Medical Device Strategy For Southern Denmark

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Medical DeviceStrategyFor Southern Denmark
URS meeting the 2008-05-20
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Idea

• Medical Device Cluster in the Southern part of
  Denmark and northern part of Germany driven by
  companies with clear synergies

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Objective

• Attract innovative projects, locally, nationally
  and internationally to be developed and produced
  in the region

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Expected from URS

• Formalized cooperation with the south Danish
  hospitals
• Promote a competence based medical device cluster
  in the south of Denmark
• Continue to help to develop the started
  cooperation with Center for Software Innovation
  (CSI) as a part of the mechatronic cooperation in
  south Denmark
• Create the right contacts and relations that
• Increase the credibility to our Medical Device
  Cluster, e.g. BIOMED COMMUNITY in Aalborg or
  abroad.

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CSI Ligthouse for the Medical Device Cluster
Sweden Stockholm Lund Linköping
Companies
National contacts
Region contacts
Danfoss AS
Local contacts
PAJ Systemteknik
Hospitals
Denmark Copenhagen
Kurt Hansen Projekt
Danmeter
SDU
3L Ludvigsen
MCI
Other Universities
Germany Hamburg
Mechatronic Cluster
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CSI Lighthouse

• Safety critical embedded software
• Safety critical real time safety operation system
  RTOS
• Documentation for SW in Medical Devices ISO
  60601-1-4
• Maintenance SW process ISO 62304 safety
  classification

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Medical Device process
HW
Mechanics
SW
Application
Product
CE Approval
Normal Mechatronic products
Risk Summary Risk Management
Clinical Test
Medical Device products
Documentation and technical approval according to
ISO 60601
Clinical Approval
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The Evolution for a medical Start Up Company
Target
Level of Professionalism
Own Financing
Seed Capital / Incubator
Venture Capital
Self Financing
-Unstructured organization
-Incomplete organization
-Structured organization
-Mature organization
-Undefined Concept
-Defining the concept
-Well defined concept
-Ongoing concepts
-Lack of business plan
-Formulation of the business plan
-Proper business plan
-Proper business plan
The key to success is the Start Up companys
ability to evolve according to the above process
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The process
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Thank you for the attention