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