| Preface |
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| Contributor List |
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Chapter 1 Identifying an Unmet Need |
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1 | (10) |
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Chapter 2 Market Analysis--Determining Market Size |
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11 | (21) |
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Chapter 3 Competitive Analysis: Understanding Your Unique Market Position |
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32 | (10) |
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Chapter 4 Forming a Solution: Defining Product Requirements Before Concept Development |
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42 | (12) |
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Chapter 5 Vetting the Concept |
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54 | (9) |
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Chapter 6 Prior Art Search: Can Your Solution be Patented? |
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63 | (15) |
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Chapter 7 Concept Development, Selection, and Testing--Passion and Planning Go Hand-in-Hand |
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78 | (15) |
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Chapter 8 Engineering Resources: First Steps to Making a Tangible Prototype |
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93 | (9) |
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Chapter 9 Patent Strategy: How do You Protect Your Intellectual Property? |
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102 | (16) |
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Chapter 10 Regulatory Basics: What Does it Take to Start Selling Your Device? |
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118 | (15) |
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Chapter 11 Research and Development and The Importance of Testing |
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133 | (51) |
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Chapter 12 What is Needed to Produce Medical Devices in Large Volumes? |
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184 | (7) |
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Chapter 13 FDA Marketing Authorization: How to Get Your Device on The US Market |
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191 | (20) |
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Chapter 14 Reimbursement Basics: Who is The Customer and How Will You Profit? |
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211 | (17) |
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Chapter 15 Business Models |
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228 | (15) |
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Chapter 16 Marketing, Sales, and Distribution |
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243 | (20) |
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Chapter 17 Business Operations: What is Needed For Sustainable Revenues |
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263 | (12) |
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Chapter 18 Funding Approaches: Who, When, Why, and in Exchange For What? |
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275 | (17) |
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Chapter 19 Alternative Pathways: Reconsidering Licensing and/or Codevelopment |
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292 | (12) |
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Chapter 20 Postlaunch Physician Relationships: How You Maintain Loyalty? |
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304 | (4) |
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Chapter 21 Successful Exit: Acquisition Considerations |
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308 | (8) |
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Chapter 22 Concept to Commercialization Case #1: Pioneering The X-Stop Interspinous Decompression Device |
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316 | (15) |
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Chapter 23 IlluminOss: The World's First Patient-Conforming Polymer Intramedullary Implant |
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331 | (26) |
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Chapter 24 Concept to Commercialization: SOMAVAC Sustained Vacuum System |
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357 | (10) |
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| Glossary |
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367 | (16) |
| Index |
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383 | |
