OPEN ISSUES AND
A PROPOSAL FOR OPEN DATA MONITORING
TO ASSURE QUALITY, RELIABILITY AND SAFETY
IN HEALTH CARE DEVICES TARGE...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Context
SO...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
ProblemNEO...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Nation-state specific
Tiered system:
CURRENT APPROACH
Open Issues in Qua...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
NEONURTURE...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
expensive
time intensive
cumbersome
stifles innovation
CURRENT APPROACH
...
WHAT IF
WE HARNESSEDTECHNOLOGIES
(WIFI, MOBILE, SENSORS, OPEN SOURCE)
TO ENABLE EASY, EFFECTIVE, AFFORDABLE
QRS ASSURANCE?...
Imagine
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Ph...
ONGOING FEEDBACK
LOOPS
DATA DRIVEN DESIGN
DECISIONS
COLLABORATIVE
DESIGN
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.or...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Research
P...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Flexible t...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Affordable...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Standardiz...
• FLEXIBLETO PRODUCT/LOCATION & EASYTO USE (TIME/COST)
• OPEN SOURCE SOFTWARE
• STANDARDIZED (CREDIBILITY) & UNIVERSAL (CR...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.orgOpenProposal
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safe...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safety (QRS) Ass...
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
OPENQRS PROPOSAL
Open Issues in Quality, Reliability & Safety (QRS) Ass...
“The greatest single
challenge facing our
globalized world is to
combat and eradicate
its disparities....
It’s up to you t...
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Open Issues & A Proposal for Open Data Monitoring to Assure Quality, Reliability & Safety of Medical Devices Designed for Low & Middle Income Countries

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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

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Open Issues & A Proposal for Open Data Monitoring to Assure Quality, Reliability & Safety of Medical Devices Designed for Low & Middle Income Countries

  1. 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. 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. 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. 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. 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. 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. 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. 8. Imagine Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Photo Credit: Andrew Biraj
  9. 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. 10. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Research Photo: Practical Sanskrit
  11. 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. 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. 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. 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. 15. Kate Michi Ettinger, JD @OpenQRS build.openqrs.orgOpenProposal OPENQRS PROPOSAL Open Issues in Quality, Reliability & Safety (QRS) Assurance
  16. 16. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org OPENQRS PROPOSAL Open Issues in Quality, Reliability & Safety (QRS) Assurance OpenProposal
  17. 17. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org OPENQRS PROPOSAL Open Issues in Quality, Reliability & Safety (QRS) Assurance OpenProposal
  18. 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

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