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Planning and Executing the Product Development and Manufacture of Medical De...MaRS Discovery District
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What is an ISO-13485-compliant QMS and can you develop a medical device without one?
How much does it really cost to transfer a medical device into manufacturing?
How do you drive alignment between the core technology and the design and business architectures during the product development process?
How do you communicate your technology readiness to investors?
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The underlying middleware is based on JOnAS (EJB3) and JORAM, but also on other technologies from the Web 3.0 (semantic web : ontologies). OCELOT is becoming an open source project, hosted at OW2.
Chimera Collaborative is a laboratory planning and design consulting firm, founded in 2009, delivering sustainable, innovative solutions for science + technology organizations.
A great laboratory design solution is by definition itself a chimera; a built environment shaped from pieces by imaginative, intellectual collaboration facilitating pursuit of advances in science + technology.
Behind every great solution rests the collaborative team efforts of experienced, talented design professionals who bring valued knowledge + expertise to every project. We provide professional design services for each phase of a project’s life cycle; from strategic master planning through design and construction to ongoing facility renovations.
Architecture:
- Facility Programming
- Lab Planning + Interior Design
- Post Occupancy/Peer Evaluations
Planning
- Strategic Master Planning
- Lab Equipment Planning
- Grant Proposal Assistance
That is Chimera Collaborative.
Planning and Executing the Product Development and Manufacture of Medical De...MaRS Discovery District
This interactive presentation will provide answers to common questions that medtech startups struggle with, such as:
What is an ISO-13485-compliant QMS and can you develop a medical device without one?
How much does it really cost to transfer a medical device into manufacturing?
How do you drive alignment between the core technology and the design and business architectures during the product development process?
How do you communicate your technology readiness to investors?
OCELOT (Open Collaborative Environment for the Leverage of Online Engineering) is issued from a research project prototype, realized at the DIOM laboratory of TELECOM Saint-Etienne, associated school of the French Institut TELECOM (formerly GET). OCELOT allows the remote control of apparatuses, instruments, devices in an industrial, research and education context. The main originality of the framework is to support synchronous collaboration (Computer-Supported Collaborative Work), and to minimize the amount of integration time when putting a new device online.
The underlying middleware is based on JOnAS (EJB3) and JORAM, but also on other technologies from the Web 3.0 (semantic web : ontologies). OCELOT is becoming an open source project, hosted at OW2.
Chimera Collaborative is a laboratory planning and design consulting firm, founded in 2009, delivering sustainable, innovative solutions for science + technology organizations.
A great laboratory design solution is by definition itself a chimera; a built environment shaped from pieces by imaginative, intellectual collaboration facilitating pursuit of advances in science + technology.
Behind every great solution rests the collaborative team efforts of experienced, talented design professionals who bring valued knowledge + expertise to every project. We provide professional design services for each phase of a project’s life cycle; from strategic master planning through design and construction to ongoing facility renovations.
Architecture:
- Facility Programming
- Lab Planning + Interior Design
- Post Occupancy/Peer Evaluations
Planning
- Strategic Master Planning
- Lab Equipment Planning
- Grant Proposal Assistance
That is Chimera Collaborative.
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Director, Point-of-Care Diagnostics
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UC Berkeley, March 5, 2015
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Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI
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FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
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In our newest case study, we outline our expertise in driving speed to clinical data and reducing development costs and time substantially.
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
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IDR Medical's Case Study. The client company is a global leader in its field of laboratory diagnostics, their range of devices is immensely successful, but there is a need to evolve and stay at the forefront of the market.
IDR Medical is an international marketing consultancy company with local offices in the UK, the US and Switzerland.
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March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...BerkeleyPoCDx
Development of the PanDx Integrated Diagnostic Platform
Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development
UC Berkeley, March 5, 2015
After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.
Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...April Bright
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
6 Tips to Accelerate MedTech Time To Clinical DataAndy Rogers
Key Tech saved CoolTech, a startup MedTech company greater than $1 million in development costs and reduced the time required to get to clinical data by six months.
In our newest case study, we outline our expertise in driving speed to clinical data and reducing development costs and time substantially.
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Presentation by Mike Jones (Lab Automation Assoc. Director) seconded into my team at the SmartLab Exchange Europe conference in Berlin on 8th February (https://smartlabexchangeeurope.iqpc.co.uk/). Brief overview about the future of scientific labs and how digital transformations are changing our approach to data capture, advanced analytics and collaboration across different scientific teams. Examples include exploratory work in augmented reality, next generation interaction, smart touch interfaces and sensor technologies.
IDR Medical's Case Study. The client company is a global leader in its field of laboratory diagnostics, their range of devices is immensely successful, but there is a need to evolve and stay at the forefront of the market.
