Imagination Lab Closeout presentation (3-Jan., 2018)

Seattle Children’s Imagination Lab Report Out
- Existing Resources
- Example Projects
- Current Metrics
- Discussion
Chris Howard, MBA, PMP
Imagination Lab Director, Manager, Technology Commercialization, CIBR
Last updated: 3-Jan-19

Conflicts or Disclosures
2
• No relevant disclosures…

Case Study : Seattle-PAP
Discovery - Identify An Unmet or Poorly Met Need
• 15 million babies are
born prematurely each
year. Over 1 million die.
3

Discovery - Identify An Unmet or Poorly Met Need
• Appropriate respiratory
support can help
prevent RDS from
developing.
4

B-CPAP System Overview
Oxygen & Air
Gas Blender
Gas Heater
& Humidifier
Seattle-PAP
Patient
Interface
5

Late 2007-2008
6
Discovery & Proof of Concept
Concept Refinement
Design and Development
Testing and Validation
Pictures Subtitles/Descriptions:
1. Identification and evaluation of existing devices
2. Testing of simple prototypes
3. Testing of simple prototypes
4. Bench and pre-clinical concept validation

B-CPAP vs. Seattle-PAP
7
Video Subtitle/Description:
1. Comparison of device concepts

1. Evaluation of design novelty and
subsequent invention disclosure
2. Formal prototype development
3. Testing of formal prototypes
4. Analysis of performance
mechanism
5. Additional prototypes development
6. Pre-clinical validation and
publication
Late 2008-2010
8
Concept Refinement

9
Clinical Trials and
Commercial Distribution
Manufacturing (and final
validation)
Design Verification and
Validation
Formal Design and
Development
Concept Phase
(Generally unregulated)
SCRI in 2010
SCRI
SCRI + Testing
Partner
Contract
Manufacturer
SCRI
Resp. system
licensee (GE
etc.)
Licensee
Licensee
Licensee
Licensee +
Testing Partner
(SCRI)
Licensee
Licensee
SCRI + ODM
SCRI
OEM
SCRI
Distribution
Partner
Partnership Licensing Ownership
Technology Development Pathway Options
2010 - 2013
2014 - 2019
1. Pathway we took and timeline

10
Concept Refinement
Late 2010-2013
1. ISO13485 Certified Quality system
development and deployment
2. Formal medical device
development and manufacture
3. FDA submission and clearance
4. Finished medical device
5. Successfully granted patents in 8
countries

11
Concept Refinement
Clinical Testing and Validation
Late 2014-2019
1. Receipt of award to study final device
on premature infants
2. Clinical trial site evaluations
3. Data use agreements with clinical
trial sites
4. DSMB Board creation and
management
5. Clinical trial insurance
6. IRB protocol development,
submission, and approval
7. Study apparatus development (video)
8. Study apparatus development (real
time pressure @ 240Hz)
9. Successful device licensing
10. Publication of study results (study 1)

Clinical Study 1 Summary
• 40 infants born <32 weeks gestation and stable on Bn-
CPAP with FiO2 <0.30 were studied within 72 h following
delivery.
• off-on-off study design.
• No infants developed pneumothoraces or nasal trauma,
and no adverse events attributed to the study were
observed.
• Unanticipated event associated with videoing infants (leg tag).
• Effort of breathing, assessed by areas under esophageal
pressure-time curves, was lower with Seattle-PAP than
with standard Bn-CPAP.
12

Clinical Study 2 Summary
• 237 infants born <28 weeks gestation; enrolled within
72hr following delivery.
• Head to head comparison study.
• No adverse events attributed to the study were observed
to date.
• Anticipated adverse events associated with extreme prematurity.
• All infants off study Jan 5th, 2019.
• Results – TBD
• Due end mid-2019
13

Project Results
• Lives Supported
• 110 so far
• Funding Used
• Internal Funds (Seed+other) = Est. US$2.5m
• Bill & Melinda Gates Foundation = US$5.3m
• North East Pediatric Device Consortium = $22k
• Project Duration
• Discovery & Proof of Concept - Late 2007-2008
• Concept Refinement - Late 2008-2010
• Design and Development - Late 2010-2013
• Clinical Testing and Validation - 2014-2019
• License/Commercialization Status
• Licensed – Dräger (Global distribution in 2019) 14

So What’s Next?
• Let’s go again…Need to create a service for moving ideas
through a system at scale and speed.
• Imagination Lab Development Plan
• Year 1 – Evaluate the need for an engineering service at Children’s?
• Year 2 – What happens when we add more complexity*
• Year 3 – Cluster ideas, work closely with clinical departments
• Year 4 – Focus on licensing, grants, and program sustainability
• Year 5 – Scale processes personnel to other facilities across US.
• Year 6 – Try to take over the world…
15
* Imagination Lab independent funding ended in year 2. Lab
services and personnel were integrated into Seattle Children’s
Hospital Innovation and Improvement Department (SCII)

