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This Defense Intelligence Agency reference document, dated 7 January 2010 and prepared under the Acquisition Threat Support series, surveys biomaterials used in medicine. It covers biocompatibility, biosensor membranes, silicones, Teflon, biodegradable polymers, hydrogels, titanium, bioceramics, tissue constructs, cardiovascular stents, contact lenses, drug delivery and dialysis. It concludes that biomaterial performance underlies many medical devices, that the industry is slow to adopt new materials because of testing costs, and that innovation mainly involves new applications of established materials.
UNCLASSIFIEDJsfFOA OliFIGll1L Wi& ONUif Numbers of Medical Device~yr. Worldwi-1) . intraocular lens contact lens vascular graft hip and knee prostheses catheter heart valve stent (cardiovascular) breast implant dental implant pacemaker renal dialyzer left ventricular assist devices 7,000,000 75.000,000 400,000 1,000,000 300,000,000 200!000 >2,000,000 300,000 500,000 200,000 25,000,000 100,000 Millions of lives saved. The quality of life improved/or millions more. A $100 billion industry Figure 2. Common Medical Devices That Use Blomaterials The development of biomaterials is the junction of materials science and chemistry. Medical devices may be composed of a single biomaterial or a combination of several materials. A heart valve might be fabricated from polymers, metals, and carbons. A hip joint might be fabricated from metals and polymers (and sometimes ceramics) and will be interfaced to the body through a polymeric bone cement. Biomaterials by themselves do not make a useful clinical therapy but rather have to be fabricated into devices. This is typically an engineer's role, but the engineer might work closely with synthetic chemists to optimize material properties and with physicians to ensure the device is useful in clinical applications. Biomaterials must be compatible with the body, and there are often issues that must be resolved before a product can be placed on the market and used in a clinical setting. Because of this, biomaterials are usually subjected to the same very stringent safety requirements as those of new drug therapies. viii UNCLASSIFIED//FOlil. Gliiliil&lf1k IHII! 8HtY
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Report, from the dia collection. The PDF is mirrored here; the original link is above. 32 pages are in the text index: search them above, or from the library's search.