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Information support for decision making. Christopher Hart 2012Christopher Hart
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www.sils-sherbrooke.com
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Similar to Imagination Lab Closeout presentation (3-Jan., 2018) (20)
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For those battling kidney disease and exploring treatment options, understanding when to consider a kidney transplant is crucial. This guide aims to provide valuable insights into the circumstances under which a kidney transplant at the renowned Hiranandani Hospital may be the most appropriate course of action. By addressing the key indicators and factors involved, we hope to empower patients and their families to make informed decisions about their kidney care journey.
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Collaborations and Partnerships
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6. Case Study : Seattle-PAP
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
8. Pictures Subtitles/Descriptions:
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
Case Study : Seattle-PAP
Late 2008-2010
8
Discovery & Proof of Concept
Concept Refinement
Design and Development
Testing and Validation
9. 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
Pictures Subtitles/Descriptions:
1. Pathway we took and timeline
10. 10
Discovery & Proof of Concept
Concept Refinement
Design and Development
Testing and Validation
Case Study : Seattle-PAP
Late 2010-2013
Pictures Subtitles/Descriptions:
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. 11
Discovery & Proof of Concept
Concept Refinement
Design and Development
Clinical Testing and Validation
Case Study : Seattle-PAP
Late 2014-2019
Pictures Subtitles/Descriptions:
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)
12. 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
13. 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
14. 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
15. 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)
16. 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
Pictures Subtitles/Descriptions:
1. Seattle Children’s service pyramid
17. 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
Pictures Subtitles/Descriptions:
1. Example projects associated with
each service line.
18. Seattle Children’s Imagination Lab
Design Services to Supporting Making at / by Seattle Children’s
Discovery & Proof of Concept
Concept Refinement
Design and Development
Clinical Testing and Validation
Design Process Training and
Skills Development
18
Pictures Subtitles/Descriptions:
1. Imagination Lab capabilities and
partnerships at time of integration
with SCII
19. 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
Pictures Subtitles/Descriptions:
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
20. 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
Pictures Subtitles/Descriptions:
1. Workshop enabled 24-7 access to basic work space
by staff and faculty at SCRI. Users undergo training
21. 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
Pictures Subtitles/Descriptions:
1. Machine shop for advanced projects and significant
risk tools. Restricted access.
22. 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
Pictures Subtitles/Descriptions:
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.
23. 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
24. ISO Certified/FDA Compliant Medical Device
QMS
• Resource for internal or external device development
24
Pictures Subtitles/Descriptions:
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.
26. 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
27. 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
29. 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
31. 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
33. Teaching and Coaching (#16 / 12%)
Photo captions from top left to bottom right
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
11.Design thinking class prototype
12.Design thinking class prototype
13.Design thinking classes project with patient family experience group wins Enterprise Analytics hackaton
33
35. Patient Specific 3D printing (clinical care and
research) (#12 / 9%)
Photo captions from top left to bottom right
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
39. Community Projects (that we know of…)
Photo captions from top left to bottom right
1. Settlers of Catan Tiles
2. Anesthetic molecule painting template
3. Ski repair
4. Donation box
39
40. 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
43. • 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)
44. 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
45. Project Savings vs. Project Duration
• Big wins come from unexpected places
45
46. 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)
50. 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
51. 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
53. 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…
55. 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
56. 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
57. 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
58. 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….
59. 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
60. 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.
61. 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…
Every year, about 15 million babies are born prematurely and this number is rising.(1)
Over 1 million children die each year as a result of complications of preterm birth.
Appropriate respiratory support, such as bubble continuous positive airway pressure (B-CPAP), can help prevent RDS from developing.
A more detailed Goal: To support delivery of and research in pediatric health care by providing the resources and support necessary for making or modifying things to all of the Seattle Children’s Community.
