extraordinary design considerations e bacon 2011 08-05
DESCRIPTION
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.TRANSCRIPT
ExtraordinaryDesign Considerationsfor Medical Devices
Elizabeth Bacon August 5, 2011
@ebacon#d3 #edc
Extraordinary Design Considerations for Medical Devices ■ D3 2011
My talk today
Introduction
Regulatory Landscape
Key Design Tools
Tips & Encouragement
I presume you are an audience of seasoned design practitioners
Extraordinary Design Considerations for Medical Devices ■ D3 2011
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
Introduction
Interaction Designer’s perspective
Principal Consultant Cooper
Sr. Human Factors Design Engineer St. Jude Medical Chief Design OfficerDevise
2002 - 2007
2007 - 2011
1999 - 2002
Liz Bacon
Director Emeritus IxDA
Extraordinary Design Considerations for Medical Devices ■ D3 2011
Regulatory landscape
Regulatory controls depend on class of device๏ Class 1๏ Class 2๏ Class 3
Extraordinary Design Considerations for Medical Devices ■ D3 2011
Agencies
FDA (U.S.) / TÜV (Europe) ๏ Enlightened, user-centered folks๏ Based on HFE approaches
Extraordinary Design Considerations for Medical Devices ■ D3 2011
HFE origins
Extraordinary Design Considerations for Medical Devices ■ D3 2011
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
Key standards
IEC 60601-1-6,60601-1-8
IEC 62366-2007HE75: 2009
Extraordinary Design Considerations for Medical Devices ■ D3 2011
Process diagrams
60601-1-6
Extraordinary Design Considerations for Medical Devices ■ D3 2011
62366
HE75
Extraordinary Design Considerations for Medical Devices ■ D3 2011
62366
HE75
Extraordinary Design Considerations for Medical Devices ■ D3 2011
HE75
Extraordinary Design Considerations for Medical Devices ■ D3 2011
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
Design “outputs”
DOCUMENTATION IS
KING
Extraordinary Design Considerations for Medical Devices ■ D3 2011
Risk management
Analyzing & mitigating systemic risk
ISO 14971:2007
Extraordinary Design Considerations for Medical Devices ■ D3 2011
Product requirements
Product requirements must be maintained — and they must be testable & traceable
The system shall...
Extraordinary Design Considerations for Medical Devices ■ D3 2011
V & V phase
Verification: that product behavior matches requirements
Validation: that requirements meet needs of user
Extraordinary Design Considerations for Medical Devices ■ D3 2011
Usability testing
Formative studies
Summative studies
Extraordinary Design Considerations for Medical Devices ■ D3 2011
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
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
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
User models
๏ Personas work well๏ So very important to
frame that these users are not ourselves
๏ Patients comprise the world
Dr. Helena ReardonInterventional Cardiologist
Extraordinary Design Considerations for Medical Devices ■ D3 2011
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
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
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
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
Patterns
Power of design patterns๏ Leverage the institutionalization of protocols
in clinical contexts
Extraordinary Design Considerations for Medical Devices ■ D3 2011
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
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
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
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
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
Review draft guidances
Organizations like HFES provide access to draft guidance documents to get member review & comment—it’s needed!
Contains Nonbinding Recommendations Draft - Not for Implementation
Draft Guidance for Industry and Food and Drug Administration
Staff
Applying Human Factors and Usability Engineering to Optimize
Medical Device Design
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 [email protected] or (301) 796-6289, or Molly Story at [email protected] 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
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
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
Thanks!
@ebacon #d3 #edc
Email [email protected] for my whitepaper
“Interaction Design for Medical Systems”