Seattle Children’s Imagination Lab
Our Goal: To support pediatric innovation by providing the
resources and support necessary for making or modifying
things to all of the Seattle Children’s Community.
16
1. Seattle Children’s service pyramid

Service Lines
(Pediatric)
Medical Device
Innovation
(New) healthcare
apparatus, product,
and device
development
Workshop
management
Clinical and
bench research
support
Patient-specific
3D printing
Design
teaching and
coaching
Parts
replacement
and repair
Medical device
clinical trial
support*
Medical device
accelerator*
17
1. Example projects associated with
each service line.

Seattle Children’s Imagination Lab
Design Services to Supporting Making at / by Seattle Children’s
Concept Refinement
Clinical Testing and Validation
Design Process Training and
Skills Development
18
1. Imagination Lab capabilities and
partnerships at time of integration
with SCII

The Tool Library
@ Seattle Children’s Research Institute (SCRI) (Outside JMB 970)
Coded door lock
with personal
access codes
Items available initially for
borrowing within SCRI:
Custom cabinet
for tool storage
19
1. Tool library enabled 24-7 access to basic tools by
staff and faculty at SCRI, reducing the need for each
lab to buy equipment. Library users undergo training

The Workshop
@ SCRI (JMB 968)
Tool
wall
Workbench
Electronics station
Drill press
Coded door
lock with
personal
access codes
Disc and
belt sander
Selection of nuts,
bolts and
materials
20
1. Workshop enabled 24-7 access to basic work space
by staff and faculty at SCRI. Users undergo training

CNC mill and lathe
Grinder, band saw, bench-
top drill press, belt sander
TIG/MIG welder and
hood
Electronics station
Cold saw Bender/shear Tube bender
Other Tools Available:
The Machine Shop
@ SCRI (JMB 972)
21
1. Machine shop for advanced projects and significant
risk tools. Restricted access.

Illustration Software
• Adobe Photoshop | Adobe Illustrator
Video Editing Software
• Adobe Premiere
3D Modeling Software
• 3D Slicer | Meshmixer | Mesh Lab
Design Engineering Software
• SolidWorks*
Mechatronic Software
• LabVIEW*
• MATLAB*
Large Format Printing
• EPSON P9000
The Design Shop
@ Seattle Children’s Research Institute (JMB 963L)
*Software is available on request 22
1. Resource for SCRI personnel looking
to use expensive software or
software not commonly available in
research labs but needed to support
poster development, promotional and
instructional video development, etc.

3D Printers and Materials Available
CubePro Trio
• Extruded Deposition Printer
• Opaque and translucent plastic
(3 color)
Form2
• Stereo lithography Printer
• Clear, opaque, and flexible
plastic (1 color)
Z250c/Projet 260c
• Powder and Binder Printer
• Opaque composite (multicolor)
ENGINE SR
• Extruded Deposition Printer
• Clay, Plasticine, Sugru, Silicone
RTV, porcelain, ABS, PLA,
Nylon, NinjaFlex, FilaFlex
Includes small format laser cutting,
and CNC machining.
23Pictures Subtitles/Descriptions:
1. A range of printer technologies for different fabrication purposes

ISO Certified/FDA Compliant Medical Device
QMS
• Resource for internal or external device development
24
1. An outline of the ISO
13485:2003 certified /QSR
compliant medical device
quality management system
for manufacturing medical
devices suitable for use on
humans.

Med.Dev Assessment Framework
25
Team
Market
Technology
Intellectual
Property
Regulatory
Financing
1. Our framework outlining the 5 key
components of a medical device
development project.

Imagination Lab
Design, Engineering,
and Technology
Services
Hardware
Concept development of new
apparatuses, prototype devices, tools,
3D printed models, clothing, etc.
Reverse engineering and fabrication of
things that cannot or can no longer be
bought
Software
Clinical and non-clinical apps
Data analysis tools and software
The control software for mechatronic
hardware to control motors, valves, etc.
Currently Out of Scope
Drugs*
Major infrastructure
Items that can be “Made at Children’s”
*Drug development costs and complexities suggests long concept
development cycles, and is supported by existing infrastructure.
26

