Additively manufactured maxillofacial implants and guides – achieving routine use

Abstract

Purpose – The purpose of this paper is to identify the key design process factors acting as drivers or barriers to routine health service adoption of additively manufactured (AM) patient-specific devices. The technical efficacy of, and clinical benefits from, using computer-aided design (CAD) and AM in the production of such devices (implants and guides) has been established. Despite this, they are still not commonplace. With AM equipment and CAD tool costs largely outside of the clinician’s or designer’s control, the opportunity exists to explore design process improvement routes to facilitate routine health service implementation. Design/methodology/approach – A literature review, new data from three separate clinical case studies and experience from an institute working on collaborative research and commercial application of CAD/AM in the maxillofacial specialty, were analysed to extract a list and formulate models of design process factors. Findings – A semi-digital design and fabrication process is currently the lowest cost and shortest duration for cranioplasty implant production. The key design process factor to address is the fidelity of the device design specification. Research limitations/implications – Further research into the relative values of, and best methods to address the key factors is required; to work towards the development of new design tools. A wider range of benchmarked case studies is required to assess costs and timings beyond one implant type. Originality/value – Design process factors are identified (building on previous work largely restricted to technical and clinical efficacy). Additionally, three implant design and fabrication workflows are directly compared for costs and time. Unusually, a design process failure is detailed. A new model is proposed – describing design process factor relationships and the desired impact of future design tools.