Choosing an Innovative Concept

Learning Objectives

Lecture – Todd Brinton, MD, Edward’s Lifesciences

Intellectual Property

Learning Objectives

Lecture – James Inskeep, Patent Attorney

Business Plan, Product Development, and Fundraising

Learning Objectives

Lecture – Stan Rowe, Edward’s Lifesciences

Requirements for Medical Device Manufacturing and Iteration FDA Point of View

Learning Objectives

Lecture – Brad Quinn, FDA

Translational Pathways for Medical Devices: Product Manufacturing – Requirements for Medical Device Manufacturing and Iteration FDA Point of View – Brad Quinn Practice Quiz

Requirements for Medical Device Manufacturing and Iteration Industry Point of View

Learning Objectives

Lecture – Richard Rapoza, PhD, Abbott Vascular

Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology

Learning Objectives

Lecture – Renu Virmani, MD, CV Path Institute

Translational Pathways for Medical Devices: Preclinical Evaluation -Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology – Renu Virmani Practice Quiz

Introduction to the Cardiac Cath Lab

Learning Objectives

Lecture – Morton Kern, MD, VA Long Beach

Translational Pathways for Medical Devices: Preclinical Evaluation: Introduction to the Cardiac Cath Lab – Morton Kern Question Practice Quiz

Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing

Learning Objectives

Lecture – Daniel Burkhoff, MD, Colombia University

Translational Pathways for Medical Devices: Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing – Daniel Burkhoff Practice Quiz

Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View

Learning Objectives

Lecture – Judith Davis, DVM, MS, FDA

Translational Pathways for Medical Devices: Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View – Judith Davis Practice Quiz

Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View

Learning Objectives

Lecture – Renu Virmani, MD, CV Path Institute

Early Feasibility Studies for Device Evaluation

Learning Objectives

Lecture – Andrew Farb, MD, FDA

Translational Pathways for Medical Devices: Early Feasibility Study – Early Feasibility Studies for Device Evaluation – Andrew Farb Practice Quiz

Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View

Learning Objectives

Lecture – David Reuter, MD, Seattle Children’s Hospital

Basic in Statistics

Clinical Study Design for Translational Research – Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Biostatistics – Basic in Statistics – Clinical Study Design for Translational Research – Chris Mullin Practice Quiz

Basic Statistical Concepts – Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Basic in Statistics- Basic Statistical Concepts – Chris Mullin Practice Quiz

Sample Size and Power – Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Basic in Statistics – Sample Size and Power – Chris Mullin Practice Quiz

Sensitivity and Specificity – Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Basic in Statistics – Sensitivity and Specificity – Chris Mullin Practice Quiz

Common Study Design – Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Basic in Statistics – Common Study Design – Chris Mullin Practice Quiz

Phases of Translational Research- Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

Translational Pathways for Medical Devices: Basic in Statistics – Phases of Translational Research – Chris Mullin Practice Quiz

Statistics for Evaluation of Cardiovascular Diagnostic Devices – Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

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

Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval

Learning Objectives

Lecture – Roseann White, PhD, Duke Research Institute

Translational Pathways for Medical Devices: Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval – Roseann White Practice Quiz

Advanced Statistical Methods for Translational Research

Learning Objectives

Lecture – Chris Mullin, PhD, NAMSA

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

Clinical Endpoints/Surrogate Endpoints

Learning Objectives

Lecture – Roseann White, PhD, Duke Research Institute

Regulatory Requirement for Marketing Approval

Learning Objectives

Lecture – Bram Zuckerman, MD, FDA

Translational Pathways for Medical Devices: Regulatory Approval – Regulatory Requirement for Marketing Approval – Bram Zuckerman Practice Quiz

Regulatory Review of Cardiovascular Diagnostic Devices FDA Perspective

Learning Objectives

Lecture – Marco Cannella, PhD, FDA

Translational Pathways for Medical Devices: Regulatory Review of Cardiovascular Diagnostic devices – FDA Perspective – Marco Cannella Practice Quiz

Regulatory Review of Cardiovascular Devices: European Regulatory Perspective

Learning Objectives

Lecture – Robert Byrne, MD, Heart Centre, Germany

CMS Criteria for Reimbursement for Cardiovascular Innovation

Learning Objectives

Lecture – Joseph Chin, MD, CMS

Translational Pathways for Medical Devices: Reimbursement – CMS Criteria for Reimbursement for Cardiovascular Innovation – Joseph Chin Practice Quiz

Reimbursement for Diagnostic Devices

Learning Objectives

Lecture – Lori Ashby, CMS

Practice Guideline Requirement for New Technology

Learning Objectives

Lecture – Alice Jacobs, MD, Boston University

Translational Pathways for Medical Devices: Practice Guideline – Practice Guideline Requirement for New Technology – Alice Jacobs Practice Quiz

Guideline Requirements for Diagnostic Devices

Learning Objectives

Lecture – Roxana Mehran, MD, Icahn School of Medicine, Mount Sinai

Adoption of Technology

Learning Objectives

Lecture – Ian Meredith, MD, Boston Scientific

Translational Pathways for Medical Devices: Technology Adoption – Adoption of Technology – Ian Meredith Practice Quiz

Global Heart Health, Implications for Translational Research

Learning Objectives

Lecture – Salim Yusuf, D. Phil, World Federation of Cardiology

Conflict of Interest and Product Development

Learning Objectives

Lecture – Anthony DeMaria, MD, UCSD

The Patients Voice

Learning Objectives

Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute

2019 Diagnostic Devices Development

2019 Device Development: Essential Concepts

2018 Requirements for CV Devices Approval

2017 Clinical Endpoints & Biostatistics

2016 Preclinical, Early Feasibility, and Safety Study for Device Development