A confusing array of terms has arisen with the rapid emergence of the subject of nanotechnology. In this article a recently derived framework for definitions of these terms is discussed.
A confusing array of terms has arisen with the rapid emergence of the subject of nanotechnology. In this article a recently derived framework for definitions of these terms is discussed.
Common medical device packaging problems are identified here together with their cause and the remedy. The discussion examines the causes of poor heat seal, misleading results from the measurement of seal strength, blister flange curl, damage to sterile barrier system and failure of the ethylene oxide sterilisation process.
Some suggest that there is no such thing as nanotechnology and that it is only what scientists have been doing for a long time. This argument and some of the fact and fiction surrounding nanotechnology are assessed.
This two-part article considers the complexities of developing and commercialising combination products using examples from experience with drug-eluting stents and drug-eluting beads. Part I discusses the technical challenges of developing these products.
Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).
Joint ventures with Chinese companies provide one of the most effective ways for international companies to establish a foothold in the booming Chinese economy. The benefits, opportunities and challenges of establishing a joint venture are explored here. Current partnering trends and successful Sino-foreign joint ventures in the fast-growing medical device industry in China are also highlighted.
This article outlines significant recent developments in radiation sterilisation and some of the initiatives currently underway. These include work on a method for sterilising combination products and revisions to several sterilisation guidelines, including those for selecting appropriate sterility assurance levels.
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