Trends in Development of Medical Devices

Trends in Development of Medical Devices
Author: Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publsiher: Academic Press
Total Pages: 216
Release: 2020-01-25
ISBN 10: 0128209615
ISBN 13: 9780128209615
Language: EN, FR, DE, ES & NL

Trends in Development of Medical Devices Book Review:

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Emerging Trends in Medical Plastic Engineering and Manufacturing

Emerging Trends in Medical Plastic Engineering and Manufacturing
Author: Markus Schönberger,Marc Hoffstetter
Publsiher: William Andrew
Total Pages: 302
Release: 2016-01-06
ISBN 10: 0323374654
ISBN 13: 9780323374651
Language: EN, FR, DE, ES & NL

Emerging Trends in Medical Plastic Engineering and Manufacturing Book Review:

Emerging Trends in Medical Plastic Engineering and Manufacturing gives engineers and materials scientists working in the field detailed insights into upcoming technologies in medical polymers. While plastic manufacturing combines the possibility of mass production and wide design variability, there are still opportunities within the plastic engineering field which have not been fully adopted in the medical industry. In addition, there are numerous additional challenges related to the development of products for this industry, such as ensuring tolerance to disinfection, biocompatibility, selecting compliant additives for processing, and more. This book enables product designers, polymer processing engineers, and manufacturing engineers to take advantage of the numerous upcoming developments in medical plastics, such as autoregulated volume-correction to achieve zero defect production or the development of ‘intelligent’ single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes. Finally, as medical devices get smaller, the book discusses the challenges posed by miniaturization for injection molders, how to respond to these challenges, and the rapidly advancing prototyping technologies. Provides a roadmap to the emerging technologies for polymers in the medical device industry, including coverage of ‘intelligent’ single use products, personalized medical devices, and the integration of manufacturing steps to improve workflows Helps engineers in the biomedical and medical devices industries to navigate and anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, and government regulations Presents tactics readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce defects in production and develop products that enable entirely new treatment possibilities

Medical Devices

Medical Devices
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 129
Release: 2010
ISBN 10: 9241564040
ISBN 13: 9789241564045
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

The Business of Healthcare Innovation

The Business of Healthcare Innovation
Author: Lawton R. Burns,Lawton Robert Burns
Publsiher: Cambridge University Press
Total Pages: 373
Release: 2005-08-25
ISBN 10: 9780521838986
ISBN 13: 0521838983
Language: EN, FR, DE, ES & NL

The Business of Healthcare Innovation Book Review:

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

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices
Author: Institute of Medicine,Board on Health Sciences Policy,Based on a Workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publsiher: National Academies Press
Total Pages: 112
Release: 2001-10-31
ISBN 10: 9780309183208
ISBN 13: 0309183200
Language: EN, FR, DE, ES & NL

Innovation and Invention in Medical Devices Book Review:

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 Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine,Committee on Technological Innovation in Medicine
Publsiher: National Academies Press
Total Pages: 225
Release: 1991-02-01
ISBN 10: 030904491X
ISBN 13: 9780309044912
Language: EN, FR, DE, ES & NL

The Changing Economics of Medical Technology Book Review:

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.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation
Author: Institute of Medicine,Committee on Technological Innovation in Medicine
Publsiher: National Academies Press
Total Pages: 244
Release: 1990-02-01
ISBN 10: 0309042860
ISBN 13: 9780309042864
Language: EN, FR, DE, ES & NL

Modern Methods of Clinical Investigation Book Review:

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.

The Role of Human Factors in Home Health Care

The Role of Human Factors in Home Health Care
Author: National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Publsiher: National Academies Press
Total Pages: 322
Release: 2010-11-14
ISBN 10: 0309156297
ISBN 13: 9780309156295
Language: EN, FR, DE, ES & NL

The Role of Human Factors in Home Health Care Book Review:

The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research--the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

Energy Efficiency of Medical Devices and Healthcare Applications

Energy Efficiency of Medical Devices and Healthcare Applications
Author: Amr Mohamed
Publsiher: Academic Press
Total Pages: 184
Release: 2020-02-15
ISBN 10: 0128190469
ISBN 13: 9780128190463
Language: EN, FR, DE, ES & NL

Energy Efficiency of Medical Devices and Healthcare Applications Book Review:

Energy Efficiency of Medical Devices and Healthcare Facilities provides comprehensive coverage of cutting-edge, interdisciplinary research, and commercial solutions in this field. The authors discuss energy-related challenges, such as energy-efficient design, including renewable energy, of different medical devices from a hardware and mechanical perspectives, as well as energy management solutions and techniques in healthcare networks and facilities. They also discuss energy-related trade-offs to maximize the medical devices availability, especially battery-operated ones, while providing immediate response and low latency communication in emergency situations, sustainability and robustness for chronic disease treatment, in addition to high protection against cyber-attacks that may threaten patients’ lives. Finally, the book examines technologies and future trends of next generation healthcare from an energy efficiency and management point of view, such as personalized or smart health and the Internet of Medical Things — IoMT, where patients can participate in their own treatment through innovative medical devices and software applications and tools. The books applied approach makes it a useful resource for engineering researchers and practitioners of all levels involved in medical devices development, healthcare systems, and energy management of healthcare facilities. Graduate students in mechanical and electric engineering, and computer science students and professionals also benefit. Provides in-depth knowledge and understanding of the benefits of energy efficiency in the design of medical devices and healthcare networks and facilities Presents best practices and state-of-art techniques and commercial solutions in energy management of healthcare networks and systems Explores key energy tradeoffs to provide scalable, robust, and effective healthcare systems and networks

