Community Research and Development Information Service - CORDIS

H2020

InForMed Report Summary

Project ID: 662155
Funded under: H2020-EU.2.1.1.7.

Periodic Reporting for period 1 - InForMed (An integrated pilot line for micro-fabricated medical devices)

Reporting period: 2015-06-01 to 2016-05-31

Summary of the context and overall objectives of the project

The goal of the InForMed project is to establish an integrated pilot line for medical devices, covering the complete innovation chain from technology concept to system qualification. It will include micro-fabrication, assembly and even the fabrication of smart catheters.

The integrated pilot line will be uniquely hosted by a large industrial end-user. It is specifically targeted and equipped to bridge an existing gap in the landscape of micro-fabrication of medical devices. This gap is caused by the following characteristics of micro-fabricated medical devices:
• Their volume is, at least initially, too low to justify production in a standard foundry, but they nevertheless initiate vital value chains in in-vitro/in-vivo diagnostics, imaging and therapy;
• They cannot be fabricated in the cleanrooms of universities and or other institutes, because these lack the required quality instruments and ISO certifications for the fabrication of medical devices;
• They require capabilities that are new in micro-fabrication, such as the processing of biocompatible polymers and other materials.

At the heart of this chain is the micro-fabrication and assembly facility of Philips Innovation Services (PInS) - formerly known as MiPlaza - which will be qualified for small/medium-scale production of medical devices. The pilot facility will be open to other users for pilot production and product validation on a normal commercial base. The demonstrators products defined in the InForMed will link the pilot line to European:
• Research institutes and universities for concept creation;
• Foundries for mass production of validated products;
• Technology partners who complement the competences of the pilot line to avoid unnecessary duplication.

The reason for Philips to take the unprecedented initiative to establish a shared micro-fabrication infrastructure is not only to safeguard its own 4 billion euro turnover business in medical diagnostic equipment, but also to create an environment and eco-system where new medical devices can be seeded and nurtured to grow into new business opportunities for Europe, in a time when there is a paradigm shift from large and expensive diagnostic machines towards small, disposable, minimally invasive and un-obtrusive diagnostic and therapeutic tools. It is the aim of the pilot line:
• To safeguard and consolidate Europe’s strong position in “traditional” medical diagnostic equipment with a pilot fabrication facility close to concept creation;
• To enable emerging markets, especially in smart minimally invasive instruments and point-of-care diagnostic equipment, by offering a fabrication facility for market demonstration and validation;
• To stimulate the development of entirely new markets, by providing an industrial micro-fabrication and assembly facility where new materials can be processed and assembled.

These three market segments are addressed by six demonstrator products which constitute an important part of the InForMed project. These demonstrator products are real products, linked to end-users such as manufacturers of medical therapeutic and diagnostic equipment. Next to the tasks related to the realisation of the demonstrator products, part of the work is reserved to define and explore roadmaps towards product innovation. Apart from being innovative products, the demonstrators additionally serve the following purposes:
• Test the pilot line in demonstrating and validating new medical devices in the different market segments covered by the demonstrator products;
• Test and demonstrate the protocols to be developed in the project for the efficient transfer of concepts from (academic) research to (pilot) production;
• To form manufacturing networks amongst expert groups in Europe to bring together the competences needed for the fabrication of these highly heterogeneous devices.

The demonstrators that are listed below address societal challenges in: “Hospital and Heuristic Care” and “Home care and well-being,” and demonstrate the trend towards “Smart Health” solutions:
1. A smart ablation catheter with ultra-sound ablation depth monitoring and revolutionary optical shape sensing technology for a more successful treatment of heart arrhythmia;
2. Novel devices for electrophysiology for the development of safer and better drugs;
3. Thin photo detectors and novel assembly technologies for spectral Computed Tomography (CT) which will allow for “color” X-ray pictures;
4. A revolutionary implantable steerable probe for Deep Brain Stimulation for a much more targeted treatment of Parkinson’s disease with strongly reduced side-effects;
5. A point of care cartridge for the early detection of “streptococcus pneumonia” bacteria for a faster and more effective treatment of pneumonia;
6. Smart body patches for: intelligent wound healing, unobtrusive heart monitoring, toxic gas screening and foot-pressure sensing.

