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Author Lee, Jen-shih
Title Biomedical Engineering Entrepreneurship
Imprint Singapore : World Scientific Publishing Company, 2010
©2010
book jacket
Descript 1 online resource (313 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Note Intro -- Contents -- Preface -- Acknowledgements -- SECTION I: INTRODUCTORY CHAPTER -- Chapter 1. Introducing Biomedical Engineering -- 1.1. Advancements in Biomedical Engineering -- 1.2. Scope of Biomedical Engineering -- 1.3. Medical Device and Pharmaceutical Industry -- 1.4. Supporting Societies and Professional Activities -- 1.5. Innovations in Biomedical Engineering -- 1.6. Hemodialysis and its Innovators -- 1.7. The Impact of Medical Device Innovations on Healthcare -- 1.8. Career Interests of Biomedical Engineering Students -- 1.9. Three Development Phases to Success -- 1.10. About the Author -- References -- SECTION II: ASSESSING THE VENTURE -- Chapter 2. Evaluating Your Entrepreneurship -- 2.1. An Entrepreneurial Team -- 2.2. John Abele, Pete Nicholas, Medi-Tech, and Boston Scientific -- 2.3. Nature of Entrepreneurship -- 2.4. Wanting To Be an Entrepreneur -- 2.5. Career Entries to Entrepreneurship -- 2.6. Practicing Entrepreneurship -- 2.7. Entrepreneurship and Visions of Uncas A. Whitaker -- References -- Chapter 3. Establishing Your Venture Invention -- 3.1. How an Entrepreneur Acquires a Venture Idea? -- 3.2. Three Inventions of Medtronic Inc. -- 3.3. Evaluating Your Invention -- 3.4. Wallace Coulter's Invention, His Venture and Legacy -- 3.5. The Venture of Howard Diamond -- 3.6. Magnetic Guidance System for Less Invasive Surgery -- 3.7. Innovations and Improvements -- References -- Chapter 4. Researching the Market for Your Invention -- 4.1. The Purpose of Market Research -- 4.2. Websites and Literatures on Medicine and Engineering -- 4.3. Two Biotech Ventures Founded by Sheridan Snyder -- 4.4. Entrepreneurial Advice and Thoughts from Snyder -- SECTION III: LAUNCHING THE VENTURE -- Chapter 5. Forming the Company -- 5.1. Rationale for the Corporation -- 5.2. Organizational Structure
5.3. Capital Required for the Company's Operation -- 5.4. Company Registration, Share Distribution and Exit Strategy -- Chapter 6. Patenting Your Invention -- 6.1. The U.S. Patent and Trademark Office -- 6.2. Utility, Design, and Plant Patents -- 6.3. Trademarks and Copyrights -- 6.4. The Importance of Patenting Your Intellectual Property -- 6.5. The Process of Patenting -- 6.6. Key Elements of a Non-provisional Patent Application -- 6.7. Special Patenting Considerations -- 6.8. Value of a Patent -- References -- Chapter 7. FDA Regulations -- 7.1. The Food and Drug Administration -- 7.2. The Safety and Effectiveness of Medical Devices -- 7.3. Device Classification -- 7.4. Investigational Device Exemption (IDE) -- 7.5. Premarket Approval Applications -- 7.6. Post Approval and Post Marketing Requirements -- 7.7. New Drug Development on Premarket Approval Application -- Chapter 8. The FDA 510(k) Submission -- 8.1. Overview -- 8.2. The 510(k) Submission -- 8.3. Preparing for the 510(k) Submission -- 8.4. Writing the 510(k) Submission -- 8.5. Outcomes -- References -- Chapter 9. Obtaining Help and Support -- 9.1. SBA Support for Small Businesses -- 9.2. Government Support for Technology Development and Commercialization -- 9.3. Community Support -- References -- Chapter 10. SBIR Grants for Product Development -- 10.1. Vision of Small Business Innovation Research (SBIR) Program -- 10.2. NIH SBIR Funding -- 10.3. NIH SBIR Grant Review Process -- 10.4. SBIR Grant Application Research Plan -- 10.5. Timelines for SBIR Grant Funding -- References -- Chapter 11. Writing and Presenting the Business Plan -- 11.1. Overview -- 11.2. Company Status before Preparing the Roadmap -- 11.3. Roadmap for the Assessing Phase -- 11.4. Action Plan for the Launching Phase -- 11.5. Business Plan for the Building-Up Phase -- 11.6. Presentation of the Business Plan -- References
