title: The new (challenging) role of academia in biomaterial translational research and medical device development.
abstract: With the ever-changing landscape of translational research, the medical device and pharmaceutical industries increasingly license technologies with the added value of clinical and/or pre-clinical data rather than those in earlier stages of development. Universities have the potential to fill the gap in product development from academic laboratories through enhanced student training and increased implementation of some development and manufacturing activities that are traditionally found only in the private sector. A development roadmap is described from initial product feasibility through commercialization in the context of efficient development practices. The specific challenges in the design and development of biomaterial-based medical devices are described in the context of this development path with an emphasis on unique challenges for academic laboratories.
authors.affiliation: Division of Pharmaceutical Sciences, University of Wisconsin-Madison School of Pharmacy, 777 Highland Ave, Madison, WI 53705, USA.
authors.forename: Kyle
authors.initials: K
authors.lastname: Kleinbeck
authors.forename: Edward
authors.initials: E
authors.lastname: Anderson
authors.forename: Matthew
authors.initials: M
authors.lastname: Ogle
authors.forename: Jeanine
authors.initials: J
authors.lastname: Burmania
authors.forename: W John
authors.initials: WJ
authors.lastname: Kao
mesh_terms: D000047:Academies and Institutes; D001672:Biocompatible Materials / Q000627:therapeutic use*; D004864:Equipment and Supplies; D006801:Humans; D057170:Translational Research, Biomedical / Q000458:organization & administration* / Q000639:trends
chemical_list: D001672:Biocompatible Materials