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Barriers Implementing Patient-Specific 3D-Printed Bone Scaffolds in Australia: A Scoping Review.
Anthony Vidler1,2, Angus Hayes1,3
1School of Rural Medicine, Charles Sturt University, Orange, New South Wales, Australia, csu.edu.au.
International Journal of Biomaterials
|April 8, 2026
Summary
Significant progress has been made in 3D printing materials for bone scaffolds, with early successes in manufacturing and trials. However, regulatory approval, professional adoption, and reimbursement remain key challenges for widespread medical use.
Area of Science:
- Biomaterials Engineering
- Medical Device Manufacturing
- Regenerative Medicine
Background:
- 3D printing technology adoption in medicine faces significant hurdles despite its potential.
- Patient-specific 3D-printed bone scaffolds were identified as a key area of focus for medical technology stakeholders.
- Five major barriers to 3D printing in Australian healthcare were identified in 2018: materials, manufacturing/approval, professional endorsement, reimbursement, and training.
Purpose of the Study:
- To assess the progress made in overcoming barriers to 3D-printed bone scaffold adoption since 2018.
- To review the literature on advancements in 3D printing for medical applications, specifically bone scaffolds.
- To identify remaining challenges for the widespread implementation of 3D-printed bone scaffolds in clinical practice.
Main Methods:
- Literature review of scientific publications from 2018 to the present.
- Analysis of progress across five identified barrier categories: materials, manufacturing/approval, endorsement, reimbursement, and training.
- Evaluation of advancements based on animal trials and human case studies.
Main Results:
- Substantial advancements in materials science, with increased variety and successful application in animal and limited human trials.
- Preliminary success in manufacturing and post-process approval for 3D-printed bone scaffolds, with documented case trials.
- Limited progression observed in medical/professional endorsement, reimbursement policies, and staff training, indicating these remain significant obstacles.
Conclusions:
- While material innovation and early manufacturing successes show promise for 3D-printed bone scaffolds, widespread clinical adoption is still contingent on addressing regulatory, economic, and professional acceptance barriers.
- Further development is needed in manufacturing and approval processes to meet commercial production standards.
- The full impact of barriers related to endorsement, reimbursement, and training may only become apparent after regulatory hurdles are cleared.
