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Title Medical innovation : concept to commercialization / edited by Kevin E. Behrns, Bruce Gingles, Michael G. Sarr
Published London ; San Diego, CA : Academic Press, an imprint of Elsevier, [2018]

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Description 1 online resource
Contents 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
Summary 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 organizations and multiple products. This importance reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians
Bibliography Includes bibliographical references and index
Notes Online resource; title from digital title page (viewed on May 06, 2020)
Subject Medical innovations.
Biomedical engineering.
Biomedical Technology
Biomedical Engineering
Translational Research, Biomedical
biomedical engineering.
HEALTH & FITNESS -- Holism.
HEALTH & FITNESS -- Reference.
MEDICAL -- Alternative Medicine.
MEDICAL -- Atlases.
MEDICAL -- Essays.
MEDICAL -- Family & General Practice.
MEDICAL -- Holistic Medicine.
MEDICAL -- Osteopathy.
Biomedical engineering
Medical innovations
Form Electronic book
Author Behrns, Kevin E., editor.
Gingles, Bruce, editor
Sarr, Michael G., 1950- editor.
ISBN 9780128149270
0128149272