New Medical Devices

New Medical Devices
Author: Institute of Medicine,National Academy of Engineering
Publsiher: National Academies Press
Total Pages: 203
Release: 1988-01-01
ISBN 10: 0309038472
ISBN 13: 9780309038478
Language: EN, FR, DE, ES & NL

New Medical Devices Book Review:

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.

China s Healthcare System and Reform

China s Healthcare System and Reform
Author: Lawton Robert Burns,Gordon G. Liu
Publsiher: Cambridge University Press
Total Pages: 482
Release: 2017-01-26
ISBN 10: 9781316616468
ISBN 13: 1316616460
Language: EN, FR, DE, ES & NL

China s Healthcare System and Reform Book Review:

This volume provides a comprehensive review of China's healthcare system and policy reforms in the context of the global economy. Following a value-chain framework, the 16 chapters cover the payers, the providers, and the producers (manufacturers) in China's system. It also provides a detailed analysis of the historical development of China's healthcare system, the current state of its broad reforms, and the uneasy balance between China's market-driven approach and governmental regulation. Most importantly, it devotes considerable attention to the major problems confronting China, including chronic illness, public health, and long-term care and economic security for the elderly. Burns and Liu have assembled the latest research from leading health economists and political scientists, as well as senior public health officials and corporate executives, making this book an essential read for industry professionals, policymakers, researchers, and students studying comparative health systems across the world.

Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices
Author: Sina Ebnesajjad
Publsiher: Elsevier Inc. Chapters
Total Pages: 368
Release: 2013-12-05
ISBN 10: 0128076682
ISBN 13: 9780128076682
Language: EN, FR, DE, ES & NL

Handbook of Polymer Applications in Medicine and Medical Devices Book Review:

This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.

Health Technology Assessment of Medical Devices

Health Technology Assessment of Medical Devices
Author: World Health Organization
Publsiher: Who Medical Device Technical
Total Pages: 39
Release: 2012-10-25
ISBN 10: 9789241501361
ISBN 13: 9241501367
Language: EN, FR, DE, ES & NL

Health Technology Assessment of Medical Devices Book Review:

WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.

Medical Devices and the Public s Health

Medical Devices and the Public s Health
Author: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publsiher: National Academies Press
Total Pages: 318
Release: 2011-10-25
ISBN 10: 0309212456
ISBN 13: 9780309212458
Language: EN, FR, DE, ES & NL

Medical Devices and the Public s Health Book Review:

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

New Medical Devices

New Medical Devices
Author: K. B. Ekelman,National Academy of Engineering,Institute of Medicine
Publsiher: Unknown
Total Pages: 186
Release: 1988
ISBN 10: 1928374650XXX
ISBN 13: OCLC:476045852
Language: EN, FR, DE, ES & NL

New Medical Devices Book Review:

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.

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
Author: Shayne C. Gad,Marian G. McCord
Publsiher: CRC Press
Total Pages: 504
Release: 2008-10-20
ISBN 10: 1439809488
ISBN 13: 9781439809488
Language: EN, FR, DE, ES & NL

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition Book Review:

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Medical Devices

Medical Devices
Author: Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publsiher: Woodhead Publishing
Total Pages: 256
Release: 2015-08-18
ISBN 10: 0081002912
ISBN 13: 9780081002919
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Plastics in Medical Devices

Plastics in Medical Devices
Author: Vinny R. Sastri
Publsiher: Elsevier
Total Pages: 352
Release: 2010-03-05
ISBN 10: 081552028X
ISBN 13: 9780815520283
Language: EN, FR, DE, ES & NL

Plastics in Medical Devices Book Review:

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Medical Device Regulations

Medical Device Regulations
Author: Aakash Deep
Publsiher: Academic Press
Total Pages: 187
Release: 2022-01-13
ISBN 10: 0323911277
ISBN 13: 9780323911276
Language: EN, FR, DE, ES & NL

Medical Device Regulations Book Review:

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Medical Technology in Canada

Medical Technology in Canada
Author: Nadeem Esmail
Publsiher: The Fraser Institute
Total Pages: 101
Release: 2008
ISBN 10: 1928374650XXX
ISBN 13: 9182736450XXX
Language: EN, FR, DE, ES & NL

Medical Technology in Canada Book Review:

This study reviews various national and international studies to evaluate the availability of medical technologies in Canada relative to other countries, analyzes data produced by the Canadian Institute for Health Information (CIHI) to measure both the age and sophistication of medical technologies in Canada, and discusses a survey undertaken for this research paper that measures the stock of cutting-edge medical technologies in Canada's five largest cities.