The GMTA and Entry Strategies for Medtec Innovations in the German Market Dr. Detlev Langmann AKM Innovationsmanagement GmbH

Medical Technology Markets Global market 2008:€bn 220 total revenue By region 1) US€bn 852) EU €bn 65 By country 1) US2) Japan3) Germany

Medical Technology Markets EU market CE Marking conformity with essential health and safety requirements within European Economic Area (EEA) declaration by manufacturer + acceptance by a European authorized conformity assessment body Germany established largest market twice the market volume of France three times the market volume of Italy or UK, resp. MPG - Law on Medical Devices applies

Medical Technology Markets German Health Care Economy 10.6% of GDP annual revenue of €bn 245 Medical devices sector €bn 22

Competition Germany 1200 companies with more than 20 employees 9% R&D investment of total sales revenue Gov. “Medical Device Action Plan” support for intelligent implants, innovative rehabilitation methods, imaging and regenerating medicines Germany 2 nd after the U.S. for new medical device patents e.g. in 2009: 20% of EPA patent applications

Competition Germany 1/3 of total business revenue from products not more than 3 years old new products in 2009 (TÜV CERT Nord)

Germany Market conditions Open and transparent market principle of freedom for foreign trade and payment Reliable logistics, communications, and energy infrastructure Competitive labor costs and flexible working practices Overall corporate tax burden ~ 30%

i.e. the EU countries paved the way for faster and less burdensome routines to product launch and hence cash flows! i.e. the EU countries paved the way for faster and less burdensome routines to product launch and hence cash flows!

GMTA German Medical Technology Alliance National Structure for Research and Transfer of Medical Technology

MedTAC: Services Medical Test and Application Center (MedTAC) One-stop shop service for cardio-vascular innovations “Putting Ingenious Ideas in Vivo ” comprises the entire process from Device specification 3D-CAD/ CAM Screening of Materials and bio compatibility testing Fluid dynamics simulation (&FEM) Rapid Prototyping & Manufacturing Laboratory testing on durability Pre-clinical testing

MedTAC: Service Modules

MedTAC: Customer Value One-stop shop service for cardiovascular innovations Significant time-to-market reduction by seamless process coordination High service reliability and quality assurance by certified partners

R&D Project ForSaTum

Outlook 2012 ForSaTum-Service Business Unit

Summary Germany is a fertile ground for Medtec innovations R&D infrastructure and top-notch innovation climate Significant European medtech market hub GMTA Your Early Facilitator for Research and Transfer of Medical Technology One-stop shop for hands-on innovation services MedTAC ForSaTum-Service BU

Chairman Mr. Stephan Albani Tel APAC contact: Dr. Detlev Langmann, MEDICA Hall 3/ C80 aachen.de Tel

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