Online Course: Translational Pathway for Medical Devices
INTRODUCTION
Meet The Course Directors
3 Topics
Course Director Spencer B. King, MD
Course Director Anthony N. DeMaria, MD
Course Director Nabil Dib, MD, MSC, FACC
Welcome and Introduction
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
ISCTR Mission
2 Topics
Learning Objectives
Lecture – Nabil Dib, MD, Msc, President of ISCTR
Translational Pathway to Expedite Scientific Discovery to Patients
2 Topics
Learning Objectives
Lecture – Robert Califf, MD, FDA
Meet the Legends of Innovation
2 Topics
Learning Objectives
Lecture – Legends of Innovation
TOPICS IN MEDICAL DEVICE DEVELOPMENT
Concept/Innovation
3 Topics
|
1 Quiz
Choosing an Innovative Concept
Learning Objectives
Lecture – Todd Brinton, MD, Edward’s Lifesciences
Translational Pathways for Medical Devices: Concept / Innovation - Choosing an Innovative Concept – Todd Brinton Practice Quiz
Intellectual Property
3 Topics
|
1 Quiz
Intellectual Property
Learning Objectives
Lecture – James Inskeep, Patent Attorney
Translational Pathways for Medical Devices: Intellectual Property – James Inskeep Practice Quiz
Business Plan, Development, and Fundraising
3 Topics
|
1 Quiz
Business Plan, Product Development, and Fundraising
Learning Objectives
Lecture – Stan Rowe, Edward’s Lifesciences
Translational Pathways for Medical Devices: Business Plan, Product Development, and Fundraising – Stan Rowe Practice Quiz
Product Manufacturing
7 Topics
|
2 Quizzes
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
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
Translational Pathways for Medical Devices: Requirements for Medical Device Manufacturing and Iteration Industry Point of View – Richard Rapoza Practice Quiz
Preclinical Evaluation
19 Topics
|
5 Quizzes
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
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
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
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
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
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
7 Topics
|
2 Quizzes
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
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
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
33 Topics
|
10 Quizzes
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
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
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
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
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
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
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
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
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
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
Translational Pathways for Medical Devices: Clinical Endpoints/Surrogate Endpoints – Roseann White Practice Quiz
Regulatory Approval
11 Topics
|
3 Quizzes
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
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
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
Translational Pathways for Medical Devices: Regulatory Review of Cardiovascular Devices: European Regulatory Perspective – Robert Byrne Practice Quiz
Reimbursement
7 Topics
|
2 Quizzes
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
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
Translational Pathways for Medical Devices: Reimbursement for Diagnostic Devices - Lori Ashby Practice Quiz
Practice Guideline
7 Topics
|
2 Quizzes
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
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
Translational Pathways for Medical Devices: Guideline Requirement for Diagnostic Devices – Roxanna Mehran Practice Quiz
Technology Adoption
7 Topics
|
2 Quizzes
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
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
Translational Pathways for Medical Devices: Global Heart Health, Implications for Translational Research – Salim Yusuf Practice Quiz
Conflict of Interest
3 Topics
|
1 Quiz
Conflict of Interest and Product Development
Learning Objectives
Lecture – Anthony DeMaria, MD, UCSD
Translational Pathways for Medical Devices: Conflict of Interest – Anthony DeMaria Practice Quiz
Patients
3 Topics
|
1 Quiz
The Patients Voice
Learning Objectives
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
Previous Topic
Lecture – Robert Califf, MD, FDA
Online Course: Translational Pathway for Medical Devices
Translational Pathway to Expedite Scientific Discovery to Patients
Lecture – Robert Califf, MD, FDA
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