This book presents the latest developments in the field of biomedical engineering and includes practical solutions and strictly scientific considerations. The development of new methods of treatment, advanced diagnostics or personalized rehabilitation requires close cooperation of experts from many fields, including, among others, medicine, biotechnology and finally biomedical engineering. The latter, combining many fields of science, such as computer science, materials science, biomechanics, electronics not only enables the development and production of modern medical equipment, but also participates in the development of new directions and methods of treatment. The presented monograph is a collection of scientific papers on the use of engineering methods in medicine. The topics of the work include both practical solutions and strictly scientific considerations expanding knowledge about the functioning of the human body. We believe that the presented works will have an impact on the development of the field of science, which is biomedical engineering, constituting a contribution to the discussion on the directions of development of cooperation between doctors, physiotherapists and engineers. We would also like to thank all the people who contributed to the creation of this monograph—both the authors of all the works and those involved in technical works.

With its focus on the offshore randomized control trials of a Pre-Exposure Prophylactic pill (PrEP) for preventing HIV infection, the volume develops a sustained analysis of the complex, virtual and topological dimensions of the expectations, ethics and evidence that surround the innovation of PrEP.

This book discusses the social control of new biomedical technologies and the problems in organization and delivery of medical care in the face of new technological and social change.

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.

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.

Published in 1994, this book examines a small segment of the medical technology innovation process to characterize the manner in which the federal government influences small business-based investigators to participate or withdraw from the medical technology innovation process. It provides an historical account of the federal government's involvement in biomedical technology research and development, and traces the social and economic significance of this involvement.

Healthcare and Biotechnology in the 21st Century: Concepts and Case Studies introduces students not pursuing degrees in science or engineering to the remarkable new applications of technology now available to physicians and their patients and discusses how these technologies are evolving to permit new treatments and procedures. The book also elucidates the societal and ethical impacts of advances in medical technology, such as extending life and end of life decisions, the role of genetic testing, confidentiality, costs of health care delivery, scrutiny of scientific claims, and provides background on the engineering approach in healthcare and the scientific method as a guiding principle. This concise, highly relevant text enables faculty to offer a substantive course for students from non-scientific backgrounds that will empower them to make more informed decisions about their healthcare by significantly enhancing their understanding of these technological advancements.

With its focus on the offshore randomized control trials of a Pre-Exposure Prophylactic pill (PrEP) for preventing HIV infection, the volume develops a sustained analysis of the complex, virtual and topological dimensions of the expectations, ethics and evidence that surround the innovation of PrEP.

The choice of what scientists decide to study is fundamental to determining what innovations are produced. Yet, rather than being solely determined by a scientist's idiosyncratic preferences, this choice is shaped in important ways by the incentives, organization environment, and supporting institutions that surround a researcher. This dissertation consists of three essays that use biomedicine as a setting to explore how institutions and organizational environment can shape the rate and direction of innovation. In the first essay, I examine how knowledge certification by professional medical society clinical practice guidelines shapes the use of extant knowledge. Employing a difference-in-differences approach, I find that after inclusion in a guideline affected subfields of knowledge grow in size and scientific impact compared to controls carefully matched on observables. Rather than the aperture of subsequent innovation narrowing, subfields shift towards exploration as they become more translational, more intellectually distant, more disruptive, and build on more diverse and less established prior research. In the second essay, I investigate how exposure to frontier research in a training program can alter the career trajectories of potential innovators. I study the careers and innovative output of physicians who applied to the Associate Training Programs of the National Institutes of Health (NIH) during the turbulent period surrounding the Vietnam War. I find program participants entered research-focused positions at higher rates and garnered more publications, citations and grant funding than synthetic controls. In particular, the direction of their research efforts was durably imprinted with a distinct "translational" style of biomedical research that was characteristic of the NIH at the time. In the third essay, I study how a specific institution, grant peer review, shapes scientific risk taking. While risk is an inherent aspect of innovation, those projects with high degrees of risk may be more likely to lead to breakthrough innovation yet may face challenges in winning the support necessary to be carried out. I analyze R01-equivalent grants from the NIH, and after carefully controlling for investigator, grant and institution characteristics, find that grants with high levels of risk taking are renewed at lower rates.

Addresses in roughly equal measure the science and management behind several recent marketable biomedical innovations.