History
3D 2003 October 30–31, 2003
3D 2004 October 14–15, 2004
3D 2005 October 27–28, 2005
American College of Cardiology Visiting Professor 2005
Ulrich Sigwart, M.D., F.R.C.P., Pfizer/American College of Cardiology Visiting Professor
Cardiology Grand Rounds: Non-surgical Myocardial Reduction Therapy for the Treatment of Hypertrophic Cardiomyopathy: From Idea to Standard-of-Care.
3D 2006 October 12–13, 2006
3D 2007 October 4–5, 2007
3D 2008 September 18–19, 2008
3D gi I, April 30–May 1, 2009
3D 2009 October 22–23, 2009
3D 2010 October 21–22, 2010
3D 2011 September 22–23, 2011
3D 2012 September 13–14, 2012
3D 2013 September 26–27, 2013
3D 2014 October 16–17, 2014
3D 2015 October 29-30, 2015
3D 2016 September 29-30, 2016
Session 1: Real World Registries’: Understanding Their Structure and Capabilities
- Established Registries-STS: Basic Facts
- Established Registries-TVT: Basic Facts
- Established Registries: Supporting the PMA Process
- Point-Counter-Point
- Will US Registries be able to Perform RCT’s to Support Novel PMA Applications:
- Basic Definitions and Perspective
Session 2: CMS Mandated Registries (TAVR, Mitral Clip, LAA-C): A Critical Analysis
- CMS Mandated Registries: An Overview and Perspective
- CMS Registries-Understanding the Costs:
- CMS Registries: An FDA Perspective
- CMS Registries: A CMS Perspective
- CMS Registries: A NICE Perspective from Across the Pond
- NEST: National Evaluation System for Health Technology
- A Real World Evaluation of Medical Technology Across the Total Product Lifecycle
Session 3: A Comprehensive Medical Device Evaluation System
- A Comprehensive Medical Evaluation System
- A Vision Moving Forward
- The Role of Private Insurers
- Utilization of Real World Date
- Implications for Market Access and Reimbursement
Session 4: Early Feasibility Studies:
- Early Feasibility Studies: A Progress Report
- Early Feasibility Studies: Medicare Coverage
- Early Feasibility Studies: A Site Perspective
- Early Feasibility Studies: An Entrepreneur’s Perspective
Session 5: Percutaneous Mitral Valve Interventions: Moving Beyond Early Feasibility
- Large Investments/Large Expectations
- Will Mitral Valve Replacement be TAVR II?
- COAPT Trial: If I knew then what I know now!
- Percutaneous Mitral Implants: Next Steps
- What is the appropriate standard and comparator?
Session 6: Listening to the Patient’s Voice: Shared Decision Making
- Shared Decision Tools
- What Can They Tell Us-How Can We Implement and Utilize Them Effectively?
Session 7: The Device Sector’s Challenge: Demonstrating Value When Utilizing Alternative Payment Models
- An Academic Medical Center’s Perspective
- A Health System Leader’s Perspective
- A Payor’s Perspective
- A Medical Technology Company’s Perspective
Session 8: Early Medical Device Investing/Development: Current Challenges in a Changing World
- The Changing World of Financing Medical Device Companies
- The Role of Investors from Emerging Markets
- The Perspective of a Large Device Manufacturer
3D 2017 October 5-6, 2017
Welcome
Welcome and Opening Remarks
Session I: Early Feasibility Studies: The Role of U.S.
- Early Feasibility Studies: Why are we here? / Where are we going?
- EFS: Making the Case
- The State of the Union
- EFS: The Importance to Academic Medical Centers
- Choke Points: Where are they? How are they addressed?
- Building on the Current Momentum: How to move forward?
Session II: Early Feasibility Studies: Mitral/Tricuspid Technologies: Practical Study Design/Meaningful Data
- Transition from EFS to Pivotal Trials
Session IIIa: Medical Device Development: Understanding the Changing Terrain in China
- How China is Addressing its Growing Health Care Need
- Is the China Window Closing?
Session IIIb: Environment: Understandin the Changing Terrain in Europe
- Europe: Understanding the Changes on the Horizon
- Impact on EFS and Device Development/Market Introduction
Session IV: The Role of Shared Decision Making: Clinical Decisions, Study Design and Reimbursement
- LAA-Closure: Lesson Learned-If we knew then what we know now
- TAVR Low Risk: Putting to work lessons from LAA-C
Session V: Cyber Security: Defining the Problem/Developing Solutions
Session VI: Insights from the “C” Suite
- Building Value Through Development and Introduction of Disruptive Technology
Session VII: Insights from the “C” Suite
- From Private Practive to Clinician Researcher to Hospital CEO
- What my New Perspective is Teaching Me
Session VIII: CED-NCDR: ICD, TAVR, MitraClip and LAA-Closure: The Sun Setting
- Implications for Moving Forward
Session IX: A Comprehensive Medical Device Evaluation System
- Implications when Moving to a Shared Risk-Value Model
3D 2018 October 25-26, 2018
Welcome
Opening Comments
Session I: Early Feasibility Study Initiative
- State of the Union and Updates
- What Happens When You Bring Legal Counsel From Sponsors and Clinical Sites Together?
- The EFS Network: Going from Virtual to Real; What Will it Take?
- Round Table Conversation
Session II: Evolving the Ecosystem: Ongoing Changes at FDA-Intent, Implementations and Impact
- Round Table Conversation
Session III: Medical Device Innovation: Sourcing Ideas, Capital and Talent
- Early Medical Device Innovation: The Importance and Selection of Venue
- Round Table Conversation
- A Leader’s Perspective: An Interview
Session IV: Medical Device Innovation: Understanding the Clinician’s Role
- Under the Microscope: The Clinician-Industry Collaboration
- The CEO’s Challenge: Maintaining One’s Balance
- Establishing Close Clinician-industry Collaboration While Managing Conflicts-of-Interest and maintaining Public Confidence
- The Investigator’s Dilemma: Falling Off the Tight Rope
- Building the Clinician-Industry Collaboration: From Earliest Insight Through Commercialization
- Trading Places: From Senior Clinician to Senior Manager
- What Has Surprised You the Most?
- What Would You Like Your (corporate/regulatory & clinical) colleagues to know?
Session V: Lessons COAPT: Implications for Moving Forward
Session VI: New Technology: Understanding the Power and Reach
- Harnessing the Power of Social Media in the Device Space:
- New Models/Tools in Study Recruitment and Device Promotion
Session VII: Understanding the Future Which May be our Current Reality
- A.I. and Machine Learning-Implications for the Medical Device Sector
- Kindle Understands You Better than You Understand What You Are Reading on Kindle
Session VIII: Evolving the Ecosystem in the Midst of a Paradigm Shift
Session IX: Shared Decision Making: Implementation by Fiat
Session X: A Comprehensive Medical Device Evaluation System
- A Comprehensive Evaluation System: “Real or Memorex”
- Realities for Firt Time Approval, Label Expansion and Post-Market Surveillance/Evaluation
Closing Comments
3D 2019 October 24-25, 2019
Coming Soon.
3D 2020 November 18 & 19, 2020
Virtual
November 18 & 19. 2020
3:00 PM – 6:00 PM
3D 2021 TBA
Location TBD