Involving End Users in Risk-Based Co-design

The increasing availability of digital technologies in healthcare provides the means for increased participation of patients in their care path. This increased empowerment is becoming more widespread day by day. Nevertheless, still little or no inclusion in the design process is part of the common practice during the mHealth medical device design. This chapter proposes an approach based on the indications of international standards for medical device design and manufacturing to foster the adoption of co-design techniques and the inclusion of end-users in the decisional process. The adoption of the proposed method, in particular, is suitable with processes based on international standards for medical device management as per a compliant quality management system (ISO 13485), usability evaluation (IEC 62366) and risk management (ISO 14971), which are the methods used by manufacturers to prove compliance with the requirements of the European Regulations. Such a method ensures a high level of protection for all stakeholders while fostering innovation and participation.