The Innovative
and
Entrepreneurial
Culture – Examples
in
Healthcare
Richard M. Satava, MD FACS
Professor of Surgery
University of Washington
Innovation Forum
Innovation Opportunities in Health
University of Saskachewan
Saskatoon, Saskachewan
13-15 September, 2009
Presenter Financial Disclosure Slide
Richard M. Satava, MD FACS
Financial Support:
None
(… but still hoping)
Consulting:
Karl Storz
ISIS Support
Stryker
SimuLab
US Surgical
Investment
InTouch Technologies, Inc
* There will be no discussion of products from these companies
Greetings
from
Monterey
California
Storytelling
Johns Hopkins
Disruptive Visions
“The Future is not what it used to be”
….Yogi Berra
Current Visions
“The Future is here …
. . . it’s the Information Age”
Entering a New
The “Fourth Wave” ??
Clayton M Christensen
TECHNOLOGY DEVELOPMENT
BIO-INTELLIGENCE AGE
CONSUMER ACCEPTANCE
Fourth Wave?
2000 BC
0
1500
1800
1900
2000 AD
TIME (year)
Satava 29 July 99
BIO-INTELLIGENCE AGE
BIOLOGIC
Biosensors
Biomaterials
Biomimetic
PHYSICAL
FUTURE
Genomics
Bioinformatics
Biocomputation
Robotics
HPCC/WWW
MEMS/Nano
INFORMATION
Satava 2 Feb 1999
Creating a New Age
Pioneers
Inventors
Implement
Discover
The Future
Entrepreneurship
Innovators
Adopt
Satava 2 Feb 1999
The Scientific Method
Evidence Based Medicine is . . .
The Scientific Method as
Applied to Medicine
The Evidence IS the Science
In order to accept evidence-based medicine
. . . we must accept the current method in Science
What is Science ?
. . . study that relate(s) to the phenomena
of the material universe and their laws
Oxford English Dictionary
Science is what we observe by using the Scientific Method
METHODS
Classical
Period
Renaissance
Observation
phenomenon
Aristotle Archimedes
DaVinci Michelangelo
Age of
Enlightenment
experiment
Newton Boyle
Industrial Age
scientific method
Einstein Fermi
Information Age
…?
Hawking Wolfram
What is the
Controversy?
Wisdom of Giants
Evidence
Creativity of Innovators
Imagination
THE
STRUCTURE
OF
SCIENTIFIC
REVOLUTIONS
The Great Debate
4 Decades of
The Logic of Scientific Discovery
Kuhn vs Popper
THOMAS S.
KUHN
Science is Evolving
. . . and so is the Scientific Method
METHODS
Classical
Period
Renaissance
Age of
Enlightenment
Observation
phenomenon
experiment
Aristotle Archimedes
DaVinci Michelangelo
Newton Boyle
Industrial Age
scientific method
Einstein Fermi
Information Age
…?
Hawking Wolfram
A Scientific Revolution occurs with a
Breakthrough or “Crisis” in Knowledge
…and a New Era emerges
. . . and with each New Era
a new method of discovery
METHODS
Classical
Period
Renaissance
Age of
Enlightenment
Observation
phenomenon
experiment
Aristotle Archimedes
DaVinci Michelangelo
Newton Boyle
Industrial Age
scientific method
Einstein Fermi
Information Age
…?
Hawking Wolfram
Scientific Method . . .
. . . is DEAD?
Not necessarily
but
...
Not all science is explainable using the scientific method
Where is the role of
Imagination
Innovation
Serendipity
Intuition
Creativity
Inspiration
FURTHER PROOF: Current evidence is inadequate for
Event horizons
Cognition
Genome
Quantum mechanics Memes
Etc
New discoveries evolve from
Emergent Properties
S The Industry Standard
I CAD/CAM
M
U
Virtual Design
L
A
T
Virtual Prototyping
I
O
N Virtual Testing & Evaluation
W here Is the Scientific Method failing us?
Hypothesis
Study Design
Experiment
Results
Reporting
1. Where does the hypothesis come from?
?
Creativity
Intuition
Inspiration
Hypothesis
Study Design
Experiment
Results
Reporting
Analogy & Metaphor
Exception-to-the-rule
Emergent properties
Outliers, etc
“We don’t know …
what we don’t know”
2. Can all evidence be demonstrated by
Randomized, controlled, double-blind trials?
