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OPENQRS 
HARNESSING NEW TECHNOLOGY 
TO ASSURE QUALITY, RELIABILITY AND SAFETY 
IN HEALTH CARE DEVICES MADE FOR 
LOW AND MI...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
NEONURTURE 
APPROPRIATE 
TECHNOLOGY 
MEDICAL DEVICE 
QUALITY? 
RELIA...
CURRENT APPROACH 
Gatekeeping model Nothing 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Nation-state specific 
...
expensive 
time intensive 
cumbersome 
stifles innovation 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
CURRENT A...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
NEONURTURE 
NEONATAL INCUBATOR 
“IF YOU WANT TO MAKE A 
DIFFERENCE I...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
NEONURTURE 
NEONATAL INCUBATOR 
EASY 
EFFECTIVE 
AFFORDABLE 
Market ...
WHY IS THE 
ADOPTION OF 
HEALTH CARE IT 
SO CHALLENGING? 
CC Wikimedia 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.o...
CHALLENGE # 1 
PRODUCT 
DESIGN 
CLINICAL 
BIOETHICS 
Failure culture of tech 
meets reality of health 
care delivery. 
Cha...
CHALLENGE # 1 
Flat Tire by Luis Prado; Pulse by TNS; Patient by Wilson Joseph 
PRODUCT 
DESIGN 
CLINICAL 
BIOETHICS 
“Whe...
CHALLENGE #2 SOCIAL 
TECH 
ENTREPRENEUR 
For technologists: 
success = working product 
Challenges 
Mountain Climber by Ju...
CHALLENGE #2 
SOCIAL 
FUNDER 
ENTREPRENEUR 
CONSULTANT For funders: 
success = product & users 
Challenges 
Mountain Climb...
CHALLENGE #2 
SOCIAL 
ENTREPRENEUR 
CLINICAL 
MEDICINE 
For clinicians: 
success = data that shows 
improved clinical outc...
CHALLENGE #2 TECH 
CLINICAL 
MEDICINE 
Different metrics for 
success result in differing 
views on product value. 
Mounta...
CHALLENGE #3 
User-centered design: 
meets one set of needs at 
the expense of the clinical 
relationship 
Challenges 
PRO...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Open Issues in Quality, Reliability & Safety (QRS) Assurance 
SOLARC...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Open Issues in Quality, Reliability & Safety (QRS) Assurance 
Resear...
Flexible to the product/location 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Open Issues in Quality, Reliabilit...
Flexible to the product/location 
Easy to use (time/cost) 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Open Issu...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Flexible to the product/location 
Easy to use (time/cost) 
Affordabl...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Flexible to the product/location 
Easy to use (time/cost) 
Affordabl...
OUR PLACE IN THE WORLD 
OBSERVATIONAL --> TELESCOPE --> SATELLITE 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
O...
OBSERVATIONAL --> RANDOMIZED --> REAL TIME DATA 
CONTROL 
TRIAL 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Ope...
WHAT IF 
WE HARNESSED NEW TECHNOLOGIES 
(WIFI, MOBILE, SENSORS, OPEN SOURCE) 
TO ENABLE EASY, EFFECTIVE, AFFORDABLE 
QRS A...
THE INTERNET OF THINGS IS COMING... 
OUR MISSION IS TO BUILD 
OPEN RESOURCES FOR QRS ASSURANCE 
Kate Michi Ettinger, JD 
@...
OPEN SOURCE MODELS 
• FLEXIBLE TO PRODUCT/LOCATION & EASY TO USE (TIME/COST) 
• OPEN SOURCE SOFTWARE 
• STANDARDIZED (CRED...
OPENQRS PROPOSAL 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Open Issues in Quality, Reliability & Safety (QRS)...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
OPENQRS PROPOSAL 
Open Issues in Quality, Reliability & Safety (QRS)...
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
OPENQRS PROPOSAL 
Open Issues in Quality, Reliability & Safety (QRS)...
Imagine 
Open Issues in Quality, Reliability & Safety (QRS) Assurance 
Photo Credit: Andrew Biraj 
Kate Michi Ettinger, JD...
ONGOING FEEDBACK 
LOOPS 
DATA DRIVEN DESIGN 
DECISIONS 
COLLABORATIVE 
DESIGN 
Kate Michi Ettinger, JD 
@OpenQRS 
build.op...
1. NEED FINDING/HUMAN FACTORS RESEARCH: 
INTERVIEWS WITH >50 STAKEHOLDERS 5 CONTINENTS 
2. DEVELOPED CONCEPTUAL FRAMEWORK ...
Product Development 
Stages 
Research & 
Development 
Deployment & 
Maintenance 
Prototype & 
Usability 
Kate Michi Etting...
