Reference model and methodology to design sensing, smart, and sustainable medical devices

Abstract

Recognizing the importance of health care, the dissertation presents the instantiation of a reference model and methodology to design the Sensing, Smart, and Sustainable S3 medical devices. The concept of Sensing Smart, and Sustainable is presented as a concept that satisfies the requirements of the new products, aligned with the trends of the Fourth Industrial Revolution (I4.0). New medical devices must be intelligent, patient-focused, flexible to world health changes, data-driven in order to support in the decision-making process such as diagnosis, connected and socioeconomically and environmentally sustainable. Although the integration gap between Life Cycle Engineering (LCE) and Health care is evident; models and methodologies currently applied in LCE can be turned over to medical devices. Moreover, the lack of health policy and management expertise in many countries has impeded progress in building sustainable medical devices. Hence, the intention of the presented project is to enable a model to guide the ideation, design and development of medical devices using the life cycle engineering principles. To support the medical devices development, an instantiated reference model and methodology is proposed based on the Integrated Product, Process and Manufacturing system Development (IPPMD); along with the best practices from World Health Organization (WHO) Research and Development Blue Print and the Biodesign “The Process of Innovating Medical Technologies” from Cambridge University. The reference model is applied in a case of study: through the application of the IPPMD in the development of an Analogous CPAP for COVID-19 ICU patients. Analysis of the results found the conclusion to further work on the IPPMD reference model and methodology to design the S3 Medical Devices.