Medical Device Link.

Originally Published EMDM May 2003

REGIONAL FOCUS

Our database of suppliers to medical device OEMs includes several hundred companies in Southern England, many of which are finding innovative ways to meet and, indeed, exceed the requirements of their customers. In this feature article and the company profiles that follow, EMDM focuses on a selection of firms in the region from Kent to Devon that provide leading-edge products and services to the medical device industry. Our journey begins, perhaps surprisingly, in the coastal resort of Paignton.

Located in the heart of the so-called English Riviera, Paignton conjures up images of family holidays and leisurely sunset promenades along the shore, not the fabrication of high-tech electronics. And yet, just a short drive inland sits the headquarters of the tantalum division of AVX, a global supplier of passive electronic components.

“TAC microchips will drive the future growth of this plant,” says marketing manager John Gill, and much of the demand will come from the device industry, he adds. Approved for use in implantable electronic devices as well as other medical products, TAC chips are among the world’s smallest capacitors. “The use of semiconductor wafer–type construction and production processes has enabled us to manufacture 0402-size components,” says Gill. The company’s TACmicrochip already has contributed to dramatic reductions in the overall size of some medical products.

“The average pacemaker contains 21 tantalum chips,” stresses Gill, so even a little R&D can go a long way. “In one case, the use of our chips contributed to a 50% reduction in the size of an implantable device,” says Gill. Hearing aids that fit completely in the auditory canal are one of the key applications of the capacitors.

Reliability Testing

More than a seaside resort with a Mediterranean feel, the English Riviera is also the headquarters of AVX’s tantalum division.

The first surface-mount capacitors were manufactured in Paignton in 1982. As demand grew, the plant’s production capacity was soon stretched to the limit. “We began by moving the fabrication of leaded capacitors to El Salvador and assembly to the Czech Republic,” says Gill. “Currently, all of the assembly is done in these two plants.” AVX is also setting up an SMT facility in China. 

To further maximize the efficient use of available space, AVX invested tens of millions of euros in automation equipment. “It was done out of necessity,” recalls Gill, but automating processes also had a beneficial effect on product quality because it “reduced the amount of handling and increased product reliability.” The company also has instituted a number of quality assurance procedures to ensure that only defect-free components leave its facilities.

A vision system inspects the chips on all four faces to verify that there no pinholes, termination wicks, or other defects; each lot is assigned a reliability number. Samples also are manually audited under a microscope, and Weibull tests are run to determine reliability. “Customers receive a full benchmark on aging, reliability, and related data with the products,” says Gill.

With much of the production and assembly relocated to other plants, engineers at Paignton are able to focus on research and development. New products that have recently seen the light of day include TAK tantalum chips and niobium-oxide capacitors.

Although TAK chips have been available as custom products, they were introduced as a commercial line to device OEMs in March with the publication of AVX’s Product Guide for Medical Applications. Surface-mount-compatible TAK capacitors offer high volumetric efficiency in a low-profile package.

Flexibility is a key feature of TAK devices, according to Gill. “Capacity can reach 1000 µf,” he adds, yet the chips can be specified in almost any height. “The commercial range is based on a specific footprint, but the customer can, in fact, specify the desired volume, height, and capacity, and we will build it.”

AVX launched its niobium-oxide capacitors at the beginning of the year. With a capacitance and voltage range similar to that of tantalum chips, niobium-oxide products are promising alternatives to low-voltage tantalum and ceramic capacitors. One reason they are appealing is the widespread availability of niobium oxide compared with tantalum and, consequently, the lower material cost. A number of other features—the absence of a piezo effect, and lighter weight and lower equivalent series resistance (ESR) at higher temperatures than tantalum—can be advantageous in certain applications.

Added-Value Packaging

Packaging suppliers, like their counterparts in other sectors, are under intense pressure to reduce costs and provide added value. Rexam Medical Packaging, located just outside Bristol, has met this challenge in a number of ways: advancing seal-and-peel technology with its Core-Peel products (see the accompanying profile in this section), instituting a six sigma programme, and developing computer simulation software to optimize thermoforming and material distribution are but three examples.

