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NC State finds new nanomaterial could be breakthrough for implantable medical devices
November 11, 2008
A team of researchers led by North Carolina State University has made a breakthrough that could lead to new dialysis devices and a host of other revolutionary medical implants. The researchers have found that the unique properties of a new material can be used to create new devices that can be implanted into the human body - including blood glucose sensors for diabetics and artificial hemo-dialysis membranes that can scrub impurities from the blood. Researchers have long sought to develop medical devices that could be implanted into patients for a variety of purposes, such as monitoring glucose levels in diabetic patients. However, existing materials present significant problems. For example, devices need to be made of a material that prevents the body's proteins from building up on sensors and preventing them from working properly. And any implanted device also needs to avoid provoking an inflammatory response from the body that would result in the body's walling off the device or rejecting it completely. Now a new study finds that nanoporous ceramic membranes may be used to resolve these issues. Dr. Roger Narayan - an associate professor in the joint biomedical engineering department of NC State and the University of North Carolina at Chapel Hill - led the research and says the nanoporous membranes could be used to "create an interface between human tissues and medical devices that is free of protein buildup." The new research, published in a special issue of Biomedical Materials, is the first in-depth study of the biological and physical properties of the membranes. The study suggests that the human body will not reject the nanoporous ceramic membrane. Narayan adds that this could be a major advance for the development of kidney dialysis membranes and other medical devices whose development has been stalled by poor compatibility with human tissues. Narayan was also the lead researcher on the team that first developed these new materials. North Carolina State University

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Biodesign: The Process of Innovating Medical Technologies
by Stefanos Zenios (Author), Josh Makower (Author), Paul Yock (Author), Todd J. Brinton (Author), Uday N. Kumar (Author), Lyn Denend (Author), Thomas M. Krummel (Author)
Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is...
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The Medical Device R&D Handbook, Second Edition
by Theodore R. Kucklick (Editor)
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time.
The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur.
Highlights Include… An Introduction to Medical Plastics Catheter Forming Equipment and Operations Basics of Catheter Construction Basics of Medical Needles Rapid Prototyping for Medical Devices Reverse Engineering for...
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Medical Device Technologies: A Systems Based Overview Using Engineering Standards (Academic Press Series in Biomedical Engineering)
by Gail Baura (Author)
The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach enables students to quickly identify the relationships between devices. Device key features are based on five applicable...
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
by Amiram Daniel and Edward Kimmelman (Author)
This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents. This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on...
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Reliable Design of Medical Devices, Second Edition
by Richard C. Fries (Author)
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...
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Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices
by Shreefal S. Mehta (Author)
Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This 2008 book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student...
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Medical Device Marketing: Strategies, Gameplans & Resources for Successful Product Management
by Terri Wells (Author)
The Insider's Guide to Success in this Unique Industry
To make it in the competitive and fast-changing medical device industry, you need to be armed with the best information available. That's where Medical Device Marketing comes in. With more than 20 years' experience in the business, author Terri Wells outlines a complete road map for a successful product cycle-from development to phase-out. You'll learn: •How to identify the customer-and why this seemingly simple task is trickier than it sounds. •Steps to a winning business plan-from conducting insightful market research to making accurate cost projections. •Keys to product development-along with what to do when the unexpected happens. •Effective sales support-including what you really need to...
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Process Validation for Medical Devices - DOCUMENT BUNDLE
by ROFRI MED Corporation
This publication is a document bundle containing the following ROFRI MED documents:
●A Strategic Road Map - GUIDANCE; ●Process Validation SOP - TEMPLATE; ●Validation Master Plan - TEMPLATE.
A Strategic Road Map – GUIDANCE
The e-book - A Strategic Road Map, is the first in a series under the title Technical Series on Process Validation Principles and Practices.
It introduces medical device manufacturing process validation road maps by first visiting the issues that face many medical device manufacturers today in the area of process validation. This is followed by a step-by-step illustration of the process validation journey that runs from the process design stage through manufacturing process qualification to continued...
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Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
by Elaine Whitmore (Author)
There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. The revised book includes: a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics,...
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Medical Devices: Use and Safety, 1e
by Bertil Jacobson MD PhD (Author), Alan Murray PhD (Author)
Patient safety is important to all health professionals, but fatal accidents occur with medical devices every year. This is the first book for people who use medical equipment, rather than for engineers or technicians. It will help personnel within healthcare to avoid accidents by bridging the gap between the design principles and the user. The book encourages safe use of a wide range of equipment, from simple thermometers and blood-pressure cuffs to complex equipment such as pacemakers, ventilators and patient monitors.Simple explanations of basic medical devicesCase histories of real-life accidents to highlight risk areasClear, attractive illustrations"Tips" boxes identify particular problems"Basic Facts" boxes supply fundamental information needed by all readers"Technology" boxes...
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