Commercialization has been slow since the Food and Drug Administration approved a medical device containing nanomaterials in 1980. In 2017, the FDA released draft guidance to accelerate approval. We highlight here that geographical and structural separations of researchers, manufacturers, and clinical servicers may slow commercialization more than FDA approval.
In addition to the expertise of the 7 start-ups and 3 FDA approved projects Webster Nanomedicine Lab’s where this work was conducted, we interviewed a number of start-ups and established nanomaterial manufactures. See our publication in Trends in Biotechnology