SlideShare ist ein Scribd-Unternehmen logo
1 von 32
UPA 2012
Usability Testing Medical Devices                             Las Vegas, NV




    Dan Berlin                     Chris Hass
    Experience Research Director   SVP of Experience Design
    @banderlin                     @chrishass
    dberlin@madpow.net             chass@madpow.net
Usability activities are NOT clinical Trials

   Generally the process will be less stringent:
   •  More loosely defined, faster
   •  Will likely involve a relatively small number of people per activity
   •  Initial studies stress simulation, with no medicinal agents or clinical
      impact.
   •  Dovetail with interaction design, visual design, and marketing activities




                         Usability	
  Tes,ng	
  Medical	
  Devices	
          2	
  
It’s going to feel like a clinical trial

   •  Extremely detailed “Usability Specification” documents
   •  “Usability Validation” (Risk assessment and amelioration)
   •  “Usability engineering file” / “Design Efficiency File”
   •  Know Federal and International regulations:
       •  FDA Quality System Regulation
       •  HE: 75 2009
       •  ISO/IEC 62366:2007
   •  Knowledge of (and inspiration for)
      emerging standards




                     Usability	
  Tes,ng	
  Medical	
  Devices	
     3	
  
Medical Device Manufacturers may be unfamiliar
 with your practices and lack of regulations




                 Usability	
  Tes,ng	
  Medical	
  Devices	
     4	
  
Safeguarding participants may be more challenging


  •  Your safety protocols must be exacting, fully defined,
     piloted, and effective
  •  Even simulated product use may put participants at risk
  •  Target audiences may be physically or cognitively
     vulnerable
  •  Activity environments may be unusual
  •  Work with client and medical care specialists




                   Usability	
  Tes,ng	
  Medical	
  Devices	
     5	
  
Reporting responsibilities, guidelines, formats, and
  requirements will be more complex
   •  Reporting guidelines, formats, and requirements will likely
      be extensive and complex
       •  Industry reporting standards (CIF)
       •  Specialized reporting formats
   •  Raw data may be reviewed again and again and again. . .




                     Usability	
  Tes,ng	
  Medical	
  Devices	
     6	
  
Research locales may be more challenging
  Device use environments may be:
  •  Unfamiliar
  •  Sterile
  •  Stressful
  •  Germ-laden
  •  Emotionally distressing
  •  Gross
  •  Secure
  •  Rarely observable
  •  Complex
  •  or otherwise unusual to non-medical personnel
  •  (And fainting can be a factor!)

                  Usability	
  Tes,ng	
  Medical	
  Devices	
     7	
  
Client Relationship

                                                      Source: http://robot6.comicbookresources.com/2010/07/take-a-look-at-the-avengers-assemble-painting-by-alex-ross/



•  A robust set of client team members is essential –
   as is knowing their roles:
    –    Legal
    –    Medical advisor
    –    Safety advisor
    –    Compliance
    –    Adverse Event Specialist
    –    Physician is helpful, but not enough
    –    The usual suspects


•  Clients may ask for proof of insurance
    –  But too much insurance could be a bad thing


                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                                                        8	
  
FDA Relationship
                                                                          Source: http://news.petpardons.com/fda-denies-rumors-over-
                                                                          possible-discovery-of-chicken-jerky-toxin/
•  If the study is for FDA approval – learn about
   the client’s relationship with the FDA:

    –  What are the relevant regulations?

    –  Who is the client’s liaison to the FDA?

    –  What is the client’s relationship with the FDA?

    –  Has the client met with the FDA?

    –  Have they received comments from the FDA?

    –  Does the client understand usability testing?

    –  Are we allowed to talk to the FDA?


                          Usability	
  Tes,ng	
  Medical	
  Devices	
                                                      9	
  
Working with an IRB


•  IRB = Institutional Review Board                                      Source: http://www.bioedge.org/index.php/bioethics/bioethics_article/
                                                                         who_is_watching_the_irb_watchdogs_asks_nature


•  For FDA approval, typically work with an independent IRB

•  Their job: to ensure that research conducted on human subjects is carried
   out correctly and humanely

•  Not as scary as you may think
    –  We are NOT evaluating medical efficacy or safety
    –  But we DO have to be conscientious

•  Have your ducks in a row and it will be a smooth process



                         Usability	
  Tes,ng	
  Medical	
  Devices	
                                                               10	
  
Working with an IRB

•  Adds about $2000-$5000 to the cost of the study
                                                                        Source: http://www.bioedge.org/index.php/bioethics/bioethics_article/
                                                                        who_is_watching_the_irb_watchdogs_asks_nature

•  Adds a day or two to the project for dealing with
   the IRB

•  Be cognizant of any non-disclosure agreements

•  Prior to the study, signature pages should be
   signed-off, circulated, and returned in a timely
   manner

•  Everyone on the team will take this very
   seriously!

                        Usability	
  Tes,ng	
  Medical	
  Devices	
                                                               11	
  
IRB Documents - Forms

                                                                        Source: http://blog.pennysaverusa.com/tag/tax-tips/

•  Indemnification Agreement: So the IRB doesn’t get sued
•  Financial Disclosure: The researchers don’t have conflicts of interest
•  Investigator Statement: The researcher code of conduct
•  Satellite Site Application: May be needed if the study involves multiple
   locations
•  Shipping & Invoice: Where documents are sent
•  Study Application: Detailed information about the study
•  Curriculum Vitae for all researchers
•  Other forms that your IRB requires


                        Usability	
  Tes,ng	
  Medical	
  Devices	
                                                12	
  
IRB Documents – Study and Device Info

•  Recruitment Screener: Be very precise                                Source: http://healthcareit.etisbew.com/



•  Recruitment Flyer: To hang in doctor’s office to aid with recruiting
•  Moderator’s Guide: A second guide may be needed if there are child
   participants
•  Consent and asset forms: For adults and children, respectively
•  Safety Concerns: Outline potential risks
•  Device Background: Detailed explanation of the device including
   indication and new features
•  Device Instructions for Use: If they are also included in the study


                        Usability	
  Tes,ng	
  Medical	
  Devices	
                                                13	
  
IRB Documents – Validation Plan

•  A detailed explanation of how the study will
   validate that the device is usable
    –  If you’re used to winging it, you can’t do that
       here
    –  Lay out every question and how it will be
       interpreted
    –  Lay out a rationale for every metric
    –  Break down the pieces of the tasks and what
       will be observed
    –  A detailed explanation of how the will be
       analyzed and presented

•  Quantitative measures (asked and observed)
    –  Rating scales
    –  Yes/No observations

                                                             Source:	
  hDp://www.vnet5.org/pub/approach/uva.html	
  




                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                  14	
  
Chart	
  Color	
  
Quantitative Measures
                                                                                                                                                             %	
  of	
  chart	
  that	
  is	
  red	
  
                                                                                                                                                             %	
  of	
  chart	
  that	
  is	
  black	
  


•  Rating Scales
        –  Asked                                                  –  Observed
                   •  Ease of use                                         •  Usability
                   •  Instructions for                                    •  Help needed
                      Use clarity                                         •  Number of
                   •  Design                                                 errors
                   •  Ergonomics


•  Yes/No observations
        –  Did the participant do this, that, AND the other thing?
 Ra,ng	
        No	
  Help	
  Needed	
              LiDle	
  Difficulty	
   Some	
  Help	
  	
   Much	
  Help	
                          Task	
  Failure	
  
 Explana,on	
   Completed	
  with	
  no	
  help	
   1-­‐2	
  small	
  errors	
   3-­‐5	
  errors	
   Moderator	
  gets	
  involved	
   Failure	
  

 Small	
  errors:	
   Doesn't	
  press	
  the	
  green	
  buDon	
  
                      Doesn't	
  remove	
  cap	
  properly	
  
                      Etc.	
  