MTantalum capacitors developed by AVX are approved for use in electronic implantable devices.

Six sigma, which is defined as achieving no more than 3.4 failures per one million actions, is part of a larger Lean Enterprise initiative at Rexam. The approach uses a combination of statistical and problem-solving tools to meet customer needs at the most competitive cost. In practical terms, this is achieved by “improving product quality by a reduction in process variation,” says Lisa Carroll, six sigma director at Rexam. It is not limited to production processes, she notes. “We have applied it to transactional processes, too, such as how we sample products to customers for new business.” The programme has been successful in identifying and eliminating material waste and wasted time, she says. In fact, Rexam is considering expanding training to some of its customers, many of whom have expressed an interest.

Another way in which the firm provides value-added services is through the use of a computer simulation program dubbed the Black Box. In use since 2002, the service was made officially available to Rexam customers at the Interphex show in March.

The Black Box allows users to experiment with what-if scenarios, explains Sean Russell, European pharma director. One area of application with proven results is the design of blister packaging. The effect a given material will have on the performance of a formed blister pocket and its barrier properties is one of many simulations that can be run rapidly. 

“The computer simulation can optimize materials distribution,” notes R&D director Roy Christopherson, “which can save as much as 20% in material costs.” Moreover, the program allows engineers to alter any number of parameters and determine how they will affect the rest of the process, all without leaving the virtual world. “You can vary the shape and composition of the material, the dimensions, the process conditions . . . until you find the optimal packaging solution for your product,” says Christopherson.

“This tool kit can cut out a number of steps during the packaging development process,” stresses Russell. “We can test the design for push-through and child resistance, barrier properties, and so forth. Based on the findings, we can then go ahead and make the tooling and do a packaging trial run in our demonstration room.”

The advantages are considerable, according to Nic Hunt, global business director for Rexam Pharma Flexibles and Rexam Pharma Services. No metal is cut for tooling, there are no initial packaging machine trials, and no initial laboratory tests, he says. All of the elements of the virtual world can be fully quantified and dimensioned, he adds, and changes and ideas can be made quickly and the output assessed for a range of materials on the same day.

Runfold Medical Ltd.

Focusing primarily on finished products ready for distribution, a supplier of outsourcing services also offers subassembly fabrication to medical device manufacturers worldwide. The integrated design and manufacturing process implemented by Runfold Medical Ltd. (Liphook, Hants) ensures effective feedback at each stage of a project. “OEMs can engage us in all three areas of product design, process development, and manufacturing,” says managing director Clive Gunther, “or in a single capacity. Because all three elements are closely linked, feedback is streamlined and development time and costs can be reduced.” The company’s capabilities have also proven beneficial when applied to existing products. “By using our reengineering expertise, we have managed to improve yields and cut production costs for our customers,” adds Gunther.

Founded in 1976 as a supplier of custom PVC mouldings, the company established Runfold Medical Ltd. within the Runfold Group at the end of 2000. “We wanted to segregate our medical device development and manufacturing operations, which had been growing over the previous four to five years,” says Gunther. The change in structure has been highly successful, he notes. The firm recently added 5000 sq ft to its purpose-built 20,000-sq-ft facility, and it is seeking to acquire another plant.

Services include in-house toolmaking, moulding in a Class 10,000 cleanroom that complies with US FDA standards, medical-grade dip moulding, integrated cleanroom assembly and packaging, and ultrasonic welding and cutting. The design bureau is equipped with state-of-the-art 3-D CAD workstations. An emphasis on process development enables the firm to design and implement manufacturing processes in concert with product development to achieve manufacturing efficiencies, cost savings, and enhanced quality.

“We make a real effort to stay ahead of the curve,” stresses Gunther. “We have excellent links to the polymers research centre at the University of Surrey, for example. If we come across a problem, we have a lot of resources we can throw at it.” Adds Gunther, “Remember, from day one Runfold has been engineering oriented.”

