Regional Focus
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The seeds of change were sown in the 1960s, when the coal mining industry declined and global market forces led to a collapse of the steel industry, says LSA managing director Sylvia Deutschmann, PhD. In the ensuing years, “lots of resources were put into restructuring the region, particularly in the improvement of healthcare and technology transfer opportunities. Then in 1996, NRW was one of three German states to receive federal aid for the development of a biotechnology pole,” adds Deutschmann. (The other regions were the Heidelberg and Munich areas.) In 2002, NRW decided to expand the scope of this initiative to include all of the life sciences. “The Life Science Agency was formed at that time by centralizing three existing associations, which focused on biotech, pharmaceuticals, and medical technology,” says Deutschmann.
Centres of Innovation
The institute has been at the forefront of implanting ProDisc spinal devices and using robotic surgery techniques to perform the procedure. Based on research and development in total disk replacement therapy refined by French orthopaedic spine surgeon Thierry Marnay in the late 1980s, the implant consists of a polyethylene core sandwiched between two titanium-coated cobalt-chromium-molybdenum plates. The PE interface between the plates ensures mobility similar to a ball-and-socket joint. The ProDisc system is widely used throughout Europe, where approximately 6500 patients have received the implant. It is currently under clinical investigation in the United States and Canada, where approval is imminent.
GIMT also develops other minimally invasive diagnostic and therapeutic techniques. In addition to disc disease, local tumour and pain therapy and the treatment of vascular diseases are its specialties.
The scope of medical-oriented research in NRW is expansive, stresses Vogt. Bioengineering and biomaterials research is conducted at the University of Aachen; the city is also home to mnemoScience GmbH, which applies its shape-memory polymer technology to medical applications. In Bad Oeynhausen near Bielefeld, the Clinic for Thoracic and Cardiovascular Surgery is a recognized global leader in treatments involving ventricular assist devices. Currently, a team working under the guidance of clinic director Reiner Körfer is developing an implantable totally artificial heart. Researchers from Ruhr-University Bochum and the Duisburg-Essen University are working on developing techniques to accurately shape and implant biodegradable materials that could eventually replace titanium for reconstructive cranial surgery. The project is described in detail in the accompanying sidebar.
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Localized drug delivery and brachytherapy are among the medical applications of a technique for placing a porous ceramic layer on a substrate, developed by AlCove Surfaces. |
Biomaterials are also a focus at AlCove Surfaces GmbH (Gladbeck). The company has developed a wet chemistry process that enables the creation of a porous ceramic layer on substrates. Applications include localized drug delivery and brachytherapy. The latter application, according to the company, allows the radioactive element to be housed within the pores of a ceramic layer. Traditionally, the radioactive compounds are sealed inside a laser-welded titanium capsule. The technology developed by AlCove reportedly eliminates this production step while maintaining acceptable and safe radiation-release rates.
Given the depth of healthcare research and device manufacturing in the region, it goes to follow that the supplier base is equally well developed.
“We estimate that there are approximately 1000 suppliers to the medical industry operating in the region,” says Vogt. They cover a vast range of technologies, from medical packaging and electronics to biomaterials. One field that has had a significant impact on the region is microtechnology, and the discipline seems to have achieved critical mass in the city of Dortmund.
Building a Microtechnology Hub
Talk about a turnaround. Dortmund, which sits in the eastern part of the Ruhrgebiet, was a centre of coal mining and steel processing for more than 100 years. Like in much of the NRW, the erosion of these industries hit Dortmund hard. Whether or not it is on the cusp of a new golden age depends on whom you talk to. But what can’t be denied is that the city has made a big splash by thinking small: microtechnology and other high-tech activities are putting Dortmund back on the industrial map.
