De tidlige udviklingsfaser Idé fasen og ContinuaHealth Alliance. Eva Kühne, forretningsudvikler DELTA Brian Hedegaard, Business Manager DELTA

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1 De tidlige udviklingsfaser Idé fasen og ContinuaHealth Alliance Eva Kühne, forretningsudvikler DELTA Brian Hedegaard, Business Manager DELTA

2 DELTA Highlights 270 employees out of which 50% are engineers Annual turnover 40 Mill Euro and 50% export 2,000 customer assignments annually Headquarters in Hørsholm Departments in Odense, Västerås, Wales, Aarhus, Nordborg and Sønderborg 2

3 DELTA Organisation 3

4 DELTA Technological Pathfinders for 70 years 4

5 DELTA Core competences Electronics Microlectronics Software technology Light & Optics Acoustics & vibration Sensor systems Point of care systems Approval processes EMC test Reliability test Wireless test Acoustic test Maturity audits Software validation 5

6 Health and welfare (medico and care) DELTA OEM capabilities 6

7 DELTA Incubation Fra koncept til produktudvikling Incubation føder nye produkter, teknologier og metoder og modner dem til forretningsmuligheder 7

8 Incubation - IdemoLab Assisterer i de tidlige udviklingsfaser Elektronisk Skitsering Eksperimenterende udvikling og afprøvning med brugere Medico Nye produkter og services, for kunder og i OPI samarbejder Energy Harvesting Erstatter batterier i produkter med energi høstet fra omgivelserne Sensor Netværk Eksperimenterer med hvordan forskellige systemer kan kommunikere i delte netværk

9 Medico Idéudvikling De tidlige faser 9

10 Medico Idéudvikling De tidlige faser Idégenerering, udvikling og kvalificering sammen med brugerne Ingen afprøvninger på brugerne, iht. MD Sikkerhed Kvalificering af ideer og løsninger Dialoger og miljøer Dokumentation 10

11 Medico Idéudvikling Eksempel: KOL og gang-pacer Regelmæssig træning Høj træningsintensitet Motivation Interface, borger Interface, Fysioterapeut Remote interface 11

12 Medico Idéudvikling Eksempel: KOL og gang-pacer 12

13 DELTA Approval Management Idea Definition Concept Specification Analysis GAP Processes Human factors Configuration management Risk control Product test Evaluation Validation Product approval Registration Vigilance Idea & req. Design Implementation Test Manufacturing & ops. Maturity check Conformity req spec. Project plan Requirements spec. Usability Quality management Risk management Technical file Maturity check Validation plan Clinical evidence Reliability / Transport EMC / Wireless Safety CE marking Market entry Production 13

14 Continua Health Alliance Overview 14

15 Continua Health Alliance Sayings Continua Health Alliance: The Next Generation of Personal Telehealth is Here A pathway and interoperable framework to deliver personal health & care systems at scale? Railroads of telemedicine 15

16 Continua Health Alliance DELTA activities DELTA is the only active member in Denmark - Vice chair EU Working group (Claus F. Nielsen) - Co-chair EU Regualtory Task Force (Brian Hedegaard) Regulatory WG TC WG EU WG (UC WG + Technical WG) Consultancy Services: - Guidelines implementation - Certification Living Independently Longer Wellness Manage Chronic Conditions 16

17 Continua Health Alliance What is it? A non-profit, open industry alliance of the finest healthcare and technology companies in the world joining together in collaboration to improve the quality of personal healthcare. 17

18 Continua Health Alliance Mission Our Mission is to establish an eco-system of interoperable personal health systems that empower people & organizations to better manage their health and wellness 18

19 Continua Health Alliance 3 domains Ageing Independently Fitness Managing Chronic Decease 19

20 Continua Health Alliance Who is it? Promoter Members Open International

21 Continua Health Alliance Who is it? 187 Contributors worldwide Device manufacturers Service providers Universities Test labs Danish: DELTA CSC MedCom Novo Nordisk 21

22 Continua Health Alliance Wellness Blood-pressure Cuff Pedometer Heart Strap Digital Home Weight Scale Cell Phone Fitness Equipment Medication Tracking PC Internet Weight loss and fitness coaching Healthcare Professionals Personal Health Record Continua member companies help individuals live healthier, more active lives by connecting them to their wellness team through a more efficient exchange of personal fitness information. 22

23 Continua Health Alliance Chronic conditions Blood-pressure Cuff Pedometer Pulse Ox Thermometer Cell Phone Digital Home Weight Scale Fitness Equipment Medication Tracking PC Personal Health System Internet Family Care Givers Disease Healthcare Management Provider Service Personal Health Record Glucose Meter Continua member companies help individuals with chronic conditions live healthier lives by connecting them to their care team through a more efficient exchange of personal health information. 23

24 Continua Health Alliance Assisted living Blood-pressure Cuff Pulse Ox Digital Home Pedometer Cell Phone Home Automation & Control Fitness Equipment Medication Tracking PC Personal Health System Internet Family Care Givers Elderly Diet and Monitoring Wellness Services Services Disease Management Service, Healthcare Provider Continua member companies help the elderly live independently longer, with dignity and security, through the efficient exchange of personal health and safety information that connects them to their family and care team. 24

25 Continua Health Alliance Architecture 25

26 Continua Health Alliance Version one device connectivity standards Thermometer Pulse Oximeter Pulse / Blood Pressure Weight Scale Glucose Meter Cardiovascular and Strength Fitness Monitor Transport Independent = Pulse Oximeter = Pulse / Heart Rate = Blood Pressure = Thermometer = Weighing Scale = Glucose = Cardiovascular Fitness Monitor = Strength Fitness Equipment = Independent Living Activity = Medication Monitor = Base Framework Protocol PC Personal Health System Cell Phone Set Top Box Independent Living Activity Medication Adherence Aggregator Personal Health Device Class Specification 26 Medical Device Profile Specification 26

27 Continua Health Alliance E2E reference toplogy 27 27

28 Eva Kuhne Brian Hedegaard