medical device design considerations in special needs populations

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Medical Device Design Considerations in Special Needs Populations
Author : Tara Lynn Johnson,Amir Manbachi
Publisher : Academic Press
Release Date : 2020-03-15
ISBN 10 : 9780128190104
Pages : 200 pages

Medical device design considerations in special needs populations describes the history of assistive technology and other medical devices that have provided independence and inclusion for individuals of all ages with special health care needs. It provides you with special considerations when making needs assessments for new devices in the field. This comprehensive title covers each step of designing a piece of assistive technology or a medical device whilst bearing in mind the user profile of patients with special needs. Fully supported with case studies of successful devices developed for special needs populations. This book includes content on designing for children with special needs and technology in the classroom. The technologies reviewed are applicable to a variety of different cases and environments. Covers design and development of technology for those with: developmental disabilities; Spinal cord injury; Cerebral palsy; Stroke; ALS; Epilepsy - VNS; Arthritis. Patenting, business models and FDA regulatory compliance are examined and discussed. Attention is given to developing technology for both developed and developing countries, and both high tech/ low tech types of devices. The content also explores development of prosthetics and orthotics for rehabilitation. The editors and contributors combine biomedical and clinical expertise to bring together a multi-disciplinary perspective and approach to designing and developing assistive technology. This book is ideal for both engineers and clinicians who work in the field of technology design for special needs populations. Challenges related to product development for a device with a small end-user population Challenges related to designing devices for conditions that are not homogeneous in their presentation across populations Benefits of multidisciplinary research teams in the development of technologies for populations with multiple special health care needs

Medical Instrumentation
Author : Jack M. Winters,Molly Follette Story
Publisher : CRC Press
Release Date : 2006-10-31
ISBN 10 : 1000654176
Pages : 474 pages

Two of the most important yet often overlooked aspects of a medical device are its usability and accessibility. This is important not only for health care providers, but also for older patients and users with disabilities or activity limitations. Medical Instrumentation: Accessibility and Usability Considerations focuses on how lack of usabi

Handbook of Medical Device Design
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 2019-08-15
ISBN 10 : 1000696952
Pages : 774 pages

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Handbook of Human Factors in Medical Device Design
Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Release Date : 2010-12-13
ISBN 10 : 1420063510
Pages : 844 pages

Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

Designing Usability into Medical Products
Author : Michael E. Wiklund,Stephen B. Wilcox
Publisher : CRC Press
Release Date : 2005-02-11
ISBN 10 : 1420038087
Pages : 376 pages

Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range of alternative approaches to the subject. Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design process. They discuss specific design and evaluation methods and tools, present case studies of user-friendly medical technologies and corporate human factors programs, and supply related resources for medical design professionals. The book conveys an in-depth understanding of the user-centered design process, covers design methods for FDA compliance, and offers guidance on performing a variety of hands-on user research, user interface design, and user interface evaluation. The authors make a compelling case for treating the user's needs and preferences as a top design priority, rather than an afterthought. They demonstrate that high-quality customer interactions with systems and products leads to effective medical diagnosis and treatment, increases the physical and mental well being of patients and caregivers, and leads to commercial success in a crowded marketplace.

Reliable Design of Medical Devices
Author : Richard C. Fries
Publisher : CRC Press
Release Date : 2005-11-21
ISBN 10 : 1420027948
Pages : 504 pages

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

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
Publisher : National Academies Press
Release Date : 2010-11-14
ISBN 10 : 0309156297
Pages : 322 pages

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.

The Future of Disability in America
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Disability in America
Publisher : National Academies Press
Release Date : 2007-09-24
ISBN 10 : 9780309134019
Pages : 618 pages

The future of disability in America will depend on how well the U.S. prepares for and manages the demographic, fiscal, and technological developments that will unfold during the next two to three decades. Building upon two prior studies from the Institute of Medicine (the 1991 Institute of Medicine's report Disability in America and the 1997 report Enabling America), The Future of Disability in America examines both progress and concerns about continuing barriers that limit the independence, productivity, and participation in community life of people with disabilities. This book offers a comprehensive look at a wide range of issues, including the prevalence of disability across the lifespan; disability trends the role of assistive technology; barriers posed by health care and other facilities with inaccessible buildings, equipment, and information formats; the needs of young people moving from pediatric to adult health care and of adults experiencing premature aging and secondary health problems; selected issues in health care financing (e.g., risk adjusting payments to health plans, coverage of assistive technology); and the organizing and financing of disability-related research. The Future of Disability in America is an assessment of both principles and scientific evidence for disability policies and services. This book's recommendations propose steps to eliminate barriers and strengthen the evidence base for future public and private actions to reduce the impact of disability on individuals, families, and society.

Ergonomics for the New Millennium
Author : International Ergonomics Association. Congress
Publisher : N.A
Release Date : 2000
ISBN 10 : 9780945289135
Pages : 329 pages

AAMI Standards and Recommended Practices
Author : N.A
Publisher : N.A
Release Date : 1994
ISBN 10 :
Pages : 329 pages

Biomedical Devices
Author : Tugrul Ozel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Release Date : 2016-09-12
ISBN 10 : 1119267048
Pages : 208 pages

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Registries for Evaluating Patient Outcomes
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Release Date : 2014-04-01
ISBN 10 : 1587634333
Pages : 356 pages

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.