Translational Pathway for Medical Devices

INTRODUCTION
Welcome from the Course Directors
3 Topics
Course Director Nabil Dib, MD
Course Director Spencer B. King, MD
Course Director Anthony N. DeMaria, MD
Course Description
8 Topics
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?
Course Topics
Translational Pathway to Expedite Scientific Discovery to Patients
Meet the Legends of Innovation
TOPICS IN MEDICAL DEVICE DEVELOPMENT
Concept/Innovation
1 Topic | 1 Quiz
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
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
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
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
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
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
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
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
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
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
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
Lecture – Anthony DeMaria, MD, UCSD
Translational Pathways for Medical Devices: Conflict of Interest – Anthony DeMaria Practice Quiz
Patients
1 Topic | 1 Quiz
Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute
Translational Pathways for Medical Devices: Patients Voice – Mark Mercola Practice Quiz
Panel Discussions
5 Topics
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
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Translational Pathway to Expedite Scientific Discovery to Patients


Robert Califf, MD, FDA

Food and Drug Administration

Learning Objectives

  • Recognize that creativity and innovation are critical for our patients and economy
  • Recognize the future of merging technology of devices, biologics and drugs
  • Understand the importance of precision medicine
  • Understand the concept of ecosystem
  • Learn the concept of integrated health system
  • Learn the importance of the preclinical data
  • Learn that evidence collected should be useful for FDA and CMS approval at the same time
  • Recognize the importance of sharing data

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