UTURE

Richard M. Satava, MD FACSProfessor of Surgery

University of Washington

Richard M. Satava, MD FACSProfessor of Surgery

University of Washington

The Innovative and EntrepreneurialCulture – Examples in Healthcare

The Innovative and EntrepreneurialCulture – Examples in Healthcare

Innovation ForumInnovation Opportunities in Health

University of Saskachewan Saskatoon, Saskachewan

13-15 September, 2009

Innovation ForumInnovation Opportunities in Health

University of Saskachewan Saskatoon, Saskachewan

13-15 September, 2009

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

Presenter Financial Disclosure Slide

Greetings from MontereyCalifornia

Storytelling

Johns Hopkins

“The Future is not what it used to be”

….Yogi Berra

“The Future is not what it used to be”

….Yogi Berra

Disruptive Visions

“The Future is here …

. . . it’s the Information Age”

“The Future is here …

. . . it’s the Information Age”

Current Visions

AgeThe “Fourth Wave” ??

Entering a New

Clayton M Christensen

BIO-INTELLIGENCE AGET

EC

HN

OL

OG

Y

DE

VE

LO

PM

EN

T

CONSUMER ACCEPTANCE

AGRICULTURAL AGE

INDUSTRIAL AGE

BIOINTELLIGENCE AGE

INFORMATION AGE

TIME (year)

2000 BC 0 2000 AD190018001500

Satava 29 July 99

Fourth Wave?

BIOLOGIC PHYSICAL

INFORMATION

FUTURE

RoboticsHPCC/WWWMEMS/Nano

GenomicsBioinformaticsBiocomputation

BiosensorsBiomaterialsBiomimetic

Satava 2 Feb 1999

BIO-INTELLIGENCE AGE

Inventors Pioneers

Innovators

The Future

Implement

Adopt

Discover

Satava 2 Feb 1999

Creating a New Age

Entrepreneurship

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 ScienceIn order to accept evidence-based medicine . . . we must accept the current method in Science

The Scientific Method

What is Science ?What is Science ?

. . . study that relate(s) to the phenomena of the material universe and their laws

Oxford English Dictionary

. . . study that relate(s) to the phenomena of the material universe and their laws

Oxford English Dictionary

METHODS

Classical Renaissance Age of Industrial Age Information Age Period Enlightenment

Observation phenomenon experiment scientific method …?

Aristotle Archimedes DaVinci Michelangelo Newton Boyle Einstein Fermi Hawking Wolfram

Science is what we observe by using the Scientific MethodScience is what we observe by using the Scientific Method

Wisdom of Giants

Creativity of Innovators

EvidenceEvidence

ImaginationImagination

What is the Controversy?

Science is Evolving . . . and so is the Scientific Method

THE STRUCTURE

OF SCIENTIFIC

REVOLUTIONS

THOMAS S. KUHN

The Great DebateThe Great Debate

4 Decades of

Kuhn vs Popper

4 Decades of

Kuhn vs Popper

METHODS




The Logic of Scientific Discovery

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. . . and with each New Era a new method of discovery

METHODS




Scientific Method . . .. . . is DEAD?

Not necessarily but . . .

Not all science is explainable using the scientific method

Where is the role of Imagination Intuition Innovation Creativity Serendipity Inspiration

FURTHER PROOF: Current evidence is inadequate forEvent horizons Cognition GenomeQuantum mechanics Memes Etc

New discoveries evolve fromEmergent Properties

SIMULATION

The Industry StandardCAD/CAM

Virtual Design

Virtual Prototyping

Virtual Testing & Evaluation

W here Is the Scientific Method failing us?

Hypothesis Study Design Experiment Results Reporting

CreativityIntuitionInspiration


??


Analogy & MetaphorException-to-the-ruleEmergent propertiesOutliers, etc “We don’t know … what we don’t know” Yogi Berra

1. Where does the hypothesis come from?

2. Can all evidence be demonstrated by Randomized, controlled, double-blind trials?


How has the Scientific Method changed ?

??


Analogy & MetaphorException-to-the-ruleEmergent PropertiesOutliers, etc

Simulation

Simulation n= 108CreativityIntuitionInspiration


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 METHODControlled, randomized, double-blind trial

Control GroupNo Parachute

Test GroupParachute

Still looking for volunteers for the control groupStill looking for volunteers for the control group

$ Government Funding $

What Reseachers Need to Know

Role of the InnovatorCrossing the Chasm

InventorInnovator Pioneer

Valleyof Death

The SecondChasm

EarlyAdoptersPragmatic

EarlyInnovatorsVisionariesInventor

TechnologyEnthusiast

Crossing the Chasm

Role of the Innovator

TRL 1 2 3 4 5 6 7 8 9

Design

Transition

( Tech Transfer ) (Sustainment)

Scientific Method

Inventor Innovator Pioneer

TIME

VISIBILITY Gartner’s Hype Cycleof Innovation

TechnologyTrigger

Peak of Inflated

Expectations

Trough ofDisillusionment

Slope of Enlightenment

Plateau ofProductivity

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

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

The Innovator Must

New IdeaProductDisposal

Research

TRL 1 2 3 4 5 6 7 8 9Transition Scientific Method

Clinical Trials

Technology Readiness Level Description

1. Basic principles observed and reported

This is the lowest "level" of technology maturation. At this level, scientific research begins to be translated into applied research and development.

