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.