Fall is in the air... - http://beckiadams.blogspot.com/2012/09/
From Top middle to bottom right
“Mouse House” temperature controlled, full body small mouse plethysmograph
Electrophysiology workbench (one of 6 spaces the Imagination Lab supported)
Micro valve holder for gas an fluid management
Laser cutter enclosure
Low cost, large mouse plethysmograph
Laser cut freezer box dividers (researcher-designed item)
Head-stage circuit board mounts (mounts to mouse skull) (researcher-designed item)
Pressurized rotary molder for silicone casting
Gas valve controller box
Zebra Fish holder, for enabling fish brain surgery
Cardiac electrophysiology simulator
Esophagus pressure monitoring data analysis and research paper
Sample temperature management system for bench top HPLC
On-demand wide format poster printing (researcher-designed items)
Low cost Barnes Maze
Solution emulsifier
Timed rotary mouse feeder array
CNC mouse stereotaxis instrument
Low cost electrophysiology tool magnetic mounting blocks
Gravity halo traction system (wheelchair, commode, and gait trainer)
Strain gage monitoring for halo traction system QA and research
Printed pump box (researcher-designed item)
On-demand wide format long-form flowchart printing (administration-designed items)
“Code Command Center” for improved visibility and management of hospital code events
Chest-abdomen neonatal breathing simulator
Medical Internet of Things (MIoT) system proof of concept (collaboration with Enterprise Analytics)
From Top left to bottom right
Brachial plexus nerve sample management tray
Gravity halo traction system (wheelchair, commode, and gait trainer, and operators and technical manual)
PACU point of care hand hygiene and isolation supplies post
Neonatal endotracial tube holder fabrication fixture
Blood bag and tubing management hooks
Halo traction observation and comparison QI assessment
Enhanced protection phone case for use in the psychiatric ward
Code Blue airway bag sourcing and testing
Vasculature carts ergonomic upgrades (push handles, locking casters, etc.)
Operating room ultrasound probe holders/hook
Cellphone-based microscope sample photography
“Smart Cart” mobile simulation management system
Patient and family food supply cart noise reduction modifications
Patient and family food supply cart maintenance plan
From Top left to bottom right
High school intern 3D printing class (yr 1)
High school intern 3D printing class (yr 2)
High school intern lab project 1
High school intern lab project 2
University of Washington bioengineering capstone project support
Design thinking classes (16 total)
Design thinking classes at Hospital
Design thinking classes with patient family experience groups
Design thinking classes at Research Institute
Design thinking class prototype
Design thinking class prototype
Design thinking class prototype
Design thinking classes project with patient family experience group wins Enterprise Analytics hackaton
From Top left to bottom right
Cardiac printing research project (multi-material) investigation
Cardiac printing research project (lubricious-material) investigation
Cardiac printing research project (augmented reality) investigation
Orthopedics and sports medicine pre-surgical planning model
Chest and airway pre-surgical planning model
Scoliosis patient model
Cardiovascular anatomy
Patient education research project (gypsum)
ENT pre-surgical planning models
ENT pre-surgical planning models
ENT difficult airway planning models
Patient education research project (nylon)
Neurosurgery pre-surgical planning model
Neurology / spinal block simulator
ENT / oncology pre-surgical planning models
Low cost, flexible, lubricious material development
From Top left to bottom right
Bleach dispenser collar redesign
Vacuum tube camera for blockage identification
-80’C Freezer tray repair
Window blind chain pulley gear replacement
Vasculature cart locking door catch replacement
?
Surgical table fabrication
Pump repair
Surgical camera holder replacement
From Top left to bottom right
Settlers of Catan Tiles
Anesthetic molecule painting template
Ski repair
Donation box
5+ business days (external) - Vendor selection + internal processing + vendor printing + shipping
By engaging and training others to learn about the capabilities of the system and approaches, we might learn some things from the imaginations of others. The transparency and visibility also could help sell others on uses of things that we create.
Google.com – https://www.google.com/maps/dir/Seattle+Children's+Hospital,+4800+Sand+Point+Way+NE,+Seattle,+WA+98105/Seattle+Children's+Research+Institute,+1904+9th+Ave,+Seattle,+WA+98101/@47.6436298,-122.3453282,13z/data=!4m18!4m17!1m5!1m1!1s0x54901482b23fe1d9:0x97010bbabfaaa9fe!2m2!1d-122.2821851!2d47.6624009!1m5!1m1!1s0x5490154a7dde498b:0x69ddb8b1feb7dc07!2m2!1d-122.3346754!2d47.6159793!2m3!6e1!7e2!8j1495533600!3e3, accessed 22-May-17
College of San Mateo Library Makerspace - http://www.libraryasincubatorproject.org/?p=15979, accessed 22-May-17
Make Way for Maker Spaces - http://www.ilovenjlibraries.org/content/make-way-maker-spaces-0, accessed 22-May-17
Peter Drucker – Innovation and Entrepreneurship – Harper – 1985
Peter Drucker – Innovation and Entrepreneurship – Harper – 1985
Derived from The Innovation Managers Handbook, Vol. 2,Steve Glaveski, and probably taken from somewhere else
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. The creation and testing of appropriate (potential) solutions then becomes possible, further informing the understanding of the problem. A useful innovation framework can also be started at any point.
Useful frameworks exhibit both the linear and non-linear nature of a learning process, and the evolving nature of the problem and the definition of the problem.
When trusted facts on which to develop a solution do not exist, or are not available, it appears necessary to explore Exploration is based on the creation and testing of potential solutions at different levels of details until an acceptable solution is reached.
Both formal and informal learning occurs prior to, during, and after every activity.