User acceptance as key factor for development and risk management of an AI-based robot arm control
O. Kozlova, A. Baumeister, S. Reutzel, E. Gardo, P. Tolle
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AbstractUser acceptance plays an important role in the risk management of medical products, as it can have a significant impact on the safety and effectiveness of a product. Usability issues in accordance with the requirements of IEC 62366 must be carefully considered in risk management (Questions Catalog 2023). This is even more important for medical products using artificial Intelligence (AI) and the development of such products. This paper aims to show how user acceptance had a meaningful impact on the development process and risk management towards the development of an AI-based control for a robot arm in the research project DoF-Adaptiv. Currently, three robot arms are available for people with severe physical impairments in Germany. These robotic arms, such as the Jaco from Kinova, are mounted on an electric wheelchair, and users control them in the same way they control their wheelchair, typically with a joystick. To make the robot arm more accessible an AI-based control using smart glasses could be a solution (Baumeister et al. 2022). However, using AI leads to new ethical and social implications that could influence the user’s acceptance of the new control.Keywords: user acceptance, user involvement, medical device regulation, risk management, AI medical product
O. Kozlova, A. Baumeister, S. Reutzel, E. Gardo, P. Tolle (2024). User acceptance as key factor for development and risk management of an AI-based robot arm control. Gerontechnology, 23(2), 1-1
https://doi.org/10.4017/gt.2024.23.s.896.opp