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Trends in Development of Medical Devices

Trends in Development of Medical Devices Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-01-25
ISBN : 0128209615
Language : En, Es, Fr & De

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Book Description :

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

New Medical Devices

New Medical Devices Book
Author : Institute of Medicine,National Academy of Engineering
Publisher : National Academies Press
Release : 1988-01-01
ISBN : 0309038472
Language : En, Es, Fr & De

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Book Description :

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.

New Medical Devices

New Medical Devices Book
Author : K. B. Ekelman,National Academy of Engineering,Institute of Medicine
Publisher : Unknown
Release : 1988
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 1439809488
Language : En, Es, Fr & De

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Book Description :

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.

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 Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 9781420071641
Language : En, Es, Fr & De

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Book Description :

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.

Development of Medical Device Policies

Development of Medical Device Policies Book
Author : World Health Organization
Publisher : Unknown
Release : 2012-10-25
ISBN : 9789241501637
Language : En, Es, Fr & De

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Book Description :

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. The number of countries with existing health technology policies and with units to implement those policies shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modified as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes.

Medical Device for the Administration of Intradermal Injections

Medical Device for the Administration of Intradermal Injections Book
Author : Charlotte Reypens
Publisher : Unknown
Release : 2012
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

There are many advantages associated with intradermal injections such as increased safety and reduced pain perception. To fully leverage these benefits there is a need to optimize old and new techniques to administer vaccines intradermally. The VAX-ID device will be able to administer several preventive and therapeutic vaccines to children, adults and the elderly at different anatomic sites, e.g. the forearm. The European Union and the United States were chosen as the main target markets. As an introduction, the development process of innovative medical devices is shown to get a general overview of all elements at stake. The scope of the VAX-ID project is limited to the first three steps hereof: from research to pre-market clinical evaluation. The market analysis is the starting point of this thesis. In a next step, the value chain of the device was constructed and adoption factors critical to each player in this chain were identified. Finally, all this information was incorporated in the design of the business model. The market analysis includes an assessment of the competition within the industry by means of Porter's five forces framework and an overview of the external forces that have an impact on the industry by means of a PESTEL analysis. First of all, it became clear that the industry is hard to enter because high invested is required and products are protected by patents. Furthermore, there are several substitutes available in the market, out of which microneedle patches will pose the biggest threat in the future. With respect to the customers, a distinction was made between the direct customers, i.e. the vaccine manufacturers , and the end users, i.e. the healthcare providers and the patients. Both categories have significant power in deciding which devices they use. Therefore, this can also be considered as a threat. As far as the suppliers are concerned, there are high switching costs because they need to live up to high standards, e.g. with respect to sterility. Finally, the industry is characterized by intense rivalry and many companies are active in the intradermal injection market. Regarding the external forces, the political aspect was first of all investigated by looking into the healthcare systems in the European Union and the United States. In both continents, reforms are in order to keep the current policies sustainable, which leads to uncertainty for medical device developers. On an economic level, an unfavorable combination of economic slowdown and rising costs raises the question of who will pay for these expenses. This forces medical device developers to cut costs. With respect to the social aspect, several positive trends were discussed. Firstly, the population is growing bigger and older in the European Union and the United States, leading to more people requiring daily care. Furthermore, due to globalization clinical trials can be outsourced to cheaper destinations. Finally, the immunization policy in the European Union and the United States was examined. From a technological perspective, a culture of innovation is a critical success factor. Open innovation is a crucial element in the medical device industry allowing several parties to openly work together on the development of a new product. Next to this, it can be noted that due to the expansion of the internet and social media, patients are more informed and can be reached through new communication channels. As a medical device developer, it is important to embrace this trend. Lastly, 3D printing is a cost efficient and environmental friendly production technique that holds tremendous opportunities for the medical device industry. As for the ecological aspect, a growing emphasis is put on waste management. Finally, the legal environment can be considered risky since it is highly regulated. Overall, the medical device industry is hard to enter and prosper in. However, the opportunities on the social, technological and ecological level increase the chance of success as long as the threats are properly managed. In a second step, the value chain of the device was constructed in order to get an overview of the adoption factors that are important for all the stakeholders in the chain. The device will reach the healthcare providers through intermediaries (group purchasing organizations, wholesalers...), after which it is used to treat the patients. Apart from this, there are two other important actors in the value chain: the health technology assessment agencies ,that influence legislation and evaluate new technologies, and the insurance agencies that partially or fully reimburse the treatment. For each of these stakeholders, several adoption factors that influence the uptake of the device were identified. First of all, for device developers the legal framework is a determining factor. In this respect, the requirements to obtain market approval were looked into both for the European Union and the United States. The most important implication hereof was that in the European Union devices are often launched first due to less stringent regulations. Moreover, the risk and uncertainty levels of the project influence its chance of success. As a result, it is crucial to perform a thorough risk assessment focused on human blunders. Lastly, from the perspective of medical device developers, including cross-functional expertise and making room for social interactions positively impacts the outcome of the project. For health technology assessment and insurance agencies, the quality of the product plays a crucial role in their decision to adopt the device. To demonstrate the quality of the VAX-ID device, it was benchmarked against several intradermal injection techniques with respect to six criteria. This led to the conclusion that the features "compatibility with the vaccine" and "patient acceptability" should be leveraged as competitive advantages. Apart from the quality of the product, clinical evidence will support the adoption process of the device. As for the healthcare providers, the added value of the product is a significant factor as well as information and follow-up. It appears that when the benefits of an innovation are explicitly communicated to its users during the development process, the probability of adoption increases. Finally, to increase commercialization success it is of vital importance that the

