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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:

  • 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
It is estimated that there are several hundred new tests and test platforms in development and near market. It is obvious that even if all of these devices make it to market, not all will enjoy successful market penetration. With the average cost to develop a new diagnostic test at least $100 - $200 million, companies have little choice but to improve the efficiency of their research and development and commercialization processes.

Among other points, this report will provide readers with the following information:

  • 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

Marketing mature products and of course new products and technologies is a mix of art, intuition and marketing science. It involves a keen understanding of the market parameters that you and your company can control - product design, pricing, distribution options and of course sales training and promotions.

Companies also should invest in research that allows them to understand market parameters that are totally not in their prevue to manage. These uncontrollables include economic trends that may result in unexpected obstacles and actions taken by competitors.

It is generally believed that consumer behavior is also a huge unpredictable market parameter. This is where the art of marketing plays its most important role. Well-designed investigative interactions between marketers and potential consumers can provide a wide window into consumers’ needs, perceptions and capabilities to embark of purchase decisions.

This report blends marketing theory with actual events to provide clues on how to implement marketing strategies appropriate for current market conditions and for the future. Anyone launching a new product into the world diagnostic market will benefit from this essential resource.


'Evidence-Based Marketing' Could be Key for Diagnostic Companies

New York — The economic downturn may create opportunity for growth if companies are willing to invest in evidence to support their product’s performance, according to What is Working in IVD: Successful Commercialization of New Products and Technologies, a new report from leading life science market research company Kalorama Information.

According to the report, it is important to design and manufacture products that are right for the target audience and then to use scientific methods to prove that the products have a positive effect on patient care. Evidence-based medicine is becoming more critical for product success as advances in medical technology create increasingly sophisticated and thus more costly new tests.

“Companies might be tempted to reduce spending on marketing in a recession,” says Shara Rosen, Kalorama Information’s lead diagnostics analyst. “But the reality is that to impress increasingly skeptical payers, they may have to spend more.”

Published clinical trials comparing a new test to existing tests providing cost/benefit analyses and peer reviewed evaluation of the technology help to persuade physicians to order the test and payers to pay for it. A new product that has gone through a cost/benefit evaluation is more likely to be awarded higher reimbursement status, which is essential for market penetration, particularly during a recession.

Early adopters - leading researchers, physicians and laboratories - also play a highly influential role in the development and commercialization of new tests. They are critical to the rapid adoption of new products by the bulk of potential users, and must be part of the strategy.

“The recession may provide an opportunity for a company that is willing to invest a fair amount in evidence-based studies for its products,” says Rosen. ”In a recession, market share lost will not be easy to gain back in the future. A company investing in evidence-based medicine that demonstrates the cost effectiveness of a test could go far to ensure future expansion.”

Kalorama Information’s new report, What is Working in IVD: Successful Commercialization of New Products and Technologies, offers tips gleaned from years of watching the market that are key to successful product launches in the current market. Rosen has developed a "six strengths approach" for companies engaging in product commercialization, combining marketing theory with the realities of the diagnostics industry. Several case studies illustrate the intricacies and complexities of successful new product commercialization.

About Kalorama Information
Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services.

  • 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
    • PRODUCT DEVELOPMENT
      • Pricing Challenges
    • DISTRIBUTION STRATEGIES
      • Table Selected IVD Distribution Agreements, 2007-2009
      • Table Selected Test Commercialization Agreements
    • A NEW LOOK AT CUSTOMER SEGMENTATION
    • CONCLUSION
  • STRENGTH POINT TWO:MANAGING INTELLECTUAL PROPERTY
    • SOME IP AND PATENT BASICS
    • TO PARTNER OR NOT
    • CONCLUSION
  • STRENGTH POINT THREE: MANAGING THE REGULATORY PROCESS
    • OVERVIEW OF REGULATORY TRENDS
    • MULTIPLEXED AND MOLECULAR TESTS
    • REGULATORY PROCESS BY COUNTRY/REGION
      • United States
      • The European Union
      • Japan
      • China
      • India
  • STRENGTH POINT FOUR: ASSURING PRODUCT REIMBURSEMENT
    • REIMBURSEMENT ISSUES AND STRATEGIES
    • GOVERNMENTS REACT
    • IVD'S IN OBAMA'S HEALTHCARE WORLD
    • WINS AND DISAPPOINTMENTS
      • Genomic Health
      • Biosite Incorporated
      • Digene Corporation
    • CONCLUSION
  • STRENGTH POINT FIVE: MANAGING THE PRODUCT LIFE CYCLE
    • Public Relations - Tell Your Story
    • SCALE-UP ISSUES
      • Building a Supportive Organizational Structure
  • STRENGTH POINT SIX:MANAGING MARKET FORCES
    • INVESTORS
      • Table Selected IVD Venture Investments
    • CONSUMER POWER
      • Table Selected Home Test Products
    • SCIENTIFIC/MEDICAL COMMUNITY
    • PAYER GROUPS
      • The Economic Environment - Marketing in a Recession
    • CONCLUSION

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