                                                        Usability	
  Tes,ng	
  Medical	
  Devices	
                                                                                 15	
  
Recruiting

•  Give your recruiter a heads up LONG before the
   study starts
    –  And start recruiting early

•  Make a flyer to be hung in doctor’s offices and
   distributed electronically which includes:
    –    The purpose of the study
    –    Why they would want to participate
    –    Compensation                                                      Source: http://www.toptenz.net/top-10-wwii-propaganda-posters.php


    –    Recruiter contact information

•  During the project, any screener changes need to be
   re-approved by the IRB

•  Many institutions can’t “promote” a study that is
   under their auspices



                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                                16	
  
Sample Flyer




               Usability	
  Tes,ng	
  Medical	
  Devices	
     17	
  
Recruiting

•  Don’t be shy – makes friends with local hospitals
   and clinics
    –  Nurses and admins are the gateway
    –  Have the sanitized IRB approval in-hand


•  Find groups that can be a gateway to your desired
   audience
                                                                           Source: http://www.toptenz.net/top-10-wwii-propaganda-posters.php

    –    Healthcare institutions
    –    Local and national support groups
    –    Federal agencies
    –    Community support groups
    –    Craigslist & Social Media


•  Plan for surprises – like extensions to the timeline


                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                                18	
  
Working with Children

•  From a legal standpoint, a child is someone under 18
   years old
                                                                           Source: http://evilstaring.com/2011/06/08/amazingly-evil-child-3/




•  Children cannot consent to participate in the study,
   they can only assent
    –  An assent form explains the details of the study, in the
       first person

•  You will treat a 17 year old different than an 8 year old
    –  Be cognizant of the protocol to ensure you are
       consistent in your data capture

•  The parent conundrum: should they participate?
    –  At what point does it become co-discovery and is that                  Source: http://cautionmagnet.blogspot.com/2011/05/confused-kids.html

       okay?



                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                                19	
  
Working with Children

•  Put the child at ease:
    –    Explain the lab (to a point)
    –    Ask if s/he would like a break                              Source: http://lovefunnypictures.com/funny-pic-bush_funny_face.php



    –    Give reminders that s/he is doing a great job in the study
    –    Structure the study so that it isn’t drudgery
    –    Don’t make them remember rating scales
    –    Not all children like to be spoken to like a child


•  Be extra vigilant for signs that the participant is telling you want you
   want to hear
    –  As well as signs of fatigue and confusion


•  You don’t need to be their friend, but don’t scare them away


                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                           20	
  
Moderator’s Guide

•  Be precise with a tightly written protocol                             Source: http://tips.tntdental.com/?tag=website-navigation




•  Must be well-defined in advance and piloted
    –  No changes to the protocol without revisiting the IRB, the client, the FDA
       approval minutes, etc.


•  Clients may be used to clinical trials and view usability methods as “thin”
    –  We’re not running a clinical trials, but that’s no excuse for not adequately
       preparing


•  Adhere to the protocol!
    –  Any changes require IRB approval



                          Usability	
  Tes,ng	
  Medical	
  Devices	
                                                   21	
  
Moderator’s Guide

•  The moderator’s guide should capture:                                    Source: http://tips.tntdental.com/?tag=website-navigation




    –  The tasks
    –  Steps in the tasks
    –  What should be observed
    –  The questions to be asked of the participants
    –  Observer rating scales
•  Basically, a shortened version of the Validation Plan
•  Be precise in the metrics and methods
    –  They cannot vary
    –  Data reporting requirements will be significant
    –  Gaps in the reporting will be very visible


                            Usability	
  Tes,ng	
  Medical	
  Devices	
                                                   22	
  
Notes Grid

•  We are using “micro-tasks” and want to
   capture precise information

•  The notes grid should facilitate the analysis
                                                                   Source: http://beta.armagetronad.net/design/tron.html

   yet be easy to use
    –  Every step and question on its own row

    –  Have clear study sections (introduction, etc.)

    –  Grey out areas that can be ignored

•  Team note taking: moderator concentrates on
   certain items, note taker does the rest


                          Usability	
  Tes,ng	
  Medical	
  Devices	
                                                      23	
  
Notes Grid




             Usability	
  Tes,ng	
  Medical	
  Devices	
     24	
  
Lab Preparation

•    Capture the participants from two
     different angles
      –  A close-up view of the device interaction
         (over-the-shoulder)

      –  Straight-on to capture the entire field

•    Have all device supplies at the ready
      –  Alcohol wipes, extra needles, batteries,          Source: http://www.ebaumsworld.com/pictures/view/218095/


         etc.

      –  You’ll use more supplies than you expect

•    Get a first aid kit and nitrile gloves
      –  Have a first aid plan and practice


                               Usability	
  Tes,ng	
  Medical	
  Devices	
                                            25	
  
Participant Safety

•  As with any usability, participant comfort and safety is the
   top priority                                                            Source: http://en.wikipedia.org/wiki/File:Sign_first_aid.svg




•  Must be mindful of participants with health conditions
    –  Will they need accessibility accommodations?
    –  Will they have an aide/caretaker?
    –  How will the condition affect their participation?

•  What you can do to ensure participant comfort and safety:
    –  Have a robust first aid kit (and possibly medical personnel)
    –  Provide water, juice, sugary, and non-sugary snacks
    –  Ensure they know that they will be working with a placebo
    –  Accessible food


                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                  26	
  
Participant Safety

•    Warn participants of safety hazards while using the device, if it’s
     part of the protocol                                                       Source: http://en.wikipedia.org/wiki/File:Sign_first_aid.svg




•    Have a plan of action if someone is injured
•    Establish a path of notification if a participant is injured
      –  Reporting may have many phases: reporting it internally, then to the
         client, to the FDA, and the IRB


•    Educate yourself about the condition
•    Ensure the protocol does not exacerbate a disease or condition
•    Be vigilant about fatigue, confusion, disorientation, dehydration, &
     stress




                               Usability	
  Tes,ng	
  Medical	
  Devices	
                                                   27	
  
Adverse Effects

•  An adverse effect (AE) event is when a participant
   tells you about a side effect or other experience
   while using a device or drug

•  This is critical information for the client and must
   be reported, typically immediately
                                                                         Source: http://www.cartoonstock.com/directory/d/Din.asp

•  Some clients may require you to go through AE
   training

•  Before the study begins, determine to whom AEs
   are reported                                                                  When in doubt,
                                                                                    report!
•  AEs can be complex to identify, but are VERY
   important

                         Usability	
  Tes,ng	
  Medical	
  Devices	
                                                               28	
  
Adverse Effects

•  In the course of a usability study for a medication website, a participant
   mentions that she stopped taking the drug. She explains that the blister
   packs and pills sometimes arrived crushed.

•  While testing an infusion pump, the participant mentions that the tube
   always falls out of his previously used pump, which is the client’s
   product.

•  During a study, a participant mentions that her arms started to itch when
   she stopped taking the client’s medication.

•  A male participant mentions that his wife got pregnant two weeks after
   he started taking the client’s medication, even though she used the birth
   control pill.


                        Usability	
  Tes,ng	
  Medical	
  Devices	
         29	
  
Analysis

•  The setup from the validation plan, moderator’s
   guide, and notes grid should make analysis easy
                                                                     Source: http://www.webseoanalytics.com/blog/how-to-conduct-market-
                                                                     research-competitor-analysis/



•  Dealing with gaps in the data can be tricky
    –  Did the question get asked?
    –  Was the behavior observed?
    –  Do we have to go back to the recordings?
         •  Make sure you HAVE the recordings!


•  Rely on quantitative measures
    –  What percentage of participants passed the task?
    –  What ease of use ratings did participants give?
    –  How many participants committed the most
       common errors?


                           Usability	
  Tes,ng	
  Medical	
  Devices	
                                                          30	
  
Analysis

•    Remember to think on a micro-task scale – every little
     step of using the device should be observed
      –  It’s difficult to watch and report on every step of a
         complex interaction and document it precisely,                    Source: http://www.webseoanalytics.com/blog/how-to-conduct-market-
                                                                           research-competitor-analysis/
         especially live
      –  Tallying needs to be specific, yet practical

•    Be mindful of capturing and organizing the important
     qualitative data
      –  This can be especially tough when dealing with many
         participants
      –  Summarize qualitative data directly after the session –
         don’t wait

•    Know what you’re reporting – there may be data to
     help marketing

•    Sometimes the goal of these studies is to identify
     marketing claims, which can raise concerns



                                 Usability	
  Tes,ng	
  Medical	
  Devices	
                                                          31	
  
Thank You!

•  Conducting a usability study for a medical
   device is similar to a typical study, except
   with much stricter protocols                                  Questions/Comments?

