Medical Technology in Bavaria - MEDIA MINDMULTIVAC Sepp Haggenmüller GmbH & Co. KG 23 MULTIVAC:...

Medical Technologyin Bavaria PROFILES

PORTRAITS

PERSPECTIVES

GLOBAL PARTNER

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Nanotechnology promises a broad range ofapplications for treating cancer and other diseases.

Successes are reflected in an inter-disciplinaryresearch approach by medical professionals,biologists and pharmacists, along with chemists,engineers and physicists.

„Personalised medicine“ is already a hot topic andwill continue to gain importance in the future.Sensors are used, for example, to measure thereaction of cells to medicines or harmful sub-stances.

This publication contains exciting topics such asstart-up companies, product and user ergo-nomics, safe packaging solutions, new study pro-grammes in medical technology and much more.Expert answers to complicated questions:

What opportunities does the InnovationResearch Lab (IRL) offer for realising newideas?

Why are communication standards soimportant in medicine?

What does „iMob“ mean for age-appropriateproducts and solutions?

How can time and money be saved by reusa-ble sterilisation containers?

In addition to the sophisticated „world ofmedical technology“, the fascination with

money and patents play a key role and enrichthe view of entrepreneurial activity (see pages60-82).

Walter Fürst, Managing Director

This publication can also be found on the

internet at www.media-mind.info

Editorial

New concepts and findings

for diagnosis and therapy

Masthead:

Publisher: media mind GmbH & Co. KG Hans-Bunte-Str. 580992 Munich/GermanyPhone: +49(0)89 / 23 55 57-3Telefax: +49(0)89 / 23 55 57-47ISDN (MAC): +49(0)89 / 23 55 57-59E-mail: [email protected]

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

Printed by: Druckerei Frischmann, Amberg

© 2015/2016 by media mind GmbH & Co. KGNo part of this magazine may be stored, copied orreproduced without the written consent of the editorial office

MULTIVAC Sepp HaggenmüllerGmbH & Co. KG

23

MULTIVAC: Reliable Packaging Solutions for the

Life Science and Healthcare Industry

Contact: MULTIVAC Sepp Haggenmüller GmbH & Co. KG

Cytotoxicity tests 20

Cytotoxicity tests on medical devices:

endpoints in comparsion

Author: Dr. Benjamin HoyEurofins BioPharma Product Testing Munich GmbH

Nanomedicine 13

Nanomedicine – The SEON-Concept

Contact: Prof. Dr. med. Christoph AlexiouHNO-Klinik Erlangen

Mainfranken 10

Health region Mainfranken

Contact: Theresia Oettle-SchnellRegion Mainfranken GmbH

seneticshealthcare

18

senetics – Intelligentservice for

innovative medical technology

Authors: Rico Brendtke, Michael Wiehl, Wolfgang Seningsenetics healthcare group GmbH & Co. KG

Ta

ble

of

co

nte

nts

Vision Engineering Ltd. 17

Looks different. Is different.

Author: Stefan SummerVision Engineering Ltd.

Forum MedTech Pharma e.V. 14

HOLZAMMERPlastic Technology

6

MedTech by VenturetecVenturetec mechatronics GmbH

24

AdvertBayern Innovativ

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AdvertForum MedTech Pharma

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Editorial 3

Advertnovel.de

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AdvertBAYERN INTERNATIONAL

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Cluster of excellenceMedical Valley EMN

8

ACTORmedROBOTIC SURGERY

22

A word of welcomeProf.Dr.-Ing. Erich R. Reinhardt

9

novel GmbH 28

pedoped ® The innovation for monitoring

body load

Contact: novel GmbH

Personalizedmedicine

42

Personalized medicine:

The benefits of electronic systems

Contact: Univ.-Prof. Dr. rer. nat. Bernhard WolfDipl.-Biol. Christian Scholze, TUM München

Hochschule Kempten 48

„iMob“ – A mechatronic AAL project of the

CoKeTT Zentrum at Hochschule Kempten

Contact: Hochschule Kempten

Institut for Medical EngineeringWeiden

34

Medical Engineering at the Ostbayerische

Technische Hochschule (OTH) Amberg-Weiden

Contact: Prof. Dr. med. Clemens BulittaProf. Burkhard Stolz

GAUDLITZ GmbH 26

IP-Protection StrategiesVossius & Partner

61

Clean utility treatment 33

All in one: the reusable sterilization, transport and

storage container

Contact: Ritter GmbH

IP rightsV.O. Patentanwälte

59

AdvertMEDIA MIND MOTION

3. CP

Advertventuretec mechatronics

4. CP

PATENTSSPECIAL

57

Sensor-based gait analysisAbt. für Molekulare Neurologie (FAU)

53

Get connectedLEONI

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AdvertC.H.BECK-Verlag

60

Central Institute ofHealthcare Engineering at FAU

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rm-port pivot armsITD GmbH

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AdvertSIEMENS

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Panoramic endoscopyFraunhofer-Institut IIS

46

Communication StandardsFraunhofer-Institut IIS

47

The metropolitain area aroundNuremberg has a very beautifullandscape and can refer to a longtradition in craftmanship as well asin industrial development. A greatmany of global market leaders isnative to this region. This is whatthe proverb “Nürnberger Tandgeht in alle Land!” means –“Goods from Nuremberg go toeach country!Today, it is medicine and medicaldevices which go to all countries.The area has advanced to a placeof the highest density for compa-nies of medical technology andmanufactures of medical devices. Nowadays and then, the basis there-fore were entrepreneurial abilityand skilled workers in order toadjust to changing circumstancesand challenges. And not least, thecolleges and universities aroundaccelerated this tremendous devel-opment. We are also domiciled inthis dynamic area and closely linkedto its craft and industry. Holzammer is a strong part of thisregion. Everyday, we are facingnew challenges. In just under 12months, a medical-technical globalcorporation developed togetherwith us a complex medical-techni-cal component, consisting ofabout 10 plastic parts with a singleweight from 100 g up to 8 kgsplus dozens of single parts. All ofthem are assembled on a base platemade of stainless steel. This plateand the aluminium profiles havebeen designed by assistance of asub-supplier. As the use of 3D-silicone gaskets was required, they

were engineered together withthe supplier.But how can a time frame of only12 months for the developmentbe held, if you consider the man-power of several thousands ofworking hours? Here, in the firstplace, we must get to know ourcustomers requirements anddemands. A prerequisite thereforeis the honest reflection of whateach partner can do for theaccomplishment of the project.We and our partner found both apositive answer to this issue.In the beginning of the task is acommon will to succeed in ouraims. Essential is a constantexchange of data: starting with draw-ings, preparing 3-D-data, manu-facture milled prototypes out ofhigh grade plastic support blocks,modification and testing of theseprototypes, making new prototypeswith paint, construction of mouldsfor production of plastic parts,injection moulding of plastic parts –at the same time with completingthe various tools, parallel develop-ment of main parts of stainless steeland aluminium profiles, proving themetal parts and adjustment aftertesting, overall proving the prepro-duction series, thereafter releasefor series production throughcustomer, design of special pack-aging convenient for sea- and air-freight. All in all, a quality insuringattendance from the beginning on.An indispensable basis for this is asense of responsibility of highestqualified employees (both fromcustomer and supplier side).

The engagement of creative sup-pliers, a reliable delivery serviceensuring a high-quality perfor-mance plus a commitment of allparticipants to a common goal,dedication to good work and apermanent checking of the entireworkflow with regard to deadlinescount as prerequisites. Achieving these goals takes theintegration of all efforts, ultra-modern machinery and technicalequipment, CAD and telecommu-nication systems. The involve-ment of external constructingengineers is a matter of course forus. This is what we from Holzammeraim to live together with our sup-pliers!

Weface

challenges

6

Pla

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te

chn

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gy Author:

Hans Holzammer, Managing Director

HOLZAMMERKunststofftechnik GmbHAm Ursprung 992369 Sengenthal/GermanyPhone: 0 91 81 / 2 95-0Fax: 0 91 81 / 2 95-34E-Mail: [email protected]

SOLUTIONS.

FOR THE FUTURE.

Bayern Innovativ GmbH promotes an open exchange

across industries and technologies and supports small

and medium enterprises in their innovation process.

It connects potential partners from industry and

science in five focal areas:

www.bayern-innovativ.de

digitalisation.

energy.

health.

material.

mobility.

15064 w

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The Medical Valley EuropeanMetropolitan Region of Nurem-berg (EMN) is a leading interna-tional cluster in the field of medicaltechnology. Here highly specialisedresearch institutions are activetogether with internationally lead-ing companies and at the same timemany growing companies as well.The latter cooperate closely withworld renowned institutions ofhealth research in the cluster tojoin together to find solutions forthe challenges of healthcare, todayand tomorrow. How extraordinarythis cluster is was emphasised inJanuary 2010 by its appointment astop national cluster by the FederalMinistry for Training and Research(BMBF).Functioning since 2007 as clustermanagement organisation has beenMedical Valley EMN.V, a consorti-um with currently 175 members frombusiness, science, healthcare, net-works and politics. Central tasks ofcluster management are further de-velopment, coordination and marke-ting of the cluster. We measure oursuccess and the relevant central issues:

Will we succeed in stimulatingnew ideas, projects and startups?Are we recruiting R&D grantsfor innovative projects?Do our services catalyse thecommercialisation of ideas?Do our operations promotecross-sector and trans-disciplinaryexchange?Do we reinforce exchanges insidethe cluster; are we improving theculture of cooperation?Do we promote creative minds?

Do we support the internationali-sation of our partners?

Our services help you in commer-cialising your ideas. The thingswe offer include recruitment ofsupport grants and counselling,promotion of startup founders,identification and brokering of clin-ical partners, market certificationand reimbursement, strategic re-quirements analysis and commer-cial health evaluation, open inno-vation as well as internationalmarket access. In order to provideyou with comprehensive support,we integrate established specia-lists and experts in the clusteraccording to the one-stop-shopprinciple.Tangible select operations on ourpart have been, and currently are,global coordination of the top-rate BMBF cluster (45 R&D pro-jects with a total project volumeof over € 80 million), manage-ment of the "Franconia ModelRegion for Digital Healthcarebusiness" (over € 8 million intotal project volumes focusing on"Optimisation of the medicationprocess"), management of theZIM cooperation networks"InnoPlanT.NET" and "Health-

care IT" and putting the project,"Science2Market," likewise sub-sidised by the Bavarian Ministryof the Economy, into practice. Inaddition, Medical Valley is anassociated partner of the top-flight European consortium "EITHealth," currently one of the larg-est health research programmesworldwide operating in the frame-work of Horizon 2020.

At the Medical Valley EMN top-rate cluster, research institutions,internationally renowned compa-nies as well as healthcare providersset standards in the field of medicaltechnology.

Cluster of excellenceMedical Valley EMN

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Contact the Cluster

Medical Valley EMN supports interna-

tionalisation – explicitly into the lead

markets of the US, Brazil and China

Jörg Trinkwalter

Medical Valley EMN e.V.

Hemkestr. 9191052 ErlangenPhone: +49 9131 5302-863E-Mail:[email protected]

Contact:

Medical technology remains a growth

market. The worldwide potential for inno-

vations in healthcare business that assist in

making care more effective and efficient is

immense. This means products for diag-

nostics and therapy as well as optimisation

of treatment processes.

Innovations are also crucial for the field

of prevention. The recognition of diseases

at an earlier stage enhances the chances of

cure and reduces the required expenses.

Particularly effective are measures that

help one remain healthy. That affects the

lifestyle and nutrition fields. Here is where

"social innovations" are needed in order to

motivate the public to exercise more and

to eat healthy foods. Motion is a very effec-

tive and efficient medication.

Databases are increasingly coming into

being which in empirical form contain

much information about health and pro-

gression of diseases in time. By evaluating

these databases knowledge is generated

that can be crucial for the treatment of

patients. For this, "big data" approaches

must be developed further with determi-

nation.

Innovations for health frequently stimu-

late concerns whether health is not be-

coming too expensive and that we cannot

afford to be healthy. In actual fact, the

innovations referred to can precisely make

contributions to keeping health financially

feasible.

The handling of all these issues makes

trans-disciplinary work necessary. That is,

structures must be created like the cluster

Medical Valley European Metropolitan

Region of Nuremberg which link up dif-

ferent disciplines, including business, and

facilitate efficient cooperation. The public

only benefits from all the outstanding

research results achieved by scientists if

they lead to products and services.

Commercialisation skills are of great

importance.

Prof. Dr.-Ing. Erich R. Reinhardt

Managing Director ofMedical Valley EMN e.V.

A word of welcome

9

The different segments of thehealth economy are highly potentgrowth markets that will decisivelycharacterise our future. A wholepalette of first-class players and opti-mal framework conditions form thebasis for successful innovations fromMainfranken.In recent years Mainfranken hasdeveloped especially dynamically in

the key technologies of biotech-nology and medical technology. Theexcellent academic environment, theproximity to the university, highereducation institutes and universityclinics, many successful traditionalcompanies and innovative start-upsare the basis for this success.In the Bavarian spa region Rhön –which, as well as Germany’s mostfamous spa location, Bad Kissingen,contains four other traditional spas –the latest therapy, spa and rehabilita-tion procedures are conducted.

The core of the university researchis formed by the faculties of medi-cine, biology, physics and chemistryand pharmacy at the prestigious Uni-versity of Würzburg. 25 institutes andresearch centres conduct research inthe medical and human-biologicalfield as well as in eight special re-search areas, for example the Bio-centre, an interdisciplinary centremade up of 14 university chairs.The Rudolf-Virchow Centre forExperimental Biomedicine, the DFG

Health region Mainfranken

Mainfranken

10

Region Mainfranken GmbH/Hub


Top biomedicine research

IGZ Würzburg

The innovation and founder cen-tre for biotechnology and bio-medicine offers fully fittedlaboratories, technical facilitiesand proximity to the Universityof Würzburg.

RSG in Bad Kissingen

Alongside ideal office and labo-ratory space, the Rhön-SaaleGründerzentrum offers a versatiletraining program in the health

business field. Other relocationoptions offer high-quality com-mercial land and business parks inthe best locations with optimalprice-performance ratios.

Research Centre, do top-classresearch in the field of key pro-teins.Fraunhofer ISC, Life Sciencedivision, does research and devel-opment particularly in the futurefields „Biohybrid Materials“ aswell as „Individualised Diagnosis“and boasts many years of excel-lent experience in the dentalmaterials field.The University of Applied SciencesWürzburg-Schweinfurt enhancesthe regional competencies withapplication-related courses and re-search projects in the field ofmedical technology.

Mainfranken is home to manyinnovative companies with world-leading medical technology. Re-gional strengths lie in the fieldsof dialysis technology, lung func-tion diagnosis and magnetic reso-nance technology:Fresenius Medical Care, Schwein-furt: Central production locationfor dialysis devices; CareFusion,Höchberg; Ganshorn MedizinElectronic, Niederlauer and ZANMessgeräte, Oberthulba: Lung func-tion/cardio-respiratory diagnosis;SKF Linearsysteme, Schweinfurt:Roller bearings, components and

systems for medical technology;Rapid Biomedical, Rimpar: High-frequency coils for MR imaging.

Under the leadership of Prof. Dr.Christoph Reiners, medical di-rector of the University Clinic ofWürzburg, and District Adminis-trator Thomas Bold, a regionalspecialist forum founded at theend of 2011 is pursuing the ob-jective of actively and positivelyshaping developments in theMainfranken health economythrough a strategy applying tothe whole region. In this, thefocus currently is on the imple-mentation of medical care pro-jects in the regional area, the useof telemedicine, the developmentof offerings for operational healthmanagement and the networkingof education and training offer-ings.In addition, Mainfranken offers aversatile and attractive range ofrelocation opportunities – de-pending on size, aim and medicalfocus.Locally, there are state-of-the-artFounder and Innovation Centresavailable, specially designed for theneeds of those starting up medicaland biotech companies:

11Mainfranken

World-leadingmedical technology

Health region facesup to the competition


Contact:

Region Mainfranken GmbH

Ludwigstraße 10 1/2 , 97070 WürzburgPhone: 0931-452652-12Fax: [email protected]

TheresiaOettle-Schnell

Project director

Nanotechnology promises a broadspectrum of applications for medi-cal imaging and molecular diagno-sis, as well as improved and tar-geted treatments for patients. How-ever, the implementation of nano-technology-based methods forthe treatment of cancer or otherdiseases requires an interdiscipli-nary approach combining theexpertise of health professionals,biologists, pharmacists, chemists,engineers and physicists. Superparamagnetic iron oxidenanoparticles (SPIONs) deserve aclose attention, as they can be uti-lized both for diagnostic imagingand for therapeutic approaches asdrug carriers. Currently, SPIONsare used for magnetic cell separa-tion in vitro and as contrast agentsfor MRI and for a new imagingmodality called “Magnetic ParticleImaging” (MPI), which is at pre-sent under development. But abovethis, SPIONs offer the uniquepossibility of combining drugdelivery and diagnostic imaging,serving as so-called “theranostics”. From the drug delivery point ofview, SPIONs are of high interestfor the individual treatment ofsolid tumors, because they can beused for magnetic accumulation ofdrugs in the tumor region. Addi-tionally, they can be used for localhyperthermia via alternating mag-netic fields and after treatmenttheir local distribution can bemonitored by MRI.A promising drug delivery approachutilizing SPIONs is MagneticDrug Targeting (MDT), whichenables the targeted local accumu-

lation of chemotherapeutics for thelocoregional treatment of cancer.Using this new treatment concept,the Section of Experimental On-cology and Nanomedicine (SEON)already showed very promisingpreclinical results in an animaltumor model (Fig. 1).The declared aim of SEON is totranslate the effective therapeutictreatment by MDT into a clinical-ly used therapy. To achieve thisgoal, a multitude of different re-quirements have to be fulfilled.Among those, a highly reproduc-ible and standardized productionprocess of the nanoparticles is oneof the prerequisites. Additionally,standardized physicochemical char-acterization, nanotoxicological eva-luation as well as ex vivo and invitro models, which simulate invivo conditions, are crucial. Bythese tests, the necessary parame-ters (e.g. magnetic field strengthand gradient, nanoparticle con-centration and drug dose etc.) areidentified to enable successful

preclinical animal studies. Theresults of these studies are thebasic requirement before startingthe GMP-compliant productionof the drug-loaded nanoparticlesand their approval by the respon-sible authorities.Additionally, the cooperation withphysicists and engineers is crucialfor the successful implementationof a suitable technical applicationenvironment in a clinical settingand for the noninvasive evaluationof the particle distribution in thetumor region after the treatment.The Section of ExperimentalOncology and Nanomedicine,which is located at the UniversityHospital Erlangen, Germany,addresses these fields of researchwith a special focus on targeteddrug delivery by using magneticnanoparticles and external mag-netic fields. The aim of this workis to improve the treatment ofsolid tumors and metastases byreducing the side effects of cancertherapy. This therapy holds thepromise of improved outcomes incancer patients and an improvedquality of life during and after thetreatment.