The project consortium consists of 43 partners originating from 10 countries. The project is structured around the seven work packages listed below, whereby each demonstrator has its own task leader in order to create the delegated management structure required for the relatively large consortium:
• Micro-fabrication pilot-line set-up (WP1);
• Assembly and catheter pilot-line set-up (WP2);
• Linking the pilot line to research and high-volume production (WP3);
• Demonstrators I: “Hospital and Heuristic care” (WP4);
• Demonstrators II: “Home care and well-being” (WP5);
• Knowledge management: dissemination, exploitation, standardization (WP6);
• Project management (WP7).

The InForMed project will enhance the competitiveness of Europe in the rapidly emerging field of micro-fabricated medical devices, it will enable 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 will generate 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 central objective of the InForMed project is the establishment of an infrastructure dedicated to this task.

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

In the first year of InForMed a solid foundation has been laid for the objective to bring the Philips Innovation Services pilot-line to the quality level suitable for fabricating and validating micro-fabricated medical devices. In the micro-fabrication facility big progress has been achieved in the introduction of good manufacturing practices, like development and implementation of standardized SOP’s for all relevant equipment, in-line and off-line SPC, the use of risk analysis methods to determine Critical to Quality parameters for medical device flowcharts, procedures for equipment release and improvement and the implementation of a CAPA system. New equipment, compliant to pilot line requirements, has been invested. A software system for manufacturing execution (MES) has been installed and has been rolled out, already covering 80% of the active flowcharts. Qualification for ISO13485 has been achieved and the practical implementation is being improved and strengthened.
In the assembly line new medical device related processes are being installed: equipment for PDMS backend processing has been released and adhesive printing is being investigated successfully. A dedicated development group was formed to assist the micro-assembly pilot line and the associated competence strategy has been proposed. Product and process creation procedures are being defined and a PDM system is being configured. The quality requirements for a small-scale smart catheter pilot line have been defined and listed. This line has been tested by means of the development and realization of a concept catheter.

In most of the demonstrator projects specifications have been drawn up, working plans have been made and roles have been defined. In this process new connections between partners have been established and an improved understanding of mutual competences has been reached. This has been taken into account when defining the best design and/or architecture. In this way European strengths are being exploited in an optimal way. Subsequently testing the first concepts and processing has started in most demonstrators.
The program to improve the efficiency of the transfer of new concepts and technology to the pilot line is on track and has started with infrastructure alignment activities and the identification of critical process steps for the process flows of demonstrators 2 and 4 by joined university-industry teams.
Comparison of existing process development gating procedures and process transfer methodologies is ongoing and has led to an initial outline of a Technology Transfer Methodology from university to industry.
Within InForMed the PhD+ programme, which will bring academic research results faster to industry, is developed and being validated in demonstrators 2 and 4.

Next to the establishment of the InForMed pilot line, also the demonstrator project for developing a detector for spectral CT was defined in order to safeguard Philips’ and Europe’s prominent position in existing medical diagnostic equipment. The technological concepts for this demonstrator were identified and architectural choices have been made. A plan to realize the most promising concepts, making use of the capabilities at the different partners which together establish a European pilot line, was made and wafer processing has started.

In order to enable the fabrication of new (catheter and implantable) devices, two demonstrator projects serve as carrier projects to define the new F2R (flex-to-rigid) platform technology which will become available in the pilot line. These projects require the integration of diverse capabilities from several European expert groups that are participating in the InForMed consortium. Designs have been agreed taking into account the boundary conditions from the different partners, masks ordered and for one of the projects first wafers have been processed.

