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Editorial

Creativity represents dynamism and growth in business and science Medical technology in Bavaria has a high degree of core competency. Innovative solutions and outstanding high-tech products are the result of a network that brings together the researcher, developer, manufacturer, supplier and service provider.

When can technology recognition and analysis processes be applied successfully? „Medical technology in Bavaria“ gives answers on current, interesting and innovative topics!

A sustainable and functioning health economy throws up many questions: What high-tech trends are to be expected in medical technology? When does the EU's new framework program „Horizon 2020“ for research and innovation enter into force?

Walter Fürst, Managing Director

This publication can also be found on the internet at www.media-mind.info

Masthead: Publisher:

media mind GmbH & Co. KG Volkartstr. 77 80636 Munich/Germany Phone: +49(0)89 / 23 55 57-3 Telefax: +49(0)89 / 23 55 57-47 ISDN (MAC): +49(0)89 / 23 55 57-59 E-mail: mail@media-mind.info www.media-mind.info

Managing director:

Walter Fürst, Jürgen Bauernschmitt

Design + DTP:

Jürgen Bauernschmitt

Prepress:

media mind GmbH & Co. KG

Responsible editor:

Ilse Schallwegg

Published annually:

1 x annually

What are the focal points of research in medical technology? What is the significance of active implants in modern medicine? Where can you find a compact assistance system for better workflow and simplified work in surgery? How do „intelligent textiles“ help with movement disorders?

Printed by: Druckerei Frischmann, Amberg © 2012/2013 by media mind GmbH & Co. KG No part of this magazine may be stored, copied or reproduced without the written consent of the editorial office


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novel.de Editorial

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BAYERN INTERNATIONAL Summary Dr. Siegfried Balleis Forum MedTech Pharma e.V. Temperature Management seiratherm GmbH Bavarian Research Alliance (BayFOR)

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EU research funding for the Medtech industry Contact: Dr. rer. nat. Iana Parvanova Bavarian Research Alliance (BayFOR) GmbH

Health region

Mainfranken

Fraunhofer IIS

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Medical Engineering Research at Fraunhofer IIS Contact: Dipl.-Inf. Christian Weigand Fraunhofer Institute for integrated Circuits IIS

Implants

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Table of contents

A Technology Platform for Diagnostic and Therapeutic Implants Contact: Prof. Dr. rer. nat. Bernhard Wolf Dr.-Ing. Johannes Clauss

TÜV SÜD Akademie

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The Rocky Road to the Market Contact: Birgit Klusmeier, Anita Lenzser TÜV SÜD Akademie GmbH

TRUMPF Medizin Systeme

GmbH + Co. KG

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Small system – big benefits Author: Dr.-Ing. Maximilian Krinninger TRUMPF Medizin Systeme GmbH + Co. KG

Progress through Division of Labour HOLZAMMER Kunststofftechnik GmbH

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senetics

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healthcare

Contract development – Consulting – Communication agency Author: Dr. Wolfgang Sening; Mitautor: Christoph Elbert senetics – Scientific institute for Innovation and consulting


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BAYERN INNOVATIV

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Successful Patent and Legal Protection VEERENIGDE

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Intelligent

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Textiles

Intelligent Textiles support in Treating Movement Disorders Authors: Dr.-Ing. Lorenzo T. D’Angelo, Yan Zhao, M. Sc., Houde Dai, M.Sc., Prof. Dr. Tim C. Lüth

Medical Valley EMN

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Methods of technology detection and evaluation Author: Charlotte Niederländer, Interdisciplinary Centre for Health Technology Assessment (HTA), Erlangen

Laser safety DUALIS

LASERVISION GmbH & Co. KG

MedTech GmbH

41 42

Intelligent,Wireless Implants Author: Julia Lorenz, Product Management DUALIS MedTech GmbH

Advert Verein zur Förderung chinesischer Waisenkinder e.V.

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Schleifring

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GigaCAP®-HD

KoKeTT

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KoKeTT – Mechatronic systems developed at the Hochschule Kempten Contact: Prof. Dr.-Ing. P. Friedrich, Univ.-Prof. Dr. rer. nat. B. Wolf, M.Sc. M. Häcker, Dipl.-Ing. K.-U. Hinderer

Biersack Technologie Software company

GmbH & Co. KG

ASTRUM IT

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Neonatology Medin Medical Innovations GmbH

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Laser Welding Systems LPKF Laser & Electronics AG

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I-Motion GmbH Patient Management Software

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Business Location

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Bavaria

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Bayerische Forschungsallianz GmbH media mind GmbH & Co. KG

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Erlangen: a driving force in healthcare land Bavaria Now it‘s official: Erlangen is a “Healthcare Region of Bavaria”. Minister of State Marcel Huber presented the seal of quality in May of this year at a press gathering held at city hall, in recognition of the unique competence that Erlangen and the region have in the field of healthcare engineering and, in particular, also telemedicine. Medical engineering has been our declared competence for many years. It is where we see the future of our city, and very successfully, too. This is borne out not only by the latest award but, above all, by our success in the Germany-wide Clusters of Excellence Competition 2010, which is giving business in the region a real boost. With 40 million euros of federal backing, the region is busily working on effective and efficient solutions for optimum healthcare that improves the wellbeing of patients while keeping the healthcare system affordable. For the first time in its history, the City of Erlangen has exceeded the “magic one-hundred-thousand mark” for jobs: 100,500 people in gainful employment – for a population of just under 106,000. It almost goes without saying that the largest proportion of new jobs are in healthcare and medical engineering. The development of business is supported by a very creative network of companies, academic institutions, politics, and citizens.

On the academic side, the Central Institute of Healthcare Engineering at the FriedrichAlexander-University of Erlangen-Nuremberg plays a central role. The institute founded in 2009 acts as an interface between the university with 68 chairs having a research focus in medical engineering and the relevant industrial companies, and provides an excellent platform for connecting top research and teaching with the work of established companies and recent start-ups. This is also the main thrust of the new bachelor‘s and master‘s programmes in healthcare engineering which were worked out in close co-operation with the high-tech businesses in the region and are very much in demand. In particular, their highly interdisciplinary nature and the combination of basic engineering training, a solid theoretical foundation and direct application in a clinical environment are important unique selling points of the new degree programmes. Come and visit us in the Medical Valley European Metropolitan Region Nuremberg and see our unique dynamism in healthcare for yourself your

Dr. Siegfried Balleis Mayor of the City of Erlangen


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Review Congress MedTech Pharma2012 Hightech-Trends from Medical Technology and Pharma BMBF-Symposium 'Medi-WING' as an integral part of the programme More than 900 participants and 120 exhibitors from 17 countries in Nuremberg Medical technology is an innovative high-tech sector, currently producing new developments for even gentler and even more targeted therapies for patients and to improve efficiency in health care. Planned and organized by Forum MedTech Pharma e. V. and Bayern Innovativ GmbH, the congress brought together more than 900 participants from 17 countries. The international congress with strong scientific participation has become one of the most important events in the healthcare industry. At the opening Bavaria‘s Science Minister Dr. Wolfgang Heubisch emphasized in a video interview with Prof. Dr. Josef Nassauer the importance of the Congress as a

A very successful congress for Organizers and participants: "MedTech Pharma2012 Medizin Innovativ" (Foto: Mauer/Bayern Innovativ GmbH)

platform for researchers, developers, manufacturers, suppliers, service providers and clinical users. 65 speeches/lectures in the plenary session, in three parallel

Concentrated information mediated by talks and the exhibition (Foto: Mauer/Bayern Innovativ GmbH)

series and one workshop gave a very informative overview of the latest developments. The Symposium „MediWING“ of the Federal Ministry of Education and Research (BMBF) added two further theme series to the congress. Emphasis was on the collaboration with the Federal Ministry of Education and Research (BMBF), whose Symposium Medi-WING was again an integral part of the programme. Three of the BMBF Leading Edge Clusters were actively involved as partners of the congress: the m4 Munich biotech cluster, the Medical Valley EMN and MicroTec Südwest.


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Efficient Health Care The plenary session focused on efficient health care. Innovative medical technology helps to reduce healthcare costs and improve efficiency in health care. Trends such as personalized medicine in the pharmaceutical sector, system convergence or complete provider on the provider side must be examined closely and their effects must be evaluated by intensive secondary research. Despite all of these discussions the patients‘ benefit should not be ignored, stated Prof. Dr. Michael Nerlich, Head of Trauma Surgery, University Hospital Regensburg and CEO, Forum MedTech Pharma. Minimally Invasive Surgery (MIS) and Endoscopy Surgical advances are now indivisibly linked to innovation in Minimally Invasive Surgery (MIS) and endoscopy. Minimally invasive surgical procedures, partly through natural orifices (NOTES), protect patients and reduce treatment costs. Miniature cameras with excellent image quality support endoscopic procedures. Neuro-endoscopes, for example made by Karl Storz GmbH, improve clearly the quality of brain tumor operations. According to Dr. Anthony Kalloo of Johns Hopkins Hospital in Baltimore, these techniques have great future potential. Microelectronics and microsystems are also innovative technology drivers. Smart Medical Devices Smart Medical Devices support violated body functions, such

Prof. Michael Nerlich

Prof. Dr. Aldo R. Boccaccini

Prof. Dr. Anthony Kalloo

Prof. Yoshiyuki Sankai

as cochlear implants, which can restore the impaired auditory perception in the inner ear or retinal implants that can restore sight of amaurotics again. New ways are also brain stimulation for the treatment of diseases such as Parkinson's and multiple sclerosis or spinal cord stimulation for pain or incontinence. Biomaterials In an aging society, the attrition of joints, bones and cartilage increases strongly. That‘s why cell-based biomaterials for the reconstruction of tissues become more and more important, Prof. Aldo Boccaccini, Universi-

In the plenum's focus: efficient healthcare (Foto: Mauer/Bayern Innovativ GmbH)

ty of Erlangen, explained. He gave an overview of promising regenerative treatments such as transplanting autologous tissues or the production of silk textile implants. Diagnostics Miniaturization, ease of use and rapid results are also trends in Diagnostics. The diagnosis at the „Point of Care“ (POC) is a technique that allows testing of body fluids without further sample preparation outside of a central laboratory. POC tests provide faster diagnoses and collect essential vital signs – independent of the location.


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Regulatory Affairs and Reimbursement A workshop on regulatory affairs and reimbursement completed the program. More than 100 exhibitors presented innovative products at an associated exhibition and 25 scientists presented their research projects in a poster exhibition. Congress highlight One of the congress highlights was the official reception at the Kaiserburg Nürnberg (Nuremberg Imperial Castle) at the

Official reception

Targeted Therapies The series “Targeted Therapies” showed impressively promising strategies of tumor treating. Novel drugs target at specific features of cancer tissue to protect the healthy tissue. New diagnostic techniques allow individual targeted therapies. Future Hospital Digitization has revolutionized the processes in therapy and care, especially in hospitals, via digital management systems,

highly developed imaging techniques, new surgical techniques, personalized medicine, point-of-care testing or telemedicine. It is possible to improve patient care and reduce costs. In the talk line “Future Hospital” Prof. Yoshiyuki Sankai, University of Tsukuba, Japan, showed the futuristic robot suit HAL (Hybrid Assistive Limb), that is controlled by brain signals and enables immobile or very severely impaired patients amazing success in rehabilitation.

Exhibition

first day‘s evening in the presence of Dr. Thomas Bauer, President of the Government of Middle Franconia. Author:

Dipl.-Biol. Andrea Gerber

Forum MedTech Pharma e.V. Office:

Guided Tour with Journalists

Dr. Thomas Feigl Gewerbemuseumsplatz 2 90403 Nürnberg/Germany Phone: +49 911 - 20671 330 Fax: +49 911 - 20671 788 info@medtech-pharma.de www.medtech-pharma.de


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Personalized Temperature Control and Volume Management with Tempedy

Therapeutic hypothermia can influence life-sustaining body functions being an essential factor in the treatment of patients. Predominantly, the mortality of cardiac arrest or apoplectic stroke seems to be reduced by cooling down the body temperature. During long surgeries, however, the warming of the patient can prevent thermal loss and thereby severe complications. Moreover body temperature regulation is applied in intensive care for example in the treatment of injuries, neurosurgery or septicemia. Nevertheless, this useful procedure has its limits. Up to now, the methods used for cooling and warming the patient are lacking effectiveness, because cool packs or warm treatments are applied on the body surface. For improvement, the body core temperature shall be influenced directly. TEMPEDY, a system invented and developed by Seiratherm GmbH, is a solution for the problems of the

Any emergency unit, any emergency room, any stroke unit or any hospital ward can use tempedy. It is flexible and mobile so it can also be used outside the clinic on intensive care transports by air or overland.

Normothermia during surgery may prevent complications

From June 2013 tempedy is available for you and your patients for individualized temperature and volume control!

existing procedures. Tempedy is a noninvasive and exact method to influence the body core temperature. It is using a venous line and infusion liquid which usually already established in the patient. To lower, hold or raise the patient‘s core temperature efficiently tempedy infuses the cooled or warmed solution in a controlled and precise process. Tempedy combines the temperature adjustment with an integrated volume management that meets even high clinical requirements.

Contact: Dr. med. Marc Baenkler CEO

This personalized temperature and volume management is worldwide unique. The administration of tempedy is relatively simple. Therefore the application in many different departments is possible and no longer restricted to intensive care units.

seiratherm GmbH BeethovenstraĂ&#x;e 10 91074 Herzogenaurach/Germany Phone: +49 (0) 89 5484 268-0 E-mail: marc.baenkler@seiratherm.de

Temperature Management

The regulation of body core temperature has been a well-established treatment strategy in medicine for the last decades. It has been made standard practice in various fields.


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Bavarian Research Alliance (BayFOR) GmbH

EU research funding for the Medtech industry In 2007 the European Commission (EC) launched the Seventh Framework Programme (FP7), which currently represents the largest research funding programme in the world with an overall budget of around Euro 53 billion. With the start of the new framework programme for research and innovation, ‚Horizon 2020‘, scheduled for 2014, FP7 is now entering its final phase. The final call for submission of project proposals under FP7 was published by the EC on July 10th 2012. In this round, a record budget of around Euro 838 million is allocated to R&D projects in the “Health” programme. This is the last opportunity for Bavarian players to submit proposals and to apply for FP7 funding as the next round of calls is unlikely to start until the beginning of 2014. Importantly, not only universities and research institutions can submit proposals but companies are also encouraged to present innovative project ideas. For small and mediumsized enterprises (SMEs) in particular, a variety of funding oppor-

The international network of science and business is one of the hallmarks of European research funding programmes

A total budget of around Euro 615 million is available for the final round of calls within the NMP programme. With regard to medical technology of particular interest are research projects in the field of nanotechnology and nanosciences aiming at improving health (biomaterials) and developing new diagnostic tools and treatment strategies for Europe.

