The Risks Of Medical Innovation

Presenting a new way of thinking about the risks of medical innovation, this volume considers the issues from a social historical perspective, and studies specific cases in their respective contexts.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

A wave of new health care innovation and growing demand for health care, coupled with uncertain productivity improvements, could severely challenge efforts to control future health care costs. A committee of the National Research Council and the Institute of Medicine organized a conference to examine key health care trends and their impact on medical innovation. The conference addressed the following question: In an environment of renewed concern about rising health care costs, where can public policy stimulate or remove disincentives to the development, adoption and diffusion of high-value innovation in diagnostics, therapeutics, and devices?

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.

"Innovation in medical technology drives improvement in the quality of health care but also the unsustainable increase in costs. This book analyzes methods of technology regulation, insurance, payment, pricing, and use, and highlights ways in which they should be reformed. The goal is to improve the value of drugs, devices, and other innovative technologies to achieve better performance at lower cost."--Provided by publisher.

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.

Medical Innovation: Concept to Commercialization is a practical, step-by-step approach on how to move a novel concept through development to realize a commercially successful product. Real-world experience cases and knowledgeable contributors provide lessons that cover the practices of diverse organizations and multiple products. This important reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians.

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.

'The book would be a great text for advanced healthcare students, as it is chock-full of fair-minded and complete discussions of different scholarly views. The book contains the musts of excellent text books too: ample caselets, boxes and figures that illustrate key concepts; chapter summaries; and a distillation of key concepts and further reading suggestions stud every chapter. It is useful for practitioners too, with excellent text and case examples of how different nations approach innovation and quality measurement — e.g. pay for performance models — and full discussions of regulations of drugs and devices. All in all, a terrific book for those of us frustrated by the plethora of ‘shoulds’ and the shortages of ‘how tos’ in healthcare innovations.'Regina HerzlingerHarvard Business SchoolAcross the world, the demands placed on health systems are growing rapidly. Developed countries face the challenge of providing services to an ageing population with changing health needs, while countries with developing health systems must find ways of ensuring their populations are provided with access to healthcare. Innovative thinking is essential to meet these twin challenges, but innovation is both a cause and cure of many struggles in healthcare — we need it, but it is hard to manage and the introduction of new technology can lead to higher costs.Using real-life examples and case studies from around the world, this book introduces the latest thinking on understanding and managing healthcare innovation more effectively. It does this from the perspective of governments responsible for shaping health policy, healthcare organisations providing services and juggling competing demands, and from the perspective of the industries that supply the new drugs, devices and other technologies.Managing Innovation in Healthcare is the perfect accompaniment for MSc, PhD and MBA students on health policy, management and public health courses, as well as managers, consultants and policy makers involved in healthcare services in both the public and private sector.

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.