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PRESENTED BY
How MadCap Flare Promotes Safety and Effectiveness in
Service Documentation
Ray Davis – Medtronic
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• 2013 – Asked to create an approach to documentation that
ensured consistent repair procedures
• Focus on
– Consistent procedures
– Consistent voice
– Ongoing safety
• Proposed using topic-based authoring
• Brand A !!
A little backstory…
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• When I change the oil in my car, I always start the same
way
– Turn off the car
– Lift the hood
• I do those things when I do other maintenance
– Change battery
– Add wiper fluid
– Check the coolant level
• Why do it differently?
Topic-based authoring – oil change analogy
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• In manufacturing
– Create the part
– Test the individual part
– Assemble it into the complete whole
– Test the completed whole
– We should take this approach with documentation
• Test the block of content
• Test the completed procedure
Topic-based authoring is analogous to manufacturing
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• Very effective with one
manual for one product
– 1,320 pages
– 159 procedures
• Parts replacements
• Calibrations
• Tests
– ~80 troubleshooting
procedures
– Took almost two years
A little backstory…
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Added products and manuals
– No clear strategy for our
re-use other than just
“Re-Use!!”
– Bring order to the chaos
A little backstory…
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Added products and manuals
– No clear strategy for our
re-use other than just
“Re-Use!!”
– Bring order to the chaos
– Became a Rube Goldberg
Content Management
System
A little backstory…
SequentialNumber
ProductLineIdentifier
ComponentLocation
ContentRevisionNumber
.FM
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Lessons learned
– Know your content.
Understand how much
content will actually be
re-used.
– Silos aren’t a bad thing.
They are a legitimate way to
limit scope
– If you have to test, scope
re-tests across all
procedures.
A little backstory…
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2016
Converted our entire documentation set from Brand A to
Madcap Flare
– Seven product lines
– 65 documents in the wild
– +1,300 blocks of content
– Fiscal year 2017 we published how many pages?
A little backstory…
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• MadCap Flare 2017
• High definition digital cameras to record procedures
• Adobe Photoshop and Illustrator for image preparation
• Capture for callout numbers
• All sits on top of an SVN repository
Already set-up from our old architecture
Our implementation today
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The Practicality of “Safe” and “Effective”
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• External defibrillators
• Pacing Systems
• Heart Valves
• Guide Wires
• Shunts
• Spinal Cord Neurostimulation Systems
• Balloon Sinus Dilation
Medtronic – What we do
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Fusion™ ENT Surgical Navigation System
“…real-time positioning information that can help
you navigate in and around the sinuses and way
from critical structures during removal of
diseased tissue.”
Medtronic – What we also do
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StealthStation™ S8 Navigation System
“…offers both optical and EM tracking
capabilities….for neurosurgery and spine
procedures including biopsy, tumor resection,
and treatment of spinal trauma…”
Medtronic – What we also do
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O-arm™ Surgical Imaging System
“…a mobile x-ray system designed for 2D
fluoroscopic and 3D imaging for adult and
pediatric patients.”
Medtronic – What we also do
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Super-heroic!!
Doctor Strange. Dir. Scott Derrickson. Perf. Benedict Cumberbatch, Rachel McAdams. Marvel Studios, 2016. Film.
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• The Food and Drug Administration is responsible for
protecting the public health by assuring the safety,
effectiveness, quality, and security of human and veterinary
drugs, vaccines and other biological products, and medical
devices.
– U.S Food & Drug Administration, FDA Fundamentals
The FDA – Safe and Effective
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• Service documentation for these capital systems
– Service documentation describes the repair, calibration,
maintenance, and testing of Medtronic Navigation equipment.
– Service documentation does not describe the use of Medtronic
Navigation equipment in a clinical setting or a therapeutic manner.
• How do you take the system apart, affect a repair, and
return it to service for a customer.
Medtronic Global Service Operations – What we do
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• When you take them apart medical devices have more in
common with industrial equipment
• Common hazards for service engineers
– Unfinished edges that easily cut skin
– Crush or amputation injury
– Extremely high voltage
– Exposure to ionizing radiation
– Exposure to laser radiation (permanent injury in milliseconds)
What we do
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• Our service procedures should be safe.
– Admonish the engineer of all hazards in all situations
– Assure easy access to information in safety sections
– Account for common failure modes
– Provide consistent warnings and cautions
Creating Safe and Effective documentation
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• Our instructions should be effective
– Consistency from procedure to procedure
– The procedure should do what we say it does.
• Nothing more. Nothing less.
• Procedure not technique
• Procedures have all the steps from 1 to the end
– Common tools throughout all procedures
Creating Safe and Effective documentation
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Promoting safety
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• Disassembled medical devices have much in common
with industrial equipment
• Warning versus Caution
Warning: Failure to observe a warning may result in physical injury
to a patient, the operator, the field service engineer, or by-standers.
Caution: Failure to observe a caution could result in damaged
equipment, forfeited time or effort, or the need to abort use of the
system.
