Medical Devices and Biomaterials for the Developing World


Book Description

This book focuses on the adoption of medical technology in the developing world, and the role that can be played by new biomaterials. These authors urge that advanced technology be aligned with the needs of developing and emerging markets, and an alternative definition of technology be embraced. This “new technology” considers natural sources of materials and tools for treatment and is not restricted to the usual traditional computerized or electronic technology. This book explores the difficulties that accompany successful transfer of technologies between disparate settings. The book then leaves the world of traditional technology and focuses on biomaterials, which represent an enormous opportunity for developing societies to become active participants in the development of new technologies. Biomaterials can be used in the treatment of disease throughout the developing world and beyond. Biomaterials encompass a range of naturally derived substances; of particular interest here are naturally derived and synthetically manufactured materials with potential applications in different body systems. Because many of these materials can be grown, the agricultural output of developing nations is an obvious potential source of these biomaterials. The book considers the cases of Ghana and Nicaragua as examples of the broader situation in West Africa and Central/South America. These two regions are uniquely positioned with regard to both health care and technological capabilities, and both stand to grow significantly in the coming years. While the agricultural sectors of the two nations are quite different, both are major producers of corn and other materials that should be investigated further. Of course, the difficulty in using a foodstuff for medical purposes is fully explored.




Biomaterials and Medical Devices


Book Description

This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.




Bio-Based Materials as Applicable, Accessible, and Affordable Healthcare Solutions


Book Description

In this book, Nigeria, the most populous country in Africa and a region in the lowest income group per capita, is used to demonstrate the potential for healthcare reorganization and collaboration with the introduction of “successful” technologies centered around available, bio-compatible, and sustainable natural resources. Our book discusses three of the top killers of children under 5 years of age in Nigeria, pneumonia (20%), diarrheal diseases (15%), and traumatic injuries (4%). These conditions are used as examples to demonstrate the potential for improved pediatric outcomes with treatments engineered from sustainable and natural resources. Furthermore, this book outlines possible action items that can help drive economic growth, educational opportunities, collaborative outreach, and workforce productivity to build a healthy and sustainable community. Medical technology in the industrialized world has seen rapid advancements leading to increased survival and greater patient outcomes. However, the development and implementation of these resources is not always applicable to regions in need of new and more basic ways to provide treatment. Moore’s Law, a paradigm that considers advancement synonymous with increased digitization and optimization of electronic processes, defines the history of technology. However, the functionality of advanced and “smart” technology is essentially useless in underdeveloped areas. These regions lack some of the basic requirements for innovative medical technologies to impact human health, such as electricity, access to spare parts, computer analysis tools, and network architecture. In addition, the poor physical infrastructure, insufficient management, and lack of technical culture are barriers for entry and sustainability of these technologies. Rather than importing medical devices from industrialized countries, we propose that the mindset and research focus for under developed areas must be on “successful” technologies. Simply put, these areas need technology that “gets the job done.”




3D Printing and Bio-Based Materials in Global Health


Book Description

This book examines the potential to deploy low-cost, three-dimensional printers known as RepRaps in developing countries to fabricate surgical instruments and medical supplies to combat the “global surgical burden of disease.” Approximately two billion people in developing countries around the world lack access to essential surgical services, resulting in the avoidable deaths of millions of individuals each year. A fundamental barrier that inhibits access to surgical care in these locations is the lack of basic surgical instruments and supplies in healthcare facilities. RepRap printers are highly versatile 3D printers assembled from basic, domestically sourced materials that can fabricate low-cost surgical instruments on-site, ultimately enhancing the interventional capacity of healthcare facilities to treat patients. Rather than focusing on one specific field of interest, this book takes an integrative approach that incorporates topics and methods from multiple disciplines ranging from global health and development economics to materials science and applied engineering. These topics include the feasibility of using bio-based plastics to fabricate surgical instruments via 3D printing sustainably, the application of "frugal innovation and engineering” in resource-poor settings, and analyses related to the social returns on investment, barriers to entry, and current and future medical device supply-chain paradigms. In taking a multi-disciplinary approach, the reader can gain a holistic understanding of the multiple facets related to implementing medical device innovations in developing countries.




Medical Device Regulations


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.




Medical Devices


Book Description

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




Biomaterials, Medical Devices, and Combination Products


Book Description

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical




Design of Biomedical Devices and Systems


Book Description

Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.




Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach


Book Description

are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.




Clinical Evaluation of Medical Devices


Book Description

The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.