Further information can be found at:http://www.hno-klinik.uk-erlangen.de/seon-nanomedizin/

Nanomedicine –The SEON-Concept

Nanomedicine

13

Contact:

Professor Dr. med. Christoph AlexiouHNO-Klinik Erlangen, Sektion fürExperimentelle Onkologie undNanomedizin (SEON)

Else Kröner-Fresenius-StiftungsprofessurPhone: 09131 85-33142E-Mail: [email protected]

Fig. 1: Tumor remissions were achieved in

30 % of the treated animals within 7 to 11

weeks after a single application of 5% to

10% of a usual single systemic dose of

chemotherapy. A) VX2-tumor at the hind

limb of a rabbit before the treatment.

B) Hind limb of the same rabbit 11 weeks

after the treatment – the tumor shows a

complete remission. Image: SEON

In the further development of

innovations, cooperation agree-

ments are an important factor

for giving companies and re-

search institutions a competitive

edge over their rivals. It was

on this background that the

Forum MedTech Pharma e.V.

was founded by the Bavarian

State Government back in

1998. Since that, the associa-

tion acts as a hub between

science, business and research.

The Forum MedTech Pharma

focuses on the identification

of skills and potentials in the

fields of business and science.

The aim is to initiate innova-

tions in healthcare and thus

constantly increase the effi-

ciency and quality of medical

care. All of the players in-

volved with healthcare are inte-

grated into this process: Re-

search and development, pro-

duction, clinical applications as

well as cost bearers and self-

administration. Bayern Innovativ

GmbH operates the Forum

MedTech Pharma via a business

management contract, which

is now unique in Germany in

terms of bringing together

potential cooperation part-

ners.

Within its theme-based net-

works, the association focuses in

symposia and expert conferenc-

es on biomaterials, diagnostics,

clinical trials, minimal invasive

medicine, health telematics,

hospitals & clinical trials and the

health care system. Regulation-

related areas, however, such as

approvals or market access, for

example in the USA, China,

India and Arabia, are also dis-

cussed by experts in workshops.

The circle from scientific prin-

ciples to marketing is therefore

closed – an important feat in an

industry with the highest pro-

portion of exports in Germany.

Accompanying trade exhibi-

tions, as well as the association

stand at MEDICA, offer small

and medium-sized companies

especially the opportunity to

present their innovations in a

targeted manner. Further areas

14

Forum MedTech Pharma –Network for Innovationsin Health Care

With more than 600 members, the Forum MedTech Pharma is one of the leading cooperation net-

works in Europe. By offering a broad portfolio of network activities, it supports research institutes,

companies, clinics and other actors within the health care market: Individual consulting, expert talks

and conferences about technological developments are supporting members to select knowledge and

to scout trends. Expertise in regulatory affairs, intellectual property rights and market access as well

as several further education courses about medical technology are also offered by Forum MedTech

Pharma.

Areas of thematic focusand projects

Every two years 150 representatives from the medtech and pharma sector come together

to meet at the B2B Event "Partnering for MedTech & Pharma"

firms and lawyers and 4%

associations and insurance

funds – reflects the heteroge-

neous nature of medicine and

healthcare. Along with Ger-

many, the association has

members in ten other Euro-

pean countries, as well as in

the USA, Japan, India, China

and Hong Kong. In the seven-

teen years since it was found-

ed, the Forum MedTech Phar-

ma has welcomed about

20,000 delegates at 200 of its

own expert conferences. The

speakers of that conferences

support the activities of the

Forum MedTech Pharma free

of charge with their expertise

– just like the entire board of

management, chaired by Pro-

fessor Michael Nerlich.

15

of focus for the network acti-

vity include the field of educa-

tion and training in medical

technology.

From 2011-2013 Forum Med-

Tech Pharma supported the

national strategy process ‚Inno-

vations in Medical technology‚,

initiated by the federal govern-

ment. At the moment, the net-

work is engaged in the setup of

the BMBF- webpage

www.medizintechnologie.de.

With about 600 members, the

Forum MedTech Pharma is

one of the leading coopera-

tion networks in Europe. Its

member structure – 68% com-

panies, 10% research insti-

tutes, 9% hospitals, 4% law

The network


Vorsitzender des VorstandsProf. Dr. Michael Nerlich

Office:

Gewerbemuseumsplatz 290403 Nürnberg/GermanyPhone: +49 911 - 20671 330Fax: +49 911 - 20671 [email protected]

Author:

Marlene Klemm

The medtech- and pharma community will meet again from June 15-16, 2016 at the

international congress Medizin Innovativ - MedTech Pharma in Nuremberg.

The event takes place for the fifth time and gathers nearly 1000 participants

and 120 exhibitors

Independent network for innovations in medicine

600 members from business, science and the healthcare sector from

16 countries

Focal areas, including electronics & IT, medical imaging, biomaterials,

minimally-invasive technologies, pharmaceuticals, diagnostics and

clinical testing, regulatory affairs, markets and products, education

and training


Congress MedizinInnovativ – MedTechPharma 2016June 15 – 16, 2016NurembergConvention Center

The international congress “Medizin Inno-vativ – MedTech Pharma 2016“ is adres-sing researchers, developers, manufactur-ers, suppliers, service providers and clinicalusers of the medical and pharmaceuticalsector. With nearly 1,000 participants, thecongress has become one of the mostimportant meeting points for the healthsector in Germany in recent years. Combining a series of lectures on scienti-fic-technical and operational market-re-lated topics with a large exhibition withover 100 exhibitors, the congress providesideal conditions to connect participantsfrom various disciplines. The variety ofparticipants from company representa-tives to scientists and clinical users hasbeen a unique feature from the beginningof the congress. The two intensive and highly efficientdays of the “Medizin Innovativ“ congressgive international participants the oppor-tunity to acquire new knowledge andexpand their contact network, givingthem a competitive edge in the globalmarket.

65 High Level Lectures in Parallel Ses-sions Congress Language: German andEnglish (all lectures will be translatedsimultaneously) 120 Exhibitors Scientific Poster Exhibition International Delegations Job Wall Evening Reception at the NurembergImperial Castle

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The product and user ergonomicsbecome more and more importantfor the industrial optical microscopy.Especially in inspection, control andrework as well as long-term opera-tions on the microscope as usally ina lot of industrial areas in quality,R&D, manufacturing and laborato-ries, the user should have a relaxedposture in front of the system andincrease the efficiency considerably.This will be particularly achievedwith the new Lynx EVO stereomicroscope.

The highlight of Vision Engineer-ing‘s Lynx EVO stereo microscope isfor sure the patented Dynascopetechnology which offers the useradvanced ergonomics by removingthe need for restrictive eyepieces.That means the user can sit in a com-fortable position in front of themicroscope and perform his work inan ergonomic posture, which can

sometimes be for long periods oftime. An increased efficiency and produc-tivity depands especially on micro-scope ergonomics. There is criticallink between operator ergonomicsand increased productivity, efficiencyand ultimately improved quality. TheDynascope technology which isintegrated in the stereo microscopehead allows almost a fatigue-freeviewing without loosing image brilli-ance and contrast.Although the eyepiece-less advan-tage of Lynx EVO stems from stun-ning 3D (stereo) imaging, the realbrilliance of the patented design isthe simplicity of operation. Superior imaging combined withunrivalled ergonomics promotessimple hand-eye co-ordination, crit-ical for precision inspection tasks,re-work, repair and other mani-pulation activities. Operators canmaintain the highest levels of per-formance, even across an entireshift.

Benefitting from a high optical spec-ification, the 10:1 zoom ratio withlong working distances providesusers the ability to inspect up to120x magnification (6x – 60x stand-ard), ideal for a wide range of appli-cations.Lynx EVO is available in a range ofconfigurations, designed for use indifferent environments, from labora-tories and medical device cleanrooms, through to production, ormanufacturing inspection. Accesso-ries include HD image capture.

The amazing 360° rotating viewer forLynx EVO is the ultimate inspectionaccessory, permitting a full 360° rotat-ing view of the subject (at an angle of34°). Operators can simply switchbetween rotating and a conventionaldirect view for ultimate flexibility.The rotation provides enhancedobservation for many applications,including electronics, mechanical,medical and plastics components.

Looks different.Is different.

Vis

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Vision Engineering Ltd.Anton-Pendele-Str. 3, 82275 EmmeringT: +49 (0)8141 401670F: +49 (0)8141 [email protected]

Stefan Summer

Central EuropeMarketing Manager

Author:

Ergonomic Advantage

Eyepiece-less Technology360° rotating viewer

The new Lynx EVO stereo microscope in the flexible multi-axis bench stand version

New stereo microscope family foroptical visual inspection

Challenge, product innovation and regulatory affairs

transfer a project idea into a prod-uct. In former projects, seneticswas able to successfully developan innovative therapy devicewhich was created for pain relief.senetics took over the conception,CAD-realization as well as mate-rial analysis and selection.Another exciting developmentproject was the support for multi-morbid patients in the home-care-area. senetics implemented bothpatient-orientated application stud-ies and usability testings of theproduct with patients as well aswith medical staff.

Sensor technology body area

network

Currently, we develop a new typeof a sensor system, in cooperationwith the work of notable partners,which has the function of targe-ting and processing vital parame-ters, located in a wireless areabody network (WBAN). We arealways looking for interested part-ners in that field of action. Useranalyses are helpful to work outrequirements of a novel sensor

network. A feasibility study issupporting the decision, whetherthe technology is practical usefulor not. A market analysis makes iteasier to target groups and workout a specification sheet. Further,already the development of theprototype should include majorrequirements of the product as toclassify the medical device de-pending on the functional prin-ciple and pave the way towardscertification.

Biological validation and

usability testing

Our mechanical and electronicaltesting department warranties toproof both functional and safetyaspects as to point out potentialrisk factors at the human-ma-chine-interface considering ethical,legal and social implications inorder to create a maximum useracceptance. This is important toguarantee the safety of the user inall cases. An unoptimized productdesign may cause the develop-ment of biofilms with microbialcontamination for instance.Approximately 80% of care-asso-ciated infections are related tobiofilms. Hence, testing of poten-tial functional and usability risksare addressed using risk manage-ment according to ISO 14971such as in system and processFMEAs. The aim of risk assess-ment is to develop of medicaldevices and equipment as safe aspossible. Additionally several aspectshave to be implemented. This

senetics - Intelligentservice for innovative

medical technology

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Innovation and competence

Success in medical technology isdefined through innovativestrength, cooperation ability,knowledge and an excellent net-work. Especially the increasingcomplexity of the medical tech-nology and its varied regularities-requires strong cooperation abil-ities not only within medical tech-nology but with the pharmaceuti-cal industry as well. The seneticshealthcare group GmbH & CoKG is specialized in the field ofcooperative project management.Our departments work closelytogether as to cope with specialneeds of clients and projects inorder to solve given tasks reliably.

From the idea to the product

The way, which an idea needs towalk along in order to be trans-formed into a product successfully,has many sights. From the devel-opment towards the validation ofa technology and the examinationof biological safety, regulatoryaspects, as well as the collection ofrelevant clinic data, many facetshave to be taken into account.Hence, interdisciplinary compe-tences are really important for asuccessful realization of a productdevelopment.

Developmental competence

in the interdisciplinary field

The development of a medicalproduct is composed of manyrelated sub-processes, which needto be merged. This enables to

Microscopic evaluation of biofilms

on medical devices at the senetics

laboratories

technology (NeZuMed) or thenetwork for carbon fiber rein-forced materials (CarboMedTech)we serve as a One-Stop-Shopstarting from application andfunctionality analysis, working outessential requirements towardsthe development of norm compli-ant documentation and the sup-port of distributors. Our team ofexperts is happy to support youwith any problem that has to besolved.

devices. Risks such as biofoulingand inflammatory reactions caneasily be investigated without theneed of using animals such asrodents. Another positive aspectis the fact that those systems arebased on human cells and there-fore have a better predictabilitycompared to animal testing ofnovel materials for instance.

From the idea towards the

development and certification

Our R&D services work as aninterface between technical en-gineering and biomedical experti-se. This serves as big advantage inthe development of novel devicescompared to competitors. Addi-tionally senetics offers regulatoryknow-how and is therefore ableto take all relevant aspects intoaccount to take ideas to products.A major point within the validati-on of innovative technologies isthe production of relevant clinicaldata in order to proof the functio-nality. Together with other part-ners such as from our network forinnovative suppliers in medical

19senetics healthcare

contains the proof of biologicalsafety according to ISO 10993,which is an essential step withinthe certification process. This isimportant as material and techno-logy has to be evaluated in thecontext of the interacting methodand tissue. This testing steps areapplied on the final product,however it is highly recommend-ed to validate several parts in ear-lier project stages as well.Regarding the reduction, replace-ment and refinement guidelinesthe number of animal testing hasto be reduced as much as possible.This is not only important fordrug testing but for medical de-vices as well. Therefore modelsystems, that mimic the in vivosituation, can be applied. For non-invasive vital parameter monitor-ing within a WBAN, the princi-ples of tissue engineering willhelp further. Three dimensionalskin equivalents can be named asrole models. Those systems mimicthe in vivo appearing structuredskin and can already be applied forcytotoxicity testing of medical

Authors:

Rico Brendtke, Michael WiehlWolfgang Sening

senetics healthcare groupGmbH & Co.KG

Henkestrasse 91, 91052 ErlangenPhone: +49 9131 - 9 201 201Fax: +49 9131 - 9 201 202E-mail:[email protected] www.nezumed.de

Schematic setup of a wireless area body network that is developed by senetics. Noninvasive sensor systems and implants are combined

as to monitor vital parameters at different body areas. The recorded informations are then transduced via novel communication

systems to responsible monitoring stations and smart phones

Cell-based methods play anincreasingly important role in thesafety evaluation of medical de-vices since they are quick to per-form, inexpensive and repeatableas often as desired as opposed toin vivo studies. Moreover, theycan avoid unnecessary animal suf-fering. Biocompatible materialsor cytotoxic contaminants duringproduction can thus be screenedalready within the developmentprocess of the medical device. Inmoreover, cytotoxicity tests areregarded as especially sensitive,since the medical device itself oran extract are given directly ontothe cells lacking natural barriers(such as skin) or detoxificationsystems (liver, kidneys). While the cell morphology anddensity are evaluated in themicroscopic examination, end-points of biochemical cytotox-icity tests are often cell viability(XTT, MTT tests) or proteinquantification assays (BCAassay). In the viability tests, XTT(2,3,-Bis-(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide) dye is reduced byenzymes (dehydrogenases) ofliving cells which can be quanti-

fied photometrically. Whenusing bicinchoninic acid (BCA)staining, the total amount of pro-tein is determined after the deadcells have been removed fromthe test system, which likewiseleads to a measurable colorime-tric change in colour.For comparison between themicroscopic evaluation and thebiochemical endpoints XTT and

BCA, monolayers treated withdilutions of a test solution con-taining varying concentrations ofthe cell toxic chemical dimethyl-sulfoxide (DMSO) were incu-bated at 37°C for three days. After-wards, the cells were evaluatedmicroscopically (grading scoresaccording to ISO 10993-5).Then, the cell viability (XTT)and the growth inhibition (BCA)were determined. Results fortreated and untreated cells werecompared for calculation of rela-tive cell viability or growth inhi-bition, that ideally add up to100% cells in total.Using this correlation, the XTTresults were transformed intoBCA-compatible data to facilitatecomparison between both end-

Cytotoxicity tests onmedical devices:

endpoints in comparison

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Safety evaluationof medical devices

Fig. 1: Preparation of cells and extracts in 96well test setup

Fig. 2: Biochemical staining methods for

determination of cytotoxicity

The test for cytotoxicity is the most important in vitro basic test in evaluating the biological

safety of medical devices according to ISO 10993. In this process, the reaction of mammalian

cells on potential toxic substances which leach out of the medical device are examined. Quali-

tative (microscopic) or quantitative (biochemical) evaluation methods can be used to determine

the cytotoxic effect. Eurofins BioPharma Product Testing Munich has validated quantitative

and qualitative methods which allows a direct comparison of all of the endpoints.

scopic evaluation is often seen assubjective since the judgementdirectly depends on the analyst.The data presented by EurofinsBioPharma Product TestingMunich demonstrates that quali-fied personnel lead to equalresults in microscopic evaluationas in the quantitative evaluation.While the acceptance criterionfor a passed test using microscopicevaluation allows a maximum of50% dead cells (Grading Score 2), athreshold of 30% growth inhibi-tion is defined for the quantitati-ve evaluation procedure. Hence,according to ISO 10993-5, thequantitative determination shallbe preferred. Nevertheless, amicroscopic evaluation should beperformed in addition, to identifyany possible false positive or falsenegative results of the quantita-tive endpoints.