An international association of companies and research institutes involved in microtechnology, IVAM (Dortmund), recently conducted a survey of microsystems technology (MST) clusters in Germany. It identified 20 such clusters throughout the country. North-Rhine Westphalia emerged as one of the federal states with the highest number of MST firms, and Dortmund was singled out along with Jena, Munich, and Berlin as hotbeds of activity. The survey also found that the life science industries represented the largest target market for the companies. Medical device OEMs accounted for 38% of sales, with biotechnology capturing 22% and the chemical and pharmaceutical industries coming in third at 17.7%. (The MST-Atlas Germany is available from IVAM for €50 plus VAT at www.mst-atlas.com. It is currently published only in German.) Frank Bartels, managing director of Bartels Mikrotechnik (Dortmund), gives the regional government a lot of credit for providing a fertile environment where MST companies could flourish.
“The regional government put a lot of effort into supporting microtechnology,” says Bartels. “And it did so even during hard economic times. It never lost focus, and that has paid off.” That level of support is crucial for a technology-based firm trying to make a go of it, he adds.
“Technology companies have a hard time finding a customer base,” says Bartels, whose company has developed an injection-moulded micropump that, because it can be mass produced, is suitable for disposable applications. “If you make a product, you can show it. Not so with a technology, which is a tool,” says Bartels. “In the beginning, we had to hunt down every euro.” Those days appear to be behind him, however. The medical industry has been especially receptive to the technology. “In 2005, medical represented about 15% of our business. In 2006, we project that it will grow to 50%,” says Bartels.
To accommodate demand from OEMs for its pump and to provide more elbow room to its engineers working on development projects, the company is in the process of moving to more-spacious quarters. When I visited the firm in January, I had to dodge staff who were busily transporting items to the new offices. Luckily, they did not have far to go: the new facilities will be located in the biomedical centre within the same complex. One reason that Bartels did not consider leaving its haven is the proximity of like-minded firms. The warren of offices near the technical university houses a number of MST-oriented firms (as well as the IVAM headquarters). The close quarters are conducive to innovation, says Bartels.
“Just this morning, I had a meaningful exchange with HL Planartechnik, which develops microsystems with sensing functions,” says Bartels. “Clusters are very beneficial in that they encourage networking. We learn from each other.”
A Brand New Bag
There is no cluster in Halle, but that has not hurt the fortunes of Kobusch-Sengewald. The maker and converter of flexible plastic packaging is headquartered in Warburg, but maintains its impressive production facilities in the tight-knit community of Halle. Supplying a range of industries, the company has been active in medical products for more than three decades.
“The medical packaging product division was started in the early 1970s,” says medical sales manager Henrik Nichols. “Today, it represents close to 20% of our turnover, and it continues to be a growing market segment for us.” The firm produces mono- and coextruded and composite films for medical applications. Extensive printing, lamination, slitting, and converting services also are available on-site. Medical bags are produced in a cleanroom.
Soft-peel systems, which are typically made of Tyvek 2FS and a peelable base film, and Formpeel products, a low-shrinkage film designed for packaging long narrow items such as catheters on form-fill-seal equipment, are among the products offered by the firm. One of its signature products, however, is a polypropylene-based material that can be used as a PVC-free alternative. The Propyflex line was recently expanded to include a four-side-seal infusion bag. It is described in the company profile in this section.
Propyflex has a number of properties similar to PVC—softness, transparency, collapsibility—as well as some advantages, according to Nichols. “You don’t need to worry about the migration of plasticizers, and PVC-related disposal issues are not a concern,” explains Nichols. The cost factor, which has long dogged PVC-replacement materials, is becoming inconsequential, he adds. “The cost difference is small enough that customers can focus on the advantages of the material,” says Nichols. As more countries enact legislation restricting the use of PVC, he predicts that economies of scale will reduce the price of PVC alternatives even further.
Boehringer Ingelheim microParts GmbH
Robust, small, and cost-efficient UV/VIS and NIR spectral sensors reportedly enhance the sensitivity of medical diagnostic equipment as well as spectral sensing devices used in harsh environments.
