MEDICON VALLEY
A cross-border initiative launched by Greater Copenhagen and Sweden's Skane region, Medicon Valley seeks to establish a European "technopole" for the healthcare industry.
Norbert Sparrow
Building bridges, metaphorically and literally, has long been on the minds of the Danes and Swedes who live on either side of the Oresund. Construction is currently under way on the fixed-link roadway that will span the Oresund and connect Copenhagen with Malmo, Sweden. The largest infrastructure project in Europe since the Channel Tunnel, the Oresund bridge is scheduled for completion by 2000, although no one is quite prepared to set a firm date for the ribbon cutting quite yet. In many ways, the bridge is a physical manifestation of a shared vision by these two regions. One aspect of this linked destiny is Medicon Valley, which incorporates greater Copenhagen and the Skane region of Sweden.
The largest pharmaceutical and biotechnological growth centre in Scandinavia, Medicon Valley also houses the third largest concentration of R&D activities in Europe. More importantly perhaps, "it marks the first creation of a cross-border region in Europe," according to Christoph Wiese, marketing manager at Copenhagen Capacity, which promotes Medicon Valley in cooperation with the Skane Regional Federation. "These are not two regions in need," stresses Wiese. "These are booming regions that have come together to make an even bigger boom."
The Medicon Valley concept originated from a dialogue in 1992 between researchers from the University of Copenhagen and the University of Lund on the Swedish side, according to Wiese. Realizing that their respective universities were involved in a greater number of collaborative projects with the US and Japan than they were with each other, "they decided to launch an investigation into what Danish companies had that might benefit their Swedish counterparts and vice versa." Because of the large number of pharmaceutical and medical device companies located on both sides of the strait and abundance of dedicated business parks such as Ideon in Lund, Sweden, and academic institutions focused on health care, the notion of a "technopole" devoted to the medical technology and pharmaceutical sectors quickly emerged. Currently, dozens of healthcare-related companies are located in the region, including such giants as Gambro and Astra-Draco.
In the years ahead, Medicon Valley plans to develop its capabilities even further, with the establishment of a biomedical centre in Lund and a biotechnology centre in Copenhagen. The overarching goal, according to professor Per Belfrage, one of the acknowledged founders of the Medicon Valley concept, is to continue to attract activities and expertise and maintain the region as a growth centre for medical science.
The emphasis on innovation and expertise has also benefitted suppliers to the device industry located in the Medicon Valley area. "Ten years ago, the type of academic-industrial partnerships that you see today did not exist here," says Michael Nobel, marketing director at Exiqon, a biotechnology company located in Vedbaek, Denmark. This shift in attitude has helped to create an environment where research-driven companies such as Exiqon can thrive.
Coating Technology Developed
"Exiqon was incorporated in January 1996 on the basis of a novel photochemical method that enables the immobilization of diagnostically interesting molecules on an array of polymer surfaces," says marketing director Michael Nobel. The company initially licensed the technology to companies and public institutions for the manufacture of diagnostic products and reactive surfaces, but Nobel feels the method has far greater potential, notably within the medical device field.
"We have been able to immobilize molecules on several types of polymers such as polystyrene, polypropylene, polyethylene, and Teflon-like materials," says Nobel. "In fact, we have yet to discover any restrictions." The coating is suited for enhancing the biocompatibility of implanted devices, says Nobel, adding that feasibility studies have been conducted on dialysis equipment.
The company has also developed a proprietary technology involving locked nucleic acids (LNAs) that achieve selective high-affinity recognition of single-stranded DNA and RNA. According to the company, unprecedented increases on the order of 3° to 8°C in the thermal stability of duplexes toward both DNA and RNA were obtained when evaluating mixed sequences of partly or fully modified LNA. Exiqon is currently considering exploiting the technology by setting up a sister company that would have exclusive rights to the therapeutic uses of LNA convention.
Easily accessed expert opinion on an array of technology issues has been instrumental in the success of Wolff & Kaaber a/s (Farum, Denmark), a contract research organization. The company started as a chemical engineering company that gradually branched out into product development. Today, 70% of its business is related to medical technology. The facilities are equipped with an R&D laboratory, microbiology laboratory, processing areas for prototyping and pilot-line evaluation, and Class 10,000 and Class 100,000 cleanrooms.
"Companies often come to us because it doesn't make sense for them to allocate resources to a project that can be done efficiently right here. Sometimes, they seek our assistance simply because they are stuck," says engineer Richard Schmidt. In that case, Wolff & Kaaber will set up a parallel project, approaching the job from a different direction and often finding a novel solution to the impasse. "It's also an effective way to bypass interdepartmental barriers that often obstruct progress within larger companies," he adds.