SECTION IV: BUILDING UP THE ENTERPRISE -- Chapter 12. Financing and Accounting -- 12.1. Angel Investors and Venture Capital Firms -- 12.2. Due Diligence by Venture Capital Firms -- 12.3. Account Management -- 12.4. Budgeting -- 12.5. Financial Projections -- References -- Chapter 13. Negotiating Deals -- 13.1. The Negotiation Process -- 13.2. The Venture Funding Term Sheet -- 13.3. Executive Employment Contracts -- 13.4. Licensing Agreement -- References -- Chapter 14. Leading People and Managing Yourself -- 14.1. Preparing Yourself and Managing Your Time and Work -- 14.2 Setting Goals, Incentives and Recognition for the Team -- 14.3. Working with the Team -- 14.4. Building the Winning Team -- References -- Chapter 15. Manufacturing Your Product -- 15.1. Procurement and Outsourcing -- 15.2. Current Good Manufacturing Practice (cGMP), Accountability and Risk Management -- 15.3. Lifecycle Management for Maximum Value -- References -- Chapter 16. Marketing and Sales -- 16.1. Know Your Customers -- 16.2. Market Characteristics of Medical Devices and Pharmaceutical Products -- 16.3. Customer Relationship Management (CRM) -- 16.4. Marketing Ethics and Legal Compliance -- 16.5. Preparing Your Marketing and Sales Campaign -- References -- Chapter 17. Globalizing Your Business -- 17.1. International Operations -- 17.2. Healthcare in the UK, Germany, France and Italy -- 17.3. The Healthcare Systems of Taiwan and China -- 17.4. World Prevalence of Diseases -- 17.5. Work Forces of Taiwan and China -- 17.6. Industrialization of Taiwan and China -- 17.7. Alliance of American, Taiwanese and Chinese Companies -- 17.8. Canada's Medical Device Industry and Manufacturing in Mexico -- 17.9. HME Markets and the Need for an Alliance -- References -- SECTION V: CONCLUDING CHAPTERS -- Chapter 18. Investing in the Future -- 18.1. Investing in Your Company and Yourself
18.2. Contributing to the Profession, the Society and the Nation -- 18.3. Doing Something for the World -- References -- Chapter 19. How to Succeed in Biomedical Engineering Entrepreneurism with Really Trying, by Shu Chien -- 19.1. The Biomedical Engineer as a Person -- 19.2. Development of a Biomedical Engineering Entrepreneur -- 19.3. Inter-personal Interactions -- 19.4. Roles of the Government and the Private Sector -- 19.5. Public Policy and Healthcare Delivery -- 19.6. Global Nature of Biomedical Engineering Entrepreneurism -- 19.7. Conclusions -- Index
This book is written for undergraduate and graduate students in biomedical engineering wanting to learn how to pursue a career in building up their entrepreneur ventures. Practicing engineers wanting to apply their innovations for healthcare will also find this book useful. The 21st century is the Biotech Century where many nations are investing heavily in biotechnology. As a result, tremendous business opportunities exist for biomedical engineering graduates who are interested in becoming successful entrepreneurs. However, many challenges await these entrepreneurs intending to invent safe and effective devices and drugs to prevent, diagnose, alleviate and cure diseases. In this publication, many examples of innovations in biomedical engineering are covered, from the conceptualization stage to successful implementation and commercialization. Part I teaches working and would-be biomedical engineers to assess how well their innovations and their team can succeed. Part II will guide budding entrepreneurs to launch their ventures to the point of pre-production models.Other important aspects like financing, negotiations, leading by example, manufacturing, marketing, venture and globalization are covered in Part III. A concluding chapter, with excerpts from leaders in community, education sectors and industries, touches on biomedical engineering investment
Description based on publisher supplied metadata and other sources
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2020. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries
Link Print version: Lee, Jen-shih Biomedical Engineering Entrepreneurship Singapore : World Scientific Publishing Company,c2010 9789814295604
Subject Biomedical engineering.;Entrepreneurship
Electronic books
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