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El. knyga: Medical Innovation: Concept to Commercialization

Edited by (Emeritus Professor of Surgery, Department of Surgery, Ma), Edited by (Vice President, Global Technology Assessment and Health Policy, Cook Medical Incorporated), Edited by (Vice President, Medical Affairs, Dean, School of Medicine, Saint Louis University)
  • Formatas: EPUB+DRM
  • Išleidimo metai: 24-May-2018
  • Leidėjas: Academic Press Inc
  • Kalba: eng
  • ISBN-13: 9780128149270
  • Formatas: EPUB+DRM
  • Išleidimo metai: 24-May-2018
  • Leidėjas: Academic Press Inc
  • Kalba: eng
  • ISBN-13: 9780128149270

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Medical Innovation: Concept to Commercialization is a practical, step-by-step approach on how to move a novel concept through development to realize a commercially successful product. Real-world experience cases and knowledgeable contributors provide lessons that cover the practices of diverse organizations and multiple products. This importance reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians.

  • Provides multiple considerations and comprehensive lessons from varied organizations, researchers and products
  • Designed to help address topics that improve success and avoid the high cost of innovation failure
  • Recommends the practical steps needed to move a novel, non-developed concept into a tangible, realistic and commercially successful product
Contributors xv
Preface xvii
1 Introduction to Medical Innovation
1(8)
Thomas P. Stossel
2 The Basics of Business Law for New Businesses
9(10)
Tom Walsh
Forming the Business
9(1)
Limited Liability Company
9(2)
Corporation
11(1)
Capitalizing the Business
12(1)
Early Stage Financing
13(1)
Grant Funding
14(1)
Operating the Business
15(1)
Business Contracts
15(1)
Enhancing Patent Assets
16(1)
Conclusion
17(1)
Important Points
18(1)
3 Regulating Medical Devices in the United States
19(12)
David E. Chadwick
But, First Things First
20(1)
The FDA's Definition of a Medical Device
21(1)
Intended Use
22(1)
Pathways to Market in the United States
22(4)
Class I General Controls
24(1)
Class II Special Controls
25(1)
Class III Premarket Approval
25(1)
Preamendments Devices
26(1)
Activities to Support Medical Device Innovators
26(1)
Early Regulatory Assistance for Medical Device Innovators
27(1)
Remember Your Audience
27(1)
Important Points
28(1)
References
29(2)
4 The Role of University Technology Transfer
31(12)
Jay Schrankler
Functions and People
31(2)
Process
33(5)
Programs
38(1)
Innovation and Entrepreneurship
38(1)
Industry Supported Research and Commercialization
39(1)
Conclusion
40(1)
Important Points
40(1)
Acknowledgments
41(2)
5 Basics of Patent Law: Strategies for Entrepreneurs and Start-Up Enterprises
43(8)
Thomas J. Filarski
What Is a Patent?
43(2)
Securing Patent Rights
45(1)
Types of Patents
45(1)
Components of a Patent
45(1)
Requirements of Patentability
46(2)
Patents and Business Goals
48(1)
Diligence and the Patent Rights of Others
49(1)
Related Intellectual Property Laws
49(1)
The Future of Patents
49(1)
Important Points
50(1)
6 Licensing Medical Devices to Manufacturers/Partnering With Large Companies
51(14)
Mark Boden
Johnathan Goldstein
Introduction
51(1)
Corporate Culture
51(1)
Understanding Corporations
52(1)
Cultural Differences
52(1)
Corporate Needs---How to Get the Giants to Want to Dance
53(2)
Preparing to Engage With the Corporation
55(1)
When to Engage
55(1)
Access Nodes in Corporations
56(1)
Other Possible Access Points
57(1)
Preparing to Share Information, Generate, and Maintain Interest
58(1)
What to Share?
