History

3D 2003 October 30–31, 2003

Medical Device Development: Barriers to Clinical Research and Commercialization. Defining the Problem from Different Perspective
Medical Device Development Clinical Development and Commercialization: Differences: United States and Europe/United Kingdom
FDAMA II
The Importance of Academic/Regulatory/Commercial Collaborations in the Development of New Therapies
Clinical Trial Design Considerations in Emerging Technology
Case I: IDE/PMA Process for 1st in Class Devices: The Development of a Percutaneously Placed Mitral Clip; Role for a Randomized Control Trial; Role of Post Market Surveillance
Case II: Drug Eluting Stents. Clinical Development Plan. Role for a Randomized Control Trial. Role of Post Market Surveillance.
Case III: “Next Generation: SVG Distal Protection. Role for a Randomized Control Trial. Role of Post Market Surveillance.
DHMC Open Forum: Early Medical Device Development: The role of the Clinician/Inventor/Entrepreneur and forces which drive early development overseas
Working Breakfast: White Paper Overview: Medical Device Development: Barriers to Clinical Research and Commercialization (U.S. and Europe). The Role of the Post-Market Surveillance in the Device Approval Process. When a RCT is NOT required for approval.

3D 2004 October 14–15, 2004

Critical issues associated with study design evaluating new devices and indications in the DES era.
Drug Eluting Stents: Strategies for effective Post Market Surveillance. Effective monitoring of low frequency serious adverse events and device failures. Evaluating common “off label” usage: AMI, SVG, CTO
Case1: Market Introduction of the No-Stenose Stent
Human Device Exemption (HDE): An Overview
Role of HDE in the early clinical development of novel therapies
Case 2: Nocva PFO Closure Device
Case 3: NuValve: A novel device for the treatment of calcific aortic stenosis
Case 4: Pump Tx: Hemodynamic support device for the treatment of cardiogenic shock
Public Registration of Clinical Trials: Developing a Device Specific Strategy
White Paper Overview: Strategies for Post Market Surveillance in the early commercialization of drug eluting stents. Human Device Eemption (HDE) in the development of cardiovascular devices. Public Registration of Trials: Strategies for Medical Devices

3D 2005 October 27–28, 2005

Post-Market Surveillance/Drug Eluting Stents: Thrombosis (Acute, Subacute and Delayed). What do we know / What do we need to know?
DES current usage: Are we getting all the benefit we think we are? A Quality perspective.
Post Market Surveillance Strategies: DES
Case Study: No-Thrombose Stent. A novel DES which elutes Newolimus and a 2b3a inhibitor. Preclinical studies demonstrate excellent reduction in intimal hyperplasia as well as elimination of platelet deposition. One year OUS data demonstrated no SAT in 250 elective patients.
Post Market Surveillance: ICD. What do we know / What do we need to know? The View from Differing Perspectives.
Post Market Surveillance Strategies: ICD. How do we create a system that provides the information we need to know?
Summing it Up. The Perspective of a Committed Contrarian. The Perspective of someone who has to make it work.
Conflicts of Interest: Medical Device Development
Key Note: Conflict of Interest: Medical Device Development. Similarities and differences between Pharma/Bio Tech and Medical Devices Perspective on the Current Climate.
Conflict of Interest: Early Device Development (Pre-Clinical/FIM). Understanding the role of the Clinician-Inventor-Entrepreneur.
Case Study: Dr. Foremost and development of a new AAA device. An in depth case study involving a world renowned vascular surgeon who invents and develops a first-in-class percutaneous device for treatment of AAA.
Conflicts of Interest: Device Development Clinical Phase. Understanding the role of the Clinician Investigator. The vast majority of clinical studies performed evaluating new therapies in interventional cardiology have been sponsored by the Companies and administered in collaboration with Clinical Investigators. These studies have provided the interventional community with a body of information which drives current practices.
Working Group Overview and Introduction. Working Groups: Post Market Surveillance (DES). Post Market Surveillance (ICD). Conflict of Interest (Clinician Entrepreneur). Conflict of Interest (Clinician Investigator)

