REGIONAL FOCUS: SCOTLAND
Scottish firms build on tradition of medical innovation and manufacturing excellence.
Norbert SparrowWhat goes around comes around, as they say, and that was certainly true for Crombie Anderson, a design bureau based in Dunfermline. "Scotland is a bit of a hotbed of medical development, and I suppose that was the starting point for our specialization in technology and health-care products," says chief executive Douglas Anderson. Magnetic resonance imaging was developed in Aberdeen, he notes, while ultrasound originated in Edinburgh. Anaesthesia, penicillin, and insulin are among the other medical breakthroughs that carry the made-in-Scotland label.
In addition to its contribution to the advancement of medical science, Scotland has earned a reputation as a world-class centre for mechanical engineering, instrument engineering, and electronics. The potential complementarity of these sectors with the development of medical technology has helped fuel the growth of firms such as Crombie Anderson and AorTech International plc, a maker of artificial heart valves located in Strathclyde Business Park's Medipark.
Crombie Anderson is one of the few design bureaus in Europe that has carved out a niche providing services to the medical sector. The 17-year-old company has designed such products as surgical handpieces, dental and surgical diode lasers, valves for anaesthetic delivery systems, incubators, reagent packs, and microplate washers and stackers.
The company grew slowly, says Anderson, relying primarily on referrals from former clients that lauded the firm's solid design concepts and its broad range of in-house services. "We provide everything from fundamental market research, conceptual work, and engineering design to the packaging and graphics. We will even supervise the product launch at exhibitions, if the client so wishes." But the essence of what the company does, says Anderson, is discovering what people are willing to pay for and converting that information into a product specification concept. It may sound simple enough, but the services of a company like Crombie Anderson can mean the difference between a successful product launch and a marketing debacle.
User-Driven Engineering
One recent project, says Anderson, is illustrative of how well-defined market research can benefit a company. "The product in question was developed by a technology-driven company, and the engineers who had worked on it were very enthusiastic about its advanced features," says Anderson. "Clearly, it had some very real advantages for the user, but when we presented the device to focus groups, we discovered that the bells and whistles--which were quite expensive--in the end didn't buy the company much in the marketplace." Consumers, he adds, were still coming to grips with the basic functionality of the device and above all wanted clarity. To make matters worse, certain features that the consumers considered to be essential in a device of this type were not included. The company, needless to say, sent the project back to the drawing board. In a nutshell, "that type of work is the first phase of what we do at Crombie Anderson," says Anderson.
The second phase, he continues, is ensuring that the concept can be articulated to a particular manufacturer. "We have a lot of experience in production engineering, design for manufacture, and in matching materials and processes," says Anderson. When the company does need to outsource, the firm is fortunate to be located in an area that has a high degree of craftsmanship in model making and other contract services. "We are located in a centre for technology products, and we have a broad range of vendors in proximity who can supply circuit boards, optics, mouldings, mechanical bits, and so forth."
The company's involvement in speculative development work led to the recent establishment of Optos, a spin-off company marketing a panoramic ophthalmoscope that represents a substantial improvement over existing technology, according to Anderson. "It's a wide-field imaging system for examining the retina," he explains. "A conventional imaging system would allow you to examine between 5 and 20% of the retina, and to achieve the maximum of 20% you would have to be quite skilled either as an examiner or as a photographer. Not to mention that you would need to use dilatory drops, which requires some degree of patient cooperation." The Plus 180 Panorama Ophthalmoscope developed by Optos is able to capture more than 80% of the retina without dilation, therefore increasing patient comfort, according to Anderson. "In addition, it does not require a high degree of operator skill," he adds.
A prototype was shown at the recent American Academy of Ophthalmology conference in California, where it attracted a great deal of attention, according to Anderson. Optos is currently engaged in the process of obtaining a CE mark for the device.
The Heart of Medical Technology
AorTech International plc has set its sights on building a better heart valve. AorTech's main product is the Ultracor cardiac valve, which combines proven tilting disk technology with recent advances in manufacturing technology. Compared to other designs, the valve offers improved haemodynamic performance and a reduction in thrombogenic potential, according to managing director Eddie McDaid. The superiority of the product will be borne out, he adds, by clinical papers based on six-year follow-ups conducted in the UK and Germany. "However," adds McDaid, "we never intended AorTech to be a one-product company, and we are looking at various other projects and product lines."
