SGER: Development of a Research Agenda for Biomedical Manufacturing

这一小笔探索性研究补助金(SGER)提供资金，用于探索生物医学制造的独特研究需求，并确定实现这些需求的适当研究机制。生物医药行业是世界经济中规模最大、增长最快的领域之一。它包括高度复杂的产品，这些产品制造复杂，产品寿命相对较短。电子产品尤其如此，其产品寿命与计算机行业相似。此外，它还将包括许多目前无法制造的产品，例如组织工程肝脏。目前有两家公司在销售人造皮肤。作为该项目的一部分，生物医学公司将接受采访，并被纳入一个顾问委员会，以帮助确定生物医学制造研究需求，以及来自政府和学术界的代表。将定义与生物医药行业相关的制造研究的最新状态。将对政府监管要求进行调查，并描述这些要求对生物医学制造的影响。这项研究的成功结束将导致生物医学制造工艺的改进，并提高生物医学原型产品和工艺向全面生产转移的效率。它将定义生物医学制造的独特研究要求，并将这些要求移交给学术和工业研究小组实施。此外，该项目将为执行生物医学制造研究确定最合适的研究机制，从而将研究成果交付给行业。

This Small Grant for Exploratory Research (SGER) provides funding for the exploration of the unique research needs of biomedical manufacturing and the definition of an appropriate research mechanism for delivering those needs. The biomedical industry is one of the largest and fastest growing segments of the world economy. It includes highly sophisticated products, which are complex to manufacturing and have relatively short product lives. This is particularly true of electronic products, with product lives similar to the computer industry. Additionally, it will include many products, which are not currently possible to manufacture, such as a tissue-engineered liver. Two companies are currently marketing manufactured skin. As part of this project, biomedical companies will be interviewed and included in an advisory board to help define the biomedical manufacturing research needs along with representatives from government and academe. The state of the art in manufacturing research relating to the biomedical industry will be defined. Government regulatory requirements will be investigated and the impact of these requirements on biomedical manufacturing will be characterized. The successful conclusion of this research will lead to improved biomedical manufacturing processes and improved efficiency in the transfer of biomedical prototype products and processes to full-scale production. It will define the unique research requirements for biomedical manufacturing and transfer those requirements to academic and industrial research groups for implementation. Further, this project will define the most appropriate research mechanism for performing biomedical manufacturing research which will deliver the research results to industry.