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.

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.

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.

What information and decision-making processes determine how and whether an experimental medical technology becomes accepted and used? Adopting New Medical Technology reviews the strengths and weaknesses of present coverage and adoption practices, highlights opportunities for improving both the decision-making processes and the underlying information base, and considers approaches to instituting a much-needed increase in financial support for evaluative research. Essays explore the nature of technological change; the use of technology assessment in decisions by health care providers and federal, for-profit, and not-for-profit payers; the role of the courts in determining benefits coverage; strengthening the connections between evaluative research and coverage decision-making; manufacturers' responses to the increased demand for outcomes research; and the implications of health care reform for technology policy.

In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Healthcare Technology Management Systems provides a model for implementing an effective healthcare technology management (HTM) system in hospitals and healthcare provider settings, as well as promoting a new analysis of hospital organization for decision-making regarding technology. Despite healthcare complexity and challenges, current models of management and organization of technology in hospitals still has evolved over those established 40-50 years ago, according to totally different circumstances and technologies available now. The current health context based on new technologies demands working with an updated model of management and organization, which requires a re-engineering perspective to achieve appropriate levels of clinical effectiveness, efficiency, safety and quality. Healthcare Technology Management Systems presents best practices for implementing procedures for effective technology management focused on human resources, as well as aspects related to liability, and the appropriate procedures for implementation. Presents a new model for hospital organization for Clinical Engineers and administrators to implement Healthcare Technology Management (HTM) Understand how to implement Healthcare Technology Management (HTM) and Health Technology Assessment (HTA) within all types of organizations, including Human Resource impact, Technology Policy and Regulations, Health Technology Planning (HTP) and Acquisition, as well as Asset and Risk Management Transfer of knowledge from applied research in CE, HTM, HTP and HTA, from award-winning authors who are active in international health organizations such as the World Health Organization (WHO), Pan American Health Organization (PAHO), American College of Clinical Engineering (ACCE) and International Federation for Medical and Biological Engineering (IFMBE)