Wearable sensors and mobilehealth services. Giuseppe Andreoni R&D Manager

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Wearable sensors and mobilehealth services Giuseppe Andreoni R&D Manager

TeDH.DESIGN @ Politecnico.di.Milano Politecnico di Milano promotes the integration of skills and collaboration with medical and social disciplines to develop innovative technologies, methodologies and services for a human-centered healthcare. Human Design Technology 2

TeDH.DESIGN @ Politecnico.di.Milano TeDH - Technology and Design for Healthcare Lecco campus 3

User Centred Design Concepts Design for HealthCare TeDH.DESIGN @ Politecnico.di.Milano Measurements and Assessment of human functions for Design Anthropometric and Functional data for extended users design HMI and Proactive Ergonomics Communication aids Ambient Intelligence & domotics New paradigms of HCI (e.g. non intrusive monitoring) / gestural interfaces Ethnography Physiological data Sensibilab Biomechanical and Anthropometrical factors Lab. of Biomedical Sensors and Systems LyPhE Lab. of Physical Ergonomics Behavioral observation data Cognitive data HCD HealthCare Design Skillpoint User testing PhyCo Lab Physical Computing Lab. 4

From research to market TT and spin-off Why? To implement the virtuous innovation chain through a difficult path - for different attitudes (researcher enterpreneur) - burocracy - funds to start up - autocensoring (but somebody else would have already thought ) - to create new opportunities - Research ROI - new young enterpreneursip - sinergies industry-research - brain keeping 5

Innovation? Find the difference: Venice, the plague Africa, Ebola Virus 1629-31 2014-5 6

From research to market: ComfTech Where we met Presidio Ospedaliero Alessandro Manzoni di Lecco Dip.Materno-Infantile U.O. di Neonatologia e Terapia Intensiva Neonatale 7

From research to market: ComfTech Why and How we met and merge University (Basic research on wearable systems) Competitive Sinergies Spin-Off Textile Company (Product innovation for preterrm newborns) 8

From research to market: ComfTech 9 Innovation strategy Research IPR I2P BP BP competition Spin Off Applications development Products portfolio Testing Production process optimization -> low costs CE Med Certification

From research to market: ComfTech ComfTech s.r.l. Comfortable Technology is a Politecnico di Milano Start-up. It was born in October 2010 at Monza, for the integration of sinergic competences: - Biomedical Technologies, in particular for the unobtrusive measurement of physiological parameters - Textiles, with Designer specialized for baby garments, from newborns to teenagers - Ergonomics and Design for usability, wearability, comfort and userfriendlyness of the system. Comfortable Technology realizes sensorized textiles for biosignal monitoring and optimized shape and fit.

From research to market Wearables and beyond 11

Scenario Future Healthcare goals Continuity of care inside and outside the hospital; shared care involving all care givers from prevention to rehabilitation, across all stages of care (prevention, diagnosis, treatment, follow-up) Citizen-centred care citizen empowerment to manage own health status; increase responsibility and knowledge provision of personalised care/individual treatment emphasis on preventative lifestyle (from care to prevention) - early diagnosis / prognosis - management of chronic diseases - independent living / ambient assisted living (aging society) 12

Scenario Healthcare 2020 from Cure to Care.. a new complex and multifactorial process in which technological factors, organizational, and human dimensions must find a balanced mix for a full success. 13

Scenario New concepts: Personalized medicine Empirical Medicine Stratified Medicine Personalized Medicine Drugs administered to all patients without differentiation Drugs administered to sub-populations of patients Complexity Drugs administered to a single patient One-size-fits-all Era Current Approach of Medicine Towards Medicine of the future 14

Scenario Personalized medicine Based on the individual molecular profile for customized diagnosis and new therapies for the best efficacy and the least collateral damages to the single patient, thus minimizing costs From B/W to multicolour medicine The right process and the right drug, to the right patient, for the right pathology, at the proper time, with the best dose, for the right therapeutic answer, at the right cost. 15

Scenario Clinical Reference Concept The Care is the new clinical approach for the theraphy of newborns in NICU (Neonatal Intensive Care Unit) and/or in the first two-hours lifetime, to assure the baby physical and comfortable experiences that could guarantee the best conditions for the most proper neuromotor development. Technicality Care 16

Scenario The Wearable Biomedical Systems Wearable Health Systems (WHS) or Wearable Biomedical Systems (WBS) are integrated systems on body-worn platforms like wrist-worn devices or biomedical clothes, offering pervasive solutions for continuous health status monitoring though non-invasive biomedical, biochemical and physical measurements. WBS would enable monitoring of patients over extensive periods of time, and they can be proposed to offer affordable and interactive healthcare, anyplace, anytime for anyone which is the future of healthcare.

