Realizing the Benefits of UDI in Health Care

Realizing the Benefits of UDI in Health Care

December 9, 2014
JW Marriott
1331 Pennsylvania Ave NW, Washington, DC 20004

8:00am – 8:30am   Coffee and Light Refreshments

Coffee, tea, breakfast pastries served on the 9th floor8:30am – 8:55am   Welcome
Welcome, introductions, and review work to-date on the UDI• Allan Coukell, Senior Director, Health Programs, The Pew Charitable Trusts
• Jeff Shuren, Director, Center for Devices and Radiological Health (CDRH), FDA8:55am – 9:25am   UDI Roadmap
A moderated discussion of the Brookings Institution’s UDI Roadmap

• Greg Daniel, Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform, Brookings Institution
Moderator: Terrie Reed, Project Leader, Clinical Research Informatics, Duke Clinical Research Institute

9:25am – 10:30am UDI Interoperability in Electronic Health Information
Assess the state of interoperable standards to transmit UDI throughout the health care system

• Russell Branzell, President and Chief Executive Officer, College of Healthcare Information Management Executives
• Jamie Ferguson, Vice President of Health Information Technology Strategy and Policy, Kaiser Permanente
• Chuck Jaffe, Chief Executive Officer, Health Level 7
• Chantal Worzala, Director of Policy, American Hospital Association
Moderator: Steve Posnack, Director, Office of Standards and Technology, ONC

10:30am – 10:50am Break

10:50am – 12:00pm  Supply Chain and Materials Management Implementation of UDI
Identify the benefits and standards needed for UDI integration in supply chain and materials management systems

• Leigh Anderson, Informatics & Technology Services Chief Operating Officer, Premier
• Joe Dudas, Vice Chair, Category Management, Mayo Clinic
• Dennis Orthman, Senior Director, Strategic Marketplace Initiative
• Mike Schiller, Supply Chain Director, Association for Healthcare Resource & Materials Management
Moderator: Karen Conway, Executive Director, Industry Relations, Global Healthcare Exchange

12:00pm – 1:15pm Lunch and Remarks
• Jon White, Acting Director, Office of Clinical Quality and Safety & Acting Chief Medical Officer, ONC

1:15pm – 2:25pm  Clinical Applications of UDI
Evaluate how UDI capture in patients’ medical records and other data systems used by providers and clinicians can improve care and affect workflow, and identify standards revisions that are needed to obtain benefits
Use Case Review: David Hunt, Medical Director, Health IT Adoption & Patient Safety, Office of Clinical Quality and Safety, ONC

• David Bates, Senior Vice President for Quality and Safety, Brigham and Women’s Hospital
• Hans Buitendijk, HS Standards & Regulations Manager, Siemens Healthcare
• Denise Downing, Perioperative Nursing Specialist, Informatics, Association of periOperative Registered Nurses
• Joe Drozda, Medical Director of Outcomes Research, Mercy
Moderator: Jon White, Acting Director, Office of Clinical Quality and Safety & Acting Chief Medical Officer, ONC

2:25pm – 2:45pm Break

2:45pm – 4:00pm Additional Uses for UDI
Examine other potential uses of UDI—for implants and other types of devices—by hospitals, clinicians, payers and researchers, and the necessary standards needed to support those efforts

• Leslie Kelly Hall, Senior Vice President of Policy, Healthwise
• Phillip Lerner, Vice President and National Medical Director, Aetna
• Brendan Mullen, Vice President of Strategy and Development, National Quality Forum
• Art Sedrakyan, Associate Professor, Weill Cornell Medical College
Moderator: Josh Rising, Director, Healthcare Programs, The Pew Charitable Trusts

4:00pm – 4:30pm Wrap-up and Next Steps

Identify key next steps that FDA, ONC, and other stakeholders need to take to advance standards for UDI adoption
• Tom Gross, Director, Office of Surveillance and Biometrics, CDRH, FDA
• Chuck Jaffe, Chief Executive Officer, Health Level 7
• Rebecca Kush, President and CEO, Clinical Data Interchange Standards Consortium
• Steve Posnack, Director, Office of Standards and Technology, ONC
Moderator: Josh Rising, Director, Healthcare Programs, The Pew Charitable Trusts

International Consortium of Vascular Registries Nov. 17, 2014

Untitled

Chaired by:

Art Sedrakyan, M.D., Ph.D., Director, Patient-Centered Comparative Effectiveness Center and MDEpiNet Science and Infrastructure Center, Weill Cornell Medical College, Cornell University
Maarit Venermo, M.D., Professor of Surgery, Helsinki University Central Hospital, Finland, Chair, VASCUNET Committee, European Society for Vascular Surgery
Jack Cronenwett, M.D., Professor of Surgery, Dartmouth-Hitchcock Medical Center, Medical Director, Society for Vascular Surgery Patient Safety Organization