Yogi Berra
How has the Scientific Method changed ?
Hypothesis
Study Design
Experiment
Results
Reporting
Simulation
?
Creativity
Intuition
Inspiration
Hypothesis
Study Design
Experiment
Simulation
Analogy & Metaphor
Exception-to-the-rule
Emergent Properties
Outliers, etc
n= 108
Results
Reporting
Where is the Scientific Method failing us?
Hypothesis
Study Design
Experiment
Results
Reporting
2. Can all evidence be demonstrated by
Randomized, controlled, double-blind trials?
SCIENTIFIC METHOD
Controlled, randomized, double-blind trial
Control Group
No Parachute
Still looking for volunteers for the control group
Test Group
Parachute
$ Government Funding $
What Reseachers Need
to
Know
Role
of the
Crossing
Innovator
the
Chasm
Role
Innovator
of the
Crossing
the
The Second
Chasm
Valley
of Death
Inventor
Technology
Enthusiast
Inventor
Early
Innovators
Visionaries
Innovator
Early
Adopters
Pragmatic
Pioneer
Chasm
( Tech Transfer )
(Sustainment)
Pioneer
Innovator
Inventor
Design
TRL 1
2
3
4
5
Transition
6
7
Scientific Method
8
9
Gartner’s Hype Cycle
of Innovation
VISIBILITY
TIME
Technology
Trigger
Peak of
Inflated
Expectations
Trough of
Disillusionment
Slope of
Enlightenment
Plateau of
Productivity
The Innovator Must
See the “big picture”
Understand the “science”
Possess entrepreneurship
Transition the technology
The inventor
...
Discovers
The pioneer
...
Adopts
but
The innovator
...
crosses the chasm ….
Twice
Research
New Idea
Product
Disposal
Technology Readiness Levels
Technology Readiness Level
Description
This is the lowest "level" of technology
maturation. At this level, scientific
1. Basic principles observed and reported
research begins to be translated into
applied research and development.
Once basic physical principles are
observed, then at the next level of
maturation, practical applications of those
2. Technology concept and/or application characteristics can be 'invented' or
formulated
identified. At this level, the application is
still speculative: there is not experimental
proof or detailed analysis to support the
conjecture.
At this step in the maturation process,
active research and development (R&D)
is initiated. This must include both
analytical studies to set the technology
3. Analytical and experimental critical
into an appropriate context and
function and/or characteristic proof of
laboratory-based studies to physically
concept
validate that the analytical predictions are
correct. These studies and experiments
should constitute "proof-of-concept"
validation of the applications/concepts
TRL 1
2
3
4
5
Transition
6
Clinical
Trials
7
8
Scientific Method
9
The Innovator Transitions
Life-cycle Management
Medical Research is an “acquisition process”
•
•
•
•
Early discovery and concept
Research (through completed prototye – TRL 6)
Commercialization (including purchasing by users)
Maintenance and sustainment
Implication to researchers of “acquisition process”
•
•
•
•
Early research – need to consider long term needs
Research and development – understand transition strategies
Commercialization – about 90% to bring a product to market
Maintenance & sustain – did the research plan for this?
What is radically new?
Classic Education and Examination
What is the REVOLUTION in Medical Education?
Training
for
New Technical Skills
Halstedian Model:
See One, Do One, Teach One
SURGICAL EDUCATION
The Revolution
is
...
Now
Roughly 100 year cycles
(1908 – Flexner Report)
It’s all about . . .
