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Translational Pathways for Cardiovascular Devices

COURSE INTRODUCTION

Welcome from the Course Directors Sample Session

Course Director Nabil Dib, MD, MSc

Course Director Spencer B. King, MD

Course Director Anthony N. DeMaria, MD

SESSION I: BASIC KNOWLEDGE FOR MEDICAL DEVICES DEVELOPMENT

Introduction to Session I: Basic Knowledge for Medical Devices

Concept/Innovation

Lecture “Choosing an Innovative Concept” by Todd Brinton, MD

Practice Quiz: Choosing an Innovative Concept – Todd Brinton

Intellectual Property

Lecture “Intellectual Property” by James Inskeep, Patent Attorney

Practice Quiz: Intellectual Property – James Inskeep

Lecture “Overview of the Patent Process” by Jason Gilbert, Patent Attorney

Practice Quiz: Overview of the Patent Process – Jason Gilbert

Business Plan, Development, and Fundraising

Lecture “Business Plan, Product Development, and Fundraising” by Stanon Rowe

Practice Quiz: Business Plan, Product Development, and Fundraising – Stanton Rowe

Product Manufacturing

Lecture “Requirements for Medical Device Manufacturing & Iteration – FDA Point of View” by Brad Quinn

Practice Quiz: Requirements for Medical Device Manufacturing & Iteration – FDA Point of View – Brad Quinn

Lecture “Requirements for Medical Device Manufacturing & Iteration – Industry Point of View” by Richard Rapoza, PhD

Practice Quiz: Requirements for Medical Device Manufacturing and Iteration – Industry Point of View – Richard Rapoza

Preclinical Evaluation

Lecture “Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology” by Renu Virmani, MD

Practice Quiz: Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology – Renu Virmani

Lecture, “Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, & Device Testing” by Daniel Burkhoff, MD

Practice Quiz: Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, & Device Testing – Daniel Burkhoff

Lecture “Pre-Clinical Study Design & Endpoints for Device Evaluation – FDA Point of View” by Judith Davis, DVM, MS

Practice Quiz: Pre-Clinical Study Design & Endpoints for Device Evaluation – FDA Point Of View – Judith Davis

Lecture “Pre-Clinical Study Design & Endpoints for Device Evaluation – Investigator Point of View” by Renu Virmani, MD

Practice Quiz: Pre-Clinical Study Design & Endpoints for Device Evaluation – Investigator Point Of View – Renu Virmani

Early Feasibility Study

Lecture “Early Feasibility Studies for Device Evaluation” by Andrew Farb, MD, FDA

Practice Quiz: Early Feasibility Studies for Device Evaluation – Andrew Farb

Lecture “Current Challenges & Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View” by David Reuter, MD

Practice Quiz: Current Challenges & Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View – David Reuter

Lecture “Basic in Statistics – Clinical Study Design for Translational Research” by Chris Mullin, PhD

Practice Quiz: Basic in Statistics – Clinical Study Design for Translational Research – Chris Mullin

Lecture “Basic Statistical Concepts” by Chris Mullin, PhD

Practice Quiz: Basic Statistical Concepts – Chris Mullin

Lecture “Sample Size and Power” by Chris Mullin, PhD

Practice Quiz: Sample Size and Power – Chris Mullin

Lecture “Sensitivity and Specificity” by Chris Mullin, PhD

Practice Quiz: Sensitivity and Specificity – Chris Mullin

Lecture “Common Study Design” by Chris Mullin, PhD

Practice Quiz: Common Study Design – Chris Mullin

Lecture “Phases of Translational Research” by Chris Mullin, PhD

Practice Quiz: Phases of Translational Research – Chris Mullin

Lecture “Statistics for Evaluation of Cardiovascular Diagnostic Devices” by Chris Mullin, PhD

Practice Quiz: Statistics for Evaluation of Cardiovascular Diagnostic Devices- Chris Mullin

Lecture “Pre-Clinical & Clinical Trial Design & Endpoints of Fast Track to Device Approval” by Roseann White, PhD

Practice Quiz: Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval – Roseann White

Lecture “Advanced Statistical Methods for Translational Research” by Chris Mullin, PhD

Practice Quiz: Advanced Statistical Methods for Translational Research- Chris Mullin

Lecture “Biostatistics Clinical Endpoints/Surrogate Endpoints” by Roseann White, PhD

Practice Quiz: Biostatistics Clinical Endpoints/Surrogate Endpoints – Roseann White

Regulatory Approval

Lecture “Regulatory Requirement for Marketing Approval” by Bram Zuckerman, MD, FDA

Practice Quiz: Regulatory Approval – Regulatory Requirement for Marketing Approval – Bram Zuckerman

Lecture “FDA Perspective on Transformative Regulatory Pathways & Device Innovation” by Bram Zuckerman, MD, FDA

Lecture “Regulatory Review of Cardiovascular Diagnostic Devices – FDA Perspective” by Marco Cannella, PhD, FDA

Practice Quiz: Regulatory Review of Cardiovascular Diagnostic devices – FDA Perspective – Marco Cannella

Lecture “Regulatory Review of Cardiovascular Devices – European Regulatory Perspective” by Robert Byrne, MD

Practice Quiz: Regulatory Review of Cardiovascular Devices – European Regulatory Perspective – Robert Byrne

Lecture “CMS Criteria for Reimbursement for Cardiovascular Innovation” by Joseph Chin, MD, CMS

Practice Quiz: CMS Criteria for Reimbursement for Cardiovascular Innovation – Joseph Chin

Lecture “Reimbursement for Diagnostic Devices” by Lori Ashby, CMS

Practice Quiz: Reimbursement for Diagnostic Devices – Lori Ashby

Practice Guideline

Lecture “Practice Guideline Requirement for New Technology” by Alice Jacobs, MD

Practice Quiz: Practice Guideline Requirement for New Technology – Alice Jacobs

Lecture “Guideline Requirements for Diagnostic Devices” by Roxana Mehran, MD

Practice Quiz: Guideline Requirement for Diagnostic Devices – Roxanna Mehran

Technology Adoption

Lecture “Adoption of Technology” by Ian Meredith, MD

Practice Quiz: Adoption of Technology – Ian Meredith

Lecture “Global Heart Health, Implications for Translational Research” by Salim Yusuf, DPhil

Practice Quiz: Global Heart Health, Implications for Translational Research – Salim Yusuf

Conflict of Interest

Lecture “Conflict of Interest & Product Development” by Anthony DeMaria, MD

Practice Quiz: Conflict of Interest & Product Development – Anthony DeMaria

Lecture “The Patients Voice” by Mark Mercola, PhD

Practice Quiz: The Patients Voice – Mark Mercola

Panel Discussions

Diagnostic Devices Development

Device Development: Essential Concepts

Requirements for CV Devices Approval

Clinical Endpoints & Biostatistics

Preclinical, Early Feasibility, and Safety Study for Device Development

FINAL QUIZ for Session I: Basic Knowledge for CV Devices Development

Translational Pathways for Cardiovascular Devices – Session I: Basic Knowledge for CV Devices Development Final Quiz

Closing: Basic Knowledge for CV Devices Development

SESSION II: TRANSLATIONAL PATHWAY FOR TRANSCATHETER AORTIC VALVE

Introduction to Session II: Translational Pathway for Transcatheter Aortic Valve

Lecture “The Clinical Need for Innovative Treatment for Aortic Valve Disease” by Martin Leon, MD

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Course Director Nabil Dib, MD, MSc

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