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


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

  1. 1.    Get more info on this report!What Is Working in IVD: Successful Commercialization of New Products andTechnologiesJuly 1, 2009For more than a decade, Kalorama Information has observed the successes andfailures of the IVD market. You can tap into this knowledge with this authoritative guide.As Kalorama Information has examined the markets for year, we have seen thecompanies whose approaches have succeeded and those who have not beensuccessful. A small pivot in strategy often may have made the difference. We havesummed up this knowledge in What is Working in IVD: Successful Commercialization ofNew Products and Technologies The report is written by Kaloramas lead diagnosticexpert, Shara Rosen, R.T. M.B.A., author of six best-selling editions of the industrysleading market research report in IVD diagnostics The Worldwide Market for In VitroDiagnostic Tests. Rosen offers tips gleaned from years of watching the market - keys tosuccessful new product launches in the industry as t is now.In some ways diagnostics is a unique industry. To achieve commercial success, IVDcompanies must earn the approval of several different groups, including regulators,payer organizations, healthcare providers and physicians, all of whom ultimatelydetermine 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 arecrucial.Rosen has developed a "six strengths approach" for companies engaging in productcommercialization, blending the solid marketing theory with the realities of thediagnostics 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
  2. 2. • 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 moreIt is estimated that there are several hundred new tests and test platforms indevelopment and near market. It is obvious that even if all of these devices make it tomarket, not all will enjoy successful market penetration. With the average cost todevelop a new diagnostic test at least $100 - $200 million, companies have little choicebut to improve the efficiency of their research and development and commercializationprocesses.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 TimesMarketing 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 marketparameters that you and your company can control - product design, pricing, distributionoptions and of course sales training and promotions.Companies also should invest in research that allows them to understand marketparameters that are totally not in their prevue to manage. These uncontrollables includeeconomic trends that may result in unexpected obstacles and actions taken bycompetitors.It is generally believed that consumer behavior is also a huge unpredictable marketparameter. This is where the art of marketing plays its most important role. Well-designed investigative interactions between marketers and potential consumers canprovide a wide window into consumers’ needs, perceptions and capabilities to embarkof purchase decisions.This report blends marketing theory with actual events to provide clues on how toimplement marketing strategies appropriate for current market conditions and for thefuture. Anyone launching a new product into the world diagnostic market will benefitfrom this essential resource.
  3. 3. Table of ContentsEXECUTIVE SUMMARY • Scope and Methodology • Keys to SuccessINTRODUCTION • Background • Crucial Keys to Successful New Product Commercialization - Six Strengths Model • Point of ViewStrength Point One - STRATEGIC PLANNING • Clinical Trial and Information Management o Qiagen/Digene o Aspen Bio AppyScore o AdvanDx PNA FISH test o Epigenomics PRESEPT o Genomic Health Oncotype DX o Hologic • Product Development o PGxHealth o Evidenced Based Medicine • Pricing Challenges o Down Economy Pricing Advice o Five Steps to Value Pricing o Pricing as an Impression • Distribution Strategies o Examples of IVD Distribution Arrangements o Test Commercialization • A New look at Customer Segmentation o Finding "Buckets Within Buckets" of Customers • ConclusionStrength Point Two - MANAGING INTELLECTUAL PROPERTY • Some IP and Patent Basics • Barriers to Patent Protection • Gene Patents • To Partner Or Not • ConclusionStrength Point Three - MANAGING THE REGULATORY PROCESS
  4. 4. • Overview Of Regulatory Trends • Multiplexed and Molecular Tests • Regulatory Process by Region/Country o United States o European Economic Union o Japan o China o IndiaStrength Point Four - ASSURING PRODUCT REIMBURSEMENT • Reimbursement Issues and Strategies • Governments React • IVDs in Obama’s Healthcare World • Wins and Disappointments o Genomic Health o Biosite/Inverness Medical Innovations o Digene/Qiagen • ConclusionStrength Point Five - MANAGING THE PRODUCT LIFE CYCLE • PR - Tell Your Story • Scale-UP Issues • Building a Supportive Organizational StructureStrength Point Six - MANAGING MARKET FORCES • Investors o Venture Capital Activities in IVD • Consumer Power o Steps between Evaluation of Needs and a Purchase Decision • Scientific/Medical Community • Payer Groups • ConclusionAvailable immediately for Online Download at   US: 800.298.5699
  5. 5. UK + +1.240.747.3093Fax: 240.747.3004