One area of research that will soon come to fruition, according to McDaid, involves the use of synthetic materials to fabricate a valve that will have the longevity of a mechanical valve but will not require the use of anticoagulants. The universities of Glasgow, Leeds, and Liverpool have contributed their expertise to the project which, according to McDaid, will represent a quantum leap in heart valve replacement. "All of the large corporations have looked into this type of technology at some point," says McDaid, "but there's no real incentive for them to promote new materials and push the project through US FDA. We will be doing final testing over the next six months--using different materials for purposes of comparison--and we intend to be into the final design phase by this summer."
Another project that would be of immense benefit to other heart valve manufacturers, according to McDaid, involves research into a coating for heart valve sewing rings that will minimize or perhaps even eliminate the necessity for anticoagulant treatments. "The sutured part of the valve is where clots are likely to form in the first three months after implant. The treatment we are looking at would result in a reduction in the potential for thrombus. This technology has the potential to affect all heart valves that are currently being manufactured," says McDaid.
AorTech also performs contract assembly work in its 18,000-sq-ft facility and 1500-sq-ft Class 10,000 cleanroom, and the firm is interested in expanding these types of operations. "The capacity is there, and we have substantial experience in producing high-value, low-volume products. We're not just looking at doing assembly work, incidentally, but want to offer a wider array of services."
Industrial Sterilization Facility to Open
Providing contract assembly services is also an ambition of one of AorTech's Medipark neighbours, Andersen Caledonia, a supplier of EtO sterilization. Part of H.W. Andersen Products Inc. (Haw River, NC, USA), which manufactures and sells surgical disposables and sterilization products, Andersen Caledonia moved into the site in June. According to plant manager Richard Cooper, the industrial sterilization facility will be up and running by this spring. The 15,000-sq-ft facility will include two sterilization chambers, a preconditioning room, and an aeration room. "If we discover that we need a larger aeration room to achieve lower EtO residuals," says Cooper, "we have the available space to expand capacity."
While contract sterilization is the company's core business, Cooper notes that he considers it to be one of three foundation stones of the company. "We also have a testing laboratory to support our sterilization facility and the device industry in general, and we offer sterilization validation, which you really need to do if you perform the other two activities." Subsequent to all of this, he adds, "we hope to be in a position to do some contract assembly in the future... a bit of vertical integration, if you like, but going backwards into the process."
While Andersen Caledonia puts the final touches on its sterilization facility, its testing lab is currently open for business. Services include bioburden, EtO residuals, and biological indicator testing as well as cleanroom validation and water testing.
Crombie Anderson, AorTech, and Andersen Caledonia are but three examples of the wealth of experience in medical technology that is available in Scotland. In the accompanying Products and Services from Scotland section, you will find additional information about these companies along with profiles of other area firms specializing in everything from electronics and automation equipment to IVD components.
Products and Services from Scotland
Contract manufacturing
Cable assemblies, printed circuit boards (PCBs), and metal and plastic components are among products manufactured to OEM specifications. The latest automation equipment is used to produce wire braids, multicore cable assemblies, fibre optics, and related components. A department within the company is dedicated to the production of PCBs; higher-level assembly services are also available. Additional capabilities include CNC machining, injection moulding, vacuum forming, mould and toolmaking, and industrial painting, finishing, and silk screening. Statistical process control is part of the company's total quality control system, and the firm is certified to ISO 9002 and EN 29002. Simclar International Ltd., Dunfermline, Fife.
Product design
Emphasizing design for manufacture, a product design consultancy seeks out cost-effective materials and thoroughly evaluates manufacturing processes early in the design cycle. State-of-the-art solid-modeling technology is used to complete projects within tight time scales, and the company is well versed in rapid prototyping techniques. Ergonomics and EMC compliance are also factored into product design. The company has a long-standing relationship with moulders and toolmakers and is able to provide full support services during tool manufacture. Marketing support is also available and incorporates product branding and launch, packaging, promotion, and exhibition design. The company has been involved in several medical devicerelated projects including the design of a laser scanning ophthalmoscope, an APL valve for an anaesthetic delivery system, a surgical diode laser, and surgical handpieces. Crombie Anderson, Dunfermline, Fife.
Automation equipment
A company has more than 50 years' experience in the design and construction of automation systems for the assembly and packaging of medical products. The firm has designed systems that assemble disposable syringes at a rate of 600 pieces per minute using linear- and continuous-motion machine formats, and others that package cannulae devices at a rate of 1200 pieces per minute. Equipment for the assembly of inhalers, IV components, catheters, and epidural and blood-collection devices can also be supplied. The company's associate firm is located in Bristol, CT, USA. Systems are being designed currently for client companies located in Germany, China, and Ireland. Arthur G. Russell Ltd., Arbroath, Angus.
