Suchergebnisse

To accelerate the pathway to affordable and quality healthcare for all, this thesis aimed at defining and exploring the added value and the limits of a new design paradigm related to the Open Source Medical Devices (OSMDs). The design methodology, the key enabling technologies and the legislative framework for their deployment to healthcare providers and patients were identified. The thesis contributed to the definition and implementation of the UBORA Platform, an e-platform for open-source co-design of new solutions to face the current and future global healthcare challenges. Through the platform, the author designed several needs-based medical technologies, starting from on-field surveys carried out in this thesis: Palpreast, an innovative wearable device for breast self-examination, based on textile sensors; affordable 3D printed adsorption columns as spare parts for oxygen concentrators. Results demonstrated the OSMD design, empowered by the framework proposed in UBORA, is a valid approach in the design of safe, effective medical and needs-based medical technologies.

My thesis work has been developed in African Biomedical Engineering Consortium (ABEC) framework and in particular during the development phase of UBORA project that has been financed by European Union. Highlighted the major issues relating to the conditions of medical devices in Africa, the thesis's goal is going to analyze four different approaches to address these issues with the goal of improving health through biomedical engineering. The first approach is focused on the development of an affordable and sustainable system for the regulation of medical devices in African Biomedical Engineering Consortium (ABEC) partner countries to establish a sustainable healthcare system. The second one describes the advantages of Open Source Medical Devices considering their accessibility, sustainability and lower costs. In support of this approach two examples are evaluated. The third approach is addressed to the development of human capital through a direct experience in Africa with the goal to help provide for the sustainable maintenance of medical equipment through the provision of training programs for the recipients, including test equipment and workshop facilities. The last approach analyze the condition of donated medical equipments through direct experience in Africa hospitals. To understand the real needs and personal opinions about the situation of medical device in Africa the author of thesis collected surveys, in particular during the period in Ethiopia and Uganda, which results are evaluated during thesis.

Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.