2. Technology concept and/or application formulated

Once basic physical principles are observed, then at the next level of maturation, practical applications of those characteristics can be 'invented' or identified. At this level, the application is still speculative: there is not experimental proof or detailed analysis to support the conjecture.

3. Analytical and experimental critical function and/or characteristic proof of concept

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 into an appropriate context and laboratory-based studies to physically validate that the analytical predictions are correct. These studies and experiments should constitute "proof-of-concept" validation of the applications/concepts

Technology Readiness Levels

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?

The Innovator Transitions

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

The Revolutionis

. . . Now

Roughly 100 year cycles (1908 – Flexner Report)

SURGICAL EDUCATION

Improved Patient Care

through

Advanced Surgical Education

ManikinVirtual Reality

It’s all about . . .

Effective

1 July 2008 All residency programs must haveRRC* a skills training (simulation) center

1 July 2009 All surgical residents must pass FLS** ABS in order to apply for board certificate

The New Mandates

• Objective Training of Technical SkillsSimulators (technology)

Curriculum (training method)

• Assessment of Cognitive and Technical SkillsCriterion-based toolsObjective metrics

• Objective Training of Technical SkillsSimulators (technology)

Curriculum (training method)

• Assessment of Cognitive and Technical SkillsCriterion-based toolsObjective metrics

Two Components of the RevolutionUsing Modeling and Simulation

Technology Current areas of simulation

VirtualVirtualVirtualVirtual LiveLive ConstructiveConstructive

ManikinManikinVRVR

CAICAI

Models, tissue, animalsModels, tissue, animals

Methodology Objective StructuredAssessment of Technical Skills

Richard Reznick, Univ of Toronto - 1998Richard Reznick, Univ of Toronto - 1998

OSATS

It’s not the Simulator

It’s the Curriculum

It’s not the Simulator

It’s the Curriculum

Standardized Curriculum

• Goals of the Simulation• Anatomy• Steps of the Procedures• Errors TEST• Skills Training• Outcomes

Suggested template

The 6 Competencies2003 Consensus by the AGCME & ABMS

• Knowledge

• Patient Care

• Interpersonal and communication skills

• Professionalism

• Practice-based learning and improvement

• Systems-based practice

MandatesMandatesRecent mandates include:

Sept, 1999 NBME - Medical students required to pass OSCE June, 2008 ACGME (RRC) - All residency programs must have access

to a simulation center July, 2009 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 mandatesAmer Coll Surg - Fundamental Skills Courses to meet ABS reqs

- Basic, advanced surgical skills, team trainingAmer Soc Anes - Airway management, etc - esp team training

Maintenance of Certification (MoC) - Retraining of all types Redeployment, pregnancy sabbatical, etc

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)

SCORE

Twenty Basic Skills

Asepsis & Instrument Identification . Knot Tying . Suturing Tissue Handling Dissection,

Wound Closure, Wound MgmtAdvanced Tissue Handling: Flaps Catheterization, Uretheral and

Skin Grafts SuprapubicAirway Management Chest Tube/ThoracentesisCentral Line Insertion, Arterial Lines Surgical BiopsyVascular Anastomosis Laparotomy Opening/ClosurePrinciples of Bone Fixation & Casting Introduction: Inguinal Anatomy Upper Endoscopy . ColonoscopyBasic Laparoscopy Skills Advanced Laparoscopy SkillsHand Sewn GI Anastomosis Stapled GI Anastomosis

ACS/APDS Core Curriculum

Pre-operative Warm-up

Surgical Rehearsal

Courtesy Jacques Marescaux, IRCAD, Strasbourg France

Nurses Residents

OR

of

ER ICUHand-off Hand-off

Second Life

Basic SkillsBasic Skills

Simple ProceduresSimple Procedures

Team TrainingTeam Training

Advanced ProceduresAdvanced Procedures

Continuity of CareContinuity of Care

Comprehensive CurriculumComprehensive Curriculum

Task Deconstruction

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 changeUnique opportunity to have ‘International’ standards

Paradigm Shift Competency (criterion) based training and assessment? Totally change structure of system (eg time-based)

Credentialing every surgeon, every procedure?

Patient Safety assurance for our patients?

Animals for training still needed, but reduced?

Quality Assurance promising too much?

Credentialing every surgeon, every procedure?

Patient Safety assurance for our patients?

Animals for training still needed, but reduced?

Quality Assurance promising too much?