SME participation is highly encouraged tunities in different areas exist. Amongst these, several calls for proposals in the field of medical technology have been published. The Bavarian Research Alliance (BayFOR) provides information about the current funding opportunities arising for Bavarian scientists and entrepreneurs.

Areas of relevance for the Medtech industry, “Health” and “New Materials” The EC has anchored medical technology research in two major areas of FP7, “Health” and “Nanosciences, nanotechnologies, materials and new production technologies (NMP)”. The focus of the Health programme is on translational research, i.e. the transfer of basic research results into clinical practice, as well as development and validation of new therapeutic applications, diagnostic tools and technologies, health promotion and prevention strategies.

Ideally, research proposals should address cutting-edge research questions, find solutions for these questions, and have a clear benefit for the European population. Moreover, the EU aims to strengthen European SMEs by making it easier for them to participate in European funding programmes. Thus, participation of partners from industry is not only desirable and in some cases even mandatory but also increases the chances to receive funding considerably. In ‚Horizon 2020‘ supporting and encouraging SME participation will be one of the key aims. This could represent a clear advantage for universities of applied sciences as they are generally well connected to industry. Another focus of FP7 is on improving the coordination of national and regional research funding programmes through specific instruments known as ERA-NETs. In this context the EuroTransBio initiative is of particular interest for SMEs. Calls for proposals in this initiative have a bottom-up


Bavarian Research Alliance (BayFOR) GmbH approach, i.e. no restriction on the research topic, and support transnational applied R&D projects between academia and SMEs in the field of biotechnology. Through ERA-NET projects, the EU aims to better coordinate, connect, and group together the technological strengths and financial resources of the companies involved. Similarly, EUREKA Eurostars also has a bottom-up approach and promotes transnational initiatives supporting SMEs in the development of innovative products and processes.

Ways to a successful EU project The large variety of available funding opportunities could confront potential applicants with a complex task as identifying a suitable funding programme and writing a successful proposal requires pro-

Advances in imaging methods are one of the EU‘s key aspects

found expertise. In this regard, the Bavarian Research Alliance could provide extensive assistance to key Bavarian players from academic science and industry. Supported by the Bavarian State Ministry of Sciences, Research and the Arts, BayFOR provides information about different funding programmes and offers training courses. Moreover, BayFOR supports the initial stages of the

proposal design as well as the proposal writing and assists the setting up of international consortia.

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Efficient assistance in international project initiation: The Bavarian University Funding Programme In 2012 the Bavarian State Ministry of Sciences, Research and the Arts launched the new ‚Bavarian University Funding Programme for the Initiation of International Projects‘ to promote cooperation projects between scientists at public Bavarian universities and international research institutions. This funding programme is designed to establish promising international research cooperations and offers grants for travel and subsistence. By providing support in the initial phase of international cooperation projects this funding programme closes a currently existing gap in the funding system. Thus, it enables researchers to exchange ideas and expertise in person and advance their work more efficiently. BayFOR has been commissioned with the handling of this new funding programme. Further information: www.bayfor.org/bayerisches-hochschulfoerderprogramm

Upon successful evaluation, BayFOR can also assist with contract negotiations with the EC and if required provides support with project management and dissemination of results throughout the project. BayFOR has an excellent network at the regional and international level. Its EU Liaison Office in Brussels represents the interests of Bavarian universities, increases their visibility and provides contacts to relevant actors in the European institutions. Moreover, BayFOR coordinates the joint activities of the Bavarian Research Cooperations and supports the expansion of their networks at the European level. Furthermore, the Scientific Coordination Office Bavaria-Québec/ Alberta/International supports bilateral research projects in these regions and develops such initiatives further in the context of European research funding. As a partner in the Enterprise Europe Network (EEN), BayFOR also provides targeted advisory services for SMEs interested in participating in EU research projects or wishing to cooperate with other companies across national borders. In the Bavarian ‚Haus der Forschung‘ (House of Research) BayFOR works closely with Bayern Innovativ GmbH, the ‚Innovations- und Technologiezentrum Bayern‘ (Bavarian Centre for Innovation and Technology, ITZB), and the ‚Bayerische For-

schungsstiftung‘ (Bavarian Research Foundation, BFS). Together, these four partners are able to cover all aspects of research and technology funding on a regional, national and European level and offer a comprehensive range of services. Links: www.bayfor.org www.hausderforschung.bayern.de Official FP7 website: http://cordis.europa.eu/fp7/home_de. html Horizon 2020 – the new framework programme for research and innovation: http://ec.europa.eu/research/ horizon2020/

Contact:

Dr. rer. nat. Iana Parvanova Head of Unit Health research & Biotechnology

Bavarian Research Alliance (BayFOR) GmbH Prinzregentenstr. 52 80538 Munich/Germany Phone: +49 (0)89 - 9901888-150 E-mail: parvanova@bayfor.org www.bayfor.org


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Health region Mainfranken

The different segments of the health economy are highly potent growth markets that will decisively characterise our future. A whole palette of first-class players and optimal framework conditions form the basis for successful innovations from Mainfranken. In recent years Mainfranken has developed especially dynamically

Mainfranken

Top-class research and all-round service provision at the University Clinic of Würzburg

Medical research and development with tradition behind it – In 1895 W. C. Röntgen discovered the radiation named after him at the University of Würzburg

in the key technologies of biotechnology and medical technology. The excellent academic environment, the proximity to the university, higher education institutes and university clinics, many successful traditional companies and innovative start-ups are the basis for this success. In the Bavarian spa region Rhön – which, as well as Germany’s most famous spa location, Bad Kissingen, contains four other traditional spas – the latest therapy, spa and rehabilitation procedures are conducted.

Top biomedicine research The core of the university research is formed by the faculties of medicine, biology, physics and chemistry and pharmacy at the prestigious University of Würzburg. 25 institutes and research centres conduct research in the medical and human-biological field as well as in eight special research areas, for example the Biocentre, an interdisciplinary centre made up of 14 university chairs. The Rudolf-Virchow Centre for Experimental Biomedicine, the DFG Research Centre, do top-class


Mainfranken

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IGZ Würzburg The innovation and founder centre for biotechnology and biomedicine offers fully fitted laboratories, technical facilities and proximity to the University of Würzburg.

World-leading medical technology - Dialysis devices from Fresenius Medical Care

research in the field of key proteins. Fraunhofer ISC, Life Science division, does research and development particularly in the future fields „Biohybrid Materials“ as well as „Individualised Diagnosis“ and boasts many years of excellent experience in the dental materials field. The University of Applied Sciences Würzburg-Schweinfurt enhances the regional competencies with application-related courses and research projects in the field of medical technology.

World-leading medical technology Mainfranken is home to many innovative companies with worldleading medical technology. Regional strengths lie in the fields of dialysis technology, lung function diagnosis and magnetic resonance technology: Fresenius Medical Care, Schweinfurt: Central production location for dialysis devices; CareFusion, Höchberg; Ganshorn Medizin Electronic, Niederlauer and ZAN Messgeräte, Oberthulba: Lung function/cardio-respiratory diagnosis; SKF Linearsysteme, Schweinfurt: Roller bearings, components and

systems for medical technology; Rapid Biomedical, Rimpar: Highfrequency coils for MR imaging.

Health region faces up to the competition Under the leadership of Prof. Dr. Christoph Reiners, medical director of the University Clinic of Würzburg, and District Administrator Thomas Bold, a regional specialist forum founded at the end of 2011 is pursuing the objective of actively and positively shaping developments in the Mainfranken health economy through a strategy applying to the whole region. In this, the focus currently is on the implementation of medical care projects in the regional area, the use of telemedicine, the development of offerings for operational health management and the networking of education and training offerings. In addition, Mainfranken offers a versatile and attractive range of relocation opportunities – depending on size, aim and medical focus. Locally, there are state-ofthe-art Founder and Innovation Centres available, specially designed for the needs of those starting up medical and biotech companies:

RSG in Bad Kissingen Alongside ideal office and laboratory space, the Rhön-Saale Gründerzentrum offers a versatile training program in the health business field. Other relocation options offer high-quality commercial land and business parks in the best locations with optimal price-performance ratios. Contact:

Theresia Oettle-Schnell Project director

Region Mainfranken GmbH Ludwigstraße 10 1/2 97070 Würzburg Germany Phone: 0931-452652-12 Fax: 0931-452652-20 info@mainfranken.org www.mainfranken.org


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Medical Engineering Research at Fraunhofer IIS

Fraunhofer IIS

The Department of Image Processing and Medical Engineering at the Fraunhofer Institute for Integrated Circuits IIS centers its work on medical image processing, vital signs sensing, biosignal processing and medical data communication, with a focus on communication protocols. Using its expertise in these areas to provide R&D services to industry, the department contributes to innovation in medical products. Accompanying tests and trials are conducted by the associated METEAN Medical Technology Test and Demonstration Center in collaboration with Erlangen University Hospitals.

In the area of medical image processing, the department develops solutions for image-based medical, biological or pharmacological analysis. An important part of our work is concerned with supporting doctors in diagnosis as well as with computer-assisted early tumor detection and therapy. We also develop methods and systems for analysis of microscopy image data in pathology, general laboratory medicine and hematology as well as microbiology. To this end, the department carries out research into new methods for segmentation and analysis of multimodal cell images. The HemaCAMÂŽ system, which has been developed for use in hematology laboratories, makes it easier to perform differential blood counts. The system has been certified as an in vitro diagnostic device and is already being used in clinical practice. It is constantly enhanced and is distributed by our industry partners Horn Imaging and Horiba Medical. In addition, we pursue research into topics such as detection of malaria-causing microor-

HemaCAMÂŽ: Computer-aided microscopy for hematology

ganisms in blood cells or automated analysis of bone marrow cells. The emphasis of this work is on development of algorithms for reliable detection, segmentation and classification of cells as well as on integration with easy-to-use microscopy systems. While the use of endoscopic procedures for diagnosis and minimally invasive surgery offers many benefits to the patient, it hinders doctors‘ perception, spatial orientation and freedom of movement. By

contrast, orientation and navigation inside the body is aided by sensorbased image correction systems and real-time panoramic imaging, which provides wider fields of view. Camera-based monitoring and control systems facilitate partly automated surgical procedures. In the area of medical data communication and sensing, a major research interest is in wearable sensing units for mobile acquisition of vital signs and motion data. Our successful development work


Fraunhofer IIS helps improve healthcare both in hospitals and in mobile everyday life. Used as health monitoring systems, our solutions enable older people to live independently in their own homes for longer. The intelligent sensor units we have developed make it possible to collect physiological signals from a patient or user and then to process and analyze it using algorithms. Equipped with RF modules, the units are able to wirelessly transmit measurement data, for instance to a smartphone, which can then forward the information to a telemedicine service provider, thus creating an extended, mobile version of the classic home medical alert system. For inconspicuous everyday use and comfortable wear, the sensors can be embedded in clothing. Our sensors facilitate care for high-risk patients, but can equally be utilized to support firefighters and other emergency responders in dangerous environments. Further uses include mobile exercise testing as well sports and leisure applications. With regard to biosignal analysis, our main objectives are to ensure optimum signal processing under everyday conditions (e.g. by suppressing motion artifacts) and to enable the derivation of additional parameters (e.g. heart rate variability from an ECG). Besides classic

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Exercise monitoring systems for rehabilitation

biosignal processing, we also work on analysis and reconstruction of human motion based on accelerometer data. Solutions created to date range from automatic detection of falls and everyday types of movement (e.g. walking, running, cycling) to sensor-network-based reconstruction of complex movements for rehabilitation applications. Furthermore, we implement standardized medical communication protocols. The use of such protocols to achieve communication and interoperability between medical devices and applications is a key task in telemedicine and other areas. To ensure standardized

interoperability, we offer clientspecific implementations and test environments on a variety of platforms, supporting our clients from implementation on special embedded systems through to certification and trials in combination with other equipment. Our experience in medical data communication includes: HL7 POCT1-A, POCT1-A2 ISO/IEEE 11073 standards 11073-20601 Continua We will be happy to help you with any issues related to medical engineering, making our expertise available in the form of R&D services that will help you achieve your goals. For inquiries please contact:

Christian Weigand Head of the Department of Image Processing and Medical Engineering

Fraunhofer Institute for Integrated Circuits IIS

Mobile sensing and wireless communications

Am Wolfsmantel 33 91058 Erlangen/Germany Phone: 09131 / 776-7300 Mail:christian.weigand@iis.fraunhofer.de www.iis.fraunhofer.de/med www.metean.de


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A Technology Platform for Diagnostic and Therapeutic Implants

Implants

Active implant systems are playing a more and more important role in modern medicine – not only due to our increasing life expectancy. Such implants are increasingly used for obtaining important physiological information with a view to targeted therapy, or compensating for impaired body functions, with the so-called closed-loop systems providing a very promising approach. These systems use an active control unit to influence a patient’s physiological functions – e.g. by administering a drug - based on the vital parameters obtained by the system.

To this end, a technology platform for diagnostic and therapeutic implants was developed at the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik of Technische Universität München [1]. The main idea was to achieve various types of telematic implant solutions simply by employing different sensors and actuator units on the same platform. This platform comprises a system on the one hand that can be implanted in the human body, and a control unit on the other hand which is able to both wirelessly receive the measurement data and send control information data to the implant. Any type of sensor system can be used for capturing the prevailing parameters. The data are recorded by a microcontroller where signal processing and implementation of the control algorithms take place. It is possible to control an actuator system depending on the measured data and, in case of a disorder for example, to initiate

Fig. 1: Block diagram of the technology platform for active diagnostic and therapeutic implants of the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik

and control the topical administration of a drug. The implant sends the data to a control unit via a wireless connection, a process that consumes a minimal amount of energy. An intelligent power management system is used to minimise the energy consumption of the entire system. To test the technology platform, we chose an intelligent occlusal splint (SensoBiteTM System) for

the diagnosis and therapy of bruxism (teeth grinding) [2,3]. This wireless measuring system was developed at the Heinz NixdorfLehrstuhl and was financed by the „Exist-Seed Förderung“ funding programme of the Bundesministerium für Wirtschaft und Technologie. The system also takes all the relevant aspects as regards biocompatibility and marketing authorisation into consideration.


