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.

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.

As in other areas of technological advance, the benefits of new medical devices are not without cost and raise many issues for study. We know that certain medical devices, such as the computed tomographic scanner, have reduced the net cost of treating som diseases. But how are other new technologies related to the rising cost of health care, and how can we ensure the most cost-effective use of new equipment? How can we promote innovation in medical technologies when the trends in the judical application of tort law have made industries hesitant to develop products for which profits may be modest and liabilities severe? The symposium considered topics in three general areas, which make up the three major devisions of this volume. These topics are 1) innovation and use of new medical devices; 2) current trends in federal and private support of technological innovation, medical device regulation, product liability, and health care reimbursement; and 3) several perspectives on how these trends interact to influence the availability and appropriate use of new medical devices.

This text provides a central resource for physicians, entrepreneurs, and the MBA students about how innovation occurs in medical device industry. The book uses the rise and fall of vaginal mesh kits to highlight the evolution of responses by the physicians, patients and the regulatory bodies. There are specific chapters reviewing the US regulatory issues and business practices that were consequential to withdrawal of most vaginal mesh kits from the US market. The book is meant to be concise, evidence-based, and practical for the first time readers to understand the innovation forces. Concise textual information from acknowledged experts is complemented by high-quality diagrams and images to provide a thorough update of this rapidly evolving medical device industry. The case study chapters fully elucidate the anatomical basis that led to conceptualization of vaginal mesh kits, their introduction into the market, medicolegal and business implications followed with innovation that occurred by the surgeons to utilize ultrasound for and innovative surgeries to overcome device complications. With a luxurious number of well-marked pictures, readers will gain a clear understanding of the medical device innovation and evolution. Innovation and Evolution of Medical Devices: The vaginal Mesh Kits provides a rich practical resource written in a simple a step-by- step approach for all readers in their approach to new medical devices and technologies.

Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

A short handbook for the medical device innovator who wishes to understand the innovation process for new medical 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.