Common hazards
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• Common hazards
– Unfinished edges that easily cut skin
– Crush or amputation injury
– Extremely high voltage
– Exposure to ionizing radiation
– Exposure to laser radiation (permanent injury in milliseconds)
Common hazards
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• Consider damage to the system or surrounding property to
be hazards as well
• Other warnings and cautions
– Use a spotter when moving the system to avoid damage to facility
walls and doors
– The part is heavy and may be damaged if allowed to fall after the
last fastener is removed
– The Ethernet cable may be damaged without sufficient strain relief
resulting in data interruptions
Hazards you might not have considered
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• Admonitions provide a consistent message
Three part admonition structure
Signal Word: Description of the hazard. Potential harm resulting
from ignoring the admonition. Methods to mitigate the hazard.
Writers create a consistent voice
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• Safety sections
– Overall hazards
– Personal Protective Equipment
– Cross-reference or re-used content?
• Admonitions
– Warnings and cautions at the point of use
– Snippet vs blocks of content
Most basic safety information
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• SVN Trunk
– Payload contains all
re-usable content
– Sibling of the individual
documents to promote
re-use
Structuring admonition information
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• Snippets directory
– Segregated by admonition
type
– Resources is still a sibling
of the other documents so
re-use is not affected.
– Admonitions can be
connected or disconnected.
Structuring admonition information
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• Pros
– Easy to re-use the content
– Easy to share across documents in a product silo or project
– Easy to create a Warnings and cautions section.
• Cons
– Admonitions are often slightly different from usage to usage.
– Links in the snippets are difficult
– Difficult to output for review
– Formatting doesn’t always shine through.
Admonitions as connected snippets
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• Pros
– Good starting point for a new admonitions
– Can be customized to the individual usage
• Cons
– Effectively becomes cut and paste
– Impossible to update universally
– Links are difficult
– Difficult to output for review
Admonitions as disconnect snippets
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• Pros
– Follows our re-use strategy
– Links are easy
– Formatting is obvious
– It’s just more content
• Cons
– Difficult to imbed in other content blocks
– Difficult to customize for specific implementation
Safety information as content block
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• Every draft is marked as
“Not for clinical use.”
• Reviewers are field personnel
• Potential for an untested procedure to be released into the
wild
• Every document has the business classification
• Supported by multiple targets for multiple review cycles
Watermarks
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Promoting effectiveness
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• Do the procedures do what we say they do?
• Do the procedures have all the steps necessary?
– Branch steps
– Do/until
– If/then/else
• Applies to all revisions of the system
– Major updates
– Minor change
• Anticipated failure modes
What is effectiveness?
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• Reviews
– SME reviews
– Dry-run testing
– Verification testing
– All documented and recorded
• Can we follow the procedures?
How do we measure effectiveness?
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• Write once. Use Many.
• Determine the best possible approach
• Re-use that approach for similar procedures
• Re-used, tested across multiple procedures is effective
Effectiveness of reusability
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• Everything you need from step 1 to the end
• Massive procedures, but each component is tested
repeatedly
• Single voice across documents
• Consistency of approach
– Wrench vs Driver
– Screw vs Bolt vs Fastener
– Screw vs Tighten
Effectiveness of reusability
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• Who knows what these are?
– Channellocks ®
– Irwin Tools® Vise-Grip
– Irwin Tools® Groove Joint
– Milwaukee® Torque Lock
Locking Pliers
– Husky® Straight Jaw Locking
Pliers
Effectiveness of reusability
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Disadvantages
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• Difficult concept because it diverges from the traditional
authoring approach
• Easy to get overwhelmed by the amount of content and
the places it is used
• Rigorous approach to assembly and tracking where
content is used
Disadvantages
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• Minor changes to content
require additional cross-
checks. No such thing as
“just change that line.”
– What other procedures or
documents are impacted?
– Does the change drive a
re-test?
Disadvantages
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• ENHANCEMENT
REQUEST: Make “Linked
From” an exportable
report.
Disadvantages
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• Easy to outpace your support
– Get ahead of the project
– Work faster than your SMEs can review
– Team looks idle when in fact they are just awesome.
Disadvantages
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In closing
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• Safe and effective
– Safe, protects the engineer, by-standers, property, and the system
– Effective, completes a repair and stays on point
Supporting “Safe and Effective”
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• Safety
– Re-usable admonitions provide consistency
– Re-usable admonitions support a common voice and message
– Common targets support multiple review cycles
Supporting “Safe and Effective”
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• Effectiveness
– One way of doing things
– One language
– Easy to distribute writing responsibilities across multiple
procedures
– Even massive procedures can be broken down to easily to scope
and implement writing tasks
Supporting “Safe and Effective”
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• Write once, Use Many
• Universal updates
• Hockey-stick productivity curve
• A measure of efficiency:
– In fiscal year 2016, three writers published only 806 pages using
Brand A
– In fiscal year 2017, three writers published almost 11,000 pages of
documentation using MadCap Flare.
Creating Efficiency
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Questions