1) Roehm, N.W., An improved colorimetric assay forcell proliferation and viabilty utilizing the tetrazoliumsalt XTT. J. Immunol Meth., 142, 257 – 265

2) Smith, P.K., et al: 1985, „Measurement of ProteinUsing Bicinchoninic Acid.„, Analytical Biochemistry150, 76 – 85

Depending on the type of medi-cal device or the different regis-tration markets, the choice ofevaluation method can play animportant role. The XTT end-point for instance is often requi-red for approval on the US-mar-ket. However, medical devicesthat are liquid and intensivelycoloured or medical devicesshowing reducing properties caninterfere with XTT staining. Inthis case, the BCA test repre-sents an alternative. Conversely,for protein-containing medicaldevices the BCA method isapplicable only to a certain extentso that using XTT may be advis-able. We were able to demon-strate that both types of assaysare equally suitable and providecomparable robust results. Micro-

21Cytotoxicity tests

points. The mean values fromnine independent experimentsshow a good correlation betweenXTT and BCA data, proving,that both methods are compara-ble (Figure 3). However, slightdeviations were observed at lowconcentrations of test solution(lower cytotoxicity). A compari-son between the quantitativemethods and the qualitativemicroscopic evaluation is depict-ed in Table 1. Column 2 showsthe ISO 10993-5 standards toevaluate the microscopic gradingscores. Data obtained with quan-titative methods correspondedwell to the grading scores deter-mined microscopically (Table 1,Columns 3 – 5) with only minordeviations between the threeendpoints in the 13.2% test solu-tion.

Author:

Dr. Benjamin HoyStudy Director in vitro Pharmacology& Toxicology

Eurofins BioPharma Product TestingMunich GmbHBehringstraße 6-8, D-82152 PlaneggPhone: +49 89 899 650-0Fax: +49 89 899 650-11E-Mail: [email protected]/pharma-services

XTT vs. BCA method

Fig. 3: Cell viability (XTT) and protein quantification (BCA) assay are comparable. Cellular

monolayers were treated with varying concentrations of DMSO and then stained using XTT

and BCA. The XTT results were transformed. Test solution: 2:3 dilutions of 7.5% v/v DMSO in

cell culture medium

Table 1: Quantitative and qualitative endpoints are comparable

employees. Thanks to the flexibleconcept of sterilisable components,the equipment is ready for the nextsurgical intervention immediatelyafter completion of the last one. Itis compatible with all current op-erating tables and endoscopes andfurthermore it is completely main-tenance-free.The assistance-system is specialisedin visceral surgery, urology and gynae-cology. Not operating the cameramanually results in a stable andshake-free image, which not onlyincreases the quality of the operationbut also relieves the assistants ofsome of their workload, allowing themto focus on more important tasks.About AKTORmed GmbH: AKTORmed GmbH is based inBarbing near Regensburg and wasfounded in 2005. Both the develop-ment and manufacture of the prod-ucts takes place at the company‘s locati-on in Barbing. The company benefitsfrom many years of experience in thedevelopment of patient positioning,robotics, sensor and actuator devices.Its objective is to develop, manufac-ture and market mechatronic assis-tance systems for minimally invasive

Ten years of experience, severalthousand successful operations: any-one applying for a job as surgical as-sistant with these kind of credentialshas excellent prospects. If you add tothat optimum precision and versatility,as well as the quality of never beco-ming tired, then it‘s clear: this is theright candidate for the job.This is exactly the decision numeroushospitals have already made whenthey chose SOLOASSIST byAKTORmed - a robotic assistancesystem for holding an endoscopiccamera during minimally invasiveprocedures. Now its successor theSOLOASSIST II is on the market,bringing with it new innovations.For a wide variety of surgical inter-ventions laparoscopic techniqueshave become established as standardprocedure. Perfect imaging is thebasis for safe and effective surgery.Both the stable support and flexiblepositioning of the endoscope are ofparamount importance. The SOLO-ASSIST, which was developed in

2005, makes the surgeon‘s job easierand takes on the role of surgical assi-stant.Based on the proven concept of itspredecessor, the SOLOASSIST IIfar outperforms the original device interms of precision, versatility and easeof use. Of particular significance is thereduction in weight: at 9.5 kg, itsweight has been reduced by almosthalf. This is very noticeable in thehandling of the device: with the assis-tance of the SOLOASSIST II, thesurgeon is able to adjust the endo-scopic image with upmost precisionusing the joystick. Operation of thedevice is intuitive and easy to learnwithin a very short time. Along withthe motorised control, the endoscopecan also be positioned dynamically byhand. The advantages are clear to see: usingthe SOLOASSIST II relieves someof the workload placed on valuable

A new standardin the

operating theatre

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SOLOASSIST II

Joystick

Contact:

Robert Geiger

AKTORmed GmbH

Borsigstraße 1393092 Barbing/GermanyPhone: +49 (0) 9401 9320-110Fax: +49 (0) 9401 9320-115E-mail: [email protected]

In 1968 MULTIVAC launched itsfirst packaging solution for sterilemedical products onto the market.What at that time began as an off-shoot to the core business of foodpackaging solutions, is today a highlyspecialised business unit, whichdevelops solutions for the automat-ed packaging to GMP standards ofmedical items, pharmaceuticals andbiotech products.

Changing regulations, shorter lifecycles for products and the transitionto just-in-time production have re-sulted in ever smaller batch sizes in themedical industry and pharmaceuticalsector. At the same time, the industryis developing ever more complex andsensitive products and applications,which in some cases are even tailoredto individual patients. Many productsare also having to be packed in eversmaller batches in order to be able to

meet regional and statutory specifica-tions. These trends require packagingmachines to be capable of being con-verted quickly and easily to otherpack formats or materials, so thatshort set-up times can be achieved.For these applications MULTIVACprovides flexible and customer-spe-cific packaging solutions, which arecharacterised by their modular con-struction. This means that new com-ponents, such as identification andinspection solutions, can be inte-grated very easily.So that there can be strict compliancewith the statutory requirements with-

in the sector, MULTIVAC offers awide range of innovative packagingsolutions, such as for example theMULTIVAC Clean DesignTM. This machine concept is speciallydesigned for the demands of the lifescience and healthcare industry, and ittakes into consideration aspects of thepackaging machine such as processreliability, ease of cleaning, cleanroomcompatibility and compliance withrequirements on cleanliness.

MULTIVAC: ReliablePackaging Solutions

for the Life Scienceand Healthcare Industry

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Contact:

MULTIVAC Sepp HaggenmüllerGmbH & Co. KG

Bahnhofstr. 4D-87787 WolfertschwendenPhone: +49(0)8334/6010Fax: +49(0)8334/601-199E-mail: [email protected]

MULTIVAC is a leading provider world-

wide of packaging solutions: in addition

to thermoforming packaging machines,

its portfolio includes traysealers, chamber

machines, chamber belt machines, label-

lers, quality control systems and automa-

tion solutions as well as turnkey lines. The

MULTIVAC Group has over 4,500 em-

ployees worldwide, with about 1,600

based at the headquarters in Wolfert-

schwenden. With more than 70 sub-

sidiaries, the Group is represented on all

continents.

Packaging solutionsfrom MULTIVAC –

flexible, modular, intelligent

The portfolio includes a GMP-compliant packaging machine

in the MULTIVAC Clean Design™

One area in which MULTIVAC specializes is the packaging of sterile medical supplies

and pharmaceutical products

Electrical and optical rotary jointsin the area of medical technologyare commonly used in CT scan-ners. With regard to the inter-face, slip ring systems with a freeinner diameter of up to 1500 mmare required.CT scanners require the slip ringto transmit up to 150 KW ofpower for the x-ray source, and atthe same time transmit data ratesup to 10 Gbit/s without loss forthe detector. The power for theX-ray source can be transferredby contacting or non-contactingslip ring solutions.If contacting transmission is used,the type of rings and brushes areselected depending on the custo-mer requirement. These refermostly to the relevant parametersof "data rates", "frequency", "bussystems", and "performance". Inaddition, topics such as executingspeed and durability of thering/brush combination play adominant role. Other importantfactors are the interface and theprevailing environmental condi-tions. The brush and contact mate-

rial has to withstand a lapse ofmore than 10.000 km withoutsystem failures.The customer requirements varydepending on their desired mar-ket and can be divided into twosegments "low-cost" and "high-

end". In the low-cost segmentthe basic functions are performedat an optimal price performanceratio. Slip rings for high-end scannersusually have to guarantee the high-est data rates for images (> 10

MedTechmade by

Venturetec

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ics

Venturetec Mechatronics‘ slip ring system for CT scanners

Slip rings for CT scanners and nuclear medical devices

Venturetec Mechatronics is a specialist in the development and production of slip rings, rotary

joints, components and complex systems for the high-tech industry.

As a well-known partner to the high-tech industry with locations in Germany, Sweden, and the

United States, Venturetec Mechatronics supports leading companies in the areas of medical

technologies, industry automation, aerospace and surveillance. As a systems supplier we inte-

grate the entire mechatronic spectrum including the fields of mechanics, electronics, and

optics. Systems are in place to monitor and track your order from inception to completion.

Within this system we combine our competencies associated with development, production,

integration, and testing.

advanced new technology, VenturetecMechatronics is responsible for theentire production of the completesystem (for additional informationplease see www.ct-imaging.de).

From Nov. 29th to Dec. 04th 2015 thetwo companies, Venturetec Mechatronicsand Ct Imaging will present our systemsin the field of medical technology atRSNA 2015 in Chicago. We will be happy to arrange an appoint-ment with you at our joint booth.

Gbit /s), high transmission power(150 to 200 kW) and contactlessControl Links (bidirectionalGigaBit Ethernet) at high speeds(> 20 m / s rotational speed).In both types of systems a biterror Failure rate > 10-12 for theimage data links is required.

The Capacitive Link technology(capacitive route) is currentlyused in many different appli-cations for electrical slip rings.Venturetec Mechatronics is ableto transmit data rates of > 5 Gb/sper channel.The newly developed "Any ratesystem" of Venturetec Mecha-tronics provides data rates of1.25 Gbit/s to 3.125 Gb/s. Thesystem operates using a con-stant-emitting structure, trans-mitter electronics, receiver an-tenna, and receiver-electronicsover the specified "Any rate"bandwidth.Venturetec Mechatronics alsodevelops and integrates thecontactless passive optical solu-tion GigaFluoTM. This technologyoffers a unique approach for datatransmission in medical technolo-gies. High data rates are contactlessand transmitted through fluores-cent colors doped polymer fiberby a laser diode with "Side Illu-mination".This passive transmission technol-ogy already meets the new IECstandards for medical technologyregarding e-Mission and / or I-Mission.Stable and smooth data rates of1.25 Gbit/s can be achieved withthis approach.Since the polymer fibers have adiameter of only 1.0 mm, the datarate can be increased by simplyadding parallel lying fibers. Toler-ances of up to 10.0 mm have noinfluence on the stability of theoverall system.

In addition to the rotating transmis-sion systems, Venturetec Mechatro-nics also manufactures componentsand systems for CT gantry. Exam-ples include frame structures, drives,shaft and bearing mounts, collimatorboxes, laser indicators and more.

On behalf of and in collaborationwith our valued customer CT Im-aging, we currently manufacture thehigh-resolution chest computedtomography "Breast CT". For this

25Venturetec Mechatronics

System componentsfor CT gantries

Breast CT

Contactless transmissionsolutions: Capactive link

and GigaFluoTM

Venturetec Mechatronics‘ components and systems for CT scanners

Breast CT of CT Imaging

Contact:

Venturetec Mechatronics GmbHFüssener Straße 20-24, 87600 KaufbeurenPhone: 08141-82960-14E-Mail: [email protected]

Ville Dollhofer

BusinessDevelopment /Marketing Manager

The company GAUDLITZ GmbHwhich is headquartered in Coburg,with subsidiaries in China and theCzech Republic, can look back onmore than 75 years of experience inthe production of high precisionplastic parts and tools. GAUDLITZsuccessfully faces the growingrequirements in the area of ther-moplastic and thermoset injectionmolding. In our tool shop inCoburg, we manufacture tools andinserts with very high standards intolerances for the subsequent serialproduction in-house.

With 570 employees worldwideand about 150 injection moldingmachines - as well as the usage ofmodern technologies and produc-tion machines - GAUDLITZ hasbeen, since the very first day asynonym for quality and customersatisfaction in the sectors automo-tive, industry, and medical techno-logy. We view a high degree ofquality as a basic requirement for thelong-term success of a product andof a company. We as GAUDLITZhave been taking on this challengefor decades.

Particular requirements notablyapply to products from the areaof medical technology: GAUDLITZmeets these standards – no matterif e.g. certificates or clean roomproduction (class 8) – for smallplastic-components in the area ofdialysis, up to housing elementsfor blood sugar devices.

To our range of services, thereare among others: 2K-plasticinjection molding, thermoplasticproduction (e. g. PEEK, LCP,

GAUDLITZ –a full service

supplier

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Core competences

simplix components are available in a variety of colors or color combinations. Thus, an individual adaption of different test procedures,

or respectively, the branding in the company colors of the customer is realizable

Products for the highest quality requirements

mized solution for their demands.As a full service supplier with aspecialized tool shop and a broadrange of components in the area ofplastics manufacturing, we convertthe concrete task of our customerinto a successful product. We alsosee ourselves as a partner for start-up-companies and are open fortheir future oriented ideas. Withour experience we can, practicallyoriented, already assist in the earlystages of the development up untilthe market-ready solution and serialproduction.

You can receive more informationunder www.gaudlitz.de or [email protected].

We would be delighted to wel-come you soon to our newly de-signed website and proudly presentyou at this point our new logo.

In October 2010 our sales teamreported the first time about ourpatented, own developed, samplepreparation system – recentlyknown under the name of “sim-plix”. With simplix we realized asignificant reduction of the pro-cessing time during the prepara-tion process in laboratories andas a result generate cost advan-tages for our clients. Clinical studieshave identified a time advantageof one minute per sample at thesame quality of the test results, incomparison to available productsof other manufacturers. Themillionfold sales of simplix towell-known customers underlinesthese results.

Only together with our custom-ers we can be successful. This iswhy we already start workingclosely together with them dur-ing the development of the plas-tic based products and modules,in order to implement the tech-nically best as well as cost-opti-

27GAUDLITZ GmbH

PPS) and thermoset processing,fully automated insert molding aswell as the finishing of individualparts and the complete assemblyof systems.

We implement new technologies(e.g. 2K with caoutchouc) to-gether with our customer. It isself-evident that we are certifiedafter all vital certificates (ISO9001, ISO 14001, ISO TS 16949,ISO 13485, and ISO 50001).

We already differentiate our-selves from our competitorsduring the research and develop-ment phase, in particular throughour technical consultation; wetherit be during the selection of theright materials for a product, thecoordination of the part geometryas well as the mold-flow analysis.Together with the customer, wedevelop and produce high qualitytechnical components along thevalue chain, in order to meet therequired product life cycle de-mands.

