UX Design in a Surgical Environment

User Experience Design in a Surgical Environment by Michelle S Berryman, FIDSA & Vicki Haberman, IDSA 25 August 2011 @EchoViz interaction user experience © Echo Visualization, LLC

Our Background 881 Memorial Drive, Suite 118 Atlanta, GA 30316 - USA p +1.404.389.0873 create@echoviz.com • EchoViz is a boutique user experience design • Areas of practice include: ﬁrm founded in 2002 by Michelle Berryman, - Corporate websites, intranets, rich internet FIDSA & Brian Lynn applications and e-marketplaces • 610 square meters (2,000 square foot) studio - Digital strategy and social media strategy located in the heart of Atlanta, Georgia, USA - Product-based interfaces and experiences • Background in industrial design - Home appliances and lighting controls • Numerous awards for interaction design, - Fuel distribution and management graphic design & interactive environments - Medical devices - Mobile devices interaction user experience © Echo Visualization, LLC

Working in MedicalThe unfamiliar side of familiar • Basic principles of research, analysis, • In medical, the learning curve for designers is synthesis and design are the same steep and critical - Always have to learn about the industry, • Skills are the same competitors, lingo, the problem, etc. • Tools are the same - This is more intense and challenging • Output is the same • Consequences are different - especially for - Requirements - Wireframes error prevention and recovery - User ﬂows - Design comps • Less clarity around the “user” - Personas - Style guide • Work is grounded and guided by very rigid laws - Site maps - Etc. and regulations • Context is different • Use error, not user error interaction user experience © Echo Visualization, LLC

We’ve got the project! Let’s do this! interaction user experience © Echo Visualization, LLC

Wait, not so fast!A primer for working in medical interaction user experience © Echo Visualization, LLC

Industry ComplianceLimiting liability and exposure for your team • Training and certiﬁcation - Exposure to Bloodborne Pathogens in the Surgical Environment - OR Protocols - Protocols for Gross Anatomy & Animal Labs • Annual vaccinations & health certiﬁcates - Flu shot - Hepatitis A - Hepatitis B - Tetanus - TB test interaction user experience © Echo Visualization, LLC

Business PreparationLimiting liability and exposure for your company • Regulations and laws for the occupational safety and health of your team - Implementation of an Exposure Control Plan - Training for proper use of Personal Protective Equipment - Hazard Communication Standard • Business Insurance - Policy modiﬁcations and/or new policies may be needed - Increased rates may apply • Easily executed interaction user experience © Echo Visualization, LLC

Patient Privacy: A Complex IssueAll medical work is heavily inﬂuenced by privacy issues • Most countries, states and territories maintain legislative code regulating the collection and handling of information “Personal information means information or about citizens an opinion (including information or an opinion forming part of a database), • Legislation typically involves whether true or not, and whether recorded in material form or not, about an individual conditions or limits on the whose identity is apparent, or can collection, storage, access, use reasonably be ascertained, from the and disclosure of personal and information or opinion.” identifying information Privacy Act of 1988 (Australia) • Must understand the concept of privacy and how it will impact research and design throughout the project interaction user experience © Echo Visualization, LLC

Personal Information & RecordsKey concepts • Usually deﬁned as information in • “Records” may include the which the identity of the following: individual is readily apparent or - Documents can be reasonably ascertained - Databases • Examples include the following: - Photographs - Name, address, phone number, - Audio and video recordings etc. - Output from medical devices - Government issued ID and systems numbers • Everything must be compliant - Account numbers with relevant privacy laws - Photographs showing the face or distinguishing features interaction user experience © Echo Visualization, LLC

Device Output ExampleProtecting privacy is often a delicate balancing act interaction user experience © Echo Visualization, LLC

Personal Information & RecordsRules of thumb for medical research • Do NOT photograph or • Record only the following as videotape any of the following differentiators if relevant: unless they are pertinent to the - Sex procedure or work: - Age - Face or head - Ethnicity - Scars - Medical condition - Tattoos - Disease state - Birthmarks - Complications - Amputation sites - Variances in anatomy - Obvious birth defects - ID tags, plates or bracelets • Request permission to take photos of staff interaction user experience © Echo Visualization, LLC

