Problem to be solved
In serious cases of COVID-19, the deterioration of the clinical conditions of the patient occurs within a few hours and can lead to acute respiratory distress syndrome (ARDS), which is a sudden and catastrophic lung condition associated with low oxygen level in the blood that requires the urgent use of mechanical ventilation. In clinical practice, the vital parameters measured to preliminarily evaluate the prognosis in patients suspected of COVID-19 are temperature, heart rate, and arterial oxygen saturation (SpO2). An additional indicator is used for deciding whether the patient needs mechanical ventilation, this is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction), also known as P/F ratio. For patients isolated at home, the early detection of ARDS symptoms represents a key challenge because they are usually not provided with monitoring equipment nor with medical knowledge. Thus, the remote telemonitoring of their vital parameters along with the automatic calculation of their P/F ratio, associated with an early warning system, would be a crucial tool for family doctors and in general for healthcare professionals to predict/detect the onset of ARDS and to guarantee timely and effective care and/or intervention for reducing disease consequences and emergency costs.
CovAid is a monitoring and early warning system based on a wearable all-in-one wireless device, designed for real-time and continuous non-invasive measurement and recording of patient vital parameters such as temperature, heart rate, and SpO2. Moreover, the device is provided with an additional tool for ECG registration. The wearable device is based on an open-source hardware platform equipped with non-invasive biosensors and a Bluetooth Low Energy (BLE) module. The device connects wireless to a data hub (smartphone and/or computer), where a dedicated app works for health data display, recording, and process (e.g., automatic calculation of P/F ratio). Moreover, the app allows digital communication to third-party telemonitoring platforms provided to healthcare professionals for remote systematic monitoring and storage of patient data over time. In case of under- or over-threshold values, a purpose-built algorithm sends alarms to healthcare professionals, which can recommend care or promptly contact the emergency services. Moreover, the system can be set to send a warning to the patient and/or to his/her family.
- wearable all-in-one device for continuous monitoring of temperature, heart rate, and SpO2
- automatic calculation of PF ratio
- tool for ECG registration
- wireless connection
- mobile app for data display, storage, and process and for communication to telemonitoring platforms
- settable early warning system
- ease of use by non-experts
- off-the-shelf technology
- cost-effective solution
What we have done during the weekend
In EUvsVirus hackaton, we focused on improving our solution from different perspectives. First of all, we defined in detail our objective (wearable all-in-one device for remote telemonitoring of ARDS symptoms and early warning) and beneficiaries (patients and healthcare professionals), and investigated the solutions already available in the market. Then we defined our innovative key features (wearable all-in-one device, automatic calculation of PF ratio, tool for ECG registration, wireless connection to already existing platforms for remote telemonitoring, home care and early warning). In terms of hardware, we assembled, optimized and tested the breadboard system. In parallel, we worked on the app, improving the user interface and the BLE communication protocol. Lastly, we started to structure our business model, analysing our potential customers, looking for suppliers, telemonitoring platform providers, and funding for prototype development and validation and product certification.
CovAid impact on the crisis
CovAid automatically digitally connects patients isolated at home, because affected by COVID-19 or suspected of being affected by this pathology, with healthcare professionals, enabling systematic remote monitoring of their vital parameters and consequent timely and effective care and/or intervention in case of emergency. Made available to patients isolated at their private home or in long-term care centers, assisted-living facilities, and nursing homes, characterized by a large number of people potentially at risk, CovAid will be crucial for supporting healthcare professionals in remote care and in making decisions in case of prediction/detection of emergency/respiratory crisis, furthemore providing essential preliminary information to first aid health workers. Moreover, CovAid could be used as surveillance tool if used by workers with high risk of virus exposure (e.g., doctors, clinicians, medical staff, nurses, first aid staff) for continuously monitoring their state of health and promptly taking actions (e.g., immediate COVID-19 test, isolation) in case of anomalies, in the perspective of barrier measures. Lastly, thanks to the location information provided by the patients, CovAid will allow health institutions to geographically map the areas of potential COVID-19 outbreak. CovAid monitoring and warning system will provide an essential support for the COVID-19 emergency management and will have a significant impact in terms of emergency actions and economic consequences for the World National Health Systems.
Needs to continue the project
For continuing the project, we will work on the business model. At the moment we consider to develop both a B2B and a B2C market strategy. In fact, the beneficiaries of our solution are both the patients and the healthcare professionals. By addressing our solution to the patients (B2C), we will provide them with non-invasive continuous home monitoring. In parallel, in order to reach out to family doctors and healthcare professionals, we plan to pursue a B2B strategy, by developing APIs which can interface to already existing telemonitoring platforms. The B2B strategy will also be addressed to insurance companies, which could reduce the costs related to hospitalization of their clients. In parallel, we will look for funding to support the development of the prototype and its validation, and for financing the final product certification. For the pre-industrial prototype, the PCBs will be designed, then ordered to an external company and components will be assembled in-house. An additional resource to complete this task will be a skilled person in PCB design, able to optimise the pre-industrial version and perform the design verification. The first version of the wearable device will be designed using CAD software and 3D-printed. The industrial version of the PCB, relying totally on SMD components, will be designed and then its manufacturing and component assembly will be completely outsourced to an external company. The high competition in the field allows to obtain a consistent volume of pieces at competitive prices. Also the final version of the wearable device will be manufactured by an external company. The group is investigating a possible partnership with companies already specialized in manufacturing wearable devices for other purposes. Moreover, we will look for already existing telemonitoring platforms, to which CovAid could be connected, in order to develop the compatible API and ask for a partnership for exploiting their already developed systems and providing value to the healthcare system.
Value of CovAid after the crisis
The number of people requiring long-term care will increase in next years due to the growing geriatric population and the increasing incidence of chronic disorders, leading to a growing demand for vital sign monitoring at home and making imperative the minimization of costs of treating lifestyle-related diseases. In this scenario, the value of CovAid will remain after the crisis, since it can be used as remote diagnostic and monitoring device for regular vital sign monitoring and early diagnosis of elderly patients and patients that suffer of chronic cardiovascular diseases. In the home healthcare market, CovAid will play an integral role in monitoring and treating various medical conditions in non-hospital settings, and in driving better health outcomes and quality of life, ultimately helping in reducing the cost of hospital care and stay.