De tidlige udviklingsfaser – Idé fasen og Continua Health Alliance Eva Kühne, forretningsudvikler DELTA Brian Hedegaard, Business Manager DELTA 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 DELTA Organisation 3 DELTA Technological Pathfinders for 70 years 4 DELTA Core competences Electronics Approval processes Microlectronics EMC test Software technology Reliability test Light & Optics Wireless test Acoustics & vibration Acoustic test Sensor systems Maturity audits Point of care systems Software validation 5 Health and welfare (medico and care) DELTA OEM capabilities 6 DELTA Incubation Fra koncept til produktudvikling Incubation føder nye produkter, teknologier og metoder … … og modner dem til forretningsmuligheder 7 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 Medico Idéudvikling De tidlige faser 9 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 Medico Idéudvikling Eksempel: KOL og gang-pacer Regelmæssig træning Høj træningsintensitet 2 1 3 • Motivation • Interface, borger • Interface, Fysioterapeut • Remote interface 11 Medico Idéudvikling Eksempel: KOL og gang-pacer 12 DELTA Approval Management Idea Definition Concept Specification Idea & req. Maturity check Conformity req spec. Project plan Analysis GAP Configuration management Processes Human factors Risk control Product test Evaluation Validation Design Implementation Test Requirements spec. Usability Quality management Risk management Technical file Maturity check Validation plan 13 Clinical evidence Reliability / Transport EMC / Wireless Safety Product approval Registration Vigilance Manufacturing & ops. CE marking Market entry Production Continua Health Alliance Overview 14 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 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: Living Independently - Guidelines implementation Longer - Certification Wellness Manage Chronic Conditions 16 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 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 Continua Health Alliance 3 domains Ageing Independently Fitness Managing Chronic Decease 19 Continua Health Alliance Who is it ? Promoter Members Open International Continua Health Alliance Who is it ? 187 Contributors worldwide Device manufacturers Service providers Universities Test labs Danish: DELTA CSC MedCom Novo Nordisk 21 Continua Health Alliance Wellness Blood-pressure Cuff Heart Strap Digital Home Pedometer Weight Scale Fitness Equipment Cell Phone Internet Weight loss and fitness coaching Healthcare Personal Professionals Health Record PC Medication Tracking 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 Continua Health Alliance Chronic conditions Pulse Ox Blood-pressure Cuff Thermometer Digital Home Pedometer Cell Phone Weight Scale PC Fitness Equipment Personal Health System Medication Tracking Internet Family Disease Healthcare Personal Care Management Provider Health Givers Service 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 Continua Health Alliance Assisted living Blood-pressure Cuff Pedometer Home Automation & Control Fitness Equipment Pulse Ox Digital Home Cell Phone PC Internet Personal Health System Family Elderly Diet and Disease Care Monitoring Wellness Management Givers Services Services Service, Healthcare Provider Medication Tracking 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 Continua Health Alliance Architecture 25 Continua Health Alliance Version one device connectivity standards Thermometer Pulse Oximeter Weight Scale Glucose Meter Cardiovascular and Strength Fitness Monitor Transport Independent Pulse / Blood Pressure PC 11073-10404 = Pulse Oximeter 11073-10406 = Pulse / Heart Rate 11073-10407 = Blood Pressure 11073-10408 = Thermometer 11073-10415 = Weighing Scale 11073-10417 = Glucose 11073-10441 = Cardiovascular Fitness Monitor 11073-10442 = Strength Fitness Equipment 11073-10471 = Independent Living Activity 11073-10472 = Medication Monitor 11073-20601 = Base Framework Protocol Personal Health System Cell Phone Set Top Box Independent Living Activity Medication Adherence Aggregator Medical Device Personal Health Device Class Specification Profile Specification 26 26 Continua Health Alliance E2E reference toplogy 27 27 Eva Kuhne Brian Hedegaard evk@delta.dk bhe@delta.dk 7219 4811 7219 4465 28
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