Being a Biomedical Entrepreneur

This book is about the great innovations that the biomedical industry has had on improving the health and treating diseases of people and the incredible effort that scientists, engineers, technologists, mathematicians and physicians has invested in conceptualizing, producing and marketing the innovations. This rapidly growing industry is a knowledge intensive industry that is constantly generating, and adapting to, new technology. The innovations are the movers leading to the growth of the biomedical industry since 1960. However, its growth may be threatened by the lack of access to capital, a burdensome and uncertain regulatory environment, and lack of R&D innovation and productivity.

It is written for students and professionals in science, technology, engineering, mathematics and medicine wanting to become a successful biomedical entrepreneur and to grow the biomedical industry. This book covers these four sectors of biomedical industries: medical technologies, healthcare information technology, pharmaceutic industry and biotech.

Many innovations are employed throughout the book to make this book as a resource of use to help you invent, evaluate, develop and market your innovative products. Part I examines the education merits of biomedical engineers and teaches biomedical professionals to conceptualize their innovations and to assess whether their innovations could be manufactured and be wanted by patients. Part II will guide budding entrepreneurs to form the company and entrepreneurial team, to raise venture capital, to patent your innovative products, to obtain regulatory approval and to write your business plan. Other important aspects of company operations like financing, negotiations, leadership, manufacturing, marketing and globalization are covered in Part III. Two concluding chapters, with excerpts from leaders in community, education and industries, touch on the development, growth and investment of biomedical entrepreneurs on the delivery of better healthcare and economy to all people in the world.

Contents:PrefaceAcknowledgementsIntroductory Chapters:The Biomedical IndustryEducation for Biomedical EngineersAssessing the Venture (Situation Analysis):Evaluating Your EntrepreneurshipEstablishing Your Venture Invention (Strategic Planning)Researching the Market for Your InventionLaunching the Venture (Tactical Planning):Forming the CompanyPatenting Your InventionFDA RegulationsThe FDA 510(k) SubmissionObtaining Help and SupportSBIR Grants for Product DevelopmentWriting and Presenting the Business PlanBuilding Up the Enterprise (Plan Realization):Financing and AccountingNegotiating DealsLeading People and Managing YourselfManufacturing Your ProductMarketing and SalesExpanding and Globalizing Your BusinessProspective Chapters:Investing in the FutureHow to Succeed in Biomedical Engineering Entrepreneurism with Really Trying, by Shu Chien
Readership: Advanced undergraduate and graduate students, academics and practitioners in biomedical engineering.