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

Global Harmonization of Regulatory Policy. Is this possible? Is it a good idea?
Large multi-national trials, variation in results among countries. Variation in Biology, Technique or Study Management?
DES: Thrombosis (Sub-acute and Delayed)
Evaluation of Next Generation Drug- Eluting Stents. Standardization of Pre-clinical & Clinical Endpoints. International End Point Study Group.
Evolving Standards for Device Approval.
Back to Basics: What do the Regulations Say…Pre-amendment Devices, PMA and 510K
Examining the Approval Process for IABP as a new PMA Device (A Hypothetical Case Study).
New Technologies/Blurring the Boundaries between Cardiology and Surgery. Lessons from Carotid Stenting: The Good as well as The Bad, The Ugly.
New Paradigms for training V Surgical-Interventionist. Perspective of a CV Surgery Resident having spent a year as an Interventional Cardiology Fellow.
Mapping out the road to Regulatory Approval.
AnnuloRad (a Hypothetical Case). AnnuloRad is an “emerging” company which has developed a percutaneous-trans-septal technology which precisely delivers radiation to the mitral annulus which in Ovine CHF chronic mitral regurgitation models predictably restores annular anatomy and reduces mitral regurgitation.
Delivery of known technology via a new route: Percutaneous Aortic Valve Replacement.
Introduction Review: Global Harmonization of Regulatory Policy. Evolving Regulatory Stndards. New Technologies/Blurring the Boundaries between Cardiology and Surgery.

3D 2007 October 4–5, 2007

Interventional Cardiology Under Siege: Perspectives on the Impact of the Current Environment.
Real World Dilemmas in the Design and Execution of Pivotal Trials Comparing Novel Catheter Delivered Device Therapies to Established Open Surgical Procedures
The Emerging role and challenges of Data Safety Monitoring Boards and Clinical Events Committees
Considerations when comparing therapies with events occurring at different times: A statistical tutorial.
Challenges in Understanding the Acute, Early and Late Outcomes Following DES Implantations.
What does the data tell us. A State-of-the-art Review. New Insights from CMS Data Bank. General Discussion. On-Label vs. Off-Label Use. Impact of Clopidogrel on Long-term outcomes. Raising the Bar for Next Generation Devices.
Seeing the World from a New Perspective: (A Hypothetical Case Study).
Playing a Different Role
The Final Word
Working Groups: Impact of the Current Environment on the introduction and development of new medical devices. Challenges and Understanding the long-term risks associated with DES. Evolving Role of Data Safety Monitoring Boards and Clinical Events Committees.

3D 2008 September 18–19, 2008

Update from FDA
Update from CMS
The Era of the Large Clinical Trials (DES). Higher hurdles for market introduction. Keeping unsafe devices off the market Or Limiting the therapeutic options for our patients.
Implications for Lesion Specific DES. The regulatory path for novel stents designed for specific patient/lesion subsets, e.g., long lesions, small diameter vessels, bifurcation lesions, etc.
Aortic Stent Valve. Differences and implications in US and European Regulatory Pathways
Aortic Stent Valve. Understanding a Patient’s Perspective
The Last Word
PFO closure/Off Label Use: Understanding a Patient’s Perspective
PFO closure devices: HUD/HDE to Clsoure I….”What a Long Strange Trip It’s Been:
Reigal v. Medtronic: The Supreme Court upholds pre-emption associated with the Medical Device Act regarding PMA Devices: Good policy or loss of an important safeguard?

3D gi I, April 30–May 1, 2009

2009: Perspective from the FDA
Session 1: The GERD Start-ups: What happened? What can we learn?
Session 2: Ethical Issues in Interventional GI Technology Development. Why is R&D occurring overseas? The challenges and need for sham procedures
Session 3: Endoscopic Bariatric Technologies. Clinical study design.
Session 4: Role Play: 3rd Party Coverage
Medical Device Development 2009: New Economic and Regulatory Realities
Session 5: NOTES: Moving Forward Without a Defined Application
Summing it all up/next step

The GERD Start-ups
Ethical Issues in Interventional GI Technology Development
Endoscopic Bariatric Technologies
Role Play: 3rd Party Coverage
NOTES: Moving forward without a defined application

3D 2009 October 22–23, 2009

Update from FDA
Transcutaneous Aortic Valve Intervention I: What can we learn from the European Experience? Impact of TAVI at a large referral center in Europe.
Transcutaneous Aortic Valve Intervention II: Report from the “V-ARC” Meeting to Standardize Definitions and Trial Design Endpoints
Transcutaneous Aortic Valve Intervention III: How will stud design evolve?
The Last Word: The introduction of valve replacement therapies. Surgical and Transcutaneous. A 40+ year perspective.
Next Generation DES/Regulatory Implications & Challenges. Non-workhorse stents, small vessels, long lesions and bifurcations.
The 510K Pathway: Making a case for change
Role Play Exercise: Pre-submission FDA Phone Call
Medical Devices: New Technology, Diffusion and Growth: An Economists Perspective. Insights from the Medicare Database
Medical Devices: New Technology, Diffusion and Growth: An Industry Perspective.
Summing it all up/Next Step

