Biomedical Engineering Entrepreneurship

by Jen-shih Lee

Overview

This book is written for undergraduate and graduate students in biomedical engineering wanting to learn how to pursue a career in building up their entrepreneur ventures. Practicing engineers wanting to apply their innovations for healthcare will also find this book usefulThe 21st century is the “Biotech Century” where many nations are investing heavily in biotechnology. As a result, tremendous business opportunities exist for biomedical engineering graduates who are interested in becoming successful entrepreneurs. However, many challenges await these entrepreneurs intending to invent safe and effective devices and drugs to prevent, diagnose, alleviate and cure diseases.In this publication, many examples of innovations in biomedical engineering are covered, from the conceptualization stage to successful implementation and commercialization. Part I teaches working and would-be biomedical engineers to assess how well their innovations and their team can succeed; Part II will guide budding entrepreneurs to launch their ventures to the point of pre-production models. Other important aspects like financing, negotiations, leading by example, manufacturing, marketing, venture and globalization are covered in Part III. Two concluding chapters, with excerpts from leaders in community, education and industries, touch on the growth and investment in biomedical engineering entrepreneurship.

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