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.

Development and surgical application of a custom implant that enables a vertical vector of mandibular distraction

“…[5][6][7] Virtual planning and additive manufacturing have demonstrated the ability to facilitate surgery, helping obtain more accurate and predictive outcomes while reducing risks and operative time. [11][12][13][14] The present case demonstrates the coordination and communication required between surgeon and engineers to produce the best surgical plan and consequently, the development of novel ideas such as a 3D printed spacer.…”

Implant system for treatment of the orbital floor defects of blowout fractures in the maxillofacial region using polypropylene yarn and bioactive bone cement

“…In addition to obtaining a shape which is as close as possible to an ideal one, the right choice of material is important. It must not show any toxic or allergic properties, and, at the same time, must meet a number of stringent requirements (Burton, Peel, & Eggbeer, ; Mayya, Banerjee, & Rajesh, ; Wekwejt, Świeczko‐Żurek, & Szkodo, ).…”

Ti6Al4V mandibular devices by additive manufacturing: Assessment of as‐built quality

“…The promising use of AM for medical applications requires strong evidence about the reliability and the quality of printed objects in terms of accuracy, surface finishing, and functional and biomechanical properties. Furthermore, an inaccurate device means not fitting with the specific patient anatomy as the surface roughness, its effect on osseointegration has been extensively studied in the litera- vices is commonly adopted by users as hospitals and professionals (Attaran, 2017;Burton et al, 2018;Jiang et al, 2017) and it has many advantages, but the quality of the results can vary from vendor to vendor. Design properties, powder quality, the setting up of process parameters and post-processing are some of the aspects that may affect the final quality and performance of the printed objects.…”