Ch. 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 -- ch. 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 -- ch. 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 -- ch. 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 -- ch. 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 -- ch. 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 -- ch. 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 -- ch. 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 -- ch. 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 -- ch. 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.