The SurgeonScientistInventor Perspective

1
The Surgeon/Scientist/Inventor Perspective
James L. Cox, M.D. Emeritus Evarts A.
Graham Professor of Surgery
Division of Cardiothoracic
Surgery Department of
Surgery
Washington University School of Medicine
St. Louis, Missouri
2
Product Development - Academia Industry
3
Product Development - Academia Industry
Education Training
1960
1980
1990
2000
2010
1970
4
Product Development - Academia Industry
Education Training
1960
1980
1990
2000
2010
1970
5
Product Development - Academia Industry
Education Training
Arrhythmia Research (5 yrs.)
1960
1980
1990
2000
2010
1970
6
Product Development - Academia Industry
Education Training
Arrhythmia Research (5 yrs.)
1960
1980
1990
2000
2010
1970
Surgical Training (7 yrs.)
7
Product Development - Academia Industry
Education Training
Professional Career
1960
1980
1990
2000
2010
1970
8
Product Development - Academia Industry
Education Training
Professional Career
1960
1980
1990
2000
2010
1970
9
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
Academic Activities
10
Product Development - Academia Industry
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
Academic Activities
11
Product Development - Academia Industry
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
12
Product Development - Academia Industry
Industry Involvement
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
13
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advice regarding development of Dual-Chamber
Pacemakers 2. Reimbursement for
expenses only, no stipend
3. Offer of 30,000 stock options --
Declined
14
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advice regarding development of Dual-Chamber
Pacemakers 2. Reimbursement for
expenses only, no stipend
3. Offer of 30,000 stock options --
Declined
15
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised regarding development of Dual-Chamber
Pacemakers 2. Reimbursement for
expenses only, no stipend
3. Offer of 30,000 stock options --
Declined
16
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised regarding development of Dual-Chamber
Pacemakers 2. Reimbursement for
expenses only, stipend approved by Duke
3. Offer of 30,000 stock
options -- Declined
17
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised regarding development of Dual-Chamber
Pacemakers 2. Reimbursement for
expenses only, stipend approved by Duke
3. Voluntarily quit
when new position assumed because of potential
conflict
18
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Annual stipend
19
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Annual stipend
20
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Annual stipend
21
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Annual stipend
22
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Annual stipend
23
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Annual stipend
24
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Advised in favor of re-introducing an old heart
valve
2. Recalled and
discontinued a new heart valve after millions
spent 3. Nixed idea for heart-lung machine

4. Nixed idea for minimally-invasive
surgery
5. Stipend approved by Washington University
25
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Involved in founding of companies based on
personal patents 2. No
3. Offer of 30,000 stock
options -- Declined
26
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Original Board Member

2. Co-Inventor on major patent
3.
Shareholder and user of medical device clinically
4. No publications
but multiple talks on medical device
27
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Original Board Member

2. Co-Inventor on major patent
3.
Shareholder and user of medical device clinically
4. No publications
but multiple talks on medical device
28
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Original Board Member

2. Co-Inventor on major patent
3.
Shareholder and user of medical device clinically
4. No publications
but multiple talks on medical device
29
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Original Board Member

2. Co-Inventor on major patent
3.
Shareholder and user of medical device clinically
4. No publications
but multiple talks on medical device
30
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Original Board Member

2. Co-Inventor on major patent
3.
Shareholder and user of medical device clinically
4. No publications
on the device
31
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Effect on Personal Practice

1. Discovered a better and cheaper
way to perform procedure
2. Discontinued use of device and never used it
again
32
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Effect on Personal Practice

1. Discovered a better and cheaper
way to perform procedure
2. Discontinued use of device and never used it
again
33
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Effect on Personal Practice

1. Discovered a better and cheaper
way to perform procedure
2. Discontinued use of device and never used it
again
34
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Effect on Personal Practice

1. Discovered a better and cheaper
way to perform procedure
2. Discontinued use of device and never used it
again
35
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Effect on Personal Practice

