REGIONAL FOCUS
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Fences may make good neighbours, in the words of the poet, but I like bridges better. The striking span that crosses the Øresund strait linking Sweden to Denmark is one of my favorites. More than a piece of transportation infrastructure, the Øresundsbron is a soaring symbol of the cross-border collaboration that has made Medicon Valley, which encompasses greater Copenhagen and Sweden’s Skane region, so successful.
The Øresund Committee was formed in 1993 to promote exchanges among members of industry and the social community on both sides of the strait. Early on, it became apparent that biotechnology had a good foothold in the area and could serve as a building block for transnational initiatives. The idea of Medicon Valley was born.
“When the Øresund Committee was established, no decision had been made to build a bridge, and Sweden was not a member of the European Union,” says Birger Olofsson, who directed the committee for 12 years before stepping down in 2005. “The bridge is important as a symbol of an integrated region,” he says, adding that national differences have lost some of their edge. “Of course, working cultures [still] differ, but there is no doubt that there are more similarities than differences. And the differences are actually quite stimulating,” says Olofsson.
In many ways, Innovation Team, Nolato Medical, and Pinol a/s epitomize that duality.
A Comfort Zone for Creativity
Innovation Team, which maintains offices in Halmstad, Sweden, and Copenhagen, is at the nexus of Scandinavian design and medical technology. This design and development bureau with a cross-border business model emphasizes a cross-functional approach to product development. It has some novel ideas on how best to prime the creative process.
To get creative juices flowing, managing director Anders Rosengren typically invites customers to spend some time in the so-called Innovation Room, located downstairs in the Halmstad office. The distractions of everyday life are eliminated from this space so that participants remain focused on the project at hand. To set the mood, a minuet by Mozart might be wafting from the facility’s speakers, notes Rosengren. “There are no clocks in the room, and cell phones and PDAs must be shut off,” he says. And as a constant visual reminder of what they are here to accomplish, all those who enter the sanctum, including roving reporters, must don a white lab coat.
The approach seems to be working. Innovation Team, which was founded in 1989 as a university startup, has approximately 40 employees and does extensive work for medical device companies. Its most recent project is a monitoring system for Redsense Medical (Halmstad, Sweden) that alerts practitioners and patients if a venous needle comes dislodged during haemodialysis.
A Few Good Customers
You rarely hear about a company turning away customers, but that’s precisely what Nolato Medical (Torekov, Sweden) did in the late 1990s. And it had nothing to do with a lack of capacity.
“It was a strategic decision,” explains Christer Wahlquist, the firm’s head. “We were a fairly small operation, but we had a lot of customers. Then we decided to channel our energy into serving fewer customers and really bringing something unique to the partnership. In a single year, we went from a customer base of 250 companies to 50,” says Wahlquist. The stratagem worked. The company maintained its turnover, and, in fact, began turning a profit.
Nolato applies the same methodical approach to acquisitions. In November 2006, it purchased Medical Rubber in nearby Horby, Sweden, a manufacturer of precision components for medical devices in silicone rubber and thermoplastic elastomers. Medical Rubber’s customer base is a good fit and will serve customer interests, according to Nolato, by rationally expanding its product and service portfolio and creating synergies. Its most recent acquisition is Cerbo (Trollhättan, Sweden), which develops packaging for pharmaceutical products.
Serving a well-defined customer base and making strategic acquisitions allows Nolato Medical to effectively channel its resources and customize development and production activities to suit individual needs. It has in-depth expertise in risk analysis and quality assurance, and has a history of working in partnership with customers on complicated medical technology processes.
Global Outlook
Pinol a/s (Gørløse, Denmark) also brims with self-confidence. According to market manager Michael Wied, Pinol became the largest family-owned manufacturer of medical devices in Europe when it merged with Elos Medical (Timmersdala, Sweden) in 2005. “We shared the same strategy,” says Wied. “We both wanted to be the number-one contract manufacturer for the medical industry in Europe. Rather than battle each other, we joined forces.” And there has been no looking back since. In fact, the company now sees the future as wide open.
“Our goal now is to be one of the top five companies in our field worldwide by 2008,” Wied told me as I toured the plant in May 2007. When I mentioned to him that the deadline was just around the corner, he smiled and simply replied, “That’s right.” To fulfill that goal, the Elos group, of which Pinol is now a part, plans to acquire one more company in Europe and set up sites in China and the United States. “We are looking for global capacity,” he says, “and putting plants in proximity to our customers.”
Ensuring that it can meet customer demand at all times is an ongoing concern. To achieve this, Pinol and Elos have built “mirror copies of the facilities,” says Wied. “They have the same machines, quality systems, and everything. If something happens in Gørløse, or if there is a sudden uptick in demand, we can transfer or add production in Sweden the next day.”
Being prepared for the unexpected, exceeding customer expectations, and doing it all with flair is part and parcel of the Scandinavian way. In the following pages, several other manufacturers from Sweden, Denmark, and Norway that deserve your attention are profiled.
