Bayon Y, Bohner M, Eglin D, Procter P, Richards R G, Weber J, Zeugolis D I
Medtronic - Sofradim Production, 116 Avenue du Formans, Trévoux, 01600, France.
Dr Robert Mathys Foundation, Bischmattstr. 12, Bettlach, CH-2544, Switzerland.
J Mater Sci Mater Med. 2016 Sep;27(9):144. doi: 10.1007/s10856-016-5759-5. Epub 2016 Aug 23.
The European Society for Biomaterials 2015 Translational Research Symposium focused on 'Innovating in the Medical Device Industry - Challenges & Opportunities' from different perspectives, i.e., from a non-profit research organisation to a syndicate of small and medium-sized companies and large companies. Lecturers from regulatory consultants, industry and research institutions described the innovation process and regulatory processes (e.g., 510K, PMA, combination product) towards market approval. The aim of the present article is to summarise and explain the main statements made during the symposium, in terms of challenges and opportunities for medical device industries, in a constantly changing customer and regulatory environment.
2015年欧洲生物材料学会转化研究研讨会从不同角度聚焦于“医疗器械行业的创新——挑战与机遇”，这些角度包括从非营利性研究机构到中小型企业和大型企业集团。来自监管顾问、行业和研究机构的讲师介绍了创新过程以及产品上市前的监管流程（例如510K、PMA、组合产品）。本文旨在总结并解释研讨会期间就不断变化的客户和监管环境下医疗器械行业面临的挑战与机遇所发表的主要观点。