Contact:

Dominic SchauberSales Management Medical and Industry

GAUDLITZ GmbH

Callenberger Str. 42D-96450 CoburgPost office box: 17 4396407 CoburgPhone: +49(0) 95 61/ 648 - 0Telefax: +49(0) 95 61 / 648 - 648E-Mail: [email protected]

Simplix

The production of the components of simplix as well as the filling procedure takes place

in our clean room class 8

simplix is an easy to use, highly functional, reliable and safe system to absorb laboratory samples. All components of the system can be

closed leak-proof and can be colored based on the customer‘s desires

With the new pedoped® technol-ogy developed by novel it is nowpossible to accurately measure thenormal ground reaction forceunder the feet statically or dynami-cally.The ground reaction force sup-ports the body during standing,walking, or running. When thebody is in motion, this force canreach a multiple of the bodyweight.The pedoped® sensor insole accu-rately measures the load under thefoot independent from which partof the foot is loaded (heel, wholefoot or only the toes). pedoped®

precisely measures the normal groundreaction force. The new pedoped® technologyincludes a matchbox sized elec-tronics and communicates wirelesslywith a smartphone via Bluetooth®.The data is transmitted real-time tothe smartphone. The user receivesinstantaneous biofeedback aboutload of the feet via sound or vibra-tion. Several smartphone apps will

be available, each tailored to thespecific application such as loadmonitoring after implanting artifi-cial joints, measuring of balance

and stability of gait, comparison ofground reaction force in sport bio-mechanics, assessment of foot func-tion with footwear, improvementof running technique, as well asother applications. pedoped® is a further advancementof the measuring systems devel-oped by novel GmbH in Munich.For over 30 years, novel‘s systemsfor foot diagnostics (pedographysystems: pedar® and emed®) have

been used successfully in researchlaboratories, athletic footwear com-panies, hospitals and in orthopedicdepartments across the globe.novel‘s product family is completedby the pliance® systems that moni-tor the load on all body surfacesduring sitting, lying down, grip-ping, and under prosthetics. Themanugraphy® system was developedfor functional hand diagnostics.As novel aims to push investiga-tions of mechanical load on surfacesof the human body, the companyregularly participates in major con-ferences related to orthopedics,biomechanics and sports. In thefield of Diabetic Footcare the novelsystems are said to be the goldstandard for early detection of footulceration that are caused by highlocal pressure under the foot.The international Expert ScientificMeeting (ESM), biennially spon-sored by novel, assembles leadingexperts from load distributionscience to present and discuss thelatest findings in basic and appliedresearch.

www.novel.de, www.pedoped.dewww.emed.de, www.pedar.dewww.pliance.de,www.manugraphy.de

pedoped®The innovation

formonitoring body load

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Contact:

novel gmbh

Ismaninger Str. 5181675 Munich, GermanyPhone: +49 (0) 89 4177 67-0Fax: +49 (0) 89 4177 67-99E-mail: [email protected]

pedoped® iPhone app display

pedoped® insole with electronics

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6. Logistics

❞❖❱❲❳◗❖❞ ❨❨joint de" nition of the

speci" cations

❳❯ ❲ ✐❙❳❩❳❱ ❘❬ ❙❲❩❱❯❖❩✐❭❳❙ ❨❨already in 2D or 3D

in the prototype phase

❱❲❳◗❘❩t❚❲❞❖ ❨❨cables based on copper

and/or optical " ber

❩❖❲❞rt❱❘t❳❯✐❱❲◗◗ ❨❨assembled cables, cable

systems and subsystems

❲✐✐❛❩❖❞ ❨❨electrically, mechanically

and thermally tested

✇❘❩◗❞✇❳❞❖ ❨❨individual logistics

concepts

Can wiring in! uence the properties of

medical products? >> Yes! LEONI has

been showing for more than 30 years

that innovative cables and system solu-

tions can support medical devices and

systems in their reliability, ! exibility,

easy handling and above all in their

patient safety.

>> Meeting the objective with know-how and creative solutions❪✦❫✥✩✮ ✥✩ ★✲✣ ✣✦✢✤✱ ✱✣✦✢✪ ✧✴✥✤★ ✦✩ ✣✰★✣✩❴

sive range of special cables for medical

devices based on existing know-how and

specialist production methods, LEONI

started its assembly business for this

market at the beginning of the 90s.

Over the years LEONI established itself as

a systems supplier by developing many

innovative ways to optimise cable compo-

nents. Business Unit Healthcare now

regards itself as a systems partner for

tailor-made and ready-to-install cable

solutions that gets involved with its

customers’ products as early as the

development phase – a range of service

that has by now convinced most of the

major medical technology OEMs.

LEONI is able to supply everything

associated with wiring from within its

own company and is also exceptionally

well positioned with respect to quality

assurance as well as certi" cation to

national and international standards. In

addition to its self-conception as a systems

provider, the strength of Business Unit

Healthcare lies in an extensive portfolio

that is virtually unique in the medical

technology sector. This includes:

>> Cable systems unsusceptible to disruption

❵✱ ✧✣✥✩✮ ✥✩❫✬✤❫✣✳ ✥✩ ★✲✣ ✵✢✬❜✣✪✪ ✬❡ ✳✣❫✣✤❴

oping a device at such an early stage,

LEONI can specify the cable systems with

the integrated components in the best

possible way and minimise interference

on the wiring. LEONI provides copper and

" ber-based cable solutions for use in radi-

ation-intensive applications whose atten-

uation remains virtually constant even

when exposed to high radiation.

>> Permanently mobile subsystems ❢✣✦✳✱❴★✬❴✥✩✪★✦✤✤ ❜✦✧✤✣ ✢✬✴★✥✩✮ ✪✱✪★✣✫✪ ✧✱

LEONI support the long-term mobility of

medical devices. Fitted with an ideally

integrated cable reservoir or spring return

system, they can reduce the tensile force

LEONI – Business Unit Healthcare

Cabling with a system

This is how innovatively systems supplier LEONI supports

the specific requirements of medical technology >>

Innovative Healthcare Technologies

✬✩ ✥✩✳✥❫✥✳✴✦✤ ❜✦✧✤✣✪♦ ❣✲✣ ✪✱✪★✣✫✪ ❡✴✤❤✤

both national and international stan-

dards, and LEONI can draw on more than

700 UL AWM styles.

>> Space-saving cable❥❦❧♠♥ ✲✱✧✢✥✳ ❜✦✧✤✣✪ ✦✢✣ ❜✴✪★✬✫ ✫✦✳✣

to individual requirements and can

contain various conductors to provide

reliable power, signal, data and light

transfer as well as media hoses. The

core diameter and thereby the overall

size of the cable is reduced by means of

LEONIzell® skin-foam-skin extrusion.

LEONI furthermore supplies highly

miniaturised cables with single-core

diameters of up to 50 AWG.

>> Optimised cable surfaces❥❦❧♠♥ ✮✥❫✣✪ ✩✬★ ✬✩✤✱ ✥★✪ ✧✥✬❜✬✫✵✦★✥✧✤✣ ✪✥✤❴

icone cables such optimised properties as

lastingly improved gliding properties,

which are maintained even after numer-

ous autoclave cycles.

In addition, an acid-based technology

gives plastic surfaces a germ-killing

e$ ect. With antimicrobial cables, LEONI

can contribute to reducing the risk of

infection in hospitals.

>> Tested quality❧✴✢ ✧✴✤♣ ❜✦✧✤✣ ✥✪ ✫✦✳✣ ★✬ ✲✥✮✲ ✪★✦✩✳✦✢✳✪

of quality and is thoroughly tested both

during production and thereafter. Every

single cable system is meticulously tested

Medical technology applications are especially varied – LEONI provides wiring optimised for both medical devices and near-patient applications.

The portfolio ranges from bulk cable to complex systems.

before it is supplied. Depending on cus-

tomer requirements, we apply dedicated

testing and measurement methods and

tests in accordance with national and

international standards. >>

Detailed contact information regarding

our international locations can be found at:

www.leoni-healthcare.com >> Sales

q❏✼ ▲✶✷✸✹ ✷s✹✷✸ ❂●✾❀✼✿✾ ❂❃✻❀✾❀❃✿❀✿❍ ✻✉✻✾✼■ ❀✻ ❋❊❄❄✼✿✾❈✉ ❊✿❉✼❄❍❃❀✿❍ ✾❏✼ ✈①② ③④⑤⑥⑦⑧ ●❂❂❄❃❁●❈ ❂❄❃❋✼✻✻ ●✿❉ ❀✻therefore not yet available for sale. Planned launch >> 2015.

“As a systems supplier ⑨✣ ✪✴✵✵✬✢★ ★✲✣ ✫✦✩✴❡✦❜★✴✢✣✢✪ ✬❡ ✫✣✳❴

ical devices and systems as early as the development process,

designing the best possible cabling for their products or supply-

ing individual components – from a small jumper wire through to

ready-to-install subsystems.

As a cables specialist ⑨✣ ✲✦❫✣ ✦ ❜✬✫✵✢✣✲✣✩✪✥❫✣ ✢✦✩✮✣ ✬❡ ✳✣✳❴

icated technologies and materials that optimise our cables for

use in a device or near a patient. We therefore in essence do not

have any solution that we supply again in identical form. We are

represented worldwide – currently strongly so in Europe and Asia

and with a focus on North America.”

⑩❶❷❸ ❹❺❸❻❶❼❸❽❾ ❿➀❻❶❽❸❻❻ ➁❽❶❾

Healthcare

Siemen-Jannes Meinders >> Contact >>

LEONI Special Cables GmbH

Business Unit Healthcare

Eschstrasse 1 · D-26169 Friesoythe

Germany

Phone: +49 (0)4491-291-5040

Fax: +49 (0)4491-291-5041

E-mail: [email protected]

www.leoni-healthcare.com

>> LEONI has developed an intui-tive and high-precision patient positioning system.❵✦✪✣✳ ✬✩ ✥★✪ ✫✦✩✱ ✱✣✦✢✪ ✬❡ ❜✤✬✪✣ ❜✬✩★✦❜★

with cancer treatment centres and inte-

gration of radiation systems, LEONI has

recognised the major demand of the

medical sector to apply its comprehen-

sive experience as well as its highly

reliable and proven industrial products

and solutions to patient positioning:

LEONI ORION.

The system’s centrepiece is an intuitively

operable software solution, which

ensures that all software and hardware

components like the robot and the 3D

camera system with real-time control

work perfectly together. Complemented

with cobotics technology, i.e. translation

of the therapist's manual guidance into

the robot's movement to achieve easy

patient positioning, LEONI ORION con-

stitutes an unprecedented standard in

radiotherapy.

Bene" ts: The system has dynamic posi-

tion control with six degrees of freedom

and accuracy of less than one millimetre.

The integrated tool changer for the

patient table reduces the cycle time per

patient signi" cantly. The system is fur-

thermore ! exible and easy to operate.

➂➃➄➅➆➇➄➈➉ ➄➊➋➌➃➍➃➆➄➃ ➄➃➆➍➎➃

Friesoythe, Germany

➏➐➑➒➓➔ ➒→➔➒➓➏ ➄➊➋➌➃➍➃➆➄➃ ➄➃➆➍➎➃

Chartres, France

➣➎➊↔↕➄➍➇➊➆ ➈➆↔ ↔➇➙➍➎➇➛↕➍➇➊➆ ➉➊➄➈➍➇➊➆➙

Friesoythe, Germany

Georgensgmuend, Germany

Halver, Germany

Roth, Germany

Stará Turá, Slovakia

Kitchener, Canada

Changzhou, China

DE Friesoythe

Georgensgmuend

Halver

Roth

SK Stará Turá

FR Chartres

CN Changzhou

CAKitchener

>> Global presence

The polySteribox® from RitterMedical for sterilization of instru-ments, storage and transportation ofsterile goods is a secure solution inline with the requirements of valida-ted processes affecting sterile goods.The polySteribox® is available infour different and compatible stand-ardized sizes (SH, M, L and XL)which are suitable for all currentsterilization automats. It is producedout of a transparent, dimensionallystable and high temperatureresistant (up to 150 °C) material.The polySteribox® is therefore suit-able for autoclave vacuum sterilizati-on up to 134°C, depending on thesterilization method recommendedby relevant authorities such as theRobert Koch Institute in Germany.In addition, it can be used for plasmasterilization (STERRAD®) as wellas for gas sterilization (formaldehyde

and ethylene oxide) at a maximumof 65 °C. Lid and bottom close her-metically and include a built-in bac-teria barrier.Ritter Medical offers two kinds ofPTFE filter sets: a permanent life-

time filter or an annual filter whichneeds to be changed once a year.The patented interlocking system iscompatible within all differentmodels and prevents fromaccidental opening of the box. Theboxes are space-saving and easy tostack, therefore they are well-suitedfor storage of sterile goods.

All in one:the reusable sterilization,

transport andstorage container

Cle

an

uti

lity

tre

atm

en

t

33

Contact:Ritter GmbHKaufbeurer Straße 5586830 SchwabmünchenPhone:08232/5003-0Fax: 08232/5003-48

Polysteribox in 4 sizes: SH, M, L and XL

Loading an autoclave with 6 polysteribox SH

Save time and money with re-usablesterilisation-container

The OTH Amberg-Weiden hasestablished a proven track recordin medical engineering over thepast years: In summer 2010, theBachelor’s programme in MedicalEngineering started operations,and a consecutive Master’s pro-gramme has been on offer sincewinter 2014/2015. Currently, thereare 170 students enrolled in thetwo programmes. In addition,roughly 1,100 square metres ofhigh-tech laboratory space havebeen set up at the WeidenTechnology Campus (WTC)(see Fig. 1). Against this background, an Insti-tute for Medical Engineering(IfMZ) with its registered seat inWeiden was founded under theauspices of the Dean, Prof. Dr. FranzMagerl, and Prof. Dr. ClemensBulitta, who also serves as theInstitute‘s director. The newinstitute‘s goal is to expand appli-cation-oriented projects in thefield of medical engineering andto intensify the network of part-ners from industry, such as hospi-tals or manufacturers of medicaltechnology.The IfMZ is a scientific researchinstitute of the OstbayerischeTechnische Hochschule (OTH)Amberg-Weiden and serves as acentral interface to connect alluniversity-related activities be-tween research, teaching and in-dustry in the field of medicaltechnology.With its team of professors,scientists and engineers from dif-ferent areas of specialisation, the

Institute can draw on a broad rangeof competencies in the fields ofmedicine, molecular biology andtechnology. In close cooperation with trans-regional and inter-regional part-ners, the IfMZ interlinks appliedmedical-technical research withthe nuts-and-bolts education ofhighly qualified specialists for thepromising field of medical tech-nology. In this context, the Insti-tute cooperates with variousbusinesses from the medical-tech-nical industry; with hospitals,medical practices as well as exter-nal research institutes. Specialemphasis is placed on the redevel-opment and advancement of diag-nostic and therapy systems as wellas on the optimisation of medicalexamination procedures.The IfMZ’s research activitiesinvolve imaging systems as well assoftware and hardware compo-nents. Further core activities in-clude the areas of hygiene, clean-room technology and microbiolo-

gy. For these activities, the IfMZhas excellent equipment and labor-atory facilities at its disposal, thusensuring outstanding conditionsfor both teaching and application-oriented research.The IfMz’s activities regardingpractical education and research-related projects are concentratedin the Weiden Technology Cam-pus (WTC). Most of the speciallaboratories are located on theground floor of the building,which is opposite the new lecturehall (see Fig. 1 and 2). The mainbuilding of the Faculty of Indus-trial Engineering accommodatesthe laboratories for ElectricalEngineering, Medical Electronicsand Biosignals as well as the la-boratory for Materials Science I.The latter is equipped with twoCT systems and an electron mi-croscope and serves to supportresearch activities and teaching inthe area of imaging.The professors of the MedicalEngineering programme are in

Medical Engineering at theOstbayerische Technische Hoch-schule (OTH) Amberg-Weiden:The Success Story Continues!

34

Inst

itu

te f

or

Me

dic

al E

ng

ine

eri

ng

We

ide

n

Fig. 1. The building of the Weiden Technology Campus (WTC)

available to graduates of Bache-lor’s programmes in MedicalEngineering, Medical Informaticsor Medical Physics. The goal ofthis programme is to equip stu-dents with the skills and qualifica-tions required to hold an execu-tive position in an internationallyoperating medical engineering orpharmacy company with variousfields of activity, such as research,development, production or ser-vices. The scope of work involves,for example, development andinnovation management; systemdevelopment and medical en-gineering development; IT andimaging systems; research anddevelopment in medical engineer-

ing; simulation-based develop-ment processes; diagnostics; orprocess and quality management.Graduates are qualified to assumeresponsibility within their groupor organisation, to provide guid-ance for mastering complex tasks

answer to this question; individualcircumstances have to be takeninto account. However, an excit-ing opportunity has arisen in

Weiden: In the winter semester2014/2015, the OTH AmbergWeiden and the OTH Regens-burg set up a joint Master’s pro-gramme in Medical Engineeringwith the main emphasis on “Tech-nologies and Systems”, which is

35Institute for Medical Engineering Weiden

charge of the different laborato-ries, which offer research facilitiesfor student projects as well as forcurrent topics in R&D. The labor-atories are also used by graduatestudents to conduct complexmeasurements under predefinedconditions within the scope oftheir final papers. They are alsomade available to our partnersfrom industry: Research problemsthat cannot be addressed by themduring day-to-day operationsmight as well be carried out in ourlaboratories under realistic condi-tions.Our research focuses on the areasof hygiene and medical technolo-gy; simulation and computer-aided engineering; dental technol-ogy and clean-room manufac-turing.