3D 2010 October 21–22, 2010

Grappling with the 2010 Realities. Economic recovery and health care reform
IDE Clinical Studies: Barriers to U.S. Participation. Understand forces driving studies outside the U.S. Identifying 3 canges that would facilitate FIM/Early Clinical evaluation in the U.S.
TAVI: Digesting the Partner’s data and its impact on study designs going forward
Structural Heart: TAVI – is this the first chapter of the structural heart story? What are the lessons for Chapter 2?
Structural Heart: TAVI Plus: Adjunctive technology opportunities and regulatory challenges
The Last Word
The 510K Pathway: Understanding the new Class II order. Overview of the FDA and Institute of Medicine Reports
IDE/PMA: The increasing challenges running the gauntlet

3D 2011 September 22–23, 2011

Year in Review
Grappling with the 2011 Realities (Session I). Economy, politics, health care reform and device development. Why Am I not Sleeping at Night?
510(k) Reform: Review & Implications of the IOM Report (Session II)
Digesting the IOM Report: Forging a Path Forward (Session III)
Health Care Reform: New Realities-New Rules (Session IV). Balancing necessity and cost: technology Evaluation/Reimbursement Determination
Innovation: Start-up and Large Corp Perspectives (Session V). Will the “Start-up” Sector Continue to Generate Disruptive Technologies or Will Large Manufacturers Play a Bigger Role?
Focus on Innovation: FDA and NIH Approaches (Session VI)
Case Study: TAVR Early Commercialization (Session VII). The Role of Post Approval Studies. Clinical Center Selection: Manufacturer, FDA, Societies, CMS…Who Decides?
Case Study: TAVR (Session VIII) Approval Pathways for Technology Iterations & Adjunctive Therapies

3D 2012 September 13–14, 2012

Session I: Point-Counter-Point: The Last Thing We Need is More New Technology the Overuse of Existing Technology is a Large Part of Our Problem
Session II: Health Care/Cardiology-In-Transition. Understanding the New Models of Delivery; ACO-Value Based Payments, Implications for Hospitals, Physicians, Industry and Patients
Session III: Early Medical Device Innovation/Financing. How will the next wave of innovation be financed/where will it occur?
Session IV: MDUFA III & New Legislation Regarding IDE’s. Understanding the implications going forward
Session V: CMS Parallel Review
Session VI: CMS Coverage with Evidence Development
Session VII: Cath Lab of the Not So Distant Future. What will the Cath Lab Daily Schedule Look Like 10 Years from Now?
Session VIII: Disruptive Technology Development. Renal Denervation: The Next Frontier?
The Last Word
Bringing Minds Together: Understanding the Collaborative Process and Its Importance in the Early Development of Interventional Cardiology and Increasing Importance Now
Session IX: TAVR: What will AVR look like in 5 & 10 years from now. An American and World Perspective
Session X: ACC-STS/CMS – TAVR: Post Approval Studies & Reimbursement. A new model moving forward
Session XI: TAVR – Early Commercial Use: The Hospital Perspective. Program development & Reimbursement. Discerning how to pay for new high value/cost technologies

3D 2013 September 26–27, 2013

Medical Device Innovation: Cardiology a Growth Vector. “The Role of Technology in the New Medical Order
Understanding the New Medical Order: Device/Therapy Decisions are Driven by Health Care Delivery Systems: What Will We Pay For?
Regulatory & Reimbursement: Focusing Beyond Procedural Success. Parellel Review. The Importance of Superiority Trials. Coverage with Evidence Development.
FIH and Early Clinical Evaluation in the U.S.: Barriers & Opportunities: A Case Study/Role Play
New Technologies on the Horizon: Point & Counter-Point. The Following Technology will be Central to My Treatment Paradigm in 2023
Medical Device CEO Forum: The Cardiovascular Sector Within the changing Health Care Terrain
The Final Word
Perspectives on the Post Approval Study Dilemma: Big Data, Prospective Registries, UDI’s. Large Investments – Large Returns?
Post Approval Dynamic: TAVR a Case Study. TVT Structure, Goals and Anticipated Impact
If I Knew Then What I Know Now: First-in-Class Medical Device Pivotal Studies.