Improved Patient Care
through
Manikin
Virtual Reality
Advanced Surgical Education
The New Mandates
Effective
1 July 2008
RRC*
All residency programs must have
a skills training (simulation) center
1 July 2009
ABS
All surgical residents must pass FLS**
in order to apply for board certificate
* Residency Review Committee (RRC)
** Fundamentals of Laparoscopic Surgery
Accreditation Council of Graduate Medical Education
Approved by American Board of Medical Specialties
Two Components of the Revolution
Using Modeling and Simulation
• Objective Training of Technical Skills
Simulators
Curriculum
•
(technology)
(training method)
Assessment of Cognitive and Technical Skills
Criterion-based tools
Objective metrics
Technology
Current areas of simulation
Models, tissue, animals
VR
Manikin
CAI
Virtual
Virtual
Live
Constructive
O
SATS
Methodology
Objective StructuredAssessment of Technical Skills
Richard Reznick, Univ of Toronto - 1998
It’s not the Simulator
It’s the Curriculum
Standardized Curriculum
Suggested template
•
•
•
•
Goals of the Simulation
Anatomy
Steps of the Procedures
Errors
TEST
• Skills Training
• Outcomes
The 6 Competencies
2003 Consensus by the AGCME & ABMS
• Knowledge
• Patient Care
•
Interpersonal and communication skills
• Professionalism
• Practice-based learning and improvement
• Systems-based practice
Mandates
Recent mandates include:
Sept, 1999 NBME
June, 2008 ACGME (RRC)
July, 2009
- Medical students required to pass OSCE
- All residency programs must have access
to a simulation center
Amer Board Surg - All residents must complete and document
Fundamentals of Laparoscopic Skills course
or have board certification application returned
Recent initiatives (curricula) to meet mandates
Amer Coll Surg
- Fundamental Skills Courses to meet ABS reqs
-
Amer Soc Anes
-
Basic, advanced surgical skills, team training
Airway management, etc - esp team training
Maintenance of Certification (MoC) - Retraining of all types
Redeployment, pregnancy sabbatical, etc
S
C
O
R
E
ACS/APDS Core Curriculum
Three Phases
Phase
Product
Complete
•Phase1
Basic Skills Curricula
July, 2007
•Phase 2
Full Procedures
July, 2008
•Phase 3
Team Training
July, 2009
ABS Training/Assessment Website
Provides educational/training resources
Clearly states expected performance outcomes (quantitative)
ACS/APDS Core Curriculum
Twenty Basic Skills
Asepsis & Instrument Identification .
Suturing
Advanced Tissue Handling: Flaps
Skin Grafts
Airway Management
Central Line Insertion, Arterial Lines
Vascular Anastomosis
Principles of Bone Fixation & Casting
Endoscopy
.
Basic Laparoscopy Skills
Hand Sewn GI Anastomosis
Knot Tying .
Tissue Handling Dissection,
Wound Closure, Wound Mgmt
Catheterization, Uretheral and
Suprapubic
Chest Tube/Thoracentesis
Surgical Biopsy
Laparotomy Opening/Closure
Introduction: Inguinal Anatomy Upper
Colonoscopy
Advanced Laparoscopy Skills
Stapled GI Anastomosis
Pre-operative Warm-up
Surgical Rehearsal
Courtesy Jacques Marescaux, IRCAD, Strasbourg France
Nurses
Residents
of
ER
Hand-off
OR
Hand-off
ICU
Second Life
Comprehensive Curriculum
Basic Skills
Simple Procedures
Advanced Procedures
Team Training
Task
Deconstruction
Continuity
of
Care
Why should we do this?
Historically
Medical education occurs in 100 yr cycles (Flexner 1910)
If don’t act now, miss “window of opportunity”
Standardization Everyone is “starting from scratch”, so everyone must change
Unique opportunity to have ‘International’ standards
Paradigm Shift Competency (criterion) based training and assessment
? Totally change structure of system (eg time-based)
Ethical Implications
Credentialing
every surgeon, every procedure?
Patient Safety
assurance for our patients?
Animals for training
still needed, but reduced?
Quality Assurance
promising too much?
And just what are these incredible new technologies?
Information Representation of a Patient
Medical equivalent of CAD/CAM
Holomer
Total body-scan
for total knowledge
Virtual Soldier Program
Multi-modal total body scan on
every trauma patient in 15 seconds
Satava
March, 2004
Total Integration of Surgical Care
Minimally Invasive
& Open Surgery
Remote Surgery
Pre-operative planning
Surgical Rehearsal
Simulation & Training
Pre-operative Warmup
Intra-operative navigation
Courtesy of Joel Jensen,
SRI International, Menlo Park, CA
The Fundamental Change
From tissue and instruments
to
Information and energy*
* “The Information Age is about changing from objects and atoms to bits & bytes”
Nicholas Negroponte “Being Digital” - 1995
Replacing human body parts
Intelligent Prostheses
Tissue Engineering
Artificial Ear
a) Rheo Bionic knee
Ossur,
Reyknavik, Iceland
b) C-leg
Otto Bock,
Minneapolis, MN
Liver Scaffolding
J. Vacanti, MD
Artificial Blood Vessel
MGH
March, 2000
Organs which have been grown synthetically
Commercial Products
Neo-bladder – a commercial synthetic bladder
A surgeon takes a
small, full-thickness
biopsy from the
patient’s bladder.
urothelial and smooth
muscle cells that are
capable of regeneration
are isolated.
