Choosing animal-derived regenerative implantable medical devices based on tissue engineering technology as a research theme, this paper presents bibliometric analysis of relative literature from the mainland of China ...Choosing animal-derived regenerative implantable medical devices based on tissue engineering technology as a research theme, this paper presents bibliometric analysis of relative literature from the mainland of China to understand such data as publication year and journal preference, authors＇ geographic location, research topics and core expertise to predict the research trends and provide an informed basis of decision making for researchers and clinicians.展开更多
This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and di...This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and disclosures,the legal status of patent families(i.e.sets of patents filed in various countries to protect a single invention),and International Patent Classification topics such as main assignee and core expertise.Analysis of research trends will enhance and inform the decision-making capacity of researchers,investors,government regulators and other stake-holders as they undertake to develop,deploy,invest in or regulate ADRIMD.展开更多
The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulato...The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulatory framework has been constructed in the USA and EU, in which risk-based regulatory strategy is used to determine which regulatory mode is more desirable between medical technique and medical product. Also, it is suggested that two-tier regulatory framework of medical products be constructed, with the first level built on existing and newly introduced regulatory provisions and the second technical level encompassing all the technical requirements. In China, the demarcation line between medical technique mode and medical product mode is not made clear and coherent and flexible regulatory framework has not been intentionally designed. If the recommendations concerning the desirability of regulatory framework will be adopted in China, it means the present application of medical technique mode should be reconsidered and adjusted based on the risk analysis. Furthermore, the construction of two-tier regulatory framework which is tailored to meet the demands of development of medical products of tissue engineering and regenerative medicine still remains a challenge.展开更多
文摘Choosing animal-derived regenerative implantable medical devices based on tissue engineering technology as a research theme, this paper presents bibliometric analysis of relative literature from the mainland of China to understand such data as publication year and journal preference, authors＇ geographic location, research topics and core expertise to predict the research trends and provide an informed basis of decision making for researchers and clinicians.
基金supported by the National Engineering Laboratory for Regenerative Medical Implantable Devices(Grant No.2012NEL2MD005).
文摘This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and disclosures,the legal status of patent families(i.e.sets of patents filed in various countries to protect a single invention),and International Patent Classification topics such as main assignee and core expertise.Analysis of research trends will enhance and inform the decision-making capacity of researchers,investors,government regulators and other stake-holders as they undertake to develop,deploy,invest in or regulate ADRIMD.
基金The present study is supported by National Hightech R&D Program of China (2011AA020104)
文摘The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulatory framework has been constructed in the USA and EU, in which risk-based regulatory strategy is used to determine which regulatory mode is more desirable between medical technique and medical product. Also, it is suggested that two-tier regulatory framework of medical products be constructed, with the first level built on existing and newly introduced regulatory provisions and the second technical level encompassing all the technical requirements. In China, the demarcation line between medical technique mode and medical product mode is not made clear and coherent and flexible regulatory framework has not been intentionally designed. If the recommendations concerning the desirability of regulatory framework will be adopted in China, it means the present application of medical technique mode should be reconsidered and adjusted based on the risk analysis. Furthermore, the construction of two-tier regulatory framework which is tailored to meet the demands of development of medical products of tissue engineering and regenerative medicine still remains a challenge.