Ethical Implications

And just what are these incredible new technologies?

HolomerTotal body-scan

for total knowledge

Satava March, 2004Virtual Soldier Program

Information Representation of a PatientInformation Representation of a PatientMedical equivalent of CAD/CAMMedical equivalent of CAD/CAM

Multi-modal total body scan on every trauma patient in 15 seconds

Total Integration of Surgical Care

Courtesy of Joel Jensen, SRI International, Menlo Park, CA

Minimally Invasive& Open Surgery

Pre-operative planningSurgical Rehearsal

Intra-operative navigation

Remote Surgery

Simulation & TrainingPre-operative Warmup

From tissue and instruments

to

Information and energy*

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

The Fundamental Change

a) Rheo Bionic knee Ossur, Reyknavik, Iceland

b) C-leg Otto Bock, Minneapolis, MN

Intelligent Prostheses Tissue Engineering

Liver Scaffolding Artificial Blood Vessel

J. Vacanti, MD MGH March, 2000

Artificial Ear

Replacing human body parts

Organs which have been grown synthetically

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.

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.

The neo-bladder construct is implanted by the surgeon using standard surgical techniques.

The body uses the neo-bladder construct to regenerate and integrate new tissue, restoring the bladder’s functionality.

The biodegradable scaffold dissolves and is eliminated from the body, leaving a functioning bladder made only of the patient’s own newly regenerated tissue.

A surgeon takes a small, full-thickness biopsy from the patient’s bladder.

Courtesy of Tengion East Norrington, PA 2007.

Neo-bladder – a commercial synthetic bladder

Tegion,

Commercial Products

Spider silk protein as biomaterial -BioSteel

Nexia Biotechnologies, Montreal Canada

Cross section of synthetic fiber

Spinnerette of spider

Orb spider - web

Genetically re-engineering the body

Brian M. Barnes, Institute of Arctic Biology , University of Alaska Fairbanks 11/02

Institute of Arctic Biology’s

Toolik Field Station,

Alaska's North Slope

Suspended Animation ( Auto-anesthesia - FRAMR )

metabolic rate 0.5 0.01 (2%)

active hibernating

body temp. 37oC -2oC

gene ongoing transcription function and translation suppressed

heart rate 300 3

resp. rate 150 <1 (breaths/min)

(beats/min)

(mlO2/g/h)

Alternative

Confidential

Technology is Neutral - it is neither good or evil

It is up to us to breathe the moral and ethical lifeinto these technologies

And then apply them with empathy and compassionfor each and every patient

The Moral Dilemma

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-hES-1. 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%).

Human embryos cloned

Chinese Cloning Control RequiredTuesday 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.

Genetically “designed” child1997

Jeffery Steinberg, MD Fertility Institutes of Los Angeles

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.

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 highly controversial.A UK couple involved in this

1. Verlinsky Y, Rechitsky S, Sharapova T, Morris R, Taranissi M and Kuliev A. Preimplantation HLA Testing. JAMA (2004) 29: 2079

Preimplantation Genetic ScreeningGeneral 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,

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. Doctors tested embryos created by the woman and her partner using in-vitro fertilisation (IVF) methods for the cancer gene. Only unaffected embryos were implanted in her womb, the newspaper said. It suggested the woman's pregnancy would increase controversy over the procedure -- pre-implantation genetic diagnosis (PGD) -- because critics say it involves destroying otherwise healthy embryos whose conditions are treatable.

Gregory Stock

Science Vol 315: 1723-25, Mar 2007

Emergence of Novel Color Vision in Mice Engineered to Express Human Cone Photo-pigment

Changes in the genes encoding sensory recptor proteins are an essential step in

the evolution of new sensory capacities“new sensory capacities" . In primates, tri-chromatic color vision evolved aftre changes in x chromosome linked photopigment genes. Heterogous mouse females human L pigments showed enhanced long-wavelength sensitivity and chromatic discrimination. An inherent plasticity in the mammalian visual system thus permits emergence

whose retinas contained both mouse pigment andhuman L pigments

http://www.physorg.com/news66717645.html

Extending Longevity

A strain of mice that have lived . . .

. . . more than three normal lifespans

Should humans live 200 years?

Life extension

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 anti-aging 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.

April 14, 2004

CAN I REPLACE MY

B O D Y ?

If I replace 95% of my body . . .

. . . Am I still “human”?

Artificial organs

Smart Prostheses

Genetic engineering

Regeneration

Should there be replacement “parts” for astronauts?

Moral and Ethical Issues

Raised by Technological Successwill 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 WorldSATAVA 7 July, 1999DARPA

6

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?

The Ultimate Ethical Question?

Do Robots Dream ?http://depts.washington.edu/biointel

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.

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.

SMIT2009 MIRA2010

January 27-30, 2010San Diego, CA - Manchester Grand Hyatt

Sinaia, Romania, 7-9 October 2009

Documents

UTURE