To maintain its competitive edge and to better serve its OEM customers, Runfold plans to expand its logistics services and to introduce a Web portal called Share Point Web to facilitate data exchange. The firm will also be installing a two-shot 2-K injection moulding machine for the production of connector seals. Medical products routinely produced at the facility include blood filter supports, laryngoscope blades, catheters, needle protectors, cannulae, and irrigation devices.

Isotron plc

With the acquisition of Gammaster International in 2002, Isotron plc (Swindon, Wilts) broadened both its geographic reach and gamma sterilization expertise. “The company is growing in volume and processes,” says corporate marketing manager Robert Hook. “The gamma knowledge we gained in that acquisition nicely complements our in-house expertise.”

The company operates gamma, EtO, and E-beam sites in several parts of the world, but it has experienced the greatest growth in the Asia Pacific region. It has a gamma plant in Thailand and gamma and EtO facilities in Malaysia. The benefit to customers, notes Hook, is that of a one-stop shop with substantial medical sterilization expertise equipped to handle multinational contracts. “Our whole mind-set is rooted in the medical device industry, which represents about 65% of our business,” says Hook.

The firm has also made significant investments in laboratory services. It routinely conducts sterility tests, bioburden evaluations, and sterilization studies in accordance with ISO 11137 to meet international standards. The next challenge in this area, according to Hook, is sterilization process validation to 25 kGy using the VD-Max method. “It’s not yet part of the international standard, but it will be,” he predicts.

Citing ways in which the company can add value, Hook notes that Isotron is constantly looking for process and logistic improvements. For example, “we were sterilizing products for a company that was located 100 or so miles to the south of us,” he recounts. “They would ship their products to us, and we would ship them back for release. And then they would transport them to their customer . . . just a few miles north of here. We could practically see the lorry coming through town,” laughs Hook. “We suggested having the release take place here at Isotron and shipping products to their customer directly from our plant.” A no-brainer, perhaps, but one that saved the company a tidy sum.

You might say that the value-added philosophy also extends to the company’s environmental impact. “We want to be good neighbours,” stresses Hook. “That’s why we have installed a catalytic converter.” (The device is pictured.) “It was expensive to build and is costly to maintain,” says Hook. But as one gazes at the nearby countryside, one could hardly argue that it is not a worthwhile investment.

Fine Tubes Ltd.

A supplier of stainless-steel, nickel alloy, and titanium tubing to medical device OEMs began life in 1940 producing nickel cathode sleeves for the electronic valves used in radar. During the past decade, however, Fine Tubes Ltd. (Plymouth) has seen a steady increase in demand for its products from medical device OEMs. “That business just kind of came in,” says senior sales specialist Steve Tomlinson. “We didn’t devote any special effort to marketing our capabilities to the medical market.” About four years ago, the company began to engage its potential customer base in the medical device field more actively. It has achieved some notable results in the orthopaedic and stent markets.
“We began making a profiled implantable fixation device in 2000,” says Tomlinson, “and have been very successful in manufacturing tubing from Ti-6Al-4V, which exhibits excellent fracture toughness and fatigue strength.” Although considerable R&D has already been devoted to this material, Tomlinson notes that Fine Tubes is continuing to improve production methods for the fabrication of tubing made from this titanium alloy.

A great deal of R&D is currently devoted to the use of nickel-cobalt (MP35N) and chromium-nickel-tungsten-cobalt (L-605) alloys to manufacture stents. “A host of factors—biocompatibility, concentricity, and so forth—come into play of course, but companies have needs for specific applications, and we are trying to put our resources to work,” says Tomlinson. “Our goal is to open a dialogue with our customers and find ways to add value. Rather than just supplying a round tube, for example, we can provide a profiled section.”
Fine Tubes, a subsidiary of US-based Superior Group, offers device OEMs seamless cold-drawn tubing with outer diameters ranging from 0.3 to 50.8 mm. Tolerances of ±0.005 mm can be achieved. Welded and redrawn tubing in straight lengths and long coil forms is also available. In addition to stents and implants, the company produces tubing for use in orthodontic instruments, ophthalmological needles, endoscopic instruments, and devices with shape-memory applications.

