Biomaterials in the Design and Reliability of Medical Devices
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Edited By:Michael N. HelmusBoston Scientific Corporation ISBN: 978-0-306-47690-7 Published: 2002-12-01 |
This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate its ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principals that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.
Chapters available from this book
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the success of traditional materials in many medical devices is unsatisfactory. Specifically, the recip...
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the success of traditional materials in many medical devices is unsatisfactory. Specifically, the recip...
Tissue Engineering Constructs and Commercialization
Kelvin G.M. Brockbank
Tissue engineering is an interdisciplinary field that applies the principles of engineering (materials science and biomedical engineering) and the life sciences (biochemistry, genetics, cell and molecular biology) to the development of biological substitutes that can restore, maintain, or improve...
Product Development in a Small Company Environment
Roger W. Snyder
A small company, particularly a start-up operation, is an exciting, and often stressful, environment. If the company has a limited number of products, all under development, there is always pressure to get those products to market as soon as possible to generate sales and income. If the new devic...
Failure Analysis: Learning for the Future from the Past
Michael N. Helmus
One of the most important tasks a medical device manufacturer can make is to have a detailed methodology in place for explant analysis. The ability to examine the device for both adverse biological responses and for durability related to fatigue, corrosion, and degradation mechanisms is an import...
Nonclinical Medical Device Testing
Sharon J. Northup
The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrument, apparatus, appliance material or other article intended by the manufacturer to be used for human ...
Regulation of Medical Devices
Barry Sall
The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufacturer may follow in order to obtain approval or clearance to market products in the U.S. Many of the s...
Standards and Guidelines for Biocompatibility of Medical Devices
Sharon J. Northup
Strategic management—the formulation, implementation and achievement of objec tives—is essential to establishing the biocompatibility of a new medical device. The harmonization of global requirements for regulated health care products requires even more attention to regulatory strategy. This Chap...
Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Michael N. Helmus
Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be categorized as synthetic polymers (nonbiodegradable and biodegradable polymers); biologically deriv...
