UX Design in a Surgical Environment

user experienceinteraction© Echo Visualization, LLC

User Experience Design in a Surgical Environmentby Michelle S Berryman, FIDSA & Vicki Haberman, IDSA

25 August 2011

@EchoViz


Our Background

• EchoViz is a boutique user experience design firm founded in 2002 by Michelle Berryman, FIDSA & Brian Lynn

• 610 square meters (2,000 square foot) studio located in the heart of Atlanta, Georgia, USA

• Background in industrial design

• Numerous awards for interaction design, graphic design & interactive environments

881 Memorial Drive, Suite 118Atlanta, GA 30316 - USA

p +1.404.389.0873 [email protected]

• Areas of practice include:

- Corporate websites, intranets, rich internet applications and e-marketplaces

- Digital strategy and social media strategy

- Product-based interfaces and experiences

- Home appliances and lighting controls

- Fuel distribution and management

- Medical devices

- Mobile devices

mailto:[email protected]



Working in Medical

• Basic principles of research, analysis, synthesis and design are the same

• Skills are the same

• Tools are the same

•Output is the same

- Requirements

- User flows

- Personas

- Site maps

• Context is different

• In medical, the learning curve for designers is steep and critical

- Always have to learn about the industry, competitors, lingo, the problem, etc.

- This is more intense and challenging

• Consequences are different - especially for error prevention and recovery

• Less clarity around the “user”

•Work is grounded and guided by very rigid laws and regulations

• Use error, not user error

The unfamiliar side of familiar

- Wireframes

- Design comps

- Style guide

- Etc.


We’ve got the project! Let’s do this!


Wait, not so fast!A primer for working in medical


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


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


•Most countries, states and territories maintain legislative code regulating the collection and handling of information about citizens

•Legislation typically involves conditions or limits on the collection, storage, access, use and disclosure of personal and identifying information

•Must understand the concept of privacy and how it will impact research and design throughout the project

All medical work is heavily influenced by privacy issues

“Personal information means information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.”

Privacy Act of 1988 (Australia)

Patient Privacy: A Complex Issue


•Usually defined as information in which the identity of the individual is readily apparent or can be reasonably ascertained

•Examples include the following:- Name, address, phone number, etc.

- Government issued ID numbers

- Account numbers- Photographs showing the face or distinguishing features

Key concepts

•“Records” may include the following:

- Documents- Databases- Photographs- Audio and video recordings- Output from medical devices and systems

•Everything must be compliant with relevant privacy laws

Personal Information & Records


Device Output ExampleProtecting privacy is often a delicate balancing act


•Do NOT photograph or videotape any of the following unless they are pertinent to the procedure or work:

- Face or head- Scars- Tattoos- Birthmarks- Amputation sites- Obvious birth defects- ID tags, plates or bracelets

Rules of thumb for medical research

•Record only the following as differentiators if relevant:

- Sex- Age- Ethnicity- Medical condition - Disease state- Complications- Variances in anatomy

•Request permission to take photos of staff

Personal Information & Records


• Medical terminology

• Anatomy and its variability

• Physiology

• Tools and equipment

• Clinical conditions

• Disease conditions

• Procedure(s) observing

• Procedure(s) designing for

Knowledge BaseFamiliarity is critically important


•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)

Getting approval for your researchInstitutional Review Board (IRB) Also: Independent Ethics Committee (IEC),

Ethical Review Board (ERB), Research Review Committee (RRC)


Medical DevicesWhat are we talking about?

• Regulatory agencies have very specific definitions for medical devices and their classifications.

- 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 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

Class II devices are higher risk and may cause harm

Class 1 devices present minimal harm to users


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?


• Include everything you need for observation and documentation

• Include appropriate cleaning supplies

• Include personal accessories that might be needed

The Researcher’s Tool kitAssemble a tool kit specifically for use in operating rooms and cadaver labs

x3 per device


Seriously, let’s do this!


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.”

Assume everything is contaminated.It’s unlikely cadavers will be fully intact. Prepare yourself accordingly.


Look! Puppies!!


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


Welcome 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.”

Smell: Cauterized flesh is unpleasantSee: It can be very messy Hear: It can be very noisy


More Puppies!


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


Satisfaction and StressAn important, symbiotic relationship for surgeons and medical personnel

•Define pleasure differently

•Enjoy stimulation and challenge

•Relish complexity

•Great pride in resolution


Sterile FieldPeople and equipment are either sterile or non-sterile in the OR

•Sterile- May include surface, equipment and people

- All items draped on or around patient are considered sterile

- Sterile personnel cannot reach over non-sterile areas

- Number of people in OR is a critical factor in maintaining sterility

- It can easily become contaminated

•Non-sterile- Researchers and observers are non-sterile

- Non-sterile people must stay at least 46 cm (18 in) from sterile field

- Always face sterile field

- Do not reach over sterile field or walk between sterile items

- People are the most common cause of contamination


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


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

•Difficult time describing something that doesn’t exist

“You don’t want to make this cookbook to the point where a lot of the (surgeon’s) intuition and experience is totally thrown out the window.”