Product Development 
For Each Stage: 
Research & 
Development 
Deployment & 
Maintenance 
Prototype & 
Usability 
2 Parts ...
SCAFFOLD 
Research & 
Development 
Prototype & 
Usability 
Deployment & 
Maintenance 
Ethical considerations Technical Cli...
Applied 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs.org 
Open Issues in Quality, Reliability & Safety (QRS) Assuranc...
Research & 
Development 
Tech developers build 
clinical decision support 
tools that enable people 
with lower levels of ...
Research & 
Development 
Current regulatory 
approaches are mismatched 
to tech’s iterative 
development 
Photo: Richard H...
Prototype & 
Usability 
mHealth by Edward Boatman from The Noun Project 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqrs....
Deployment 
& 
Maintenance 
Systemic Pressures 
Personal/Family 
Pressures 
mHealth by Edward Boatman from The Noun Projec...
WHAT’S NEXT 
Open Issues in Quality, Reliability & Safety (QRS) Assurance 
Kate Michi Ettinger, JD 
@OpenQRS 
build.openqr...
“The greatest single 
challenge facing our 
globalized world is to 
combat and eradicate 
its disparities.... 
It’s up to ...
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OpenQRS: Harnessing New Technology to Assure the Quality, Reliability & Safety of Health Care Devices in Low & Middle Income Countries

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OpenQRS: Harnessing New Technology to Assure the Quality, Reliability & Safety of Health Care Devices in Low & Middle Income Countries presented to the Center for Affordable Healthcare Technology group at the Institute for Biomedical Engineering, Oxford University on June 30, 2014

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OpenQRS: Harnessing New Technology to Assure the Quality, Reliability & Safety of Health Care Devices in Low & Middle Income Countries

  1. 1. OPENQRS HARNESSING NEW TECHNOLOGY TO ASSURE QUALITY, RELIABILITY AND SAFETY IN HEALTH CARE DEVICES MADE FOR LOW AND MIDDLE INCOME COUNTRIES Institute for Biomedical Engineering, Oxford University 30 Jun 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 NEONURTURE APPROPRIATE TECHNOLOGY MEDICAL DEVICE QUALITY? RELIABILITY? SAFETY? -QRS- Open Issues in Quality, Reliability & Safety (QRS) Assurance Problem
  3. 3. CURRENT APPROACH Gatekeeping model Nothing Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Nation-state specific Tiered system: Open Issues in Quality, Reliability & Safety (QRS) Assurance Current Images: Compass CC by Laura Thierry; Gate by Matt Beynon (The Noun Project)
  4. 4. expensive time intensive cumbersome stifles innovation Kate Michi Ettinger, JD @OpenQRS build.openqrs.org CURRENT APPROACH Open Issues in Quality, Reliability & Safety (QRS) Assurance Hurdle by Desbenoit from The Noun Project Current
  5. 5. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org NEONURTURE NEONATAL INCUBATOR “IF YOU WANT TO MAKE A DIFFERENCE IN THE WORLD, YOU HAVE TO DESIGN OUTCOMES.” - TIMOTHY PRESTERO #FAILBETTER2014 Open Issues in Quality, Reliability & Safety (QRS) Assurance Timing
  6. 6. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org NEONURTURE NEONATAL INCUBATOR EASY EFFECTIVE AFFORDABLE Market GAP Open Issues in Quality, Reliability & Safety (QRS) Assurance Need QUALITY RELIABILITY SAFETY
  7. 7. WHY IS THE ADOPTION OF HEALTH CARE IT SO CHALLENGING? CC Wikimedia Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  8. 8. CHALLENGE # 1 PRODUCT DESIGN CLINICAL BIOETHICS Failure culture of tech meets reality of health care delivery. Challenges Flat Tire by Luis Prado & Pulse by TNS (The Noun Project) Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  9. 9. CHALLENGE # 1 Flat Tire by Luis Prado; Pulse by TNS; Patient by Wilson Joseph PRODUCT DESIGN CLINICAL BIOETHICS “When we fail, we fail real people.” - Christie George Impact Investor New Media Ventures Challenges Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  10. 10. CHALLENGE #2 SOCIAL TECH ENTREPRENEUR For technologists: success = working product Challenges Mountain Climber by Juan Pablo Bravo from The Noun Project Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  11. 11. CHALLENGE #2 SOCIAL FUNDER ENTREPRENEUR CONSULTANT For funders: success = product & users Challenges Mountain Climber by Juan Pablo Bravo & Team by Jon Prepeluh Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  12. 12. CHALLENGE #2 SOCIAL ENTREPRENEUR CLINICAL MEDICINE For clinicians: success = data that shows improved clinical outcomes Challenges Mountain Climber by Juan Pablo Bravo & Patient by Wilson Joseph Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  13. 13. CHALLENGE #2 TECH CLINICAL MEDICINE Different metrics for success result in differing views on product value. Mountain Climber by Juan Pablo Bravo; Patient by Wilson Joseph & Team by Jon Prepeluh Challenges Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  14. 14. CHALLENGE #3 User-centered design: meets one set of needs at the expense of the clinical relationship Challenges PRODUCT DESIGN CLINICAL BIOETHICS Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  15. 15. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance SOLARCLAVE DIY AUTOCLAVE MEDIKIT DIY NEBULIZER Photo: Little Devices Photo: Little Devices Need