Some may ask themselves, “I havefinished my Bachelor’s degree;now what?” There is no general

Fig. 4. Electronic Laboratory – Brain Computer Interface

Fig. 2: Diagnostic Laboratory

Fig. 3. Biophysics Laboratory

Fig. 5. Materials Science Laboratory

Our Master’s Programmein Medical Engineering –

a Master of Science Degreein Three Semesters

and to specifically foster the pro-fessional development of the teammembers. A further qualification ofa Master’s in Medical Engineeringinvolves both application and re-search oriented tasks and projects.The skills acquired in this degreeprogramme enable the graduates toassume complex tasks and manage-rial functions and may provide abasis for participation in a consecu-tive cooperative doctorate pro-gramme or for a position in a scien-tific institution.The excellent research facilities inthe area of medical engineering atthe OTH form an essential pre-requisite for the transfer and applica-tion of expert knowledge in the fieldsof new technologies and medicalsystems. This particularly includesthe laboratory for nuclear medicine,the hybrid operating theatre, thein-vitro diagnostic laboratory, thebiomechanical laboratory and theindustrial clean room.Within two semesters of full-timestudy, students gain in-depth in-sight into innovative topic areas. Amultitude of term papers, labora-tory projects, presentations andfield trips open up opportunitiesfor the participants to enhanceboth their knowledge and their

personal skills as well as to expandtheir personal network by estab-lishing contacts with numerouspartners from industry. The third semester is intendedfor preparing the master’s thesis.This arrangement enables stu-dents to complete their thesis faraway from the University, forexample at an international loca-tion of an industrial company.Against this backdrop, a decisionin favour of the Master’s program-me at the OTH Amberg-Weidenshould be easy. Industrial enter-prises are looking for highly-skilledemployees willing to assumecomplex tasks and managerialfunctions - this programme pro-vides all the necessary contents.

The Free State of Bavaria providesfunding for the Technology andScience Network Upper Palatinate(TWO), a joint project of the OTHAmberg-Weiden and the OTHRegensburg. This network includesthe strategic field of medicalengineering, which is provided withfunds for professorships and re-search assistants, as well as with

investment capital for laboratoryequipment for the Medical Engineer-ing Department in Weiden.

Institute for

Medical Engineering:

http://www.oth-aw.de/einrichtun-gen/institut_fuer_medizintechnik/ueber_das_ifmz/

Facilities and Laboratories:

http://www.oth-aw.de/einrichtun-gen/labore/labore_fakultaet_wirt-schaftsingenieurwesen/labore_medizintechnik/

Studies and course programme:

Bachelor: http://www.oth-aw.de/studium/bachelorstudiengaenge/medizintechnik/allgemein/ Master: http://www.oth-aw.de/studium/masterstudiengaenge/medizintechnik/allgemein/

36 Institute for Medical Engineering Weiden

Contact:

Ostbayerische TechnischeHochschule (OTH) Amberg-Weiden

Hetzenrichter Weg 1592637 Weiden i. d. OPf.Fon : +49 961 382-1620Fax.: +49 961 382-2620Mail: [email protected]

Ostbayerische Technische Hoch-schule (OTH) Amberg-Weiden

Hetzenrichter Weg 1592637 Weiden i. d. OPf.Fon : +49 961 382-1609Fax.: +49 961 382-2609Mail: [email protected]

Prof. ClemensBulitta, MDDirector, Institute forMedical Engineering

Director of the Bachelor’sprogramme in MedicalEngineering. Subjectarea: Diagnostic Systemsand Medical EngineeringManagement

Prof.Burkhard Stolz

Director of the Master’sprogramme in MedicalEngineeringSubject area: TechnicalDevelopment ofDiagnostic Systemsand Microsystems

Technology and ScienceNetwork Upper Palatinate

(TWO) – a Factor of Success

Further Information

Fig. 6.A Glimpse into the Master’s programme in Medical Engineering

❲�✁✂ ✄☎✆✁☎✂✁ ✝✁✞☎✆✁✄ ✄✁✟iously ill, the story of his or her

life changes. So does the story of the people who unselfishly

care for them every day. Parents. Siblings. Children. Doctors.

Their story becomes one of support. Perseverance. And hope

that it ends with the best possible outcome. Today, Siemens

is strengthening that hope. With a host of new and innovative

technologies like the Biograph mMR scanner, healthcare

professionals around the globe are combating illness more

efficiently and effectively. Offering patients and caregivers

a greater chance to end their story with a “happily ever after”.

Every day we’re working with the world to create answers

that will last for years to come.

Siemens technology is helping to give families the answers they need, when they need them.

More healthcare stories with

happier endings.

s✠✡☛✡☞s✌✍✎☛✏✑✡✒✓✔✑✍✒✕✡

❆✖✗✘✘✙✖✚✛✜✙❆✗✙✢✣✛✛

Upon completing their studies,many students dream of eitherfounding their own startup com-pany, becoming an entrepreneur,or making a difference through newdevelopments in a well-estab-lished company. While there arevarious ways to achieve personalgoals, a more direct and guidedpath will always prove to be moreefficient. Every company is drivenby the urge for new innovativeproducts. Therefore, it relies on astrong R&D-department in orderto stick out in today’s competitivemarket. Innovation also means toimplement change in the rightareas through new perspectives.Young students with unbiasedminds need the opportunity tolearn and gain experience throughpractical training. The InnovationResearch Lab provides a creativeenvironment for the implementa-tion and development of new ide-as and concepts. The topics origi-nate from the students themsel-ves or are suggested by differentindustry partners, researchers orthird parties.The IRL is led by Sultan Haider,the founder and head of theInnovation Think Tank and Key-Expert within Siemens Health-care. The main driving factor forsuccess comes from the remark-able variety of disciplinary back-grounds of the participating stu-

dents; interdisciplinary collabora-tion is the driving force of inno-vation. The wide spectrum ofexpertise includes but is not limi-ted to: design, liberal arts, eco-nomics and a multitude of engi-neering sciences.These different viewpoints combi-ned produce diverse ideas andprototypes with various applicati-ons for industry and researchareas. The IRL is always lookingfor any interested partners forcollaboration in supporting thenew lab.The Innovation Research Lab isthe most recent lab at FAU. “Weare happy that we were able to

commit Mr. Sultan Haider to runthe IRL within our university“,says Prof. Dr.-Ing. JoachimHornegger, president of FAU.Mr. Sultan Haider has alreadybeen giving several lectures atFAU on the topic of InnovationManagement and now has thepossibility to expand his academicprogram to contribute to his net-work of worldwide experts.

IRL is located at Medical ValleyCenter in Erlangen and belongs tothe Central Institute for HealthcareEngineering (ZiMT) serving as a

Room for creative ideas atthe Central Institute of

Healthcare Engineering

38

Ce

ntr

al I

nst

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te o

f H

ea

lth

care

En

gin

ee

rin

g a

tFA

U

Structure and integrationof the IRL

„Innovation Research Lab (IRL)“ atFriedrich-Alexander-Universität Erlangen-Nürnberg (FAU)

Students are developing their innovative creativity in the new IRL rooms

3D printed applications in medi-cine, applications of camera andmobile systems, optimization ofclinical workflows, medical de-vices for children, green innova-tions, sports medicine, orthopedicimplants, physiotherapy, home-care systems, next-generation IT,elderly care, etc.The IRL cover a range of projectsfrom research based on futuristicdevelopments all the way to cur-rent challenges and problems forthe implementation of researchrelevant topics. The opportunityto work on different projects withintheir own field of study as well aswithin interdisciplinary teams isprovided to the participants.During the course, the studentscan decide independently how toimplement their ideas. For thispurpose, the IRL Lab in theMedical Valley Center in Erlan-gen is available, offering not onlydifferent facilities to realize pro-totypes but also support fromvarious scientists and experts ofindustry and research. Moreoverindustry designers provide sup-port for the visualization of com-plex correlations to make thecontent accessible and understan-dable to everybody. Additionally,students are encouraged to design

therefore has a close tie to theIRL. A board of students takescare of: organization of the lab,management of the internal andexternal communication, coordi-nation of the management of pro-jects and finances as well as admi-nistration of the internal training.

The participants of any offeredcourse at IRL work in teams ondifferent topics and projects with-in the following areas: hospitalsand medical devices of the future,

39Central Institute of Healthcare Engineering at FAU

structural interface between scien-tific research, training and indu-stry in the field of medicalengineering. This project perfect-ly underlines one of ZiMT’s coreobjectives as an initiator of inter-regional and international scientificresearch in the Medical Engineer-ing sector.Dr.-Ing. Kurt Höller, ManagingDirector of ZIMT, emphasizes thecharacteristic feature of the IRLand the courses, which are offeredin its context: “Here, technicalchallenges, as well as questionsthat come from synergies bet-ween technology, production,marketing, usability and societalacceptance, are solved in multicul-tural and interdisciplinary teams”. „On the one hand this developsthe competences of the partici-pants in intercultural communica-tions with representatives of dif-ferent fields of study, e.g.engineering with humanities. Onthe other hand, these coursesteach that an innovative solutionwill take more than a view from atechnical perspective“, says DrRudolf Kötter, CEO of the Cen-ter for Applied Ethics and ScienceCommunication (ZIEW). ZIEWoffers seminars on key qualifi-cations from different facultiesand departments at the FAU and

Involvement of the students

Sultan Haider, head of Innovation Think Tank, Siemens Healthcare GmbH, and initiator of

IRL, in discussion with participating students

The president of FAU Prof. Joachim Hornegger (center) with his managing directors of

ZiMT Dr Kurt Höller (left) and Tobias Zobel (right), supported the IRL with space at

ZiMT to organize the lab

3D printed prototypes to supportand explain forward-looking con-cepts for healthcare by appliedrealization and evaluation.

As motivation, the students havethe opportunity to participate at theannual Innovation Research LabExhibition (IRLE). It took place forthe first time on September 3rd,2015 at the Medical Valley Center.The top 20 projects from the IRLteams and other international stu-dents are presented and awarded.Among others, Prof. Dr.-Ing. JoachimHornegger, president of the Fried-rich-Alexander-Universität Erlan-gen-Nürnberg, and Dr. Peter Molnar,CEO of CV within SiemensHealthcare GmbH were present in

2015 to participate as part of theguest jury to determine the threebest projects of the semester.The winners receive the “FAU-Siemens Award” and prize money.Furthermore, they have the chanceto participate in a three- or six-month-fellowship at the Innovati-on Think Tank within SiemensHealthcare in Germany, Turkey,China or India. The collaboration between IRLand FAU at ZiMT provides oppor-tunities for students to developfundamental training through real-world applications and their owninitiatives. It would be desirable that not onlySiemens Healthcare and otherestablished partners give input, butalso that small and middle-sized

companies use this pool of engagedand creative students for solutionsto current challenges. The MedicalValley Center offers a perfect en-vironment for students to realizetheir own ideas and potentially gearthem towards the development of asmall start-up.This offer is available for any stu-dent, whether they have a medical,engineering, humanities, sciencesor economics background. To-gether they can develop innovativeideas for several groups of interestsuch as university, public services,or industry.

http://www.zimt.fau.de/innovation-research-lab/


40 Central Institute of Healthcare Engineering at FAU

About the author:

Kurt Hoeller studied Electrical Engineering and achieved his doctoral degree at the Pattern Recognition Lab, FAU

Erlangen-Nuernberg, TUM Graduate School of Information Science in Health (GSISH), Munich, and Johns Hop-

kins University (JHU), USA. Since 2009, Kurt Hoeller is the founding managing director of the Central Institute of

Healthcare Engineering (ZiMT) at FAU Erlangen-Nuernberg. ZiMT supervises joint interdisciplinary research pro-

jects with more than 75 associated professors as well as the FAU Bachelor and Master programs in healthcare

engineering with more than 800 students. Dr Hoeller also coordinated the thematic campaign “3-D Imaging in

Medicine - Cutting-Edge Research in Germany's Medical Valley” that was part of the international campaign

“Germany – Land of Ideas” launched and supported by the Federal Ministry of Education and Research (BMBF).

By end of this campaign in 2013, he was founding CEO of the evolving university spin-off CiNNAMED GmbH that focuses on Communi-

cation, Consulting and Commerce especially in Biomedical Engineering projects. Dr Hoeller is also active in local politics as a municipal

councilor and member of the supervisory board of Erlangen‚s municipal energy supplier. Since 2015, he is spokesperson of the German

Academic Core Partners and universities within the European Institute of Innovation and Technology for Health (EIT Health).

Contact:

Dr.-Ing. Kurt Höller, MBA

CiNNAMED GmbH, Henkestraße 91, D-91054 Erlangen, Phone: +49 9131 974991, Fax: +49 9131 974992, [email protected]

IRL Exhibition 2015

Modern electro-medical applica-tions require innovative mountingsystems. The secure mounting ofmonitors or other equipment,intuitive positioning, quick installa-tion and compliance with thehygiene requirements, has to there-by be ensured.The support arm system rm-portof the new product generation ofthe ITD GmbH, fully meets thesedemands. The "rapid-mounting" (s.Fig.) allows easy installation as wellas subsequent installations of theequipment to given hospital infra-structures. In addition to the seam-lessly easy securing, the handlingof the attached devices is also veryconvenient. The new rm-port nolonger needs to be readjusted orfixed manually. This generation ofthe pivot arms is already set to theoptimal adjustment force, wherebya secure, precise and effort-freepositioning of even heavy monitorscan be made effortlessly. rm-portsupport arms are of course also

designed to accommodate diversecables. The cables are accuratelylaid and latched in the inner cableduct with a click-&-slide cover. In

addition to the many technicaladvantages, the rm-port also con-vinces on account of its contem-porary design and concomitantlyfulfils the hygiene requirements inhospitals. This is confirmed by ahygiene certificate. A special service for users is of-fered by online tools, such as theProductfinder and the Online-

Configurator on the website of theITD GmbH. This provides theusers with an easier orientation ofthe wide variety of product variantsand thereby enables the users toconfigure optimal customised prod-uct solutions for themselves in afew minutes.As a manufacturer of stationary andmobile equipment carriers, theITD GmbH has established itselfsince 1995 as one of the leadingcompanies in Europe and disposesover a global sales network. Thecompany offers modular standardproducts as well as professionallycompetent advice and customisedsystem solutions for medical equip-ment carriers. All ITD equipmentcarriers are medical products of theclass 1 and therefore meet therequirements according to DIN60601-1 as well as the Directive93/42 EEC. The ITD GmbH is ofcourse certified according to ISOEN 13485.

ITD GmbHpresents the new

product line rm-port

rm-portpivotarm

s

41

Contact:

ITD GmbHGrünwalder Weg 13a82008 UnterhachingGermanyPhone.: +49 89 61 44 25 0Fax: +49 89 61 44 25 20Web: www.itd-cart.comE-Mail: [email protected]

rm-port pivot arms – new support arm systemsfor patient monitoring

All humans are the same, yet different. Our faces are a good example: We all have eyes, a nose and a

mouth – but our appearances differ. This also applies to our cells and tissues. In all of us, they follow the

same functional principle, but in cell metabolism there may be subtle differences from one individual to

the next. This can have serious consequences in terms of medical therapy. A drug that is very beneficial to

one patient may be less effective in others. Hence it will take only a few years for a single drug, used as a

standard therapy for all patients suffering from a particular condition, to become outdated – for the good

of the patients. Meanwhile, what is called "personalized medicine" has become the latest trend, and will

gain in importance in the future: treatments customized to the individual patient.

This said, how can we determinewhat makes the cells of a certainindividual tick? In the past, scien-tists attempted to do this bystudying a patient‘s genetic make-up, but discovered that the possi-bilities were somewhat limited bythe confines of molecular biology.At Heinz Nixdorf-Lehrstuhl fürMedizinische Elektronik (HNLME)of Technische Universität Mün-chen, however, we have recentlydeveloped sensors that enablecells to be monitored. Some ofthese sensors can be used to mea-sure the reaction of cells to drugsand also to harmful substances.Sample cells taken from a patientare grown directly on the sensorchip, leading to intergrowth of thetissue with the electronic compo-nents. A small reaction chamber forintroducing substances (e.g. thedrugs to be tested) is located abovethe sensor. Different parameters(oxygen concentration, pH, elec-trical signals) in the cell environ-ment can be measured with these“lab-on-chip” systems. The re-sults thus obtained can be used to

ascertain whether the cells toleratethe substance and to assess theirsubsequent vitality. This is a veryeffective way of testing active sub-stances – potentially renderingcertain animal experiments super-fluous.

