title: Innovating in the medical device industry - challenges & opportunities ESB 2015 translational research symposium.
abstract: 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.
authors.affiliation: Medtronic - Sofradim Production, 116 Avenue du Formans, Trévoux, 01600, France. yves.bayon@covidien.com.
authors.forename: Y
authors.identifier: http://orcid.org/0000-0002-0232-3079
authors.initials: Y
authors.lastname: Bayon
authors.affiliation: Dr Robert Mathys Foundation, Bischmattstr. 12, Bettlach, CH-2544, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Bohner
authors.affiliation: AO Research Institute Davos, Clavadelerstrasse 8, Davos, 7270, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Eglin
authors.affiliation: Medical Device Industry Consultant, Divonne les Bains, 01220, France.
authors.forename: P
authors.initials: P
authors.lastname: Procter
authors.affiliation: AO Research Institute Davos, Clavadelerstrasse 8, Davos, 7270, Switzerland.
authors.forename: R G
authors.initials: RG
authors.lastname: Richards
authors.affiliation: Boston Scientific, Martinolaan 50, Maastricht, 6229GS, Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Weber
authors.affiliation: Regenerative, Modular & Developmental Engineering Laboratory (REMODEL), National University of Ireland Galway (NUI Galway), Galway, Ireland.|Centre for Research in Medical Devices (CÚRAM), National University of Ireland Galway (NUI Galway), Galway, Ireland.
authors.forename: D I
authors.initials: DI
authors.lastname: Zeugolis
mesh_terms: D000818:Animals; D001672:Biocompatible Materials; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D004059:Diffusion of Innovation; D004864:Equipment and Supplies; D005060:Europe; D006801:Humans; D012955:Societies, Medical; D057170:Translational Research, Biomedical / Q000379:methods* / Q000639:trends*
chemical_list: D001672:Biocompatible Materials