Biomedical Engineering Entrepreneurship available in Hardcover
- ISBN-10:
- 9814295604
- ISBN-13:
- 9789814295604
- Pub. Date:
- 06/02/2010
- Publisher:
- World Scientific Publishing Company, Incorporated
- ISBN-10:
- 9814295604
- ISBN-13:
- 9789814295604
- Pub. Date:
- 06/02/2010
- Publisher:
- World Scientific Publishing Company, Incorporated
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Product Details
ISBN-13: | 9789814295604 |
---|---|
Publisher: | World Scientific Publishing Company, Incorporated |
Publication date: | 06/02/2010 |
Pages: | 316 |
Product dimensions: | 5.90(w) x 9.00(h) x 0.90(d) |
Table of Contents
Preface vii
Acknowledgements ix
Section I Introductory Chapter
Chapter 1 Introducing Biomedical Engineering 1
1.1 Advancements in Biomedical Engineering 1
1.2 Scope of Biomedical Engineering 2
1.3 Medical Device and Pharmaceutical Industry 3
1.4 Supporting Societies and Professional Activities 5
1.5 Innovations in Biomedical Engineering 7
1.6 Hemodialysis and its Innovators 13
1.7 The Impact of Medical Device Innovations on Healthcare 16
1.8 Career Interests of Biomedical Engineering Students 19
1.9 Three Development Phases to Success 22
1.10 About the Author 24
Section II Assessing the Venture
Chapter 2 Evaluating Your Entrepreneurship 26
2.1 An Entrepreneurial Team 26
2.2 John Abele, Pete Nicholas, Medi-Tech, and Boston Scientific 29
2.3 Nature of Entrepreneurship 31
2.4 Wanting to Be an Entrepreneur 32
2.5 Career Entries to Entrepreneurship 33
2.6 Practicing Entrepreneurship 35
2.7 Entrepreneurship and Visions of Uncas A. Whitaker 37
Chapter 3 Establishing Your Venture Invention 43
3.1 How an Entrepreneur Acquires a Venture Idea? 43
3.2 Three Inventions of Medtronic Inc. 45
3.3 Evaluating Your Invention 49
3.4 Wallace Coulter's Invention, His Venture and Legacy 53
3.5 The Venture of Howard Diamond 57
3.6 Magnetic Guidance System for Less Invasive Surgery 59
3.7 Innovations and Improvements 60
Chapter 4 Researching the Market for Your Invention 63
4.1 The Purpose of Market Research 63
4.2 Websites and Literatures on Medicine and Engineering 65
4.3 Two Biotech Ventures Founded by Sheridan Snyder 68
4.4 Entrepreneurial Advice and Thoughts from Snyder 71
Section III Launching the Venture
Chapter 5 Forming the Company 75
5.1 Rationale for the Corporation 75
5.2 Organizational Structure 79
5.3 Capital Required for the Company's Operation 80
5.4 Company Registration, Share Distribution and Exit Strategy 82
Chapter 6 Patenting Your Invention 87
6.1 The U.S. Patent and Trademark Office 87
6.2 Utility, Design, and Plant Patents 87
6.3 Trademarks and Copyrights 90
6.4 The Importance of Patenting Your Intellectual Property 91
6.5 The Process of Patenting 93
6.6 Key Elements of a Non-provisional Patent Application 95
6.7 Special Patenting Considerations 97
6.8 Value of a Patent 98
Chapter 7 FDA Regulataions 101
7.1 The Food and Drug Administration 101
7.2 The Safety and Effectiveness of Medical Devices 102
7.3 Device Classification 103
7.4 Investigational Device Exemption (IDE) 105
7.5 Premarket Approval Applications 107
7.6 Post Approval and Post Marketing Requirements 107
7.7 New Drug Development on Premarket Approval Application 109
Chapter 8 The FDA 510(k) Submission 112
8.1 Overview 112
8.2 The 510(k) Submission 112
8.3 Preparing for the 510(k) Submission 114
8.4 Writing the 510(k) Submission 116
8.5 Outcomes 119
Chapter 9 Obtaining Help and Support 121
9.1 SBA Support for Small Businesses 121
9.2 Government Support for Technology Development and Commercialization 126
9.3 Community Support 129
Chapter 10 SBIR Grants for Product Development 131
10.1 Vision of Small Business Innovation Research (SBIR) Program 131
10.2 NIH SBIR Funding 132
10.3 NIH SBIR Grant Review Process 134
10.4 SBIR Grant Application Research Plan 135
10.5 Timelines for SBIR Grant Funding 137
Chapter 11 Writing and Presenting the Business Plan 138
11.1 Overview 138
11.2 Company Status before Preparing the Roadmap 139
11.3 Roadmap for the Assessing Phase 145
11.4 Action Plan for the Launching Phase 149
11.5 Business Plan for the Building-Up Phase 152
11.6 Presentation of the Business Plan 155
Section IV Building Up the Enterprise
Chapter 12 Financing and Accounting 159
12.1 Angel Investors and Venture Capital Firms 159
12.2 Due Diligence by Venture Capital Firms 165
12.3 Account Management 169
12.4 Budgeting 171
12.5 Financial Projections 172
Chapter 13 Negotiating Deals 180
13.1 The Negotiation Process 180
13.2 The Venture Funding Term Sheet 184
13.3 Executive Employment Contracts 188
13.4 Licensing Agreement 190
Chapter 14 Leading People and Managing Yourself 194
14.1 Preparing Yourself and Managing Your Time and Work 194
14.2 Setting Goals, Incentives and Recognition for the Team 196
14.3 Working with the Team 198
14.4 Building the Winning Team 200
Chapter 15 Manufacturing Your Product 203
15.1 Procurement and Outsourcing 203
15.2 Current Good Manufacturing Practice (cGMP), Accountability and Risk Management 208
15.3 Lifecycle Management for Maximum Value 211
Chapter 16 Marketing and Sales 214
16.1 Know Your Customers 214
16.2 Market Characteristics of Medical Devices and Pharmaceutical Products 222
16.3 Customer Relationship Management (CRM) 225
16.4 Marketing Ethics and Legal Compliance 228
16.5 Preparing Your Marketing and Sales Campaign 229
Chapter 17 Globalizing Your Business 232
17.1 International Operations 233
17.2 Healthcare in the UK, Germany, France and Italy 240
17.3 The Healthcare Systems of Taiwan and China 241
17.4 World Prevalence of Diseases 242
17.5 Work Forces of Taiwan and China 244
17.6 Industrialization of Taiwan and China 247
17.7 Alliance of American, Taiwanese and Chinese Companies 253
17.8 Canada's Medical Device Industry and Manufacturing in Mexico 257
17.9 HME Markets and the Need for an Alliance 258
Section V Concluding Chapters
Chapter 18 Investing in the Future 262
18.1 Investing in Your Company and Yourself 262
18.2 Contributing to the Profession, the Society and the Nation 268
18.3 Doing Something for the World 275
Chapter 19 How to Succeed in Biomedical Engineering Entrepreneurism with Really Trying, by Shu Chien 280
19.1 The Biomedical Engineer as a Person 280
19.2 Development of a Biomedical Engineering Entrepreneur 281
19.3 Inter-personal Interactions 282
19.4 Roles of the Government and the Private Sector 282
19.5 Public Policy and Healthcare Delivery 283
19.6 Global Nature of Biomedical Engineering Entrepreneurism 283
19.7 Conclusions 285
Index 289