Contributors |
|
xv | |
Preface |
|
xvii | |
|
1 Introduction to Medical Innovation |
|
|
1 | (8) |
|
|
2 The Basics of Business Law for New Businesses |
|
|
9 | (10) |
|
|
|
9 | (1) |
|
Limited Liability Company |
|
|
9 | (2) |
|
|
11 | (1) |
|
Capitalizing the Business |
|
|
12 | (1) |
|
|
13 | (1) |
|
|
14 | (1) |
|
|
15 | (1) |
|
|
15 | (1) |
|
|
16 | (1) |
|
|
17 | (1) |
|
|
18 | (1) |
|
3 Regulating Medical Devices in the United States |
|
|
19 | (12) |
|
|
|
20 | (1) |
|
The FDA's Definition of a Medical Device |
|
|
21 | (1) |
|
|
22 | (1) |
|
Pathways to Market in the United States |
|
|
22 | (4) |
|
|
24 | (1) |
|
Class II Special Controls |
|
|
25 | (1) |
|
Class III Premarket Approval |
|
|
25 | (1) |
|
|
26 | (1) |
|
Activities to Support Medical Device Innovators |
|
|
26 | (1) |
|
Early Regulatory Assistance for Medical Device Innovators |
|
|
27 | (1) |
|
|
27 | (1) |
|
|
28 | (1) |
|
|
29 | (2) |
|
4 The Role of University Technology Transfer |
|
|
31 | (12) |
|
|
|
31 | (2) |
|
|
33 | (5) |
|
|
38 | (1) |
|
Innovation and Entrepreneurship |
|
|
38 | (1) |
|
Industry Supported Research and Commercialization |
|
|
39 | (1) |
|
|
40 | (1) |
|
|
40 | (1) |
|
|
41 | (2) |
|
5 Basics of Patent Law: Strategies for Entrepreneurs and Start-Up Enterprises |
|
|
43 | (8) |
|
|
|
43 | (2) |
|
|
45 | (1) |
|
|
45 | (1) |
|
|
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) |
|
|
49 | (1) |
|
|
50 | (1) |
|
6 Licensing Medical Devices to Manufacturers/Partnering With Large Companies |
|
|
51 | (14) |
|
|
|
|
51 | (1) |
|
|
51 | (1) |
|
Understanding Corporations |
|
|
52 | (1) |
|
|
52 | (1) |
|
Corporate Needs---How to Get the Giants to Want to Dance |
|
|
53 | (2) |
|
Preparing to Engage With the Corporation |
|
|
55 | (1) |
|
|
55 | (1) |
|
Access Nodes in Corporations |
|
|
56 | (1) |
|
Other Possible Access Points |
|
|
57 | (1) |
|
Preparing to Share Information, Generate, and Maintain Interest |
|
|
58 | (1) |
|
|
58 | (1) |
|
Maintaining Momentum in the Relationship: Information Sharing and Communication |
|
|
59 | (2) |
|
|
61 | (1) |
|
Ground Rules for Communication |
|
|
61 | (1) |
|
|
62 | (1) |
|
|
62 | (3) |
|
7 Understanding Venture Capital in the Health Industry |
|
|
65 | (12) |
|
|
|
Securing of a VC Investment: Sourcing and Diligence |
|
|
67 | (1) |
|
|
68 | (2) |
|
Planning for Success: Valuation, Control, and the Inevitable Setback |
|
|
70 | (3) |
|
The Role of the Founder/Inventor |
|
|
73 | (1) |
|
|
74 | (1) |
|
|
74 | (1) |
|
|
75 | (1) |
|
|
75 | (2) |
|
8 The Process for Innovators/Founders to Raise Capital to Start a Company |
|
|
77 | (10) |
|
|
Identifying the Right Investor |
|
|
78 | (3) |
|
|
81 | (2) |
|
Targeting Qualified Investors |
|
|
83 | (1) |
|
|
84 | (1) |
|
|
85 | (2) |
|
9 An Introduction to the National Institutes of Health SBIR/STTR Programs |
|
|
87 | (14) |
|
|
|
Overview and Goals of the Program |
|
|
87 | (1) |
|
Key Differences Between SBIR and STTR |
|
|
87 | (1) |
|
|
88 | (1) |
|
Program Structure: Funding Phases |
|
|
88 | (2) |
|
|
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) |
|
|
99 | (1) |
|
|
99 | (1) |
|
|
99 | (1) |
|
|
100 | (1) |
|
|
100 | (1) |
|
10 Clinical Trials for Medical Device Innovators |
|
|
101 | (8) |
|
|
|
Designing Clinical Trials |
|
|
101 | (1) |
|
Regulatory Considerations for Clinical Studies |
|
|
102 | (2) |
|
|
104 | (1) |
|
Clinical Events Committee (CEC) |
|
|
104 | (1) |
|
Data Safety Monitoring Board (DSMB) |
|
|
104 | (1) |
|
|
105 | (1) |
|
|
105 | (1) |
|
Cost Drivers for Clinical Studies |
|
|
105 | (1) |
|
|
106 | (3) |
|
11 Innovating in a Rural Setting |
|
|
109 | (8) |
|
|
|
|
|
Protocols and Algorithms for Critical Events |
|
|
112 | (1) |
|
|
