Current Trends in the Development and Use of Personalized Implants: Engineering Concepts and Regulation Perspectives for the Contemporary Oral and Maxillofacial Surgeon

Alessandro Tel,Giovanni Totis,Lorenzo Fedrizzi,Massimo Robiony,Elisabetta Ocello,Marco Sortino,Alessandra Bordon,Salvatore Sembronio

doi:10.3390/app112411694

Abstract

The recently adopted Medical Device Regulation (MDR) has finally entered into force on 26 May 2021. As innovation and especially the advent of customized prostheses has deeply modified many surgical procedures in our discipline, it is imperative for the contemporary surgeon to become aware of the impact that the MDR will have on many aspects, including the choice of the manufacturer, the evaluation of the devices, point-of-care 3D printing labs, and medical software. In this paper, the authors tried to identify the cultural gaps in clinical practice that the MDR is supposed to fill. To achieve this purpose, a task force of experts was reunited, including CMF surgeons with direct expertise in medical software and 3D printing, mechanical and material engineers, facing the topic of the MDR from a multidimensional perspective. In this article, surgeons and engineers review many crucial aspects concerning the points of the regulation that mostly affect the field of implantable devices for the cranio-maxillo-facial skeleton. The result of interdisciplinary research is a paper aiming to provide surgeons with the knowledge on the fundamental processes of additive manufacturing, increasing the clinician’s awareness on the evaluation of a customized implant before surgery and on the underlying regulatory framework.

Highlights

As of 26 May 2021, the EU Medical Device Regulation (EU MDR) has come into force [1], replacing the EU Medical Device Directive 93/42/EEC [2,3].This new set of rules has implications for both in-house facilities, namely, small laboratories which are integrated in hospitals and are managed partially or entirely by clinicians, as well as for large-scale companies, which only provide the final product to be implanted.In-house laboratories are nowadays present at many institutions, but without a regulatory framework, processes are highly heterogeneous and poorly standardized
It is important that such small facilities implement what is called a Quality Management System (QMS), through which they can certify the quality of processes [4]
While creating and designing the virtual model, it is fundamental to follow some guidelines for the 3D powder bed fusion (PBF) printing, which need to respect some feasibility requirements to avoid possible issues during the production steps:

Summary

Introduction

As of 26 May 2021, the EU Medical Device Regulation (EU MDR) has come into force [1], replacing the EU Medical Device Directive 93/42/EEC [2,3].This new set of rules has implications for both in-house facilities, namely, small laboratories which are integrated in hospitals and are managed partially or entirely by clinicians, as well as for large-scale companies, which only provide the final product to be implanted.In-house laboratories are nowadays present at many institutions, but without a regulatory framework, processes are highly heterogeneous and poorly standardized. As of 26 May 2021, the EU Medical Device Regulation (EU MDR) has come into force [1], replacing the EU Medical Device Directive 93/42/EEC [2,3] This new set of rules has implications for both in-house facilities, namely, small laboratories which are integrated in hospitals and are managed partially or entirely by clinicians, as well as for large-scale companies, which only provide the final product to be implanted. It is important that such small facilities implement what is called a Quality Management System (QMS), through which they can certify the quality of processes [4] In modern hospitals, such laboratories generally represent the place where virtual surgical planning is performed by surgeons, or, in the most advanced realities, where non-implantable devices, such as molds and surgical guides, are manufactured using 3D printers. Implants are ordered and received ready for surgery, and oftentimes no validation of their quality is performed by surgeons, that generally have little or no knowledge on production processes related to craniomaxillo-facial (CMF) implants fabrication

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