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
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DELTA
Organisation
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DELTA
Technological Pathfinders for 70 years
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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
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Health and welfare (medico and care)
DELTA OEM capabilities
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DELTA Incubation
Fra koncept til produktudvikling
Incubation føder nye produkter,
teknologier og metoder …
… og modner dem til forretningsmuligheder
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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
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Medico Idéudvikling
De tidlige faser
Idégenerering, udvikling og kvalificering sammen med brugerne
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Ingen afprøvninger på brugerne, iht. MD
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Sikkerhed
↕↕↕↕
•
Kvalificering af ideer og løsninger
•
Dialoger og miljøer
↕↕↕↕
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Dokumentation
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Medico Idéudvikling
Eksempel: KOL og gang-pacer
Regelmæssig træning
Høj træningsintensitet
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3
• Motivation
• Interface, borger
• Interface,
Fysioterapeut
• Remote
interface
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Medico Idéudvikling
Eksempel: KOL og gang-pacer
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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
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Clinical evidence
Reliability / Transport
EMC / Wireless
Safety
Product approval
Registration
Vigilance
Manufacturing & ops.
CE marking
Market entry
Production
Continua Health Alliance
Overview
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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”
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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
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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.
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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”
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Continua Health Alliance
3 domains
Ageing Independently
Fitness
Managing Chronic Decease
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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
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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.
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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.
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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.
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Continua Health Alliance
Architecture
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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
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Continua Health Alliance
E2E reference toplogy
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Eva Kuhne
Brian Hedegaard
[email protected]
[email protected]
7219 4811
7219 4465
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