  16. 16. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Research Photo: Practical Sanskrit
  17. 17. Flexible to the product/location Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Easy to use (time/cost) Photo: Practical Sanskrit Research
  18. 18. Flexible to the product/location Easy to use (time/cost) Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Affordable to the market Access across borders Photo: Practical Sanskrit Research
  19. 19. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Flexible to the product/location Easy to use (time/cost) Affordable to the market Access across borders Standardized sufficiently for clinical credibility Open Issues in Quality, Reliability & Safety (QRS) Assurance Photo: Practical Sanskrit Research
  20. 20. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Flexible to the product/location Easy to use (time/cost) Affordable to the market Access across borders Standardized sufficiently for clinical credibility Something is not better than nothing. Something delivered in a way that respects human dignity is better than nothing. Open Issues in Quality, Reliability & Safety (QRS) Assurance Photo: Practical Sanskrit Research
  21. 21. OUR PLACE IN THE WORLD OBSERVATIONAL --> TELESCOPE --> SATELLITE Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Vision (SCIENTIFIC) (REAL TIME)
  22. 22. OBSERVATIONAL --> RANDOMIZED --> REAL TIME DATA CONTROL TRIAL Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Vision
  23. 23. WHAT IF WE HARNESSED NEW TECHNOLOGIES (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 What if? Graphic Images by Laura Thierry
  24. 24. THE INTERNET OF THINGS IS COMING... OUR MISSION IS TO 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
  25. 25. OPEN SOURCE MODELS • FLEXIBLE TO PRODUCT/LOCATION & EASY TO USE (TIME/COST) • OPEN SOURCE SOFTWARE • STANDARDIZED (CREDIBILITY) & UNIVERSAL (CROSS BORDER) • WWW DEVELOPMENT MODEL • AFFORDABLE TO THE MARKET & EASY TO 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
  26. 26. OPENQRS PROPOSAL Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Open Proposal
  27. 27. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org OPENQRS PROPOSAL Open Issues in Quality, Reliability & Safety (QRS) Assurance Open Proposal
  28. 28. Kate Michi Ettinger, JD @OpenQRS build.openqrs.org OPENQRS PROPOSAL Open Issues in Quality, Reliability & Safety (QRS) Assurance Open Proposal
  29. 29. Imagine Open Issues in Quality, Reliability & Safety (QRS) Assurance Photo Credit: Andrew Biraj Kate Michi Ettinger, JD @OpenQRS build.openqrs.org
  30. 30. 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
  31. 31. 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 Status Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org WHAT WE’VE DONE
  32. 32. Product Development Stages Research & Development Deployment & Maintenance Prototype & Usability Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Scaffold
  33. 33. Product Development For Each Stage: Research & Development Deployment & Maintenance Prototype & Usability 2 Parts to Inquiry: Technical Development | Clinical Application Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Scaffold
  34. 34. SCAFFOLD Research & Development Prototype & Usability Deployment & Maintenance Ethical considerations Technical Clinical Technical Clinical Technical Clinical Respect for Persons Beneficence Non-Maleficence Justice Research Ethics - Risk-Benefit - Informed Consent - Harm from research Privacy Quality | Reliability | Safety Transparency Relation-centered design Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Scaffold
  35. 35. Applied Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance
  36. 36. Research & Development Tech developers build clinical decision support tools that enable people with lower levels of training to provide higher Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Applied
  37. 37. Research & Development Current regulatory approaches are mismatched to tech’s iterative development Photo: Richard Holder Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Applied
  38. 38. Prototype & Usability mHealth by Edward Boatman from The Noun Project Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Applied
  39. 39. Deployment & Maintenance Systemic Pressures Personal/Family Pressures mHealth by Edward Boatman from The Noun Project Kate Michi Ettinger, JD @OpenQRS build.openqrs.org Open Issues in Quality, Reliability & Safety (QRS) Assurance Applied
  40. 40. WHAT’S NEXT Open Issues in Quality, Reliability & Safety (QRS) Assurance Kate Michi Ettinger, JD @OpenQRS build.openqrs.org • FEASIBILITY TEST CONCEPT WITH 5 MORE PRODUCTS [DIAGNOSTIC, PROSTHETIC, THERAPEUTICS (IN-HOSPITAL & FIELD), SUPPORT TECHNOLOGY] • 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 Next Step
  41. 41. “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: openqrs.org @OpenQRS

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