Fabrication and Functionalization of BioMedical Microdevices

Summary
The aim of FaBiMed proposal is to improve and develop new manufacturing techniques, based on micromoulding, specific for biomedical microdevices. The project will be to reducing the cost of mass production of diagnosis and therapeutic micro devices which have a common problematic: medium sized batches, customization needs, micron-scale geometrical features. These include optofluidic sensors (MIR technology) used for different lab-on-chip diagnostic systems, and micro-needle arrays used for drug delivery and micropiezodevices for intravascular ultrasound (IVUS) and similar medical imaging techniques. This kind of medical microdevices lack nowadays of specific manufacturing techniques, and depend from conventional miniaturization methods inherited from silicon processing technologies, developed for the microelectronics industry. Such methods, based on expensive masters and masks, are only economic for high volume production, and prevent for applying the modern tendency of personalized medical devices. The development in this market is dominated by technology based SMEs, start-ups and spin-offs from academy, which have very strong product development capabilities, but depend on the existing technologies for the manufacturing, due to their difficulty for development their own materials processing equipment.
More information
Web resources: http://www.fabimed.eu
https://cordis.europa.eu/project/rcn/108888/factsheet/en
Start date: 02-09-2013
End date: 01-09-2016
Total budget - Public funding: 4 133 747,00 Euro - 3 010 000,00 Euro
Call topic: Manufacturing of highly miniaturised components (FoF.NMP.2013-11)
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Location

Manufacturing performance characteristics - (4)

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    Comment: Together with the avance of replication technologies, by using novel tool materials and tool concepts, the project will develop an integrated monitoring method based on optical measurement inside the microrreplication chamber, which will help reducing the setup time in new parts or materials, improve flexibility, reduce cycle times, and enable zero-defect approaches based on adaptive replication machine behaviour.
    Economic feasibility is addressed all along the development of the project by monitoring the impact of toolmaking technologies (tool material, design, modularity, toolmaking/refurbish/repair technologies, ...) in the overall economy of the manufacturing process.
      Comment: The project will develop a complete manufacturing path, including not only the replication itself, but also the device design, part design, tool design, tool making, as integrated steps which must take into account .
    Comment: The project planning includes the monitoring and evaluation of the overall impact and sustainability indicators of the developed complete manufacturing path against current State of the Art baseline (benchmarks), with throughful collection of the Life Cycle Inventories of each individual process step and the impact of batch size, design change and other contingencies in the overall environmental impact of the complete manufacturing chain.

Manufacturing future products - (6)

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    Comment: Future of medicine is driven by the concepts of early, remote and patient-managed diagnostic, teleasistance, minimal invasive and TIC enhanced treatment, to improve service, effectivity and reduce costs. All these advances rely on novel biomedical devices, which are currently being designed and developed, but which are complex and expensive to manufacture with current technologies. Advanced microrreplication developed in FaBiMed will allow to produce such novel devices in a cost effective way, while keeping the flexibility required for patient-specific functionalization.
      Comment: The project will deal with the combination of meso/micro/nano feature integration by combination of micromachining and nanostructuring technologies, while keeping cost efficiency through the use of proper coating and reconfigurable nanostructuring, to enable multiple nano-enabled functionalization in the same microstructured mould.
      Comment: Micron-resolution and high aspect ratio microrreplication of keramics is a novel approach which will be faced in this project, both for keramic microneedle production and for highly customized piezotransducers.
      Comment: Customization (patient specific features) is one of the main drivers of the project: modular replication tools with reconfigurable details will be demonstrated, as well as reversible and reconfigurable nano-
      Comment: Direct fabrication of toolings by modular inserts and additive manufacturing, will allow resource efficient tooling, and resource efficient mould reconfiguration for reducing the cost of small batch fabrication.

Technologies and enablers - (11)

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      Comment: The manufacturing path to be developed in FaBiMed does not consider additive manufacturing as the production method, instead microrreplication is used. But the concept of cost-effective, flexible and reconfigurable tool will be implemented through Additive Manufacturing.
      Comment: Slurry casting, injection molding and hot embossing are well known and established production technologies. The project will take these cost effective replication methods and take them a step further in accuracy, flexibility, micro-nano replication capability and reliability by integrating novel materials, tooling concepts, control and monitoring technologies .
      Comment: OCT, interferometry and LUS based inspection and monitoring techniques will be implemented in the project as part of the zero defect, total quality, low quality cost and low lead time philosophies, which are required to be adopted by the manufacturing companies competing in the disposable medical product market.
      Comment: Laser based technologies are central to the project. Laser is used as a tool for micromachining, additive and generative production (by means of selective melting, photopolymerization), and reconfiguration (laser induced chemical modification, laser enhanced chemical etching), as well as the key tool for process monitoring and part geometrical/functional quality assessment.
      Comment: Microrreplication (in particular, high precision ceramic casting, polymer micro-injection molding, hot embossing and nanoimprinting) are the core technologies of FaBiMed project. Scalable and flexible production will be enable through the combined design of the replication equipment and the replication tooling.
      Comment: The project will develop novel approaches to the shaping of piezokeramics by using specially formulated slurries and novel compliant mould desings. Regarding the forming of hard to process polymers, the embossing and injection-compression molding will be improved.
      Comment: Novel and inedit tool materials, particularly glass, DLC and sapphire based tools, will be used as alternative materials for microrreplication inserts, thanks to their thermal, physical, optical, surface and mechanical properties, which make them . Siloxane-based moulds produced by direct fabrication (masterless production) will also be used as novel tooling material for ceramic microrreplication, with mechanical properties adapted to the evolution .
      Comment: Closed-loop control multieffector replication equipment will be developed to enable thin foil structured polymer injection via injection-compression molding and hot embossing. This advanced mechatronic design is intended to improve the replicated part quality, respond to unexpected material behaviour, and considerably reduce cycle times with respect to conventional single effector and open-loop controlled replication machines, currently used in industry.