Specificity of 3D Printing and AI-Based Optimization of Medical Devices Using the Example of a Group of Exoskeletons

Featured Application The application of this work concerns the use of 3D printing and AI as systems supporting the design and manufacture of medical devices, especially powered exoskeletons and passive orthoses. Three-dimensional-printed medical devices are a separate group of medical devices necessary for the development of personalized medicine. The present article discusses a modern and specific group of medical devices and exoskeletons, which aims to present our own experiences in the selection of materials, design, artificial-intelligence optimization, production, and testing of several generations of various upper limb exoskeletons when considering the Medical Devices Regulation (MDR) and the ISO 13485 and ISO 10993 standards. Work is underway to maintain the methodological rigor inherent in medical devices and to develop new business models to achieve cost-effectiveness so that inadequate legislation does not stop the development of this group of technologies (3D scanning, 3D printing, and reverse engineering) in the healthcare system. The gap between research and engineering practice and clinical 3D printing should be bridged as quickly and as carefully as possible. This measure will ensure the transfer of proven solutions into clinical practice. The growing maturity of 3D printing technology will increasingly impact everyday clinical practice, so it is necessary to prepare medical specialists and strategic and organizational changes to realize the correct implementation based on the needs of patients and clinicians.