Implants

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Fig. 2: The intelligent occlusal splint used to test the technology platform for intelligent implants (left), and the complete system (right): occlusal splint (1); tactile biofeedback system (2); front-end computer (3)

Thanks to its small size, the device may be integrated into a conventional occlusal splint. The patient’s chewing activities are measured by means of a piezo-electric sensor system. A wireless radio transmitter sends the measured data to a receiver the size of a matchbox which can be placed at the patient’s bedside or may also be worn on the body. The receiver is able to store the data captured over a period of several months. Via a USB interface, the stored data can be transmitted to the computer of the physician. This system allows the bruxism activity to be monitored both

during the day and at night without disturbing the patient. Computer software allowing for analysis of the time, intensity and frequency of teeth grinding complements the system. Fig. 3 depicts the data measured from a subject during a threemonth trial period. Each bar reflects the frequency of the teeth grinding activity in one night. In the given patient, bruxism activity increased at the end of the month. An interview revealed that towards the end of every month the patient would suffer from occupational stress, thereby causing an increase in bruxism. As in this

example, the analysis software permits the individual causes of bruxism to be identified and personalised treatment options to be derived from the data acquired. In addition to using the system for diagnostic purposes, it can also prompt immediate tactile (vibration) or acoustic biofeedback via the receiver, thus serving treatment purposes. In the long run, the biofeedback stimulation will help to condition the patient and to reduce his/her bruxism activity. Using the intelligent splint, we were able to create a biocompatible and extremely energy-efficient microelectronic system that is suitable for use in the human body. Meanwhile, the SensoBiteTM system has been granted approval as a medical device. Based on the platform discussed in this article, it is possible to test and evaluate sensor and actuator applications for active implants without the need for surgery, i.e. complex procedures for implanting devices in the body. An implant system for monitoring dissolved oxygen levels [4,5], developed during the project „IntelliTUM“ which was funded by the Bundesministerium für Bildung und Forschung, has become one of the major uses for this technology platform. The saturation of tissues with dissolved

Fig. 3: Data suggesting increased bruxism activity may easily be identified on analysis of the data. Each bar corresponds to the teeth grinding activity of one single night (measuring period: April – July)


Implants

20 oxygen plays a leading role in invasive processes in malignant tumours, with the hypoxia (oxygen deficiency) found in many solid tumours correlating to tumour growth and sensitivity to radiation therapy. An amperometric planar oxygen sensor placed in the direct vicinity of such a tumour (or metastasic tumour) may detect increasing hypoxia and provide important information on tumour activity. The information on the tumour growth behaviour may then be used as the basis for individualised therapy. Via a bidirectional wireless radio circuit, the implant remains in permanent contact with a receiver box transmitting the data to a control station. If increased tumour growth is detected, the control station may promptly initiate therapeutic intervention. This approach allows for continuous monitoring of the therapeutic outcome, thus eliminating the need for the patient to stay in hospital. In case of a potential increase in cell growth, early interventions are possible at any time. In a similar way, this method may also be used to monitor wound healing or the healing process after prosthetic surgery. Tumour patients usually receive systemic therapy and suffer from a variety of side effects. A closedloop implant system with localised, intracorporeal drug delivery enables the patient's normal quality of life to be restored. If the implant detects an increase in

Fig. 5: Vision of the implant system as a closed-loop application. Depending on the functional state of the sensor, it is possible to deliver a chemotherapeutic agent

tumour growth, the system will autonomously deliver a chemotherapeutic drug in the direct vicinity of the tumour. Researchers at the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik are currently working on implementing a suitable actuator interface for controlling a drug delivery pump [6,7]. The system may also be designed to supply oxygen, thereby modifying the microenvironment of the tumour or the metastasis so that cell proliferation is inhibited. Rapid advances in microelectronics, along with increasing miniaturisation of the systems, has contributed substantially to our ability to implement these devices. This in turn leads to an increased acceptance of the systems among patients and physicians. Nevertheless, there are still technologi-

cal problems to solve, such as the very important aspect of energy supply. Compared to the rapid development in microelectronics during recent decades, batteries and rechargeable batteries have hardly been enhanced at all with respect to their power density and internal resistance. In view of the expanded functionality and the increased energy consumption of these implants, it is therefore necessary to focus on using rechargeable systems. Inductive energy transfer plays an important role here. Another promising approach is to generate energy within the human body, e.g. by means of piezo-generators designed to convert kinetic energy into electric energy.

Acknowledgements We would like to express our gratitude to the Bundesministerium für Bildung und Forschung and the Heinz Nixdorf Stiftung for kindly funding and supporting our research projects FKZ 16SV3777 „Intellitum“ and 16SV5044 „Themic“.

References

Fig. 4: Prototype of the implant for tumour diagnosis and therapy with an external planar oxygen sensor (device when open)

[1] J. Clauss, S. Becker, M. Sattler, B. Wolf: In vivo Diagnostik mit intelligenten Implantaten. In: Bernhard Wolf (Hg.): Bioelektronische Diagnose- und Therapie-


Implants systeme. m3: microelectronic meets medicine. 1. Aufl. 2012, Aachen: Shaker Verlag, S. 237–246. ISBN: 978-3-8440-0831-9 [2] K. Vahle-Hinz, J. Clauss, W.-D. Seeher, B. Wolf, A. Rybczynski, M. Ahlers, M. Oliver: Development of a wireless measuring system for bruxism integrated into occlusal splint. Journal of Craniomandibular Function 1 (2009), No. 2, Page 125 ff. [3] J. Clauss, M. Sattler, W.-D. Seeher, B. Wolf, In-vivo monitoring of bruxism with an intelligent tooth splint –Reliability and validity. World Congress on Medical Physics and Biomedical Engineering 2009, IFMBE Proceedings 25/XI, p. 108 ff.. [4] S. Becker, Y. Eminaga, D. Hofsöy, J. Clauss, J. Wiest, M. Sattler, M. Brischwein, H. Grothe, B. Wolf: Implantable dissolved oxygen sensor system for monitoring disease and healing processes, Proceedings Deutsches Biosensor Forum 2011,

21 ISBN 978-3-00-034073-4, p.30, 3.-6. April 2011, Bad Heiligenstadt [5] S. Becker, Y. Eminaga, D. Hofsöy, J. Wiest , J. Clauss, M. Sattler, und B. Wolf: Intelligent implants for monitoring the hypoxia status of tissue, BMT2010; 55 (Suppl 1) pp. 4-5, 44. DGBMT Jahrestagung, 5.10.-8.10.2010, Rostock. [6] S. Becker, Y. Eminaga, D. Hofsöy, K.-U. Hinderer, H. Zhang, A. Sifferlinger, M. Brischwein, H. Grothe und B. Wolf: Towards a closedloop diagnostic and therapeutic implantable system for tumors, Proceedings Smart Systems Integration 2011, ISBN 978-3-80073324-8, paper 41, 22.-23.3. 2011 Dresden. [7] S. Becker, T. Xu, F. Ilchmann, J. Eisler B. Wolf, „Concept for a gascell-driven drug delivery system for therapeutic applications”, Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, DOI: 10.1177/0954411911423348

Contact: Prof. Dr. rer. nat. Bernhard Wolf

Technische Universität München Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik Phone: 089/28922948 wolf@tum.de Theresienstr 90/Gebäude N3 (Building N3) 80333 Munich http://www.lme.ei.tum.de/

Dr.-Ing. Johannes Clauss

Innovationszentrum Medizinische Elektronik e.V. Phone: 089/28922977 clauss@tum.de Karlstr. 96 80335 Munich www.ime-muenchen.de


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The Rocky Road to the Market TÜV SÜD Akademie Qualifies Managers in Clinical Development

TÜV SÜD Akademie

Munich: "Experienced Hikers Only". This sign warns hikers on demanding mountain tours that they can only reach the summit by traversing through rough terrain and going over chasms. Those who develop new medications today face a similar adventure yet the outcome is uncertain. According to a U.S. study, only five out of 10,000 drugs in pre-clinical trials ever make it to the clinical phase. And of these, only one is finally approved and put on the market.The others get stuck in the process and, since the average development period can take up to twelve years, all the money invested is lost.Yet innovative products continue to be approved, such as the 23 new drugs which came on the market in Germany in 2011. The certified training course for „Manager Clinical Development Pharmaceuticals and Biotechnology“, developed jointly by TÜV SÜD Akademie GmbH and BioM Cluster Management GmbH, offers a comprehensive overview of how, despite obstacles, drug development projects can be guided from laboratory to final approval.

The road to the approval of a drug is hindered by many stumbling blocks in the form of complicated standards, guidelines, and different international approval procedures. The transition from invitro to in-vivo research and from scientific to clinical and bureaucratic work poses problems for many research-based companies. Researchers who accustomed to working in a laboratory environment are required to deal with administrative procedures they are not familiar with. CEOs, who provide the financial backing for a project, are suddenly faced with having to estimate clinical risks. Without experience, it is difficult to judge how early decisions, such as those involving documentation, will affect the approval process. „Many persons in positions of responsibility come from the areas of research and development,

TÜV SÜD Akademie in Munich, Germany

quality, or business administration and grow into their new tasks during the course of the project“, reports Anita Lenzser, product manager at TÜV SÜD Akademie. „In order to be well prepared for all phases of the drug approval

process, it is important to have an early overview of what is coming up. Our training course provides the knowledge required“. The course of studies is divided into four modules, which build up consecutively to reach the desired


TÜV SÜD Akademie

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TÜV SÜD Akademie GmbH is a leading provider of basic and continuing vocational training for industry, commerce, trade, and private individuals. With over 350 employees in over 80 locations, the Academy offers up-to-date, hands-on knowhow in the fields of management, health, and technology. The professional qualifications and certificates comply with the highest standards and enjoy an excellent reputation world-wide. www.tuev-sued.de/akademie

Development of New Medications in Germany

TÜV SÜD certificate. Lenzser notes that both the time needed for the course (four sessions of two days each) as well as the participation fee have been kept manageable. She thinks it is important for the participants to be able to take the training course while working full-time, as many of them are already employed in small and medium-sized research, biotechnology, or pharmaceutical companies which are in the middle of the development process. The curriculum is oriented toward those at the management level who are responsible for interdisciplinary monitoring and coordination and for dealing with all phases of development, including the most critical. The participants should gain increased sensitivity in asking decisive questions at the right time and in recognizing why specialists are needed. A current update has been made to the standards and control regulations presently in effect in Germany, in the EU, and in important world markets. Apart from that, there is the issue of "Best Practice" when working with the regulatory authorities. The instructors, all experienced professionals, share valuable tips and trend assessments on, for example, the development of health-related political policies.

Professor Horst Domdey, managing director of the BioM Cluster Management GmbH in Martinsried, is of the opinion that the specialised training of managers in clinical development is long overdue. Under his auspices, BioM, in collaboration with TÜV SÜD Akademie, developed the curriculum and acquired experts from the BioM Network as instructors. „The cutting-edge field of Life Sciences is very competitive“, he notes. „There is no room for mistakes and financial resources are usually exhausted after just one attempt“. Domdey, after many years of research and teaching, is now responsible for the promotion of Bavaria, and companies based there, as a top biotechnology location. „Together with the TÜV SÜD Akademie, we have been able to implement a certified specialist training structure“, says Domdey, and he predicts that there will be a growing need for specialists in research-based companies in the future. For further information see www.tuev-sued.de/akademie/ medizinprodukte or contact Anita Lenzser Tel.: +49 (89) / 5791-3691 E-mail: anita.lenzser@tuev-sued.de.

BioM Cluster Management GmbH is a network agency of the Munich Biotech Clusters m4 as well as the Overall Bavarian Biotechnology Clusters. On behalf of the Bavarian Ministry of Economic Affairs and with the support of the Ministry for Education and Research, BioM supports entrepreneurs and companies from their inception to their launch on the market with a wide variety of services and an international network of partners. www.bio-m.org

Contact: Birgit Klusmeier Competence Center Medical Devices and Health

Tel.: +49 (0) 89 / 57 91 - 3306 E-Mail: birgit.klusmeier@tuev-sued.de

Anita Lenzser Product Management Medical Devices and Health

Tel. +49 (0) 89 / 57 91 - 3691 E-Mail anita.lenzser@tuev-sued.de

TÜV SÜD Akademie GmbH Westendstraße 160 80339 München www.tuev-sued.de/akademie


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Small system – big benefits Compact surgical assistance system improves the surgical workflow and makes the surgeon’s job easier

TRUMPF Medizin Systeme GmbH + Co. KG

Minimally invasive surgical procedures have been adopted as a standard technique in operating rooms across the industrialized world. Based on the principles of ‚keyhole surgery‘, special instruments are used to perform surgery inside a patient's body without the surgeon having a direct view of the surgical site. This offers major benefits to patients. This is a surgical procedure that requires the utmost concentration on the part of the surgeon. While looking at a monitor, they must hold long-shafted instruments precisely in place and guide them through the patient’s body. The difficulty is that the image the surgeon sees on the screen is two-dimensional and the instruments can only be moved to a certain degree due to the limited freedom of movement. In addition, the working direction of the instruments seldom corresponds to the direction of view, and the invariant point in the abdominal wall causes the orientation of the instruments to be reversed. Haptic feedback is limited and effects such as tremors are amplified by the instruments’ long shafts and the magnification factor of the endoscope camera on the monitor. Since the surgeon needs both hands, to operate the instruments, the endoscope camera must be held and positioned by an assistant, who must constantly try to predict where the surgeon will want to look next. The surgeon‘s loss of direct control is accompanied by reduced image stability and steadiness. In addition, the tissue to be dissected must be clamped and held in a stable position

Fig. 1: The surgical assistance system holds and guides the endoscope, offering a steady, stable view and enabling the surgeon to focus on performing the operation. Unlike standard techniques, this method allows surgeons to control their own endoscopic view

to enable the surgeon to work. In many cases it is necessary to maintain a stable position for a very long period of time – a monotonous task which frequently becomes exhausting. It is almost impossible to prevent the endoscope optics coming into contact with tissue, so that surgery has to be interrupted at regular intervals for cleaning. One of the key goals of TRUMPF Medical Systems is to offer innovative solutions for the surgical workplace which ensure that even the most complex surgical procedures and

medical devices do not come into conflict with users‘ ergonomic requirements and the efficiency of surgical workflows. Benefits offered to patients by new technologies should not mean that workplace ergonomics suffer as a result. TRUMPF therefore favors solutions that make use of intelligent and compact surgical assistance systems which are simple and intuitive to operate and quick and easy to assemble and disassemble. This prompted TRUMPF to enter into a strategic alliance with Endo-


TRUMPF Medizin Systeme GmbH + Co. KG control, one of the world’s leading manufacturers of medical robotics. ViKY, a resulting new product, brings significant improvements to the surgical workplace in the fields of general surgery, urology and gynecology. ViKY can be used as an endoscope positioning system or as a holding and positioning system for uterine manipulators. It consists of a control unit and a compact robotic unit which is attached to the OR table rail system by means of an articulated arm. Adapters are available to connect it to all standard endoscope optics, endoscope cameras and uterus manipulators from all manufacturers. The surgeon takes full control of the system using voice commands or a foot pedal. As well as enabling the surgeon to hold, guide and position the instruments during surgery, ViKY also offers the ability to save selected positions and return to them later.