1. Discovered a better and cheaper
way to perform procedure
2. Discontinued use of device and never used it
again 3. Retired and
company sold
4. Received
money for vested shares
36
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Effect on Personal Practice

1. Discovered a better and cheaper
way to perform procedure
2. Discontinued use of device and never used it
again
37
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
1960
1990
2000
2010
1970
1980
Academic Activities
Relationship with the Companies
1.
Co-Inventor on patent upon which Epicor was
founded 2. Retired
from clinical practice
3. Received
stipend and stock from Epicor during development
4. Stayed
on as a Consultant for St. Jude when Epicor was
bought
38
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
1960
1990
2000
2010
1970
1980
Academic Activities
Relationship with the Companies
1.
Co-Inventor on patent upon which Epicor was
founded 2. Retired
from clinical practice
3. Received
stipend and stock from Epicor during development
4. Stayed
on as a Consultant for St. Jude when Epicor was
bought
39
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
1960
1990
2000
2010
1970
1980
Academic Activities
Relationship with the Companies
1.
Co-Inventor on patent upon which Epicor was
founded 2. Retired
from clinical practice
3. Received
stipend and stock from Epicor during development
4. Stayed
on as a Consultant for St. Jude when Epicor was
bought
40
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
1960
1990
2000
2010
1970
1980
Academic Activities
Relationship with the Companies
1.
Co-Inventor on patent upon which Epicor was
founded 2. Retired
from clinical practice
3. Received
stipend and stock from Epicor during development
4. Stayed
on as a Consultant for St. Jude when Epicor was
bought
41
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
1960
1990
2000
2010
1970
1980
Academic Activities
Relationship with the Companies
1.
Co-Inventor on patent upon which Epicor was
founded 2. Retired
from clinical practice
3. Received
stipend and stock from Epicor during device
development
4. Stayed on as a Consultant for St. Jude when
Epicor was bought
42
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
1960
1990
2000
2010
1970
1980
Academic Activities
Relationship with the Companies
1.
Co-Inventor on patent upon which Epicor was
founded 2. Retired
from clinical practice
3. Received
stipend and stock from Epicor during device
development
4. Stayed on as a Consultant for St. Jude when
Epicor was bought
43
Colleagues Problems with Ethics
1960
1980
1990
2000
2010
1970
44
The Brennan Article
Brennan, TA, et al. Health Industry Practices
that Create Conflicts of Interest, JAMA, 2006,
295(4)429-33.
More stringent regulation is necessary,
including the elimination or modification of
common practices related to small gifts,
pharmaceutical samples, continuing medical
education, funds for physician travel, speakers
bureaus, ghostwriting, and consulting and
research contracts.
45
Where do we set the bar?
At the perception level? - The
action/relationship is ethical but the perception
is bad. At the ethical level? - The
action/relationship is legal but it is not really
ethical in my opinion. At the legal
level? - I just want to stay out of jail.
46
Individual Issues vs Bar Level
Perception Level
Legal Level
Ethical Level
Individual Issue
Visits by Sales Reps
OK
OK
OK
Using devices / Own Stock
OK
No
Personal
Using devices / On SAB
OK
OK
OK
Own Stock / Publish Papers
OK
No
No
Using Devices / Res. Grants
OK
OK
Personal
Personal Gifts / Travel
OK
OK
No
Trinkets Pizza
OK
OK
No
47
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

48
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

49
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

50
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

51
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Teaching, Publications, Editorial Duties, V.Ps
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
AATS
Relationship with the Company
1.
Original Board Member

2. Co-Inventor on major patent
3.
Shareholder and user of medical device clinically
4. No publications
and no talks on device mentioned as one approach
52
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

53
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

54
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

55
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

56
The Rules of Engagement

• While in Active Clinical Practice.
• Maintain complete transparency with university,
  surgical colleagues and company regarding any and
  all relations with industry
• Avoid ownership (i.e., stock or stock options) in
  any company whose device you use
• Any stipend received from any company for
  consulting, advisory board membership, etc. must
  be pre-approved by the university
• Publish no papers and give no public talks on
  devices that you use for which you receive a
  stipend (consulting, advisory board member, etc.)
• Accept no gifts, travel or other financial favors
  from any company whose device you use
• Disclose all relationships with industry in all
  publications and public talks

