Human-Centric Regulatory in Point-of-Care Manufacturing for 3D Printed PEEK Polymer Implants with Functionalized Implant Surface
JUNIPER PUBLISHERS- ACADEMIC JOURNAL OF POLYMER SCIENCE 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. Keywords: POC solution; polymer; smart implant; regulatory thinking; human-centric regulatory; S.P.E.L.; surface functionalization; additive manufacturing Introduction The healthcare industry is in a transformative change: one of the key enablers of these changes is the proliferation of point-of-care (POC) technologies, which can improve clinical outcomes and reduce costs by increased access. POC technologies have the potential to improve the management and treatment of variou...