Nolato Medical
Part of a high-tech group focussed on the development and manufacture of polymer systems and components, Nolato Medical (Torekov, Sweden) began its medical manufacturing activities in 1957. Over the years, Nolato’s medical division has honed its expertise in this sector and built a portfolio of products for use in diabetes therapy and asthma treatment, as well as components for diagnostic systems, home-care products, and surgical instruments.
One of the company’s strengths is its unique combination of technologies. It has in-depth knowledge of plastic injection moulding and extrusion of thermoplastic elastomers, silicone, and related materials. The firm also offers automated dipping, a service it provides to customers in the cardiac products field who require exacting levels of precision. Primary and secondary packaging, assembly services, decoration, insert moulding, and logistics are also available.
The firm recently acquired Medical Rubber, a supplier of silicone rubber and thermoplastic elastomer components, and Cerbo, which is a developer of primary packaging for pharmaceutical products. It also maintains medical manufacturing operations at a facility in Hungary.
Nanon a/s
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A technical evaluation of the cold-cure process recently conducted by Momentive Performance Materials (formerly GE Bayer Silicones) found that it effectively removes volatiles from liquid silicone rubber at a low temperature. “The process does not result in higher network density, and so the mechanical performance remains as moulded,” according to the authors of the evaluation.
Nanon also has introduced hands-free postcuring by using autoclavable bags. Immediately following moulding or extrusion, silicone parts are packed directly into the pouches. They are then loaded into the cold-cure machine, where they are washed with liquid CO2. The bags’ permeable membrane allows the CO2 to flow freely, bathing the silicone parts and removing the oligomers.
The firm, which describes itself as a specialist in the nanoscale manipulation of silicone and other difficult polymers, actively collaborates with nearby universities in coatings research projects.
Melitek a/s
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“Ten years ago, people would always say that there is no alternative to PVC in certain medical applications because of its kinking characteristics,” says Laursen. “That debate has become irrelevant. Replacement materials are available, and they don’t kink any more than PVC.”
Meliflex is produced in a controlled environment. In addition to the main production line, the company operates a pilot line with enough throughput for many mainstream applications, according to Laursen. The plant currently has a 3000-m2 production space, but capacity will increase in the near future. “We plan to buy a plot of land just behind our current plant that will provide us with 10,000 square meters of usable space,” says Laursen.
The polyolefin alloy is suited for use in medical film, tubing, injection moulding, and blow moulding applications. It complies with USP Class VI, US FDA, and European Pharmacopoeia additive guidelines.
Pinol a/s
Positioning itself as a one-stop shop for the development and manufacture of medical products, Pinol a/s (Gørløse, Denmark) supplies dental and orthopaedic products, drug-delivery systems, hearing aids, and complex Class I, Class II, and Class III devices. “We can do everything from product design to packaging to logistics,” says market manager Micheal Wied.
Prototyping, turning, milling, grinding, assembly, laser processing, surface treatment, and cleaning are done in-house. An ISO Class 7 cleanroom is on-site, and quality systems are certified to ISO 9001:2000 and ISO 13485.
Seeking the most efficient use of resources is a point of pride at the firm. During a product’s development phase, for example, “we always assign two people to a project because it’s good to have a second opinion,” says Wied. “We propose two different solutions and let the customer decide which one is best.”
To add value to its services, the company has invested in a state-of-the-art logistics system. “We can monitor a customer’s inventory worldwide with our ERP system,” explains Wied. “It’s fully automated, and maintains inventory at a level determined by the customer. It even manages incoming supplies as they are needed to produce device parts.”
Chempilots a/s
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“In many cases, the integration of product and process development is key to putting a successful product on the market,” says Elbek. “During R&D, it’s easy to forget that the product generally will have to conform to high-speed, high-volume production methods. So, during the product design phase, you have to ask yourself: how can I best fit the design and materials into a standard process platform? Striking the right balance in relation to your objectives is very important,” Elbek adds.
“We always keep that in mind when we are working on a project.”
This year, the company celebrates 50 years dedicated to applied polymer chemistry. The 5000-m2 facility is equipped with Class 10,000 and Class 100,000 cleanrooms.
RR Rotary a/s
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Continuous-motion manufacturing, which requires rotary tooling, is popular for high-volume production. “It’s much faster than stamping,” says Eberhardt. “Rotary die-cutters can achieve a throughput of 300 to 400 metres per minute.” To enhance tooling stability and maintain accuracy at high speeds, the firm mounts its rotary dies in specially designed bearing retainers, adds Eberhardt.
The company offers rotary die-cutting systems that was initially designed to produce Class I medical devices. The RX-series machines are engineered to outperform other die-cutters while dramatically reducing cost of ownership, according to Eberhardt. High-tolerance rods, precision linear bearings, and heavy-duty needle-bearing support rollers eliminate the need for heavy side frames and extra bearing packages. Tool changeover can be done in as little as 10 minutes.
Medical Rubber
Operating out of a stunningly clean state-of-the-art facility in Hörby, Sweden, Medical Rubber manufactures precision injection-moulded components from silicone rubber and thermoplastic elastomers to customer specifications. The company has developed in-house expertise in materials and moulding technology over the years, and it has also invested heavily in advanced manufacturing and automated inspection equipment. Typical products include gaskets, balloon catheters, check valves, introducer tips, and filter membranes.
