What is Working in IVD: Successful Commercialization of New Products and

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What is Working in IVD: Successful Commercialization of New Products and Technologies

Published Date: July 2009

Published By: Kalorama Information

Page Count: 110

Order Code: R566-498

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Table of Contents

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TABLE OF CONTENTS EXECUTIVE SUMMARY

Scope and Methodology
Keys to Success

INTRODUCTION

Background
Crucial Keys to Successful New Product Commercialization - Six Strengths Model
Point of View

Strength Point One - STRATEGIC PLANNING

Clinical Trial and Information Management
- Qiagen/Digene
- Aspen Bio AppyScore
- AdvanDx PNA FISH test
- Epigenomics PRESEPT
- Genomic Health Oncotype DX
- Hologic
Product Development
- PGxHealth
- Evidenced Based Medicine
Pricing Challenges
- Down Economy Pricing Advice
- Five Steps to Value Pricing
- Pricing as an Impression
Distribution Strategies
- Examples of IVD Distribution Arrangements
- Test Commercialization
A New look at Customer Segmentation
- Finding "Buckets Within Buckets" of Customers
Conclusion

Strength Point Two - MANAGING INTELLECTUAL PROPERTY

Some IP and Patent Basics
Barriers to Patent Protection
Gene Patents
To Partner Or Not
Conclusion

Strength Point Three - MANAGING THE REGULATORY PROCESS

Overview Of Regulatory Trends
Multiplexed and Molecular Tests
Regulatory Process by Region/Country
- United States
- European Economic Union
- Japan
- China
- India

Strength Point Four - ASSURING PRODUCT REIMBURSEMENT

Reimbursement Issues and Strategies
Governments React
IVDs in Obama’s Healthcare World
Wins and Disappointments
- Genomic Health
- Biosite/Inverness Medical Innovations
- Digene/Qiagen
Conclusion

Strength Point Five - MANAGING THE PRODUCT LIFE CYCLE

PR - Tell Your Story
Scale-UP Issues
Building a Supportive Organizational Structure

Strength Point Six - MANAGING MARKET FORCES

Investors
- Venture Capital Activities in IVD
Consumer Power
- Steps between Evaluation of Needs and a Purchase Decision
Scientific/Medical Community
Payer Groups
Conclusion

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