Non-invasive smart wearable solution for continuous monitoring of physiological parameters and biomarkers for chronic patients with cardiac and respiratory diseases from the neonate to the elderly

Project Information

ONALABS

Grant agreement ID: 809604

DOI

10.3030/809604

Project closed

EC signature date 10 February 2018

Start date 1 March 2018

End date 31 August 2018

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ONALABS INNO-HUB SL
Spain

Periodic Reporting for period 1 - ONALABS (Non-invasive smart wearable solution for continuous monitoring of physiological parameters and biomarkers for chronic patientswith cardiac and respiratory diseases from the neonate to the elderly)

Reporting period: 2018-03-01 to 2018-08-31

Summary of the context and overall objectives of the project

The global health-care industry faces two critical challenges: large variation in patient outcomes and continually increasing costs. The variations are mainly the results of differences in medical practices. The second major health-care problem is that most developed countries are experiencing increases in spending rates that are simply unsustainable. Therefore, there is an urgent need to find new ways to create value in health care. Value-based health care, which focuses on patient outcomes and the costs of delivering these outcomes, can address both challenges.
Such outcomes are important for our society because citizens are foreseen to be at the centre of a new health management model, accessing and controlling their own healthcare information to make informed decisions about their own care and treatment. This empowerment of citizens is based on an integrated care model, bridging home care and hospitalization, sharing health and care information at different levels.
Additionally, the medical technology industry is in a unique position to boost value-based health care, helping providers deliver better care at more reasonable costs and we take advantage of it.
ONALABS main objective is to provide to the new health digital sector a biosensing platform, fully developed and tested for the connected health ecosystem. A more comfortable concept based on non-invasive diagnosis, continuously monitoring the main biochemical parameters for cardiac and chronic respiratory patients. Our connected care system will assist with both in-hospital and at home hospitalization, fully connecting with care professionals and services.
Within this objective first step is to improve disease management and risk prevention for chronic cardiac and respiratory adult patients through the establishment of effective and affordable monitoring programs with our non-invasive wearable Labband, that measures CO2, pH, lactacte and glucose through sweat with a friendly interface. We are developing, up-grading and validating the technology following the regulatory path established by the EU medical agency for these applications and once approved and launched we will explore other markets
During this phase 1 Feasibility Study we completed product demonstrations to end users, obtained the feedback of professionals and reviewed and overhauled our market entry strategy
As we show in this report, technical feasibility of the prototype has been proved in clinical investigation tests and its presentation to several stakeholders has received a very positive feedback. Both medical doctors and patients are willing to test it and found it very useful to improve patient monitoring, self-management, reduction of hospital visits and costs. We are now moving forward to the next step with the industrialization of the prototype, further development of the app and cloud software, clinical validation of the technology and market launch.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We carried out a thorough research regarding competing solutions currently available or expected to be launched, market share, rate of growth, service costs, regulatory compliance and marketing costs, among other variables. Based on the information gathered we have been able to overhaul and improve our goto market approach and business plan.

We visited 50 hospitals from Spain, Germany, France and UK to disseminate and obtain valuable feedback for our Labband medical device. Additionally, we have demonstrated our prototype in several disease associations. The feedback has been very positive in all cases and questionaries have been done both for medical doctors and patients. Moreover, 0ur technology has been presented in 2 international meetings. Additionally, several news have been published in our website. University Autonoma de Barcelona and University of Burgos have both published about our technology in their website

We have three patents that will protect our Labband Medical Device: one for the wearable device, one for the lactate sensor and another one for the glucose sensor. In order to validate our freedom to operate (FTO) we reviewed our patent portfolio and carried out several studies of patentability of the technologies that protect the first version of our prototype all of them were positive. We have also protected our brand as a company “Onalabs healthcare” in the EUIPO (European Union Intellectual Property Office) with application number 017427139. In order to enter the EU market a CE marking is necessary and we now know the steps and costs to get it. Once we manufacture an industrialized prototype we will apply for the CE marking. Results are detailed in sections 2.5.4 and 2.5.5 of the Feasibility Study Report.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The multi-sensing monitoring device are spread worldwide but as far as we are aware, there is no commercial wearable and reliable system to measure lactate, glucose, pH and pCO2 using skin direct measures. ONALABS project consists on an integrated smart wearable device with embedded microsensors for continuous monitoring of mentioned parameters and biomarkers in a non-invasive format for chronic patients with cardiac and respiratory diseases at any age, from the neonate to the elderly. The smart wearable device will connect sensing data to mobile devices, such as smart phones, to process the data from the wearable. Additional complex data processing will be supported through the communication with a backend hospital server. The most important part, from the technological point-of-view is the integration of micro-sensors in a textile wearable, as a wristband through advanced printing technologies is easily applied, to the skin. This will ensure that is comfortable for patients hiding away the microelectronics. The patient interface developed by decision algorithms gives accurate and clear information to our patients regarding their health status, and if necessary, advising them to contact their medical team empowering self-management on their health in a digital environment.

At commercial level competition to monitor specific metabolic deterioration is focused on the continuous measurement of heart rate, human stress, respiratory rate, oxygen saturation, etc. (vital parameters). On the other hand, for chronic respiratory patients, combining physiological sensors with activity monitors is a promising way of identifying not only the type of activity performed by subjects undergoing monitoring but also the intensity with which the activity was performed. Some US companies are developing products based on multi-sensing system, which measured galvanic skin response, heat flow and skin temperature in addition to motion, provided accurate estimates of energy expenditure.

ONALBAS solution looks for offering to the customer the simplicity to have a wearable on their body able to exchange information about the chemical/biochemical state of a set of critical biomarkers giving the physiological situation of the patient, in real time and using a non-invasive format, to the medical team and to all other selected people. This interconnectivity would be through all the digital value chain from sensors, smartphone/tablet and web service to mobile App as an info manager of medical data. So, our expected results deal with on the deployment of medical data of the state of the patient, even outside the medical institution.

Finally, the expected potential impact will be related with the deployment of the periodic control of chronic patients. The implementation of this type of digital diagnostics will allow the self-control at home, with a new model of interconnectivity together with the professionals and services of hospitals, and open a more sustainability of the sanitary services.

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