Chapter
Chapter 1: Introduction to Medical Innovation
Chapter 2: The Basics of Business Law for New Businesses
Limited Liability Company
Capitalizing the Business
Chapter 3: Regulating Medical Devices in the United States
The FDA's Definition of a Medical Device
Pathways to Market in the United States
Class I, General Controls
Class II, Special Controls
Class III, Premarket Approval
Activities to Support Medical Device Innovators
Early Regulatory Assistance for Medical Device Innovators
Chapter 4: The Role of University Technology Transfer
Innovation and Entrepreneurship
Industry Supported Research and Commercialization
Chapter 5: Basics of Patent Law: Strategies for Entrepreneurs and Start-Up Enterprises
Requirements of Patentability
Patents and Business Goals
Diligence and the Patent Rights of Others
Related Intellectual Property Laws
Chapter 6: Licensing Medical Devices to Manufacturers/Partnering With Large Companies
Understanding Corporations
Corporate Needs-How to Get the Giants to Want to Dance
Preparing to Engage With the Corporation
Access Nodes in Corporations
Other Possible Access Points
Preparing to Share Information, Generate, and Maintain Interest
Maintaining Momentum in the Relationship: Information Sharing and Communication
Ground Rules for Communication
Chapter 7: Understanding Venture Capital in the Health Industry
Securing of a VC Investment: Sourcing and Diligence
Planning for Success: Valuation, Control, and the Inevitable Setback
The Role of the Founder/Inventor
Chapter 8: The Process for Innovators/Founders to Raise Capital to Start a Company
Identifying the Right Investor
Targeting Qualified Investors
Chapter 9: An Introduction to the National Institutes of Health SBIR/STTR Programs
Overview and Goals of the Program
Key Differences Between SBIR and STTR
Program Structure: Funding Phases
Building a Successful Application
Application Tip 1. Start Early
Application Tip 2. Understand What Peer Reviewers Want
Application Tip 3. Provide Clear Details
Application Tip 4. Remember the Postsubmission Requirements
Success Stories From the NIH SBIR and STTR Programs
SBIR and STTR Programs: More Than Just Funding
Chapter 10: Clinical Trials for Medical Device Innovators
Designing Clinical Trials
Regulatory Considerations for Clinical Studies
Clinical Events Committee (CEC)
Data Safety Monitoring Board (DSMB)
Cost Drivers for Clinical Studies
Chapter 11: Innovating in a Rural Setting
Protocols and Algorithms for Critical Events
The Portable Blood Count Monitor
Cardiascan TM Ambulatory Vital Signs Monitor
Chapter 12: How Good Ideas Die: Understanding Common Pitfalls of Medtech Innovation
Enhancing the Probability of Success
What Doesn't Work—How Good Ideas Die
The Lack of a Deliberate Process
Assuming Invention = Innovation
An Incomplete or Flawed Team
Chapter 13: Managing Institutional Barriers to Entrepreneurship
Chapter 14: Concerns About the Current Pharmaphobia in the World of Innovation: Its Consequences and Risks
Chapter 15: Adoption of Technology: Appealing to the Hospital and Health System Value Analysis
Evidentiary Support Packages ``Show Me the Numbers´´
Reimbursement: To Buy or Not to Buy
You Have Defined Your Value, Now What?
Prepare Yourself Appropriately
Chapter 16: Technology Adoption: Appealing to Payers and Capturing Economic Value
After Regulatory Approval: Getting the Device to Patients
Evidence Requirements for Reimbursement: Need for Evidence-Based Data
Provider-Based, Risk-Sharing Agreements (PBRSAs)
Chapter 17: Market Adoption of Innovation Into the Operating Room: The ``Hospital Chief Financial Officer as the Customer´´
Pressures on the Operating Room (OR) Financial Committees Are Serious and Accelerating
A Myth of ``Value´´ in the OR Sometimes Conflicts With Financial Reality
Hospitals Seek to Purchase Specific Types of Surgical Innovations
Replace Expensive Goods With Cheaper Ones
Understanding CFOs Will Enhance the Overall Impact of Surgeon Innovators
Chapter 18: Accelerating Physician Entrepreneurship: Perspective of a Recently Graduated Medical Student
Part One: Advancing Health care Innovation in the Context of Medical Education
Opportunities for Improvement in the Mentality and Culture of Medicine
Opportunities for Improvement in the Medical School Experience
Part Two: Thoughts and Advice for Medical Trainee-Innovators
Reflections on Medical Student Innovation
Entrepreneurial Lessons I Learned Along the Way
Chapter 19: Accelerating Physician Entrepreneurship: The Perspective of a Resident Entrepreneur
Recognition of Unmet Clinical Needs
Evaluating Opportunities and the Potential Impact on Workflow
Accelerating Ideation and Development of Prototypes With a Cross-Functional Team
Invention Disclosures and Licensing IP
De-Risking Your Idea With Business Canvasing and Data Generation Through Approved Studies
Company Formation, Operating Agreements, and Capitalization Tables
Funding and Furthering Innovative Ideas in Health Care
Chapter 20: Fostering and Expanding Diversity in the Workforce in Innovation
The Current Entrepreneurial Landscape
The Role of Female Physicians in the Current Landscape (or Lack Thereof)
Explanation for Lack of Female Entrepreneurs
Julie Silver-Oncology Rehab Partners
Chapter 21: Preparing America's Entrepreneurial Workforce: Reinventing the Medical Curriculum
The Medical School Pathway of Excellence in Innovation and Entrepreneurship
The Surgical Innovation and Entrepreneurial Development Program
Evaluating Return on Investment
Chapter 22: A Dean's Perspective on Entrepreneurship in the University
Entrepreneurship at a University
Entrepreneurship in a Medical School
Entrepreneurship and the Clinical Mission
Entrepreneurship in the Research Mission
Entrepreneurship in the Education Mission
Creating an Entrepreneurial Environment
Office of Technology Transfer
Relationship Between the University and Community Entrepreneurship
Chapter 23: The Role of Medical Societies and Their Foundations in Supporting Entrepreneurs: A View From Anesthesiology
Chapter 24: Surgical Societies as Supporters of Innovation
The Birth of SAGES as ``the Surgical Society for Innovation´´
The Times They Are a Changin'…
SAGES and Innovation Today
Chapter 25: Role of Medical Journals in Promoting Innovation
Chapter 26: Inspiration, Perspiration, and Perseverance: An Innovator's Perspective
Strengths, Weaknesses, and the Art of Getting the Team Right
Patience and Perseverance
Medical Innovation
：Concept to Commercialization
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