produce more discreet packaging."
melab Medizintechnik und Labor GmbH
Monika Löffler, product manager at melab Medizintechnik und Labor GmbH (Leonberg, Germany), draws a parallel between installing testing equipment and implementing ISO 9001 quality systems. "The full benefit of both is only recognized after their incorporation," she says, adding that manufacturers often have an emotional reaction to the idea of using testing equipment. "Their initial thought is, 'This is going to raise the number of rejects and lower my output,'" she says. According to Löffler, this is only half the truth. "Our philosophy is that it is more cost-effective to catch problems early in the process," she says. Melab specializes in the production of in-line testing equipment for medical disposables.
Manufacturers can perform kinking tests on all kinds of tubing systems using the company's new KINK machine. The machine operates by monitoring kinking radius in relation to flow rates. These data are recorded, and resistance to kinking is measured by a load-displacement sensor. Designed for use in random laboratory tests, the machine includes a computer interface and is supplied with specialized software for data analysis and storage.
The company also offers the KADI-S machine (pictured), a semiautomated leak tester designed for use with multiluminal central venous catheters. The machine can detect leaks to adjacent lumens, leaks to the environment, and separator leaks. Other products include a tester that checks luer closing and opening to the ISO 584 standard, and a flow rate tester. Melab also offers a range of testing services at its laboratory facilities.
Interface Associates
A full range of manufacturing equipment for the production of catheters is supplied by Interface Associates (Aliso Viejo, CA, USA).
The company's balloon forming machines aid manufacturers with the difficult task of consistently and quickly forming various balloons from polymer tubing. The 9800 Series balloon forming machine offers complete control over all balloon forming parameters. All machine functions are centralized on an integrated touch screen display. The unit includes a computer interface and closed-loop digital control of pressure, gas flow, and stretch force. Operators can build custom, 18-step sequences for balloon formation.
One of the innovative features of the 9800 is its use of three separate circuits to provide zone-specific heating and cooling at different points on a balloon. Company president Josef Stupecky emphasizes the significance of this feature, explaining that the machine can control temperature precisely to regulate wall thicknesses. "This is a big advantage in thin-wall applications," he says, adding, "I'm not aware of any other balloon machine that offers this feature." The 9800 is being introduced at the Medical Design and Manufacturing West 2000 show in Anaheim, CA, USA.
Interface also supplies tubing stretchers, tubing welders, folding machines, and leak testing equipment to the device sector. The company offers training and consultation services.
SEBRA
A semiautomated, briefcase-sized system converts thermoplastics into finished catheters by tipping and welding. The PIRF system from SEBRA (Tucson, AZ, USA) can be used for both R&D and production, providing fast, precise, and repeatable control of heating time, cooling time, and insertion pressure. The system is suited for use with polyethylene, fluoropolymers, polyvinyl chloride, polypropylene, and polyurethane.
Tipping and welding are performed inside moulds designed with temperature profiles, and a proprietary closed-loop system provides precise control over mould temperatures. Marketing associate Judy Laurel explains that tight control over temperatures is an important feature. "If you're making a catheter tip, you may want to concentrate the heat in the back, and make it cooler at the tip, in order to avoid flash," she says. According to Laurel, a further advantage of the PIRF system is that it is air cooled, which makes it more portable than water-cooled systems.
Boston Matthews Plastics Machinery Ltd.
A designer and manufacturer of single-screw extruders, complete integrated extrusion lines, and downstream equipment for the production of medical tubing in a variety of polymers, Boston Matthews Plastics Machinery Ltd. (Worcester, UK) supplies 30-, 45-, and 60-mm extruders that are suited for the production of catheter tubing. The firm has supplied machinery to the medical industry for more than 40 years, ranging from individual units to complete turnkey solutions.
"For catheter production, the quality of the tube is essential because of the number of postextrusion processes that must take place," says Richard Brookes, marketing manager at Boston Matthews. "It is important to manufacture the tube without any stresses so as to avoid any reversion during these processes," he adds, noting that the company produces all component parts in-house to strict quality standards.
Boston Matthews also supplies small injection moulding machines used to manufacture catheter connectors. Brookes notes that the company's small injection moulding machines are used extensively throughout the medical industry because of their level of precision, accuracy, and reliability. "The Model BM10 offers fast tool changes, easy tool maintenance, reduced capital expenditure, reduced energy costs, and compliance with all cleanroom conditions," he says.
Maspac Ltd.
A full-service contract manufacturing company specializes in the production of minimally invasive vascular catheters. Managing director Ravinder Gill describes Maspac Ltd. (Galway, Ireland) as "a device development, engineering, and manufacturing solutions company."
Working from a product concept or patent, Maspac engineers produce prototypes for clinical trials. Typical projects include catheters, vascular accessories, and endosurgical devices. The company's in-house manufacturing processes include laser welding, metal forming, heat treatment and processing, UV and solvent bonding, injection and insert moulding, and RF welding and forming. Materials processed include nitinol, stainless steel, polyurethane, polyethylene, nylon, and polyvinyl chloride. The firm also offers assembly, packaging, sterilization, and worldwide shipping services.
In addition to providing manufacturing services, Maspac develops protocols for validation of all manufacturing processes, and offers companies rapid application of the CE marking through a European notified body. Maspac's staff includes quality systems and regulatory affairs personnel. "Most companies working with contract manufacturers still have to deal with CE marking on their own," says Gill. "At Maspac, we can offer manufacturers quality and regulatory services that relieve them of this burden."
Tecnoideal S.r.l.
Designed to process two different diameters of tubing simultaneously, the TWINcut machine incorporates two cutting units that can be programmed for 30-step cutting sequences. Manufactured by Tecnoideal S.r.l. (Mirandola, Italy), the machine is fully automated and can be used in production lines.
"TWINcut provides manufacturers with reduced assembly and personnel costs," says Roberta Borsari, marketing and sales manager at Tecnoideal. She notes that a cycle of a certain length and speed can be programmed on the machine to repeat automatically.
Tecnoideal's other products include READYcut (pictured), a benchtop programmable cutting machine with a system for dispensing solvent on the tube end. The company's machines are particularly suitable in applications where precision, accuracy of cut, and quality of solvent dispensing are important. The firm also supplies solvent dispensers, leak detectors, and tubing expanders. All machines are CE marked, microprocessor controlled, and suitable for cleanroom use.