Fig. 2: The compact and lightweight surgical assistance system can be completely sterilized by autoclaving. This removes the need for sterile draping and maintains full accessibility to the surgical site. The system’s articulated arm can be fastened to the OR table in a matter of seconds

By using ViKY, surgeons gain the freedom to control the orientation of the endoscope and uterus manipulator themselves. The robot is able to hold the endoscope still, maintaining a steady position that improves the quality of the endoscopic images. The assistance system also enables surgeons to carry out certain laparoscopic procedures alone, which can be particularly use-

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Fig. 3: As well as guiding an endoscope, the surgical assistance system can also be used as a positioning system for a uterine manipulator in laparoscopic gynecology. The surgeon benefits from a stable view of the uterus that can be adjusted at any time

ful in emergencies and on night duty. ViKY not only frees up the surgeon’s assistant, allowing them to be more effectively employed in more complex surgeries; the system also enables the development of new minimally invasive surgical procedures. ViKY’s precise positioning of the endoscope optics reduces contact with patient tissue, reducing the number of cleaning intervals. The robot also offers welcome relief from the arduous and tiring task of manually holding a uterus manipulator. Thanks to its compact design and low weight, ViKY can be seamlessly integrated in OR set-ups and surgical workflows. Any components used in close proximity to the surgical site can be completely sterilized by autoclaving, which removes the need for sterile draping and provides greater access to the surgical site than other systems. The robot’s movements are predictive and correspond to the style typically used by the surgeon. Available in three different sizes, the system caters to a broad range of applications, ranging from conventional laparoscopy with multiple trocars, to single port surgeries. ViKY is a truly unique surgical assistance system which offers significant ergonomic benefits to surgeons and OR assistants in comparison to conventional methods. The added value for hospitals stems from the more efficient use of existing resources, while patients benefit from minimally invasive surgical procedures,

cutting-edge medical technology and surgeons who feel relaxed and comfortable with their work. ViKY marks TRUMPF‘s entry into the world of active assistance systems, a tremendous growth field that is expected to play a leading role in the future of surgery. Innovation, quality and a local presence are the underlying philosophy of the entire TRUMPF Group. Rather than seeing innovation as an end in itself, TRUMPF strives to apply its innovative capabilities to addressing the real needs of its users. Milestones in medical technology that have emerged from the company’s site in Puchheim near Munich, Germany, include the first installation of OR ceiling mounts in 1978, the world’s first LED-based OR lights in 2005 and the launch of the first modular ceiling-mounted supply unit in 2010. Author: Dr.-Ing. Maximilian Krinninger Product Management Patient Management Solutions

TRUMPF Medizin Systeme GmbH + Co. KG Benzstrasse 26 82178 Puchheim Germany Phone: +49 89 80907-40284 Fax: +49 89 80907-40222 Cell: +49 171 6335609 maximilian.krinninger@de.trumpf.com www.trumpf.com


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Progress through Division of Labour

Holzammer Kunststofftechnik GmbH

A considerable part of our progress results from division of labour. We do have division of labour for thousands of years. It experienced an enormous increase by the beginning of industrialization and the development of both traffic and information ways. The division of labour explosively bounced up by the means of new media and their possibilities of cooperation. In the fields of development and science, the division of labour is exceeding the continents and is being considered as a standard nowadays. In the medical science, new methods of diagnosis are constantly arising. These procedures usually come along with the development of new devices. As self-evident as the commitment of external specialists is in the field of science, it should also be for the construction of casings and components. But unfortunately we are often faced with the fact, that the existing means for a division of labour are not applied to the extent as they could be today. When reaching out for a new aim, one should have to compile a profile of requirements by listing the essential criteria of the casings. In addition to the performance of a casing, there should be established a catalogue of all criteria for the casings and covers. Therefore, the requirement should be specified. And the result of this catalogue of criteria should be: How can these requirements be met in a cost-saving way by the use of division of labour? Issues which already have found

Prototype console, AFreeze GmbH

good respectively very good answers in our world for division of labour are the ones for materials, whether plastics or metals, or standard parts, beginning from screws up to functional valves, drives etc. Every device to be developed has its own profile of requirements. The developing person rarely disposes of an allembracing knowledge, to be enabled to deal with the following issues: What kind of forces is this device exposed to? How can radiated noises be insulated? How can an EMCscreening be established? How can the design be arranged with colours? Another very important subject is the ergonomic presentation, and how does such a device affect the psyche of a patient, especially children, elder people and people, who don‘t have a ‚technical mind‘.

Most of the devices from former generations were from their design very much adjusted to the sentiment of their users or operators. The psyche of a patient was at that time of minor interest. But to lower this barrier of fear for the patient, new thoughts have to be generated. The issues – as depicted before – literally scream for a division of labour. The company Holzammer Kunststofftechnik GmbH disposes of an experience for many years in this set of problems. Division of labour is an essential component of our company‘s philosophy, as we also do operate a department for mould construction, a jig department and a model making department besides of the manufacturing of devices and components for the medical industry. The crossover of the duties had for us the consequence, that we successfully deal with issues like coating, EMC-screening, sound insulation, metal working, etc., for years. Author:

Hans Holzammer, Managing Director HOLZAMMER Kunststofftechnik GmbH Am Ursprung 9 92369 Sengenthal P hone: 0 91 81 / 2 95-0 Fax: 0 91 81 / 2 95-34 E-Mail: kontakt@holzammer.de


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Contract development – Consulting – Communication agency Innovations for medical technology – realized by senetics The scientific institute for innovation and consulting – senetics healthcare – is a developing and consulting company in the area of medical technology, pharmacy and biotechnology. With a great expertise in biology, medicine and regulatory affairs, senetics supports its clients to establish them in a competitive environment. The business activities of senetics contain contract development, trainings and consulting regarding the product placement of new products, development of integral marketing strategies, support of business expansion or start-ups, and finally contract work in the research field.

senetics healthcare

Contract development As a partner, senetics offers support services over the complete value chain, working as an external project management, businessdevelopment and R&D department. The results are implemented together – beginning with producibility, development, market admission, reimbursement, health economic studies up to the marketability and market introduction. In addition to that, an effective market, competition and technology analyses is part of the portfolio. The project management is geared to networking and enables an optimized development regarding costs, quality and time optimization - from the idea to the complete product. Research and development playing a significant part Half of the sales volume of medical technology companies is achieved by products which are not older than three years. For the decision

Project development for an in-vitro-diagnostic measurement system at senetics

whether a product idea can be taken as a project, market and technology analyses are essential. Especially significant is the coordination of all development stages with the corresponding regulatory affairs, Medicinal Devices Act, DIN EN ISO 13485 and

DIN ISO 14971: “We see us as a partner to our clients. We support them as an external project management, business development and R&D department regarding the complete value added chain”, argues the Managing Director Dr. Wolfgang Sening.


senetics healthcare Focus – global competition The mentioned aspects can be applied for suppliers as well as for distributors. Additionally, the advancement of R&D projects regarding the development of medical technology products, components, processes and services as well as their application-technological implementation are focused. Particularly in the growing market of combination products, the project management of senetics bunches strength to activate potentials, which not have been used yet, and to position the client in the global market, using his unique features.

Consulting and training The growing complexity of the medical technology sector as well as the various formalities require a stronger communication between companies. Additionally, the healthcare, biotechnology and pharmacy sectors are growing more and more together, especially the market of combination products is increasing. senetics has developed project management, supporting and networking models, which sustainably will improve cooperation and economic success. The enterprise considerably offers supporting, training and qualification programs, for instance: Business expansion and sales in the medical technology area Suppliers in medical technology Customer requirements and regulatory affairs Biology and medicine for nonphysicians

Communication agency and marketing The team of senetics organizes all necessary marketing measures. Do you want to improve your external communication or are you looking for market mavens, who create flyers, advertising and communication materials for you? Our expertise and know-how allows

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Trainings in biomedical technology, here: biology and medicine for non-physicians

an ideal presentation for you – for your success in the market. With the healthcare communication agency of senetics, you receive a complete package – content related to the specific field, design and master plan. We display the contents of your company presence – on demand via SWOT analyses – to the representation of documents, presentations, announcements, flyers and finally booths. We complement the efficient marketing strategy for our clients offering joint booths at Medica/ Compamed, Arab Health and MedTec.

improvement of the cooperation between the supplier industry and producers. „With our networking philosophy, we fit the future plans of companies. We expect a lively and interdisciplinary transfer with other partners and we would like to support you with our know-how”, explains Dr. Sening.

Author:

Dr. Wolfgang Sening Managing Director

Networking management From the idea to the complete product – senetics healthcare attends all processes within the product life cycle and explores the efficiency potentials. That applies to both suppliers and producers: that is the reason why senetics forces the company-wide communication with an innovative networking model. „Within the top cluster medical technology, we founded the Network for innovative suppliers in medical technology (NeZuMed)”, says Dr. Sening. The network is comprehended as a platform for defining and implementing measures, which serve the progress of medical technology as well as the bordering sectors and the

Co-Author:

Christoph Elbert Scientific Assistant

senetics - Scientific institute for innovation and consulting Biotechnology - Medical Technology Pharmacy Henkestrasse 91, 91052 Erlangen, Germany Phone: +49(0)9131 - 9 201 201 Fax: +49(0)9131 - 9 201 202 E-mail: wolfgang.sening@senetics.de www.senetics.de www.nezumed.de


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... encountering the future. Bayern Innovativ GmbH Gewerbemuseumsplatz 2 90403 Nuremberg Germany

Phone +49 911 - 20671 - 0 Fax +49 911 - 20671 - 792

info@bayern-innovativ.de www.bayern-innovativ.de

Today ' s knowledge for tomorrow ' s innovations


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Successful Patent and Legal Protection Profile is our goal

Expertise is our strength Our attorneys are European, German, Dutch, Belgian and Russian patent attorneys, US patent agents, Benelux and European trademark attorneys and attorneys-at-law who

Branch office Regensburg

are specialized in the field of Intellectual Property. They draft and process patent and utility model applications, as well as trademark and design applications, file Supplementary Protection Certificates, provide validity and infringement opinions, for example, and are involved in the opposition or defence of Intellectual Property rights. Further, they supervise due diligence proceedings and portfolio management, are involved in the negotiation and drafting of licensing agreements, and much more.

ing and, here in particular, in the field of medical technology. Our goal is to offer an optimal priceperformance ratio and to maximise the value of client´s IP rights.

Contact: Dr. Bettina Hermann

Medical technology at the focal point

Our office is located in the heart of Munich

Our patent attorneys have technical expertise, amongst others, in the field of biology, biotechnology, pharmacy, organic-, inorganic- and clinical chemistry, but also in mechanical and electrical engineer-

VEREENIGDE Rindermarkt 5 80331 München/Germany Phone: 089/890 63 69 36 Fax: 089/890 63 69 99 E-mail: b.hermann@vereenigde.com www.vereenigde.com

VEREENIGDE

Our firm has existed since 1916. It is the largest patent firm in The Netherlands and is today considered to be one of the leading patent firms in Europe. We are internationally active, have offices in The Netherlands and Belgium, and present our proximity to customers in Germany via offices in Munich and Regensburg. In addition, there exists an intensive exchange with China. 52 patent attorneys and attorneysat-law represent the interests of our clients in all fields of Intellectual Property with the aim of maximising client´s success. In this context, it is advantageous that our attorneys are involved in various Intellectual Property associations, where they actively work on developing this field further.


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Intelligent Textiles support in Treating Movement Disorders Doctors and surgeons are confronted with challenges when monitoring the therapeutic success in movement disorders. They must be able to determine the severity of the disorders in a short time and as objectively as possible. In future intelligent textiles, as the ones developed at the Technische Universität München, will be able to support them.

Intelligent Textiles

Movement disorders assessment Movement disorders are the cause of impairments and of autonomy loss in the lives of many people of different ages. They can occur for several reasons, of which is Parkinson‘s disease is a prominent example. It affects about 3% of the population over 65 years and causes symptoms as rigidity (stiffness), bradykinesia (slowness of movement), tremor and postural instability (unstable standing). It is believed that the cause of the disease is a decay of nerve cells in the brain which produce dopamine: a neurotransmitter affecting motor skills. The most common therapy consists in administering drugs which compensate for the lack of dopamine. The effect of these drugs can be different from patient to patient and can change over time, i.e. depending on how long the last administration dates back and how long the patient is receiving this kind of medication. Also, complications as involuntary movements or movement restrictions (dyskinesia) can occur. In most cases, when the medication does not achieve the desired effect any more, a second therapy is chosen:

deep brain stimulation (DBS). In this therapy, the brain is stimulated with an electrical current. When it is set correctly, the impairment can be largely suppressed in many cases. During the implantation electrodes are inserted into the brain, their connections are led out of the skull and to the actual stimulation device, which is attached under the skin on the chest. After the surgery, the stimulation parameters can be set onto the stimulation device through the skin. Both in drug therapy and in DBS, for physicians it is important to be able to assess the movement disorder‘s severity. During drug therapy, knowing how the disorder develops is necessary to verify the effect of the medication and, if necessary, to adjust the administration times and dosage. During DBS surgery it is necessary to assess the symptom‘s severity in order to find the optimal position for the electrode‘s implantation (the patient is awake during the surgery) and to set the stimulation parameters optimally after the implantation. Current methods used in the assessment of movement disorders are based on questionnaires

and surveys. A well-known scale for evaluating Parkinson‘s disease‘ progress is the Unified Parkinson‘s Disease Rating Scale (UPDRS). In this assessment tool, among other things, the patient or his relatives are interviewed in order to assess his impairments in everyday life, or the patient is asked to perform specific exercises. These exercises are then observed and evaluated by a physician. The disadvantage of scales based on this approach is that an evaluation is only possible in the presence of an evaluator, thus it is difficult to use them in order to judge the symptom‘s development throughout the day in daily life, that is, outside of a residential facility. In addition to this, the assessment itself is subjective, as it is dependent on the evaluator and on whether the patient or his relatives are asked in the survey.

Using intelligent textiles for motion measurement In order to measure objectively movement disorders in daily life, we pursued the approach of integrating the measuring system in clothing. This has the advantage that clothing is worn anyway and close to the body. It is therefore


Intelligent Textiles possible to detect movements in daily life without disturbing the wearer excessively. This is also the essential distinguishing feature compared to systems detecting movements over reflecting markers or which transmit motion data wirelessly to a nearby receiver, as those systems can only be used within a limited radius and thus not in daily life. However, also challenges derive from this approach: these garments must be like normal clothes, i.e. withstand being washed and the electronic components must be integrated in such a way that the wearer will not be disturbed by their presence. It must also be examined to what extent the elasticity and flexibility of the garment changes the measurement in respect to body mounted sensors. To detect movements of the upper body, eight sensors are required: four sensors for the upper and lower arms, two sensors on the sides and two sensors under the neck and on the abdomen. These are integrated into a shirt or into a sweater (Fig. 1, [1]). For the movements of the legs we need five sensors: a sensor on the waistband and four on the upper

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Fig. 2 Concept for the glove measurement system [1]. It is used during surgery to find the optimal electrode placement for deep brain stimulation.The data is available immediately after the acquisition via a cable connection [2]

and lower legs. These are integrated into a pair of pants (Fig. 1, [2]). During DBS surgery, a static measurement system is necessary. In this case, the hand‘s movements and the arm‘s stiffness (rigidity) are evaluated by the surgeon. For this application, a system integrated into a glove is sufficient. In the glove, sensors are attached in proximity of the middle finger, of the back of the hand and of the wrist (Fig. 2, [1]).

