Purchasing Medical Innovation

Innovation in medical technology generates a remarkable supply of new drugs, devices, and diagnostics that improve health, reduce risks, and extend life. But these technologies are too often used on the wrong patient, in the wrong setting, or at an unaffordable price. The only way to moderate the growth in health care costs without undermining the dynamic of medical innovation is to improve the process of assessing, pricing, prescribing, and using new technologies. Purchasing Medical Innovation analyzes the contemporary revolution in the purchasing of health care technology, with a focus on the roles of the Food and Drug Administration (FDA), Medicare and private health insurers, physicians and hospitals, and consumers themselves. The FDA is more thoroughly assessing product performance under real-world conditions as well as in laboratory settings, accelerating the path to market for breakthroughs while imposing use controls on risky products. Insurers are improving their criteria for coverage and designing payment methods that reward efficiency in the selection of new treatments. Hospitals are aligning adoption of complex supplies and equipment more closely with physicians’ preferences for the best treatment for their patients. Consumers are becoming more engaged and financially accountable for their health care choices. This book describes both the strengths and deficiencies of the current system of purchasing and highlights opportunities for buyers, sellers, and users to help improve the value of medical technology: better outcomes at lower cost.

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. Provides multiple considerations and comprehensive lessons from varied organizations, researchers and products Designed to help address topics that improve success and avoid the high cost of innovation failure Recommends the practical steps needed to move a novel, non-developed concept into a tangible, realistic and commercially successful product

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

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.

The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.

This book brings together a collection of empirical case studies featuring a wide spectrum of medical innovation. While there is no unique pathway to successful medical innovation, recurring and distinctive features can be observed across different areas of clinical practice. This book examines why medical practice develops so unevenly across and within areas of disease, and how this relates to the underlying conditions of innovation across areas of practice. The contributions contained in this volume adopt a dynamic perspective on medical innovation based on the notion that scientific understanding, technology and clinical practice co-evolve along the co-ordinated search for solutions to medical problems. The chapters follow an historical approach to emphasise that the advancement of medical know-how is a contested, nuanced process, and that it involves a variety of knowledge bases whose evolutionary paths are rooted in the contexts in which they emerge. This book will be of interest to researchers and practitioners concerned with medical innovation, management studies and the economics of innovation. Chapter 5 of this book is freely available as a downloadable Open Access PDF at www.tandfebooks.com/openaccess. It has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license.

From one of America's top physicians, a "riveting," "fascinating," and "timely" (Nature) history of risk in medicine Every medical decision--whether to have chemotherapy, an X-ray, or surgery--is a risk, no matter which way you choose. In You Bet Your Life, physician Paul A. Offit argues that, from the first blood transfusions four hundred years ago to the hunt for a COVID-19 vaccine, risk has been essential to the discovery of new treatments. More importantly, understanding the risks is crucial to whether, as a society or as individuals, we accept them. Told in Offit's vigorous and rigorous style, You Bet Your Life is an entertaining history of medicine. But it also lays bare the tortured relationships between intellectual breakthroughs, political realities, and human foibles. As we have learned from the COVID pandemic--the debates over lockdowns, masks, and vaccines--it's all too easy to get everything wrong. Updated with a new introduction, You Bet Your Life is an essential read for getting the future a bit more right.

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.