Knowledge BaseFamiliarity is critically important • Medical terminology • Clinical conditions • Anatomy and its variability • Disease conditions • Physiology • Procedure(s) observing • Tools and equipment • Procedure(s) designing for interaction user experience © Echo Visualization, LLC

Institutional Review Board (IRB) Also: Independent Ethics Committee (IEC), Ethical Review Board (ERB),Getting approval for your research Research Review Committee (RRC) • What is it? - Board formally designated to review, (dis)approve and monitor biomedical and behavioral research involving humans to ensure their rights and welfare are protected • Protocols generally must be approved by the IRB at each healthcare facility prior to conducting research. Note: The IRB may only meet once a month. • Researchers may be required to have passed a course on protecting human research subjects (e.g., US National Institutes of Health Protecting Human Research Participants Course) interaction user experience © Echo Visualization, LLC

Medical DevicesWhat are we talking about? • Regulatory agencies have very specific definitions for medical devices and their classifications. Class 1 devices present minimal harm to users - Australia: Therapeutic Goods Administration (TGA) - US: Food and Drug Administration (FDA) - EU: Medical Device Directive (MDD) • Generally speaking, a medical device is an instrument, apparatus, implement, machine, software, implant or other Class II devices are higher risk and may cause harm article, including accessories or component parts which are intended for use in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. Class III devices sustain or support life interaction user experience © Echo Visualization, LLC

Working with the ClientPartnership • How did the project get to where it is today? - Conducting formative or summative research? - Which clinical pathway? - Transitions between phases: concept, clinical feasibility, pre- clinical trial, clinical trial, etc. • What pre-conditions or assumptions need to be addressed? • What regulations have to be met? • How will success be measured? interaction user experience © Echo Visualization, LLC

x3 per deviceThe Researcher’s Tool kitAssemble a tool kit speciﬁcally for use in operating rooms and cadaver labs • Include everything you need for observation and documentation • Include appropriate cleaning supplies • Include personal accessories that might be needed interaction user experience © Echo Visualization, LLC

Seriously, let’s do this! interaction user experience © Echo Visualization, LLC

It’s unlikely cadavers will be fully intact. Prepare yourself accordingly. Assume everything is contaminated.Welcome to the Cadaver LabAn opportunity to observe and interact with medical personnel and engineers 1. Change into scrubs (they will not ﬁt very well). 2. Don’t forget your safety glasses, hairnet, shoe covers and mask. 3. Grab your equipment (see earlier slide). 4. Experience the sights, sounds, smells and space. 5. Try to stay out of the “splash zone.” interaction user experience © Echo Visualization, LLC

Look! Puppies!! interaction user experience © Echo Visualization, LLC

Importance of Cadaver LabsBleeding has already stopped, so let’s discover Explore, learn, test, reﬁne and validate new procedures, equipment and technologies 1. Assess gaps and/or breakdowns in process and procedure 2. Identify ergonomic and human factors issues 3. Get feedback from surgeons 4. Required for regulatory purposes and approvals interaction user experience © Echo Visualization, LLC

See: It can be very messy Hear: It can be very noisy Smell: Cauterized ﬂesh is unpleasantWelcome to the Operating RoomAn opportunity for observational research with limited medical staff interaction 1. It’s 19°C (66°F). You will be cold. 2. Stay out of the sterile ﬁeld (more later...)! 3. Do not answer questions or participate in any way - even if asked. 4. Experience the sights, sounds, smells and space. 5. Try to stay out of the “splash zone.” interaction user experience © Echo Visualization, LLC

More Puppies! interaction user experience © Echo Visualization, LLC

The Operating RoomA highly choreographed dance, ideally • Everyone has a job, continually anticipating the next move • Efﬁciency and precision are key • It’s a coordinated activity where everyone knows the implications if something goes wrong • High velocity human factors: the unexpected is anticipated interaction user experience © Echo Visualization, LLC

Satisfaction and StressAn important, symbiotic relationship for surgeons and medical personnel • Deﬁne pleasure differently • Relish complexity • Enjoy stimulation and challenge • Great pride in resolution interaction user experience © Echo Visualization, LLC