ICVR meeting schedule part 1

ICVR meeting schedule part 2

MDEpiNet Annual Meeting 2014

MDEpiNet-Globe-80-Logo3 Days of MDEpiNet Meetings

FDA-WhiteOak-800x150

White Oak Campus, FDA Headquarters
10903 New Hampshire Avenue, Silver Spring, MD

Contact info@MDEpiNet.org for additional details or comments


Day 1: October 14, 2014
10:00 – 17:30

 MDEpiNet Annual Meeting:

Data, Infrastructure and Methods – Crossroads & Bridges

Meeting Agenda: (View as PDF)

09:30-10:00  Arrival/Registration

 10:00-10:10  Welcome, Introduction, and Goals for the Day 

             Mitchell Krucoff, Duke and Danica Marinac-Dabic, FDA/CDRH

10:10-11:10  National Investments: Synergies and Potential for Medical Device Research and Surveillance                Moderators:  Mitchell Krucoff, Duke and Elizabeth Paxton, Kaiser

  • William Maisel, FDA/CDRH
  • Joe Selby, PCORI
  • Richard Kronick, AHRQ
  • Jodi Daniel, ONC
  • Patrick Archdeacon, FDA/CDER

11:10-13:00  The MDEpiNet Accomplishments

     Moderators:  Daniel Caños and Nilsa Loyo-Berrios, FDA/CDRH 

11:10-11:25  MDEpiNet Alignment with FDA Priorities

            Danica Marinac-Dabic, FDA/CDRH

11:25-12:05  MDEpiNet: Building Innovative Infrastructure

 11:25-11:35  Registries, Consortia, Implant Classification Libraries: Art Sedrakyan, Cornell

11:35-11:45  International Vascular Registry Consortium:  Jack Cronenwett, Dartmouth

11:45-11:50  International TAVR consortium:  Michael Mack, Baylor Scott

11:50-11:55  Infrastructure for Non-Implantable Devices:  Jo Ann Broeckel Elrod, University of Washington

11:55-12:05  Partnership Development:  Mitchell Krucoff, Duke

12:05-12:25  MDEpiNet:  Developing Innovative Methodologies

 12:05-12:10  Common Methodological Issues with Surveillance:  Sharon-Lise Normand, Harvard

12:10-12:15  Shrinkage Targets: Laura Hatfield, Harvard

12:15-12:20  Loss Functions: Laura Hatfield, Harvard

12:20-12:25  Opportunities of Linked Registries and Claims Data: Matthew Brennan, Duke

12: 25-12:40  MDEpiNet: Active Surveillance Efforts

 12:25-12: 30  DELTA in the National Registries:  Frederic Resnic, Lahey

12:30-12:35  Current Surveillance Practices:  Joseph Ross, Yale

12:35-12:40  Device Specific Surveillance/UDI Demonstration and Beyond:  Joseph Drozda, Mercy

12:40-13:00  Discussion

 13:00-14:00  Lunch Session: Overarching  Issues:  Legal, Access,  Transparency and International

     Moderators:  James Saviola and Benjamin Eloff, FDA/CDRH

  • Ralph Hall, University of Minnesota
  • Kathleen Hewitt, ACC
  • Ann Ferriter, FDA/CDRH
  • Philip Desjardins, Arnold &Porter’s
  • Kimberly Trautman, FDA/CDRH

Open Discussion

 14:00-15:30  Big Data/ Big Analytics: National and International Challenges and Opportunities  

Moderators:   Frederic Resnic, Lahey and James Tcheng, Duke

14:00-14:10  Industry Challenges: Richard Kuntz, Medtronic

 14:10-14:30  Integration of Disparate Data for Regulatory Science:

                             Simonyan Vahan, FDA/CBER and Yelizaveta Torosyan, FDA/CDRH

 14:30-14:40  The Interdisciplinary Journey Through the Big Data/Big Analytics:  Joseph Ross, Yale

 14:40-14:50  Experiences from the World’s Largest Orthopedic Registry: Richard Armstrong, Northgate, UK

 14:50-15:00  Big data:  Where Conventional Methods Meet Unconventional:  Sharon-Lise Normand, Harvard

 15:00-15:30  Open Discussion

 15:30-15:45  Break

 15:45-17:15  Building Sustainable Partnership Models: MDEpiNet Value Added

 15:45-16:00  Moving Forward:  Terrie Reed, Duke

16:00-17:00  Panel: Stakeholders View

Moderator: Art Sedrakyan, Cornell

  • Murray Sheldon, FDA/CDRH
  • Richard Armstrong,  Northgate, UK
  • Bray Patrick-Lake, Patient Representative
  • Gregory Daniel, Brookings Institution
  • Jeffrey Secunda,AdvaMed
  • Elise Berliner, AHRQ
  • Kathleen Hewitt,  ACC
  • Bram Zuckerman,  FDA/CDRH
  • Elizabeth Paxton, Kaiser
  • Ralph Brindis, ACC

