PATHWAY to SUCCESS BIF-4 Richard M. Satava, MD, FACS, ABCD, ETC Presenter Financial Disclosure Slide Richard M.
Download ReportTranscript PATHWAY to SUCCESS BIF-4 Richard M. Satava, MD, FACS, ABCD, ETC Presenter Financial Disclosure Slide Richard M.
PATHWAY to SUCCESS BIF-4 Richard M. Satava, MD, FACS, ABCD, ETC 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 TRL Levels 1 2 3 4 5 6 7 8 9 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. At this step in the maturation process, active research and development (R&D) is initiated. This must include both analytical studies to set the 3. Analytical and experimental critical function and/or characteristic proof of technology into an appropriate context and laboratory-based studies to concept physically validate that the analytical predictions are correct. These studies and experiments should constitute "proof-of-concept" validation of the applications/concepts formulated at TRL 2. Disruptive Visions “The Future is not what it used to be” ….Yogi Berra Current Visions “The Future is here … . . . it’s the Information Age” TECHNOLOGY DEVELOPMENT BIO-INTELLIGENCE AGE CONSUMER ACCEPTANCE 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 Science and the Clash of the Dinosaurs and Mammals Wisdom of Giants Evidence “… standing on the shoulders of Giants” Robert Hooke Creativity of Innovators Imagination “Imagination is more important than knowledge” Albert Einstein Scientific Method . . . . . . is DEAD? Not necessarily but ... Not all science is explainable using the scientific method Where is the origin of : Imagination Innovation Creativity Intuition Inspiration Serendipity Current evidence is inadequate Event horizons Cognition Quantum mechanics Memes New discoveries evolve from Emergent Properties Genome Where is the Scientific Method failing us? Hypothesis Study Design Experiment Results Reporting 1. Where does the hypothesis come from? ? Hypothesis Study Design Experiment Results Creativity Intuition Inspiration 2. Can all evidence be demonstrated by controlled, randomized, double-blind studies? Reporting SCIENTIFIC METHOD Controlled, randomized, double-blind trial Control Group No Parachute Still looking for volunteers for the control group Test Group Parachute And just what are these incredible new technologies? Virtual Autopsy . . . . . . is a SIMULATED Autopsy Wound Tract Less than 2% of hospital deaths have autopsy Statistics from autopsy drive national policies N.O.T.E.S. Courtesy of N Reddy, Hyderbad, India 20005 First Transgastric Appendectomy – N.O.T.E.S. Courtesy of N Reddy, Hyberdad India 2005 So What ? Integrating Surgical Systems for Autonomy The Operating Room (personnel) of the Future 100,000 Surgeon Assistant Scrub Nurse Circulating nurse Borrowing from the standard practices of other industries Demonstration of Phase 1 Operating Room with no People SRI International, Menlo Park, CA January, 2007 Demonstration of Phase 1 Operating Room with no People SRI International, Menlo Park, CA January, 2007 Surgical Cockpit Simulated tele-operation Chrysalis directed by Julien Leclercq. October 2007 “BrainGate” John Donohue, Brown University, 2001 Richard Andersen, CalTech, 2003 Greg Kovacs. Stanford University, 1990 Brain Machine Interface – Controlling motion with thoughts Recorded activity for intended movement to a briefly flashed target. TARGET PLAN MOVEMENT Time Courtesy Richard Andersen, Cal Tech, Pasadena, CA Direct brain implant control of robot arm Miguel Nicholai, Duke University, 2002 NICHD/NCMRR Fully Implantable Neural Interface NIH Bioengineering Resea Partnership QuickTime™ and a TIFF (Uncompressed) decompressor are needed to see this picture. QuickTime™ and a TIFF (Uncompressed) decompressor are needed to see this picture. NCMRR Qu i c k Ti m e ™ a n d a TIF F (Un c o m p re s s e d ) d e c o m p re s s o r a re n e e d e d t o s e e th i s p i c tu re . QuickTime™ and a TIFF (Uncompressed) decompressor are needed to see this picture. Brain Sensor Arto Nurmikko: Engineering, University Wireless,Brown Implantable Optical Fiber QuickTime™ and a decompressor are needed to see this picture. 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 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 Be careful of unintended consequences Experience is the name everyone gives to their mistakes - Oscar Wilde The only thing more dangerous than trying too hard and failing … … is not trying hard enough and succeeding ! Michelangelo 1503 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 with technology 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” 6 How will we decide who gets the technology, especially in 3rd World 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 ? 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