Sensor data is read and computed by a miniaturized computer to a measure which must be comparable to the UPDRS rating. In outpatient applications, the textile (shirt or pants) measuring results will be stored on the textile for later read-out. The sensors, the miniaturized computer and the memory module (Fig. 1, [3]) have to be integrated into the garment together with the necessary power supply components. In the stationary application for DBS surgery, data is acquired and evaluated inside the measurement textile but is output immediately after the evaluation via a cable connection (Fig. 2, [2]). This cable connection also supplies the system with power.

The prototype‘s realization

Fig. 1: Concepts for measuring shirt [1] and measuring pants [2].The collected movement data is processed and stored on an electronics unit [4]. After the recording, the data is available on a removable storage medium [3]

Starting from the concept, the electronic components have been designed. Also, a solution had to be found on how to integrate them into the garment and how to ensure its washability. As sensors we use microelectromechanical (MEMS) accelerometers, which permit high resolution measurements (0.038 m/s2 at a measurement range of ±19.62 m/s2) in compact dimensions (3x3x0.9 mm3).


Intelligent Textiles

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Fig. 3: Electronics unit (right) and charger for up to five electronics units (left)

These are connected in a cable network and stitched into the garment. This cable network runs in textile tubes on the garments inside, so that no direct contact to the electronics is possible, assuring a soft feel for the wearer. Several cables have been tested until a sufficiently thin and flexible one was found. The network is connected via a plug to the central electronics unit (Fig. 1, [4]), which is located inside a garments pocket. The electronics unit contains the components necessary to analyse the data, store it with a timestamp, and power supply in a compact (83x48x20 mm3) case (Fig. 3, right). The sensors were glued into a protective watertight jacket made of plastic and firmly connected to the cable network. The plug is also watertight and glued with the cable network. It is thus possible to separate the electronics unit before washing the garment and to recharge it while the garment, including the sensor network, is being washed. The electronics unit can be reconnected as soon as the garment is dried.

The glove measurement system for application during DBS surgery is built on a pharmacist‘s cotton glove. The sensors and the evaluation electronics are fixed prior use via Velcro fasteners on the gloves outer side. After use, these are detached and the glove can be disposed of.

Fig. 4: Measurement shirt (left) and measurement pants (right). The plug for the electronics unit is visible

The textiles in use In order to test the measurement textiles with clinical partners or to make it available to interested research groups, it was necessary to produce them in a small series, to support their adaptation to other applications and to conduct the certification process. While this has been done for the measurement shirt and pants (Fig. 4), the glove measurement system for DBS is still a functional model (Fig. 5) which will be further developed in near future. For the measurement shirt and pants the single production steps have been simplified so that they can be partly carried out externally and more reliably. The electronics unit‘s design has been unified for both measurement textiles and

consists largely of standard components. The measurement parameters can be easily modified by changing a text file located on the data storage medium. Using the same medium, a firmware upgrade can be carried out without using a special programming device. An example of the clinical use of the textiles is their application in the detection of freezing of gait (FOG). This is a specific symptom in Parkinson‘s disease in which the patients “freeze” in their walk and have the feeling of their feet being glued to the ground. It is a particularly unpleasant symptom, as it impairs mobility and can lead to falls. To monitor the course of disease and adjust medication accordingly a good know-


Intelligent Textiles

35 of Parkinson's disease using sensor based smart glove, Computer-Based Medical Systems (CBMS), 2011 24th International Symposium on, 27-30 June 2011, pp. 1-8. Niazmand K., Kalaras A., Dai H., Lueth T.C.: Comparison of methods for tremor frequency analysis for patients with Parkinson's disease, Biomedical Engineering and Informatics (BMEI), 2011 4th International Conference on, 15-17 Oct. 2011, pp. 693-697.

Fig. 5: Functional model of the glove measurement system

ledge of the FOG episodes occurring during the day is desirable. This is achieved through an algorithm that can find out at which times FOG events took place starting from the data recorded by the measuring pants. In future, the measuring pants could even detect a FOG event immediately and support the patient, e.g. with an audible “cue”, in overcoming the FOG event. The algorithm has been evaluated with six patients. The patients walked through a course while wearing the pants and were filmed at the same time. Then, a physician determined the number of FOG occurrences watching the video recording for each patient. This was then compared with the result of the algorithm. The accordance was very good, with a sensitivity of 88% and a specificity of 85%.

been produced in a small series. The authors are grateful for the good cooperation with the clinical partners in the Schön Klinik München Schwabing (Prof. Dr. Ceballos-Baumann), in the Innovation Center for Computer-assisted Surgery (Prof. Dr. Strauss) and in the Neurosurgical Clinic of the University of Munich (LMU), Campus Grosshadern (Prof. Dr. Tonn). Special thanks go to the Alfried Krupp von Bohlen und Halbach-Stiftung.

Conclusion

Niazmand K., Tonn, K., Kalaras A., Kammermeier S., Boetzel K., Mehrkens J.H., Lueth T.C.: A measurement device for motion analysis of patients with Parkinson's disease using sensor based smart clothes, Pervasive Computing Technologies for Healthcare (PervasiveHealth), 2011 5th International Conference on, 23-26 May 2011, pp. 9-16.

The presented intelligent textiles for support in the treatment of movement disorders provide a basis for detecting movement disorders in daily life or in stationary applications (during surgery). They enable the acquisition of accelerations, pre-processing and time stamped recording integrated into washable, everyday clothing. The systems have been used clinically; two of the three presented systems have

Literature Niazmand K., Jehle C., D'Angelo L.T., Lueth T.C.: A New Washable Low-Cost Garment for Everyday Fall Detection, Engineering in Medicine and Biology Society (EMBC), 2010 Annual International Conference of the IEEE, Aug. 31 2010-Sept. 4 2010, pp. 6377-6380.

Niazmand K., Tonn K., Kalaras A., Fietzek U.M., Mehrkens J.H., Lueth, T.C.: Quantitative evaluation

Niazmand K., Tonn K., Zhao Y., Fietzek U.M., Schroeteler F., Ziegler K., Ceballos-Baumann A.O., Lueth, T.C.: Freezing of Gait detection in Parkinson's disease using accelerometer based smart clothes, Biomedical Circuits and Systems Conference (BioCAS), 2011 IEEE, 10-12 Nov. 2011, pp. 201-204. Zhao Y., Tonn K., Niazmand K., Fietzek U.M., D'Angelo L.T., Ceballos-Baumann A., Lueth, T.C.: Online FOG Identification in Parkinson‘s disease with a time-frequency combined Algorithm, Biomedical and Health Informatics (BHI), 2012 IEEE-EMBS International Conference on, 5-7 Jan. 2012, pp. 192-195.

Authors: Dr.-Ing. Lorenzo T. D‘Angelo Yan Zhao, M.Sc. Houde Dai, M.Sc. Prof. Dr. Tim C. Lüth Technische Universität München Department for Micro Technology and Medical Device Technology Boltzmannstr. 15 85748 Garching/Germany Phone: 089 / 289 15171 Fax: 089 / 289 15192 E-Mail: lorenzo.dangelo@tum.de


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Methods of technology detection and evaluation

Medical Valley EMN

Medical technology is characterized by a high degree of innovation speed. For companies, it is important to understand at an early stage of the innovation process, what effect the introduction of new technological innovations has on the health care process and what the implications are for the health system as a whole. Billions of dollars are spent every year on developing medical products for the global market. It is estimated that the global medical device market is valued at $ 300 billion, with an annual growth rate of 4.6% until 2013. Therefore, the health system is referred to as a sustainable megatrend by politics and economics

because of the demographic change of an ageing population and growing demand for medical services. It is not necessary for an innovation to be related to products, but it may also appear in the form of new processes, marketing strategies or organizations. The pressure to innovate due to shortened product life cycles, which means that products age faster, is growing rapidly. The available financial resources must be controlled accurately and efficiently and within strategically appropriate intervals. Innovations are essential to generate medical progress and growth in the healthcare industry as well

as to address new challenges, such as demographic development. It is also essential to study the product environment in order to remain up to date and competitive. However, it is not easy to detect the corresponding signals. Information must be found and its relevance has to be evaluated. The idea is to detect so-called weak signals, which are manifested by their low information density. Management and decision-making in these areas are complex and require market knowledge and methodological skills. In the area of innovation and technology management, there are concepts that warn business and politics at an early stage, identify technologies for specific applications or assist with the evaluation. In the following text, the most important concepts that focus on different points in the process of technology development and market introduction are listed briefly (Table 1) and are also distinguished by activity (Table 2).

Concepts

Tab. 1: Delimitation of the concepts on time of application, development, early or late diffusion

Technology Assessment (TA) Technology Assessment is the systematic identification, analysis and evaluation of the potential secondary effects (whether beneficial or harmful) of a technology in terms of its impact on the social, cultural, political and ecological systems and processes. (Van Eijndhoven, 1997).


Medical Valley EMN Early Technology Assessment (ETA) and Health Technology Assessment (HTA) Early Technology Assessment (ETA) can be understood as development-related technology assessment. It is part of the evaluation process that takes place in the company prior to marketing. This includes, for example, the risk assessment and the assessment of the market potential. There are similar methods in the healthcare industry, which are known as Health Technology Assessment. However, the conditions are different, because the market is much more regulated and that is why it cannot be called a classical free market. Therefore, the closely interwoven relationships and interdependencies require a novel, advanced concept of technology assessment. Nevertheless, HTA for assessment of health systems only occurs after the completion of primary studies, market access and diffusion. The objective of classical HTA is to control the diffusion of a product on remuneration policies and not to improve the situation for the developer and manufacturer of the technology. Consequently,

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Tab. 2: Classification of approaches by activity

the need for an accompanying development approach in healthcare becomes clearer. Figure 1 exhibits the diffusion of a medical product through its lifecycle. The sections are divided on the one hand according to the research status (basic science, translational, clinical research, regulatory approval and pricing), and on the other hand according to the field of activity in the development process (prototyping). If necessary, the product life cycle is accompanied by HTA, early HTA and very early HTA, as well as, over time, decreasing uncertainty.

Fig. 1: Embedding of HTA concepts into the product development cycle (and Ijzermann Steuten, 2011 S. 3351)

Horizon Scanning Horizon Scanning implies programs and systems that have the goal of early identification of significant new and emerging technologies. Thus, information on their possible effects on the health system can be made available. In this way, developments can be influenced politically and even be controlled in some ways. This check can be carried out in two directions. On the one hand, the unstoppable diffusion of a technology can be regulated, on the other hand a dissemination that is too weak can be reinforced. The goal is to support the strategic management and to increase the innovativeness of the company. The Horizon Scanning process ideally consists of five steps: identification and filtering, prioritization, assessment, dissemination, monitoring and impact assessment. In principle, Horizon Scanning considers technologies that are about two to three years before market launch. Here, the fundamental problems are expressed, which all concepts that relate to the early stages of technology development and diffusion have in common: evidence versus speed and evidence versus earliness of approach of timing. Horizon Scanning is a possible first step of the HTA process and is used to select technologies by setting priorities.


Medical Valley EMN

38 Technology Forecasting and Technology Foresight Technology Forecasting predicts the future regarding the rise of technologies and processes, and their developments, properties and effects. Like the weather forecast, Technology Forecasting specifies a possibility of the future that is deemed to be most probable based on scientific methods. The goal of Technology Foresight is to focus several future scenarios, select a favorite one and derive strategies and actions that make their way to the desired future possible. It is assumed that the future is neither predictable, nor unpredictable, but that

Fig.2: One possible future (Cuhls, 2003 S. 94)

there are certain signs in the present, which are indicative of possible future scenarios. Especially, the concept of ‚weak signals‘ plays a role. Future-Oriented Technology Analysis (FTA) FTA unites the various concepts of forecasting, foresight, intelligence, assessment and roadmapping. Furthermore, it is a goal of FTA ‚ [to] better inform technology management as well as science and research policy.‘ (Working Group, 2004, S. 287) Technology Roadmapping navigates a company to achieve a preset objective. The roadmap outlines the obstacles and shows the user the skills and resources necessary for the achievement of the target. Technology Roadmapping works at the early stages of product development. Early Technology Awareness Early Technology Awareness has the goal to gather, evaluate and communicate information at an early point in time, based on the development of a technology. A company should be able to ade-

Fig. 3: Ideal typical schematic of Early Technology Awareness (Landwehr, 2007 S. 28)

quately respond to technological trends to take advantage of opportunities and to recognize and avoid risks.

Prospective Health Technology Assessment (ProHTA) ‚Prospective Health Technology Assessment‘ (ProHTA) is a project within the national excellence cluster Medical Valley EMN (European Metropolitan Region of Nuremberg), supported by the German Ministry of Education and Research (BMBF). The goal of ProHTA is to assess the effect of new technologies and products in terms of quality of care and health care costs and to identify potentials for efficiency within the supply chain. Therefore, innovative health technologies

Fig. 4: ProHTA vs. HTA

are evaluated in advance of their launch (Fig. 4). In the development of health technologies, it was common practice to study what options were technically possible. Thus, products were developed based on these options. These products were placed on the market, even though efficiency improvements in the health care sector could not be expected. The market was only created for the products as it is usually done in the consumer goods industry. However, this approach is counterproductive in health systems, which are usually collectively financed by taxes or contributions of the insured. In contrast, ProHTA pursues the approach to understand the impact on the medical and organizational processes already in


Medical Valley EMN the early stages of the innovation process for products and solutions and to optimize them with the new possibilities of the technology. Simulations are created that demonstrate the potential effects of new technologies on the health care system and medical or organizational processes. In this way, the innovation process can be optimized very early. The interdisciplinary structure of the project consisting of university and industry partners ensures the pooling of know-how with regard to health care, information technology and management (Fig. 5). For an effective handling of the project, a modular structure has been identified, consisting of Healthcare, Health System, Knowledge Management and Simulation. Health Care and Health System provide knowledge and information on the various aspects described below, which are permanently integrated into the database via Knowledge Management, in a way that they can be reused and later used by the simulation.

epidemiology of the disease and the patients using quantitative parameters. This applies for example to population size, incidence and prevalence, severity of illness, health care needs and the costs of disease. For health technology to be evaluated, a benefit assessment will be conducted over existing technologies in the market.

The technical objective of the model block in the overall project is to provide a database to inform the simulation environment. The primary sources of information, such as disease registries, have to be merged and according to the requirements of different simulation scenarios they have to be integrated into consistent and adjusted datasets.

Model component ‘Health system’ In addition to the actual supply environment and the representation of utilization of the supply system, the technology is studied in a larger context of the health system. Systemic conditions are critical for the diffusion of a technology and its future market launch. Regulatory requirements by regulatory authorities and HTA institutions, market access restriction, incentives and compensation and contract forms are included. The budget impact can be determined from the estimation of the technology‘s diffusion and the cost-saving effects.

