The need for component-level specifications for medical applications has been long identified; the existing process today is inconsistent. There are no medical industry specifications for the qualification of components or their suppliers. Thus every component that is purchased for highreliability medical products today must be individually qualified. Component suppliers have no industry standa...

The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic developm...

Software traceability is central to medical device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements including risks through the different stages of the software development and maintenance lifecycles. The regulatory bodies reques...

近年，医療に携わる製造業が手術用途に合わせた医療材料のキット化やそれに伴う競合他社との協業関係の構築，手術室の物流および情報管理など，自社をプラットフォームとして生産体制と供給体制をシームレスに繋げようとする動きが活発である。本研究では，医療に携わる製造業がビジネス・エコシステムを構築し，「製造業のサービス化」による新たな価値創出の可能性について検討した。医療機器および医療材料企業84社を対象に価値創出の状況を確認した結果，伝統的なバリューチェーンモデルに基づき，顧客に対し「製品価値」を中心とした価値提供を行っていることが示された。さらに，製品とサービスの一体化の状況を検討すべく，サービタイゼーション誘因モデルによる検証を行い，「サービタイゼーション」につながる「カスタマイズソリューション」および「ビジネスプロセスの統合」に企業が対応できていない構造的空隙があることを確認した。最後に...

BACKGROUND Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors. METHODS AND FINDINGS Using survey responses from a national sample of 1,...

Nanoparticles classified in 4 overall groups containing: Metallic nanoparticles, ceramic nanoparticles, polymeric nanoparticles and semiconductor nanoparticles. These nanoparticles are used in some biomedical applications such as carrying medicine and photographing agents. With attention to different criteria which are both qualitative and quantitative, selecting the most suitable nanoparticles...