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InForMed Report Summary

Project ID: 662155
Funded under: H2020-EU.

Periodic Reporting for period 2 - InForMed (An integrated pilot line for micro-fabricated medical devices)

Reporting period: 2016-06-01 to 2017-05-31

Summary of the context and overall objectives of the project

Objectives and context
It is the objective of InForMed to create a pilot line manufacturing infrastructure for the fabrication of micro-fabricated medical devices, making it possible that these devices can be validated in the market and further tuned until they can be transferred to volume foundries and contract manufacturers. The InForMed pilot line will be a crucial instrument in safe guarding Europe’s premier league position in medical equipment and tools, and in the opening of new markets with the overarching goal to create growth in Europe’s smart health industry in its broadest sense, and to help reducing the cost of healthcare and keeping the aging society manageable.
Enable the next generation of medical instruments & tools
The health care industry is going through a radical transition, characterized by the fact that micro-fabricated devices are moving towards the front-end of medical equipment, devices and instruments. In these systems, they are the interface between the human body - or more in general, living cells and tissue - and the machine. As such they determine to a large extent the quality of the total system.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work Package 1:
This work package has achieved significant progress in the process of transformation from a cleanroom laboratory environment to a certified manufacturing pilot line for medical devices. Internal business processes like program management, procurement, supply chain management, product life cycle maintenance, product verification, sales and marketing etc. have been professionalized and strengthened. The operational focus in the cleanroom has shifted from setting up the procedures and systems for SPC, MES and ISO13485 to actual implementation, rigorous deployment and training. Next to this, an integrated method for equipment status registration has been developed and implemented. In the technical domain, initial development flowcharts have been introduced for polymer processing and plans are being developed for the industrialization of the polymer process modules, all closely aligned with the needs of the InForMed partners.
Work Package 2:
The focus in the assembly line on new process modules for medical devices has resulted in the successful implementation and release of polymer coating and adhesives printing. These have already proven their value by helping realizing some of the demonstrators in work package 5. Work is continuing with die handling in the assembly line and building guide wire competencies in the catheter line.
A new Product Data Management system has been configured and implemented. Robust procedures for stage gating of process development in relation to product development and project management have been defined and implemented.
These are essential prerequisites to be able to satisfy the requirements for the manufacturing of medical components.
Work Package 3:
In this work package, the technology transfer methodology is developed further. The methodology is validated in the innovation tracks related to demonstrator 2 and demonstrator 4. Within the framework of the PhD+ programme, in a much earlier phase than normally would be the case in academic research, industrial insights are taking into account when making technical choices. This has resulted in early adaptations to the flowcharts based on insights with respect to manufacturability and is expected to significantly smoothen the transfer, which will take place in the third year of InForMed. In addition, steps in infrastructure alignment have been made in the reporting period, which are expected to be beneficial to an efficient technology transfer.
Validation of applying the transfer methodology from pilot line to volume manufacturing and from foundry to foundry is ongoing and will be completed shortly.
Work Package 4:
In this work package dedicated to the demonstrators D1, D2 and D3, significant progress has been achieved in the first two. Demonstrator 1 has shown strong collaboration between the involved partners, resulting in significant progress towards the working demo of an ablation catheter with optical shape sensing and with ablation monitoring. Furthermore, integration of optical shape sensing in the Cath. Lab has been shown, a fully optically powered smart catheter has been demonstrated and the study on bio encapsulation has progressed significantly. In demonstrator 2, a new version of the Cytostretch chip with electrodes was successfully fabricated. Also packaging was developed, test setups prepared and first biocompatibility assay testing has started. Two different approaches to obtain a device for high-throughput electrophysiological measurements are being explored. In demonstrator 3, the aim was to prove that the direct conversion suppression was sufficient to allow for the anticipated advanced horizontal architecture of a spectral CT detector. All preparations for this assessment were completed, but lack of cooperation of Iszgro, responsible for the photo diode manufacturing, made it impossible to assess this in an objective way. Continuation of this demonstrator is under discussion after termination of the participation

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The InForMed pilot line and the demonstrator products that are being developed in the project will increase Europe’s innovative capacity in all medical markets that are related to the Electronic Components and Systems (ECS) industry. The products of the pilot line will help fighting the increasing healthcare cost and managing the aging European population and will help to develop the MEMS industry to broaden its scope in completely new markets and applications.
• The pre-competitive InForMed pilot line will bridge the gap between research and full scale exploitation by product demonstration and validation in an industrial setting, strengthening Europe’s innovation capabilities and creating economic and employment growth.
• The InForMed pilot line will be vital in:
- Consolidating Europe’s premier position in medical (diagnostic) equipment;
- Enabling emerging markets; e.g. in Smart Catheters;
- Stimulating entirely new markets; e.g. implantables, Organ-on-Chip.
• The InForMed pilot line, which encompasses microfabrication, extensive assembly facilities and even catheter fabrication, will be a shared facility open to other users, offering Europe unrestricted access to the consortium partners for the development of solutions for societal challenges.
• The microfabricated products of the pilot line will fuel an entire value chain in the market of medical equipment and systems.
• The InForMed pilot products that serve as demonstrators of the pilot line are innovative smart health solutions that address societal challenges in hospital, heuristic and home care.

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