Potential for tool and mould manufacturers in medical technology
How is tool and mould manufacturing developing in the field of medical technology in the German-speaking region? Do you see any potential for other providers to become active here?
Globally, I definitely see an opportunity for further development, because the companies in the sector here at this location not only master the technological implementation of the specification requirements, but also because they understand how to work in compliance with directives, to qualify a tool and to validate an injection moulding process. Technology and documentation are of equal importance in the weighing pan of medical technology.
What are the current trends? What do you anticipate in the next five years?
One trend topic is certainly high-cavity tools that can be used in fully automated processes. But in future it will also be important to increase the production of complete assemblies. For this purpose, we will need tool technologies that also allow the functionalisation of plastics, for example in the direction of two-component injection moulding or in the direction of surface technology – in the sense of microstructuring or precision.
What special challenges characterise tool and mould manufacture in the area of medical technology?
One thing that certainly must be understood is what risk arises from the use of the tool on the product that the patient will subsequently use. This means, for example, that the tool maker must position the separation plane for an inhaler mouthpiece so that no sharp ridge is formed. If a patient cuts their lip when using the medical product and gets an infection, I have failed as a tool maker. The same applies if lubricants with toxic effects are used which - once they have vaporised - leave deposits on the tool cavity which are partially invisible. Problems are preprogrammed if a plastic part from such tools is put in the mouth or even inserted into the body. In this respect, a medical product must simply never pose a danger. The tool maker must contribute with his know-how to ensuring that as far as possible no risk is caused by his tool that may have a negative effect on the patient or user. A holistic consideration of the risk must therefore not be seen as a shackle or as a bothersome accessory, but must be recognised as a useful and necessary means of reducing risks. Because here the tool maker is in the same boat as the manufacturer of medical products who uses the tool in his production process. Only then can specifications be met, for example in order to manufacture low-particle and low-contamination products.
Which regulatory requirements are of most concern to tool and mould making and why?
The most important requirement is good manufacturing practice (GPM), i.e. guidelines for quality assurance and risk consideration for production processes and environments, which always evaluate the processes from the product side.
To what extent are the efforts and expense changing in the areas of risk assessment, qualification, validation, product documentation and product support?
Significantly. For everything is becoming international. For medical and pharmaceutical technology, a tool and mould making company must in actual fact provide much of the documentation from start to finish in English. This means that all protocols, all inspection reports etc., 80 per cent of the paperwork, is in English. That wasn't the case a few years ago.
What must be taken into account for material selection?
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The tool maker must actually – exactly as in the automotive sector – ensure that a specified plastic can be processed with his tool. However, the product should as far as possible be made from "medical grade plastics", as described in VDI Directive 2017. Here, the tool maker must ensure that the temperature control e.g. in the hot runner does not result in the material being thermally damaged and thus becoming cytotoxic. This can certainly happen without being visible in the material. In brief, it is important for the tool designer to understand what product is to be manufactured by his tool, what will happen to it and how it will be used. After all, in particular within the framework of tool design, the decisive course is set with regard to a robust production process taking into consideration the required specifications.