With personalized therapy it isnecessary to go one step further.The aim is not only to measurethe effect of a drug on the cellsof a patient, but also to examinedifferent concentrations of anactive substance and possiblyeven active substance combina-tions. This means that largeseries of measurements must be

taken in a short period of time.To this end, we have created the"Intelligent Microplate Reader"(IMR), a fully automated analysisplatform. Biosensors are placedon the bases of microtiter plates –each of the 24 wells of a plate con-tains a multiparametric sensoron which cells can grow, e.g.tumor tissue taken from a patient.Thanks to a sophisticated fluidicssystem, the cells can be suppliedwith a constantly renewed cul-ture medium. In a single operati-on, the fully automated pipettingrobot of the IMR permits 24 dif-ferent active substances or 24 dif-ferent concentrations of an activesubstance to be added to the 24wells. In this way, quick measurementscan be taken to determine whichdose of which chemotherapeuticagent or which drug combinationis best able to destroy the tumorcells in a particular patient. Thiscould aid in the selection andprecise adaptation of therapy foran individual patient – one whichwould be more effective and atthe same time less onerous thanconventional cancer therapies.With most cancers, only about

Personalized medicine:The benefits

of electronic systems

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Fig. 1: A wide range of sensor chips has

been developed (and produced using sili-

con, glass, ceramics and printing techno-

logies) at HNLME for use in bioanalysis

Sensor systems insteadof genetics

Gentle cancer therapies

We plan to use a battery that canbe recharged externally, requi-ring the patient to occasionallyplace a coil on the part of the bodywhere the implant is located.Such an active implant could beplaced within the body in thearea of the tumor. The sensorson its outer surface permit theoxygen saturation in the tissue tobe measured, transmitting theresults to a receiver outside thebody. With many solid tumors, decrea-sing oxygen saturation values arean indication of increased growth.If this is the case, the implantwould inject a chemotherapeuticagent from its drug reservoirdirectly into the tumor or supplyoxygen to the tissue. There isnothing worse for a tumor cellthan molecular oxygen. A circuitcomprising automated measure-

43Personalized medicine

20 % of patients respond well toconventional chemotherapeuticagents, but all suffer the burdenof severe side effects.In the future, this situation couldbe improved by means of IMR.

More effective therapeutic strate-gies would in fact be those inwhich an implant releases thedrug directly where it is needed –in the case of a tumor this wouldbe within the tumor itself or atleast in the adjacent tissue. Thiswould make sense, since by far thegreatest amount of a drug ad-ministered orally or intravenouslydoes not travel further than theliver or kidneys. Our team atHeinz Nixdorf-Lehrstuhl fürMedizinische Elektronik has beenworking on such "intelligent im-plants" for quite some time – andhas already developed a numberof prototypes. The resultingimplant would hardly be anylarger than the size of a sugarcube and hold a small battery forthe supply of energy, a miniaturi-zed electronic system, a radiounit, and a small drug reservoir.

Fig. 2: "Intelligent Microplate Reader" (IMR) analysis platform with pipetting robot, sensor

plate and process microscope for automated imaging. Bottom right: Sensor plate

with integrated microfluidics and sensor systems; each of the 24 wells has a sensor for

measuring the pH, the dissolved oxygen concentration and impedance.

Implant with drug reservoir

Link to a video showing

the operation of the IMR

Fig. 3: Concept of an implant the size of a sugar cube, comprising a collapsible electronic

unit, a sensor chip on its outer surface, and an integrated drug pump

Fig. 4: Concept of a closed-loop system (with implant) for cancer therapy

ments and diagnoses as well ascontrolled therapy would thus becreated – what experts call a "closed-loop system".This would already offer a highdegree of personalization andenable patients to undergo thera-py without having to stay in hos-pital; it would be much moreeffective and would involve fewerside effects than conventionaltherapy.

The same applies to our currentproject, the "intelligent nano pill" –a form of implant that can beswallowed. It consists of a plasticfoil onto which sensors, callednanoparticle sensors, are appliedby means of inkjet printing, aneffective yet inexpensive process.The sensor foils can be rolledand formed into small, ediblecapsules that also contain micro-electronic chips, a battery and aradio unit – all in miniature. Thesensors on the outer surface ofthe foil could then detect andattach itself to a bleeding stom-ach ulcer, for instance. Sub-sequently, the nano pill couldmonitor the ulcer, wirelesslysend the data to an externalreceiver and potentially alsorelease active substances – again,precisely at the target site, i.e. theulcer, without causing the patientdiscomfort.

It is not only in drug discoveryand oncology, but also in otherhealthcare segments where scien-tists are pursuing personalizedmedicine. In the future, patientssuffering from cardiovasculardiseases will be able to monitortheir vital signs independently.This is another area where ourexperience with sensor systemshas proved beneficial.We have developed an all-in-onemedical device for taking dailymeasurements of parameters suchas blood pressure, heart rate, oxy-genation of the blood and hydra-tion, simply by slipping a fingerinto the integrated sleeve thatcontains a variety of sensors.Blood glucose can be measuredwith a drop of blood and a teststrip.

The device uses mobile radio ser-vices to automatically transmit allthe measurements to a database –this is facilitated by the COMES®

telemedical system developed inrecent years. The treating physi-cian can access the data of his/herpatients at all times and will bealerted immediately about abnor-mal values so that all the necessarysteps can be taken.COMES® also sends automatedwarning messages to the patientdepending on the measurementstaken, and offers personalizedadvice. Initial studies have report-ed a positive response frompatients with cardiovascular diseases,who felt safer and at the sametime more independent thanks tothe constant monitoring providedby the system. Obviously, per-sonalized medicine using new

44 Personalized medicine

All-in-one medical device

Fig. 5: Sensor made of nanoparticles applied to plastic foil by inkjet printing (left). The foil is then equipped with electronic components

and rolled to form a nano pill (right)

Intelligent nano pill

Link to a video showing

the production of the

nano pill

Fig. 6: a) All-in-one telemedical device as developed by Heinz Nixdorf-Lehrstuhl für

Medizinische Elektronik, Technische Universität München, in collaboration with the

Fachgruppe Produktentstehung, Heinz Nixdorf Institut, Universität Paderborn.

Design: Abteilung für Industrial Design, Kunstuniversität Linz, Prof. Axel Thallemer;

b) Sensor sleeve, detailed view

electronic systems gives thempeace of mind.

We would like to express our grati-tude to the Heinz Nixdorf Stif-tung for supporting our projectsand research for so many years.

Wolf B, Brischwein M, GrotheH, Stepper C, Ressler J, Weyh T:„Lab-on-a-chip systems for cellu-lar assays.” In: G. Urban (ed.)BioMEMS Series: Microsystems(2006), 16, pp. 269–308. SpringerVerlag, Dordrecht (NL), 2006.ISBN-10:0-387-28731-0, ISBN-13:978-0-387-28731-7.

Mzoughi N, Neumann B, GrotheH, Wolf B: "SensorikChemo/Bio. Inkjet printed elec-trodes on PET substrate for bio-sensing applications", Biomedizi-nische Technik/BiomedicalEngineering, Band 56, Heft s1,Seiten 1–12, ISSN 0013-5585,DOI: 10.1515/BMT.2011.844,September 2011

Kleinhans R, Brischwein M,Wang P, Becker B, Demmel F,Schwarzenberger T, ZottmannM, Niendorf A, Wolf B: „Sensor-Based Cell and Tissue Screening

for Personalized Cancer Chemo-therapy“. Medical and BiologicalEngineering and Computing,(2012) 50, 117–126

Clauss J, Becker S, Sattler M,Wolf B, „In vivo Diagnostik mitintelligenten Implantaten“, In:Wolf B (Hg.): BioelektronischeDiagnose- und Therapiesysteme.m3: microelectronic meets medi-cine. 1. Aufl. 2012, Aachen: Sha-ker Verlag, S. 237–246. ISBN:978-3-8440-0831-9.

Brischwein M, Scarpa G, GrotheH, Wolf B, Thalhammer S.:"Toward printable lab-on-a-chiptechnologies for cell analytics" in:Biological and Medical SensorTechnologies, KryzysztofIniewski, ed. CRC press 2012,p. 125-148, Print ISBN: 978-1-4398-8267-2, eBook ISBN: 978-1-4665-5257-9

Wolf B, Spittler T, Herzog K,Clauss J, Friedrich P, Scholz A:„COMES® – Cognitive Medizini-sche Systeme für Diagnose undTherapie“. Duesberg, F. (ed): e-Health 2014 Informations- undKommunikationstechnologien imGesundheitswesen.Solingen/Mittweida, medicalfuture verlag, 2013, 254-262.

Wolf P, Brischwein M, KleinhansR, Demmel F, SchwarzenbergerT, Pfister C, Wolf B: “Automatedplatform for sensor-based moni-toring and controlled assays ofliving cells and tissues”. Biosen-sors and Bioelectronics (2013), 50,111-117

Clauss J, Herzog K, Wolf P:„Sensorgestützte regionaleTumortherapie“. Meditronic-Journal, 2/2014, 14-16.

Demmel F, Brischwein M, WolfP, Huber F, Pfister C, Wolf B:“Nutrient depletion and metabo-lic profiles in breast carcinomacell lines measured with a label-free platform”. PhysiologicalMeasurement (2015), 36, 1367-1381

45Personalized medicine

Contact:

Technische Universität MünchenHeinz Nixdorf-Lehrstuhl fürMedizinische Elektronik

Theresienstr. 90 / Gebäude N380333 MünchenPhone 089 / 28922948www.lme.ei.tum.deE-Mail: [email protected];[email protected]

Univ.-Prof.Dr. rer. nat.

Bernhard Wolf

Dipl.-Biol.

Christian Scholze

Acknowledgements

Literature

Fig. 7: The overall COMES® concept: Cognitive Medizinische Systeme (Cognitive Medical

Systems) as an intelligent telemedical assistance system, accompanying the user every-

where, in all walks of life

Cystoscopy is the term for amedical examination of theurinary bladder in order to detecttissue changes early enough and ifneeded, to carry out treatment.The procedure involves the inser-tion of a rigid or flexible endo-scope through the patient’surinary tract and into the bladderto inspect the tissue structure.Although these minimally invasiveprocedures alleviate patient dis-comfort, they harbor challengesfor the attending physician. Because the endoscope providesthe physician a limited field ofview (so-called “keyhole perspec-tive”), it is difficult to determine ifthe bladder wall has been com-pletely examined. In order to obtaina complete scan of the bladder,the endoscope has to be pivotedand moved by the user,, forcingthe physician to form a compositepicture in his own mind. Digitalimage processing techniques makeit possible use the acquired imagedata stream from an endoscopicexamination to create a panoramicview for the physician. TheEndorama© software developed bythe Fraunhofer Institute for Inte-grated Circuits IIS in Erlangengenerates a composite picturefrom a series of successive ac-quired images by searching fordistinctive and correlating pointsin the images and then calculatingan overall view. Although pano-ramic images are a standard featureof conventional digital camerasand can also be created withsmartphone apps as an example,they present a challenge withendoscopic images.

Endoscopic images typically havemore distortion, a lower resolu-tion and a comparatively low con-trast due to the uneven lightingconditions. And because the tis-sue structures in the bladder arenot very pronounced, the challengeis finding distinct points of corres-pondence that can be used tomerge the overlapping imagesinto a composite picture. To com-pensate for these conditions, in afirst step the Endorama© soft-ware removes the optical distor-tion and balances the shadows thatresult from the irregular lighting.Various calculation processes thenmerge the images together. Whileone process looks for image cha-racteristics such as vascular struc-tures on the bladder wall, anotherarranges the images in the properorder. The software also relies onmathematical models to accountfor the geometry of the bladder.To provide the attending physi-cian a direct impression of theexpanded field of view and thusvisual feedback regarding thecompleteness of the examination,the possibility exists to generate apanorama view during the exami-nation; in effect in real-time.The physician can see the entirearea of the bladder that has beenexamined at a glance. The soft-

ware displays the camera’s currentimage in the middle of the moni-tor. If the panorama image showsa gap or a "hole" at a certain point,the physician knows that this areastill has to be examined. After theexamination has been completed,the digital panorama can be placedin the patient's file in the form ofan interactive overview image inorder to document the results ofthe exam. Such panorama imagescan also serve to verify the com-pleteness of the examination,which creates new opportunitiesfor assuring the quality of cysto-scopic examinations. Compared toconventional documentation thatrelies on video sequences andsingle images, with panorama im-ages the completeness of theexamination can be documentedat a glance, thus saving valuabletime. The Endorama software hasmeanwhile been successfullytested using a phantom bladdermade from plexiglass, with videosequences during regular bladderexaminations and also with aphantom pig's bladder.

Panoramic endoscopyof the bladder

46

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Panorama of the bladder wall, the white

line indicates the endoscope motion

Contact:

Fraunhofer-Institute for IntegratedCircuits IISDepartment of Image Processingand Medical Engineering

Am Wolfsmantel 33, 90158 Erlangenphone: 09131 / 776-7330mail:[email protected]

PD Dr.-Ing.-habil.ThomasWittenberg

When the question of the advan-tages of communication stand-ards for the medical industry israised, the most common respon-se is „cost efficiencies“, followedclosely by „quality assurance“.Although both terms belong inthe plus column of opportunities,the consistent utilization of com-munication standards in medicalsystems is far removed from rea-lity. What can this be traced to?Without question, the primarycauses are related to technicalheterogeneity and governmentstructures in the health care sec-tor. Different operating and hard-ware systems, a lack of networkinfrastructures, application soft-ware from various manufacturersand countless data formats, struc-tures and models with differentsemantics are hampering end-to-end interoperability and quicklythwart any efforts to standardize.Nevertheless, for specific fieldsof application there do existsome established communicationstandards that have proven theirvalue for many years already.Most notably is the set of so-calledHealth Level 7 (HL7) internatio-nal standards that focus primarilyon the exchange of patient andhealth care services data, as wellas diagnostic results. Despite thefact that HL7 has been aroundfor 30 years, it still has limitationssuch as no plug-and-play functio-nality since the processing ofHL7 messages is not part of thestandard, which leaves it up tothe application developer. As a rule, even systems that usethe same version of the standard

cannot communicate with oneanother without further modifica-tions. This puzzling developmentoccurs in many other medicalcommunication standards. Thequestion then is: why even botherstandardizing? The answer is as simple as it isinadequate: without standardiza-tion, it would no longer be possi-ble to manage the complexityinvolved in the development ofcommunication standards. On theother hand, a standardized speci-fication can only describe a lim-ited sub-system. The concrete im-plementation is still application-specific. Even POCT1-A, a standard thatdescribes communications bet-ween so-called point-of-care test-ing devices and which is viewedas an extension of HL7, is un-clear in many of the details. Thisleaves too much room for inter-pretation, which is what stand-ardization is actually meant toprevent. That leads to divergentimplementations and incompat-ible systems. In summary, there is no denyingthat communication standards formedical systems create one major

advantage: when developing medicalsystem software, uniform inter-faces allow companies to concent-rate on their core expertise andavoid having to deal with the de-tails of data exchange. The selec-tion of the suitable standard isdetermined mainly by the re-spective application software. When the decision is made to gowith an existing standard, onething must be kept in mindhowever: there is little chance itwill function properly withoutbeing modified. Using its reference implementa-tions, Fraunhofer IIS offerslibraries tailored to the cus-tomer's requirements in additionto services such as the systematictesting and integration of ex-isting standards. Fraunhofer IISparticipates in the ISO, CEN,HL7 and DIN standards com-mittees and through the Fraun-hofer Ambient Assisted Living(AAL) Alliance is also a memberof the Continua Health Alliance.

Medical TechnologyCommunication Standards –Opportunities and Obstacles

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Fraunhofer-Institute forIntegrated Circuits IIS

Department of Image Processing andMedical Engineering

Am Wolfsmantel 3390158 Erlangenphone: 09131 / 776-7345mail: [email protected]

Matthias StruckContact:

CoKeTT is the first AAL applica-tion center at Hochschule Kemptenin the Gesundheitsregion Allgäu,the Alpine region in southwesternGermany offering a wide variety ofspas and health resorts, sports andleisure activities. It is an application,test and training center, or livinglab, for products and solutions tai-lored to specific age groups, wherethe main aim is to develop and testmechatronic-telematic healthcaresystems for all generations. CoKeTT, founded in the autumnof 2011, is a joint project with theHeinz Nixdorf-Lehrstuhl fürMedizinische Elektronik of Tech-nische Universität München andstands for "COMES® KemptenTest- und Trainingszentrum". Ambient Assisted Living (AAL) isa field of research that focuses onproblems and solutions related todemographic change. Technicalassistance systems offer peoplewith a physical handicap help intheir everyday activities and enablethe elderly to continue living athome for as long as possible. Tothis end, all spheres of life, such asworking, living, health, mobilityand social interaction, are takeninto account.

In their joint "iMob" project, theHeinz Nixdorf-Lehrstuhl fürMedizinische Elektronik and theCoKeTT application center ofHochschule Kempten aims to de-velop a new assistance system inthe form of a novel wheelchairfor people with limited mobility.

The project name "iMob" is anacronym, standing for "intelligentmobility", and the project abidesby the motto "unlimited mobilityfor all ages at all times". Theassistance system is based on ahighly maneuverable wheelchairwith which even obstacles such asstairs can be overcome unaided[1].

