Journal
JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART B-APPLIED BIOMATERIALS
Volume 109, Issue 11, Pages 1953-1959Publisher
WILEY
DOI: 10.1002/jbm.b.34833
Keywords
advanced manufacturing; bacterial Nanocellulose; biofabrication; biomaterial; medical device regulation
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The text discusses the relationship between the field of Biofabrication and its challenges, emphasizing the importance of emerging materials such as Bacterial Nanocellulose in medical device manufacturing, and the need for guidance from health authorities to address issues in industry development.
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.
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