Rexam Medical Packaging

In the medical packaging world, Core-Peel technology qualifies as something of a game changer. A concept more than five years in the making, the proprietary technology developed by Rexam Medical Packaging (Bristol) involves coextruding or laminating the seal-and-peel system with a variety of backing materials. The finished web can then be sealed to an array of partner webs including uncoated Tyvek. The technology is described as a “step change in peelability” by industry marketing manager Richard Rigby.

“The split peel and seal layers in a coextruded structure allow modification of one material function without affecting the other,” says Rigby. “The product has consistent peel strength across a very wide range of sealing conditions, and offers an unparalleled particulate- and fibre-free peel.” The materials can be supplied as bespoke rollstock or as a Core-Peel pouch, manufactured in a purpose-built white room at the company’s US facility, as well as in European locations.

The clean peeling properties of Core-Peel are a result of the functionality of the seal-and-peel technology. During heat sealing, the layers are embedded into the fabric structure of Tyvek. On subsequent opening, the seal layer breaks through cleanly into the peel layer, through which the peel continues. Colouring the seal layer offers a visual seal transfer, confirming seal integrity on opening.

The technology also has production advantages. “It can run on high-speed machinery, where coated systems had previously been necessary,” says Rigby. “This system has a wider operating window and can be processed at faster speeds” than other polymer-based peel products that may not be able to accommodate high-speed processes.
OEMs producing invasive devices such as coronary stents and catheters are understandably attentive to the elimination of particulates in packaging. Core-Peel products address this concern and offer a low-cost alternative to pouches made with coated Tyvek, according to the firm.

The company offers a vast range of sterilizable medical packaging supplies to the medical, pharmaceutical, and personal-care markets. Products include coextruded thermoformable films; flexible, peelable, and high-barrier laminates; and coated and noncoated porous webs. The firm recently introduced a latex-free cold-seal coated paper for packaging self-adhesive dressings.

AVX Ltd.

A supplier of passive and electronic components has developed the smallest tantalum capacitors currently on the market. Available in an 0402 size and approved for implantable applications, the TACmicrochip line developed by AVX Ltd. (Paignton, Devon) “offers solutions that were previously not available to medical device OEMs,” says marketing manager John Gill. “We produced an 1105 package for a completely-in-the-canal hearing aid. The tantalum caps have also enabled a dramatic size reduction in defibrillators and pacemakers, which typically contain 21 tantalum chips,” says Gill. “In one case, we were able to contribute to a 50% reduction in the size of a device.”
The development and production of TAC microchips will drive the future growth of the Paignton plant, according to Gill. The medical device industry, in particular the life support and implantable sectors, is a key market for the firm, notes Gill. “We have installed a segregated medical production area in the plant,” he stresses. Although it wasn’t required, “our thinking is that if you try to do this in a full-scale production environment, it can get lost. We don’t want to lose focus.”

To further demonstrate its commitment to the medical device market, the company has just published a product guide for medical applications. The attractive brochure includes pictures and capsule descriptions of components manufactured by AVX that are suited for use in medical devices. It also contains a handy grid that matches parts to specific medical device applications. In addition to a range of tantalum chips, products featured in the catalogue include other types of capacitors, oscillators, connectors, ferrites, and feed-through filters. A CD-ROM highlighting medical applications, with a sophisticated search engine that can suggest a part based on user-entered specifications, will be available by the end of 2003. The firm’s goal, says marketing communications manager John Bradshaw, is to “provide design engineers with a powerful set of tools that will help them to make informed decisions about our products.”