57
The Rules of Engagement

• If not in an Active Clinical Practice.
• Remember that the two most important things you
  have to offer are
• Knowledge
• Credibility
• If you see a company acting in an unethical way,
  it is your obligation to call it to the attention
  of the proper people and if there is no
  satisfactory response, you must discontinue your
  relationship with that company

58
Why are these panels necessary?
Honesty pays, but it doesn't seem to pay enough
to suit some people. Kin Hubbard (1868
- 1930)
59
Thank You
60
(No Transcript)
61
(No Transcript)
62
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63
(No Transcript)
64
(No Transcript)
65
High-Intensity Focused Ultrasound HIFU
66
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

67
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
1960
1990
2000
2010
1970
1980
Medical Developments
68
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
WPW
1960
1990
2000
2010
1970
1980
22 yrs.
WPW
Medical Developments
69
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
His Ablation
1960
1990
2000
2010
1970
1980
8 yrs.
His Ablation
Medical Developments
70
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
VT
1960
1990
2000
2010
1970
1980
17 yrs.
VT
Medical Developments
71
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
AAT
1960
1990
2000
2010
1970
1980
13 yrs.
AAT
Medical Developments
72
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
AVNRT
1960
1990
2000
2010
1970
1980
9 yrs.
AVNRT
Medical Developments
73
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
A-Fib
1960
1990
2000
2010
1970
1980
11 yrs.
A-Fib
Medical Developments
74
Interventional Treatment for Cardiac Arrhythmias
Surgical Developments
AVNRT
His Ablation
AAT
WPW
VT
A-Fib
1960
1990
2000
2010
1970
1980
His Ablation
AAT
A-Fib
WPW
VT
AVNRT
Medical Developments
75
Human Epicardial Atrial Electrodes
76
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

77
The Maze Procedure
78
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

79
Animal Model of Atrial Fibrillation
80
3D Animal Atrial Electrodes
81
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

82
Cryosurgical Maze Procedure
Cryosurgical Lesions
Standard Incisions
A
B
D
C
E
83
Long-Term Freedom from AF
100
97 (Concomitant)
92 (Stand-Alone)
Percent Freedom from AF
50
0
5
10
15
Years Postop
Damiano, et al., JTCVS, 2003
84
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

85
Founding the Start-Up Company
University Professor
7 Patents Jointly Owned by Professor University
(Negotiations)
Consultant
Holding Company for 7 Patents
Valve Patent
ACME Products Menlo Park, California Patent 1
Patent 2
Start-Up Company 1 Tubular Heart Valves, Inc.
Sold
Start-Up Company 2 AF Surgical Devices, Inc.
Patent 48 (AF Surgical
Devices)
86
Funding the Start-Up Company
Funding the Start-Up Company
University Professor
7 Patents Jointly Owned by Professor University
(Negotiations)

• Round 1 Funding - ( 3 years)

Holding Company for 7 Patents
Valve Patent
Start-Up Company 1 Tubular Heart Valves, Inc.
Start-Up Company 2 AF Surgical Devices, Inc.
Venture Capital 3 - 7.0 M
87
Funding the Start-Up Company
University Professor
7 Patents Jointly Owned by Professor University
(Negotiations)

• Round 2 Funding - ( 2 years)

Holding Company for 7 Patents
Valve Patent
Start-Up Company 1 Tubular Heart Valves, Inc.
Start-Up Company 2 AF Surgical Devices, Inc.
Venture Capital 3 - 10.0 M
88
Epicor HIFU Feasibility Study
European Feasibility Study Type of AF n
Cured Cure Rate Intermittent AF 25 25
100 Continuous AF 75
60
80 Overall Results 100 85
85
89
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