58(1)
Maintaining Momentum in the Relationship: Information Sharing and Communication
59(2)
Maintaining Interest
61(1)
Ground Rules for Communication
61(1)
Conclusion
62(1)
Important Points
62(3)
7 Understanding Venture Capital in the Health Industry
65(12)
Barry S. Myers
Charles Robert Hallford
Securing of a VC Investment: Sourcing and Diligence
67(1)
The Term Sheet
68(2)
Planning for Success: Valuation, Control, and the Inevitable Setback
70(3)
The Role of the Founder/Inventor
73(1)
Conclusions
74(1)
Important Points
74(1)
Acknowledgment
75(1)
References
75(2)
8 The Process for Innovators/Founders to Raise Capital to Start a Company
77(10)
Rudy A. Mazzocchi
Identifying the Right Investor
78(3)
Preparing for Investment
81(2)
Targeting Qualified Investors
83(1)
Closing the Deal
84(1)
Important Points
85(2)
9 An Introduction to the National Institutes of Health SBIR/STTR Programs
87(14)
Deepa Narayanan
Michael Weingarten
Overview and Goals of the Program
87(1)
Key Differences Between SBIR and STTR
87(1)
Eligibility
88(1)
Program Structure: Funding Phases
88(2)
Funding Opportunities
90(1)
Building a Successful Application
91(4)
Application Tip 1 Start Early
91(1)
Application Tip 2 Understand What Peer Reviewers Want
92(1)
Application Tip 3 Provide Clear Details
92(2)
Application Tip 4 Remember the Postsubmission Requirements
94(1)
Success Stories From the NIH SBIR and STTR Programs
95(1)
SBIR and STTR Programs: More Than Just Funding
96(3)
Summary
99(1)
Important Points
99(1)
Acknowledgments
99(1)
Disclosures
100(1)
References
100(1)
10 Clinical Trials for Medical Device Innovators
101(8)
William D. Voorhees
Theodore W. Heise
Designing Clinical Trials
101(1)
Regulatory Considerations for Clinical Studies
102(2)
Managing Clinical Trials
104(1)
Clinical Events Committee (CEC)
104(1)
Data Safety Monitoring Board (DSMB)
104(1)
Core Laboratory
105(1)
Analyzing the Results
105(1)
Cost Drivers for Clinical Studies
105(1)
Important Points
106(3)
11 Innovating in a Rural Setting
109(8)
Elizabeth Cole
Lames Hood
Dennis Matthews
Thomas Hobday
Protocols and Algorithms for Critical Events
112(1)
mTBI Diagnosis System
112(1)
The Portable Blood Count Monitor
113(1)
Cardiascan TM Ambulatory Vital Signs Monitor
114(1)
References
115(2)
12 How Good Ideas Die: Understanding Common Pitfalls of Medtech Innovation
117(12)
Katherine S. Blevins
Dan E. Azagury
James K. Wall
Venita Chandra
Elisabeth K. Wynne
Thomas M. Krummel
Introduction
117(1)
Enhancing the Probability of Success
117(2)
What Doesn't Work --- How Good Ideas Die
119(1)
The Lack of a Deliberate Process
120(1)
Assuming Invention = Innovation
121(1)
An Incomplete or Flawed Team
122(1)
Inadequate Resources
123(1)
Lack of Cultural Support
124(1)
Conclusions
125(1)
Important Points
125(1)
References
126(3)
13 Managing Institutional Barriers to Entrepreneurship
129(10)
Thomas R. Mackie
Eric Leuthardt
Financial Disclosures
137(1)
References
138(1)
14 Concerns About the Current Pharmaphobia in the World of Innovation: Its Consequences and Risks
139(8)
Thomas P. Stossel
15 Adoption of Technology: Appealing to the Hospital and Health System Value Analysis
147(8)
Jenell Paul-Robinson
Evidentiary Support Packages "Show Me the Numbers"
148(2)
Reimbursement: To Buy or Not to Buy
150(1)
You Have Defined Your Value, Now What?
151(1)
Committee Expectations
152(1)
Prepare Yourself Appropriately
153(2)
16 Technology Adoption: Appealing to Payers and Capturing Economic Value
155(12)
Carla L. Zema
Introduction
155(1)
After Regulatory Approval: Getting the Device to Patients
156(1)
Reimbursement Pathways
156(2)
Coding
158(2)
Payer
160(1)
Evidence Requirements for Reimbursement: Need for Evidence-Based Data
161(1)
Provider-Based, Risk-Sharing Agreements (PBRSAs)
162(1)
Global Considerations
163(1)
Conclusions
164(1)
Important Points
164(1)
References
165(2)
17 Market Adoption of Innovation Into the Operating Room: The "Hospital Chief Financial Officer as the Customer"
167(12)
Ryan D. Egeland
Zachary Rapp
Frank S. David
Pressures on the Operating Room (OR) Financial Committees Are Serious and Accelerating
168(1)
A Myth of "Value" in the OR Sometimes Conflicts With Financial Reality
169(1)
Hospitals Seek to Purchase Specific Types of Surgical Innovations
170(3)
Boost Efficiency
173(1)
Prevent High-Cost Events
173(1)
Replace Expensive Goods With Cheaper Ones
173(1)
Understanding CFOs Will Enhance the Overall Impact of Surgeon Innovators
174(1)
Important Points
175(1)
Acknowledgments
175(1)
Disclaimer
176(1)
References
176(3)
18 Accelerating Physician Entrepreneurship: Perspective of a Recently Graduated Medical Student
179(12)
C. Corbin Frye
Part One Advancing Health care Innovation in the Context of Medical Education
180(1)
Opportunities for Improvement in the Mentality and Culture of Medicine
180(2)
Opportunities for Improvement in the Medical School Experience
182(2)
Part Two Thoughts and Advice for Medical Trainee-Innovators
184(1)
Reflections on Medical Student Innovation
184(2)
Entrepreneurial Lessons I Learned Along the Way