Not surprisingly for a Danish company, clean technologies are a priority at the firm. "We always keep waste out of the process," says Schmidt, "because it's just throwing money down the drain. We did projects 20 years ago that are green even by today's standards."
The multidisciplinary team can assume project management duties, guiding the process from concept to production, or it can simply intervene in a specific phase of the project. "We can even do a pilot production run and validate the process within our own facilities," says Schmidt, who notes that the technology currently used to manufacture soft contact lenses was developed at Wolff & Kaaber.
A centre of excellence located in Lund, the European Institute of Science offers its resources to researchers and smaller companies that "possess promising ideas," according to institute chairman Dario Kriz. The SIRE biosensor for the detection of chemical substances in blood and food, presently marketed by Chemel AB, was developed there. The firm's current project involves a magnetic-particle-based method that enables the rapid diagnosis of cancer markers and hormones in blood samples. An offshoot of this research is the potential use of the magnetic particles for the treatment of cancer. The company doesn't view itself as a producer or distributor of different medical technologies, says Kriz. Rather, it is a think tank, he adds, where projects are created and developed in the institute's research facilities and then marketed through offspring companies and by licensing agreements.
High-throughput Hologrammes Developed for Medical Products
A contract manufacturer specializing in the development and manufacture of thermoplastic components, Knudsen Plast a/s (Frederiksvaerk, Denmark) recently developed a technology that allows high-throughput and high-pressure incorporation of nanometre-deep hologrammes on plastic items. According to marketing manager Henrik Aunstrup, the process has several promising applications for the medical industry. "For pharmaceuticals, the lot and batch code can be part of the hologramme," he says, "and secondary packaging can be eliminated. It can also be used to guarantee the authenticity of a product. Or in the case of disposables, the word valid could be made to disappear from the hologramme once the device has been sterilized." The company has been able to place the hologramme on a variety of materials including polycarbonate and polyethylene.
Knudsen Plast is currently expanding its cleanroom facility. When completed, the Class 100,000 cleanroom will house 29 injection moulding machines, making it the largest of its kind in Scandinavia, according to Aunstrup. "We have achieved expertise in the production of transparent polycarbonate and soft polyvinyl chloride products," he says. "We are able to control the size down to 5 µm." Consequently, the firm has seen steady growth and is engaged in sourcing export opportunities.
Cleanroom expansion is also the order of the day at Medical Rubber AB (Hörby, Sweden), a developer and manufacturer of liquid silicone rubber and thermoplastic elastomer components. Named company of the year in 1997 by Skane Regional Development in recognition of its consistent growth and manufacturing expertise, Medical Rubber is preparing to inaugurate a new 3000-m2 facility. "In addition to expanding our Class 100,000 and Class 10,000 cleanroom capabilities, we will be adding a new 70-m2 testing lab," says sales manager Tommy Mansson. The company's growth won't affect its business philosophy, Mansson is quick to add, stressing that the company adopts a partnership approach to customer relations. In-depth knowledge of liquid silicone rubber and thermoplastic elastomers as well as the moulding process enables the company to provide efficient solutions in material selection, production optimization, and product design, says Mansson.
You will find additional information on these companies along with other suppliers located in the Medicon Valley region in the accompanying product and service reviews. To learn more about Medicon Valley as a business location, contact Christoph Wiese at Copenhagen Capacity, Kongens Nytorv 6, DK-1050 Copenhagen K, Denmark; phone: +45 33330333; fax: +45 33337333; or Gudmunder Kristiansson at Regionfoerbundet Skane, Lugna gatan 84, S-211 59 Malmo, Sweden; phone: +46 40 359207; fax: +46 40 359204.
Products & Services from Medicon Valley
Plastic products
Plastic products are manufactured to tight tolerances in Class 100,000 cleanrooms. A wide range of items that require high levels of transparency and surface quality are routinely produced, and the firm has particular expertise in the manufacture of soft plastic products. Complete traceability of materials is guaranteed and deliveries are controlled according to MIL-STD 105 E or DS/ISO 2859-1. Staff engineers are available to consult with clients on product development and related issues. A proprietary process that involves the application of hologrammes that are only a few nanometres deep on polymer materials was recently developed for use with disposable devices and pharmaceutical packaging. Knudsen Plast a/s, Frederiksvaerk, Denmark.
