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  /    /  Part I – Basic Concepts in Device Development

Part I: Basic Concepts In Device Development

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I.1 Introduction
Anthony DeMaria, MD; David R. Holmes, MD; Spencer King III, MD; David G. Reuter, MD, PhD
I.2 Overview of Cardiovascular Translational Research
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 Regulatory Requirement for Marketing Approval
Felipe Aguel; Deborah G. Castillo, PhD; Joseph Chin, MD; Bram D. Zuckerman, MD
I.6 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.7 Requirements for Reimbursement for Innovation
Joseph Chin, MD; Seth Clancy
I.8 Requirement for New Technology to be Included in the Guidelines: “The Ultimate Goal”
Alice Jacobs, MD
I.9 Advanced Biostatistics for Translational Research
Chris Mullin; Roseann White
I.10 Early Feasibility Studies
Andrew Farb, MD; David G. Reuter, MD, PhD