Flexible production systems for “Batch Size1”

Industrial manufacture of highly individual medical products

Personalized therapies are assuming an increasingly important role in modern medicine: The majority of the concepts relating to individualization are patient-centered and focus on complex and correspondingly high-cost medical products such as dentures, exoprostheses or osteosynthesis material. Economically efficient manufacture of highly customized products, i.e. “Batch Size 1” is an important aim in this context. The central challenge facing production engineering is the need to enable companies to produce these customized products industrially and, at the same time, economically.

The Fraunhofer IPT is working on production systems which will be capable of manufacturing medical, personalized disposables cost-efficiently. The Fraunhofer IPT in conjunction with eight project partners is developing a pilot production system within the publicly funded OPENMIND project, which will enable demand-driven production of customized, minimally invasive guidewires. These guidewires are used during minimally invasive procedures such as positioning catheters into blood vessels for diagnostic or therapeutic purposes. Unlike metallic wires, the new guidewires can also be used in magnet resonance imaging systems (MRI) and are thus suited for radio-sensitive individuals such as babies or pregnant patients.  The aim is to close the gap between economically efficient mass production and customized made-to-order production.

In order to attain this goal, separate machining steps were previously connected and conflated in one automated, continuous process. This does not have any adverse effect on the high quality requirements since all relevant system components work in a network and all process and product parameters are filed in a central database.

On the basis of the process model and historical data sets, data mining is used to optimize process parameter records for known product configurations continuously and use them for new product configurations. In this way, an adaptive and cost-effective production operation develops, which is oriented towards meeting acute need and extends as far as “Batch Size 1”.