Sterile FieldPeople and equipment are either sterile or non-sterile in the OR • Sterile • Non-sterile - May include surface, equipment and - Researchers and observers are non- people sterile - All items draped on or around patient - Non-sterile people must stay at least are considered sterile 46 cm (18 in) from sterile field - Sterile personnel cannot reach over - Always face sterile field non-sterile areas - Do not reach over sterile field or walk - Number of people in OR is a critical between sterile items factor in maintaining sterility - People are the most common cause of - It can easily become contaminated contamination interaction user experience © Echo Visualization, LLC

Example FlowChoreography in action • Space is at a premium - Patient - Table - Staff - Equipment - Manufacturer’s/ Pharmaceutical Representatives • As observers, you will be competing for space in the OR • The device you are designing will be competing for space in the OR interaction user experience © Echo Visualization, LLC

Art of MedicineWorking to improve patient care • Top in field (Rock Stars!) • Have basic routine, but highly nuanced - Tacit knowledge of procedure - No right or wrong way - Not easily convinced new tools or technology will be better than current state of the art - Potentially invented the tools that are current state of the art • Confident and opinionated (Type A) • Highly value the mentor model “You don’t want to make this cookbook to • Difficult time describing something that the point where a lot of the (surgeon’s) doesn’t exist intuition and experience is totally thrown out the window.” interaction user experience © Echo Visualization, LLC

Value PropositionMust be there and must be clear • Considerations “The device can’t cost more than the surgeon. If it does, it must provide that level of value.” - Payment structure - Maintenance “Is this really geared towards the high volume surgeon or the low volume surgeon? Does it - Operator/technician make the high volume surgeon better? Does it make the low volume surgeon better?” interaction user experience © Echo Visualization, LLC

Getting into DesignFamiliar process, different design considerations interaction user experience © Echo Visualization, LLC

Analyzing the ResearchBuckets, buckets and more buckets • A project can have - Thousands of photographs - Hundreds of hours of audio and/or video - Pages of written notes • Pay attention to the nuances • Look for patterns - Behavior - Responses - Reactions - Outcomes • Look for outliers interaction user experience © Echo Visualization, LLC

Software Meets HardwareAppropriate integration - Becoming part of the dance • You are introducing a new device • Must understand what you can and or procedure into an already cannot inﬂuence in terms of device dense web of activity form, inputs and controls • Requires close collaboration with - Existing device vs. new device? industrial designers and engineers - Regulatory requirements? in addition to software developers interaction user experience © Echo Visualization, LLC

Leveraging FindingsKey considerations • Focus is always where the clinical decisions are being made - How many things vie for attention? - What initiates a shift in attention? • What type of procedure is it? - Linear vs. non-linear ﬂow • Who is involved in the procedure? - Multiple users - Interactions outside of device • Need for redundancy - Controls, feedback and engineering “It’s just like pumping gas.” (well, not exactly...) interaction user experience © Echo Visualization, LLC

Controls and DisplayDesign considerations • Who will be operating the device? - Surgeon? - Technician? - Other surgical staff? • How should the device be operated? - Traditional mouse and keyboard? - Foot control? - Hand controls on device? • What is the location relative to the surgical activity? - Implications for hand-eye coordination? interaction user experience © Echo Visualization, LLC

“There’s a bit of kabuki dance when you have to do that. I saw (the other surgeon) do it, so I remembered the steps, but...” interaction user experience © Echo Visualization, LLC

FeedbackAppropriate, timely and meaningful • To whom is the feedback • What is the purpose of the targeted? feedback? - Surgeon - Advancement in procedure - Patient - Informational - Surgical/technical staff - Warnings or errors - Proximity to boundaries or constraints interaction user experience © Echo Visualization, LLC

Visual FeedbackDesign considerations • Informative vs. actionable visual cues on device/display • Spacial relationship between device/display and the surgical activity • Lighting: bright to dark • Legibility and contrast • Appropriate depiction of content - Anatomical representations - Surgical instruments - Charts, graphs and numerical data - Progress interaction user experience © Echo Visualization, LLC

