The Role of Additive Manufacturing in the Design Workflow of a physical Human – Robot Interface for an Active Orthosis

Active orthoses are gaining increasing interest, particularly those intended for lower limbs, due to their potential to enhance independence in performing Activities of Daily Living (ADLs). Nevertheless, numerous impediments to their widespread adoption persist. Among these are the necessity for an adequate production process to ensure the quality of a custom-made product and the absence of a detailed workflow to guide the design of such devices. Additive Manufacturing (AM) emerges as a promising technology for the production of patient-specific active orthoses intended for ADLs assistance.The present work proposes a comprehensive methodological workflow for the design of active orthoses to be produced via AM. The workflow delineates the critical guidelines and certification criteria to be followed, highlighting the hardware and software resources necessary for AM-based design implementation. The workflow is validated through a case study of an active knee orthosis. This case study highlights the importance of a detailed workflow that specifies the resources needed to carry out integrated design, in order to ensure an efficient and effective design process. This methodological approach addresses all project requirements, including safety, functionality, production process, and comfort, to create a compliant device. The workflow developed in this manner, thus, serves as a comprehensive practical guide for those interested in exploring AM as a technology for active orthosis production.