The GMTA and Entry Strategies for Medtec Innovations in the German Market
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The GMTA and Entry Strategies for Medtec Innovations in the German Market Dr. Detlev Langmann AKM Innovationsmanagement GmbH
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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. - PowerPoint PPT Presentation
Transcript of The GMTA and Entry Strategies for Medtec Innovations in the German Market
The GMTA and
Entry Strategies for Medtec Innovations
in the German Market
Dr. Detlev LangmannAKM Innovationsmanagement GmbH
Medical Technology Markets
Global market
2008: €bn 220 total revenueBy region
1) US €bn 85 2) EU €bn 65
By country1) US 2) Japan 3) Germany
Medical Technology Markets
EU marketCE 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 markettwice the market volume of Francethree times the market volume of Italy or UK, resp.MPG - Law on Medical Devices applies
Medical Technology Markets
German Health Care Economy10.6% of GDPannual revenue of €bn 245
Medical devices sector €bn 22
Competition
Germany1200 companies with more than 20 employees9% R&D investment of total sales revenue
Gov. “Medical Device Action Plan”support for intelligent implants, innovative rehabilitation methods, imaging and regenerating medicines
Germany 2nd after the U.S. for new medical device patents
e.g. in 2009: 20% of 134.542 EPA patent applications
Competition
Germany1/3 of total business revenue from products not more than 3 years old
400.000 new products in 2009 (TÜV CERT Nord)
Germany
Market conditionsOpen and transparent market
principle of freedom for foreign trade and payment
Reliable logistics, communications, and energy infrastructureCompetitive labor costs and flexible working practicesOverall corporate tax burden 22.83 ~ 30%
More difficult approval process
Longer approval time
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!
GMTAGerman 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 specification3D-CAD/ CAMScreening of Materials and bio compatibility testing Fluid dynamics simulation (&FEM)Rapid Prototyping & ManufacturingLaboratory testing on durabilityPre-clinical testing
MedTAC: Service Modules
MedTAC
Putting Ingenious Ideas in Vivo
ManagING ConsultING DesignING EngineerING TestING ManufacturING
Customer Care
One-stop shop service
Seamless process coordination
Service resourceallocation
Complete order Processing
Processdocumentation
Bio-Material screening andevaluation
Testing StrategyDevelopment
Mechanical Testing
Biological safetytesting
Bio-compatibilitytesting in-vitro/ In-vivo
Testing for reusableproducts
Preclinical testing
Contact:[email protected]
Quality assuranceISO 9001:2008 ISO 13485:2003/9 CAN/CAS 13485 US-QSR (21CFR 820) cGMP
Risk mitigation (ISO 14971 andISO 22442-1)
Counselingand support for application topreclinical tests
3D CAD/ CAM Design
Development of high-quality component parts
Rapid Prototyping
In-house toolmaking
Injection molding
Thermoforming
Dipping of plastic Parts
Small-batchproduction for plastic medical engineering
Certified cleanroom ISO 7 for complex products
ISO13485:2010 certified manufacturer
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
Molecular Imaging for Preclinical Cancer Research
Outlook 2012
ForSaTum-Service Business Unit
Summary
Germany is a fertile ground for Medtec innovations
R&D infrastructure and top-notch innovation climateSignificant European medtech market hub
GMTA Your Early Facilitator for Research and Transfer of Medical Technology
One-stop shop for hands-on innovation services MedTACForSaTum-Service BU
ChairmanMr. Stephan AlbaniEmail: [email protected]. +49 441 2172 100
APAC contact:Dr. Detlev Langmann, MEDICA Hall 3/ C80Email: [email protected]. +49 241 5652 8981
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DevelopINGSynergies for Medical Technology
ConsultING
DesignING
ManufacturING
TestING
ManagING
EngineerING