Assembly services
A company that manufactures and markets the Ultracor heart valve provides contract assembly services to other makers of high-value, low-volume medical devices. One recent project involved the assembly of a defibrillator. The company is also developing a tissue valve made from a synthetic material that will be as durable as a mechanical valve but will not require anticoagulants, and a surface treatment that will prevent the formation of clots around heart valve sewing rings. AorTech International plc, Bellshill, Strathclyde.
Dispensing system
A proprietary technology for particle weighing, dispensing, and positioning is available under licence or as a complete package with either single- or multihead dispensers. The system enables precise, rapid dispensing and filling operations from the 1-mg level into precision or awkward devices. It is suited for cleanroom and laboratory use. The company also performs contract manufacturing, dispensing, filling, and warehousing of sterile fluids, diagnostic reagents, and related products. An on-site cleanroom encompassing laboratory and production areas enables the firm to service the most demanding and complex processes. In addition to its contract services, the company manufactures a range of tissue culture media, stains, and associated product lines that it markets under the brand names Biomedia and Biostain. Biomedia International Ltd., Cumbernauld, Strathclyde.
Plasma systems
Plasma systems offer an alternative to chlorofluorocarbons, solvents, and acids
for cleaning a variety of surfaces. Plasma technology is routinely used to increase wettability in test tubes, to prepare angioplasty balloons and catheters for bonding, and to treat membranes used in blood-filtration applications. The company's plasma systems feature impedance matching and include a PC-compatible cpu, an RF power generator, and two gas-handling channels. Four-channel systems and custom configurations are available on request. GaSonics International, Edinburgh.
A contract EtO sterilization facility that will be operational by this summer currently offers a range of testing and sterilization validation services. Laboratory services available to device manufacturers include bioburden, EtO residuals, and biological indicator testing. Validation of EtO cycles is performed in compliance with ISO standards and US FDA good manufacturing practices. Consultancy support is available to help clients achieve required standards of operation. Cleanroom validation is also offered. At a future date, the company will also provide contract assembly services for medical device manufacturers in a Class 10,000 cleanroom. Andersen Caledonia Ltd., Strathclyde.
Heat-shrink tubing
Based on polymer thick-film ink technology, heat-shrink tubing eliminates EMI-related problems on data, signal, and power lines. ShrinkMate provides a circumferential seal around the cable shielding and base of the connector, thereby preventing cable-to-connector leakage. It attains a commercial shielding rating of 4082 dB over 30 Mhz 1 GHz. The seal also eliminates the need to solder braided cable shielding in connector assemblies. The tubing integrates easily into overmoulding operations during cable assembly. ShrinkMate can be applied using a heatgun, oven, or conventional heat source, and because of its inherent low resistance--around 1 (omega)/in.--it is suited for use on connector assemblies and spliced cables. Methode Electronics Europe Ltd., Dumbarton, Dunbartonshire.
IVD products
A company that develops, manufactures, and markets IVD products can format assays as kits, for use in automated systems, or for end-use requirements. The company also performs contract manufacturing to international quality standards and provides product development and consultancy services. The firm is certified to ISO 9001. Cogent Diagnostics Ltd., Dunblane, Fife.
Battery packsBattery pack systems are designed and manufactured to customer specifications for portable medical electronic and other applications. The packs are designed using advanced 2-D and 3-D CAD systems and are manufactured in a facility certified to ISO 9002. Only the highest-quality cells are used, and the company offers a broad array of battery sizes and electrochemical systems including rechargeable lithium batteries. The firm applies just-in-time principles to product development, assembly, packaging, and delivery operations, and it services the European market from a recently established 55,000-sq-ft plant in Dundee and sales offices in southern England, Germany, and France. TDI Batteries, Dundee.
Packaging services
A manufacturer of printed coextruded burette cylinders also supplies sterile medical packaging services in a Class 10,000 cleanroom. Extrusion, injection moulding, silk-screen printing, and assembly under laminar-flow cabinets are also performed in the cleanroom. The company's packaging process is especially well suited for the handling of delicate components such as catheters. It is the sole supplier of the Sharps Compak, designed for the safe disposal of used syringes. Quality systems are certified to BS EN ISO 9002, and the firm reports that it undergoes regular audits from some of the world's leading medical device OEMs. Intercobra Ltd., Glenrothes, Fife.
Precision components
Precision components are manufactured for medical and anaesthetic device companies on a contract basis. The plant is equipped with CNC turning, milling, grinding, and inspection equipment complemented by a high-level assembly and testing area. CAD/CAM services are available, and the firm is certified to ISO 9002. Fife Autocam & Tool Services (FACTS), Glenrothes, Fife.
