Reporting fidelity in the literature for computer aided design and additive manufacture of implants and guides

Abstract:

The aim of this study was to critically evaluate the nature and reporting fidelity of literature about applications of computer aided design (CAD) and metal additive manufacture (AM) to surgical guides and implants. Increasingly, non-specialist designers such as surgeons or prosthetists are partaking in some or all of the design process. To comply with local regulations, it is imperative that quality is ensured during the design process, yet it is rare for literature to report on the design process of medical devices with sufficient detail to allow proper evaluation or reproduction. This study reviewed the CAD/AM literature for implant and guide design, focussing on detailed justifications for design decisions, economic impacts, and production methods. This review showed that the fidelity of reporting in the literature was low; with opportunities to report crucial design decisions, engineering parameters, and how these relate to clinical results being frequently missed. This research proposes the low fidelity in reporting is likely due to a combination of: reporting for different specialisms, resulting in a lack of expert knowledge in certain areas and assumed knowledge in others; commercial sensitivity of design and manufacturing methods; low volume of clinical cases; and a large gap in translating research to clinical applications. This study concluded that higher fidelity in reporting methods are required when discussing the design of AM medical implants, which would allow comparisons between studies, provide evidence to support design quality, and enable evidence-based decision-making.