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

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

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

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

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

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

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. 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. 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. 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. 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. “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