Model component ‘Model development’ ProHTA adapts simulations for individual questions as well as large simulation models for holistic problems. On a detailed level, patients and stakeholders of the supply system are modeled as agents. From such a model, by simulating various design dimensions, such as utilization of the scheme, the overall effectiveness of a technology that affects the costs and other aspects can be derived.

Fig. 5: ProHTA project partners

Model component ‘Health care’ The model component health care shows the conditions and

Fig. 6: Model components

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Model component ‘Information and Knowledge base’ The focus is on database schema design and data quality assurance.

Use Case Scenarios The Use Case ‚Stroke‘ is used as a disease example. For the treatment and therapy of stroke, detailed guidelines exist, but also innovative technical diagnostic and therapeutic procedures are being developed. This Use-Case Scenario 1 is used to evaluate the methodology, not least because of the good access to data by the Erlangen Stroke Registry at the Neurological Clinic of the University Hospital of Erlangen. As a further use case, ‚Personalized Medicine in Oncology‘ with the examples prostate and colorectal cancer is also performed and evaluated. Here, novel methods for early detection and targeted personalized therapies are in focus. These technologies have the potential of significantly improving the prognosis of oncology patients in some cases. However, because of the high costs of these therapies, early evaluation is necessary.


Medical Valley EMN

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Fig. 7: ProHTA in the context of technology assessment (by Aisenbrey & Issing, 2009)

Prospect The major difference between ProHTA and other methods like HTA, Early HTA and Horizon Scanning, is the ability to detect the potential to improve efficiency in health care by outlining the health system using simulation. Thus, bottlenecks and weak points can be identified before they have an impact. The time of evaluation is crucial. While Horizon Scanning, so-called emerging health technologies, and classical HTA retrospectively assess already established health technologies (post market launch), ProHTA is applied prospectively in contrast. ProHTA already happens at an early stage of the innovation process and is seen as a building block in a more comprehensive innovation management (Fig. 7). ProHTA has a wider thematic focus and is applied at a very early stage of technology development. ProHTA can be used by different actors (companies, government agencies, regulators, health insurance, etc.), and for a variety of technologies, treatment processes or pharmaceutical products.

Positive effects of ProHTA and the Cluster of Excellence on the Bavarian medical technology industry The Cluster of Excellence Medical Valley EMN has the potential to achieve global outstanding positions and significantly influences the development of economic and scientific centers in the field of medical technology and health in Germany. The unique characteristic of the cluster for excellence Medical Valley EMN is the close integration of all stakeholders (industry, research, health care) and the common objective, which helps to focus all activities and expertise. This is reinforced by the interdisciplinary approach, which helps to recognize the potential of new technologies to improve efficiency in the health system. Thus, this results in continually expanding knowledge and an experience pool for optimal health care and in significant competitive advantages for all partners participating in the cluster. The innovations planned for products and services address attractive growth markets. By strengthening the economic power in the region, many existing jobs are protected and we expect the creation of 2,500 new jobs.

Author:

Charlotte Niederländer BSc, MSc Research fellow

Co-Authors: Melanie Viebahn, Christine Kriza, Prof. Dr. Peter Kolominsky-Rabas Interdisciplinary Centre for Health Technology Assessment (HTA) and Public Health University of Erlangen-NurembergNational BMBF-Cluster of Excellence ‚Medical Technologies Medical Valley EMN‘

Schwabachanlage 6 91054 Erlangen/Germany Phone: +49-9131-8539106 Fax: +49-9131-8535854 E-mail: charlotte.niederlaender@uk-erlangen.de www.public-health.de www.prohta.de


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Celebrating 25 years of laser safety made by LASERVISION About us LASERVISION was founded 25 years ago and is now integrated part of the UVEX Safety Group. The company has successfully established itself as one of the leading companies in laser safety and especially in laser safety eyewear. Rapid advancement of medical laser technology is making laser safety more important now than ever before. LASERVISION keeps pace with such advances in laser technology through an aggressive programme of new product and technology innovation. Doing this LASERVISION is able to offer an enormous variety of laser safety goggles based on absorptive materials such as plastic or glass filters. A special focus is put on reflective filters. These coatings are applied to almost every kind of glass and/or plastic in the LASERVISIONs own coating facility. Reflective filters on clear substrates reach very high protection levels and are clearly brighter and more lightweight than comparable absorbing glass filters. Therefore they are offering improved color vision as required in most medical appli-

Perfect laser protection in dental applications

cations. The combination of coatings with absorbing filters allows a nearly unlimited number of variations for all possible wavelengths.

Product range – medical laser protection Laser safety glasses and goggles with coated filters Magnifying loupe with plastic laser protection filter Eyewear for IPL-Applications Patients eyewear with laser protection filters Reusable, self-adhesive patient eye caps Metal eyeball goggle for all laser wavelength

Clear evidence of the LASERVISION commitment to quality can be found in each and every one of our products. Effective laser protection requires rigorous quality standards and exhaustive testing. Laser damage threshold testing, advanced spectrophotometry, filter characterization and optical quality are only some of the detailed test requirements for each LASERVISION product. All laser safety eyewear is manufactured, tested and CE certified in accordance with the legal European standards.

LASERVISION is people The key to the success of LASERVISION is people. Our dedicated and motivated employees are responsible for achieving the exceptional levels of innovation, service and quality for which LASERVISION is well known. With 25 years of experience in laser safety, effective teamwork and committed leadership we will continue to offer users laser safety solutions tailored specifically to all new medical laser technologies and applications

Dipl. Phys. Frank Billhardt Sales and Marketing Manager

LASERVISION GmbH & Co. KG

Brand new: new gray filter for IPL-applications

Siemensstr. 6 90766 FĂźrth/Germany Tel: +49(0)911-9763-8100 E-mail: info@lvg.com

Laser safety

Contact:


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Intelligent, Wireless Implants Challenges and Solutions

DUALIS MedTech GmbH

Fig. 1: Intelligent, Wireless Implants – Challenges and Solutions

Improvement of therapies and diagnostic possibilities in medicine and development of new treatment methods are goals currently determining trends in the active implant market. This trend can be seen in increasing system complexity, functionality, and miniaturization. Higher resolution of measurement and photo data, improved implant regulation, as well as continuous patient and therapy monitoring are the results of these developments. Intelligent implants unite actuator and sensory elements, rechargeable batteries, and interfaces for the energy and data transfer to an overall system. By means of integrated sensor technology, reactions can be automated to specific environmental conditions, thereby improving control of the therapy. The spectrum of intelligent implants ranges from established systems, such as neurostimulators or cochlea implants, to the newest developments and research projects, such as an artificial pancreas or artificial sphincter.

The development of intelligent implants confronts companies with various challenges. Since active implants rank among the most regulated category of medical devices, the entire development process must be oriented towards upholding required regulations and norms, making development correspondingly complex. Technical challenges arise, for example, in the assurance of electromagnetic compatibility between implants, as well as compliance to the permissible generation of heat. The surface temperature of an implant may raise the surrounding tissue a maximum of 2 degrees Celsius, which creates a crucial limit, especially in the charging of accumula-

tors. Wireless energy and data transfer in intelligent implants must also fulfill the highest requirements. A highly efficient and reliable energy transfer combined with a quick and secure data transfer creates the basic requirements for a successful energy and data supply of the implant. With MedBase®, DUALIS offers a basis technology for wireless transfer which fulfills requirements of medical technology and can therefore be applied to various implants. MedBase® applies the principal of inductive coupling, thereby enabling the wireless transfer of energy through the body. Various secure RF-communication technologies can be

Fig. 2: Principle of energy and data transmission with MedBase®: By means of two inductive coils, energy is transmitted wirelessly through body tissue. Through RFcommunication, data is exchanged between the implant and the external device and is displayed on an information unit


DUALIS MedTech GmbH

Fig. 3: MedBase® range of applications

deployed, depending on intended use, for telemetric control. Fig. 2 illustrates the functionality and design of MedBase®. Through different variations of the technology, an energy spectrum of µWatt to 20 Watts can be covered. The modular construction further enables efficient customization and integration of the technology. Synchronous transfer of energy and data, telemetry supply for implants which supply their own energy, as well as the possibility of inductively charging an implanted accumulator, could be realized on the basis of MedBase®. The spectrum of application ranges from artificial heart systems, neurostimulators, and drug pumps to myoelectric prostheses and implantable sensors (Fig. 3). In addition to efficient and reliable energy transfer through body tissue, MedBase® offers a high tolerance towards horizontal and vertical displacement of the coupling elements. These characteristics are especially crucial for the application of implants, since the coupling elements both inside and outside the body are constantly in motion and cannot be precisely aligned. Patients profit from the wireless energy and data transfer for intelligent implants in many regards. Continuous monitoring for highrisk patients, personalized therapies, improved alarm functions, decreased chance of follow-up operations, and fewer infections

caused by wires lead to improvements in current therapies, completely new treatment possibilities and an increase in patients‘ quality of life. DUALIS MedTech GmbH is an innovative medical technology company based in Wessling and Seefeld, Germany. The company specializes in the field of miniaturized mechatronic systems, functional surfaces, as well as pump, membrane, and wireless technologies for intelligent implants. DUALIS offers research and development services, as well as technologies developed in close collaboration with the German Aerospace Center. In astronautics, quality is an indispensable prerequisite for the protection of human life. This applies for medical technologies as well. Ever at the core of our development work, reliable safety

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used in research projects. In cooperation with the Biofluid Mechanics Lab at Charité – Universitätsmedizin and the Deutsches Herzzentrum in Berlin, DUALIS is involved in a 36-month long project on a low-hemolysis blood centrifugal pump for long-term heart support. The research project is sponsored by the German Ministry of Education and Research (BMBF). Additionally, DUALIS is working together with pfm medical titanium gmbh, as well as the Heart Surgery Clinic and the Institute for Microbiology at the University of Regensburg, on the development of optimized surface structures on the nanoscale, for the improvement of the bio- and haemocompatibility (blood compatibility) of polyurethane for implantable medical devices. The company DUALIS has its roots in astronautics and its future in medical technology. The successful implementation of this technology transfer is attributed to the DUALIS team of highly motivated experts from various fields.

Fig. 4: The quality management system is certified to EN ISO 13485 and guarantees the utmost quality standards

coincides with improving the patient‘s quality of life. All products and technologies undergo comprehensive testing and quality controls and are developed and produced in accordance with industry standards in order to be approved as medical products with the necessary technical documentation. DUALIS‘ quality management system is certified to EN ISO 13485 and guarantees the utmost quality standards. As a full- service partner, DUALIS offers other companies in the industry comprehensive services, from concept to the approval of medical technology products. In addition to development services, DUALIS technologies are also

Author: Julia Lorenz Product Management

DUALIS MedTech GmbH Am Technologiepark 8 + 10 82229 Seefeld/Germany Phone: +49 81 52 99 372 0 Fax: +49 81 52 99 372 72 E-Mail: julia.lorenz@dualis-medtech.de www.dualis-medtech.de


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GigaCAP®-HD The logical further development of the GigaCAP® technology with up to ten times the data rate in a compact design

Schleifring would have offered a rotary transmitter with three parallel 10Gb/s tracks. However, the use of parallel tracks increases the package size, whereas the GigaCAP®-HD is able to transmit these three tracks in the same diameter by segmenting the coupling structures. Thus it is possible to integrate up to 10 tracks in the space that previously would have been required to transmit a single track. This opens up totally new possibilities for the design engineers. Moreover, GigaCAP® lowers system costs. The smaller rotary transmitter allows the CT scanner as a whole to be compacter, lighter and thus cheaper. Further saving potential is offered by the use of GigaCAP® data links with lower speed classes. For example, 2,5 Gb/s or 4,25 Gb/s data links are significantly cheaper than the state-of-the-art 10 Gb/s data links. Thanks to GigaCAP®-HD, 10 data links with cheaper data rates can now be combined in order to obtain the system bandwidth required.

A further significant advantage of the GigaCAP®-HD technology is the scalability of the bandwidth. Thus, for example, it is possible to manufacture a midrange and a highend CT scanner from the same product range using the same rotary transmitter. The higher bandwidth requirements of the high-end system are then fulfilled easily by adding further GigaCAP®-HD segments. That reduces development costs and increases the number of identical parts. To sum up, it can be said that the GigaCAP®-HD (patented by Schleifring as US7466794) is the natural further development of the GigaCAP® technology and offers a data rate up to ten times higher in a compact design. Furthermore, GigaCAP®-HD offers decisive advantages with regard to costs and flexibility.

Contact: Schleifring und Apparatebau GmbH Am Hardtanger 10 82256 Fürstenfeldbruck Germany Phone: +49 8141 403-0 Fax: +49 8141 403-45 sales-med@schleifring.com www.schleifring.de

Schleifring

In a modern computer tomography (CT) scanner, the X-ray sensors rotate at more than 200 rpm around the patient and deliver large amounts of image data, which has to be transmitted from the rotating part of the CT scanner to the stationary part. Schleifring has been delivering rotary transmitter solutions for computer tomography scanners for more than 10 years, and thanks to the continuous technological progress achieved has become the market leader. This led to the introduction of the GigaCAP® technology at the turn of the millennium, enabling contactless transmission of CT data. GigaCAP® works with up to 10 Gb/s per track at a bit error rate below 10-12 as required. With regard to the data rate, GigaCAP® thus outperforms contact data slip rings by a factor of 200. Due to constantly increasing bandwidth requirements, the Xring joint venture was established in 2011, specialising in the real-time compression and decompression of CT data. Today, lossless compression with a compression factor of 2:1 can be achieved, in the case of lossy compression even 3:1 to 8:1. The newest Schleifring transmission technology is called GigaCAP®-HD (GigaCAP® High Density) and is setting new bandwidth standards. If in the past a CT scanner manufacturer wanted to build a system with a bandwidth of 30 Gb/s for example,


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KoKeTT – Mechatronic systems developed at the Hochschule Kempten For both healthcare and assistance in old age Introduction In the autumn of 2011, the KoKeTT Zentrum (KoKeTT Centre) was founded as part of a joint venture with the Hochschule Kempten and the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik of Technische Universität München. KoKeTT is associated with the area of specialisation Ambient Assisted Living (AAL) in the university course for mechatronics at the universi-

KoKeTT

Fig. 1: The KoKeTT areas of research

ty’s department of electric engineering. In this context, we have come to the conclusion that the application-oriented problems arising with the KOMPASS project (Kognitives Medizinisches Personalisiertes Assistenzsystem, personalised cognitive medical assistence system) at the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik should be studied intensively at a specifically equipped laboratory of the Hochschule Kempten. The aim of KoKeTT (KOMPASS Kempten Test- und Trainingszentrum) is to test the systems developed at Tech-

nische Universität München in cooperation with existing and new user groups for their practical usability. In this context, KoKeTT is available for all medical institutions intending to employ personalised assistance systems with modern information and communications technology or requiring support in the use of these systems. KoKeTT enables the testing of practically oriented therapy management systems for conditions such as diabetes, obesity, cardiovascular diseases, psychosomatic disorders, as well as for patients who require rehabilitative care. For this purpose, the test and training centre is equipped with various telematic measuring systems, providing different configuration options and allowing for different settings according to the different ICT infrastructures of medical institutions. Landline and mobile communications-enabled analysis and therapy platforms can be used, all of which are able to access an already existing server

