The New (Challenging) Role of Academia in Biomaterial Translational Research and Medical Device Development

Biointerphases

article

Kyle Kleinbeck¹  Edward Anderson²  Matthew Ogle²  Jeanine Burmania³  W. John Kao¹ 

[1] Division of Pharmaceutical Sciences, University of Wisconsin-Madison School of Pharmacy;Vatrix Medical, Inc.;Wisconsin Alumni Research Foundation;Department of Biomedical Engineering, University of Wisconsin-Madison College of Engineering;Department of General Surgery, University of Wisconsin-Madison School of Medicine and Public Health

关键词: Product Development;    Medical Device;    Critical Path;    Good Manufacturing Practice;    Regulatory Filing;   

DOI  :  10.1007/s13758-011-0012-8

学科分类：基础医学

来源: SpringerOpen

【 摘 要 】

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.

【 授权许可】

CC BY