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


Working in Medical
The 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

We’ve got the project! Let’s do this!


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


Industry Compliance
Limiting 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 Preparation
Limiting 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


Patient Privacy: A Complex Issue
All 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


Personal Information & Records
Key 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


Device Output Example
Protecting privacy is often a delicate balancing act


Personal Information & Records
Rules 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


Knowledge Base
Familiarity is critically important
• Medical terminology • Clinical conditions
• Anatomy and its variability • Disease conditions
• Physiology • Procedure(s) observing
• Tools and equipment • Procedure(s) designing for


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)


Medical Devices
What 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

Working with the Client
Partnership

• 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?


x3 per device

The Researcher’s Tool kit
Assemble 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


Seriously, let’s do this!


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

Welcome to the Cadaver Lab
An 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.”


Look! Puppies!!

Importance of Cadaver Labs
Bleeding 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

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

Welcome to the Operating Room
An 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.”


More Puppies!

The Operating Room
A 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 Stress
An important, symbiotic relationship for surgeons and medical personnel

• Deﬁne pleasure differently • Relish complexity

• Enjoy stimulation and challenge • Great pride in resolution


Sterile Field
People 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


Example Flow
Choreography 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 Medicine
Working 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.”

Value Proposition
Must 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?”


Getting into Design
Familiar process, different design considerations


Analyzing the Research
Buckets, 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 Hardware
Appropriate 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


Leveraging Findings
Key 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 Display
Design 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!

Feedback
Appropriate, 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

Visual Feedback
Design 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


Visual Feedback
First-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.”


Bunnies!

Auditory and Tactile Feedback
Increasingly 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.”


User Experience Design in a Surgical Environment
Top 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!

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


Thank you
Michelle S Berryman (michelle@echoviz.com) & Vicki Haberman (vicki@echoviz.com)


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
File:Venﬂon_intravenous_cannula_2.jpeg
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


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