Your Best Ideas
Why save good ideas?
Bradley Fuhrman
Chief, Pediatric Critical Care
Women & Children’s Hospital of Buffalo
“To change the world…”
Bill Nye the Science Guy
1
2
Good Ideas
Your best ideas can get lost in your brain:
Best Idea
Bad Ideas
3
4
Other Ideas
3 Classes of Good Ideas
Ideas can walk…
Exemplified by
Louis Pasteur (1822-1895)
It’s amazing we can
find anything, including
yesterday’s ideas…
5
New Insight
Germ Theory
New Process
Pasteurization
New Thing
Rabies Vaccine
6
Insight: Germ Theory
Insight: Fermentation is caused by micro-organisms
Louis Pasteur(1822–1895)
Chemist
Director Scientific Studies
Ecole Normale Superieure
Father of Five
Disproved theory of “spontaneous generation”
7
8
Process: Vaccination
Process: Pasteurization of Wine
Micro-organisms spoil milk, sour wine and cause disease
(eg. scrofula).
Prevention by pasteurization
Homeopathy
• Cowpox less virulent than Smallpox
• Milk Maids not generally susceptible to
Smallpox
• Cowpox discharge used to prevent
Smallpox as early as 200 BC
• Benjamin Jesty (a farmer) said to have
treated his wife to protect from Smallpox
9
Mass Vaccination – Using Cowpox
10
Thing:
Cholera and Anthrax Vaccines
Edward Jenner (1749-1823)
English Country Doctor
As a forward-thinking doctor who liked to experiment,
Jenner wanted to prove his theory. In 1796 he inserted pus
taken from Sarah Nelmes, a milkmaid with cowpox, into a cut
made in the arm of a local boy, James Phipps. Several days
later, Jenner exposed the boy to smallpox. He proved to be
immune.
11
• Pasteur isolated causative agent (vibrio cholerae)
and proved that it induced disease in chickens
• Charles Chamberland (his assistant) left the culture
out and went on holiday
• On his return, the culture failed to induce illness
• Chickens infected with ineffective culture found to be
immune to cholera from fresh culture
• Pasteur recognized the significance of “attenuation”
and developed attenuated vaccines for both cholera
and anthrax
“…chance favors… the prepared mind” (1854)
12
Louis Pasteur - Pragmatist
Thing: Rabies Vaccine
Vaccines using attenuated agents:
Cholera, Anthrax and Rabies
Dried (attenuated) Rabies-Infected Spinal Cord in Roux Bottle
Rabies Vaccine
funded Pasteur
Institute
Administered attenuated rabies to Joseph
Meister, a 9-year-old mauled by a rabid dog.
13
How to grow an idea:
•
•
•
•
•
•
•
•
“There are no such things as applied sciences,
14
only applications of science.”
Preserve It
Preserve it – Write it down.
Disclosure it – Publish it.
Embody it – Produce it.
Prove it – Show that it works.
Gain Regulatory Approval – (FDA)
Gain Patent Protection – (USPTO)
Obtain Funding to Advance it – (Grants and Investment)
Win Acceptance/ Shift the Paradigm
• First step to avoid losing it in the recesses
of the mind
• Give it a home in which to develop
• Provide a “paper trail” of how it evolved
– Chain of evidence of priority and ownership
– Create a map of branch points for revision
15
Preserve It
Fermi’s Laboratory Notebook – Columbia University
17
Ideas are seldom complete when first conceived.
16
Disclose It – Special Relativity
18
Disclose - It
• Engage others in your work
• Start the paradigm shift
NICHOLAS COPERNICUS (1473-1543)
Dedication to Pope Paul III, from "The Revolutions of the Heavenly Bodies", by
Copernicus, 1543.
I CAN easily conceive, most Holy Father, that as soon as some people learn that in
this book which I have written concerning the revolutions of the heavenly bodies, I
ascribe certain motions to the Earth, they will cry out at once that I and my theory
should be rejected.
19
Modern Paradigm Shift
20
Publication and Prior Art
Needleless Technology
If the idea will require future financial
investment, initiate protection of future profit
before disclosure.
21
22
Patent Protection
The first patents protected monopolies.
Patent Protection
In the modern world, patent protection is
conferred to protect investment in novel (risky)
development.
• Provide time-limited freedom from competition
• Protect the investor’s cost of development
• Leverage the value of an idea so that it can
compete with the status quo.
Boston Tea Party – 1773 – to protest unfair protection of the British East India
Company, a tea exporter that competed with colonial merchants – may be seen
as a case of aggressive patent infringement…
23
24
"Next came the Patent laws. These
began in England in 1624; and, in this
country, with the adoption of our
constitution. Before then, any man
might instantly use what another had
invented; so that the inventor had no
special advantage from his own
invention. The patent system changed
this; secured to the inventor, for a
limited time, the exclusive use of his
invention; and thereby added the fuel
of interest to the fire of genius, in the
discovery and production of new and
useful things."