90
Exit Strategy for the Start-Up Company
University Professor
7 Patents Jointly Owned by Professor University
(Negotiations)
Holding Company for 7 Patents

• Options
• Remain a private, non- public company
• Become a private company (IPO)
• Sell to a larger company
• Failure

Valve Patent
Start-Up Company 1 Tubular Heart Valves, Inc.
Start-Up Company 2 AF Surgical Devices, Inc.
91
Idea to Commercialization

• Background
• The Idea
• Experimental Testing
• Clinical Implementation
• Founding the Start-Up Company
• Sale of the Start-Up Company
• Commercialization

92
HIFU Band to Encircle PVs
93
Idea to Commercialization
Experimental Testing
Found Start-up Company
Background Begins
Clinical Implementation
Commercial Product
Idea
1960
1990
2000
2010
1970
1980
14
2
7
12
4
2
Sell Start-up Company
94
Idea to Commercialization
Experimental Testing
Found Start-up Company
Background Begins
Clinical Implementation
Commercial Product
Idea
1960
1990
2000
2010
1970
1980
41 years
Sale of Startup for 200 Million Surgeon/Scientist
/Inventor received 1 Million - This is
approximately 25,000 per year
95
Change in Attitude of Specialty
1960
1990
2000
2010
1970
1980
41 years
Thats a nice clinical study but Ill believe it
only when it has been properly tested in the
laboratory.
Thats a nice experimental study but Ill
believe it only when it has been proven in
patients.
96
Changes in Research Funding
1960
1990
2000
2010
1970
1980
41 years
97
Changes in Research Funding
100
NIH Grant Approval Rate
50
1960
1990
2000
2010
1970
1980
41 years
98
Changes in Research Funding
100
NIH Grant Approval Rate
50
1960
1990
2000
2010
1970
1980
Industry
Relative Funding Sources
NIH
Clinical
99
Thank You
100
Product Development - Academia Industry
101
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
102
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
College
103
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
104
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
Med School
105
Product Development - Academia Industry
Arrhythmia Research
1960
1980
1990
2000
2010
1970
Med School
106
Product Development - Academia Industry
Arrhythmia Research
1960
1980
1990
2000
2010
1970
107
Product Development - Academia Industry
Arrhythmia Research
1960
1980
1990
2000
2010
1970
Surgical Training
108
Product Development - Academia Industry
Active Military Duty
Arrhythmia Research
1960
1980
1990
2000
2010
1970
Surgical Training
109
Product Development - Academia Industry
Arrhythmia Research
1960
1980
1990
2000
2010
1970
Surgical Training
110
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
111
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
Associate Professor (Duke)
112
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
113
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
Professor Chief (Wash. U.)
114
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
115
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
Professor Chairman (Georgetown)
116
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
117
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
Emeritus Evarts A. Graham Professor (Wash. U.)
118
Product Development - Academia Industry
1960
1980
1990
2000
2010
1970
119
Product Development - Academia Industry
1960
1990
2000
2010
1970
1980
Academic Activities
120
Product Development - Academia Industry
1960
1990
2000
2010
1970
1980
Continuous RO1 NIH Grant Support
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
Sec./Pres. AATS
121
Product Development - Academia Industry
Industry Involvement
1960
1990
2000
2010
1970
1980
Continuous RO1 NIH Grant Support
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
Sec./Pres. AATS
122
Product Development - Academia Industry
Industry Involvement
Epicor
SJM
3f - Ther.
ATS
HeartPort
SH
PM
Medtronic
Chase
1960
1990
2000
2010
1970
1980
Continuous RO1 NIH Grant Support
TSFRE Board
St. Sec.
RRC
CTS Net Board
ABTS
Academic Activities
Sec./Pres. AATS
123
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124
Funding the Start-Up Company
University Professor
7 Patents Jointly Owned by Professor University
(Negotiations)
Holding Company for 7 Patents
Valve Patent
Start-Up Company 1 Tubular Heart Valves, Inc.
Start-Up Company 2 AF Surgical Devices, Inc.