(COMES®) by means of which problems such as telemonitoring and the development of personalised telematic therapy structures may be addressed [1]. Together with KoKeTT, potential users may develop suitable test scenarios, enhance existing equipment and also perform on-site tests of new diagnostic and therapeutic systems. Figure 3 on the next page illustrates the COMES® system employed here. Based on COMES®, we in Kempten are currently doing research in the following fields: 1. Development of novel therapy concepts for diabetes and obesity By using the mobile diagnosis and therapy platform COMES®, patients are enabled to view their physiological data such as blood pressure, blood glucose or their weight as well as their trends over time everywhere, at all times. Thanks to the already existing option of sen-

Fig. 2: From innovative therapeutic concept to user test in KoKeTT


KoKeTT

47

Fig. 3: COMES® is a modular telemedical diagnosis and therapy system serving both for self-monitoring and telematic therapy concepts

ding individualised feedback from the system to the user, he or she can rely on a telemedical companion and coach as a support during therapy or when changing habits and lifestyle. In addition, it is possible to transmit motivating messages and information - for example relating to diet and exercise - if desired. Currently, this concept is implemented and tested in the joint project PUMA, Prävention und Motivation am Beispiel von Adipositas (prevention and motivation concept for obese patients), of Hochschule Kempten and the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik which is sponsored by the Bavarian State Ministry of the Environment and Public Health. 2. The Virtual Lab in research and teaching The Virtual Lab, as implemented in COMES®, offers a great variety of application options in diagnosis and therapy. For the first time ever, individual data patterns can be gathered from the patient's real-life environment, thus allowing for an immediate and realistic impression of all manners of intervention structures to be obtained. The Virtual Lab is therefore well suited for clinical trials. In recent years, we have conducted a great number of

studies using the Virtual Lab, in particular with patients suffering from hypertension [2]. In research and teaching, the Virtual Lab may be used as a flexible learning tool for the use of mechatronic systems for healthcare and the assistance in old age. In hands-on projects, the students learn about the associated sensor and actuator systems, human-machine interfaces, telemedical assistance systems as well as various testing methods. 3. Biophysical feedback therapies Tone and Tonus is an exemplary project for a feedback therapy that employs our Cognitive Medical System COMES®. In this project, we have especially investigated the anti-hypertensive effect of certain iterative sound-patterns as a possible intervention option for patients suffering from arterial hypertension [2]. Another example for such a project is the creation of therapyrelevant lighting systems with modern LED technology which were developed in cooperation with the company Ambright GmbH. Besides the known physiological effects light has on humans, it also has psycho-active effects. The use of dynamic and individual lighting solutions in healthcare and in AAL is more and more appreciated.

4. Telemedical exercise therapies During the ongoing AAL research at the Hochschule Kempten, a telemedical exerciser intended as a home care product is being developed in a joint project with the Heinz NixdorfLehrstuhl (see Fig. 4). With this therapeutic exerciser, elderly persons with mobility impairments are encouraged to make their daily exercise. The training data such as calories and rotations per minute are recorded and transmitted to the COMES® database. The data thus obtained are used as a basis for a real-time animation in the form of a game that can be played on a TV set, for example a bicycle race. The results are evaluated by a physician who then gives feedback to the patient in the form of a message along with recommendations for further exercise. The project also includes the integration of further telemedical services and rehabilitation concepts. 5. Home – lifestyle – work The development of new solution concepts for work processes and workplaces may enable our working lives to be extended. In this context, technical assistance systems, e.g. in and around production environments, offer direct assistance and support for the employees. These systems help to compensate for age-related

Fig. 4: Illustration of the process during a training session with the Thera-vital exerciser of medica Medizintechnik GmbH in connection with COMES®


KoKeTT

48

impairments, and at the same time they offer the individual an additional degree of safety and freedom in the workplace or at home. The telemedical concepts described above can efficiently and sustainably be employed in company health and prevention schemes. 6. Assisted mobility We closely cooperate with the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik of Technische Universität München to develop personalised mobility aids for persons of all ages having mobility impairments. A main project in this context is „Der Rollstuhl als Fahrersitz - iMOB“ (wheelchairs used as driver seats iMOB). This project is conducted at Hochschule Kempten due to the high competence in mechatronics at our university. Conserving the mobility of persons with impaired movement capabilities is of paramount importance and thus the central aim in modern rehabilitation and exercise programmes. Studies have given evidence that even only 15 minutes of daily exercise do not only lead to a significant improvement in the individual’s quality of life but also increase life expectancy. Therefore, controlled motivation and exercise programs are the central aim of rehabilitative measures. The laboratory set up in Kempten complements the efforts made in the expansion programme „Gesundheitsregion Allgäu“ of the Bavarian Ministry of Public Health. It is predominantly intended for all estab-

Fig. 5: Illustration of the principle underlying the project "iMOB – Der Rollstuhl als Fahrersitz" (iMOB – wheelchairs used as driver seats)

Fig. 6: The implementation chain of KoKeTT: from user tests to everyday use

lished regional health care providers. In the existing cooperation of the universities at Lake Constance (Internationale Bodensee Hochschule IBH), this laboratory is, of course, also available to all further institutions for research, test and training studies.

Contact: Prof. Dr.-Ing. Petra Friedrich1

Hochschule Kempten1

Acknowledgements We would like to express our gratitude to the Heinz Nixdorf Stiftung, the DRV Klinik Bayern Süd in Höhenried, to KOMPASS, the companies Synergy Systems, medica Medizintechnik GmbH and OMRON Medizintechnik Handelsgesellschaft GmbH, as well as to the Bavarian State Ministry of the Environment and Public Health.

Literatur [1] Friedrich, P., Spittler, T., Tübinger, S., Tiedge, W., Wolf, B.; COMES® - ein Konzept zur personalisierten telemedizinischen Assistenz - oder - Auf Anruf Arzt, in eHealth 2011 Informationstechnologien und Telematik im Gesundheitswesen / Frank Duesberg (Hrsg.) Solingen, Medical Future Verlag, 2010 [2] Friedrich, P.; Etablierung einer telemedizinisch gestützten bioakustischen Hypertonie-Therapie mittels Virtual Lab, Dissertation am Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik, Technische Universität München, 2010. 1

COMES is a registered trademark of the Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik, Technische Universität München

Bahnhofstraße 61 87435 Kempten (Allgäu) Phone: 0831 2523 9256 Fax: 0831 2523 197 E-Mail: petra.friedrich@fh-kempten.de www.hochschule-kempten.de

Univ.-Prof. Dr. rer. nat. Bernhard Wolf 2

Heinz Nixdorf-Lehrstuhl für Medizinische Elektronik Technische Universität München2 Theresienstraße 90, Building N3 80333 Munich Phone: 089/ 289 22947 Fax: 089/ 289 22950 E-Mail: wolf@tum.de www.lme.ei.tum.de

M.Sc. Michael Häcker 1, 2

Dipl.-Ing. Kai-Uwe Hinderer 1, 2


49

We develop ideas of our custumers to a serial solution. Our mechanical knowledge is the base for industry and material independent system solutions. With our technology, and our services, we assist our customers on their way to success. Independent of the material and quantities, we work for many OEMs Industries.

Solutions for medical industry Biersack offers the complete competency of medical technology, especially in medical devices or mechanical components such as implants, we always deliver complete solutions. For years Biersack produced a large part of its business volume for the medical industry. Biersack develops innovative solutions and delivers from prototypes to series. So our customers can concentrate on their core competencies and successfully bring their products to market. Customers of Biersack trust the complete range of services: Support for R&D Chipping of all mechanical Precision Parts Sheet metal parts Welding of assemblies Leading parts because of radiation protection Procurement and supply chain management

Biersack assembles about 500 C-arms each year

Surface finishing (E.g., powder coating) by qualified partners Ongoing quality control and Documentation Screen printing and labels Assembly and final inspection Delivery and Storage Repairs, overhauls Spare parts service.

There is also a big experience in titanium machining, to produce high-precision components for implants or instruments. Flexibility, fast response times and individual adaptation to the customer wishes belong to Biersack’s philosophy. Satisfaction in terms of price, performance and punctuality is our top priority. We are looking for the challenge.

BIERSACK HISTORY Fundation 1948 by Johanna and Joseph Biersack Family owned company in 3rd Generation 2 plants with today about 5,000 sqm production area Specially trained workers Currently about 120 employees Annual turnover about 14 million euros High vertical integration, high degree of

Many customers appreciate the decades of expertise and experience in the field of radiation protection. Thus Biersack manufactured various components of lead. Biersack also offers services in the field of composite materials. Especially carbon fiber finds in medical industry more applications. Biersack produced hybrid components, of metal and carbon fibre benefits are e.g. weight and radiolucency. Biersack offers not only the complete Individual process chain but also precision parts from the inhouse workshop: for example, large aluminum castings for computer tomography are machined and prepared for assembly.

automation, modern machinery Certified to ISO9100, TS16949, ISO 14001

Author: Dominik Biersack A member of the Company management

Biersack Technologie GmbH & Co. KG Meisenweg 8 92339 Beilngries/Germany Phone: +49 (0) 84 61 64 15 - 12 Fax: +49 (0) 84 61 64 15 - 98 12 E-mail: dominik.biersack@biersack.de www.biersack.de

Biersack Technologie GmbH & Co. KG

We realize Ideas


50

Research projects in medical technology

Software company ASTRUM IT

How ideas become innovations The software company ASTRUM IT and its more than 130 employees are located right in the centre of the so-called “Medical Valley” in the European Metropolitan Region of Nuremberg. From its beginnings, this 20-year old company has been a preferred supplier and development partner for major manufacturers in the medical technology sector. The software specialists intend to use their innovations to take an active role in shaping the future of health care. Together with partners from the medical, scientific and industrial sectors, ASTRUM IT is focusing its efforts in several areas. Within the scope of its research projects, the company is developing the most modern technologies to network cooperation among physicians, along with innovative methods to support diagnosis and treatment in the area of neurologically-related movement disorders. The goal of this Erlangenbased company is to always be just slightly ahead of its time. Already in July 2010 ASTRUM IT launched the first research project of its own, and two more followed – in 2011 and the beginning of 2012. As a development partner, ASTRUM IT is supporting a research project by a company in the bioprocess engineering field. This takes advantage of the many years of experience in signaland imaging processing that have led to measurement- and analysis software for the online monitoring of cell growth.

Research projects in sensor-based movement analysis Together with the Division of Molecular Neurology of the University Hospital Erlangen (Outpatient Clinic for Movement Disorders) and the Chair for Pattern Recognition at the FriedrichAlexander Universität ErlangenNürnberg, ASTRUM IT is developing a complete mobile sensorbased system for automated

Sensor setup: The motes, which feature gyroscopes, acceleration sensors and Bluetooth for wireless data logging, are attached to customary trainers

movement analysis, in particular for Parkinson‘s Syndrome. The system will support the early diagnosis of neurodegenerative diseases and at the same time allow for continuous monitoring of the patient‘s treatment in his or her daily surroundings. Movement disorders lead to significant impairment of an individual’s autonomy and quality of life. With increasing age, the probability of gait abnormalities increases, as does the risk of suffering from Parkinson’s Disease. The diagno-

sis of this clinical picture at an early stage is difficult because visible motor symptoms appear only once the disease has progressed. In addition, due to demographic patterns, the number of patients diagnosed with Parkinson‘s is anticipated to continue to increase in the future. The medical research partner, the Outpatient Clinic for Movement Disorders of the University Hospital, has decided to focus on the care of patients with Parkinson’s Syndrome, and therefore offers good access to a comprehensive group of patients. In the clinical environment data on gaits of these patients, as well as those of a healthy control group are recorded with ASTRUM IT’s mobile sensor system, and analysed using pattern recognition methods. The goal of the mobile sensor system is to make objective sensor data available to the therapist to be used the basis for diagnosis and therapy, thus contributing to the improvement of patient care at all stages of the disease. In another research project being pursued jointly with the Chair for Pattern Recognition and adidas AG, a central “wearable computing platform” to be used in the health and sports sector is being developed. The goal here, and the challenge, is to integrate various sensors into clothing to compile their signals into a uniform plat-


Software company ASTRUM IT

51 Sponsors and partners The projects are being sponsored by: Federeal Ministry of Education and Research Medical Valley European Metropolitan Region Nuremberg Bavarian Research Foundation Bavarian Ministry of Economic Affairs, Infrastructure, Transport and Technology

Raw signal of an acceleration sensor, which was worn on the shoe for 90 minutes

form and to make the evaluations available for mobile applications such as health monitoring, movement motivation, but also for team- and individual sports. As part of the leading edge cluster in the Medical Valley European Metropolitan Region Nuremberg, ASTRUM IT is developing a communications platform for the networking of information systems in the area of private practices.

Networking of health service providers The rapid growth of comprehensive medical care centres and physician networks reflects the tremendous need for cross-practice collaboration among physicians in Germany. Clinical pictures are becoming more complex, and the growing trend towards sub-specialization among physicians further increases this need. Cooperation among physicians that spans locations will be the care model of the future. A preconditions for cooperation among physicians is the mutual exchange of information. The aggregation of business data allows for cross-location financial controlling. The ability of medical personnel at different locations to simultaneously see patient information guarantees the patient the optimal integrated treatment, resulting in better quality of care. Both due to the lack of uniform data exchange formats and the

lack of data quality, these electronic communication needs have not yet been filled. In cooperation with medical partners (Medizentrum Erlangen, Medic Center Nürnberg, MainArzt) and scientific ones (Chair for Computer Science 6 (Data Management) at the FriedrichAlexander Universität ErlangenNürnberg), ASTRUM IT is developing a platform that addresses precisely these problems. The platform compiles information from the different practice locations into a physicians’ cooperative. This data exchange takes place irrespective of the manufacturer of the primary information systems. Aside from this, processes are being developed that assure successive increases in data quality, thus enabling information to be transformed into knowledge.

Project partners: University Hospital Erlangen Molecular neurology -> Outpatient Clinic for Movement Disorders Psychiatric and Psychotherapeutic Clinic Friedrich-Alexander Universität Erlangen-Nürnberg Chair for Informatics 5 (Pattern recognition) Chair for Computer Science 6 (Data Management) Medizentrum Erlangen Medic Center Nürnberg MainArzt GmbH & Co. KG Practice of Dr. Käfferlein & colleagues, Bamberg Adidas AG, adidas innovation team, Herzogenaurach PreSens - Precision Sensing GmbH Author: Chantal Peter

Multi-professional networking Through their work on a variety of different issues, those in charge of projects at ASTRUM IT are particularly aware of the value of a close-knit network that connects all the partners in a collaboration. The exchange of know-how and experience among all those involved, whether from the medical, industrial or scientific sectors, goes hand in hand with the joint creation through these projects of technologies and methods that achieve the goal of product maturity.

