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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
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-
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
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)
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
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
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
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
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
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
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
CHALLENGES?
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
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
“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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OpenQRS at Impact Hub Berlin

  • 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. 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. 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. 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 Need
  • 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. 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. 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. 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. 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. 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
  • 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. 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. “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