A wide variety of production solutions for medical technology

Innovative materials at the nanoscopic scale, faster production methods and new supply chains: The 4th COMPAMED Spring Convention featured heated debates about current technological trends as well as new solutions and partnerships in the field of medical technology. The encounters and discussions that began there will be able to continue from 17 - 19 November during COMPAMED 2010 in Düsseldorf, which will be held in Halls 8a and 8b.

Screws that dissolve on their own
Screws are needed in connection with many operations, for example following rupture of a cruciate ligament. Up to now, these screws have been made of titanium. The problem with this is that a second operation is needed to remove the screws again. The Fraunhofer Institute for Manufacturing Technology and Applied Materials Research (IFAM, Bremen) has now developed an alternative that is well tolerated by the human body and dissolves over time. It is made of biocompatible materials that can be processed using novel manufacturing methods such as micro powder injection moulding. “We have modified biomaterials in such a way that they can be used to create strong, bioactive and resorbable screws using a special injection moulding process”, explains Dr. Philipp Imgrund, Head of the Department of Biomaterials Technology at the IFAM, adding that “depending on their composition, they can be resorbed within as little as 24 months.” Medical technology already uses biodegradable screws made of polylactic acid. The disadvantage with these screws is that when they degrade, they can leave holes in the bone. This was why the researchers at the IFAM set out to improve the material. They developed a composite consisting of polylactic acid and hydroxyapatite, a ceramic material that is the main constituent of bone, which is capable of being injection moulded. In addition to this, other parts such as heart valve annulae and stirrup bones (a bone in the middle ear) are now also made by injection moulding from of a variety of different materials. It is also possible to give implants a surface microstructure to improve the control over grafting using this method.

Another step in the direction of individualised medicine has been taken by The University of Applied Sciences of Northwestern Switzerland (FHNW), which is working on the generative processing of biomaterials for the production of patient-specific implants. Such unique implants are far better suited to the specific requirements of the patient than “off the shelf” implants. “The basic procedure consists of three steps: Generating the CAD data, making a 3D volume model and the actual layering“, as Ralf Schumacher from the Institute for Medical and Analytical Technologies explained at the COMPAMED Spring Convention. The layering, which is done using a laser, can use a wide variety of materials including metals, alloys, polymers and ceramics and allows very complex components to be produced.

Jüke Systemtechnik GmbH (from Altenberge near Münster) is a fine mechanics and electronics service provider. Companies like this are gaining increasing importance in medical technology, as this is an area characterised by relatively low unit numbers (in comparison to the automobile industry, for example), high complexity and a large variety of components and product variants. “The manufacturers are faced with an increasing degree of specialisation of components and systems, exponentially increasing demands on documentation as well as increasing regulatory requirements and standardisation”, explains Martin Hovestadt, Managing Director and Partner of Jüke. The only way forward in the light of such challenges often lies in entering partnerships with engineering companies or system suppliers like those already much more commonplace in the automotive industry. By bundling orders for more than one manufacturer it is possible to negotiate better purchasing prices and specialised knowledge of the market makes it possible to implement more standards. “Improved standard IT interfaces make communication and data transfer much easier in such partnerships”, Hovestadt added. “The close, efficient and very well networked interaction between industrial partners gives Germany a particular advantage as a location to do business”, adds Dr. Uwe Kleinkes, Managing Director of IVAM, the International Association of Microtechnology.

The three-dimensional printed circuit board
The Swiss company Harting AG (Biel) is also totally focussed on system integration. The Mitronics division offers a complete supply chain for 3D-MID Technologies from development through to serial production of customised products. MID stands for Moulded Interconnect Devices, “in other words, a special form of printed circuit board that is three dimensional”, explains Albert Birkicht, Managing Director of Harting AG. The three dimensional use of high temperature thermoplastics and structured metallization opens up a new dimension of circuit carrier design, which offers enormous potential for technical rationalisation and is much more environment-friendly than conventional circuit boards. This method uses the so called 2C process, in which two components – a metallizable and a non-metallizable plastic material – are injection moulded to form a single part. A wide variety of plastics can be used for this process. Then the moulded shape can be metallized and assembled. 3D-MID allows the combination of electronic and mechanical requirements in a single component, which also has great advantages for medical technology, including reduced total size, lower costs, a greater system integration and reduced complexity.

Even if electronics are gaining increasing importance in medical technology, the global demand for semiconductors in this sector is estimated at less than one percent according to experts. On the other hand, development in microelectronics is proceeding apace, but even medical technology products are required to be available for as long as ten years or more in some cases. Working under these conditions makes material management of such components a very important matter. “The issue of re-design is gaining ever increasing importance, although the role played by the service providers is definitely gaining significance”, Frank Unland from Lacroix Electronics GmbH (Willich) emphasised at the COMPAMED Spring Convention. Outsourcing to companies like this, which have a broad product base of electronic parts, components and systems makes good sense for a number of reasons: It is especially difficult for SMEs, which are typical in the medical technology sector (at least in Germany), to do business at competitive prices. Also, this does away with the need to tie up your own R&D capacity, which would be better put to use for your core business, and on top of that, electronics specialists have a better understanding of the various alternatives and the new developments that come into question. “Fundamentally it is most beneficial to use semiconductors that can be used in as many different products as possible, not just in the field of medical technology, as these materials stay on the market longer”, explains Unland.

Medical technology that has become well established doesn’t just disappear again overnight – especially if the systems and appliances have proved themselves and are popular. There are often mandatory delivery commitments lasting as long as ten years. The problem for the manufacturer is exacerbated firstly by the fact that appliances and systems can no longer be sold at the original price and that number of units sold falls and secondly by the greater pressure on costs from the new appliances developed and introduced by competitors. “In the final phase of a product’s life cycle, targeted outsourcing is often the best path to take. Occasionally, re-engineering may also help, as it can allow the use of cheaper components and manufacturing processes”, says Dan Negrea, Technical Manager at AEMtec GmbH in Berlin. “The bottom line is that this approach allows you to make savings of over 25 percent. As a service provider offering a very comprehensive range, this company from Berlin can cater for any customer requirement, including proper storage of products, requalification and the associated documentation”.

COMPAMED.de; Quelle: Messe Düsseldorf GmbH