B.J. Casey, G. Kumar, P. Petrochenko, S.A. Skoog, R.J. Narayan, P.L. Goering, B.J. Dair
U.S. Food and Drug Administration, US
nanoengineered surface, biocompatibility, characterization
There is a growing trend in the medical device industry to manipulate the surface topography of a device with nanoscale features in order to promote advantageous biological responses such as better tissue integration and/or faster tissue regeneration. Due to the considerable growth in the field it is imperative that the scientific and regulatory community develop an understanding of this technology, specifically how such nanoscale features influence biological response. This understanding and knowledge is crucial for the development of novel materials with enhanced properties yet is also equally important for the proper assessment of the safety and efficacy of these new materials to better protect the public health. Various types of nanoengineered surfaces ranging in both structure and composition were evaluated in the present study. The research focused on three main areas which included: 1) physico-chemical characterization 2) protein and cellular response and 3) biocompatibility.