112 | (1) |
|
The Portable Blood Count Monitor |
|
|
113 | (1) |
|
Cardiascan TM Ambulatory Vital Signs Monitor |
|
|
114 | (1) |
|
|
115 | (2) |
|
12 How Good Ideas Die: Understanding Common Pitfalls of Medtech Innovation |
|
|
117 | (12) |
|
|
|
|
|
|
|
|
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) |
|
|
123 | (1) |
|
|
124 | (1) |
|
|
125 | (1) |
|
|
125 | (1) |
|
|
126 | (3) |
|
13 Managing Institutional Barriers to Entrepreneurship |
|
|
129 | (10) |
|
|
|
|
137 | (1) |
|
|
138 | (1) |
|
14 Concerns About the Current Pharmaphobia in the World of Innovation: Its Consequences and Risks |
|
|
139 | (8) |
|
|
15 Adoption of Technology: Appealing to the Hospital and Health System Value Analysis |
|
|
147 | (8) |
|
|
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) |
|
|
152 | (1) |
|
Prepare Yourself Appropriately |
|
|
153 | (2) |
|
16 Technology Adoption: Appealing to Payers and Capturing Economic Value |
|
|
155 | (12) |
|
|
|
155 | (1) |
|
After Regulatory Approval: Getting the Device to Patients |
|
|
156 | (1) |
|
|
156 | (2) |
|
|
158 | (2) |
|
|
160 | (1) |
|
Evidence Requirements for Reimbursement: Need for Evidence-Based Data |
|
|
161 | (1) |
|
Provider-Based, Risk-Sharing Agreements (PBRSAs) |
|
|
162 | (1) |
|
|
163 | (1) |
|
|
164 | (1) |
|
|
164 | (1) |
|
|
165 | (2) |
|
17 Market Adoption of Innovation Into the Operating Room: The "Hospital Chief Financial Officer as the Customer" |
|
|
167 | (12) |
|
|
|
|
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) |
|
|
173 | (1) |
|
|
173 | (1) |
|
Replace Expensive Goods With Cheaper Ones |
|
|
173 | (1) |
|
Understanding CFOs Will Enhance the Overall Impact of Surgeon Innovators |
|
|
174 | (1) |
|
|
175 | (1) |
|
|
175 | (1) |
|
|
176 | (1) |
|
|
176 | (3) |
|
18 Accelerating Physician Entrepreneurship: Perspective of a Recently Graduated Medical Student |
|
|
179 | (12) |
|
|
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) |
|
|
189 | (1) |
|
|
190 | (1) |
|
19 Accelerating Physician Entrepreneurship: The Perspective of a Resident Entrepreneur |
|
|
191 | (10) |
|
|
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) |
|
|
198 | (1) |
|
|
199 | (1) |
|
|
199 | (2) |
|
20 Fostering and Expanding Diversity in the Workforce in Innovation |
|
|
201 | (8) |
|
|
|
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) |
|
|
204 | (1) |
|
|
204 | (1) |
|
Sophia Yen---Pandia Health |
|
|
204 | (1) |
|
Julie Silver---Oncology Rehab Partners |
|
|
205 | (1) |
|
|
205 | (1) |
|
|
206 | (1) |
|
|
207 | (2) |
|
21 Preparing America's Entrepreneurial Workforce: Reinventing the Medical Curriculum |
|
|
209 | (12) |
|
|
|
|
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) |
|
|
218 | (1) |
|
|
219 | (1) |
|
|
219 | (1) |
|
|
220 | (1) |
|
22 A Dean's Perspective on Entrepreneurship in the University |
|
|
221 | (10) |
|
|
|
|
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) |
|
|
230 | (1) |
|
|
230 | (1) |
|
23 The Role of Medical Societies and Their Foundations in Supporting Entrepreneurs: A View From Anesthesiology |
|
|
231 | (4) |
|
|
24 Surgical Societies as Supporters of Innovation |
|
|
235 | (8) |
|
|
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) |
|
|
240 | (1) |
|
|
240 | (1) |
|
|
240 | (3) |
|
25 Role of Medical Journals in Promoting Innovation |
|
|
243 | (8) |
|
|
|
248 | (1) |
|
|
248 | (3) |
|
26 Inspiration, Perspiration, and Perseverance: An Innovator's Perspective |
|
|
251 | (10) |
|
|
|
|
252 | (1) |
|
|
253 | (2) |
|
|
255 | (1) |
|
|
256 | (1) |
|
|
256 | (1) |
|
Strengths, Weaknesses, and the Art of Getting the Team Right |
|
|
257 | (1) |
|
Patience and Perseverance |
|
|
258 | (1) |
|
|
259 | (1) |
|
|
259 | (1) |
|
|
260 | (1) |
Index |
|
261 | |