1. Background

The growing population of sen-iors in many countries worldwidedue to higher life expectanciesand a simultaneous drop in birthrates has given rise to a new wayof thinking and transformation inall spheres of everyday life, theeconomy, and society as a whole.One of the most essential areas inall of this is mobility, particularlyduring retirement when manypeople feel they should be travel-ing the world and doing all the

things they never managed to doduring their working lives [2].Figure 1 illustrates a decrease inthe average mobility data for peo-ple aged over 74 years: time,distance, number of journeys.According to the results from thestudy Mobilität in Deutschland[3], however, these individuals donot leave their homes often: overtwo thirds of their journeys aremade for shopping and privatepurposes, a pattern that becomesincreasingly important with age.Figure 2 illustrates the relativeincrease in the journeys made forprivate purposes by those olderthan 68 years. The older webecome, the more important areour daily chores and shoppingtrips, with increased age correlat-ing to a shorter average distance. The study also revealed that theelderly tend to travel more by carwhereas among the younger

„iMob“ - A mechatronic AALproject of the CoKeTT Zentrum at

Hochschule Kempten in cooperationwith Technische Universität München

48

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Fig. 1: Key mobility data classified by age sets [2]

The "iMob" project

[2], three quarters of all accidentsare caused by seniors at junctionsand crossings when they fail tocomply with the traffic rules. Ananalysis of police data in theBonn area revealed that amongdrivers over 65 years of agemaneuvers such as U-turns andreversing are the second mostcommon cause of accidents (seeFigure 3). High speed, or physical or men-tal disorders, on the other hand,account for a small percentageonly [5]. Schlag [2] states thatthe following psycho-physicaldevelopments in old age have adirect impact on the ability todrive: Impaired vision, a dimin-ished ability to multi-task and areduced selective attention, whicheasily leads to distraction, slowerdecisions and/or responses, re-duced physical mobility and re-sistance to physical and mentalstress.With the aid of the driver assis-tance systems that are alreadyavailable, the elderly can maintaintheir mobility. Technical aidssuch as parking assist systems,head-up displays, traffic moni-toring with radar and laser scan-ners, automated braking maneu-vers, tactile, acoustic and opticalalarms, can compensate for age-related functional limitations.

1.2 The elderly in the driver's

seat

According to MID 2008 [3],elderly people who have enjoyedunlimited use of their own carthroughout their lives and whoare still mentally capable of doingso, will wish to maintain thisstandard of living. For the "newelderly", having their own auto-mobile is a symbol of activity,prosperity and independence [4].Although they are not responsi-ble for the majority of car acci-dents at present, an increase inincidents involving over 75-year-olds has been noted in recentyears [2]. According to Schlag

49Hochschule Kempten

population, especially in urbanareas, the use of automobiles isdecreasing. At the same time, theuse of local public transport isdecreasing among the elderly,since older seniors cover 38% ofall distances on foot, meaning thatwalking has become the secondmost important mode of trans-port. It was also found that seniorsingles are less mobile than theirpeers who live in a household oftwo or more people.

1.1 Old-age mobility

In our aging society, mobility is avital, basic need that is closelylinked to quality of life. To limitthis basic need would mean todeprive people of the possibilityto maintain their social contactsand independence, which in turnwould have psychological and so-cial consequences [5].According to Schlag [2] mobility isan important way to prevent age-related degeneration and in manyseniors it can even be beneficial tohealth. The fact that maintainingthe daily routine and runningerrands are all the more importantin old age can be seen from thedistances illustrated in Figure 2. If aperson's daily routine is disrupteddue to limited mobility, this has amassive impact on social integra-tion and also on the quality of life.

Fig. 2: Age cohort born 1940-44 and distances traveled classified by purpose, including

commercial traffic, given as thousands per day for the years 2002 (left column) and 2008

(right) [2]

Fig. 3: Analysis of the human factors as causes for road accidents in the Bonn area,

Germany [3]

The study conducted by Schlag[2] further shows that seniorstend to compensate for the age-related loss of sensory, cognitiveand motor skills in everyday activi-ties: the more experience anelderly person has of road traffic,the lower the risk of an accident.

With increasing age and diversehealth issues, many people find itincreasingly difficult to walk andthus become dependent on othersfor help. Possible causes includestroke, sarcopenia, degenerativejoint disease and other conditionsaffecting the joints or bones. Technical solutions are alreadyavailable for those who neverthe-less wish to remain independentand mobile with as little supportfrom others as possible. Rollatorsare practical walking aids, for in-stance, while mobility scooterscan be used for longer distances. De-pending on the model, theseelectrically driven single-seatvehicles have a maximum speedof 6 to 15 km/h, and in some casesdo not require a driving license.Mobility scooters are recommen-ded for individuals who havegreat difficulty walking and needassistance when leaving the home[6].When it comes to electric wheel-chairs, there are two categories:those for indoors and those foroutdoors. Models for outdoor useare usually sturdier, heavier andlarger, and are designed to coverlonger distances at a higher speed,whereas indoor models need tobe very compact and easy tomaneuver. Wheelchairs are gen-erally recommended for individu-als who have lost their ability towalk or at least have great difficul-ty walking. As described above, formany seniors the automobilebecomes all the more importantwith increasing age and having togive up driving signifies a tremen-dous loss of mobility and free-dom.

Experience shows that olderseniors who have driven a car alltheir lives and still are mentallycapable of driving, are not willingto swap their car for a mobilityscooter or electric wheelchair,despite the fact that they couldthen travel shorter distances suchas for buying groceries. This maybe due to the unwillingness to letgo of a habit, or because theybelieve a car is more comfortableand convenient, or simply that itallows them to travel longerdistances. If an elderly person canno longer walk unaided but coulddrive a car that is equipped withadequate assistance systems, addi-tional technologies will be requi-red. Another obstacle to be tack-led by anyone in a wheelchair aresteps and staircases that cannot beovercome without help.

To date there are no products onthe market that offer adequatesolutions. In this project, we havetherefore analyzed and discussednew approaches to solving theseissues. The main focus is on acompletely autonomous technicalaid that offers the user mobilitywithout being dependent onothers. Looking at the individualproducts offered by various com-panies, it is clear that only a com-bination of these options candeliver a holistic solution. A com-pletely autonomous solution is allthe more important for singleseniors in helping them to remainsocially integrated. The combination of a stair-climb-ing wheelchair and a vehicleintegration concept which elimi-nates the difficulty and strain oftransferring from wheelchair tocar, offers a solution for the pre-sent and future driving generationaged 75+. With this car-wheel-chair combination, the user doesnot expect his or her electricwheelchair to reach high speedsand long distances. Here, the

focus is more on a design thatoffers easy maneuverability, bothindoors and also over shorterdistances outdoors. Furthermore,it is imperative that such a systemoffers easy and intuitive handlingand a reliable stair-climbing mech-anism. Today's built-in driverassistance systems and those stillin the planning phase already makea valuable contribution to thesafety of seniors. However, themore complex they become, themore difficult they will be to use.Therefore, such systems shouldalso be simple to use and offer allthe assistance required in particu-lar by the elderly.

3.1 Chassis with

stair-climbing function

Excellent maneuverability isachieved with a Segway-likechassis design which enables thewheelchair to move on one axleand one pair of wheels only. Toachieve this, each wheel is drivenby a separate motor. Based on theprinciple of the inverse pendu-lum, these motors are dynamically

50 Hochschule Kempten

Fig 4: Climbing stairs with the iMob

wheelchair

2. The situation

3. The solution - approachesand implementation

actuated in order to always keepthe center of gravity preciselyabove the wheel axle. Figures 4and 5 illustrate the design fromdifferent angles.In stair-climbing mode, two fold-out legs which each consist of anupper and lower leg just like thatof a human limb are located be-

tween the wheels. These legspush the wheelchair up or downthe stairs as shown in Figure 6. A3D camera system combined withan intelligent control algorithmspecifies the correct leg positionfor each step [7].

3.2 Production vehicle

interface

To travel longer distances in com-fort, the iMob wheelchair isequipped with interfaces that canbe easily integrated into a produc-tion vehicle. The automotive integration sys-tem is based on a modified ver-sion of the seat transfer systemproduced by Autoadapt. It fea-tures a pivoting mechanism thattransfers the driver, while in thedriver’s seat, out of the car and

onto the wheelchair chassis. Withthe original system, another per-son is always needed to place thechassis by the driver's door, andfold and stow it in the trunk, re-spectively. An additional feature of thissystem developed during theproj ect is the ability of thewheelchair chassis to unfold anddrive autonomously from thetrunk to the driver's door andreturn after use. The automatedstowing process is illustrated inFigure 7. Thus, the elderly driver-'s dream of independent mobilitybecomes a reality.

We would like to express ourgratitude to the HochschuleKempten for funding our projectand to the Heinz Nixdorf Stif-tung for partly funding it fromthe KOMPASS project.

[1] Häcker, M.:Barrierefreiheit in der Stadt derZukunft am Beispiel von iMob:VDE Kongress 2014,20/21.10.2014 Frankfurt am Main

[2] Schlag, B.:Sichere Mobilität im Alter?DVR-Presseseminar -Raum für alle!?,Dresden 2008

Fig. 6: Climbing mechanism of the iMob

wheelchair

References

51Hochschule Kempten

Fig. 5: iMob wheelchair from different angles

Fig.7: Concept of the vehicle interface for the iMob wheelchair

Acknowledgements

[3] Mobilität in Deutschland2008, publ. by the Bundes-ministerium für Verkehr,Bau und Stadtentwicklung,Bonn and Berlin 2010

[4] Zauner, P., Wolf, B. [Ed.]:Der Autofahrer der GenerationPlus,Cuvillier Verlag Göttingen, 2007

[5] Pottgießer, S., Kleinemas, U.,Dohmes, K., Spiegel, L., Schäd-lich, M., Rudinger, G.,Profile von Senioren mit Auto-unfällen, Zentrum für Alterns-kulturen at Universität Bonn,Mensch und Sicherheit, 2012

[6] Herner, S., Rollstühle:So findet man das richtigeModell. [Online], Available:http://senioren-ratgeber.de[last visited on Nov. 21, 2012].

[7] Häcker, M.:New mobility concepts fordisabled and elderly people:IEEE Third InternationalConference on ConsumerElectronics -Berlin (ICCE-Berlin) 2013.

52 Hochschule Kempten

Hochschule KemptenCoKeTT Zentrum

Bahnhofstraße 6187435 Kempten (Allgäu)Tel: 0831 2523 9256Fax: 0831 2523 197E-Mail: petra.friedrich@hs-kempten.dewww.hochschule-kempten.dewww.cokett.info

Prof. Dr.-Ing.Petra Friedrich

Heinz Nixdorf-Lehrstuhl für Medizinische ElektronikTechnische Universität München

Theresienstraße 90, Building N380333 MunichTel: 089/ 289 22947Fax: 089/ 289 22950E-Mail: [email protected]

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

Lehrstuhl für ErgonomieTechnische Universität München

Boltzmannstraße 15885747 GarchingTel: 089/ 289 15400Fax: 089/ 289 15389E-Mail: [email protected]

Prof. Dr. phil.Klaus Bengler

Hochschule KemptenCoKeTT Zentrum

Bahnhofstraße 6187435 Kempten (Allgäu)Tel: 0831 2523 9300Fax: 0831 2523 197E-Mail: [email protected]

M.Sc.Michael Hinderer

Contact details:

Recent developments of moderntechnology using wearable/body-worn sensors are increasing inour daily lives. Smartphone, brace-lets, watches, or pulse measure-ment belts are now available asconsumer products monitoringthe health and sport activities inmanifold design. This progressand the commercialization of therelevant technologies are the driv-ing force to apply modern sensorsystems also in the diagnosis andtreatment of a broad range ofdiseases. In medicine, sensorsprovide objective and comparablesurrogate markers of clinicalintervention and complement thetraditional examination strategiesthat depend on the experienceand availability of the physician.In addition, sensor can generateobjective information on the pa-tients symptoms and wellbeing,independent of the doctor visits,and thereby provide telemedicalhome-monitoring approaches ineveryday life of the patient.

In contrast to activity monitoringconcepts of wearable sensors infitness and health, two funda-mentally different conditions inthe application under medicalconditions are to be considered:During activity monitoring in

healthy subjects, a non-restrictedbody function has to be assumed,in fact, it is typically excluded bythe manufacture to use activitymonitor systems under diseaseconditions. Assuming normalbody function the sensor canmeasure and correlate activity tofitness and training concepts. Inaddition, medical device regula-tions do not apply to the respec-tive sensor system in respect tomedical privacy, patients’ dataownership rights, and productand application specific qualitycriteria. Therefore, the scientificdevelopment and validation, aswell as the requirements for theplacing sensor systems as medicalproducts on the market in thisfast-paced world of technologicaldevelopment are much morecomplex. Nevertheless, due tothe possibility of medical applica-tion in continuous diagnostic, e.g.monitoring concepts, wearablesensors will fundamentally changethe healthcare concepts for diag-nosis and treatment of chronicdiseases in the near future.

Albeit the patients’ needs aresubstantially different the classiccare concepts of today’s healthcare system remain largely similarfor acute and chronic diseases.

Diagnostic and treatment of out-or inpatients includes the assess-ment of clinical information,symptoms, and patients history aspresented by the patients’ usingvarious diagnostic proceduresaiming to find the right diagnoseand to initiate treatment. Foracute diseases, this paradigmworks very well, since it makesvery costly diagnostic proceduresclinically as well as economicallyefficient. The best therapy isinitiated with the goal to (at leastpartially) restore the impairedbody function specific for thedisease of the patient. In chronicdiseases, this procedure alsoresults in the process of findingthe right diagnose, however, thecare concept for the subsequentchronic phase of these disease isfacing several crucial challenges:A) Chronic diseases require con-stant therapy monitoring. B) Theselected therapy is mostly symp-tomatic in several chronic disea-ses, thus requiring continuousobservation of progression oraggravation of the diseases‘ sym-ptoms. C) Importantly, duringthe chronic phase of these dis-eases the requirements to medi-cal care are highly predictable,since the characteristics of poten-tial progression, additional symp-

Sensor-basedgait analysis

in Parkinson‘s disease

53

Se

nso

r-b

ase

d g

ait

an

aly

sis

Medical-technical applicationsin the treatment of chronic movement disorders

for the patient. The effect of thechosen therapy is assessed by theattending neurologist during thenext visit of the patient at thedoctor‘s office. As the diseaseprogresses these control visitshave to be constantly repeated.With increasing progressionseveral symptoms cannot becompletely reduced anymore bydrugs and require additional thera-peutic strategies. In addition, gaitimpairment and other symptomsbecome considerably variableduring the course of a day – anadvanced stage of the disease thatis referred to as motorfluctuatingphase. Information on the chang-es of motor symptoms mainlyrelies on historical description ofthe patient to the doctor and isnot validated by continuousobjective data. Therefore, theaim of wearable sensor systems isto recognize symptoms, or theirdeterioration at an early stageenabling to adjust and optimizethe therapy as fast as possible.

In the Medical Valley EuropeanMetropolitan Area Nürnberg,our consortium at the Friedrich-Alexander University of Erlan-gen-Nuremberg (FAU) consist-ing of the Department of Mole-cular Neurology, UniversityHospital Erlangen, the PatternRecognition Laboratory, and theindustrial partner ASTRUM ITGmbH developed a mobile gaitanalysis system that is easy tohandle for doctors and patientsand provides objective and com-plementary parameter for themovement impairment of pa-tients with Parkinson syndrome.The project was launched in adirect co-operation betweenmedical, technical and industrialpartners promoted by the Bavari-an Research Foundation. It hasreceived the medical-technicalprice in health care of the city ofErlangen in 2014, and the Bavari-an Innovation Award eHealth in2015. Since 2014 it is also a new

and need for almost constantcontrol of symptoms and treat-ment is the Parkinson syndrome.It is the most common neurode-generative movement disorderwith about 4.1 million peopleaffected worldwide an estimated250,000 to 280,000 patients inGermany (German ParkinsonSociety). Due to increasing lifeexpectancy, environmental andindustrialization factors a regiondependent doubling of its preva-lence is estimated by 2030. Inmost patients the disease is diag-nosed at an age between 55 and65 years. In Parkinson's diseasethe progressive dysfunction andloss of specific nerve cells in thebrain leads to a constant in-creasing disabilities by the typicalmotor symptoms, e.g. tremor(shaking), rigor (muscle stiff-ness), bradykinesia (slowness),and postural instability (impairedpostural reflexes). The resultingmovement and gait impairmentsare well known to the generalpublic. They also serve as clinicaltarget symptoms defining thediagnosis for the attending neuro-logist. The symptomatic therapyaims to improve the movementand thus to minimize the result-ing restriction of quality of life

toms, and therapeutic adjust-ments are known over the courseof chronic diseases, but can onlybe presented to the doctorduring the patient visits. Thetypical scenario of these visits isthat the patient has eitherunchanged conditions (e.g. theappointment would not havebeen necessary), or he experien-ced changes in symptoms thatwould have required an even ear-lier adjustment of treatment para-digm. Thus, a major need ofnowadays health care systems isto monitor changes of symptomsor related limitations constantlyin patients under at home condi-tions. Wearable sensor systemsare able to meet these needs.They can provide a simple andinexpensive measure allowing toquantify therapeutic effects, de-tect early signs of progression ornon-respsonder to treatmentallowing to change therapy re-gimes, as therapy monitoring. Inthis respect, they can supporttherapeutic decisions or neces-sary treatment adjustments in thefuture even before the next sched-uled doctor’s appointment.

A frequent and typical chronicdisease with progressive course

Requirements for diagnostical workup:

Acute diseases require rapid and intensive diagnostics to identify the disease and initiatethe treatment leading to immediate (optimally complete) remission of symptoms andrecovery of the patient. Chronic diseases require constant diagnostics and therapy adjust-ment

54 Sensor-based gait analysis

flagship project of the EmergingField Initiative (EFIMoves) ofthe FAU. Our goal is to supportthe medical care of patients withmovement disorders by instru-mented movement analysis usingwearable motion sensors. Theclassic diagnosis of movementdisorders relies on the clinicalexamination by the movementdisorder specialist. Therefore, thissubjective assessment depends onthe experience of the attendingneurologist and the medical eval-uation differs from doctor todoctor thereby limiting its com-parability. Thus, our newly devel-oped sensor-based movementanalysis system helps to objec-tively capture changes of gaitimpairment in Parkinson syn-drome.

