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Medical innovation : concept to commercialization /

Medical Innovation: Concept to Commercialization is a practical, step-by-step approach on how to move a novel concept through development to realize a commercially successful product. Real-world experience cases and knowledgeable contributors provide lessons that cover the practices of diverse organ...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Behrns, Kevin E. (Editor ), Gingles, Bruce (Editor ), Sarr, Michael G., 1950- (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London ; San Diego, CA : Academic Press, an imprint of Elsevier, [2018]
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover; Medical Innovation: Concept to Commercialization; Copyright; Dedication; Contents; Contributors; Preface; Chapter 1: Introduction to Medical Innovation; References; Chapter 2: The Basics of Business Law for New Businesses; Forming the Business; Limited Liability Company; Corporation; Capitalizing the Business; Early Stage Financing; Grant Funding; Operating the Business; Business Contracts; Enhancing Patent Assets; Conclusion; Important Points; Chapter 3: Regulating Medical Devices in the United States; But, First Things First; The FDA's Definition of a Medical Device
  • Intended UsePathways to Market in the United States; Class I, General Controls; Class II, Special Controls; Class III, Premarket Approval; Preamendments Devices; Activities to Support Medical Device Innovators; Early Regulatory Assistance for Medical Device Innovators; Remember Your Audience; Important Points; References; Chapter 4: The Role of University Technology Transfer; Functions and People; Process; Programs; Innovation and Entrepreneurship; Industry Supported Research and Commercialization; Conclusion; Important Points; Acknowledgments
  • Chapter 5: Basics of Patent Law: Strategies for Entrepreneurs and Start-Up EnterprisesWhat Is a Patent?; Securing Patent Rights; Types of Patents; Components of a Patent; Requirements of Patentability; Patents and Business Goals; Diligence and the Patent Rights of Others; Related Intellectual Property Laws; The Future of Patents; Important Points; Chapter 6: Licensing Medical Devices to Manufacturers/Partnering With Large Companies; Introduction; Corporate Culture; Understanding Corporations; Cultural Differences; Corporate Needs-How to Get the Giants to Want to Dance
  • Preparing to Engage With the CorporationWhen to Engage; Access Nodes in Corporations; Other Possible Access Points; Preparing to Share Information, Generate, and Maintain Interest; What to Share?; Maintaining Momentum in the Relationship: Information Sharing and Communication; Maintaining Interest; Ground Rules for Communication; Conclusion; Important Points; Chapter 7: Understanding Venture Capital in the Health Industry; Securing of a VC Investment: Sourcing and Diligence; The Term Sheet; Planning for Success: Valuation, Control, and the Inevitable Setback; The Role of the Founder/Inventor
  • ConclusionsImportant Points; Acknowledgments; References; Chapter 8: The Process for Innovators/Founders to Raise Capital to Start a Company; Identifying the Right Investor; Preparing for Investment; Targeting Qualified Investors; Closing the Deal; Important Points; Chapter 9: An Introduction to the National Institutes of Health SBIR/STTR Programs; Overview and Goals of the Program; Key Differences Between SBIR and STTR; Eligibility; Program Structure: Funding Phases; Funding Opportunities; Building a Successful Application; Application Tip 1. Start Early