17:00-17:15  Summary and Next Steps:  Danica Marinac-Dabic, FDA/CDRH and Mitchell Krucoff, Duke


Day 2: October 15, 2014
07:30-17:45

MDEpiNet in the Cardiovascular Arena:

Predictable And SuStainable Implementation Of National
Registries for Cardiovascular Devices
Launching The PASSION Registries for Cardiovascular Devices,
An MDEpiNet PPP Think Tank

Meeting Agenda: (View as PDF)

07:30-08:00  Continental Breakfast

08:00-08:10  Welcome & Introductions

08:10-09:00  Plenary Session: Infrastucture Transformation & the Innovation Ecosystem (10 minute presentations)

  • What we can and need to implement in the USA: An FDA View: William Maisel
  • What we can and need to implement in the USA: An Industry View: Mark Carlson
  • What we can and need to implement in the USA: An Academic View: Ralph Brindis
  • The value of information accrual over the total product life cycle through registry infrastructure: A Legacy View: David Feigal
  • The PASSION Registries Program: Brief Overview: Mitch Krucoff

09:00-10:30  Overarching Issues for Registries & Medical Device Benefit/Risk Assessment (5 minute presentations)

  • Overview of Key Regulatory Issues: Jim Saviola (10 min)
  • Governance & business models for clinical trials or safety surveillance: Predictable ownership, cost & contracting across partners
    • Industry view: Kristi Mitchell
    • FDA view: Danica Marinac Dabic
  • Methodologic approaches to heterogeneous data sources:
  • Claims data for long term follow up: a rational resource?
    • CMS view: Rosemarie Hakim
    • Academic view: Jessica Jalbert
  • Open Discussion (35 minutes) Lead Discussants: Joe Drozda; Julia Skapik; Owen Faris

10:45-11:00  Break

11:00-12:30  PASSION for Coronary Stents

12:30-12:45  Break

12:45-13:30  Luncheon Panel: International PASSION: Perspectives from home & abroad
(Lead Discussants: Kazuhiro Sase (Japan); Marie Claude Morice (EU); Kimberly Trautman (USA); Larry Kessler (USA)

13:30-15:00  PASSION for Aortic & Mitral Valves

15:00-16:30  PASSION for Rhythm & Heart Failure

  • Overview: Update on ICD and CRT registries: Academic view (10 min) Sana Al-Khatib
  • Registry-based IDEs for ICDs: Industry View (5 min): Eric Schorsch
  • Registry-based IDEs for ICDs: Regulatory View (5 min): FDA Mitch Schein
  • Registry-based IDEs for CRT: Industry View (5 min): Ken Stein
  • Registry-based IDEs for CRT: Regulatory View (5 min): Mitch Schein
  • Open Discussion (55 minutes) Lead Discussants: Todd Fonseca; Daniel Caños; Hussein Al-Khalidi, Jeff Brinker

16:30-17:30  PASSION for Peripheral and Endovascular (5 min presentations)

17:30-17:45  Final Comments & Next Steps:

  • Lead Discussants:
    • Bram Zuckerman
    • Terrie Reed
    • Danica Marinac-Dabic

 


Day 3: October 16, 2014
07:30-16:45

 MDEpiNet in the Orthopedic Arena:

Integrating International Consortium of Orthopaedic Registries (ICOR)
Surveillance Capabilities and the Global Orthopedic Classification Database

 Meeting Agenda: (View as PDF)

07:30-08:00  Arrival / Registration

 08:00-08:15  Welcome, Introduction, and Goals for the Day
Danica Marinac-Dabic, FDA/CDRH and Art Sedrakyan, Cornell

08:15-09:15  Global Orthopedic Classification Library: Current Efforts        

Moderators: Art Sedrakyan, Cornell and Elizabeth Paxton, Kaiser

 08:15-08:22  Current State of Harmonization Efforts: Rob Nelissen, Netherlands

08:22-08:29  UK Classification Efforts: Martyn Porter/Keith Tucker, UK

08:29-08:36  German Classification Database: Christof Veit, Germany

08:36-08:43  Dutch Classification Database: Rob Nelissen, Netherlands

08:43-08:50  ICOR Global Classification Library: Stephen Graves, Australia

08:50-08:57  Update on UDI implementation Efforts: Indira Konduri, FDA/CDRH

08:57-09:15  Discussion

09:15-09:30  Break

  09:30-11:30  ICOR Database Rules of Engagement: Governance, Maintenance, Access, Funding

