The following appendices are directly referenced in the second edition of the Biodesign book. They provide supplementary information that expands upon information provided in the text. The following is a complete listing of all online appendices. However, each one can also be accessed through the chapter page with which it is associated.

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Listing by Chapter

1.1 Strategic Focus

Appendix 1.1.1 – Professional Associations for Select Medical Conditions

2.2 Existing Solutions

Appendix 2.2.1 – Risks and Benefits of AF Treatments
Appendix 2.2.2 – Gap Analysis Matrix for AF

2.4 Market Analysis

Appendix 2.4.1 – Porter’s Five Forces
Appendix 2.4.2 – SWOT Analysis

2.5 Need Selection

Appendix 2.5.1 – Sample Need Specification
Appendix 2.5.2 – Sample Need Specification

4.1 Intellectual Property Basics

Appendix 4.1.1 – Sample Provisional Patent Applications
Appendix 4.1.2 – Sample Utility Patent
Appendix 4.1.3 – Sample Confidentiality and Nondisclosure Agreement

4.2 Regulatory Basics

Appendix 4.2.1 – Sample FDA Approval Letter

4.3 Reimbursement Basics

Appendix 4.3.1 – Common Reimbursement Codes Used to Support Inpatient/Outpatient and Facility/Non-Facility Charges

4.4 Business Models

Appendix 4.4.1 – Decision Tree and Rules of Thumb for Choosing a Business Model

4.5 Concept Exploration & Testing

Appendix 4.5.1 – Special Considerations for the Development of Mechanical Device Prototypes
Appendix 4.5.2 – Special Considerations for the Development of Bio-Material Device Prototypes
Appendix 4.5.3 – Special Considerations for the Development of Electrical Device Prototypes
Appendix 4.5.4 – Special Considerations for the Development of Application and Software Prototypes

5.3 Clinical Strategy

Appendix 5.3.1 – Comparison of Pilot, Pivotal, and Post-Marketing Studies to Trials in the Pharmaceutical Industry
Appendix 5.3.2 – The Null Hypothesis, Type I/Type II Error, P-values and Sample Sizes
Appendix 5.3.3 – Circumstances Under Which Investigational Devices Can Be Used Outside an IDE-Approved Clinical Trial

5.4 Regulatory Strategy

Appendix 5.4.1 – Common Regulatory Pitfalls

5.5Quality Management

Appendix 5.5.1 – More Information About Medical Device Reporting
Appendix 5.5.2 – More Information About ISO 13485
Appendix 5.5.3 – FDA’s 21 Code of Federal Regulations (CFR) Part 820 QUality System Regulations
Appendix 5.5.4 – Compliance Actions and Enforcement

5.6 Reimbursement Strategy

Appendix 5.6.1 – Blue Cross Blue Shield Technology Evaluation Center (TEC) Assessment
Appendix 5.6.2 – Examples of Common Cost Models

5.8 Sales & Distribution Strategy

Appendix 5.8.1 – Summary of Indirect Sales and Distribution Models

6.1 Operating Plan & Financial Model

Appendix 6.1.1 – Sample Proxy Company Analysis

6.3 Funding Approaches

Appendix 6.3.1 – Company Valuation Example
Appendix 6.3.2 – Common Sections of Term Sheets