Integrated Process Model for Development and Manufacturing of Customized Orthopedic Implants

Customized orthopedic implants are one of the first successful applications of additive technologies in the medical field, and their usage provides significant advantages for patient treatment. The design of customized orthopedic implants and their manufacturing based on advanced additive and subtractive technologies and quality assurance necessitate flexible production management that requires careful process planning for cost and time management. The paper uses the business process model and notation to discuss computer-integrated manufacturing modeling for customized implants. The study highlights the key business roles and their respective tasks and identifies five main stages of customized implant development and production: initial data acquisition, reverse engineering, design, prototyping, and manufacturing. The required human, information, and material resources for each stage were analyzed, and the dependencies of time and cost were obtained. Optimization tasks based on time or cost minimization criteria were formulated for development and manufacturing. The results obtained in this study can provide a foundation for efficient time and cost management.