3D printing traceability in healthcare using 3Diamond software.

Background: 3D printing is one of the fastest-growing technologies in medicine, but it is essential to have a system for 3D printing documentation that is accessible for not only clinical engineers and surgeons, but also quality managers and data-privacy officers in hospitals. Dedicated software such as product lifecycle management (PLM) software could enable comprehensive management and traceability of all data relevant to 3D printing tasks in a hospital and would highly beneficial. Therefore, customizable software called 3Diamond was developed for 3D printing in medicine.

Methods: The software development process involved several stages, including setting specifications based on end-user requirements, design, implementation, and testing. In order to ensure the software's long-term success and smooth operation, critical phases were also considered, such as deployment and maintenance.

Results: The developed software provides immediate and complete traceability of all preparations and controls, as well as management of reports, orders, stock, and post-operative follow-up of tasks related to 3D printing in a hospital. Based on user requirements, software testing is provided automatically with each release. The software was implemented in a natural clinical environment with a developed 3D printing center.

Conclusion: Although 3D printing has potential for innovation in the medical profession, it is nevertheless subject to regulations. Even though there are exemptions for patient-specific products, the effects of their local legal implementations related to 3D printing cannot be fully overseen. To this end, 3Diamond provides a robust system for 3D printing documentation that is accessible to different personnel in hospitals.