Visual FeedbackFirst-hand experience“The way that is drawn, right there, it’s not exactly clear where it is...” “I normally don’t wear glasses, but for [this] procedure you can see I have to wear glasses to see the screen.”“I couldn’t see it. Hopefully, it wasn’t important.” “It’s like my laptop. There’s a lot of things on there that I don’t know what they do. If it’s important then it needs to be visible. If it’s not important then it shouldn’t be there.” interaction user experience © Echo Visualization, LLC

Auditory and Tactile FeedbackIncreasingly critical •Auditory •Tactile - Conﬁrmation - Haptic - Warnings and errors - Force and location - Competition with other - Anatomical considerations equipment and personnel “You’ve got this sophisticated - Frequency sweeps (equipment) with 2mm precision, and you’re whacking it with a 10 lb. mallet.” interaction user experience © Echo Visualization, LLC

User Experience Design in a Surgical EnvironmentTop 10 take-aways • It’s REAL and it’s serious • UX designers can play a profound role and have a huge impact • The stakes are high • It can be a humbling experience • In the long run, you could be helping yourself or someone you • It’s always cutting edge love • It’s aspirational, satisfying and • The problems are very complex meaningful and exciting work and intellectually challenging • There is an abundance of • There is NO room for bad design opportunity to work in this space! interaction user experience © Echo Visualization, LLC

If you would like to learn more . . . Medical Device Bootcamp 2-4 November 2011 University of Cincinnati Cincinnati, Ohio, USA Medical Device Innovation & Entrepreneurship Program Mary Beth Privitera, M. Design +1.513.556.0647 privitmb@ucmail.uc.edu interaction user experience © Echo Visualization, LLC

Thank youMichelle S Berryman (michelle@echoviz.com) & Vicki Haberman (vicki@echoviz.com) interaction user experience © Echo Visualization, LLC

References & Credits Photo & Image Credits • National Health and Medical Research Council, Privacy Committee. The • Slide 06: Centers for Disease Control and Prevention Public Health Regulation of Health Information Privacy in Australia, A description and Library (http://phil.cdc.gov/phil/home.asp), Image ID# 9297 f comment. Professor Colin Thomson, 2004 • Slide 07: http://www.osha.gov/Publications/osha3186.pd • US National Institutes of Health Protecting Human Research Participants Course - http://phrp.nihtraining.com/users/login.php • Slide 10: Michelle Berryman, Echo Visualization, LLC • US Food and Drug Administration - http://www.fda.gov/AboutFDA/ • Slide 11: Michelle Berryman, Echo Visualization, LLC Transparency/Basics/ucm193731.htm • Slide 13: Wikimedia Commons • US Occupational Safety and Health Administration - Model Plans and - http://commons.wikimedia.org/wiki/File:TelesneRavnine.jpg Programs for the OSHA Bloodborne Pathogens and Hazard Communications Standards - http://www.osha.gov/Publications/ - http://commons.wikimedia.org/wiki/File:Hyoglossal_muscle.PNG osha3186.pdf - http://commons.wikimedia.org/wiki/File:Rostralcaudal.svg • BlackHagen Design - http://commons.wikimedia.org/wiki/File:Gray86.png - http://commons.wikimedia.org/wiki/File:Gray203.png • Medical Device Innovation Program at the University of Cincinnati, Mary Beth Privitera, MDes., IDSA • Slide 15: Wikimedia Commons - http://commons.wikimedia.org/wiki/ File:Adhesive_bandage_drawing_nevit.svg - http://commons.wikimedia.org/wiki/ File:Venﬂon_intravenous_cannula_2.jpeg - http://commons.wikimedia.org/wiki/ File:St_Jude_Medical_pacemaker_in_hand.jpg • Slide 22: Photos courtesy of the Medical Device Innovation Program at the University of Cincinnati, Mary Beth Privitera, MDes., IDSA • Slide 27: Image courtesy of BlackHagen Design • Slide 42: Images courtesy of the Medical Device Innovation Program at the University of Cincinnati, Mary Beth Privitera, MDes., IDSA interaction user experience © Echo Visualization, LLC

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UX Design in a Surgical Environment

by Michelle Berryman on Sep 04, 2011

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UX Design in a Surgical Environment — Webinar Transcript