3D 2014 October 16–17, 2014

Session I: Early Feasibility Trials
- Early Feasibility/FIH in the US: Making the Case “The Run is Well Worth The Jump!”
- Early Feasibility/FIH in the US: Time to Move On This ‘Ship Has Sailed’.. It is not Mission Critical. Get over it!
- Participation in Early Feasibility Testing (Truth or Fantasy):
  - Impact on Design Most Relevant to US/Developed Markets
  - Impact on FDA Dialog
  - Important to the US Device ‘Ecosystem’
Session II: Focusing on the Post-Market/TVT Registry
- The TVT Registry
- History & Update
- TVT A Success?: By What Metrics?
- Are there issues which require a finer focus: Cognitive Impairment
- Sustaining TVT after CED
- Lessons Learned: If I Knew Then What I Know Now
- Lessons Learned: TAVR Specific or Generalizable
Session III: Focusing on the Post-Market/Coverage with Evidence Development
- Coverage with Evidence Development (CED)
- Basics and A Perspective
- Quality vs Appropriateness vs Regulatory vs Decision Tool
Session IV: Focusing on the Post-Market/New Technology-New Models
- Healthcare in the Big Data – iPhone/Galaxy World: Getting Beyond Shock & Awe
- Addressing Clinical/Market Needs Through New Service and Solution Models
Session V: Re-examining How We Do Things: Clinical Trials
- Will The Electronic Medical Record, Big Data, Dedicated Registries Eliminate the Need for Randomized Trials?
Session VI: Medical Device Leadership Forum
- The Role of Medical Device Innovation within a Changing Health Care Landscape:
- What is a Sustainable Innovative Model?
- Perspectives from Current and Past Leaders
The Final Word
Introduction & Welcome – Duane A. Compton, Ph.D. Dean, Geisel School of Medicine
Key Note – Technology, Health Care & The Current Economic Environment – Matthew J. Slaughter, Ph.D. Associate Dean for Faculty Tuck School of Business at Dartmouth
Session VII: The US Should Be More Like The EU/The EU Should Be More Like The US
- Regulatory Change in Europe: Live or Memorex?
- Panel Discussion
Session VIII: Focus on First-In-Class Devices
- First-In-Class Devices: Pivotal Study Design
- Integrating Patient Preferences and Clinical Reality into Study Design
  - Are We Asking The Correct Questions?
  - Are We Performing Pivotal Studies Prematurely?
- Renal Denervation (Baby or Bath Water)
- Death by Simplicity Data
- Moving Forward Better Informed
- Panel Discussion
  - Non-responder vs Non-compliance
  - Testing Proof-Of-Concept In A Single Drug Responder Population
  - Managing Pressures To Perform Pivotal (Sector Killing) Trials Prematurely
Session IX: Focus on First-In-Class Devices: Left Atrial Appendage Closure
- LAA Closure: Update and Perspective
- Panel Discussion
  - Oral Anticoagulation: Relative vs Absolute Contraindication
  - Post Market Surveillance Strategies

3D 2015 October 29-30, 2015

The Wide Lens: What Successful Innovators See that Others Miss
Looking Through a Wide Lens: Seeing the “Uberization” of Health Care
Early Medical Device Investing: Do We Need a Wider Lens?
Forces Driving Risk Capital Away From Series A Medical Device Investments:
U.S. & World Wide Perspectives
New Challenges Moving Forward in a Quickly Changing World
Early Feasibility Testing: Moving into the Clinic
Early Feasibility Testing in the U.S. An Update
How Changes in the Regulatory Environment (US/OUS) Impact My Decision?
Post Approval Integrated Medical device Evaluation Systems
21st Century Cures: An Overview and Perspective
Study Design.2015
Applying New Strategies to Device Approval
“If I Were King of the Forest”: What I Would Require for Device Approval
Medical Innovation Post Health Care Reform/New Payment Models
New Payment Models: Impact on Payors and Medical Device Sector
Health Care Reform & New Payment Models: Medical Device Manufacturers
The Impact on Thinking Within the “C Suite”
Digital Health, Value-Based Care and New Payment Models: Predicting the Future:
What Will be Different in 10 Years?
A Medical Device Analyst Perspective
An FDA Perspective
Consumerization of Healthcare

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

November 18th - 19th
3:00-6:00 PM Eastern Time