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| Preface | |
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| Acknowledgements | |
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| Introductory Chapter | |
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| Introducing Biomedical Engineering | |
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| Advancements in Biomedical Engineering | |
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| Scope of Biomedical Engineering | |
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| Medical Device and Pharmaceutical Industry | |
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| Supporting Societies and Professional Activities | |
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| Innovations in Biomedical Engineering | |
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| Hemodialysis and its Innovators | |
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| The Impact of Medical Device Innovations on Healthcare | |
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| Career Interests of Biomedical Engineering Students | |
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| Three Development Phases to Success | |
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| About the Author | |
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| Assessing the Venture | |
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| Evaluating Your Entrepreneurship | |
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| An Entrepreneurial Team | |
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| John Abele, Pete Nicholas, Medi-Tech, and Boston Scientific | |
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| Nature of Entrepreneurship | |
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| Wanting to Be an Entrepreneur | |
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| Career Entries to Entrepreneurship | |
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| Practicing Entrepreneurship | |
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| Entrepreneurship and Visions of Uncas A. Whitaker | |
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| Establishing Your Venture Invention | |
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| How an Entrepreneur Acquires a Venture Idea? | |
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| Three Inventions of Medtronic Inc. | |
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| Evaluating Your Invention | |
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| Wallace Coulter's Invention, His Venture and Legacy | |
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| The Venture of Howard Diamond | |
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| Magnetic Guidance System for Less Invasive Surgery | |
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| Innovations and Improvements | |
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| Researching the Market for Your Invention | |
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| The Purpose of Market Research | |
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| Websites and Literatures on Medicine and Engineering | |
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| Two Biotech Ventures Founded by Sheridan Snyder | |
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| Entrepreneurial Advice and Thoughts from Snyder | |
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| Launching the Venture | |
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| Forming the Company | |
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| Rationale for the Corporation | |
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| Organizational Structure | |
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| Capital Required for the Company's Operation | |
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| Company Registration, Share Distribution and Exit Strategy | |
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| Patenting Your Invention | |
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| The U.S. Patent and Trademark Office | |
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| Utility, Design, and Plant Patents | |
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| Trademarks and Copyrights | |
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| The Importance of Patenting Your Intellectual Property | |
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| The Process of Patenting | |
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| Key Elements of a Non-provisional Patent Application | |
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| Special Patenting Considerations | |
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| Value of a Patent | |
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| FDA Regulataions | |
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| The Food and Drug Administration | |
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| The Safety and Effectiveness of Medical Devices | |
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| Device Classification | |
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| Investigational Device Exemption (IDE) | |
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| Premarket Approval Applications | |
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| Post Approval and Post Marketing Requirements | |
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| New Drug Development on Premarket Approval Application | |
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| The FDA 510(k) Submission | |
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| Overview | |
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| The 510(k) Submission | |
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| Preparing for the 510(k) Submission | |
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| Writing the 510(k) Submission | |
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| Outcomes | |
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| Obtaining Help and Support | |
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| SBA Support for Small Businesses | |
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| Government Support for Technology Development and Commercialization | |
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| Community Support | |
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| SBIR Grants for Product Development | |
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| Vision of Small Business Innovation Research (SBIR) Program | |
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| NIH SBIR Funding | |
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| NIH SBIR Grant Review Process | |
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| SBIR Grant Application Research Plan | |
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| Timelines for SBIR Grant Funding | |
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| Writing and Presenting the Business Plan | |
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| Overview | |
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| Company Status before Preparing the Roadmap | |
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| Roadmap for the Assessing Phase | |
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| Action Plan for the Launching Phase | |
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| Business Plan for the Building-Up Phase | |
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| Presentation of the Business Plan | |
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| Building Up the Enterprise | |
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| Financing and Accounting | |
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| Angel Investors and Venture Capital Firms | |
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| Due Diligence by Venture Capital Firms | |
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| Account Management | |
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| Budgeting | |
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| Financial Projections | |
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| Negotiating Deals | |
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| The Negotiation Process | |
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| The Venture Funding Term Sheet | |
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| Executive Employment Contracts | |
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| Licensing Agreement | |
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| Leading People and Managing Yourself | |
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| Preparing Yourself and Managing Your Time and Work | |
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| Setting Goals, Incentives and Recognition for the Team | |
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| Working with the Team | |
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| Building the Winning Team | |
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| Manufacturing Your Product | |
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| Procurement and Outsourcing | |
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| Current Good Manufacturing Practice (cGMP), Accountability and Risk Management | |
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| Lifecycle Management for Maximum Value | |
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| Marketing and Sales | |
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| Know Your Customers | |
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| Market Characteristics of Medical Devices and Pharmaceutical Products | |
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| Customer Relationship Management (CRM) | |
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| Marketing Ethics and Legal Compliance | |
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| Preparing Your Marketing and Sales Campaign | |
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| Globalizing Your Business | |
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| International Operations | |
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| Healthcare in the UK, Germany, France and Italy | |
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| The Healthcare Systems of Taiwan and China | |
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| World Prevalence of Diseases | |
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| Work Forces of Taiwan and China | |
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| Industrialization of Taiwan and China | |
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| Alliance of American, Taiwanese and Chinese Companies | |
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| Canada's Medical Device Industry and Manufacturing in Mexico | |
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| HME Markets and the Need for an Alliance | |
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| Concluding Chapters | |
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| Investing in the Future | |
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| Investing in Your Company and Yourself | |
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| Contributing to the Profession, the Society and the Nation | |
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| Doing Something for the World | |
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| How to Succeed in Biomedical Engineering Entrepreneurism with Really Trying, by Shu Chien | |
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| The Biomedical Engineer as a Person | |
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| Development of a Biomedical Engineering Entrepreneur | |
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| Inter-personal Interactions | |
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| Roles of the Government and the Private Sector | |
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| Public Policy and Healthcare Delivery | |
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| Global Nature of Biomedical Engineering Entrepreneurism | |
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| Conclusions | |
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| Index | |