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OPENQRS
HARNESSING NEW TECHNOLOGY
TO ASSURE QUALITY, RELIABILITY AND SAFETY
IN HEALTH CARE DEVICES MADE FOR
LOW AND MIDDLE...
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
expensive
time intensive
cumbersome
stifles innovation
CURRENT APPROACH
...
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
Open Issues in Quality, Reliability & Safety (QRS) Assurance
NEONURTURE...
WHAT IF
WE HARNESSED NEWTECHNOLOGIES
(WIFI, MOBILE, SENSORS, OPEN SOURCE)
TO ENABLE EASY, EFFECTIVE, AFFORDABLE
QRS ASSURA...
THE INTERNET OF THINGS IS COMING...
OUR MISSION ISTO BUILD
OPEN RESOURCES FOR QRS ASSURANCE
Kate Michi Ettinger, JD
@OpenQ...
Status
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
1. ...
Status
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
PRE...
Status
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
• F...
CHALLENGES?
hallenges
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
...
hallenges
Open Issues in Quality, Reliability & Safety (QRS) Assurance
Kate Michi Ettinger, JD
@OpenQRS
build.openqrs.org
...
“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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OpenQRS at Impact Hub Berlin

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OpenQRS: An Open Source Community Developing Tools
to Assure the Quality, Reliability and Safety of Health Care Devices pitched our project & shared our current challenges at Impact Hub Berlin's Hubpertivo on 13 June 2014. Here are our slides- join us in solving these challenges!


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OpenQRS at Impact Hub Berlin

  1. 1. OPENQRS HARNESSING NEW TECHNOLOGY TO ASSURE QUALITY, RELIABILITY AND SAFETY IN HEALTH CARE DEVICES MADE FOR LOW AND MIDDLE INCOME COUNTRIES Impact Hub Berlin Jun13 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 ProblemNEONURTURE APPROPRIATE TECHNOLOGY MEDICAL DEVICE QUALITY? RELIABILITY? SAFETY? -QRS-
  3. 3. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org expensive time intensive cumbersome stifles innovation CURRENT APPROACH Open Issues in Quality, Reliability & Safety (QRS) Assurance Hurdle by Desbenoit from The Noun Project Current
  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 Need
  6. 6. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance NEONURTURE NEONATAL INCUBATOR EASY EFFECTIVE AFFORDABLE Need QUALITY RELIABILITY SAFETY Market GAP
  7. 7. WHAT IF WE HARNESSED NEWTECHNOLOGIES (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. THE INTERNET OF THINGS IS COMING... OUR MISSION ISTO BUILD OPEN RESOURCES FOR QRS ASSURANCE Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Mission Graphic Images by Laura Thierry
  9. 9. Status Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org 1. NEED FINDING/HUMAN FACTORS RESEARCH: INTERVIEWS WITH >50 STAKEHOLDERS 5 CONTINENTS 2. DEVELOPED CONCEPTUAL FRAMEWORK FOR SOLUTION 3. APPLIED CONCEPTUAL FRAMEWORK (PROOF OF CONCEPT) A. MHEALTH APP (DIAGNOSTIC FOR PNEUMONIA) B. 3D PRINTING MEDICAL DEVICES FOR POST-DISASTER WHAT WE’VE DONE
  10. 10. Status Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org PRESENTED TEDXCHANGE: POSITIVE DISRUPTION GLOBAL HEALTH APRIL 2013 •INTEGRITY BY DESIGN bit.ly/integritybydesign UNESCO TECH4DEV, LAUSANNE JUNE 2014 •OPENQRS bit.ly/openqrs_tech4dev •PILOT MHEALTH APP bit.ly/integritybydesign_tech4dev WHERE WE’VE BEEN
  11. 11. Status Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org • FEASIBILITYTEST CONCEPT WITH 5 MORE PRODUCTS [DIAGNOSTIC, PROSTHETIC,THERAPEUTICS (IN-HOSPITAL & FIELD), SUPPORTTECHNOLOGY] • COMMUNICATE VISION & ENGAGE COMMUNITY [TELL HOW IT WORKS, SHARE RESEARCH IN ECOSYSTEM MAP & CREATE METHODS GUIDE] •HOST WORKSHOP AT OPEN SCIENCE DAY 18 JUL, BERLIN •? POSSIBLY HOST AN OPENQRS HACKATHON 19-20 JUL, BERLIN WHAT’S NEXT
  12. 12. CHALLENGES?
  13. 13. hallenges Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org ADDRESSINGTHE “CUSTOMER” FOR A SOCIAL IMPACT PROJECT Photo: Practical Sanskrit
  14. 14. hallenges Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org CURRENT CHALLENGES •NICHETOPIC = COMMUNICATION DIFFICULT •OPEN DEVELOPMENT = DOCUMENTATIONTAKESTIME!!! •ENGAGEMENT [WE WELCOME COMMUNITY CATALYSTS, DIGITAL DELIGHT DESIGNERS,TECHNICALTINKERERS, WORDPRESS WIZARD &VIPS OF EVERYTHING ELSE] •FUNDING FOR FEASIBILITY STUDY: •ANALYZE 5-10 PRODUCTS WITH OPENQRS FRAMEWORK •IDENTIFY OPENQRS OPPORTUNITIES |TOOL NEEDS FOR EACH PRODUCT •DETERMINE FEASIBILITY/VIABILITY & HACK PROTOTYPETOOLS IDENTIFIED •SHARE LEARNINGS
  15. 15. “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 FOLLOW US: build.openqrs.org @OpenQRS JOIN US: OPENQRS.ORG/GET-INVOLVED articipate

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