| I.1 |
Introduction (Preview Free Article) |
|
David R. Holmes, MD; Anthony DeMaria, MD; Nabil Dib, MD, MSc; Spencer King III, MD; David G. Reuter, MD, PhD
|
| I.2 |
Overview of Cardiovascular Translational Research (Preview Free Article & Lectures From Doctors Dib & Califf) |
|
Nabil Dib, MD, MSc |
| I.3 |
A Needs-Based Approach to Health Technology Innovation: The Stanford Biodesign Process Concept Development for Unmet Clinical Needs |
|
Todd J. Brinton, MD; Uday N. Kumar, MD; Jonathan G. Schwartz, MD; Paul G. Yock, MD |
| I.4 |
Intellectual Property and Strategy Development |
|
Neil K. Nydegger, Esq |
| I.5 |
Business Planning, Product Development and Fundraising: The Three Amigos of Your Device Start-Up |
|
Stanton Rowe |
| I.6 |
Regulatory Requirement for Marketing Approval |
|
Felipe Aguel; Deborah G. Castillo, PhD; Joseph Chin, MD; Bram D. Zuckerman, MD |
| I.7 |
Regulatory Assessment of Medical Devices in the European Union |
|
Alan G. Fraser, MD; Robert A. Byrne, PhD; Tom Melvin, MD; Niall MacAleenan, MD; Olga Tkachenko, PhD; Paul Piscoi, MD |
| I.8 |
Requirements for Reimbursement for Innovation |
|
Joseph Chin, MD; Seth Clancy |
| I.9 |
The ABCs of Reimbursement for Breakthrough Devices |
|
Tonya Dowd, MPH; Simran Madhani |
| I.10 |
Requirement for New Technology to be Included in the Guidelines: “The Ultimate Goal” |
|
Alice Jacobs, MD |
| I.11 |
Advanced Biostatistics for Translational Research |
|
Chris Mullin; Roseann White |
| I.12 |
Early Feasibility Studies |
|
Andrew Farb, MD; David G. Reuter, MD, PhD |