Product Manager

Press: Katja Rümmele PR-Manager

ASTRUM IT GmbH Am Wolfsmantel 2 91058 Erlangen/Germany Phone: 09131/9408-221 Fax: 09131/9408-108


52

Premature babies need special treatment

Neonatology

Around 145 million babies are born all over the world each year, and about 14 million of them come into the world too early, before 37 weeks. They are called premature babies.

One of the most important aims in neonatology is the prevention of organ damage caused by therapeutic interventions; but at the same time it is essential that sick neonates receive the best possible care. This topic is particularly important in the management of premature babies. The two most vulnerable organs are the lungs and the brain. In the past few years we have learned that the way infants are handled during initial stabilisation in the delivery room can affect the long-term development of these organs. A few jets of gas supplied by a ventilator at high pressure appear to impair subsequent surfactant interventions and cause irreversible lung damage. Use of high FiO2 at birth affects the cerebral circulation for a few hours, and hypocapnia (low arterial CO2 partial pressure as a consequence of hyperventilation) could lead to cerebral ischaemic injuries as a result of interrupted blood supply to an organ. Preventive strategies such as CPAP and HFV are becoming increasingly popular in this context. A number of studies that have investigated CPAP have found this technique to cause lower rates of lung disease and unfavourable cerebral outcomes than more aggressive strategies.

success, it was decided that it would be logical to further develop the ”sindi”, and the result is the medin-cno.

The beneficial effects of CPAP include preventing RDS and lung trauma; it also has little or no harmful effect on the circulation. Nasal CPAP is given to most premature babies as initial respiratory support. Infants suffering from RDS are often intubated and given oxygen and surfactant, then extubated and switched to nasal CPAP. Starting with a non-invasive treatment can avoid putting a young life under so much stress. Medin Medical Innovations Gmbh has focused specifically on this technology in the past 15 years. The ”sindi” has now earned a very good reputation on the global market as a simple but effective CPAP driver. The device is very easy to operate and, when used in combination with the Medijet, produces very good therapeutic outcomes. After years of

This completely new device combines the conventional CPAP mode with other useful modes, such as apnea detection, support ventilation and oscillation. We can confidently describe this combination of modes as a world first; it is also worth pointing out that this is also the first device in the world to offer a non-invasive oscillation mode. Of course, the Medijet will also continue to be used for this purpose. In addition to these devices, Medin also offers the full range of accessories for effective treatment that does not cause infants any distress.

Contact:

Medin Medical Innovations GmbH Lindberghstrasse 1 D-82178 Puchheim www.medin-innovations.com info@medin-innovations.com


53

Safe, clean, fast

Two meters of highly precise weld seam on an area the size of a mobile phone – laser plastic welding is a convincing technology not only in the microfluidics segment

Putting people first – this equates to especially high specifications for products and processes. Laser plastic welding scores in both these areas. A safe welding process, tried-andtested validation processes in real time as the welding proceeds, and clean room capability, highlight the benefits of laser welding in the production of medical products. During laser plastic welding, the laser beam passes through the upper lasertransparent welding partner to melt the underlying laser-absorbent part. Thermal conduction then also melts the overlying part as well along the weld seam. When the component has cooled, the two parts are firmly joined together – as proven directly by several different quality control monitoring systems. Microfluidics is an area of application where all of these criteria are crucial

for success: hygiene, no particles, and precise welding geometries are absolutely vital for this innovative technology – and very convincing arguments in favor of laser plastic welding. A spectrum of testing methods guarantees the quality of the welded products: melt travel monitoring, pyrometer control, and burn detection all ensure that only passed parts leave the production process. The patented reflection diagnostic method

rent welds. This flexible and compact laser welding machine is specially equipped for the economical processing of small and medium series. In addition, LPKF supports interested companies with comprehensive expertise on process qualification and development with respect to materials, clamping and feeding technology. “We have an enormous amount of experience with medical technology components. Our Application Center uses this know-how to quickly help interested businesses configure their own processes to make them much more reliable,” says Frank Brunnecker, Vice President LPKF Laser Welding.

Ideal for every production set up The welding energy only affects the join line.

evaluates the light reflections from boundary surfaces to reliably assess whether or not welding has been successful. LPKF has responded to the growing demand with a special version of the LQ-Vario. In the MF version, a high-precision fiber laser is good for ultrafine weld seams with a width of only 70µm – as specified by microfluidics applications. The 2µm version, a special fiber laser with a wavelength of approx. 2µm, produces perfect joins for transparent-transpa-

LPKF laser welding has developed systems for laser plastic welding for more than ten years. The spectrum of products ranges from integratable and stand-alone laser systems for small, medium and large series. Contact:

Dipl.-Ing. Frank Brunnecker Vice President Laser Welding

LPKF Laser & Electronics AG Laser Welding Division Gundstr. 15 91056 Erlangen/Germany Tel.: +49 (9131) 61657-0 Fax: +49 (9131) 61657-77 info.laserwelding@lpkf.com www.lpkf-laserwelding.com

Laser Welding Systems

The laser welding systems from LPKF Laser & Electronics AG continuously confirm their outstanding suitability for medical technology applications. Unlike the other conventional welding methods, transmission laser plastic welding is a safe, hygienic and absolutely particle-free joining technology, which also boasts several different methods for online process monitoring.


54

PVVS – Better Networking in Healthcare

Patient Management Software

I-Motion GmbH developed a cross-web-based accounting software to manage patient data and to simplify the billing of medical services.The German abbreviation PVVS stands for Patient Management and Utility Software.

The PVVS (Patienten Verwaltungs- und Versorgungs-Software) by I-Motion GmbH is a comprehensive web-based management program (VPN). It is a cross-documentation program for integrated care in medical offices for networking in the professional and intersectoral patient care and for the implementation of IV contracts and its financing, accounting and data transmission system with dedicated rights and opportunities to develop their own form construction, management, and handling of various contract-specific tariffs. The software is Microsoft certified in its performance and the data protection commissioners of the insurances secure it from the data protection law. Further the software is able to make budget distributions to Morbi-RSA and to demonstrate a daily current budget utilization and to conduct any patient online registration and to show patient participation precise quarterly free of bureaucracy. Before using PVVS GPs, specialists, hospitals and health insurances communicated infrequently and not very effi-

Online statement of account (payers and health service providers bill charges) All contracts - every quarter at a glance

ciently. Each care provider entered his patient data in its local computer system and replaced it only once per quarter for the settlement of medical services with the clearing houses. Between physicians and hospitals, the data flow was rarely digital, but by printed referral letter or fax. Specialists or clinics explained in the doctor's letter the diagnosis and recommended treatment for the GP. The aim of I-Motion GmbH was to simplify and accelerate processes. The exchange with

the clearing houses should take place regularly, not only at the end of the quarter, it should also be possible to transfer diagnostic data in addition to the codes for billing. With PVVS the doctors and hospitals can quickly and easily access the digital patient data via their browser, they can document discussions and treatments and bill medical services directly. They see the current diagnosis, blood tests and test results of the other doctors and clinics.


Patient Management Software

55 on. Also the computer system of doctor‘s surgeries can be integrated within this program. I-Motion GmbH has developed, installed and operated communication solutions since 1998 for the German health system. In cooperation with the GMZ they began in 1998 with the construction of the website, went through several versions of a payroll software on to the latest project PVVS. End of 2011, I-Motion finished the first version of the Silverlight application PVVS and tested it live with 200 users for the first time.

Budget calculator for each contract - Current feedback in 15-minute intervals of your financial status of IV contract - Looking back at all previous quarters

The doctors clearly save time as writing medical reports is eliminated. In addition, the care for patients improves, since repetitive tests and the double regulation of drugs does not occur. Thanks to PVVS each doctor sees immediately after entering the settlement figure, how much budget is still available for the treatment of his patients. Through the direct budgetary control, the doctor can assess his financial situation at any time and doesn‘t need to

wait for the quarterly settlement that often requires later discussions. The doctor is now able to work indicatively and offer his services purposefully. PVVS is a centrally hosted web application based on Microsoft Silverlight, Microsoft Windows Server 2008 R2 with Microsoft Internet Information Services 7.5 and the Microsoft. NET Framework 4.0. The graphical user interface was programmed using Windows Presentation Foundati-

At the beginning of January 2012 experts from the Microsoft Testing Service tested the quality of patient management software thoroughly for a whole week. The PVVS application was specifically optimized by the test results and is very stable. Since February 2012, PVVS has successfully been in operation with 400 users. Our aim is efficient networking in health care and to reach this goal, better integration of pharmacies and patients is in planning.

Author: Robert Wölzlein CEO of I-Motion GmbH Internet healthcare provider

I-Motion GmbH Gesellschaft für Kommunikation & Service

All contracted members combined within the total network - Patient management - Lookup database for accountability - Information about local GP

Nordring 23 90765 Fürth/Germany Phone: ++49 911 936 336 - 0 Fax: ++49 911 936 336 - 10 E-Mail: info@i-motion.de www.i-motion.de


56

BavariaPartner of the World and Business Location with Future

Business Location Bavaria

The Free State of Bavaria ranks among the most economically strongest regions of Europe. Thanks to an offensive economic policy and a first class infrastructure, Bavaria is and remains a location with future. A productive network of "global players" and a wide class of efficient small and medium-sized enterprises exists to ensure growth and employment for almost all sectors.

The Free State of Bavaria covering more than 70,000 km2 is the largest Federal state in Germany in terms of area and with a population of 12.4 million people is the second largest Federal state after North RhineWestphalia in terms of inhabitants. Apart from the indisputable advantage as a living and leisure location, Bavaria enjoys an excellent reputation worldwide primarily as a hightech and service location. Compared with other countries in Europe, nearly all national economic data has reached peak values.

Successful race to catch up In an unprecedented race to catch up, Bavaria has developed from being an Agrarian state with an above average level of unemployment and a below average economic value-added at the end of the Second World War into a first rank economic power. A low rate of unemployment compared with all other federal states, a far higher proportion of self-employed persons and a high level of immigration primarily during the last ten years verify this fact. The rapid upswing in Bavaria has been

The free state of Bavaria is the largest Federal state in Germany in terms of area, and the second Federal state in Germany measured in terms of the inhabitants

Germany and Bavaria

accompanied by an above average employment dynamic. As a result, the number of employees subject to social insurance contribution regulations has increased by almost one quarter and is thus considerably greater than in all other federal states.

Offensive economic policy In the context of an offensive economic policy, the Bavarian state government is pursuing four strategic primary objectives:

Cost relief of the economy in global competition Release of free enterprise dynamics for the benefit of more growth and employment Support of the economy in the structural change in the line of „new products, new enterprises, new markets“ Through further development and expansion of the infrastructure based on the motto „Save – reform – invest“, the state and administration in Bavaria are being made fit for the future.

New Element „Cluster policies“ This is the next logical stage in the offensive of Bavarian innovative policies geared towards the „High-Tech-Offensive“ and the „Future of Bavaria“ offensive. Through the application of cluster policies, the existing state measures for the promotion of innovation are being expanded by organising the networking of economy and science. These clusters can basically be subdivided into


Business Location Bavaria

57

European Patent Office

Nuremberg

High-Tech clusters e.g. biotechnology, aviation and aerospace, medical engineering, environmental technology Production oriented clusters e.g. automotive, energy, engineering, logistics, sensors Cross-sectional technologies e.g. nanotechnology, new materials, mechatronics The cluster policy should create momentum to intensify the dynamics between companies and research establishments and optimise possibilities for cooperation

Prepared for the future The structure of the Bavarian economy is robust and future-oriented. A productive network comprising „global players“ and a wide class of efficient small and mediumsized enterprises in the industrial,

Wieskirche

Munich Airport

Munich Exhibition Centre

handcraft and service sectors ensures economic strength. The industrial sector is dominated by the industries of automotive and mechanical engineering, biotechnology and medical engineering as well as energy and transport technology. In the service sector, Bavaria holds leading positions in Germany as an insurance, banking and stock exchange centre. The infra-

structure is first rate in the key sectors of transport, energy and telecommunications. The large number of foreign companies that have been set up in South Germany within the last few years and decades, bears testimony to Bavaria‘s high degree of attractiveness as an international innovation location for high-quality research and development activities and productions. And last but not least, Bavaria has a variety of attractive „soft“ locational factors: world class culture, intact environmental conditions, high recreational value, a cosmopolitan outlook, interior security as well as social and political stability. Source: Bavarian Ministry of State for Economy, Infrastructure, Transport and Technology


58

Keep In Touch With The Future! finger pressure

Measurement systems

The novel company is the specialist in the development of pressure distribution measurement systems. With more than 30 years of experience our scientists and engineers are setting the benchmark for accuracy and reliability of pressure distribution measurement systems. Moreover, our team plays a leading role in expanding the systems’ fields of application.

nish the patient’s earning ability or make it even necessary to look for a different job. The pliance® manugraphy system from novel is an accurate and reliable system for monitoring the forces of each individual finger and the palm of the hand during gripping. For that purpose, up to 900 calibrated capacitive sensors are applied to each of three handgrip cylinders of different dia-

In addition to the emed® pedography platform (barefoot measurement for foot diagnostics and assessment of foot function), the pedar® in-shoe measuring system (evaluation of local load between foot and shoe) and the pliance® systems (assessing pressure distribution on soft surfaces and 3-D areas) the latest of novel’s innovations is the pliance® manugraphy system. Up to now the functional diagnostics of the hand has been often performed by using a dynamometer which is only able to capture the total force of the hand and fails to show the contribution of each single finger or even its phalanxes. It is exactly this information one needs to evaluate traumatic or degenerative changes of the hand’s anatomy which could dimi-

finger forces Moreover the pliance® audio cueing system with commands for gripping and releasing provides standardized and objective testing without external influences. The pliance® manugraphy system is also an important tool for therapy and rehabilitation because its integrated audio feedback system with user-definable gripping force thresholds allows the patient an autonomous training. Today well-known major corporations as well as prominent research institutions in medicine, biomechanics and industry worldwide rely on systems from novel. The pliance® manugraphy system is the next step to understand what does exactly happen when we touch the world with our hands!

meter. Each sensor is scanned 20 times per sec. which makes not only static but also dynamic measurement possible. By attributing the measured load distribution to the individual fingers, their phalanxes, to the ball of the hand and the thumb, it becomes possible to make a specified assessment of the function of each part of the hand.

For further information please contact: Contact: novel gmbh Ismaninger Strasse 51 81675 Munich, Germany Phone +49 (0) 89 4177 67-0 Fax. +49 (0) 89 4177 67-99 E-Mail: novel@novel.de www.novel.de


Magazines Future Technologies in Bavaria

the also in n o i t a ic d.info s publ nd thi .media-min i f l l i You w rnet www inte

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