SGER: Development of a Research Agenda for Biomedical Manufacturing

探索性研究小额赠款（SGER）为探索生物医学生产的独特研究需求和定义满足这些需求的适当研究机制提供资金。生物医药产业是世界经济中规模最大、增长最快的部分之一。它包括高度精密的产品，这些产品制造起来很复杂，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生产的产品，比如组织工程肝脏。目前有两家公司在销售人造皮肤。作为该项目的一部分，生物医药公司将接受采访，并被纳入一个顾问委员会，以帮助确定生物医药生产研究需求，以及来自政府和学术界的代表。将定义与生物医学工业有关的制造研究的最新状况。将调查政府监管要求，并描述这些要求对生物医药生产的影响。这项研究的成功结论将导致改进生物医学制造工艺，提高生物医学原型产品和工艺向全面生产转移的效率。它将确定生物医学制造的独特研究要求，并将这些要求转移给学术和工业研究小组实施。此外，该项目将确定最合适的研究机制，以进行生物医学制造研究，并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 manufacturingand 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 currentlypossible 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 anadvisory 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.