Surface treatment
A photochemical method has been introduced that covalently attaches a broad spectrum of ligands, reactive groups, and biomolecules to a variety of polymer surfaces. The company, whose core activity is to undertake proprietary R&D projects for diagnostics companies, anticipates numerous applications for its coating method beyond the diagnostic sector. One promising area, according to a company spokesperson, involves the treatment of medical devices either to promote or repel cell adhesion. The company adopts a collaborative approach with its clients to maximize efficiency and minimize development time. Exiqon, Vedbaek, Denmark.
Moulding services
Liquid silicone rubber and thermoplastic elastomer components are developed and manufactured according to customer specifications. The company combines expertise in material selection with in-depth knowledge of moulding technology. Advanced CAD systems are used to develop prototypes and production moulds, and each injection moulding machine on the shop floor has been modified by staff engineers to meet strict company parameters. Products manufactured at the ISO 9002/EN 46002–certified facility include biocompatible and radiopaque probe caps, laryngeal prosthetic devices, and silicone grommets designed for middle-ear aeration. Medical Rubber AB, Hörby, Sweden.
Certification services
A notified body offers quality systems certification, product certification, evaluation of clinical data, training, and CE-marking assistance. The company is designated for quality system certification according to annexes II, V, and VI of the Medical Devices Directive (93/42/EEC) and for the certification of active and nonactive medical devices. Depending on the type of medical device that is being certified, the notified body is able to outline a strategy to help ensure that production methods are in compliance with the relevant directive. The company also conducts courses on achieving compliance with the directives. DGM, Danish Medical Devices Certification, Charlottenlund, Denmark.
Contract research services
A contract research organization with a background in chemistry and chemical engineering describes its core competence as R&D related to polymer science and medical device technology. Assistance can be provided at all stages of product development, from concept generation, laboratory prototyping, and pilot studies to process validation. The 2800-m2 facility includes various laboratories; Class 100,000 and Class 10,000 cleanrooms; and pilot production areas with 5-, 40-, 100-, 450-, and 900-L steel reactors. Previous projects have included the design and development of surgical equipment, coating systems, and a production method for the manufacture of soft contact lenses. Wolff & Kaaber a/s, Farum, Denmark.
Metal fabrication services
Semiround medical-grade studs and contact rivets for ECG electrodes are manufactured by a supplier of metal products. The studs can be produced according to customer-specified hole, collar, and height dimensions; they are available in brass or acid-resistant stainless steel. The brass contact rivets can be supplied with a smooth surface or plated with nickel, silver, or gold. The collar size also can be modified to suit client requirements. The company is equipped with the latest CAD/CAM equipment; tooling is produced on-site using modern CNC-controlled machines. Nordtool, Gilleleje, Denmark.
Metal components
Machined parts, seamless tubing, and wire are supplied for medical applications. Precision machined components are manufactured in platinum alloys to individual customer specifications. Because of their biocompatibility, platinum alloys are typically used for permanently implanted devices such as pacemaker leads. Seamless tubing for radiopaque marker bands can be supplied in a variety of inner and outer diameters, wall thicknesses, and cut lengths. Wire products with high tensile strength also are routinely manufactured in diameters down to 0.020 mm. In-house enameling is available. A comprehensive range of technical assistance is provided. Johnson Matthey a/s, Brønshøj, Denmark.
Logistics services
A distributor of pharmaceuticals and OTC products to pharmacies nationwide also provides logistics services to suppliers within the healthcare sector. Forecasting, order management, import activities, warehousing, invoicing, and national and international distribution can be outsourced to the company. It can also provide office space and accounting and human resources assistance. Other services include bulk packaging, repackaging, relabelling, distribution of point-of-sale materials, sample handling, and clinical trials assistance. Nomeco a/s, Copenhagen, Denmark.
Research and development
Research and development for the medical device and biotechnology sectors is conducted by an international network of professors, researchers, and engineers. A current project involves the use of a magnetic-particle-based method for rapid and simple diagnosis of cancer markers and hormones in blood samples. Applying this technology to the treatment of cancer is also under investigation. A biosensor designed for the detection of chemical substances in blood or food was also developed at the institute and resulted in the formation of a company to exploit the technology. European Institute of Science AB, Lund, Sweden.
Electrotherapy products
A developer and manufacturer of transcutaneous electrical nerve stimulation (TENS) and transcutaneous electrical muscle stimulation (TEMS) devices offers contract manufacturing services within its field of expertise. The company has also developed a four-channel stimulator for electrical acupuncture procedures and it supplies a broad range of accessories such as self-adhesive electrodes and electrode gel and tape. Cefar Medical Products AB, Lund, Sweden.
