This guide is written for biomedical innovators seeking to improve the lives of patients bytranslating innovative technologies into medical technologies. The contents are focusedprimarily on business principles that have been distilled from hundreds of projects as part ofthe Coulter Foundation's Translational Partners Program and Coulter Translational RewardAwards. To date, the Foundation has funded more than 600 projects, which in the first 11 yearshave raised close to $6 billion in funding.The course Concept to Clinic: Commercializing Innovation (C3i), offered by the NationalInstitutes of Health (NIH), forms the basis of this Guide. This course has helped hundredsof university innovators, engineers, clinicians, and scientists learn how to commercialize thetechnologies they have developed in a very demanding market. The C3i program is basedon the Coulter commercialization process, an approach to biomedical research translationdeveloped and continuously refined by the Foundation in collaboration with its academicpartners across the country.

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.

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

The topic of this book, the commercialization of public-sector technology, continues to grow in importance in the United States and sirnilarsocieties. The issues involved are relevant to many roles including those of policy makers, managers, patent attorneys, licensing agents, and technical staff members of public technology sources. Institutions increasingly involved in the process include federal and other governmentallaboratories and their related agencies, public universities and their state governments, public and private transfer agents and, of course, all the private recipients of public technology. Scarcely a day goes by without a significant event related to technology transfer and commercialization. The popular business press is regularly carrying articles addressing the issues, explaining new initiatives and describing events of notable success or failure.[l] As an example of current important events, the Technology Reinvestment Project (TRP) is forrnu lating its initiatives totransfer public technology and promote technology-based publiclprivate partnerships as a collaboration between the Advanced Research Projects Agency (ARPA), the National Institute of Standards and Technology (NIST), the National Science Foundation (NSF) the National Aeronautics and Space Administration (NASA), and the Department of Energy, Defense Programs (DOE/DP).

The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.

Clinical laboratory tests play an integral role in helping physicians diagnose and treat patients. New developments in laboratory technology offer the prospect of improvements in diagnosis and care, but will place an increased burden on the payment system. Medicare, the federal program providing coverage of health-care services for the elderly and disabled, is the largest payer of clinical laboratory services. Originally designed in the early 1980s, Medicare's payment policy methodology for outpatient laboratory services has not evolved to take into account technology, market, and regulatory changes, and is now outdated. This report examines the current Medicare payment methodology for outpatient clinical laboratory services in the context of environmental and technological trends, evaluates payment policy alternatives, and makes recommendations to improve the system.

Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.

This collection of papers—by American and Russian specialists—addresses a variety of legal, regulatory, institutional, and financial issues that can promote or hinder technology commercialization. The book is the result of a series of workshops organized by the National Research Council with the Russian Academy of Sciences on commercialization of technologies, particularly those developed at research and educational institutions. Technology Commercialization concludes with a list of actions, programs, and policies which warrant further consideration as Russia tries to improve the success of technology commercialization. This book will be of interest to those concerned with small-business development in post-communist states, university technology management, and comparative technology commercialization.

The most recent high-profile advocate for Americans with disabilities, actor Christopher Reeve, has highlighted for the public the economic and social costs of disability and the importance of rehabilitation. Enabling America is a major analysis of the field of rehabilitation science and engineering. The book explains how to achieve recognition for this evolving field of study, how to set priorities, and how to improve the organization and administration of the numerous federal research programs in this area. The committee introduces the "enabling-disability process" model, which enhances the concepts of disability and rehabilitation, and reviews what is known and what research priorities are emerging in the areas of: Pathology and impairment, including differences between children and adults. Functional limitationsâ€"in a person's ability to eat or walk, for example. Disability as the interaction between a person's pathologies, impairments, and functional limitations and the surrounding physical and social environments. This landmark volume will be of special interest to anyone involved in rehabilitation science and engineering: federal policymakers, rehabilitation practitioners and administrators, researchers, and advocates for persons with disabilities.

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.