Medical Engineering Technologies

Working in partnership with companies that are considered experts in their fields, a firm describes itself as a one-stop resource for engineers in the medical device and pharmaceutical industries. Medical Engineering Technologies (MET; Folkestone, Kent) can supply services, equipment, and related consumables to support the entire production process. Consulting services and training courses can also be provided.

Biocompatibility, microbial, and release and audit testing are performed at an on-site laboratory. A comprehensive range of medical-grade adhesives is available; if off-the-shelf products are not suitable for an application, custom formulations can be prepared. Dispensing and curing equipment also is supplied. In addition, the firm routinely sources metal and plastic components, production equipment, packaging machines, quality assurance systems, and sterilization solutions for customers.

MET also offers First Line QA, a postmarket surveillance programme designed for OEMs and distributors. Product returns from the field are sent directly to MET by the customer, which decontaminates each device and files an inspection report with the manufacturer within 48 hours.

Kinneir Dufort

Although it has more than 25 years of experience in product design and prototyping for the medical and healthcare sector, Kinneir Dufort is a resolutely forward-looking design bureau. One of its trophy projects, the Handihaler marketed by Boehringer Ingelheim, is indicative of its belief in the consumerization of medical products.
“Children who need to use a device like the Handihaler are going to be self-conscious,” says senior design consultant David Cottle. “We wanted to create something that looked more like a lifestyle product [than a medical device], a product that would compare favourably with a mobile phone or Gameboy.” The company also introduced functional improvements, such as a built-in fold-over lid, to the device. The predecessor product came with a pouch designed to hold the inhaler. “Of course, kids would lose the pouch and simply drop the inhaler into their pants pocket,” says Vanessa Tutt of marketing and communications. “Dirt, dust, and all sorts of things would contaminate the device.” By rationalizing the design and eliminating components, Kinneir Dufort also contributed to a 50% reduction in production costs.

One of the company’s more recent projects is the Smartsigns Assist vital signs monitor (pictured) from Huntleigh Healthcare. Kinneir Dufort was awarded the contract at the end of 2001, when the OEM had reached an advanced stage in the functional product development phase but required a more attractive and cohesive package. Kinneir Dufort created a shelled surface model based on one of its designs, and Huntleigh then developed the design through to production. “It’s a good example of how a relatively modest investment in industrial design can still make a significant difference in a product’s usability and appearance,” says senior designer Chris Althorpe.

Mecmesin Ltd.

The offices of Mecmesin Ltd. (BroadBridge Heath, W Sussex) sit near a Roman road that was carved into the countryside approximately 2000 years ago. A redundant railroad station from the Victorian era is also nearby. Both are examples of some rather remarkable feats of engineering, says sales and marketing coordinator Chris Grant. “We like to think that we are, in our own way, carrying on a 2000-year-old engineering tradition,” he adds. The most recent iterations of that custom are the Basic Force Gauge and Mark III Advanced Force Gauge (AFG). Grant calls the AFG the company’s “new flagship product.” The gauges were introduced in March.

Both force gauges feature a robust case, invertible digital matrix display, and analogue trend bar indicating total load. A dual peak function captures maximal tensile and compressive data, while hot keys allow the gauges to be tailored to individual customer needs. The instruments also offer a comprehensive range of capacities up to 2500 N.

Additional features found on the AFG include test-stand control, rapid data acquisition rates, and interchangeable load cells. An Advanced Load Cartridge attaches by means of a snap-fix connector to dramatically increase the range of tests that can be performed with a single instrument.

One of the company’s strengths, according to Grant, is the ability of its engineers to build systems that address unique concerns. For example, Mecmesin developed a system for one medical device OEM that needed to verify that the crimping force applied to a needle was within the specified tolerance and would be repeatable over a number of tests. It has also developed a myometer to evaluate shoulder function with the collaboration of specialists at Nottingham City Hospital.

Vision Engineering Ltd.

