Bio And Medtech Entrepreneurship

The process of innovation in life science is capital intensive, associated with a high risk as well as highly regulated and is therefore distinct from other types of innovation. This book closes the educational gap in life science entrepreneurship and fills a market niche. It allows you to understand, manage and successfully lead the innovation process in life science. Learn how to develop and successful market biomedical technology Increase the return of your investments in biomedical innovation Get ready for a new career in a life science start-up Discover how to transfer a bio- or medtech project from academia to industry Obtain a comprehensive overview of the innovation process in life science

Winner of Maverick of The Year Award and Ernst & Young Entrepreneur of the Year Finalist, and featured by WSJ, Fortune and Bloomberg TV for his battle to defeat unlawful actions by the FDA, Dr. Gulfo provides a first-hand riveting account of an against-all odds fight that demonstrates what it takes to advance breakthrough medical products that truly benefit patients. Having been responsible for the development and FDA approval of three innovative cancer products, he provides the reader with ringside seats to the struggles that entrepreneurs of biotech and medtech companies must fight to successfully bring ideas to marketed innovative products that truly advance the lives of patients. As exclaimed by one real-life witness to a high profile public battle recounted in the book, “It was like watching Gladiator!” The only difference is that this really happened. Sometimes life is more dramatic and unbelievable than fiction; the courtroom-like trial in front of FDA’s medical Advisory Panel is certainly one of those times. A second was the “declaration of war” – filing a Citizen Petition against the FDA demanding that it follow its own laws and acts transparently in honoring its binding agreements. A third was a Congressional Hearing at which the FDA subsequently admitted that a mistake was made. The book contains public record facts woven together in a series of compelling stories complete with unique characters and deeply personal insights. Unrelenting focus, even to the level of personal destruction, and leadership through crises are other major themes. Part One describes how medical innovation occurs in small companies and details the challenges in moving those start-ups along a course that is anything but straightforward. It addresses issues such as the psychology of inventors and founders versus investors, the challenges of attracting and retaining talent, and the vagaries of early phase product development. Part Two takes a deep dive into the unlawful actions and cover-ups by the U.S. FDA that had to be overcome in our effort to obtain approval of a non-invasive product that saves lives. It is a brutal blow-by-blow account of a public slugfest that forever damaged the company. Part Three explains how the unnecessary and very public battle with the FDA left an indelible mark on the company, a taint that was exploited by nefarious Wall Street actors who then preyed on the company for their own benefit. It details how with a Scarlet Letter on its back and an albatross around its neck, Wall Street’s short sellers and dark pool traders hamstrung the course toward widespread use and adoption. The book concludes with The Innovation Manifesto, an actionable list of changes to help fix this horribly broken system, including reform to the legal system to reduce meritless shareholder lawsuits; securities reform to stop manipulative trading, analysis, and predatory shorting of small companies; and FDA reform that will bring in leadership that is committed to, and unafraid of, promoting health by proactively advancing the development and approval of innovative products, rather than simply blocking drugs and devices that are not deemed to be safe. The FDA needs to get back to its first principles and to stop the propaganda - the author knows how to make that happen. In medical school and residency, the author was taught to “see one, do one, and teach one” as the means to master a procedure and to complete the “circle of education.” With respect to biotech and medtech companies that have been severely compromised by an untenable system, having “seen one, done one, and taught one” he now seeks to “prevent a hundred” similar unfortunate examples. Continued advancement of our national health depends on it.

Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.

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.

In terms of becoming a successful bioentrepreneur, there is still much more to learn. There are many ways to learn the essential fundamentals of entrepreneurship, including through the mistakes of previous businesses and models. Increased knowledge and a better understanding of what works can be derived from these previous failures and mistakes. Additionally, learning from other bioentrepreneurs can help businesses run successfully. By looking deeper into business models, product development, the fundamental concepts of bioentrepreneurship, and the essential characteristics of bioentrepreneurs, one can become better equipped to understand the role of biological sciences in entrepreneurship, specifically the role of product development. Bioentrepreneurship and Transferring Technology Into Product Development provides a comprehensive understanding of the role of biological sciences, specifically in transforming technology into commercial product. This book compiles the theoretical and practical aspects of bioentrepreneurship and discusses the various factors, including creating business plans, acquiring funding, and successful business models. The chapters also cover areas such as small-scale product development, intellectual property rights, funding schemes for start-ups, and new prospective biotechnology product development. This book is essential for bioentrepreneurs, entrepreneurs, product developers, scientists, practitioners, researchers, academicians, and students interested in product development from a biological science perspective.

Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

Providing an important and timely overview of research on the exciting area of entrepreneurship in biotechnology, The Handbook of Bioentrepreneurship examines one of the most promising industries of the 21st century. While genetically engineered food and biopharmaceuticals have made biotechnology part of our everyday life, starting a bioventure is among the most complex and risky entrepreneurial tasks given long development cycles, high technological and market uncertainty, and high capital intensity. Providing unparalleled in-depth and detailed analysis, this Handbook sheds light on business models and strategies, financing, cooperation networks between firms and universities, among other issues. With new developments in biotechnology increasingly in the news, this is an important source for readers interested in public policy, entrepreneurship, and business in the 21st century.

This book is written for undergraduate and graduate students in biomedical engineering wanting to learn how to pursue a career in building up their entrepreneur ventures. Practicing engineers wanting to apply their innovations for healthcare will also find this book usefulThe 21st century is the ?Biotech Century? where many nations are investing heavily in biotechnology. As a result, tremendous business opportunities exist for biomedical engineering graduates who are interested in becoming successful entrepreneurs. However, many challenges await these entrepreneurs intending to invent safe and effective devices and drugs to prevent, diagnose, alleviate and cure diseases.In this publication, many examples of innovations in biomedical engineering are covered, from the conceptualization stage to successful implementation and commercialization. Part I teaches working and would-be biomedical engineers to assess how well their innovations and their team can succeed; Part II will guide budding entrepreneurs to launch their ventures to the point of pre-production models. Other important aspects like financing, negotiations, leading by example, manufacturing, marketing, venture and globalization are covered in Part III. Two concluding chapters, with excerpts from leaders in community, education and industries, touch on the growth and investment in biomedical engineering entrepreneurship.