Bacterially derived medical devices: How commercialization of bacterial nanocellulose and other biofabricated products requires challenging of standard industrial practices.

Abstract

The objectives of innovation are often diametrically opposed to industrially standardized practices. The burgeoning field of Biofabrication represents one type of challenge that falls outside the norms of not only standardized industrial practices, but also those of Health Authorities. Biofabrication produces complex "biological products from raw materials such as living cells, molecules, extracellular matrices, and biomaterials" Mironov V, et al. Biofabrication, 2009, 1, 1-16. One such material is Bacterial Nanocellulose, a biologically derived cellulose structure with tissue like qualities, which does not fit within standardized manufacturing methods nor the well-established parameters of medical device quality system regulations found within 21 CFR 820. Materials like this are necessary to address the hidden risks associated with their contending products, animal derived tissues, to move to a more sustainable manufacturing, and an animal cruelty free approach to medical device production. The goal of this manuscript, therefore, is to provide an example roadmap for navigating established quality system parameters while highlighting the need for Health Authorities to provide guidance to both industry and themselves as the field of advanced manufacturing continues to rapidly progress.