Open Issues & a Proposal for Open Data Monitoring to Assure Quality, Reliability & Safety of Medical Devices Designed for Low & Middle Income Countries presented at UNESCO Technology for Development 2014, Lausanne, Switzerland on Jun 4. ICT panel: The Openness Paradigm chaired by Denisa Kera, National University of Singapore and Sachiko Hirosue, Ecole Polytechnique Fédérale de Lausanne. For more information: http://wiki.epfl.ch/opentech4dev Please Message To Request Copy of this Presentation for Download

1. OPEN ISSUES AND
A PROPOSAL FOR OPEN DATA MONITORING
TO ASSURE QUALITY, RELIABILITY AND SAFETY
IN HEALTH CARE DEVICES TARGETING
LOW AND MIDDLE INCOME COUNTRIES
UNESCOTech4Dev
Lausanne, 2014
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance

2. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Context
SOLARCLAVE
DIY AUTOCLAVE
MEDIKIT
DIY NEBULIZER
Photo: Little Devices Photo: Little Devices

3. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
ProblemNEONURTURE
APPROPRIATE
TECHNOLOGY
MEDICAL DEVICE
QUALITY?
RELIABILITY?
SAFETY?
-QRS-

4. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Nation-state specific
Tiered system:
CURRENT APPROACH
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Current
Gatekeeping model Nothing
Images: Compass CC by Laura Thierry; Gate by Matt Beynon (The Noun Project)

5. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
NEONURTURE
NEONATAL INCUBATOR
“IFYOU WANT TO MAKE A
DIFFERENCE IN THE WORLD,
YOU HAVE TO DESIGN OUTCOMES.”
- TIMOTHY PRESTERO
#FAILBETTER2014
Timing

6. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
expensive
time intensive
cumbersome
stifles innovation
CURRENT APPROACH
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Current
Hurdle by Desbenoit from The Noun Project

7. WHAT IF
WE HARNESSEDTECHNOLOGIES
(WIFI, MOBILE, SENSORS, OPEN SOURCE)
TO ENABLE EASY, EFFECTIVE, AFFORDABLE
QRS ASSURANCE?
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Whatif?
Graphic Images by Laura Thierry

8. Imagine
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Photo Credit: Andrew Biraj

9. ONGOING FEEDBACK
LOOPS
DATA DRIVEN DESIGN
DECISIONS
COLLABORATIVE
DESIGN
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Imagine

10. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Research
Photo: Practical Sanskrit

11. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Flexible to the product/location
Easy to use (time/cost)
Research
Photo: Practical Sanskrit

12. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Affordable to the market
Access across borders
Research
Flexible to the product/location
Easy to use (time/cost)
Photo: Practical Sanskrit

13. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Standardized sufficiently
for clinical credibility
Research
Affordable to the market
Access across borders
Flexible to the product/location
Easy to use (time/cost)
Photo: Practical Sanskrit

14. • FLEXIBLETO PRODUCT/LOCATION & EASYTO USE (TIME/COST)
• OPEN SOURCE SOFTWARE
• STANDARDIZED (CREDIBILITY) & UNIVERSAL (CROSS BORDER)
• WWW DEVELOPMENT MODEL
• AFFORDABLETOTHE MARKET & EASYTO USE (TIME/COST)
• LINUX
• VERSATILE, OPT-IN SYSTEM
• GITHUB
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Models
OPEN SOURCE MODELS

15. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.orgOpenProposal
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safety (QRS) Assurance

16. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safety (QRS) Assurance
OpenProposal

17. Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safety (QRS) Assurance
OpenProposal

18. “The greatest single
challenge facing our
globalized world is to
combat and eradicate
its disparities....
It’s up to you to make
a difference.”
- Nelson Mandela
Open Issues in Quality, Reliability & Safety (QRS) Assurance
JOIN US:
build.openqrs.org
@OpenQRS