“We are good at producing thin-walled parts that weigh between 0.02 and 140 g,” says R&D manager Peter Persson. The company has achieved breakthroughs recently in streamlining operations by automating slitting, implementing a centralized material-feeding system, and expediting the development of moulds while lowering their cost of fabrication. “The automation of parts inspection is also a key area of focus,” says Persson, who explains that automated testing is quite difficult to accomplish with silicone parts because of the material’s transparency and flexibility.
The company operates two plants in Sweden dedicated to advanced medical projects, and one in Poland that supplies industrial products. The Swedish facilities have Class 10,000 and Class 100,000 cleanrooms on-site.
Tantec
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Plasma treatment is conducted in a controlled environment inside a sealed chamber with a 2- to 10-mbar vacuum. The product that requires treatment is placed in a holding fixture, which is drawn into the chamber. The chamber door slides down automatically and the process starts. The process cycle takes about 120 seconds.
VacuTEC systems come in three standard sizes; custom configurations are also available. Although they are generally used in batch processing, the systems can be integrated into in-line processes as well. The machines’ expected life span is between 15 and 20 years.
Carmeda AB
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“Carmeda’s coating is the gold standard,” says Elisabeth Scholander, vice president, research and development. “We have the clinical records, and a long history of effectiveness.” One reason why Carmeda’s coating is successful where others may fall short has to do with its patented end-point–attachment covalent bonding method.
In a heparin preparation, only one in three molecules actually work, says Scholander. The active sequence of heparin sugar residues binds to the device surface and potentiates antithrombotic action. Ensuring that a sufficient amount of active heparin is properly exposed on the device surface, even for long-term use, is part of the company’s expertise, says Scholander.
The company’s CBAS technology is available for licensing. Carmeda is certified to ISO 13485:2003, and contract coating services for Class III devices are available at the company’s facility. Class 10,000 and Class 100,000 cleanrooms are on-site.
The coating currently is used on vascular grafts, haemodialysis catheters, and heart assist devices.
Innovation Team
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The firm contributes product development and project management services for Class I, II, and III devices. Its regulatory affairs personnel and consultants are well versed in ISO 13485, the US FDA QSR and 510(k) requirements, and CE marking compliance.
Some of the firm’s recent projects include the ultralight SpinX Wheelchair for Invacare Inc. (Elyria, OH, USA) and an alarm system that monitors the IV needle during haemodialysis, recently put on the market by Redsense Medical (Halmstad, Sweden).
Søbygaard Machine Design ApS
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The company’s TF-05 machine with integrated punching tools can form closed, open, curved, whistle, or Tiemann tips, and punch single or dual side-cut eyes. Controlled by a touch screen, the unit can store up to 20 different product programs. When a product profile is chosen, all of the associated settings are selected and displayed on the screen.
The forming process begins when the catheter tubes are placed in the glass or nickel moulds. Heat is applied, causing the material to melt. By pressing the tube into the mould, the desired tip shape is obtained. Punching takes place simultaneously. The shape is then stabilized by cooling the mould.
Designed to handle four tubes at a time—while two of the tubes are being heated, two others are cooling off—the TF-05 can process between 500 and 800 tubes per hour.
HP Etch
Located in a former IBM facility that used to etch print bands for IBM printers, HP Etch (Järfälla, Sweden) carries on that tradition, and more. The company continues to fabricate print bands for IBM—in fact, it is the company’s sole print band supplier in the world—but it also precision etches parts for a variety of other applications. Interest in the technology is growing among medical device manufacturers, adds company president Jan Kilén. It’s a customer base that he is keen to pursue.
Also called chemical machining, etching has a number of benefits for medical technology companies, explains Kilén. “First and foremost, we can achieve extremely precise tolerances. For example, we can etch holes from 0.8 to 0.2 mm diam with tolerances in the micrometer range. And the holes can be different diameters on the top and bottom sides of the workpiece,” he says. “You can’t stamp to that level of precision.”
Other benefits of etching, according to Kilén, include an absence of burrs on the part and the fact that the technique does not stress the material. Moreover, chemical machining can boost productivity.
“With this process, you don’t need to make stamping tools,” says Kilén. “That can be a real advantage given shrinking product life cycles. You don’t have to waste time making a tool. You can have a prototype within 3 to 4 days,” adds Kilén.
Vetaphone a/s
Corona treatment equipment is designed to increase the surface energy of a material and thus prime it for printing, lacquering, or adhesion. The CP Spot Kit from Vetaphone a/s (Kolding, Denmark) improves wettability and adhesion on three-dimensional products made from polyethylene, polypropylene, polysulphone, EPDM, and other similar substrates.
Fitted with a flexible positioning arm, the system features a slim design and can be used in semi- or fully automated production environments. The high-voltage high-frequency corona discharge can treat 25 to 30 mm of substrate at a time.
Medical filters, catheters, syringes, and lenses are among the products that can be processed with this device.
