Provisional Table of Contents
1. EXECUTIVE SUMMARY 7
2. INTRODUCTION 9
- 2.1 Pressures on bringing a medical device to the market. 9
- 2.2 Commonalities to some reimbursement systems 10
- 2.2.1 Diagnosis related groups 10
- 2.2.2 Health technology assessment 12
- 2.3 The target audience 12
3. THE TWO R' s 13
- 3.1 Regulations ? being allowed into a market 13
- 3.1.1 US medical device and diagnostic regulations 13
- 3.1.2 Europe' s medical device and diagnostic regulations 14
- 3.1.3 Japan' s medical device and diagnostic regulations 15
4. GLOBAL REIMBURSEMENT STRATEGIES 17
- 4.1 Health technology assessment 17
- 4.2 Clinical trial architecture for reimbursement 20
- 4.3 Pricing 25
- 4.3.1 Price skimming 26
- 4.3.2 Penetration pricing 27
- 4.3.3 Cost-based pricing 27
- 4.3.3.2 Experience curve pricing 28
- 4.3.4 Demand-based pricing 29
- 4.3.4.1 Prestige or premium pricing 29
- 4.3.4.2 Product line pricing 29
- 4.3.4.3 Pricing differentiation 30
- 4.3.5 Competition-based pricing 31
- 4.3.5.1 Economy pricing 31
- 4.3.5.2 Competitive parity 32
- 4.3.6 Cost-benefit pricing strategy 32
5. THE MAJOR MARKETS 34
- 5.1 The US 34
- 5.1.1 Regulations 35
- 5.1.1.1 51 0(k) Pre-Market Notification 35
- 5.1.1.2 Pre-Market Approval Application 38
- 5.1.1.2.1Product Development Protocol 39
- 5.1.1.3 Investigational Device Exemption 39
- 5.1.1.4 Post-marketing regulations 40
- 5.1.2 Reimbursement 40
- 5.1.2.1 Medicare 41
- 5.1.2.2 Medicaid 42
- 5.1.2.3 Private insurers 43
- 5.1.2.4 Uninsured 43
- 5.1.2.5 Health technology assessment 43
- 5.1.3 Reimbursement system 44
- 5.1.3.1 Company issues with reimbursement 46
- 5.2 Japan 49
- 5.2.1 Regulations 49
- 5.2.2 Reimbursement 55
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