Personalization for surgical implants

A new era in surgical implant manufacturing has been enabled by the development of digital human modeling to capture patient anatomy and pathology to guide the design of patient-specific implants. Where traditional, mass-manufactured implants are not suitable for specific cases, the transition to customization has played a critical role in several surgical disciplines, from the development of hand-made stents with specific dimensions and branching in vascular surgery to the rapid additive manufacturing of titanium components for joint replacement and bone fixation in orthopedics. While the impact of using these devices in the clinical sphere is largely positive, as seen by improved patient outcomes and reduced surgical times and costs, the implications of this transition to single-unit implant manufacturing has yet to be fully understood in the commercial and regulatory space. This chapter will explore the recent adoption of specific terminology for personalized medical devices and the use of personalized products in different surgical fields, as well as providing perspectives on how regulation and commercialization will play a role in guiding the future of personalized surgical implants in routine clinical practice.