Redesign, development and industrialization of a Multi-Parameter medical device.

Monitoring Electrocardiogram (ECG), Blood Oxygen Saturation (SpO2) and blood pressure is of crucial importance for individuals' health and well-being. These parameters provide crucial insights into cardiac and respiratory function, as well as blood pressure levels, which are key for diagnosing and managing a wide range of medical conditions. This thesis work is a comprehensive exploration, redesign and development of PulseECG, a sophisticated medical device originally designed by the Neuronica department at Politecnico di Torino. PulseECG was conceived to acquire ECG signals using a derivation method based on Einthoven's Triangle, monitoring the blood oxygenation level and to compute, through a neural network, the blood pressure. The goal was not only to optimize its performance but also facilitate its integration into industrial production. It was imperative to address the unique challenges posed by the post-COVID-19 global component supply crisis, which added a layer of complexity to the project. The original PulseECG prototype encountered several critical issues, spanning both hardware and firmware domains. Prohibitively expensive or hard-to-find hardware components, a suboptimal PCB design, a lack of provisions for mechanical assembly, non-optimized firmware architecture, and excessive power consumption. Each component of the old working prototype underwent a detailed examination and was compared with alternative options that provided the closest feasible response within specified tolerances. After establishing the Bill of Materials (BOM), the Printed Circuit Board (PCB) was redesigned with a focus on optimizing component placement and area utilization to facilitate straightforward electrical testing. The prototype's signal performance in the frequency domain was also evaluated against a reference instrument developed by General Electric. The initial prototype had exhibited an impractical degree of power consumption, rendering it unsustainable. To address this pressing challenge, an engineered energy-efficient state machine was integrated within one of the two involved firmware tasks. The state machine played an important role in optimizing both data acquisition and transmission processes, while also introducing a strategically designed shutdown state aimed at conserving precious energy resources. Subsequently, the attention was devoted to both the aesthetic aspects of the product and the electrodes design. This involved the creation of an STL file, ensuring that assembly was trivial, fast and cheap. At the moment, the device is under test, intended to secure the requisite certifications essential for a successful market launch. Ten samples have been dispatched to accomplished cardiologists who will rigorously evaluate the device through trial testing. Moreover, the scope of this thesis transcends the boundaries of device development, embracing the broader concept of telemedicine. In a rapidly evolving healthcare landscape, the design of user-friendly and effective devices takes center stage, delivering not only enhanced patient experiences but also providing healthcare professionals with a responsive and efficient system capable of optimizing the contemporary medical infrastructure. The research was conducted in close collaboration with GeneralMed, an innovative start-up located in Bruino, Turin (TO). GeneralMed has been established with a clear mission: to introduce a cutting-edge, high-quality medical product to the market.