What is Working in IVD: Successful Commercialization of New Products and Technologies
As Kalorama Information has examined the markets for year, we have seen the companies whose approaches have succeeded and those who have not been successful. A small pivot in strategy often may have made the difference. We have summed up this knowledge in What is Working in IVD: Successful Commercialization of New Products and Technologies
The report is written by Kalorama's lead diagnostic expert, Shara Rosen, R.T. M.B.A., author of six best-selling editions of the industry's leading market research report in IVD diagnostics The Worldwide Market for In Vitro Diagnostic Tests. Rosen offers tips gleaned from years of watching the market - keys to successful new product launches in the industry as t is now. In some ways diagnostics is a unique industry. To achieve commercial success, IVD companies must earn the approval of several different groups, including regulators, payer organizations, healthcare providers and physicians, all of whom ultimately determine the value of a product and how well it will do in the market. For that reason, strategic market-focused product development and effective commercialization are crucial. Rosen has developed a six strengths approach for companies engaging in product commercialization, blending the solid marketing theory with the realities of the diagnostics indusry:
The report is written by Kalorama's lead diagnostic expert, Shara Rosen, R.T. M.B.A., author of six best-selling editions of the industry's leading market research report in IVD diagnostics The Worldwide Market for In Vitro Diagnostic Tests. Rosen offers tips gleaned from years of watching the market - keys to successful new product launches in the industry as t is now. In some ways diagnostics is a unique industry. To achieve commercial success, IVD companies must earn the approval of several different groups, including regulators, payer organizations, healthcare providers and physicians, all of whom ultimately determine the value of a product and how well it will do in the market. For that reason, strategic market-focused product development and effective commercialization are crucial. Rosen has developed a six strengths approach for companies engaging in product commercialization, blending the solid marketing theory with the realities of the diagnostics indusry:
- Strategic Market Planning, including: Pricing, Clinical Trial Information Management, Distribution, The New Customer Segmentation and more
- Intellectual Property and Patent Protection, offers the basics of IP and discusses whether to seek a partner.
- Regulatory Process Management , including: US, Europe, Japan, India, China and more
- Reimbursement, looks at Trends, Past Successes and Failures, IVD and the Obama Administration
- Product Life Cycle Management, how to Tell Your Story, Scale Up, Build a Organizational Structure
- Market Forces Management, strategies for working with: Investors, the Scientific Community, Consumers and more
- How Time-Tested Marketing Techniques Can be Applied to Diagnostics?
- What Can IVD Marketers Glean from the Success Stories of Major Players in the Market
- How to Create a Successful Strategic Plan
- What Can IVD Marketers Learn from the Latest Customer Segmentation Techniques?
- How to Use - and not to Use - Patents
- What Early Steps Marketers Can Take -- Even in the Clinical Trial Stage?
- How to Make Optimal Pricing Decision in Down Economic Times
EXECUTIVE SUMMARY
INTRODUCTION
Strength Point One - STRATEGIC PLANNING
Strength Point Two - MANAGING INTELLECTUAL PROPERTY
Strength Point Three - MANAGING THE REGULATORY PROCESS
Strength Point Four - ASSURING PRODUCT REIMBURSEMENT
Strength Point Five - MANAGING THE PRODUCT LIFE CYCLE
Strength Point Six - MANAGING MARKET FORCES
- 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
