This presentation was delivered at Device Design Day 2011 by Elizabeth Bacon of Devise. The talk was recorded, so if you're interested in seeing that please contact liz(dot)devise(at)gmail(dot)com for a link.
2. My talk today
I presume you are an audience of seasoned design practitioners
Introduction
Regulatory Landscape
Key Design Tools
Tips & Encouragement
Extraordinary Design Considerations for Medical Devices ■ D3 2011
3. Thesis
Typical design tools apply, but they have to
play out in a unique regulatory framework
Rather text-heavy on purpose to be a helpful
artifact for people not here today
Extraordinary Design Considerations for Medical Devices ■ D3 2011
4. Introduction
Interaction Designer’s perspective
Principal Consultant 1999 - 2002
Cooper
Sr. Human Factors Design Engineer 2002 - 2007
St. Jude Medical
Liz Bacon Chief Design Officer 2007 - 2011
Devise
Director Emeritus
IxDA
Extraordinary Design Considerations for Medical Devices ■ D3 2011
5. Regulatory landscape
Regulatory controls depend on class of device
๏ Class 1
๏ Class 2
๏ Class 3
Extraordinary Design Considerations for Medical Devices ■ D3 2011
6. Agencies
FDA (U.S.) / TÜV (Europe)
๏ Enlightened, user-centered folks
๏ Based on HFE approaches
Extraordinary Design Considerations for Medical Devices ■ D3 2011
7. HFE origins
Extraordinary Design Considerations for Medical Devices ■ D3 2011
8. Burden is on the process
Formalizing product design & development process
with “design controls” is critical for regulatory
compliance
๏ Regulatory bodies produce guidance
documents via ANSI/AAMI, and IEC
๏ Companies have SOPs: standard operating
procedures
๏ Departments have DOPs: departmental
operating procedures
Extraordinary Design Considerations for Medical Devices ■ D3 2011
9. Key standards
HE75: 2009 IEC 60601-1-6, IEC 62366-2007
60601-1-8
Extraordinary Design Considerations for Medical Devices ■ D3 2011
10. Process diagrams
60601-1-6
Extraordinary Design Considerations for Medical Devices ■ D3 2011
11. 62366
HE75
Extraordinary Design Considerations for Medical Devices ■ D3 2011
12. 62366
HE75
Extraordinary Design Considerations for Medical Devices ■ D3 2011
13. HE75
Extraordinary Design Considerations for Medical Devices ■ D3 2011
14. Design “inputs”
Design inputs are recorded in a “design history
file” or “usability engineering file”
COMMUNICATION IS KEY
Extraordinary Design Considerations for Medical Devices ■ D3 2011
15. Design “outputs”
DOCUMENTATION
IS
KING
Extraordinary Design Considerations for Medical Devices ■ D3 2011
16. Risk management
Analyzing & mitigating systemic risk
ISO 14971:2007
Extraordinary Design Considerations for Medical Devices ■ D3 2011
17. Product requirements
Product requirements must be maintained
— and they must be testable & traceable
The system shall...
