Effect of Sterilization on the Dimensional and Mechanical Behavior of Polylactic Acid Pieces Produced by Fused Deposition Modeling.

To successfully implement additive manufacturing (AM) techniques for custom medical device (MD) production with low-cost resources, it is imperative to understand the effect of common and affordable sterilization processes, such as formaldehyde or steam sterilization, on pieces manufactured by AM. In this way, the performance of low-risk MDs, such as biomodels and surgical guides, could be assessed for complying with safety, precision, and MD delivery requirements. In this context, the aim of the present work was to evaluate the effect of formaldehyde and steam sterilization on the dimensional and mechanical stability of standard polylactic acid (PLA) test pieces produced by fused deposition modeling (FDM). To achieve this, PLA samples were sterilized according to the sterilization protocol of a public hospital in the city of Bucaramanga, Colombia. Significant changes regarding mechanical and dimensional properties were found as a function of manufacturing parameters. This research attempts to contribute to the development of affordable approaches for the fabrication of functional and customized medical devices through AM technologies, an issue of particular interest for low- and middle-income countries.

Present and future for technologies to develop patient-specific medical devices: a systematic review approach.

The main purpose of this investigation was to systematically review the literature regarding case studies on patient-specific implants and devices, with the goal of analyzing the process of developing custom-made medical devices. A content analysis was performed to identify design processes and methodologies implemented to develop devices such as implants adapted to bone geometries. Reverse engineering, computer-aided design, simulation of assets, and rapid prototyping technologies were selected according to their interoperability in a process framework for developing new products. Finally, results from the case studies and process stages identified in the consulted research were analyzed. These results showed a relationship between the scope and complexity of the process and the stage of technology integration of the patient-specific device development. The analyzed case studies were characterized by technical, scientific, and multidisciplinary components to achieve research goals. Likewise, integration of technologies using patient-specific technologies is needed for product development that converges into designing devices, such as implants, biomodels, and cutting drilling guides.