Value PropositionMust be there and must be clear

•Considerations

- Payment structure

- Maintenance

- Operator/technician

“Is this really geared towards the high volume surgeon or the low volume surgeon? Does it make the high volume surgeon better? Does it make the low volume surgeon better?”

“The device can’t cost more than the surgeon. If it does, it must provide that level of value.”


Getting into DesignFamiliar process, different design considerations


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


Software Meets HardwareAppropriate integration - Becoming part of the dance

•You are introducing a new device or procedure into an already dense web of activity

•Requires close collaboration with industrial designers and engineers in addition to software developers

•Must understand what you can and cannot influence in terms of device form, inputs and controls

- Existing device vs. new device?

- Regulatory requirements?


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...)


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?


“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...”


Kittens!


FeedbackAppropriate, timely and meaningful

•To whom is the feedback targeted?

- Surgeon- Patient- Surgical/technical staff

•What is the purpose of the feedback?

- Advancement in procedure- Informational- Warnings or errors- Proximity to boundaries or constraints


• 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

Visual FeedbackDesign considerations


Visual FeedbackFirst-hand experience

“The way that is drawn, right there, it’s not exactly clear where it is...”

“I couldn’t see it. Hopefully, it wasn’t important.”

“I normally don’t wear glasses, but for [this] procedure you can see I have to wear glasses to see the screen.”

“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.”


Bunnies!


Auditory and Tactile FeedbackIncreasingly critical

•Tactile- Haptic- Force and location- Anatomical considerations

•Auditory- Confirmation- Warnings and errors- Competition with other equipment and personnel

- Frequency sweeps“You’ve got this sophisticated (equipment) with 2mm precision, and you’re whacking it with a 10 lb. mallet.”


User Experience Design in a Surgical EnvironmentTop 10 take-aways

• It’s REAL and it’s serious

•The stakes are high

• In the long run, you could be helping yourself or someone you love

•The problems are very complex and intellectually challenging

•There is NO room for bad design

•UX designers can play a profound role and have a huge impact

• It can be a humbling experience

• It’s always cutting edge

• It’s aspirational, satisfying and meaningful and exciting work

•There is an abundance of opportunity to work in this space!


If you would like to learn more . . .

Medical Device Bootcamp2-4 November 2011

University of CincinnatiCincinnati, Ohio, USA

Medical Device Innovation & Entrepreneurship Program

Mary Beth Privitera, M. [email protected]




Thank youMichelle S Berryman ([email protected]) & Vicki Haberman ([email protected])






References & Credits Photo & Image Credits• National Health and Medical Research Council, Privacy Committee. The

Regulation of Health Information Privacy in Australia, A description and comment. Professor Colin Thomson, 2004

• US National Institutes of Health Protecting Human Research Participants Course - http://phrp.nihtraining.com/users/login.php

• US Food and Drug Administration - http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193731.htm

• US Occupational Safety and Health Administration - Model Plans and Programs for the OSHA Bloodborne Pathogens and Hazard Communications Standards - http://www.osha.gov/Publications/osha3186.pdf

• BlackHagen Design

• Medical Device Innovation Program at the University of Cincinnati, Mary Beth Privitera, MDes., IDSA

• Slide 06: Centers for Disease Control and Prevention Public Health Library (http://phil.cdc.gov/phil/home.asp), Image ID# 9297 f

• Slide 07: http://www.osha.gov/Publications/osha3186.pd

• Slide 10: Michelle Berryman, Echo Visualization, LLC

• Slide 11: Michelle Berryman, Echo Visualization, LLC

• Slide 13: Wikimedia Commons

- http://commons.wikimedia.org/wiki/File:TelesneRavnine.jpg

- http://commons.wikimedia.org/wiki/File:Hyoglossal_muscle.PNG

- http://commons.wikimedia.org/wiki/File:Rostralcaudal.svg

- http://commons.wikimedia.org/wiki/File:Gray86.png

- http://commons.wikimedia.org/wiki/File:Gray203.png

• 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

http://phrp.nihtraining.com/users/login.php

http://phrp.nihtraining.com/users/login.php

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193731.htm




http://www.osha.gov/Publications/osha3186.pdf




http://phil.cdc.gov/phil/home.asp

http://phil.cdc.gov/phil/home.asp



http://www.osha.gov/Publications/osha3186.pd

http://www.osha.gov/Publications/osha3186.pd

http://commons.wikimedia.org/wiki/File:TelesneRavnine.jpg

http://commons.wikimedia.org/wiki/File:TelesneRavnine.jpg

http://commons.wikimedia.org/wiki/File:Hyoglossal_muscle.PNG

http://commons.wikimedia.org/wiki/File:Hyoglossal_muscle.PNG

http://commons.wikimedia.org/wiki/File:Rostralcaudal.svg

http://commons.wikimedia.org/wiki/File:Rostralcaudal.svg

http://commons.wikimedia.org/wiki/File:Gray86.png




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




UX Design in a Surgical Environment

Technology

Transcript of UX Design in a Surgical Environment