Extraordinary Design Considerations for Medical Devices ■ D3 2011
18. V & V phase
Verification: that
product behavior
matches requirements
Validation: that
requirements meet
needs of user
Extraordinary Design Considerations for Medical Devices ■ D3 2011
19. Usability testing
Formative studies
Summative studies
Extraordinary Design Considerations for Medical Devices ■ D3 2011
20. Collaboration rules
Cross-disciplinary
collaboration
๏ colleagues are highly
technical
๏ too much work for design
to handle alone
Extraordinary Design Considerations for Medical Devices ■ D3 2011
21. Key design tools
Typical UX methods apply
๏ research in context
๏ conceptual design approaches
๏ detailed design iteration
๏ usability testing
Extraordinary Design Considerations for Medical Devices ■ D3 2011
22. Research in context
๏ Call it
“contextual
inquiry”
๏ Learn context
of use pressures
๏ Identify hazards
& systemic risk
Follow-up room at Lehigh Valley Cardiology Associates EP Clinic,
Bethlehem, PA
Extraordinary Design Considerations for Medical Devices ■ D3 2011
23. User models
๏ Personas work well
๏ So very important to
frame that these users
are not ourselves
๏ Patients comprise the
world
Dr. Helena Reardon
Interventional Cardiologist
Extraordinary Design Considerations for Medical Devices ■ D3 2011
24. Conceptual design
Scenario-based design:
๏ helps us define ideal
experiences
๏ helps articulate UX
requirements
๏ informs verification &
validation activities
๏ even influences user
documentation &
marketing communications
Extraordinary Design Considerations for Medical Devices ■ D3 2011
25. Detailed design
Iterative, naturally
๏ Interactive prototypes for
usability testing and
communication with
development
Warning: a prototype
speaks a thousand
sentences, but can be hard
to maintain
Extraordinary Design Considerations for Medical Devices ■ D3 2011
26. Usability testing
Classic, moderated,
one-on-one usability
testing
๏ Small sample sizes are
OK per HE75
๏ Define clear usability
objectives up front in
the project
Extraordinary Design Considerations for Medical Devices ■ D3 2011
27. Tips & encouragement
Consider user research to be an investment
๏ long shelf life for personas
๏ power of roles in medical domain
๏ nobody can own this as well as IxD
Extraordinary Design Considerations for Medical Devices ■ D3 2011
28. Patterns
Power of design patterns
๏ Leverage the institutionalization of protocols
in clinical contexts
Extraordinary Design Considerations for Medical Devices ■ D3 2011
29. Style guides
Power of style guides
๏ Must be testable & low-
maintenance
๏ Allows design outputs
to be in low-fidelity
format
Extraordinary Design Considerations for Medical Devices ■ D3 2011
30. Beyond hazard mitigation
Hazards can be avoided with great
design
Follow principles like:
๏ Make errors impossible
๏ Don’t expect users to be experts
Extraordinary Design Considerations for Medical Devices ■ D3 2011
31. Stages & phases
Design controls
necessitate phases
๏ Ideation, Modeling,
Testing process stages
๏ Conception,
Framework, Detailed
Design project phases
Extraordinary Design Considerations for Medical Devices ■ D3 2011
32. Systems & QA best friends
๏ Make nice with Systems & QA team members
๏ Train QA folks in usability testing methods
for summative usability testing
Extraordinary Design Considerations for Medical Devices ■ D3 2011
33. Closing exhortations
๏ Consulting to medical device firms is going to
be challenging
๏ Few design agencies are equipped with
regulatory know-how
๏ Documentation is crucially important
๏ Plan for lengthy engagements with long tails
Extraordinary Design Considerations for Medical Devices ■ D3 2011
34. Review draft guidances
Organizations like HFES Contains Nonbinding Recommendations
Draft - Not for Implementation
Draft Guidance for Industry and
provide access to draft Food and Drug Administration
Staff
guidance documents to get Applying Human Factors and
Usability Engineering to Optimize
member review & comment— Medical Device Design
it’s needed!
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Document issued on: June 22, 2011
You should submit comments and suggestions regarding this draft document within 90 days
of publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit written comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit
electronic comments to http://www.regulations.gov. Identify all comments with the docket
number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact Ron Kaye at ron.kaye@fda.hhs.gov or (301)
796-6289, or Molly Story at molly.story@fda.hhs.gov or (310) 796-1456.
When final, this document will supersede Medical Device Use-Safety: Incorporating
Human Factors Engineering into Risk Management
(Issued July 18, 2000).
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
FDA Draft Guidance
Extraordinary Design Considerations for Medical Devices ■ D3 2011
35. Network
HxD (conference)
HFES or lesser extent AAMI (org
& conference)
CHI (org & conference)
LinkedIn Groups
Your local universities
Extraordinary Design Considerations for Medical Devices ■ D3 2011
36. Get involved!
This is esoteric! This sounds like an
extraordinary burden for a designer!
But please, persevere—
the industry needs you to do good.
Extraordinary Design Considerations for Medical Devices ■ D3 2011
37. Thanks!
@ebacon #d3 #edc
Email liz.devise@gmail.com for my whitepaper
“Interaction Design for Medical Systems”
Extraordinary Design Considerations for Medical Devices ■ D3 2011