Types of Work supported (as of Dec. 2018)
% # / % Type of Work supported
79
42 / 32 Research - External
34 / 26 Process Improvement
12 / 9 Clinical Care
16 / 12 Teaching
21
8 / 6 New product development
5 / 4 Research - Internal
3 / 2 Vendor alternative
9 / 7 Repair
3 / 2 Supported Staff Project
132 / 100 Total Completed
27

Research (#47 / 36%)
Photo captions, starting from top middle to bottom right
1. “Mouse House” temperature controlled, full body small mouse plethysmograph
2. Electrophysiology workbench (one of 6 spaces the Imagination Lab supported)
3. Micro valve holder for gas an fluid management
4. Laser cutter enclosure
5. Low cost, large mouse plethysmograph
6. Laser cut freezer box dividers (researcher-designed item)
7. Head-stage circuit board mounts (mounts to mouse skull) (researcher-designed item)
8. Pressurized rotary molder for silicone casting
9. Gas valve controller box
10. Zebra Fish holder, for enabling fish brain surgery
11. Cardiac electrophysiology simulator
12. Esophagus pressure monitoring data analysis and research paper
13. Sample temperature management system for bench top HPLC
14. On-demand wide format poster printing (researcher-designed items)
15. Low cost Barnes Maze
16. Solution emulsifier
17. Timed rotary mouse feeder array
18. CNC mouse stereotaxis instrument
19. Low cost electrophysiology tool magnetic mounting blocks
20. Gravity halo traction system (wheelchair, commode, and gait trainer)
21. Strain gage monitoring for halo traction system QA and research
22. Printed pump box (researcher-designed item)
23. On-demand wide format long-form flowchart printing (administration-designed items)
24. “Code Command Center” for improved visibility and management of hospital code events
25. Chest-abdomen neonatal breathing simulator
26. Medical Internet of Things (MIoT) system proof of concept (collaboration with Enterprise Analytics)
29

Process Improvement (#34 / 26%)
30

Process Improvement (#34 / 26%)
Photo captions from top left to bottom right
1. Brachial plexus nerve sample management tray
2. Gravity halo traction system (wheelchair, commode, and gait trainer, and operators and technical manual)
3. PACU point of care hand hygiene and isolation supplies post
4. Neonatal endotracial tube holder fabrication fixture
5. Blood bag and tubing management hooks
6. Halo traction observation and comparison QI assessment
7. Enhanced protection phone case for use in the psychiatric ward
8. Code Blue airway bag sourcing and testing
9. Vasculature carts ergonomic upgrades (push handles, locking casters, etc.)
10.Operating room ultrasound probe holders/hook
11. Cellphone-based microscope sample photography
12.“Smart Cart” mobile simulation management system
13.Patient and family food supply cart noise reduction modifications
14.Patient and family food supply cart maintenance plan
31

Teaching and Coaching (#16 / 12%)
32

Teaching and Coaching (#16 / 12%)
1. High school intern 3D printing class (yr 1)
2. High school intern 3D printing class (yr 2)
3. High school intern lab project 1
4. High school intern lab project 2
5. University of Washington bioengineering capstone project support
6. Design thinking classes (16 total)
7. Design thinking classes at Hospital
8. Design thinking classes with patient family experience groups
9. Design thinking classes at Research Institute
10.Design thinking class prototype
13.Design thinking classes project with patient family experience group wins Enterprise Analytics hackaton
33

Patient Specific 3D printing (clinical care and
research) (#12 / 9%)
34

Patient Specific 3D printing (clinical care and
research) (#12 / 9%)
1. Cardiac printing research project (multi-material) investigation
2. Cardiac printing research project (lubricious-material) investigation
3. Cardiac printing research project (augmented reality) investigation
4. Orthopedics and sports medicine pre-surgical planning model
5. Chest and airway pre-surgical planning model
6. Scoliosis patient model
7. Cardiovascular anatomy
8. Patient education research project (gypsum)
9. ENT pre-surgical planning models
10.ENT pre-surgical planning models
11.ENT difficult airway planning models
12.Patient education research project (nylon)
13.Neurosurgery pre-surgical planning model
14.Neurology / spinal block simulator
15.ENT / oncology pre-surgical planning models
16.Low cost, flexible, lubricious material development
35

Repairs, Part Replacements (#9 / 7%)
36

Repairs, Part Replacements (#9 / 7%)
1. Bleach dispenser collar redesign
2. Vacuum tube camera for blockage identification
3. -80’C Freezer tray repair
4. Window blind chain pulley gear replacement
5. Vasculature cart locking door catch replacement
6. ? / DNK
7. Surgical table fabrication
8. Pump repair
9. Surgical camera holder replacement
37