The isolated cells are
cultured separately until
there are a sufficient
quantity.
The cultured cells are
properly seeded onto a
biodegradable scaffold
shaped like a bladder.
The biodegradable
scaffold dissolves
and is eliminated
from the body,
leaving a functioning
bladder made only of
the patient’s own
newly regenerated
tissue.
The body uses the
neo-bladder construct
to regenerate and
integrate new tissue,
restoring the bladder’s
functionality.
The neo-bladder
construct is implanted
by the surgeon using
standard surgical
techniques.
Quality assurance that the
cells attach and grow
properly throughout the
scaffold. After about 8
weeks, the neo-bladder
construct is returned to the
surgeon for implantation.
Tegion,
Tengion
Courtesy of
East Norrington, PA 2007.
Genetically re-engineering the body
Orb spider - web
Spinnerette of spider
Spider silk protein as biomaterial -BioSteel
Cross section of synthetic fiber
Nexia Biotechnologies, Montreal Canada
Suspended Animation
( Auto-anesthesia - FRAMR )
Institute of Arctic Biology’s
Toolik Field Station,
Alaska's North Slope
heart rate
active
hibernating
300
3
(beats/min)
resp. rate
150
<1
(breaths/min)
body temp.
gene
function
metabolic rate
37oC
-2oC
ongoing
transcription
and translation suppressed
0.5
0.01 (2%)
(mlO2/g/h)
Brian M. Barnes,
Institute of Arctic Biology , University of Alaska Fairbanks 11/02
The Moral Dilemma
Technology is Neutral - it is neither good or evil
It is up to us to breathe the moral and ethical life
into these technologies
And then apply them with empathy and compassion
for each and every patient
Human embryos
cloned
Chinese Cloning Control Required
Tuesday 16 April, 2002, 10:41 GMT 11:41 UK
Strict ethical guidelines are needed in China to
calm public fears about new cell technologies such
as cloning, the country's leading scientist said.
Professor Ching-Li Hu, the former deputy
director of the World Health Organization, was
speaking at the Seventh Human Genome Meeting
in Shanghai. His call follows recent reports that
Chinese scientists are making fast progress in
these research fields.
One group in the Central South University
in Changsa is said to be producing human
embryo clones, while another team from the Sun
Yat-sen University of Medical Sciences in
Guangzhou is reported to have fused human and
rabbit cells to make tissues for research.
February 12, 2004
South Korean team demonstrates
cloning efficiency for humans similar
to pigs, cattle
| Thersa Tamkins
After outlandish claims, a few media circuses,
and some near misses by legitimate
researchers, a team of South Korean
researchers reports the production of
cloned human embryos. The findings, were
released Wednesday (Science, DOI:10.1126
/science.1094515, February 12, 2004).Wook
Suk Hwang and Shin Yong Moon of Seoul
National University used somatic cell nuclear
transfer to produce 30 human blastocysts and
a single embryonic stem cell line; SCNT-hES1. Using 242 oocytes and cumulus cells from
16 unpaid donors, the group achieved a
cloning efficiency of 19 to 29%, on par with
that seen in cattle (25%) and pigs (26%).
Jeffery Steinberg, MD
Fertility Institutes of Los Angeles
Genetically “designed” child
1997
Five "designer babies"
created for stem cell
harvest
Five healthy babies have been born to provide stem
cells for siblings with serious non-heritable conditions.
Preimplantation Genetic Screening
General Science: May 13, 2006
A British woman has become the first in the
country to conceive a "designer baby" selected
specifically to avoid an inherited cancer,
This is the first time "savoir siblings" have been
created to treat children whose condition is not genetic,
says the medical team.The five babies were born after
a technique called preimplantation genetic diagnosis
(PGD) was used to test embryos for a tissue type match
to the ailing siblings, reports the team, led by Anver
Kuliev at the Reproductive Genetics Institute in
Chicago, US.The aim in these cases was to provide
stem cells for transplantation to children who are
suffering from leukaemia 'Unlawful and
unethical' However, the use of this technology to
provide a "designer baby" to treat an ill sibling is
Science Vol 315: 1723-25, Mar 2007
highly controversial.A UK couple involved in this
Gregory Stock
The woman, who was not identified, used
controversial genetic screening technology to ensure
she does not pass on to her child the condition
retinoblastoma, an hereditary form of eye cancer
from which she suffers.
