Introduction: Traditionally, orthosis manufacturing is time and labor-intensive. Digitalization of some of the fabrication process is already ubiquitous, yet extension across device types could reduce the burden of manual labor and advance automation to help unblock access to assistive technologies globally. It seems, however, that appropriately strong evidence is holding this back. This review looks to thoroughly examine the current state of evidence to make this clear.

Objectives: To identify gaps in the literature that create barriers to decision-making on either appropriate uptake by clinical teams or setting research directions, by identifying what forms of evidence the current research literature provides to the orthotics community.

Study design: Scoping literature review.

Methods: A comprehensive search was completed in the following databases: AMED, MEDLINE, EMBASE, Global Health Archive, CINAHL Plus, Cochrane Library, Web of Science, ACM, IEEE, and Engineering Village, resulting in 3487 articles to be screened. Results: After screening, 121 lower limb orthosis, 104 upper limb orthosis, and 30 spinal orthosis articles were included in this review. For some areas such as CAD/CAM-produced insoles and spinal orthoses, the evidence base is strong. For most additive manufacture articles, long-term, larger-scale studies as well as research into training requirements are lacking.

Conclusion: The advantages of digital fabrication technology that could streamline orthotic device production in many cases are still blocked by a lack of strong formal evidence, ie large longitudinal studies with a range of evaluation measures. Increased collaboration between clinicians, patient/service users, academia, and industry could be a route to addressing these gaps and creating a better pathway to market for new technologies.