Virtual Surgical Planning for Point-of-Care Manufacturing

Two factors motivating the achievement of safe and effective Point-of-Care Manufacturing (POCM) are (1) to provide personalized medical devices to patients with short treatment windows (e.g., trauma, advanced stage cancer) and (2) to ensure that those devices improve outcomes and reduce revision surgery rates. In-hospital use of Virtual Surgical Planning (VSP) now commonly includes the production of surgical models and procedure guides (e.g., cutting, drilling, or placement guides and tool jigs). As this technology becomes widely available, we envision the FDA approving VSP software with tools for personalized, implantable, medical device design and POCM. Indeed, VSP for local optimization of device shape (external surfaces and internal pore geometry), placement (anatomical location), materials (via interactive simulation of postoperative device performance), and the fabrication process engineering plan can be executed in real time. This is nothing short of a paradigm shift from manual personalization of off-the-shelf devices or the factory-based fabrication of personalized medical devices. As an example of this new paradigm, we present here a hypothetical VSP pathway for the design and POCM of personalized mandibular graft fixation devices where optimized performance avoids both stress shielding-induced bone loss as well as stress concentration-induced device failure. © 2024 The Authors.

Virtual Surgical Planning for Point-of-Care Manufacturing Academic Article in Scopus