•  Your safety and the safety & comfort of the                         Dan Berlin
   participants are paramount                                     dberlin@madpow.net
                                                                      @banderlin
•  Use quantitative measures and report
   percentages of participants that did or                              Chris Hass
   didn’t perform an action                                         chass@madpow.net
                                                                        @chrishass
•  It’s all about proper planning!



                        Usability	
  Tes,ng	
  Medical	
  Devices	
               32	
  

Weitere ähnliche Inhalte

Was ist angesagt?

User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...UXPA Boston
 
EDRA_2008_Inboard Outboard Study
EDRA_2008_Inboard Outboard StudyEDRA_2008_Inboard Outboard Study
EDRA_2008_Inboard Outboard StudyUpali Nanda
 
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...Greenlight Guru
 
HCD_2010_Inflexibility in Flexible Design
HCD_2010_Inflexibility in Flexible DesignHCD_2010_Inflexibility in Flexible Design
HCD_2010_Inflexibility in Flexible DesignUpali Nanda
 
Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014gregvb
 
Regulatory Challenges to Successful Global Clinical Studies
Regulatory Challenges to Successful Global Clinical StudiesRegulatory Challenges to Successful Global Clinical Studies
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
 
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311Jones Wu
 
FDA Inspections ( How to Survive an FDA Inspection).ppt
FDA Inspections ( How to Survive an FDA Inspection).pptFDA Inspections ( How to Survive an FDA Inspection).ppt
FDA Inspections ( How to Survive an FDA Inspection).pptshaik malangsha
 
FDA inspections ( how to survive an FDA inspection)
FDA inspections ( how to survive an FDA inspection)FDA inspections ( how to survive an FDA inspection)
FDA inspections ( how to survive an FDA inspection)shaik malangsha
 
Handling of a fda inspection [compatibility mode]
Handling of a fda inspection [compatibility mode]Handling of a fda inspection [compatibility mode]
Handling of a fda inspection [compatibility mode]Kiran Kota
 
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesmHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesLevi Shapiro
 
Mammoptics E245 Final Presentation
Mammoptics E245 Final PresentationMammoptics E245 Final Presentation
Mammoptics E245 Final PresentationStanford University
 
FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012
FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012
FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012Jason Soltis, MBA, CCRC
 
Extraordinary design considerations e bacon 2011 08-05
Extraordinary design considerations e bacon 2011 08-05Extraordinary design considerations e bacon 2011 08-05
Extraordinary design considerations e bacon 2011 08-05Elizabeth Bacon
 
Lean in healthcare (ugm)
Lean in healthcare (ugm)Lean in healthcare (ugm)
Lean in healthcare (ugm)Jorge A. Gaspar
 
Anthony Presentation at DIA Chicago Oct 2008
Anthony Presentation at DIA Chicago Oct 2008Anthony Presentation at DIA Chicago Oct 2008
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
 
Essential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical TrialsEssential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical TrialsTrialJoin
 
Lean Healthcare & Lean Design
Lean Healthcare & Lean DesignLean Healthcare & Lean Design
Lean Healthcare & Lean DesignMark Graban
 

Was ist angesagt? (20)

User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...User Interface Design for Medical Devices - The Relationship Between Usabilit...
User Interface Design for Medical Devices - The Relationship Between Usabilit...
 
EDRA_2008_Inboard Outboard Study
EDRA_2008_Inboard Outboard StudyEDRA_2008_Inboard Outboard Study
EDRA_2008_Inboard Outboard Study
 
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...
FDA Feedback Regarding Chemistry for Toxicological Risk Assessment – How to M...
 
HCD_2010_Inflexibility in Flexible Design
HCD_2010_Inflexibility in Flexible DesignHCD_2010_Inflexibility in Flexible Design
HCD_2010_Inflexibility in Flexible Design
 
Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014Medical Device Overview Greg Browne 2014
Medical Device Overview Greg Browne 2014
 
Regulatory Challenges to Successful Global Clinical Studies
Regulatory Challenges to Successful Global Clinical StudiesRegulatory Challenges to Successful Global Clinical Studies
Regulatory Challenges to Successful Global Clinical Studies
 
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311
 
FDA Inspections ( How to Survive an FDA Inspection).ppt
FDA Inspections ( How to Survive an FDA Inspection).pptFDA Inspections ( How to Survive an FDA Inspection).ppt
FDA Inspections ( How to Survive an FDA Inspection).ppt
 
FDA inspections ( how to survive an FDA inspection)
FDA inspections ( how to survive an FDA inspection)FDA inspections ( how to survive an FDA inspection)
FDA inspections ( how to survive an FDA inspection)
 
Handling of a fda inspection [compatibility mode]
Handling of a fda inspection [compatibility mode]Handling of a fda inspection [compatibility mode]
Handling of a fda inspection [compatibility mode]
 
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesmHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca Moses
 
Mammoptics E245 Final Presentation
Mammoptics E245 Final PresentationMammoptics E245 Final Presentation
Mammoptics E245 Final Presentation
 
FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012
FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012
FDA Inspections_jasonsoltisMBAccrc_ACRPpresentation2012
 
Resume Karthik_08-Dec-14
Resume Karthik_08-Dec-14Resume Karthik_08-Dec-14
Resume Karthik_08-Dec-14
 
Extraordinary design considerations e bacon 2011 08-05
Extraordinary design considerations e bacon 2011 08-05Extraordinary design considerations e bacon 2011 08-05
Extraordinary design considerations e bacon 2011 08-05
 
Lean in healthcare (ugm)
Lean in healthcare (ugm)Lean in healthcare (ugm)
Lean in healthcare (ugm)
 
Anthony Presentation at DIA Chicago Oct 2008
Anthony Presentation at DIA Chicago Oct 2008Anthony Presentation at DIA Chicago Oct 2008
Anthony Presentation at DIA Chicago Oct 2008
 
Essential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical TrialsEssential Regulatory Documents in Clinical Trials
Essential Regulatory Documents in Clinical Trials
 
Lean Healthcare & Lean Design
Lean Healthcare & Lean DesignLean Healthcare & Lean Design
Lean Healthcare & Lean Design
 
Wyatt 1b
Wyatt 1bWyatt 1b
Wyatt 1b
 

Andere mochten auch

Social Media Content Strateg- Dan Berlin - UPA International 2012
Social Media Content Strateg- Dan Berlin - UPA International 2012 Social Media Content Strateg- Dan Berlin - UPA International 2012
Social Media Content Strateg- Dan Berlin - UPA International 2012 Mad*Pow
 
Using Design Psychology for Evil - UXPA 2014 - Susan Mercer
Using Design Psychology for Evil - UXPA 2014 - Susan MercerUsing Design Psychology for Evil - UXPA 2014 - Susan Mercer
Using Design Psychology for Evil - UXPA 2014 - Susan MercerMad*Pow
 
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy Cueva
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy CuevaDesigning an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy Cueva
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy CuevaMad*Pow
 
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...Mad*Pow
 
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...Mad*Pow
 
Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan...
 Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan... Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan...
Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan...Mad*Pow
 
PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...
PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...
PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...Amy Cueva
 
Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...
Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...
Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...Mad*Pow
 
Rebounding with Web Animation - Nick Snyder, 2014
Rebounding with Web Animation -  Nick Snyder, 2014Rebounding with Web Animation -  Nick Snyder, 2014
Rebounding with Web Animation - Nick Snyder, 2014Mad*Pow
 
Designing Design Workshops
Designing Design WorkshopsDesigning Design Workshops
Designing Design WorkshopsAdam Connor
 
Working Better Together: Characteristics of Productive, Creative Organization...
Working Better Together: Characteristics of Productive, Creative Organization...Working Better Together: Characteristics of Productive, Creative Organization...
Working Better Together: Characteristics of Productive, Creative Organization...Mad*Pow
 
Meeting at the Intersection of Content Strategy and UX
Meeting at the Intersection of Content Strategy and UXMeeting at the Intersection of Content Strategy and UX
Meeting at the Intersection of Content Strategy and UXMarli Mesibov
 
Service Design in Experience Design
Service Design in Experience DesignService Design in Experience Design
Service Design in Experience DesignPaul Kahn
 
Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...
Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...
Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...Mad*Pow
 
Customer Journey Mapping: Illustrating the Big Picture
Customer Journey Mapping: Illustrating the Big PictureCustomer Journey Mapping: Illustrating the Big Picture
Customer Journey Mapping: Illustrating the Big PictureMegan Grocki
 