Developed by Boehringer Ingelheim microParts GmbH (Dortmund), the sensors are based on micro-injection-moulded planar waveguide spectrometers. All of the functional elements are integrated into a single device,
which has enabled a dramatic size and weight reduction compared with conventional products. The monolithic design of the sensors and the materials used in their fabrication ensure stable operation and protect them from mechanical shock and vibration as well as shifts in temperature.
Application-specific algorithms can be transferred directly among several devices, eliminating the need to calibrate each device. Consequently, manufacturing costs for products based on the company’s microspectrometers can be significantly reduced compared with discrete mounted devices.
Combined with a specially configured optical sampling unit, light source, and electronics, the microspectrometers can be integrated into US FDA–approved handheld devices to quantify haemoglobin and bilirubin. Stationary diagnostic measurement equipment may also benefit from the sensing products. For example, an InGaAs-array-based microspectrometer can be used to monitor pharmaceutical ingredients during drying, blending, and granulation processes.
The UV/VIS and NIR microspectrometers are available as OEM modules or PC-based systems. Light sources and optical sampling systems can be tailored to meet user specifications.
Bartels Mikrotechnik GmbH
Microfluidic products based on microelectromechanical systems (MEMS) technology have a range of applications, not the least of which is medical devices. Named one of the 20 leading global vendors of microfluidic products by French consultancy Yole Développement (Lyon, France), Bartels Mikrotechnik GmbH (Dortmund) has entered into strategic partnerships to advance integration of the technology into medical equipment. These relationships have enabled the company to begin offering mass production capabilities.
The company recently introduced a low-priced injection-moulded micropump, which it touts as the first serially produced microfluidic product to reach the market. The chemically resistant micropump achieves flow rates from 50 nl/min to 5 ml/min for liquids and 50 µl/min to 15 ml/min for gases. In addition to medical applications, the product is used for chemical analysis and consumer products. Numerous other opportunities abound, according to the firm.
The pump is injection moulded from polyphenolsulphone and is powered by a piezo-based device that operates between two double valves. The design’s simplicity is a key attribute of the product, according to the firm. Production and assembly techniques are straightforward, and the use of injection moulding renders mass production of the micropump cost-effective.
Center of Advanced European Studies and Research
Focused on the commercialization of leading-edge technologies by fostering spin-off companies, a research and development centre targets projects at the juncture of physics, mathematics, chemistry, medicine, and information technology. The Center of Advanced European Studies and Research (CAESAR; Bonn) organizes large-scale research projects under a so-called “triplet” structure, meaning that modeling, experimental, and engineering groups work collaboratively to achieve a common goal. Basic areas of research of particular relevance to the life sciences include materials and nanotechnology, the coupling of biological and electronic systems, and ergonomics in communication technology and computer-aided surgery.
A group conducting rapid prototyping research generates patient-specific anatomical models, implants, and prototypes to customer requirements. Custom anatomical models for oral and maxillofacial surgery are available with realistic soft-tissue properties and coloured surfaces. Transparent models featuring marked interior structures can also be provided. The group offers an array of other services including the development of polymer- and ceramic-based biocompatible materials, and computer-assisted processing of the materials.
Other avenues of device-related research at CAESAR include the development of minimally invasive surgical tools, biosensors, and image-guided navigation systems for surgical procedures.
microTEC
Microfluidic components and electronic microsystems can be mass-produced directly from computer-aided design data without the use of tools. The generative process creates products in parallel from liquid plastic, even in large quantities. The patented rapid micro product development (RMPD) and three-dimensional chip-size packaging (3D-CSP) technologies, developed by microTEC (Bad Dürkheim), eliminate the need for subsequent assembly stages as well. The specialist manufacturer uses these technologies to realize time and cost benefits for clients by streamlining processes for projects in the fields of optical miniaturization and biotechnological microfluidics.