The realization of the objective to stimulate the development and introduction of emerging technologies has several aspects.
Firstly, the link of industry to academia, where concept creation is taking place, is being strengthened by the work within InForMed on improved transfer methodologies and better technological alignment. In WP3 significant initial steps on alignment and transfer have been made.
Secondly the investment in new polymer technologies in the pilot line, which are very relevant for medical devices, enables new device concepts. The equipment for PDMS processing in the backend has been installed and released, in the micro-fabrication pilot line new process modules for advanced polymer processing are being defined.
Thirdly, challenging demonstrator projects that require the use of new technologies serve as catalyst to develop these emerging technologies. The three projects in InForMed that are relevant for this purpose have completed their specifications and have started processing.

The objective to help keeping the cost of healthcare and the aging society manageable is being served by the generation of platform technologies which will become available in the pilot line and which will be used in societal relevant demonstrators. The first building blocks for this objective have been put in place in this first year of InForMed.

Work Package 7 Project Management:
Project management guidelines have been established and published on the project internal SharePoint (as the central project management information system), including quality assurance, governance, publications, meetings, calendar, information and communication etc.

Plenary Technical Workshops have been organized on overall project level, including a kick-off meeting. Monthly Project Management Board meetings have been organized.

All deliverables and milestones due for the reporting period have been achieved. Due to funding problems in Spain, few deliverable are delayed. For this reason a change reuest is in preparation. No other further delays foreseen.

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 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 micro-fabrication, 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 solutions for societal challenges.
The micro-fabricated 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.

The InForMed pilot line and the demonstrator products that will be 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.

Expected potential impact is to Increase Europe’s innovation capacity in medical markets
The micro-fabricated devices that will be fabricated in the InForMed pilot-line will find their way into the heart of almost all medical equipment. They are the key components that determine the overall quality of the complete system, but they also enable an entire ECS industry in medical tools. The InForMed project will be vital for:
• Safeguarding traditional markets by consolidating Europe’s premier position in medical (diagnostic) equipment, which for Philips Medical Systems alone represents a 4 billion euro market.
• Enabling emerging markets; e.g. in Image guided Interventional therapies and point-of-care diagnostics
• Stimulating new markets and business opportunities in upcoming new segments; e.g. implantables, electroceuticals, organ-on-a-chip and smart body patches.

Fighting healthcare costs and managing the aging European population
The key items in fighting healthcare costs are:
• Better and faster diagnosis;
• More effective and less invasive treatment and interventions with cost-effective and mass producible instruments;
• Reduced hospitalization and keeping elderly people longer in their home environment while reducing the need for intensive personal care.
More than any other industry, micro-fabrication has mastered the skill of fabricating complex devices and systems in very high volumes at high yield and at extremely low cost. The InForMed pilot line, qualified for micro-fabrication and assembly of medical devices, addresses exactly this goal: it provides the ideal infrastructure for pilot fabrication and validation of many innovative medical products that will deliver better medical service at lower cost.
In section 2.1.3 of this proposal, the relation of the demonstrator products with the more general challenge to provide better healthcare at reduced cost will be discussed and analysed in detail.

Develop the MEMS industry towards new applications and markets
The world market for MEMS in 2012 was $ 2.9 billion, which is predicted to increase to more than $ 8 billion in 2018, with the largest share in medical-oriented devices ($ 5.8 billion) . It is expected that this number will be significantly higher in reality, since the larger industrial players in this field will not disclose their production statistics and plans for the development of new key technologies that play an enabling role in their innovation roadmaps. The diagram below shows the market forecast for existing MEMS devices for Europe for the coming five years, split out by application. The trends are based on the existing markets for pressure sensors and flow sensors (blood, respiratory and kidney dialysis), microphones (hearing aids), gyroscopes (pacemakers and human motion detection), IR temperature sensors (in-ear thermometers), and microfluidics. Microfluidics is a special case, because its volume is determined for a dominant part on glass processing and plastic injection moulding, but it does represent a large volume and turnover (50%).

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