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

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.

The future prospects of microbial cellulose in biomedical applications.

Microbial cellulose has proven to be a remarkably versatile biomaterial and can be used in wide variety of applied scientific endeavors, such as paper products, electronics, acoustics, and biomedical devices. In fact, biomedical devices recently have gained a significant amount of attention because of an increased interest in tissue-engineered products for both wound care and the regeneration of damaged or diseased organs. Due to its unique nanostructure and properties, microbial cellulose is a natural candidate for numerous medical and tissue-engineered applications. For example, a microbial cellulose membrane has been successfully used as a wound-healing device for severely damaged skin and as a small-diameter blood vessel replacement. The nonwoven ribbons of microbial cellulose microfibrils closely resemble the structure of native extracellular matrices, suggesting that it could function as a scaffold for the production of many tissue-engineered constructs. In addition, microbial cellulose membranes, having a unique nanostructure, could have many other uses in wound healing and regenerative medicine, such as guided tissue regeneration (GTR), periodontal treatments, or as a replacement for dura mater (a membrane that surrounds brain tissue). In effect, microbial cellulose could function as a scaffold material for the regeneration of a wide variety of tissues, showing that it could eventually become an excellent platform technology for medicine. If microbial cellulose can be successfully mass produced, it will eventually become a vital biomaterial and will be used in the creation of a wide variety of medical devices and consumer products.