The RMPD process allows such desired surface properties as hydrophilic areas to be created automatically during the generative growth process. The more than 300 plastics available for specific applications make subsequent treatment stages essentially unnecessary. Even data from circuit layouts can be incorporated directly by the manufacturer for the production of microsystems.
GE Bayer Silicones
Recently introduced biocompatible silicone rubbers for extruded tubing applications provide consistency and precision in fluid delivery while offering low manufacturing costs and long device life. The platinum-cure silicone elastomers are supplied by GE Bayer Silicones (Leverkusen) in single- and two-component versions.
The one-component Tufel 1 material is a ready-to-use product that does not require mixing or additional quality testing. It offers fast cure rates at elevated extrusion-oven temperatures and has a 3-month shelf life at room temperature. Sterilizable by steam, gamma, and EtO methods, the material’s applications include catheter and IV lines, gaskets, and seals.
Two-component Tufel III silicone rubber features elastic memory and resilience, and low hysteresis and compression set. Because of these properties, the material is suited for use in peristaltic pump tubing, which must withstand significant flexural stress. Achieving minimal compression set without postcuring, the material also can be used in a range of sealing applications.
Eliminating peroxide from the curing process ensures the absence of volatile organic compounds that can affect air quality or outgas into fluids or medication.
Ernst & Engbring
Special cables and cable systems are manufactured to custom specifications. Ernst & Engbring (Oer-Erkenschwick) offers a range of products including ECG cables, camera cables for use in dental equipment, and endoscope cables. Hybrid coaxial and energy cables can also be produced.
The company’s products can withstand high and low temperatures, as well as sterilization and disinfection. Cable diameters range from 0.1 to 100 mm. All the products, from miniature to hybrid cables, can be supplied as prefinished plug-and-play systems designed according to customer specifications. Modern workstations for the assembly, soldering, and crimp processes ensure short delivery times. The company is certified to ISO 9001.
Kobusch-Sengewald
A company recently expanded its range of PVC-free infusion systems with the introduction of a four-side-seal bag. Available in 100-, 250-, and 500-ml versions, the bag joins the Propyflex product line offered by Kobusch-Sengewald (Warburg).
The four-side-seal bag is designed to provide enhanced packaging integrity. “It’s especially suited for customers who ship their products over long distances,” says Henrik Nichols, medical sales manager.
Although they are PVC-free, Propyflex bags are soft and transparent. They completely collapse when emptied, preventing penetration of air that could contaminate the contents. Compared with PVC, the material features superior water-vapour barrier properties, according to the company.
Initially, PVC replacement materials were cost-prohibitive, concedes Nichols. “Today, however, the cost differential is not that great. In fact, it’s small enough that potential users can focus on the alternative materials’ advantages.” For example, the material used to make Propyflex bags is typically thinner than PVC, resulting in reduced disposal costs. “And, of course, the potential migration of plasticizers from PVC products is becoming an increasing concern worldwide,” adds Nichols. “China, Japan, and Germany have switched to PVC alternatives. Public pressure is forcing South Korea to do the same,” he notes. As more countries restrict the use of PVC, economies of scale will further reduce the cost of alternative materials, says Nichols.
Kobusch-Sengewald produces and processes a range of flexible packaging films. Specializing in primary and secondary packaging, the medical division offers extruded and composite films that, because of their structure, can be precisely tailored to customers’ end-use requirements.
HL Planartechnik
Described as noncontact temperature-measurement sensors, thin-film thermopiles are processed on a 400-µm silicon substrate. The products are available from HL Planartechnik (Dortmund), which develops, manufactures, and sells a range of components and subsystems integrating microstructures with sensory functions.
Commonly used in ear thermometers, the thermopiles’ flexibility enables their use in a range of instruments that measure body temperature in a number of novel ways. The OEM sensors feature accuracy, high sensitivity, low resistance, and a high signal-to-noise ratio. They are available in TO5 and TO18 housings, and with application-specific filters. The products also can be supplied without a housing.