Community Projects (that we know of…)
38

Community Projects (that we know of…)
1. Settlers of Catan Tiles
2. Anesthetic molecule painting template
3. Ski repair
4. Donation box
39

Interesting Products
(Some we can talk about, and some we can’t)
40
• DARCI
• HazCap
• Others
• Point of Care Supply Post
• Seattle Gravity Traction
• Video Diagnostics for Infant breathing
• Secure Lure Protector
• Infant nasal suction for home use

DARCI (DAta Recording Instrument) for measuring air pressure.
41

HazCap (Point of Care Secure Waste Management)
42

• Opened October 2016
• Test the hypothesis that there is a demand for a service to make things at Seattle
Children’s
• ~50 Imagination Lab members
• Member = Work shop access
• >750 internal interactions
• Talks, classes, discussions
• Projects from across Seattle Children’s
• Includes clinical and support services
• ~130 completed (77 products/items)
• 11 in-progress (6 early-stage medical devices)
• ~52% impacted directly by 3D printing
• 19 (14%) projects lost money, 113 (86%) saved money
Imagination Lab metrics (as of Dec. 2018)

Service financials (Oct. 2016 – Dec. 2018)
• Attributed project costs
• ~$458,000 (Imagination Lab costs – time and materials)
• ~$878,000 (est. vendor costs for projects completed by Imagination
Lab
• Assumes external vendor interest in these projects
• New grant revenue (direct funding or in key supporting role)
• ~$1.18m
• (2x PDC@$83k 1x R03@$150k, 1x K23@$944k)
• 3D printing costs
• Save 50-90% on every part printed internally
• Clinical care savings thru. use of 3D printing undetermined
• 3D printing turn around time
• 6-24 hr (internal)
• ~5+ business days (external)
44

Project Savings vs. Project Duration
• Big wins come from unexpected places
45

Program Development Goals
• Need service IN the Hospital
• Find the hidden workshops…
• Accessible (and visible) to entire
Children’s community
• Workforce…
• …and patients and families, and
volunteers
• Our core team can’t make
everything
• Offer design and fabrication classes
• Taught by us (or expert volunteers)

Starts with Deliberate, Repeatable Processes
48

How WE can do this… Open Intake Process
49

Concept Design and Development Testing (Outcome)
Smart Cart Development Process
Custom carts for supporting in-situ simulation activities.
Sponsor Area Supported
Estimated
Staff Time
Volunteer
Time
Materials
Estimated
Internal Cost
Estimated
Vendor Costs
(based on our time)
Duration
(Calendar
Days)
Save money?
(Estimated Vendor -
Internal Costs)
Simulation
Program
New product
development
260 hrs 0 hrs $35,500 $53,700 $141,250 169 Saved $87,550
50

Blood Bag Organizer
A storage system to reduce contamination risk in blood storage fridges by improving the management of blood bags and tubes.
Blood bags and attached tubing
and aliquot bags hang down into
other supplies
Initial prototype showed concept
worked. May have issues with
center of gravity
Second prototype improves
aesthetics and printed using
different techniques and materials.
Second prototype is in use.
Sponsor Area Supported
Estimated
Staff Time
Volunteer
Time
Materials
Estimated
Internal Cost
Estimated
Vendor Costs
(based on our time)
Duration
(Calendar
Days)
Save money?
(Estimated Vendor -
Internal Costs)
Bloodworks/
Hematology
Process Improvement 8 hrs 60 hrs $30 $590 $2,500 93
(~1 academic quarter)
Saved $1,910
51

Project Halo Traction System
Source Orthopedics and Sports Medicine / Physical Therapy
Category Process Improvement, New product development
Cost estimate Internal = TBD (est. $30,000) External = $80,000 (design and development)
Outcome Built 3 new traction systems (wheelchair, commode/shower, and gait trainer) that increases
adjustment range, weight capacity, safety and ease of use over the existing traction system.
Eventually tackling more complex products…

Final Thoughts on Innovation
54

What is Innovation? What isn’t innovation?
• For our purposes:
• Innovation is taking an idea from determining the problem
(conception) through to making a solution available for others to
save lives, and maybe make some money (delivery).
• Can be confused with:
• Invention
• Creativity
• Change
• Creation of knowledge
• Research
• Process improvement
• Antonym
• Exnovation
55

Internal Sources of Innovation
(Internal to the industry) (Peter Drucker – Innovation and Entrepreneurship – Harper – 1985)
This order is based on reliability and predictability.
1. The unexpected
The unexpected success, failure, and/or outside event
2. Incongruities
A discrepancy, a dissonance, between what is and what
"ought" to be
3. A process need
Process improvement
4. Industry and market structures
Changes that catch everyone in the industry unaware
56

