The SIGMA3D project, funded by the German Federal Ministry of Education and Research under grant number 16SV8386, ran from 1 March 2020 to 31 August 2023. Its aim was to create a fully digital value chain for orthopaedic aids, enabling patient‑specific 3D‑modeling, virtual testing, and additive manufacturing of orthoses. Mecuris GmbH, acting as consortium leader and future platform operator, focused on building the web‑based platform infrastructure and integrating the various development strands into a single digital workflow.
The technical outcome of the project is a complete digital process chain that starts with patient data acquisition—using 3‑D scanning, photography, and CT imaging—proceeds through CAD/CAM design, biomechanical simulation, and virtual safety verification, and ends with the production of a 3‑D‑printed orthosis. The platform automatically performs virtual load and function tests to certify safety before any physical prototype is fabricated. A prototype hand orthosis was produced and subjected to a comparative evaluation against a conventional orthosis; the study found no functional or safety deficits, confirming the reliability of the virtual testing pipeline. The platform also supports integration with third‑party systems through defined interfaces, allowing seamless data exchange and workflow automation.
Key technical work packages included: (1) the development of scanning and measurement procedures to capture accurate patient geometry; (2) analysis of suitable additive manufacturing processes, materials, and structures, leading to the selection of optimal 3‑D‑printing materials; (3) design and development of a hand‑orthosis case study, where patient requirements were translated into a biomechanically sound design; (4) implementation and validation of the orthosis within the digital platform, including usability testing and patient feedback; and (5) the creation of a validation strategy that combines virtual simulation with physical testing on custom test rigs. Throughout the project, iterative refinement of the simulation models and design parameters ensured that the final product met clinical performance criteria.
Collaboration involved a multidisciplinary consortium of orthopaedic technology experts, clinicians, modelers, simulation specialists, IT engineers, software developers, material scientists, biomechanists, 3‑D scanning and printing specialists, and regulatory experts. Orthopaedic hospitals contributed clinical expertise and patient data, while third‑party vendors supplied scanning hardware and additive manufacturing equipment. Mecuris coordinated the integration of these contributions, managed the platform development, and led the validation activities. The project experienced delays due to the COVID‑19 pandemic, particularly in coordinating with clinical partners and in patient‑contact activities, which led to a six‑month extension approved by the BMBF and the project sponsor.
The resulting platform offers orthopaedic practices a novel, web‑based environment for designing, testing, and producing patient‑specific orthoses. By providing an automated safety verification step and a fully digital workflow, the platform promises to reduce time to market, lower costs, and improve the quality of orthotic care. The success of the hand‑orthosis case study demonstrates the feasibility of extending the approach to other orthopaedic devices, positioning the SIGMA3D platform as a scalable solution for the broader orthopaedic aid industry.