186(3)
Important Points
189(1)
References
190(1)
19 Accelerating Physician Entrepreneurship: The Perspective of a Resident Entrepreneur
191(10)
Kyle Miller
Recognition of Unmet Clinical Needs
191(1)
Evaluating Opportunities and the Potential Impact on Workflow
192(1)
Accelerating Ideation and Development of Prototypes With a Cross-Functional Team
193(1)
Invention Disclosures and Licensing IP
194(1)
De-Risking Your Idea With Business Canvasing and Data Generation Through Approved Studies
195(1)
Company Formation, Operating Agreements, and Capitalization Tables
196(1)
Funding and Furthering Innovative Ideas in Health Care
197(1)
Important Points
198(1)
References
199(1)
Further Reading
199(2)
20 Fostering and Expanding Diversity in the Workforce in Innovation
201(8)
Priya Kumthekar
Mamta Swaroop
The Current Entrepreneurial Landscape
201(1)
The Role of Female Physicians in the Current Landscape (or Lack Thereof)
202(1)
Explanation for Lack of Female Entrepreneurs
202(2)
Models of Success
204(1)
Elise Singer---Doximity
204(1)
Sophia Yen---Pandia Health
204(1)
Julie Silver---Oncology Rehab Partners
205(1)
Future Directions
205(1)
Important Points
206(1)
References
207(2)
21 Preparing America's Entrepreneurial Workforce: Reinventing the Medical Curriculum
209(12)
Mark S. Cohen
Seth Klapman
Introduction
209(1)
The Medical School Pathway of Excellence in Innovation and Entrepreneurship
210(5)
The Surgical Innovation and Entrepreneurial Development Program
215(2)
Evaluating Return on Investment
217(1)
Conclusion
218(1)
Important Points
219(1)
Acknowledgments
219(1)
References
220(1)
22 A Dean's Perspective on Entrepreneurship in the University
221(10)
Kevin E. Behrns
Andy Hayden
Introduction
221(1)
Entrepreneurship at a University
222(1)
Entrepreneurship in a Medical School
223(1)
Entrepreneurship and the Clinical Mission
223(1)
Entrepreneurship in the Research Mission
224(2)
Entrepreneurship in the Education Mission
226(1)
Creating an Entrepreneurial Environment
227(1)
Office of Technology Transfer
228(1)
Relationship Between the University and Community Entrepreneurship
228(2)
Philanthropy
230(1)
Important Points
230(1)
23 The Role of Medical Societies and Their Foundations in Supporting Entrepreneurs: A View From Anesthesiology
231(4)
James C. Eisenach
24 Surgical Societies as Supporters of Innovation
235(8)
Lee L. Sanstrom
The Birth of SAGES as "the Surgical Society for Innovation"
235(2)
The Times They Are a Changin'
237(1)
SAGES and Innovation Today
238(2)
Conclusions
240(1)
Important Points
240(1)
References
240(3)
25 Role of Medical Journals in Promoting Innovation
243(8)
Michael G. Sarr
Important Points
248(1)
References
248(3)
26 Inspiration, Perspiration, and Perseverance: An Innovator's Perspective
251(10)
Josh Makower
Lyn Denend
Need-Driven Innovation
252(1)
Picking Winners
253(2)
Ruthless Objectivity
255(1)
Learning From Failure
256(1)
Do What You Care About
256(1)
Strengths, Weaknesses, and the Art of Getting the Team Right
257(1)
Patience and Perseverance
258(1)
The Advisor Effect
259(1)
Defining Success
259(1)
References
260(1)
Index 261
Behrns has more than 20 years of experience as a highly accomplished educator, researcher, physician and administrator. He currently oversees the educational, research, clinical and service activities of SLUs nationally ranked School of Medicine. The CEO of SLUCare, the Universitys physician practice, reports to Behrns, who also serves as a key liaison with SSM Health, which owns and operates SSM Health Saint Louis University Hospital. After earning a bachelors degree in biology from Indiana University, Bruce Gingles joined Cook Medical in in 1979, when relocated to Los Angeles to be the companys first sales representative for the newly formed Critical Care division. He moved to Northern California (Mountain View) in 1984 as regional manager, and to Bloomington, Indiana, in 1991 as director of sales and marketing. Mr. Gingles was promoted to global business leader and vice president in 1999. He now represents Cook in the areas of translational research, commercial regulation and technology assessment. The ethical foundation of commercial relationships and translational algorithms are personal interests. Mr. Gingles serves on the external advisory committee for the Indiana University and UCSF (devices) CTSIs. He has been invited to discuss translational research and medical device innovation at more than 30 CME/CLE-accredited programs in the Asia, Europe and the United States. Sarr is the emeritus professor of surgery at the Mayo Clinic. He has hundreds of papers published in peer reviewed journals. He is on the Mayo Clinic Scientific Advisory Council. He is a member of 10+ editorial boards. He is the co-editor of two peer reviewed journals. He is the recipient of James C. Masson Professor of Surgery from the Mayo Clinic College of Medicine and the winner of the International Health Professional of the Year award from the International Biographical Centre of Cambridge.