Extraordinary design considerations e bacon 2011 08-05

ExtraordinaryDesign Considerations for Medical DevicesElizabeth Bacon @ebaconAugust 5, 2011 #d3 #edc

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

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 1999 - 2002 Cooper Sr. Human Factors Design Engineer 2002 - 2007 St. Jude MedicalLiz Bacon Chief Design Officer 2007 - 2011 Devise 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 HE75: 2009 IEC 60601-1-6, IEC 62366-2007 60601-1-8 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

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 riskFollow-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 Reardon Interventional 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 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

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 liz.devise@gmail.com for my whitepaper “Interaction Design for Medical Systems” Extraordinary Design Considerations for Medical Devices ■ D3 2011

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Extraordinary design considerations e bacon 2011 08-05

by Elizabeth Bacon on Aug 11, 2011

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