In an increasingly digitized world, Vision Engineering Ltd. (Woking, Surrey) is bucking the trend. Developing eyepiece-free and expanded-pupil microscopes as well as three-axis noncontact measuring equipment, the company has not abandoned its focus on the “real thing,” says international marketing manager Geoff Collins. “The edges are much clearer on a true optical display,” he notes, “and dark or transparent objects, as well as shiny metals such as those used in hip implants, are much easier to see.” There is often a loss of colour and detail in a digitized image, he adds.

The company manufactures almost all of the components, with the exception of some lenses, and performs assembly in-house. The manufacturing plant in nearby Send houses an impressive array of CNC and manual production equipment for this purpose. Vertical integration is another example of how the firm is “going against the grain,” acknowledges Collins.

The firm’s newest product is the Hawk metrology system designed for industrial noncontact applications. The product range encompasses two-axis manual models as well as fully automatic edge-detecting three-axis platforms, and features a range of options. One of the device’s unique features, according to Collins, is the availability of optical and video edge detection. While image processing can be used to automatically locate and measure most edges, many complex and low-contrast applications require a manual process. The company’s Dynascope technology transmits a clear optical image through the expanded-pupil display head. Because the image has not been digitized, there is no loss of colour or contrast.

Map80 Systems Ltd.

A defining moment in the evolution of Map80 Systems Ltd. (Finchampstead, Berks), a Prisym Group company that supplies labelling solutions, happened in 1994. The company had been in existence since the mid-1980s and was doing fairly well when one of its customers in the pharmaceutical sector raised a red flag. It would have to start looking for another supplier, the OEM said, unless Map80 devoted more resources to developing systems in compliance with emerging standards. “Unlike some of our competitors, we didn’t simply try to fix the DOS code,” says Bob Tilling, director of new business development. “We migrated to a Windows platform and started fresh with a focus on life-cycle documentation. This approach took longer, but we wanted to do it right the first time,” Tilling says. Map80 hasn’t looked back since.

Prisymedica, the company’s core product, is an off-the-shelf solution with built-in flexibility that satisfies the requirements of US FDA’s 21 CFR Part 11 as well as European regulatory bodies. A dedicated software department that has developed all of the company’s labelling software since the pre-DOS days continues to work on upgrading systems and meeting unique customer requirements. It recently introduced a single-workstation version of the Prisymedica software.

The product has the same functionality as the company’s flagship product, but its scalability has been reduced to provide smaller companies with access to compliant labelling software. The single-workstation iteration can be used with up to seven printers and can be upgraded to a fully networked version as the company grows. Standard life-cycle documentation and on-site validation is included.

The firm also sells complete labelling systems, based on its software, that include printers, on-line applications, bar code readers, and custom software solutions. A full range of industrial label printers and consumables are also available.

“We have positioned ourselves to be a one-stop resource for regulated industries,” says Tilling. He recommends that customers sourcing a labelling solutions provider apply the 80% rule. “If a standard product does not meet 80% of your needs, then you should keep looking,” says Tilly. Ultimately, he intimates, you will end up at Map80’s doorstep.

Advanced Input Devices

A US-based supplier of electronic products and services recently established a UK office and project management team in Eastleigh, Hants. Advanced Input Devices describes its activities as a technology-neutral approach to the development and production of complex user-input subsystems. As a provider of electronics-manufacturing services, the company can manage projects from the concept and prototype stage to engineering and volume production. It offers technical support related to the integration of keyboards, cursor controls, displays, electronic interfaces, and custom enclosures into a complete input subsystem.

Current clients include the US divisions of such global OEMs as Abbott Laboratories, General Electric, and Siemens Medical. The company’s implantation in the UK is designed to provide the same level of support to new and existing European customers. “The input to an electronics system . . . presents a broad combination of technical, manufacturing, and logistic challenges,” says European sales manager Phil Bradshaw. “The pressure for vendor reduction and the increasing focus by OEMs on core competence means that the time is right to bring our complete subsystem approach to European system manufacturers.” 

Copyright ©2003 European Medical Device Manufacturer