Scenario The Wearable Biomedical Systems 18

Scenario The wearable market and its forecast HC 19

Scenario The wearable market and its forecast 20

WBS & research WBS integrate a multifactorial and multi-technological complexity: every element is essential even in its extreme simplicity: Sensors Actuators Materials Wireless communication Power supply CPU User interface Algorithms for data processing Connectors Sensors washability and stability Sensors position in body (in relation to activities, tasks, signals adn anthropometry) Elasticity and adherence. multidisciplinarity 21

WBS History Research: history 22

WBS history ORIGINS OF THE CONCEPT OF SMART GARMENT FOR BIOMEDICAL SENSING - M.I.T. (1996-1997) - DARPA (Defense Advance Research Projects Agency) & Georgia Institute of Technology Sensatex - SmartShirt 23

WBS definition WBS are intelligent and integrated systems in contact or close to the human body and capable to measure, process and transmit biomedical, biochemical and physical parameters, and even to perform mechanical actions if needed. Human as source of information (A), sensors (B) and their link (C) to measuring devices (D) and wireless data transmission (E). 24

WBS: signals and preferable sensors positioning FHT2. Future of Health Technology-2, 2005, IOS Press, Health. Care. Anywhere. Today., D. Andre and A. Teller

WBS: sensors and materials

WBS: sensors and implementation

WBS: sensors and implementation Wearable strain gauges by Piezoresistive Ink Elbow flexion

WBS: sensors and implementation Pressure Sensors

WBS: sensors and implementation WBS are a wide area for IPR: More than 1000 patents in the last 10 years

From theory to pratice: Examples in medicine 31

Wearable Sensors in NICU From The Problem Ensure monitoring (Cure) but... improve comfort, protection, physical and psychological wellbeing of the newborn (Care) - Replace the standard adhesive electrodes; - Maintain clinical quality signal; - Interface to monitor hospital. - Increase thermal protection - Introduce the function of "containment" - Respect the clinical procedures (e.g., access quickly to the chest for emergencies). To The Solution Design and production of sensorized systems/garments* for monitoring the preterm newborn or the infants in the first two hours of life with dedicated and fitting shape to the needs of babies (Cure+Care) Patented & licensed Start up Home monitoring 12 june 2012 09:35:54 25 C 78 16 rest

Wearable Sensors in NICU Innovative Pros User No effects on the skin No influence on vital phenomena and daily actions Quality of care and compliance Textiles: Selected and certified fibers for biomedical applications Washing and Sterilization resistance TT and spin-off Technology Compatibility with Hospital devices no gel required

NewBorn Monitoring Clinical trial setup Sala parto Control Room Sensing garment BT-WiFi 3 users: nurse, mother, father CLINICAL TRIAL: 23.04 06.06 2014-30 newborns - 2 hours continuous monitoring Measurement Rationale: Reliability assessment Usability assessment Ergonomic assessment 34

NewBorn Monitoring 2.5 2h - NewBorn monitoring 2 1.5 1 0.5 0-0.5-1 -1.5-2 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 x 10 5 35

NewBorn Monitoring Data example (zoom+) 2h - NewBorn monitoring 2 1.5 Breathing 1 0.5 0-0.5-1 -1.5-2 9.5 9.55 9.6 9.65 9.7 9.75 9.8 9.85 9.9 9.95 36 x 10 4

NewBorn Monitoring Smart garment Wearable device for data measurement and transmission Smartphone App for data processing and display (HR, BR, posture and activity level). 37

Mother & Foetus monitoring 38 TeleFetal Care Hospital and Home Mother-fetal Monitoring QRS Fetal Amplitude > 5-150 µvpp Frequency ~120 bpm QRS Mat Amplitude > 1mVpp Frequency ~70bpm

