Wearable Multifunctional Body Sensor (MedSens)
Problem and solution
Despite the world of ubiquitous m-Health enabling ICT devices, there is a lack of widely accepted m-Health solutions. Among the most distinguished medical ICT devices are the wearable wireless sensors that have become advanced enough to provide reliable physiological readings for health management. The key weakness of the implemented approaches is that they mainly focus on the technology, while the importance of its acceptance by users and health care practitioners is largely neglected.
Jožef Stefan Institute (JSI) has developed the technology and software for a multifunctional wireless body sensor (dimensions: 2x9cm, weight: 14 g) that measures vital physiological and environmental parameters, with two electrodes at the distance of 8 cm. The device primarily measures differential surface potential (ECG) between the proximal electrodes. The sensor has a long autonomy (up to 7 days), a low power wireless connection (BT4) to a Smartphone or other personal device, and corresponding software for standard interpretation of measurements. The moderate resolution ECG is suitable for long-term personal cardiac activity monitoring, as well as for clinical use. Its exceptionally lightweight design allows for unobstructed use also during sports activities or during exhaustive physical work. Besides ECG, other features can be extracted from the measured potential, such as muscle activity and respiration. The sensor can also detect information about the measurement conditions such as movement and temperature, thus providing information which allows for ambient intelligence. The device can support solutions to every-day problems of the medical personal in hospitals, health clinics, homes for the elderly and health resorts. The system has been registered as a technology innovation at JSI since April 15th, 2015.
How did TETRACOM help?
JSI and the private medical centre SIMED d.o.o found their mutual ambition in making the m-Health solution, developed at JSI, a mainstream for modern healthcare, which will be fully supported by medical experts and users. The CE certification of the innovation as a medical device was recognized as a crucial requirement for further industrialization and mass production. The TETRACOM project supported the activities for CE certification, and consequently for successful know-how transfer from research to industry. The activities included preparation of technical maps and other documentation for medical device certification. SIMED d.o.o. established the spin-off company Saving d.o.o exclusively for the purpose to take up the developed technology and organize the production and marketing.
At the end of the technology transfer project, a certified system as a medical device according to the directive MDD 93/42/EEC, and standards EN 60601 and EN ISO 14971 will be ready. Start of marketing is planned for May 2016. The certified and high quality device can attract other investors for further upgrades. The introduction of wireless body sensors in medical and social practice will pose the opportunity for new employments for support staff that will assist patients and the elderly in the use of the new technology. In addition, new jobs will open for engineers who will act as a link between the medical staff and the m-Health system.
The economic impact is estimated to 10,000 customers for 2017 and 100,000 until 2020, which will result in services sold in the value of 512,000 EUR for 2017 and 3,350,000 EUR until 2020. The return of investment is estimated as follows: 2016 (30%), 2017 (35%), 2018 (55%), 2019 (75%), 2020 (55%).
The academic impact is already manifested by 6 scientific publications, 1 fare, and 2 technical papers. Fully operating pilot systems with more than 100 volunteering test users (healthy citizens and patients) are currently running in: the biggest Slovenian hospital and health station, a wellness centre, an AAL centre, and a rehabilitation centre for dystrophic patients.
End-user: Saving d.o.o. (SME, SI)
Technology Provider: Jožef Stefan Institute (JSI, SI)