External Sources of Innovation
(External to the industry)
5. Demographics
Population changes
6. Changes in perception, mood and meaning
Glass is half full, glass is half empty
7. New knowledge
Scientific and non-scientific
And what about the “Bright Idea”?
The ball point pen, the zipper…
Highly risky, playing the odds,
Lacks of evidence of repeatable method.
57

Learning
and
Exploration
Problem
definition
CreationMeasurement
An Innovation Loop
Understand the problem, build and test the solution
58
• There are many conceptual-level frameworks outlining workflows and processes that can support innovation
activities. Useful frameworks highlight the importance in identifying, learning about, and defining problems
appropriately.
• A useful innovation framework can be started at any point, but usually starts with problem definition. Products
solve problems; the problem is also the root of potential customer demand.
• When trusted facts are not available, exploration is required. Exploration is based on the creation and testing of
potential ideas and solutions at different (increasing) levels of detail until an acceptable solution is reached.
• Both formal and informal learning occurs prior to, during, and after every activity.
• This framework can be use in a linear and non-linear way to account for the evolving nature of the problem and
the problem definition/statement.
Learning /
Testing Doing / Building…OR….

Takeaways
• “Innovation” is a misused and misunderstood term
• Try to start the conversation with a common definition or understanding
• Innovation activities are a necessity
• Innovation enables organizational evolution and helps maintain
competitiveness, especially in a capitalist economic system.
• Innovation and entrepreneurship are tightly linked
• Both can be taught. Both need organizational support.
• Entrepreneurship is not limited to start-ups or based on blind risk-taking
• The ability to learn is the (probably) the core of innovation
• Measurement and metrics should reflect this.
• Failure is relative (to what was expected)
• Existing knowledge only gets us so far.
• Innovation is derived from novelty, but interacts with incredibly complex,
variable systems; thoughtful experimentation is required to unlock
value… 59

Acknowledgements
60
• Lab members
• Tom Hansen, Skip Smith, Peter Richardson, Jeremy Ford,
Larissa Stanberry, Ty Morton, Jonathan Poli, Connor Aylor…
• Work developed with various teams and individuals at
Seattle Children’s
• Radiology, Cardiology, Otolaryngology, Simulation Program,
Orthopedics and Sports Medicine, Pulmonary, B&E, EHS,
Research PIs and staff… (35+ Depts. And Centers, 600+ people)
• Funding
• Seattle-PAP
• Bill & Melinda Gates Foundation , PI Seed funds, Hansen
Innovation Endowment.
• Imagination Lab
• Hansen Innovation Endowment, CDT and CIBR Departmental
Funds, and CDAC.

Questions?
Additional Contacts:
Ty Morton – Tyler.Morton@seattlechildrens.org
Jonathan Poli – Jonathan.Poli@seattlechildrens.org
61
Send me an email: chrisrahoward@gmail.com
Visit our internal SCH web site: Imagination Lab
http://child.childrens.sea.kids/Research/Centers_and_Programs/Imagination_Lab.aspx
Drop by JMB 9th Floor North Carrels and/or Rm. 968 (almost) anytime…

Misc. Tools
• Drill | Driver | Drill Bits | Driver Bits | Counter Sinks
• Portable Soldering Iron | Battery Charger
• Step Ladder
Tool Bag Contents
• Claw Hammer | Ball-Peen Hammer |
• Rubber Mallet
• Razor Blade | Metal Snips | Scissors
• Hacksaw | Junior Hacksaw
• Mill File | Round File | Taper File | Needle Files
• 5”, 7”, & 10” Vice Grips
• Level | Speed Square | Tape Measure
• US & Metric Folding Hex Wrenches
• Screwdrivers
• Digital Multi-Meter
• Wire Stripper | Wire Cutter | Wire Crimper |
• Wire
• Flashlight | Work Light
Socket Set Contents
• 1/4” Sockets US(5/32~9/16”)/Metric(4~13mm)
• 3/8” Deep Sockets US(3/8~3/4”)/Metric(12~17mm)
• 1/4”, 3/8”, & 1/2” Extensions
• 3/8”(F) x 1/4”(M) Adapter
• 1/4”, 3/8”, & 1/2” Ratchets
• Combo Wrenches US(5/16-5/8”) &
Metric(8~15mm)
• Long Nose & Groove Joint Pliers
• Adjustable Wrench (8”)
• US & Metric Hex Wrenches
• Screw Drivers | Driver Bits
• Magnetic Bit Driver
The Tool Library Tool List
@ Seattle Children’s Research Institute

Imagination Lab Closeout presentation (3-Jan., 2018)

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