Medical Device Technology - Changing Reimbursement Environment in Key Markets

1. EXECUTIVE SUMMARY

2. INTRODUCTION
2.1 Pressures on bringing a medical device to the market.
2.2 Commonalities to some reimbursement systems
2.2.1 Diagnosis related groups
2.2.2 Health technology assessment
2.3 The target audience

3. THE TWO R’s
3.1 Regulations - being allowed into a market
3.1.1 US medical device and diagnostic regulations
3.1.2 Europe’s medical device and diagnostic regulations
3.1.3 Japan’s medical device and diagnostic regulations

4. GLOBAL REIMBURSEMENT STRATEGIES
4.1 Health technology assessment
4.2 Clinical trial architecture for reimbursement
4.3 Pricing
4.3.1 Price skimming
4.3.2 Penetration pricing
4.3.3 Cost-based pricing
4.3.3.2 Experience curve pricing
4.3.4 Demand-based pricing
4.3.4.1 Prestige or premium pricing
4.3.4.2 Product line pricing
4.3.4.3 Pricing differentiation
4.3.5 Competition-based pricing
4.3.5.1 Economy pricing
4.3.5.2 Competitive parity
4.3.6 Cost-benefit pricing strategy

5. THE MAJOR MARKETS
5.1 The US
5.1.1 Regulations
5.1.1.1 51 0(k) Pre-Market Notification
5.1.1.2 Pre-Market Approval Application
5.1.1.2.1Product Development Protocol
5.1.1.3 Investigational Device Exemption
5.1.1.4 Post-marketing regulations
5.1.2 Reimbursement
5.1.2.1 Medicare
5.1.2.2 Medicaid
5.1.2.3 Private insurers
5.1.2.4 Uninsured
5.1.2.5 Health technology assessment
5.1.3 Reimbursement system
5.1.3.1 Company issues with reimbursement
5.2 Japan
5.2.1 Regulations
5.2.2 Reimbursement
5.2.2.1 Company issues with reimbursement
5.3 Europe
5.3.1 Regulations
5.3.2 Reimbursement

6. REIMBURSEMENT IN EUROPEAN MARKETS
6.1 France
6.1.1 Reimbursement system
6.1.2 Company issues with reimbursement
6.2 Germany
6.2.1 Reimbursement system
6.3 Italy
6.3.1 Reimbursement system
6.4 Spain
6.4.1 Reimbursement system
6.5 United Kingdom
6.5.1 Reimbursement system

7. COMPANY EXAMPLES
7.1 Eastman Kodak
7.1.1 Background
7.1.2 Finances
7.1.3 Reimbursement situation
7.2 Guidant
7.2.1 Background
7.2.2 Finances
7.2.3 Reimbursement situation.
7.3 Hologic
7.3.1 Background
7.3.2 Finances
7.3.3 Reimbursement situation.
7.4 Roche Diagnostics
7.4.1 Background
7.4.2 Finances
7.4.3 Reimbursement situation.

8. CONCLUSIONS