Mother & Foetus monitoring Design for wearability Best design 39

Mother & Foetus monitoring 1) Detection of maternal QRS 2) Subtraction of maternal QRS 3) Detection of fetal QRS Maternal HRV Estraction of fetal ECG Fetal HRV 40

0 500 1000 1500 2000 2500 3000 1 693 1385 2077 2769 3461 4153 4845 5537 6229 6921 7613 8305 8997 9689 10381 11073 11765 12457 13149 13841 14533 15225 15917 16609 17301 17993 18685 19377 20069 20761 21453 22145 22837 23529 24221 24913 25605 26297 26989 27681 28373 29065 29757 30449 31141 31833 32525 33217 33909 34601 35293 35985 36677 37369 38061 38753 3650 3700 3750 3800 3850 3900 1 87 173 259 345 431 517 603 689 775 861 947 1033 1119 1205 1291 1377 1463 1549 1635 1721 1807 1893 1979 2065 2151 2237 2323 2409 2495 2581 2667 2753 2839 2925 3011 3097 3183 3269 3355 3441 3527 3613 3699 3785 3871 3957 4043 4129 4215 4301 4387 4473 4559 4645 4731 4817 1600 1700 1800 1900 2000 2100 2200 2300 1 29 57 85 113 141 169 197 225 253 281 309 337 365 393 421 449 477 505 533 561 589 Elderly monitoring in ADL 41

Sleep Monitoring Integrated textile sensors and snaps for device General Specifications - The t-shirt measures heart rate, the estimate of breathing rate, and movements while sleeping. - device and textile electrodes embedded. - On board recording and data download through Bluetooth Preliminary test Subject: 1 male, 44 yrs 5,5 hrs sleep 1 ECG lead 3D Accelerations Sensorized t-shirt 42

Accelerations along the 3 single axes = body movements Sleep Monitoring 1200 Sleep Monitoring - GA - 28march2014 1000 Falling asleep 800 600 Start sleeping in posture 1 Change of posture Change of posture Change of posture Change of posture Change of posture Change of posture Awakening 400 200 0 0 0.5 1 1.5 2 2.5 Time in samples (Fc=128Hz) 43 x 10 6

Sleep Monitoring & Sensor validation ECG track (total signal) 2000 1500 1000 Zoom area 500 0-500 -1000-1500 -2000 0.5 1 1.5 2 2.5 x 10 6 44

Sensor validation Zoom on ECG track (clinical quality) 60 50 40 30 20 10 0 1.13 1.135 1.14 1.145 1.15 1.155 1.16 1.165 1.17 1.175 1.18 45 x 10 5

Sensor validation Zoom+ on ECG track (clinical quality) 1200 1000 800 600 400 200 0 7.468 7.469 7.47 7.471 7.472 7.473 46 x 10 5

Sensor validation Ideal ECG track and recording example (clinical quality) 47

Sensor validation Textile ECG track compared with ideal ECG track 48

Systems portfolio Sporty Eldy Ally Mammy Baby 49

Lifestyle and performance monitoring Walk Run Walk ECG Vertical accel 3000 Antero-post accel lareral Accel Breathing 2500 2000 ADC levels 1500 Sky Race 1000 500 Running 2.8 2.85 2.9 2.95 3 3.05 3.1 Samples (Fc=125Hz) Soccer x 10 4 Automotive Wearable monitoring Cycling Fitness 50

Award and future perspectives March 2013 Comfortable Technology is selected and participates to the action line Health & Wellbeing - of EIT ICT Labs one of the first Knowledge and Innovation Communities set up by the European Institute of Innovation and Technology, as an initiative of the European Union to drive European leadership in ICT innovation for economic growth and quality of life. Health & Wellbeing Boosting the quality of everyday life by accelerating ICT innovation\

Contacts ComfTech s.r.l. Via Castello 9, 20900 Monza (MB) - Italy Tel. +39 039 830197 e-mail info@comftech.com Giuseppe Andreoni giuseppe.andreoni@comftech.com Design Dept. Politecnico di Milano Tel. +39 02 2399.8881 Fax +39 02 2399.5989 giuseppe.andreoni@polimi.it