Preference and Desirability Testing: Measuring Emotional Response to Guide De...
Preference and Desirability Testing: Measuring Emotional Response to Guide De...Preference and Desirability Testing: Measuring Emotional Response to Guide De...
Preference and Desirability Testing: Measuring Emotional Response to Guide De...Paul Doncaster
 
Moral Issues in Behavior Change - SXSW 2017 - Amy Bucher
Moral Issues in Behavior Change - SXSW 2017 - Amy BucherMoral Issues in Behavior Change - SXSW 2017 - Amy Bucher
Moral Issues in Behavior Change - SXSW 2017 - Amy BucherMad*Pow
 
Production of x rays & generators
Production of x rays & generatorsProduction of x rays & generators
Production of x rays & generatorsRakesh Ca
 
Components of X-Ray Machine
Components of X-Ray MachineComponents of X-Ray Machine
Components of X-Ray MachineSyed Jamal
 
Introduction to the parts of x ray machine
Introduction to the parts of x ray machineIntroduction to the parts of x ray machine
Introduction to the parts of x ray machineHuzaifa Oxford
 

Andere mochten auch (20)

Social Media Content Strateg- Dan Berlin - UPA International 2012
Social Media Content Strateg- Dan Berlin - UPA International 2012 Social Media Content Strateg- Dan Berlin - UPA International 2012
Social Media Content Strateg- Dan Berlin - UPA International 2012
 
Using Design Psychology for Evil - UXPA 2014 - Susan Mercer
Using Design Psychology for Evil - UXPA 2014 - Susan MercerUsing Design Psychology for Evil - UXPA 2014 - Susan Mercer
Using Design Psychology for Evil - UXPA 2014 - Susan Mercer
 
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy Cueva
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy CuevaDesigning an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy Cueva
Designing an Ecosystem of Care - Health 2.0 Fall 2014 Conference - Amy Cueva
 
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...
Building a Culture to Motivate and Inspire Creative Teams - 2012 Webinar - Bu...
 
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...
Maps, Diagrams and Timelines, Inspiration for Interactive Design - Webinar 20...
 
Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan...
 Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan... Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan...
Beyond Just Usability: Desirability & Usefulness Testing - UXPA 2014 - Susan...
 
PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...
PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...
PatientDoctor Relationships & Social Media - Himss Virtual Conf 09 - Amy ...
 
Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...
Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...
Designing an Ecosystem of Care' at Human Factors and Ergonomics Society - HXR...
 
Rebounding with Web Animation - Nick Snyder, 2014
Rebounding with Web Animation -  Nick Snyder, 2014Rebounding with Web Animation -  Nick Snyder, 2014
Rebounding with Web Animation - Nick Snyder, 2014
 
Designing Design Workshops
Designing Design WorkshopsDesigning Design Workshops
Designing Design Workshops
 
Working Better Together: Characteristics of Productive, Creative Organization...
Working Better Together: Characteristics of Productive, Creative Organization...Working Better Together: Characteristics of Productive, Creative Organization...
Working Better Together: Characteristics of Productive, Creative Organization...
 
Meeting at the Intersection of Content Strategy and UX
Meeting at the Intersection of Content Strategy and UXMeeting at the Intersection of Content Strategy and UX
Meeting at the Intersection of Content Strategy and UX
 
Service Design in Experience Design
Service Design in Experience DesignService Design in Experience Design
Service Design in Experience Design
 
Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...
Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...
Let's Get Real: Creating Tangible Experiences - Content Strategy Summit 2015 ...
 
Customer Journey Mapping: Illustrating the Big Picture
Customer Journey Mapping: Illustrating the Big PictureCustomer Journey Mapping: Illustrating the Big Picture
Customer Journey Mapping: Illustrating the Big Picture
 
Preference and Desirability Testing: Measuring Emotional Response to Guide De...
Preference and Desirability Testing: Measuring Emotional Response to Guide De...Preference and Desirability Testing: Measuring Emotional Response to Guide De...
Preference and Desirability Testing: Measuring Emotional Response to Guide De...
 
Moral Issues in Behavior Change - SXSW 2017 - Amy Bucher
Moral Issues in Behavior Change - SXSW 2017 - Amy BucherMoral Issues in Behavior Change - SXSW 2017 - Amy Bucher
Moral Issues in Behavior Change - SXSW 2017 - Amy Bucher
 
Production of x rays & generators
Production of x rays & generatorsProduction of x rays & generators
Production of x rays & generators
 
Components of X-Ray Machine
Components of X-Ray MachineComponents of X-Ray Machine
Components of X-Ray Machine
 
Introduction to the parts of x ray machine
Introduction to the parts of x ray machineIntroduction to the parts of x ray machine
Introduction to the parts of x ray machine
 

Ähnlich wie Usability Testing Medical Devices - UPA International 2012.-Chris Hass and Dan Berlin

R&D Directions Webcast June Final[1]
R&D Directions Webcast June   Final[1]R&D Directions Webcast June   Final[1]
R&D Directions Webcast June Final[1]cmowen0206
 
R&D Directions Webcast June Final[1]
R&D Directions Webcast June   Final[1]R&D Directions Webcast June   Final[1]
R&D Directions Webcast June Final[1]cmowen0206
 
Conducting a Summative Study of EHR Usability: Case Study
Conducting a Summative Study of EHR Usability: Case StudyConducting a Summative Study of EHR Usability: Case Study
Conducting a Summative Study of EHR Usability: Case StudyUXPA Boston
 
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
 
Trends in clinical research and career gd 09_may20
Trends in clinical research and career gd 09_may20Trends in clinical research and career gd 09_may20
Trends in clinical research and career gd 09_may20Dr. Ganesh Divekar
 
FDA’s approach to regulation of in vitro diagnostic tests
FDA’s approach to regulation of in vitro diagnostic testsFDA’s approach to regulation of in vitro diagnostic tests
FDA’s approach to regulation of in vitro diagnostic testsMaRS Discovery District
 
Demystifying the FDA's Human Factors Guidance
Demystifying the FDA's Human Factors GuidanceDemystifying the FDA's Human Factors Guidance
Demystifying the FDA's Human Factors GuidanceGreenlight Guru
 
Challenges of Summative Usability Testing in a Community Hospital Environment...
Challenges of Summative Usability Testing in a Community Hospital Environment...Challenges of Summative Usability Testing in a Community Hospital Environment...
Challenges of Summative Usability Testing in a Community Hospital Environment...David Schlossman MD
 
Cinical trial protocol writing
Cinical trial protocol writingCinical trial protocol writing
Cinical trial protocol writingUrmila Aswar
 
Strategies for Dealing with the CRF
Strategies for Dealing with the CRFStrategies for Dealing with the CRF
Strategies for Dealing with the CRFMary K.D. D'Rozario
 
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?CTSI at UCSF
 
Fact finding techniques
Fact finding techniquesFact finding techniques
Fact finding techniquesimthiyasbtm
 
Lean Healthcare Overview
Lean Healthcare OverviewLean Healthcare Overview
Lean Healthcare Overviewbroper
 
Facts finding techniques in Database
Facts finding techniques in Database Facts finding techniques in Database
Facts finding techniques in Database Afrasiyab Haider
 
The Business of Genomic Testing by James Crawford
The Business of Genomic Testing by James CrawfordThe Business of Genomic Testing by James Crawford
The Business of Genomic Testing by James CrawfordKnome_Inc
 
Engaging physicians with evidence based medicine
Engaging physicians with evidence based medicineEngaging physicians with evidence based medicine
Engaging physicians with evidence based medicineTrimed Media Group
 
Knowledge transfer research examples
Knowledge transfer research examplesKnowledge transfer research examples
Knowledge transfer research examplestaem
 
CIS375 Interaction Designs Chapter13
CIS375 Interaction Designs Chapter13CIS375 Interaction Designs Chapter13
CIS375 Interaction Designs Chapter13Dr. Ahmed Al Zaidy
 

Ähnlich wie Usability Testing Medical Devices - UPA International 2012.-Chris Hass and Dan Berlin (20)

R&D Directions Webcast June Final[1]
R&D Directions Webcast June   Final[1]R&D Directions Webcast June   Final[1]
R&D Directions Webcast June Final[1]
 
R&D Directions Webcast June Final[1]
R&D Directions Webcast June   Final[1]R&D Directions Webcast June   Final[1]
R&D Directions Webcast June Final[1]
 
Best Practices for Promotional Content Review
Best Practices for Promotional Content ReviewBest Practices for Promotional Content Review
Best Practices for Promotional Content Review
 
Conducting a Summative Study of EHR Usability: Case Study
Conducting a Summative Study of EHR Usability: Case StudyConducting a Summative Study of EHR Usability: Case Study
Conducting a Summative Study of EHR Usability: Case Study
 
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...
 
