Human-Centric Regulatory in Point-of-Care Manufacturing for 3D Printed PEEK Polymer Implants with Functionalized Implant Surface

Abstract

This article aims to define a regulatory approach for future medical technologies to be applied to the research, design, development, and manufacturing of smart medical devices. In the scope of this perspective: A human-centric regulatory approach and regulatory thinking method for 3D printed PEEK polymer implants. The mode of operations of the functionalization method, its safety and clinical performance, was verified and validated beforehand by means of mechanical testings, comparative cell tests in vitro and in vivo in a comparative animal model: The MBT procedure was developed using ISO 13485 certified processes and GLP standards. MBT was also developed considering the safety and (clinical) performance requirements as prescribed by the Medical Device Regulation (EU) 2017/745 for implants. For this purpose, the requirements from Annex I of the Medical Device Regulation (Regulation EU 2017/745) were adapted to the requirements for coating technologies. Mechanical testing followed a precise defined test and verification matrix. Each test followed its own rationale and test setup. Where possible, standard test methods and accredited facilities have been used. As MBT is an entirely innovative SFT, general standard test methods for this technology are not established but have been defined, described, executed, and evaluated. During the design and development and during design transfer, comparative cell tests have been performed. Relevant cell lines have been used to prove the unique characteristics of MBT compared to standard and golden standard materials: Titanium coated PEEK, Ha-enhanced PEEK, and pure PEEK. A comparative animal model has been performed according to GLP standards by Vetsuisse Zurich. The study protocol was approved by the veterinarians of the Kanton ZH (University of Zurich, Vetsuisse, study protocol number: ZH132/18, study title: MBT - a new covalent binding molecule for enhancing osseointegration). A comparative split mouth study setup was used. Screw-design test dowels have been implanted in dense bone of sheep and analyzed via histology measurements. For the applicability of MBT, it can be stated that the SFT does not influence the clinical applicability of the connected medical device: