Translational Pathway for Medical Devices

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Course Directors: Nabil Dib, MD; Spencer King, MD; Anthony DeMaria, MD

This course will fulfill an unmet educational need and provide you with valuable knowledge to be successful in developing therapies and expediting scientific discovery to patients. Ultimately, this course will enable you to contribute to product development to improve survival and the quality of life while decreasing costs. This course will change your approach to medicine and innovation. The information is critical for anyone who works in product development, whether as an innovator, physician, scientist, engineer, regulator, or at a reimbursement agency. The course contains 33 lectures and there is a Final Quiz which consists of 107 Q & A’s.

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Regulatory Requirement For Marketing Approval – Bram Zuckerman, MD, FDA

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INTRODUCTION

Welcome from the Course Directors 3 Topics Sample Session

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Course Director Nabil Dib, MD

Course Director Spencer B. King, MD

Course Director Anthony N. DeMaria, MD

Course Description 8 Topics Sample Session

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Fulfill Unmet Educational Need (Knowledge Gap)

Translational Pathway for Trans Aortic Valve Replacement-TAVR

FlowFusion ND Infusion Catheter

U.S. Regulatory Device Evaluation

Translational Pathways for Cardiovascular Devices

Translational Pathway for Cardiovascular Therapy

Who should take this course?

Translational Pathway to Expedite Scientific Discovery to Patients Sample Session

Meet the Legends of Innovation Sample Session

TOPICS IN MEDICAL DEVICE DEVELOPMENT

Concept/Innovation 1 Topic | 1 Quiz

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Lecture – Todd Brinton, MD, Edward’s Lifesciences

Translational Pathways for Medical Devices: Concept / Innovation – Choosing an Innovative Concept – Todd Brinton Practice Quiz

Intellectual Property 1 Topic | 1 Quiz

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Lecture – James Inskeep, Patent Attorney

Translational Pathways for Medical Devices: Intellectual Property – James Inskeep Practice Quiz

Business Plan, Development, and Fundraising 1 Topic | 1 Quiz

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Lecture – Stan Rowe, Edward’s Lifesciences

Translational Pathways for Medical Devices: Business Plan, Product Development, and Fundraising – Stan Rowe Practice Quiz

Product Manufacturing 2 Topics | 2 Quizzes

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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

Lecture – Richard Rapoza, PhD, Abbott Vascular

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

Preclinical Evaluation 4 Topics | 4 Quizzes

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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

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

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

Lecture – Renu Virmani, MD, CV Path Institute

Translational Pathways for Medical Devices: Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View – Renu Virmani Practice Quiz

Early Feasibility Study 2 Topics | 2 Quizzes

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Lecture – Andrew Farb, MD, FDA

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

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

Translational Pathways for Medical Devices: Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View – David Reuter Practice Quiz

Biostatistics 10 Topics | 10 Quizzes

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Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Chris Mullin, PhD, NAMSA

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

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

Lecture – Chris Mullin, PhD, NAMSA

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

Lecture – Roseann White, PhD, Duke Research Institute

Translational Pathways for Medical Devices: Clinical Endpoints/Surrogate Endpoints – Roseann White Practice Quiz

Regulatory Approval 4 Topics | 3 Quizzes

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Lecture – Bram Zuckerman, MD, FDA

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

FDA Perspective on Transformative Regulatory Pathways and Device Innovation

Lecture – Marco Cannella, PhD, FDA

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

Lecture – Robert Byrne, MD, Heart Centre, Germany

Translational Pathways for Medical Devices: Regulatory Review of Cardiovascular Devices: European Regulatory Perspective – Robert Byrne Practice Quiz

Reimbursement 2 Topics | 2 Quizzes

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Lecture – Joseph Chin, MD, CMS

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

Lecture – Lori Ashby, CMS

Translational Pathways for Medical Devices: Reimbursement for Diagnostic Devices – Lori Ashby Practice Quiz

Practice Guideline 2 Topics | 2 Quizzes

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Lecture – Alice Jacobs, MD, Boston University

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

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

Translational Pathways for Medical Devices: Guideline Requirement for Diagnostic Devices – Roxanna Mehran Practice Quiz

Technology Adoption 2 Topics | 2 Quizzes

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Lecture – Ian Meredith, MD, Boston Scientific

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

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

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

Conflict of Interest 1 Topic | 1 Quiz

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Lecture – Anthony DeMaria, MD, UCSD

Translational Pathways for Medical Devices: Conflict of Interest – Anthony DeMaria Practice Quiz

Patients 1 Topic | 1 Quiz

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Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute

Translational Pathways for Medical Devices: Patients Voice – Mark Mercola Practice Quiz

Panel Discussions 5 Topics

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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

Translational Pathway for Medical Devices Final Quiz