Trends in clinical research and career gd 09_may20
Trends in clinical research and career gd 09_may20Trends in clinical research and career gd 09_may20
Trends in clinical research and career gd 09_may20
 
FDA’s approach to regulation of in vitro diagnostic tests
FDA’s approach to regulation of in vitro diagnostic testsFDA’s approach to regulation of in vitro diagnostic tests
FDA’s approach to regulation of in vitro diagnostic tests
 
eHealth Foundations: Can openEHR Provide One Layer?
eHealth Foundations: Can openEHR Provide One Layer?eHealth Foundations: Can openEHR Provide One Layer?
eHealth Foundations: Can openEHR Provide One Layer?
 
Demystifying the FDA's Human Factors Guidance
Demystifying the FDA's Human Factors GuidanceDemystifying the FDA's Human Factors Guidance
Demystifying the FDA's Human Factors Guidance
 
Challenges of Summative Usability Testing in a Community Hospital Environment...
Challenges of Summative Usability Testing in a Community Hospital Environment...Challenges of Summative Usability Testing in a Community Hospital Environment...
Challenges of Summative Usability Testing in a Community Hospital Environment...
 
Cinical trial protocol writing
Cinical trial protocol writingCinical trial protocol writing
Cinical trial protocol writing
 
Strategies for Dealing with the CRF
Strategies for Dealing with the CRFStrategies for Dealing with the CRF
Strategies for Dealing with the CRF
 
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?
 
Fact finding techniques
Fact finding techniquesFact finding techniques
Fact finding techniques
 
Lean Healthcare Overview
Lean Healthcare OverviewLean Healthcare Overview
Lean Healthcare Overview
 
Facts finding techniques in Database
Facts finding techniques in Database Facts finding techniques in Database
Facts finding techniques in Database
 
The Business of Genomic Testing by James Crawford
The Business of Genomic Testing by James CrawfordThe Business of Genomic Testing by James Crawford
The Business of Genomic Testing by James Crawford
 
Engaging physicians with evidence based medicine
Engaging physicians with evidence based medicineEngaging physicians with evidence based medicine
Engaging physicians with evidence based medicine
 
Knowledge transfer research examples
Knowledge transfer research examplesKnowledge transfer research examples
Knowledge transfer research examples
 
CIS375 Interaction Designs Chapter13
CIS375 Interaction Designs Chapter13CIS375 Interaction Designs Chapter13
CIS375 Interaction Designs Chapter13
 

Mehr von Mad*Pow

Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...
Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...
Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...Mad*Pow
 
Webinar: Intro to Strategic Foresight & Futures Thinking
Webinar: Intro to Strategic Foresight & Futures ThinkingWebinar: Intro to Strategic Foresight & Futures Thinking
Webinar: Intro to Strategic Foresight & Futures ThinkingMad*Pow
 
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...Mad*Pow
 
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...Mad*Pow
 
Webinar: When Nothing is Fine
Webinar: When Nothing is FineWebinar: When Nothing is Fine
Webinar: When Nothing is FineMad*Pow
 
Design More Innovative Solutions with a Holistic Understanding of the Chronic...
Design More Innovative Solutions with a Holistic Understanding of the Chronic...Design More Innovative Solutions with a Holistic Understanding of the Chronic...
Design More Innovative Solutions with a Holistic Understanding of the Chronic...Mad*Pow
 
Accessibility Workshop July 2020
Accessibility Workshop July 2020Accessibility Workshop July 2020
Accessibility Workshop July 2020Mad*Pow
 
FXD 2019 Keynote: Joseph Smiley, E*TRADE
FXD 2019 Keynote: Joseph Smiley, E*TRADEFXD 2019 Keynote: Joseph Smiley, E*TRADE
FXD 2019 Keynote: Joseph Smiley, E*TRADEMad*Pow
 
FXD 2019 Keynote: Stephen Gates, InVision
FXD 2019 Keynote: Stephen Gates, InVisionFXD 2019 Keynote: Stephen Gates, InVision
FXD 2019 Keynote: Stephen Gates, InVisionMad*Pow
 
FXD 2019: Brian McLaughlin, Bottomline Technologies
FXD 2019: Brian McLaughlin, Bottomline TechnologiesFXD 2019: Brian McLaughlin, Bottomline Technologies
FXD 2019: Brian McLaughlin, Bottomline TechnologiesMad*Pow
 
FXD 2019 Keynote: Rob Gifford, Mad*Pow
FXD 2019 Keynote: Rob Gifford, Mad*PowFXD 2019 Keynote: Rob Gifford, Mad*Pow
FXD 2019 Keynote: Rob Gifford, Mad*PowMad*Pow
 
FXD 2019 Interactive Session: Behavior Based Design
FXD 2019 Interactive Session: Behavior Based DesignFXD 2019 Interactive Session: Behavior Based Design
FXD 2019 Interactive Session: Behavior Based DesignMad*Pow
 
FXD 2019 Keynote: Marti Gold, SiriusXM
FXD 2019 Keynote: Marti Gold, SiriusXMFXD 2019 Keynote: Marti Gold, SiriusXM
FXD 2019 Keynote: Marti Gold, SiriusXMMad*Pow
 
FXD 2019 Keynote: Christine Berglund, CapitalOne
FXD 2019 Keynote: Christine Berglund, CapitalOneFXD 2019 Keynote: Christine Berglund, CapitalOne
FXD 2019 Keynote: Christine Berglund, CapitalOneMad*Pow
 
FXD 2019 Keynote: Andy Vitale, SunTrust Bank
FXD 2019 Keynote: Andy Vitale, SunTrust BankFXD 2019 Keynote: Andy Vitale, SunTrust Bank
FXD 2019 Keynote: Andy Vitale, SunTrust BankMad*Pow
 
FXD 2019 Leadership Round Table
FXD 2019 Leadership Round Table FXD 2019 Leadership Round Table
FXD 2019 Leadership Round Table Mad*Pow
 
HXD 2019 Leadership Round Table
HXD 2019 Leadership Round TableHXD 2019 Leadership Round Table
HXD 2019 Leadership Round TableMad*Pow
 
Aline Holzwarth, Pattern Health
Aline Holzwarth, Pattern HealthAline Holzwarth, Pattern Health
Aline Holzwarth, Pattern HealthMad*Pow
 
Vanessa Mason, Institute for the Future
Vanessa Mason, Institute for the FutureVanessa Mason, Institute for the Future
Vanessa Mason, Institute for the FutureMad*Pow
 
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...Mad*Pow
 

Mehr von Mad*Pow (20)

Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...
Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...
Webinar: What Did I Miss? The Hidden Costs of Depriortizing Diversity in User...
 
Webinar: Intro to Strategic Foresight & Futures Thinking
Webinar: Intro to Strategic Foresight & Futures ThinkingWebinar: Intro to Strategic Foresight & Futures Thinking
Webinar: Intro to Strategic Foresight & Futures Thinking
 
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...
Let’s Get Meta: Applying Service Design To Improve Employee Experiences… and ...
 
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...
Behavior Change Design: A Comprehensive Yet Practical Approach to Improving H...
 
Webinar: When Nothing is Fine
Webinar: When Nothing is FineWebinar: When Nothing is Fine
Webinar: When Nothing is Fine
 
Design More Innovative Solutions with a Holistic Understanding of the Chronic...
Design More Innovative Solutions with a Holistic Understanding of the Chronic...Design More Innovative Solutions with a Holistic Understanding of the Chronic...
Design More Innovative Solutions with a Holistic Understanding of the Chronic...
 
Accessibility Workshop July 2020
Accessibility Workshop July 2020Accessibility Workshop July 2020
Accessibility Workshop July 2020
 
FXD 2019 Keynote: Joseph Smiley, E*TRADE
FXD 2019 Keynote: Joseph Smiley, E*TRADEFXD 2019 Keynote: Joseph Smiley, E*TRADE
FXD 2019 Keynote: Joseph Smiley, E*TRADE
 
FXD 2019 Keynote: Stephen Gates, InVision
FXD 2019 Keynote: Stephen Gates, InVisionFXD 2019 Keynote: Stephen Gates, InVision
FXD 2019 Keynote: Stephen Gates, InVision
 
FXD 2019: Brian McLaughlin, Bottomline Technologies
FXD 2019: Brian McLaughlin, Bottomline TechnologiesFXD 2019: Brian McLaughlin, Bottomline Technologies
FXD 2019: Brian McLaughlin, Bottomline Technologies
 
FXD 2019 Keynote: Rob Gifford, Mad*Pow
FXD 2019 Keynote: Rob Gifford, Mad*PowFXD 2019 Keynote: Rob Gifford, Mad*Pow
FXD 2019 Keynote: Rob Gifford, Mad*Pow
 
FXD 2019 Interactive Session: Behavior Based Design
FXD 2019 Interactive Session: Behavior Based DesignFXD 2019 Interactive Session: Behavior Based Design
FXD 2019 Interactive Session: Behavior Based Design
 
FXD 2019 Keynote: Marti Gold, SiriusXM
FXD 2019 Keynote: Marti Gold, SiriusXMFXD 2019 Keynote: Marti Gold, SiriusXM
FXD 2019 Keynote: Marti Gold, SiriusXM
 
FXD 2019 Keynote: Christine Berglund, CapitalOne
FXD 2019 Keynote: Christine Berglund, CapitalOneFXD 2019 Keynote: Christine Berglund, CapitalOne
FXD 2019 Keynote: Christine Berglund, CapitalOne
 
FXD 2019 Keynote: Andy Vitale, SunTrust Bank
FXD 2019 Keynote: Andy Vitale, SunTrust BankFXD 2019 Keynote: Andy Vitale, SunTrust Bank
FXD 2019 Keynote: Andy Vitale, SunTrust Bank
 
FXD 2019 Leadership Round Table
FXD 2019 Leadership Round Table FXD 2019 Leadership Round Table
FXD 2019 Leadership Round Table
 
HXD 2019 Leadership Round Table
HXD 2019 Leadership Round TableHXD 2019 Leadership Round Table
HXD 2019 Leadership Round Table
 
Aline Holzwarth, Pattern Health
Aline Holzwarth, Pattern HealthAline Holzwarth, Pattern Health
Aline Holzwarth, Pattern Health
 
Vanessa Mason, Institute for the Future
Vanessa Mason, Institute for the FutureVanessa Mason, Institute for the Future
Vanessa Mason, Institute for the Future
 
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...
Trina Histon, Aubrey Kraft, W. Scott Heisler, Kaiser Permanente Care Manageme...
 

Kürzlich hochgeladen

The future of UX design support tools - talk Paris March 2024
The future of UX design support tools - talk Paris March 2024The future of UX design support tools - talk Paris March 2024
The future of UX design support tools - talk Paris March 2024Alan Dix
 
How to use Ai for UX UI Design | ChatGPT
How to use Ai for UX UI Design | ChatGPTHow to use Ai for UX UI Design | ChatGPT
How to use Ai for UX UI Design | ChatGPTThink 360 Studio
 
Construction Documents Checklist before Construction
Construction Documents Checklist before ConstructionConstruction Documents Checklist before Construction
Construction Documents Checklist before ConstructionResDraft
 
WCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptx
WCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptxWCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptx
WCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptxHasan S
 
Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024
Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024
Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024Ted Drake
 
High-Quality Faux Embroidery Services | Cre8iveSkill
High-Quality Faux Embroidery Services | Cre8iveSkillHigh-Quality Faux Embroidery Services | Cre8iveSkill
High-Quality Faux Embroidery Services | Cre8iveSkillCre8iveskill
 
Create Funeral Invites Online @ feedvu.com
Create Funeral Invites Online @ feedvu.comCreate Funeral Invites Online @ feedvu.com
Create Funeral Invites Online @ feedvu.comjakyjhon00
 
Embroidery design from embroidery magazine
Embroidery design from embroidery magazineEmbroidery design from embroidery magazine
Embroidery design from embroidery magazineRivanEleraki
 
Designing for privacy: 3 essential UX habits for product teams
Designing for privacy: 3 essential UX habits for product teamsDesigning for privacy: 3 essential UX habits for product teams
Designing for privacy: 3 essential UX habits for product teamsBlock Party
 
LRFD Bridge Design Specifications-AASHTO (2014).pdf
LRFD Bridge Design Specifications-AASHTO (2014).pdfLRFD Bridge Design Specifications-AASHTO (2014).pdf
LRFD Bridge Design Specifications-AASHTO (2014).pdfHctorFranciscoSnchez1
 
Khushi sharma undergraduate portfolio...
Khushi sharma undergraduate portfolio...Khushi sharma undergraduate portfolio...
Khushi sharma undergraduate portfolio...khushisharma298853
 
Models of Disability - an overview by Marno Retief & Rantoa Letšosa
Models of Disability - an overview by Marno Retief & Rantoa LetšosaModels of Disability - an overview by Marno Retief & Rantoa Letšosa
Models of Disability - an overview by Marno Retief & Rantoa Letšosaannemarleenolthof1
 
UI UX Process for SaaS Product Design Success
UI UX Process for SaaS Product Design SuccessUI UX Process for SaaS Product Design Success
UI UX Process for SaaS Product Design SuccessThink 360 Studio
 
Unlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdf
Unlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdfUnlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdf
Unlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdfIBM
 
Design mental models for managing large-scale dbt projects. March 21, 2024 in...
Design mental models for managing large-scale dbt projects. March 21, 2024 in...Design mental models for managing large-scale dbt projects. March 21, 2024 in...
Design mental models for managing large-scale dbt projects. March 21, 2024 in...Ed Orozco
 
UX Conference on UX Research Trends in 2024
UX Conference on UX Research Trends in 2024UX Conference on UX Research Trends in 2024
UX Conference on UX Research Trends in 2024mikailaoh
 
Math Group 3 Presentation OLOLOLOLILOOLLOLOL
Math Group 3 Presentation OLOLOLOLILOOLLOLOLMath Group 3 Presentation OLOLOLOLILOOLLOLOL
Math Group 3 Presentation OLOLOLOLILOOLLOLOLkenzukiri
 
AMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara Rakovska
AMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara RakovskaAMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara Rakovska
AMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara RakovskaBarusRa
 

Kürzlich hochgeladen (18)

The future of UX design support tools - talk Paris March 2024
The future of UX design support tools - talk Paris March 2024The future of UX design support tools - talk Paris March 2024
The future of UX design support tools - talk Paris March 2024
 
How to use Ai for UX UI Design | ChatGPT
How to use Ai for UX UI Design | ChatGPTHow to use Ai for UX UI Design | ChatGPT
How to use Ai for UX UI Design | ChatGPT
 
Construction Documents Checklist before Construction
Construction Documents Checklist before ConstructionConstruction Documents Checklist before Construction
Construction Documents Checklist before Construction
 
WCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptx
WCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptxWCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptx
WCM Branding Agency | 210519 - Portfolio Review (F&B) -s.pptx
 
Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024
Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024
Introduce Trauma-Informed Design to Your Organization - CSUN ATC 2024
 
High-Quality Faux Embroidery Services | Cre8iveSkill
High-Quality Faux Embroidery Services | Cre8iveSkillHigh-Quality Faux Embroidery Services | Cre8iveSkill
High-Quality Faux Embroidery Services | Cre8iveSkill
 
Create Funeral Invites Online @ feedvu.com
Create Funeral Invites Online @ feedvu.comCreate Funeral Invites Online @ feedvu.com
Create Funeral Invites Online @ feedvu.com
 
Embroidery design from embroidery magazine
Embroidery design from embroidery magazineEmbroidery design from embroidery magazine
Embroidery design from embroidery magazine
 
Designing for privacy: 3 essential UX habits for product teams
Designing for privacy: 3 essential UX habits for product teamsDesigning for privacy: 3 essential UX habits for product teams
Designing for privacy: 3 essential UX habits for product teams
 
LRFD Bridge Design Specifications-AASHTO (2014).pdf
LRFD Bridge Design Specifications-AASHTO (2014).pdfLRFD Bridge Design Specifications-AASHTO (2014).pdf
LRFD Bridge Design Specifications-AASHTO (2014).pdf
 
Khushi sharma undergraduate portfolio...
Khushi sharma undergraduate portfolio...Khushi sharma undergraduate portfolio...
Khushi sharma undergraduate portfolio...
 
Models of Disability - an overview by Marno Retief & Rantoa Letšosa
Models of Disability - an overview by Marno Retief & Rantoa LetšosaModels of Disability - an overview by Marno Retief & Rantoa Letšosa
Models of Disability - an overview by Marno Retief & Rantoa Letšosa
 
UI UX Process for SaaS Product Design Success
UI UX Process for SaaS Product Design SuccessUI UX Process for SaaS Product Design Success
UI UX Process for SaaS Product Design Success
 
Unlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdf
Unlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdfUnlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdf
Unlocking Conversion_ The Art of Turning Visitors into Loyal Customers.pdf
 
Design mental models for managing large-scale dbt projects. March 21, 2024 in...
Design mental models for managing large-scale dbt projects. March 21, 2024 in...Design mental models for managing large-scale dbt projects. March 21, 2024 in...
Design mental models for managing large-scale dbt projects. March 21, 2024 in...
 
UX Conference on UX Research Trends in 2024
UX Conference on UX Research Trends in 2024UX Conference on UX Research Trends in 2024
UX Conference on UX Research Trends in 2024
 
Math Group 3 Presentation OLOLOLOLILOOLLOLOL
Math Group 3 Presentation OLOLOLOLILOOLLOLOLMath Group 3 Presentation OLOLOLOLILOOLLOLOL
Math Group 3 Presentation OLOLOLOLILOOLLOLOL
 
AMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara Rakovska
AMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara RakovskaAMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara Rakovska
AMBER GRAIN EMBROIDERY | Growing folklore elements | Barbara Rakovska
 

Usability Testing Medical Devices - UPA International 2012.-Chris Hass and Dan Berlin

  • 1. UPA 2012 Usability Testing Medical Devices Las Vegas, NV Dan Berlin Chris Hass Experience Research Director SVP of Experience Design @banderlin @chrishass dberlin@madpow.net chass@madpow.net
  • 2. Usability activities are NOT clinical Trials Generally the process will be less stringent: •  More loosely defined, faster •  Will likely involve a relatively small number of people per activity •  Initial studies stress simulation, with no medicinal agents or clinical impact. •  Dovetail with interaction design, visual design, and marketing activities Usability  Tes,ng  Medical  Devices   2  
  • 3. It’s going to feel like a clinical trial •  Extremely detailed “Usability Specification” documents •  “Usability Validation” (Risk assessment and amelioration) •  “Usability engineering file” / “Design Efficiency File” •  Know Federal and International regulations: •  FDA Quality System Regulation •  HE: 75 2009 •  ISO/IEC 62366:2007 •  Knowledge of (and inspiration for) emerging standards Usability  Tes,ng  Medical  Devices   3  
  • 4. Medical Device Manufacturers may be unfamiliar with your practices and lack of regulations Usability  Tes,ng  Medical  Devices   4  
  • 5. Safeguarding participants may be more challenging •  Your safety protocols must be exacting, fully defined, piloted, and effective •  Even simulated product use may put participants at risk •  Target audiences may be physically or cognitively vulnerable •  Activity environments may be unusual •  Work with client and medical care specialists Usability  Tes,ng  Medical  Devices   5  
  • 6. Reporting responsibilities, guidelines, formats, and requirements will be more complex •  Reporting guidelines, formats, and requirements will likely be extensive and complex •  Industry reporting standards (CIF) •  Specialized reporting formats •  Raw data may be reviewed again and again and again. . . Usability  Tes,ng  Medical  Devices   6  
  • 7. Research locales may be more challenging Device use environments may be: •  Unfamiliar •  Sterile •  Stressful •  Germ-laden •  Emotionally distressing •  Gross •  Secure •  Rarely observable •  Complex •  or otherwise unusual to non-medical personnel •  (And fainting can be a factor!) Usability  Tes,ng  Medical  Devices   7  
  • 8. Client Relationship Source: http://robot6.comicbookresources.com/2010/07/take-a-look-at-the-avengers-assemble-painting-by-alex-ross/ •  A robust set of client team members is essential – as is knowing their roles: –  Legal –  Medical advisor –  Safety advisor –  Compliance –  Adverse Event Specialist –  Physician is helpful, but not enough –  The usual suspects •  Clients may ask for proof of insurance –  But too much insurance could be a bad thing Usability  Tes,ng  Medical  Devices   8  
  • 9. FDA Relationship Source: http://news.petpardons.com/fda-denies-rumors-over- possible-discovery-of-chicken-jerky-toxin/ •  If the study is for FDA approval – learn about the client’s relationship with the FDA: –  What are the relevant regulations? –  Who is the client’s liaison to the FDA? –  What is the client’s relationship with the FDA? –  Has the client met with the FDA? –  Have they received comments from the FDA? –  Does the client understand usability testing? –  Are we allowed to talk to the FDA? Usability  Tes,ng  Medical  Devices   9  
  • 10. Working with an IRB •  IRB = Institutional Review Board Source: http://www.bioedge.org/index.php/bioethics/bioethics_article/ who_is_watching_the_irb_watchdogs_asks_nature •  For FDA approval, typically work with an independent IRB •  Their job: to ensure that research conducted on human subjects is carried out correctly and humanely •  Not as scary as you may think –  We are NOT evaluating medical efficacy or safety –  But we DO have to be conscientious •  Have your ducks in a row and it will be a smooth process Usability  Tes,ng  Medical  Devices   10  
  • 11. Working with an IRB •  Adds about $2000-$5000 to the cost of the study Source: http://www.bioedge.org/index.php/bioethics/bioethics_article/ who_is_watching_the_irb_watchdogs_asks_nature •  Adds a day or two to the project for dealing with the IRB •  Be cognizant of any non-disclosure agreements •  Prior to the study, signature pages should be signed-off, circulated, and returned in a timely manner •  Everyone on the team will take this very seriously! Usability  Tes,ng  Medical  Devices   11  
  • 12. IRB Documents - Forms Source: http://blog.pennysaverusa.com/tag/tax-tips/ •  Indemnification Agreement: So the IRB doesn’t get sued •  Financial Disclosure: The researchers don’t have conflicts of interest •  Investigator Statement: The researcher code of conduct •  Satellite Site Application: May be needed if the study involves multiple locations •  Shipping & Invoice: Where documents are sent •  Study Application: Detailed information about the study •  Curriculum Vitae for all researchers •  Other forms that your IRB requires Usability  Tes,ng  Medical  Devices   12  
  • 13. IRB Documents – Study and Device Info •  Recruitment Screener: Be very precise Source: http://healthcareit.etisbew.com/ •  Recruitment Flyer: To hang in doctor’s office to aid with recruiting •  Moderator’s Guide: A second guide may be needed if there are child participants •  Consent and asset forms: For adults and children, respectively •  Safety Concerns: Outline potential risks •  Device Background: Detailed explanation of the device including indication and new features •  Device Instructions for Use: If they are also included in the study Usability  Tes,ng  Medical  Devices   13  
  • 14. IRB Documents – Validation Plan •  A detailed explanation of how the study will validate that the device is usable –  If you’re used to winging it, you can’t do that here –  Lay out every question and how it will be interpreted –  Lay out a rationale for every metric –  Break down the pieces of the tasks and what will be observed –  A detailed explanation of how the will be analyzed and presented •  Quantitative measures (asked and observed) –  Rating scales –  Yes/No observations Source:  hDp://www.vnet5.org/pub/approach/uva.html   Usability  Tes,ng  Medical  Devices   14  
  • 15. Chart  Color   Quantitative Measures %  of  chart  that  is  red   %  of  chart  that  is  black   •  Rating Scales –  Asked –  Observed •  Ease of use •  Usability •  Instructions for •  Help needed Use clarity •  Number of •  Design errors •  Ergonomics •  Yes/No observations –  Did the participant do this, that, AND the other thing? Ra,ng   No  Help  Needed   LiDle  Difficulty   Some  Help     Much  Help   Task  Failure   Explana,on   Completed  with  no  help   1-­‐2  small  errors   3-­‐5  errors   Moderator  gets  involved   Failure   Small  errors:   Doesn't  press  the  green  buDon   Doesn't  remove  cap  properly   Etc.   Usability  Tes,ng  Medical  Devices   15  
  • 16. Recruiting •  Give your recruiter a heads up LONG before the study starts –  And start recruiting early •  Make a flyer to be hung in doctor’s offices and distributed electronically which includes: –  The purpose of the study –  Why they would want to participate –  Compensation Source: http://www.toptenz.net/top-10-wwii-propaganda-posters.php –  Recruiter contact information •  During the project, any screener changes need to be re-approved by the IRB •  Many institutions can’t “promote” a study that is under their auspices Usability  Tes,ng  Medical  Devices   16  
  • 17. Sample Flyer Usability  Tes,ng  Medical  Devices   17  
  • 18. Recruiting •  Don’t be shy – makes friends with local hospitals and clinics –  Nurses and admins are the gateway –  Have the sanitized IRB approval in-hand •  Find groups that can be a gateway to your desired audience Source: http://www.toptenz.net/top-10-wwii-propaganda-posters.php –  Healthcare institutions –  Local and national support groups –  Federal agencies –  Community support groups –  Craigslist & Social Media •  Plan for surprises – like extensions to the timeline Usability  Tes,ng  Medical  Devices   18  
  • 19. Working with Children •  From a legal standpoint, a child is someone under 18 years old Source: http://evilstaring.com/2011/06/08/amazingly-evil-child-3/ •  Children cannot consent to participate in the study, they can only assent –  An assent form explains the details of the study, in the first person •  You will treat a 17 year old different than an 8 year old –  Be cognizant of the protocol to ensure you are consistent in your data capture •  The parent conundrum: should they participate? –  At what point does it become co-discovery and is that Source: http://cautionmagnet.blogspot.com/2011/05/confused-kids.html okay? Usability  Tes,ng  Medical  Devices   19  
  • 20. Working with Children •  Put the child at ease: –  Explain the lab (to a point) –  Ask if s/he would like a break Source: http://lovefunnypictures.com/funny-pic-bush_funny_face.php –  Give reminders that s/he is doing a great job in the study –  Structure the study so that it isn’t drudgery –  Don’t make them remember rating scales –  Not all children like to be spoken to like a child •  Be extra vigilant for signs that the participant is telling you want you want to hear –  As well as signs of fatigue and confusion •  You don’t need to be their friend, but don’t scare them away Usability  Tes,ng  Medical  Devices   20  
  • 21. Moderator’s Guide •  Be precise with a tightly written protocol Source: http://tips.tntdental.com/?tag=website-navigation •  Must be well-defined in advance and piloted –  No changes to the protocol without revisiting the IRB, the client, the FDA approval minutes, etc. •  Clients may be used to clinical trials and view usability methods as “thin” –  We’re not running a clinical trials, but that’s no excuse for not adequately preparing •  Adhere to the protocol! –  Any changes require IRB approval Usability  Tes,ng  Medical  Devices   21  
  • 22. Moderator’s Guide •  The moderator’s guide should capture: Source: http://tips.tntdental.com/?tag=website-navigation –  The tasks –  Steps in the tasks –  What should be observed –  The questions to be asked of the participants –  Observer rating scales •  Basically, a shortened version of the Validation Plan •  Be precise in the metrics and methods –  They cannot vary –  Data reporting requirements will be significant –  Gaps in the reporting will be very visible Usability  Tes,ng  Medical  Devices   22  
  • 23. Notes Grid •  We are using “micro-tasks” and want to capture precise information •  The notes grid should facilitate the analysis Source: http://beta.armagetronad.net/design/tron.html yet be easy to use –  Every step and question on its own row –  Have clear study sections (introduction, etc.) –  Grey out areas that can be ignored •  Team note taking: moderator concentrates on certain items, note taker does the rest Usability  Tes,ng  Medical  Devices   23  
  • 24. Notes Grid Usability  Tes,ng  Medical  Devices   24  
  • 25. Lab Preparation •  Capture the participants from two different angles –  A close-up view of the device interaction (over-the-shoulder) –  Straight-on to capture the entire field •  Have all device supplies at the ready –  Alcohol wipes, extra needles, batteries, Source: http://www.ebaumsworld.com/pictures/view/218095/ etc. –  You’ll use more supplies than you expect •  Get a first aid kit and nitrile gloves –  Have a first aid plan and practice Usability  Tes,ng  Medical  Devices   25  
  • 26. Participant Safety •  As with any usability, participant comfort and safety is the top priority Source: http://en.wikipedia.org/wiki/File:Sign_first_aid.svg •  Must be mindful of participants with health conditions –  Will they need accessibility accommodations? –  Will they have an aide/caretaker? –  How will the condition affect their participation? •  What you can do to ensure participant comfort and safety: –  Have a robust first aid kit (and possibly medical personnel) –  Provide water, juice, sugary, and non-sugary snacks –  Ensure they know that they will be working with a placebo –  Accessible food Usability  Tes,ng  Medical  Devices   26  
  • 27. Participant Safety •  Warn participants of safety hazards while using the device, if it’s part of the protocol Source: http://en.wikipedia.org/wiki/File:Sign_first_aid.svg •  Have a plan of action if someone is injured •  Establish a path of notification if a participant is injured –  Reporting may have many phases: reporting it internally, then to the client, to the FDA, and the IRB •  Educate yourself about the condition •  Ensure the protocol does not exacerbate a disease or condition •  Be vigilant about fatigue, confusion, disorientation, dehydration, & stress Usability  Tes,ng  Medical  Devices   27  
  • 28. Adverse Effects •  An adverse effect (AE) event is when a participant tells you about a side effect or other experience while using a device or drug •  This is critical information for the client and must be reported, typically immediately Source: http://www.cartoonstock.com/directory/d/Din.asp •  Some clients may require you to go through AE training •  Before the study begins, determine to whom AEs are reported When in doubt, report! •  AEs can be complex to identify, but are VERY important Usability  Tes,ng  Medical  Devices   28  
  • 29. Adverse Effects •  In the course of a usability study for a medication website, a participant mentions that she stopped taking the drug. She explains that the blister packs and pills sometimes arrived crushed. •  While testing an infusion pump, the participant mentions that the tube always falls out of his previously used pump, which is the client’s product. •  During a study, a participant mentions that her arms started to itch when she stopped taking the client’s medication. •  A male participant mentions that his wife got pregnant two weeks after he started taking the client’s medication, even though she used the birth control pill. Usability  Tes,ng  Medical  Devices   29  
  • 30. Analysis •  The setup from the validation plan, moderator’s guide, and notes grid should make analysis easy Source: http://www.webseoanalytics.com/blog/how-to-conduct-market- research-competitor-analysis/ •  Dealing with gaps in the data can be tricky –  Did the question get asked? –  Was the behavior observed? –  Do we have to go back to the recordings? •  Make sure you HAVE the recordings! •  Rely on quantitative measures –  What percentage of participants passed the task? –  What ease of use ratings did participants give? –  How many participants committed the most common errors? Usability  Tes,ng  Medical  Devices   30  
  • 31. Analysis •  Remember to think on a micro-task scale – every little step of using the device should be observed –  It’s difficult to watch and report on every step of a complex interaction and document it precisely, Source: http://www.webseoanalytics.com/blog/how-to-conduct-market- research-competitor-analysis/ especially live –  Tallying needs to be specific, yet practical •  Be mindful of capturing and organizing the important qualitative data –  This can be especially tough when dealing with many participants –  Summarize qualitative data directly after the session – don’t wait •  Know what you’re reporting – there may be data to help marketing •  Sometimes the goal of these studies is to identify marketing claims, which can raise concerns Usability  Tes,ng  Medical  Devices   31  
  • 32. Thank You! •  Conducting a usability study for a medical device is similar to a typical study, except with much stricter protocols Questions/Comments? •  Your safety and the safety & comfort of the Dan Berlin participants are paramount dberlin@madpow.net @banderlin •  Use quantitative measures and report percentages of participants that did or Chris Hass didn’t perform an action chass@madpow.net @chrishass •  It’s all about proper planning! Usability  Tes,ng  Medical  Devices   32