Patent Protection - Requirements
•
•
•
•
•
Thing or process, not just an idea
Useful
Novel
Non-obvious
Not intrinsic to a known thing or process
25
26
“I’d never have an idea worth patenting…”
Patents are not subject to practicality tests…
27
May protect inventor’s
sole use…
28
May apply elements already in the
public domain for novel use…
29
30
Amateur inventors are common…
Inventor’s often cross professions…
Inventions need not be shown to work…
31
Motivation often obscure…
33
32
34
Inventors are often versatile…
35
Not all inventions are “serious”…
36
Patent Power
Patent Protection - Mechanics
Protection from Infringement
University
IP Office
• University Disclosure (if appointed)
• Provisional Patent Application
• Non-Provisional Patent Application
Infringer
– Full Claim Set
• International Patent Application
– (PCT – Patent Cooperation Treaty)
Inventor
37
Regulatory Pathways
Regulatory Pathway - Drugs
Idea
38
Device with Predicate
Idea
Embodiment
Drug
Investigational New Drug Application
FDA
Clinical Trials
Safety
Efficacy
Embodiment
Device With Predicate
Iterative Design
Win Trials
FDA
Test to Established
Specifications
Approval
Approval
Change the World
Change the World
39
Regulatory Pathways
Investment and Development
Device without Predicate
Idea
40
Invention
Embodiment
$$
$
Device Without Predicate
Patent Protection
Iterative Design
FDA
$$
Develop Specifications
$$$
Approval
$$
Regulatory Approval
$$$
License
Test to Agreed Specifications
Clinical Trials
Change the World
Embodiment
Testing
$$
$$$
Change the World
41
42
Conflicts of Interest
Conflicts of Interest
• Intrinsically financial
• Is your last paper a conflict of interest
• Require transparency for integrity of test data
• Do not require abandonment of ideas
• Fostered yet feared by universities
43
44
Counter-Point
Entrepreneurial Spirit - Point
Escalating Polio Epidemic - 1952
58,000 US cases – mostly children
3,000 deaths
21,000 of survivors remained paralyzed
There is nothing wrong with seeking
to change the world or profit by it.
Wilson Greatbatch – Implantable Pacemaker:
“Nine out of 10 things I’ve done have never
worked. And that doesn’t bother me.”
>300 Patents
Chinese
Chop
Bill Gates – Former CEO Microsoft & CoChair Bill & Melinda Gates Foundation –
Net Worth ~ $50 B
45
"There is no patent. Could you patent the sun?"
Profit and Paradigm Shifts
Profit and Paradigm Shifts
Fixed Array, Movable Type
Automobile & Assembly Line
Bi Sheng (ca. 990–1051) Johannes Gutenberg (1397 - 1468)
Cloth Vendor
Goldsmith
47
Sung Dynasty - China
Gutenberg Bible 1450-1455
Henry Ford with Model T Ford
Buffalo, 1921
46
48
Profit and Paradigm Shifts
Profit and Paradigm Shifts
Model T Assembly Line – Circa 1913
49
Plumber and Retailer
1836-1910
50
George Washington Carver
Medical Paradigm Shifts
300 Uses for Peanuts
Turned Peanuts into a cash crop
Volatile Anesthesia
Sam’s favorite paradigm shift
William T. G. Morton (1819-1868)
Specialist in Artificial Teeth
Surgeon: John Collins Warren
Anesthesia: William T. G. Morton
52
51
Medical Paradigm Shifts
Semmelweis – Hand-Washing Lowered Maternal Mortality
Asepsis - Antisepsis
Ignaz Semmelweis (1818-65)
Handwashing Reduces Infection
Joseph Lister (1827-1912)
Sterilization of Instruments
Vienna General Hospital in Austria
53
54
Medical Paradigm Shifts
Medical Paradigm Shifts
Antiseptic Surgery
Lister Carbolic Acid Sprayer
Therapeutic Inhalation of Nitric Oxide to Reverse
Pulmonary Vasoconstriction
Carbolic Acid Sterilized
Catgut Ligatures
Made Surgery Practical
55
56
Medical Paradigm Shifts
Medical Paradigm Shifts
Rashkind Procedure
Interventional Cardiology
57
58
Medical Paradigm Shifts
Modern Medical Paradigm Shifts
Hand Management
Lister vs Semmelweis
Multidisciplinary Intensive Care Unit
59
Peter Safar (1924 –2003)
Open Airway Head-Tilt – Mouth-to-Mouth Resuscitation
Father of Modern CPR
First Multidisciplinary Intensive Care Unit (Baltimore City Hospital 1958 )
60
An Idea is a terrible thing to waste.
Thank you…
61