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An integrated pilot line for micro-fabricated medical devices

Periodic Reporting for period 3 - InForMed (An integrated pilot line for micro-fabricated medical devices)

Reporting period: 2017-06-01 to 2018-09-30

Within the InForMed project, a European wide pilot line for medical devices has been established, centred around the facilities of Philips Innovation Services.

Transition in healthcare
The healthcare 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. The InForMed project has enabled innovation in medical equipment and instruments.

Fighting healthcare cost
One of the driving forces in the development of new medical instruments and techniques is the desire “to offer better and affordable health care and health cure, both in hospitals and homes” (ECSEL Multi-Annual Strategic Plan, 2014). Microfabrication can help to offer a better treatment at lower cost in hospital, home and heuristic care. As no other, the microfabrication and electronics industry has mastered the skill of cost reduction by miniaturization and parallel wafer-scale processing. This places it in an excellent position to lead in this highly relevant and emerging field of medical devices.
A pilot line for the future
In the InForMed project, a pilot line infrastructure has been established, suitable for the manufacturing of these medical devices, so that they can be demonstrated and validated by the market until they reach volumes that justify a transfer to high-volume foundries.
Uniquely one of the largest manufacturers of medical instruments, Philips Electronics, hosts the pilot line. The pilot line is part of Philips Innovation Services and is shared with third party users. The pilot line consists of three facilities:
- A 2650 m2 microfabrication cleanroom;
- An extensive micro-assembly facility;
- A pilot catheter fabrication line.
These three components together offer a complete fabrication chain from silicon wafer to system.
Typically, microfabricated medical devices consist of a number different components, all made in specialized technologies, like: CMOS, sensor technologies and micro-fluidics. These different components are combined using advanced assembly techniques to form truly heterogeneous systems. The InForMed project has brought together industrial and academic experts so that the extensive capabilities available in Europe needed to realize these systems are utilized and aligned in the most efficient way.

Bridging valley of death
The pilot line is available for other industrial users who require a microfabrication facility in an industrial setting for the pilot fabrication of their medical devices. This service allows them to develop, demonstrate and validate their products in the market, thereby bridging “the valley of death” between concept creation and high volume manufacturing. The demonstrator products that have been developed in the context of this project, have illustrated that the pilot line is also explicitly open for SME’s.
The InForMed pilot line allows for validation of micro-fabricated medical devices in the market and for further tuning until they can be transferred to volume foundries and contract manufacturers. It is a crucial instrument in safeguarding Europe’s premier league position in medical equipment and tools. It allows for opening of new markets with the overarching goal to create growth in Europe’s smart health industry in its broadest sense, and for helping to reduce the cost of healthcare and keeping the aging society manageable.

Pilot line validation
The pilot line has been tested and its value has been proven with the realization of several demonstrator products. Both with the pilot line itself and with the demonstrator products, Europe’s innovative capacity in the medical markets that are related to the Electronic Components and Systems (ECS) industry has been increased considerably.
The products of the pilot line that have been realized during the runtime of the project but also future products, of which realization will be enabled by the pilot line, will help fighting the increasing healthcare cost and managing the aging European population. From a technological perspective, it will also will help to develop the MEMS industry to broaden its scope in completely new markets and applications.
This InForMed integrated pilot line– incorporating the complete innovation chain for the development and manufacturing of micro fabricated medical devices, to our knowledge is the first one of this kind in the industry.
Project outcome
The InForMed project has enhanced the competitiveness of Europe in the rapidly emerging field of micro fabricated medical devices. It is vital in consolidating the 4 billion euro turnover business in medical diagnostic and imaging equipment of Philips, the host of the pilot line. Because Philips offers the pilot line as a shared facility, it enables the further development of the European R&D and manufacturing capability in an extremely innovative industrial segment with a high economic importance, not only encompassing the micro fabricated device itself, but also the various value chains that they enable.
As a result, the project has generated and will keep on generating societal benefits. The ageing population and the increasing costs of healthcare constitute a major global challenge. Potential technology solutions are being developed by multidisciplinary efforts in medicine, biology, physics and engineering, but these can only be implemented successfully if the research results can be transferred to economically viable products. The establishment of an infrastructure dedicated to this task has been the central objective of the InForMed project:
- The pre-competitive InForMed pilot line has proven that it has the potential to bridge the gap between research and full scale exploitation by product demonstration and validation in an industrial setting. This strengthens Europe’s innovation capabilities and creates economic and employment growth.
- With this, the InForMed pilot line plays an important role in:
o Consolidating Europe’s premier position in medical (diagnostic) equipment
o Enabling emerging markets, like in Smart Catheters
o Stimulating entirely new markets, like in BioElectronics and Organ-on-Chip.
- The InForMed pilot line that has been established, encompassing both microfabrication and extensive assembly facilities, is a shared facility open to other users, offering access to European companies and institutes to develop solutions for societal challenges.
- The microfabricated products of the pilot line do not only have huge value on their own, but they fuel an entire value chain in the market of medical equipment and systems.
- The InForMed pilot products that have served 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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Timeline
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Demo overview
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