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Special Report

Additive manufacturing in biomedical sciences and the need for definitions and norms

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Abstract

The application of additive biomanufacturing represents one of the most rapidly advancing areas of biomedical science, in which engineers, scientists, and clinicians are contributing to the future of health care. The combined efforts of a large number of groups around the globe have developed a strong research thrust that has resulted in a large number of publications. Reviewing this body of literature, there is an increasing trend of research groups inventing their own definitions and terminology. This has made it difficult to find and compare the results. Therefore, to move the field constructively forward, it is a conditio sine qua non to clarify various terminologies and standards. Based on this background, this article advocates tightening the terminology and has the objective of penning out definitions that will ultimately allow the development of official industry standard terms, such as American Society for Testing and Materials and or International Organization for Standardization for technologies developed for Tissue Engineering and Regenerative Medicine.

Financial & competing interests disclosure

This paper was sponsored by Bayersichen Forschungstiftung Post-Doctoral Fellowship, QUT Write-Up Scholarship from Queensland University of Technology, Hans-Fischer Senior Fellowship from Technische Universität München and Department of Industry and Science-Australian Research Council FT110101117 Future Fellowship. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues
  • Standards are required primarily to ensure conformity and safety of newly developed methodologies, products and processes.

  • Additive manufacturing technologies are rapidly being integrated into the fields of tissue engineering and regenerative medicine; however, there is an increasing trend of research groups inventing their own definitions and terminology, making it difficult to find and compare the results of different research groups.

  • There are international standards already developed separately for AM and TE/RM; however, ASTM/ISO standard should be developed to define the terms commonly used within AM technologies used for TE/RM purposes.

  • The establishment of such international standards would ultimately reduce barriers to knowledge transfer and economic inefficiencies within the tissue engineering and regenerative medicine industry.

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