In addition to thermopiles, HL Planartechnik offers inclination sensors, magnetoresistive sensors, and subsystems with these components. Custom products can be developed, and the company provides a foundry service.
Bayer AG
A special additive system enables a transparent polycarbonate film for medical components and packaging to remain colour stable when exposed to high-energy gamma and E-beam radiation. The product is available from Bayer AG (Leverkusen).
Useful for titration plates, instrument boxes, implant packaging, and the like, Makrofol LP 209 offers the mechanical characteristics of polycarbonate, such as high impact strength and stiffness, which make products created from the material robust. The extruded film satisfies the biocompatibility requirements of both ISO 10993-1 and USP Class VI.
Available in standard thicknesses between 175 and 500 µm, the top and bottom layers of the film are glossy. Nonstandard thickness and surface structure can be provided upon request.
Dewert, a Phoenix Mecano Co.
A company that specializes in the development and manufacture of drive systems and associated components takes advantage of the expertise of a cohort of sister companies to produce its assemblies. Dewert (Kirchlengern) is part of the Phoenix Mecano AG group, headquartered in Stein am Rhein, Switzerland, which also controls companies supplying contract electrical product manufacturing, and electrotechnical and mechanical components. Large-scale production is carried out in a facility in Hungary, where all of the business activities of the group are consolidated. Dewert’s Kirchlengern headquarters is used primarily for product and prototype development, testing, and sample and small-quantity production runs.
Being able to source parts and services from trusted sister companies has been a tremendous advantage for Dewert, says Mathias Bünte, in charge of product marketing. “It’s a great constellation of service providers,” he says. “We can use microswitches from Hartmann and profiles from Rose+Krieger, for example, and not have to worry about any quality control issues.” One thing that does keep Bünte on his toes, though, is the contradictory nature of the drive system business.
“Our work revolves around customization in terms of stroke length, dimensions, colours, and so forth—indeed, no two actuators that we produce for hospital bed lines are alike—and yet we must constantly seek out cost- efficiencies,” explains Bünte. “In this business, we negotiate in cents, not euros. That contradiction is hard to reconcile, but somehow we manage,” he adds.
Dewert develops complete packages for OEMs comprising drives, lifting columns, handsets, and control technology. “We produce everything that is needed to motorize a hospital bed,” says Bünte. The healthcare sector currently represents a little more than one-third of its business, and it continues to grow. One of the reasons the company has been so successful in this field, says Bünte, is because of its ongoing emphasis on new product development.
Customers typically will send a bed to the Kirchlengern facility, where engineers develop custom applications. “We can also send a design team to the customer, if he doesn’t want to ship the bed to us.”
All Dewert drives in the Care and Hospital series feature single-fault protection and fault signaling as standard features. Each system is subjected to comprehensive quality control and safety tests that are part of a certified production process.
Gira Kunstofftechnik GmbH
A supplier of injection moulding services recently announced the installation of a Class 10,000 cleanroom for the production of medical device components. Pressure sensors for eye surgery instruments and components for heart-lung machines are among the products currently being manufactured by Gira Kunstofftechnik GmbH (Radevormwald) for med-tech OEMs.
The injection moulding machines are located outside of the cleanroom, eliminating contamination concerns and optimizing accessibility. After the parts have been moulded, they are immediately transferred to a hermetically sealed conveyor belt (or similarly controlled handling system). They are transported to the cleanroom working area, where they are packaged and ultimately dispatched for shipping.
Cleanroom-based med-tech production is a new field of activity for Gira Kunstofftechnik. “Our aim is to focus intensively on the market for medical technology products,” explains company director Alfred Bulitz. In the long term, the firm wants to expand cleanroom technology into a key pillar of its plastics manufacturing activities.
The firm offers a full range of services including product development, materials selection, prototype and sample production, tooling engineering, and complete project management.