Emergence of Novel Color Vision in Mice Engineered
Doctors tested embryos created by the woman and
her partner using in-vitro fertilisation (IVF) methods
to Express Human Cone Photo-pigment
for the cancer gene. Only unaffected embryos were
implanted in her womb, the newspaper said.
Changes in the genes encoding sensory recptor proteins are an essential step in
It suggested the woman's pregnancy would
the evolution of new sensory capacities“new sensory capacities" . In primates, triincrease controversy over the procedure -- prechromatic color vision evolved aftre changes in x chromosome linked photopigment genes.
implantation genetic diagnosis (PGD) -- because
Heterogous mouse females whose retinas contained both mouse pigment and
critics say it involves destroying otherwise healthy
human
humanLLpigments
pigments showed enhanced long-wavelength sensitivity and chromatic
embryos whose conditions are treatable.
discrimination. An inherent plasticity in the mammalian visual system thus permits emergence
1.
Verlinsky Y, Rechitsky S, Sharapova T, Morris R, Taranissi M and Kuliev A. Preimplantation HLA Testing. JAMA (2004) 29: 2079
Extending Longevity
Life extension
A strain of mice that have lived . . .
. . . more than three normal lifespans
Should humans live 200 years?
April 14, 2004
Life extension consists of attempts to extend
human life beyond the natural lifespan. So far
none has been proven successful in humans.
Several aging mechanisms are known, and antiaging therapies aim to correct one or more of
these:
Dr. Leonard Hayflick discovered that mammalian
cells divide only a fixed number of times. This
"Hayflick limit" was later proven to be caused by
telomeres on the ends of chromosomes that
shorten with each cell-division. When the
telomeres are gone, the DNA can no longer be
copied, and cell division ceases. In 2001,
experimenters at Geron Corp. lengthened the
telomeres of senescent mammalian cells by
introducing telomerase to them. They then
became youthful cells. Sex and some stem cells
regenerate the telomeres by two mechanisms:
Telomerase, and ALT (alternative lengthening of
telomeres). At least one form of progeria (atypical
accelerated aging) is caused by premature
telomeric shortening. In 2001, research showed
that naturally occurring stem cells must
sometimes extend their telomeres, because some
stem cells in middle-aged humans had
anomalously long telomeres.
CAN I REPLACE MY
BODY ?
Artificial organs
Smart Prostheses
Genetic engineering
Regeneration
If I replace 95%
of my body . . .
. . . Am I still “human”?
Should there be replacement
“parts” for astronauts?
Moral and Ethical Issues
Raised by Technological Success
will take DECADES of debate
Summary of Examples
Should we do research in areas we may not be able to control?
(eg, genetics, cloning, nanobots, intelligent machines?)
Will prolonging life result in more disease in the overall population
Can we change medicine from treatment to prevention of disease
In defeating diseases, will technology change a human into a combination
of man and machine - what does it mean to be “human”
How will we decide who gets the technology, especially in 3rd World
6
SATAVA 7 July, 1999
DARPA
The Ultimate Ethical Question?
For the first time in history,
there walks upon this planet,
a species so powerful,
that it can control its own evolution,
at its own time of choosing …
… homo sapiens.
Who will be the next “created” species?
http://depts.washington.edu/biointel
Do Robots Dream ?
SMIT2009
MIRA2010
January 27-30, 2010
San Diego, CA - Manchester Grand Hyatt
CALL FOR ABSTRACTS DEADLINE:
August 14, 2009
Program Chair: Santiago Horgan, MD
Minimally Invasive Robotic Association (MIRA)
MISSION
To raise the level of robotic surgery care in the world.
Sinaia, Romania, 7-9 October 2009
As a multidisciplinary association, MIRA invites not only surgeons, but
also internists, radiologist, engineers and computer scientists, interested
in robotics, telerobotics, telepresence, teleconferencing and
telementoring, to join the association and take part in the 2010
International Congress.