Medical Device Safety

Medical Device Safety Book
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Device Safety book written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Emerging Trends in Medical Plastic Engineering and Manufacturing

Emerging Trends in Medical Plastic Engineering and Manufacturing Book
Author : Markus Schönberger,Marc Hoffstetter
Publisher : William Andrew
Release : 2016-01-06
ISBN : 0323374654
Language : En, Es, Fr & De

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Book Description :

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

Future Trends in Biomedical and Health Informatics and Cybersecurity in Medical Devices

Future Trends in Biomedical and Health Informatics and Cybersecurity in Medical Devices Book
Author : Kang-Ping Lin,Ratko Magjarevic,Paulo de Carvalho
Publisher : Springer Nature
Release : 2019-09-27
ISBN : 3030306364
Language : En, Es, Fr & De

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Book Description :

This book gathers the proceedings of the IV International Conference on Biomedical and Health Informatics (ICBHI 2019), held on 17-20 April, 2019, in Taipei, Taiwan. Contributions span a range of topics, including medical imaging, biosignal processing, biodata management and analytics, public and personalized health systems, mobile health applications and many more. The IV conference edition gave a special emphasis to cybersecurity issues and cutting-edge medical devices, as it is reflected in this book, which provides academics and professionals with extensive knowledge on and a timely snapshot of cutting-edge research and developments in the field of biomedical and health informatics.

Medical Devices

Medical Devices Book
Author : United States. Congress. Senate. Committee on Labor and Human Resources
Publisher : Unknown
Release : 1991
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Devices book written by United States. Congress. Senate. Committee on Labor and Human Resources, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Therapeutic Delivery Solutions

Therapeutic Delivery Solutions Book
Author : Chung Chow Chan,Kwok Chow,Bill McKay,Michelle Fung
Publisher : John Wiley & Sons
Release : 2014-06-27
ISBN : 1118903498
Language : En, Es, Fr & De

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Book Description :

Provides a comprehensive review of all types of medical therapeuticdelivery solutions from traditional pharmaceutical therapydevelopment to innovative medical device therapy treatment to therecent advances in cellular and stem cell therapy development • Provides information to potentially allow futuredevelopment of treatments with greater therapeutic potential andcreativity • Includes associated regulatory requirements for thedevelopment of these therapies • Provides a comprehensive developmental overview ontherapeutic delivery solutions • Provides overview information for both the general reader as well as more detailed references forprofessionals and specialists in the field

Medical Device Law

Medical Device Law Book
Author : Anonim
Publisher : Unknown
Release : 2015
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Device Law book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices Book
Author : Kayvon Modjarrad,Sina Ebnesajjad
Publisher : Elsevier
Release : 2013-12-05
ISBN : 0323221696
Language : En, Es, Fr & De

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Book Description :

While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they’re creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. Gathers discussions of a large number of applications of polymers in medicine in one place Provides an insight into both the legal and clinical implications of device design Relevant to industry, academic and medical professionals Presents the latest developments in the field, including medical devices on a nano-scale

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices Book
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
Publisher : National Academies Press
Release : 2001-10-31
ISBN : 9780309183208
Language : En, Es, Fr & De

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Book Description :

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.

Medical Devices

Medical Devices Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2010
ISBN : 9241564040
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices Book
Author : Len Czuba
Publisher : Elsevier Inc. Chapters
Release : 2013-12-05
ISBN : 012807664X
Language : En, Es, Fr & De

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Book Description :

This chapter will present a look at the medical device market with a particular focus on the materials of construction of devices and what we can expect in new products looking ahead. A deeper look at some other trends that have an effect on the direction of the medical device industry will be done. Finally, consideration will be given to a number of global factors that can have dramatic effects on our industry.

Energy Efficiency of Medical Devices and Healthcare Applications

Energy Efficiency of Medical Devices and Healthcare Applications Book
Author : Amr Mohamed
Publisher : Academic Press
Release : 2020-02-15
ISBN : 0128190469
Language : En, Es, Fr & De

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Book Description :

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

Sources of Medical Technology

Sources of Medical Technology Book
Author : Committee on Technological Innovation in Medicine,Institute of Medicine
Publisher : National Academies Press
Release : 1995-01-15
ISBN : 0309587611
Language : En, Es, Fr & De

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Book Description :

Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.

Medical Device Regulations

Medical Device Regulations Book
Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Release : 2003-09-16
ISBN : 9241546182
Language : En, Es, Fr & De

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Book Description :

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.