Design Process of Medical Devices for Robotic Rehabilitation: An Open Innovation-Inspired Approach

Abstract

The design process of innovative medical devices, and especially robotic systems for rehabilitation purposes, entails the collaboration among different stakeholders. Moreover, regulations strongly affect the products development, e.g. providing unexpected technical requirements and design constraints. In this paper, an innovative open innovation-inspired model for the design process of medical devices is presented. This model aims at optimizing the employed resources (such as time and cost) and allows overcoming the limits of the traditional linear design model, and specifies i) which stakeholders are involved in the different phases of the process, and ii) the role of the regulations. Special emphasis is placed on the contribution of users and operators (as physiotherapists or caregivers), in addition to physicians and engineers. The contribution of the regulatory aspect is analysed both from a general point of view, with international validity, and punctually, referring to MEDDEV 2.7/1 guideline as illustrative case study. Strength points and limits of the proposed model are highlighted, evaluating examples of incremental and disruptive innovation, like the adoption of new materials or the implementation of functional innovations.KeywordsDesign processBiomedical devicesOpen innovationDesign requirementsRegulationsStakeholdersRobotic rehabilitationMEDDEV 2.7/1