The recently developed studysystem for sensor-based gaitanalysis – eGaIT: „embeddedGait Analysis Using IntelligentTechnology“ - consists of inertialsensors attached to the shoewhich measure acceleration (accel-erometer) and angular velocity(gyroscope) during distinct wal-king sequences. Mathematicalalgorithms using signal analysis

and pattern recognition methodscompute spatio-temporal gaitparameters such as stride length,velocity, foot angles and clearance.These objective gait parametersthat are assessed independent ofthe subjective judgment of thephysician characterize movementimpairment of patients and com-plementary support therapeuticdecisions. eGaIT was validated incooperation with the geriatrichospital (Waldkrankenhaus Er-langen) in geriatric patients withdifferent gait impairments asso-ciated with increased risk of fal-ling. Until now, the analysis ofstandardized walking sequencesof more than 800 patients andcontrols with different move-ment disorders clearly supportthat objective gait parameters canbe used characterize the diag-nose, the stage of the disease, andthe effect of treatment. Instru-mented movement analysis hasthe potential to be performed in„mobile“ movement laboratoriesin the everyday care of patientsthereby complementing the reg-ular medical examination in outand inpatient units for movementdisorders. In addition to the one-stage sensor-based gait analysis

during the diagnostic workup ourcurrent research aims to transferthe findings from controlledinstrumented gait analysis tocontinuous monitoring conceptsinto everyday life of the patient.In advanced Parkinson’s disease,it is a particular challenge to opti-mally adapt the time and dose ofmedication throughout the dayfor the individual patient. This isnecessary because the level ofmotor impairment changes dur-ing the course of a day. Rapidchanges from drug-induced hy-permobility to phases with se-verely impaired movement aresubstantially limiting the quality oflife. Here, the adjustment of themedication represents a majorchallenge to the continuous treat-ment of this chronic disease, sin-ce the therapeutic decisions relypurely on the subjective impres-sion of the patient and his his-torical information. Here, subjec-tive and incomplete patientdiaries provide only little objec-tive information. A continuousand objective gait analysis couldtherefore supported complemen-tary and objective information forthe treatment of Parkinson pa-tients. In the future, instrumentedmovement monitoring conceptswill lead to earlier detection ofaggravation of the disease andrapid identification of responderand non-responder to initiatedtherapies. Our results suggestthat eGaIT can also be used tomonitor the so-called „invasivetherapies“ in advanced Parkin-son’s disease, where continuousdrug pumps or deep brain stimu-lation concepts are applied suc-cessfully treating the motorimpairment of patients. Thisleads to a more rapid increase inthe quality of life for the patient,and thus a higher efficiency inhealth care.

Our experience and findingsduring the scientific and industrialdevelopment of eGaIT clearly

55Sensor-based gait analysis

eGaIT – Embedded Gait Analysis using IT:

eGaIT was been developed by the Department of Molecular Neurolgy (PD Klucken, Prof.Winkler), the Pattern Recognition Lab (Prof. Eskofier), and the industrial partner Astrum ITGmbH. The study system enables automated and mobile gait analysis. Motion sensorrecord movement signals to a tablet PC or smart phone from distinct movement tests.Gait parameters are computed on the server and results are provided to the physician orpatient

shown that sensor-based move-ment analysis approaches reach-ing high biomechanical resolu-tion need to be adjusted to theparticular symptom and disease.In future, modular sensor sys-tems will be selected and appliedto effectively monitor differentbody functions providing therapy-relevant information for the indi-vidual patient and the treatingphysician. This information canalso be used to provide objectiveevidence for therapy efficacyusing objective, reproducible, andcomparable data. These conceptswill allow to validated therapeutictargets in health care, ultimatelyleading to a greater benefit forthe patient due to better andfaster therapy adjustments. Both,the adaptation and further devel-opment of technical solutions, aswell as the ethical and legal def-initions of appropriate platforms,patient privacy rights, and medi-cal data protection require fur-ther research. Using the exampleof Parkinson's disease eGaIT canprovide objective parameters on

human gait as a measure formotor impairment and mobility.

The eGaIT system is currentlyfurther developed for its applica-tion in other neurological dis-eases, e.g. Multiple sclerosis, butalso musculo-skeletal movementimpairments. In particular, ager-elated chronic and multifactorialgait impairments require constantnursing and medical care. It is themost important patients’ need torapidly adapt the various thera-pies for successful treatment, andto prevent secondary comorbidityand serious complications.

Developments in medical tech-nology can provide complemen-tary information on the medicalstatus of patients across thedistinct sectors of care from cost-effective and easy to use solu-tions. Long-term and continuoustherapy monitoring or teleme-dical applications will supportpatient care and significantlychange the treatment processessustainably.

Informations:

www.egait.de

Literature:

Barth, et al., Sensors, 15: 6419-6440.2015Rampp, et al. IEEE Trans BiomedEng, 62: 1089-1097. 2015Klucken, et al., PLoS One, 8: e56956.2013Klucken, et al., Neurologie & Rehabi-litation 19: 69-76. 2013Klucken, et al., Nervenarzt, 82:1604-1611. 2011

56 Sensor-based gait analysis

Sensor-based Home-Monitoring concepts:

A variety of sensor systems are adapted to the specific symptoms of patients and measure respective body functions, classify distinctimpairments and monitor therapeutic effects or progression of diseases. Sensor-based parameters complement aditional informationon the patient and results are provided to physicians, medical services, or the individual patient

Author:

Abteilung für Molekulare Neurologie,Universitätsklinikum Erlangen,Friedrich-Alexander-Universität (FAU)

Schwabachanlage 691054 Erlangen/GermanyPhone: +49 9131 85 39324Fax: +49 9131 85 34672E-mail: [email protected]

Priv. Doz. Dr. med.Jochen Klucken

Stellv. Leiter, Oberarzt

Patents

Medical technology is a relativelysmall, but very innovative and fast-growing branch of German indus-try. Alongside some big companies,the creative backbone of thisbranch is formed by about 1.500small- and midsize companies. In2014 the export quota reached aninternational top position of 70 %.Intellectual property (IP) rights areessential to secure and strengthenthis economic-scientific success, andnew developments (products, theiruse, processes) should regularly beassessed as to whether IP rightscould be secured.

German medical technology

in international top position

As regards patents and the relativeshare of world trade, Germany holdsposition 2 behind the USA. Researchenterprises in the field of medicaltechnology reinvest, on the average,about 9 % of their turnover in re-search and development; in compa-rison, the highly innovative chemi-cal industry reinvests about 5 % inresearch and development, and theprocessing industry about 3.8 % intotal (BV-Med Annual report 2015).This innovative capacity is reflectedin the filing figures of Europeanand German patent applications.

European Patent Applications

according to the countries of

origin1

In 2014 the number of Europeanpatent applications rose to 274,174

which is a plus of 3.1 % in compari-son to the previous year. Medicaltechnology again holds the leadingposition with 11,124 filed Europeanpatent applications, followed byelectrical devices (10,944) and digitalcommunication (10,018). Most of theapplications originate from USA,Japan, Germany, China and SouthKorea. In Europe, the number ofapplications from Germany are fol-lowed by applications from France,The Netherlands and Switzerland,as well as the UK, as shown inthe following graph from theEuropean Patent Office (EPO).

Also the German Patent- andTrademark Office (GPTO) regis-tered an increase of 3.7 % in thenumbers of patent applications inthe field of medical technology,as well as an increase of 2.1 % inthe filing of trademarks.

Which IP rights are suitable?

Patents and utility models aretechnical IP rights which protectthe technical embodiment. Trade-marks and designs are non-tech-nical IP rights, where designsprotect the 2- and 3-dimensionalform of a product and a trade-

IP rightsfor the

protection ofmedical technologies

58

IP r

igh

ts

1 Direct, first European filings as well as European filings after PCT(http://www.epo.org/about-us/annual-reports-statistics/statistics/filings_de.html)

process on the market. If the analy-sis does not identify relevantthird party rights, nothing standsin the way for the launch; if theanalysis identifies potentiallyrelevant third party rights, earlyconsiderations should be under-taken to modify the productand/or process so as to delimit itfrom and avoid infringement ofthe older IP right.

Conclusion

The safeguarding of innovationsby IP rights plays a particularlyimportant role in the field ofmedical technology. The IP stra-tegy should be harmonized withthe innovation- and company strat-egy and follow a sensible budgetplan to attain maximal success forthe enterprise.

mark allows for the assignment ofa product or service to an enter-prise or, as the case may be,“brands” the enterprise.

Patents provide a protection termof 20 years, utility models 10 years,registered designs 25 years, non-registered designs 3 years, andtrademarks 10 years, whereby theprotection term of a trademarkcan be extended endlessly bypayment of a renewal fee. Inprinciple, any invention which isnovel, inventive and industriallyapplicable can be protected by apatent or utility model which isnovel, inventive and industriallyapplicable. It has to be taken intoaccount that treatment of thehuman or animal body is exclu-ded from patent or utility modelprotection in many countries orregions, including the EPO andGPTO, to ensure that the treat-ment of humans and animals isnot hindered or even preventedby patent or utility model protec-tion. In addition, under Germanutility model law, the protectionof processes in general is ex-cluded.

Combination of IP rights

increase protection

The different aspects of a prod-uct or process can be protectedby different IP rights, wherebythe safeguarding of an inventioncan be increased and the possi-bilities to defend an inventionagainst copying competitors(“me-too products”) can be opti-mized. For example, the techni-cal embodiments of an inventioncan be protected by one or morepatents and/or utility models, theform of a medicinal product by adesign, and the product name bya trademark. Designs and trade-marks are often particularly effec-tive in acting against “me-tooproducts” since the assessment oftheir infringement is, in general,easier than of a technical IPright. “Me-too products” also

primarily attempt to copy theproduct form and make use ofthe trademark and, to a much les-ser extent, copy the technicalquality. Accordingly, trademarksand designs are particularly suita-ble for forming the basis forquick enforceable legal meanssuch as border seizure or prelimi-nary injunctions to avoid “me-tooproducts” accessing the market orto remove them early from themarket. This is highly importantfor medicinal products as “me-too products” of low quality maylead to health risks and have tobe removed from the marketquickly so as to avoid the originalproduct being removed from themarket due to a negative reputa-tion created by the lower quality“me-too product”.

Observing third party rights

All the above mentioned IPrights provide the owner of theright to prohibit third partiesfrom copying the form, the trade-mark, or the technical embodi-ment of an invention during thetime the IP right is in force. Inthe case of patents or utilitymodels, a protected product orprocess cannot be produced,brought onto the market or used bythird parties without the consentof the IP right owner. Con-sequently, it is possible for the IPright owner to block the marketfor competitors and to generatesales by licensing out the IPright(s).

However, a granted or registeredIP right does not provide the IPright owner the guarantee thatthe protected subject matter canbe realized and brought onto themarket without infringing anolder third party IP right wherethe scope of protection maycomprise the later more specificinvention. Therefore, it is advis-able to conduct a “freedom-to-operate” analysis early and beforethe launch of the product and/or

59IP rights

Author:

V.O. Patentanwälte

Rindermarkt 580331 München/GermanyPhone: +49 89 890636936E-mail: [email protected]

Dr. Bettina Hermann

P�✁✂✄☎✆✝✆✞✆✄✟✠✡✝✆☛

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The trade with counterfeit prod-ucts continues to boom. In itsannual report on EU customsenforcement of intellectual prop-erty rights of July 31, 2014, theEuropean Commission informsthat in the year 2013 the customsauthorities in the EU have de-tained almost 36 million goodssuspected of infringing an IPR.The medical technology sectorwhich in the year 2013 alone wasresponsible for more than 10,000patent applications does not es-cape such unfair competition.According to the German MedicalTechnology Association, 8% ofthe medical technology productssold worldwide are counterfeits.A large number of these productsfind their way over the externalborder of the EU and are after-wards exhibited at one of thenumerous large medical technol-ogy trade fairs, such as theMEDICA, most of them takingplace in Germany.

Thus, trade fairs are often thescene of patent and trademark dis-putes. Here - from the point ofview of the IP right holder - thefast and effective enforcement ofIPRs already prior to or during atrade fair is of particular impor-tance. Further issues of interestare strategies for preventing alegal dispute and an effectivedefense in the case of a legalaction.

For IP right holders, trade fairsare the best opportunity to obtainan overview of competitors‘ prod-ucts already at an early stage,often even prior to the relevantmarket entry, and to investigatethem for possible IPR infringe-ments. It is seldom that easy toget to know the competitors‘ prod-ucts and innovations and to clarifyrelevant infringement issues, forexample with respect to specificproduct features or the distributi-on channels in Germany, and inthis way to already collect eviden-ce for later court proceedings.

If the IP right holder knows thatpotentially infringing products ofa competitor will be exhibited at atrade fair, he has basically threeoptions, namely:

to send a warning letter

to apply for a preliminaryinjunction

to request a border seizure

A warning letter is a serious andfinal demand to the competitor tocease and desist from committinga particular act (e.g. from offeringa specific product). In the warningletter, a term will be set withinwhich the competitor has to sub-mit a declaration that he will infuture desist from committing theacts objected to. Failing which he

is threatened with legal proceed-ings. It may also be considered toserve a legal action during thetrade fair in order to avoid delaysthat would ensue from a serviceabroad. If the warning letter isjustified, the competitor regularlyhas to bear the fees of the lawyerhandling the warning letter.

The option of applying for apreliminary injunction againstcounterfeiters is of particular rele-vance prior to or during a tradefair, because if the application issuccessful it is possible to surprisethe competitor, without priorwarning, with an injunction title.Consequently, ideally it will bepossible to enjoin the competitoralready prior to or during thetrade fair from exhibiting andoffering infringing products.

With regard to infringing goodsfrom EU countries, the IPR holdercan file an application for a bor-der seizure with the competentcustoms department.

In contrast to what is suggestedby the term border seizure, theeffectivity of an application for aborder seizure action does notend at the external border of theEU. Rather, the German Cus-toms Investigation Office has theright to seize infringing goods atany place within the EuropeanUnion and thus also at a trade fair.

IP ProtectionStrategies

for Medicinal Products

61

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so-called “Keksstangen” Decisionof the Federal Supreme Court, itseems to be indispensible to havespecialists analyze the individualcase. In any case, it is advisable tohave a good look at one‘s ownIPRs and also at relevant IPRs ofothers already before a trade fair,in order to avoid missing opportu-nities, to minimize risks, and to beprepared for the worst case ofbeing taken to court for an allegedIPR infringement.

Where there is a risk of a legalaction for infringement of a patentor trade mark, it can be crucial toprepare for possible attacks by theIPR holder already before thetrade fair so as to be in a positionto quickly take counter measures.Primarily the following optionsexist:

obtaining a “freedom-to-operate opinion”

license negotiations

deposition of protective letters

In the case of a so-called “free-dom-to-operate opinion”, spe-cialized attorneys will analyze theproduct portpolio intended to beexhibited and promoted at thetrade fair with a view to IPRinfringements already prior to thetrade fair. They will point outpossibilities to circumvent rele-vant IPRs or even to destroythem. Thus, the risk of an infrin-gement suit can be minimized. Ofparticular interest to researchingand innovative medical technolo-gical companies is the experimen-tal use exemption under patentlaw, which offers scope for rese-arch in the area of patented tech-nologies.

If it is already known that a com-petitor considers one‘s own prod-

ucts to infringe his IPRs and if anIPR infringement cannot be rejec-ted out-of-hand it is advisable toenter into licensing negotationswith the competitor already priorto or even during the trade fair inorder to prevent a surprise attackat the trade fair.

Where there is reason to fear thatcompetitors will apply for a pre-liminary injunction against one‘sown company, the deposition of aprotective letter at the relevantcourts is an option. It is the objectof such a protective letter to pre-vent the grant of a preliminaryinjunction. For this purpose, thepotential respondents will arguethat the requirements for thegrant of a preliminary injunctionare not met and that the potentialrespondent must in any case beheard before a decision about theinjunction claim is taken.

Expert advice by specialized pa-tent attorneys and attorneys-at-lawguarantees an effective use oflegal instruments with respect totrade fair activities. Especially inview of the question of whetherin the individual case the mereexhibition of a product at a tradefair can be considered as consti-tuting an infringing act againstwhich the IPR holder can takeaction, which continues to be con-troversial in particular due to the

62 IP Protection Strategies

Author:

Vossius & PartnerSiebertstr. 381675 München/GermanyPhone +49 89 41304-0Fax +49 89 41304-430E-mail: [email protected]

Dr. Johann Pitz

Attorney-at-LawPatent Disputes andPatent Litigation

MagazinesFuture Technologies in Bavaria

Hans-Bunte-Str. 5 · 80992 München · Tel.: 089-23 55 57-3 · Fax: 089-23 55 57-47


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