 Moderators:  Art Sedrakyan, Cornell and Richard Armstrong, Northgate, UK

09:30-09:45  FDA View: Danica Marinac-Dabic and Mark Melkerson, FDA/CDRH

09:45-10:00  Industry View: Blair Fraser, Smith & Nephew

10:00-10:15  Registry View: Elizabeth Paxton, Kaiser

10:15-10:30  European Perspective: Gerold Labek, Austria

 10:30-11:30  Panel

Martyn Porter, UK
Blair Fraser, Smith & Nephew
Elizabeth Paxton, Kaiser
Rob Nelissen, Netherlands
Wilhelm Blömer, Germany

 11:30-12:30  Lunch Session: Evidence Gaps and Innovative Solutions

 Moderators: Patricia Franklin , UMass and Rosemary Hakim, CMS

 11:30-11:35  Overarching Infrastructure Gaps: David Lewallen, AJRR

11:35-11:40  Existing Efforts to Advance Data Quality/Gaps Standards: FDA/CDRH/ODE

11:40-11:45  Potential of Unconventional Data Sources: Yelizaveta Torosyan, FDA/CDRH

11:45-11:50  Explant Analysis: Value Added, Daniel MacDonald, Drexel

11:50-11:55  Innovative Methods: Points to Consider: Sharon-Lise Normand, Harvard

11:55-12:00  Quality Measures: Jay Lieberman, AJRR

12:00-12:05  Outlier Detection: Experiences from Australian Registry: Stephen Graves, Australia

 

12:05-12:30  Discussion

 12:30-14:30  How to Leverage Registries to Advance Life Cycle Evidence Evaluation?    

 Moderators: Sharon-Lise Normand, Harvard and Yelizaveta Torosyan, FDA/CDRH

12:30-12:37  ICOR USA/BO-PIE Model Vision: Danica Marinac-Dabic, FDA/CDRH

12:37-12:44  Industry Perspective: Jing Xie, Biomet

12:44-12:51  Global Academic Research Organization: Henrik  Malchau, Sweden/ Stephen Graves, Australia)

12:51:12:58  Beyond Compliance (Martyn Porter/Keith Tucker), UK

12:58:13:05  Current US Orthopedic Registries Harmonization Efforts: Elizabeth Paxton, Kaiser

13:05-13:12  Payer’s Perspective: Rosemarie Hakim, CMS

13:12-13:19  Opportunities to Advance Premarket Evaluation via Registries: Telba Irony/Phyllis Silverman/Pablo Bonangelino, FDA/CDRH

13:19-13:26  What Can MDEpiNet PPP Add? Art Sedrakyan, Cornell

 13:26-14:30  Panel: National / International Registry Leads

AJRR
FORCE TJR
California
Health East
Virginia
Michigan
Kaiser
Australian
UK
Dutch
German
Swedish

14:30-14:45  Break

14:45-16:45  Leveraging Existing Efforts: Bringing It All Together to Enhance Evidence Evaluation

 Moderators: Henrik Malchau, Sweden / Stephen Graves, Australia

 William Maloney, AJRR/AAOS
Art Sedrakyan, Cornell
Pamela Plouhar, J&J, AdvaMed,
Martyn Porter, UK
Elizabeth Paxton, Kaiser
Vahan Simonyan, FDA/CDER
Rob Nelissen , Netherlands
Mark Melkerson, FDA/CDRH
Danica Marinac-Dabic, FDA/CDRH
Rosemary Hakim, CMS

16:45  Wrap up and Next Steps
Danica Marinac-Dabic, FDA/CDRH and Art Sedrakyan, Cornell

 


 

 Confirmed Faculty:

Jodi Akin
Consultant, MedTech
Hussein Al-Khalidi, PhD
Duke University
Sana Al-Khatib, MD, MHS
Duke University
Richard Armstrong
Northgate, National Joint Registry, UK
Elise Berliner, PhD
Center for Outcomes and Evidence/AHRQ
Kathleen Blake, MD, MPH
American Medical Association
Sandeep Brar, MD
Medtronic
Matthew Brennan, MD, MPH
Duke University
Ralph Brindis, MD, MPH
American College of Cardiology
Jack Cronenwett, MD
Dartmouth-Hitchcock Medical Center
Greg Daniel, PhD, MPH
The Brookings Institution
Joseph Drozda, Jr., MD
Mercy
Roberta Antoine Dressen, MBA
White Rock Partners
Fred Edwards, MD
University of Florida
Benjamin Eloff, PhD
U.S. Food and Drug Administration
Neal Fearnot, PhD
Cook Group
Tara Federici
AdvaMed
Patricia Franklin, MD, MBA, MPH
University of Massachusetts
Elisabeth George
Philips Healthcare
Ralph Hall, JD
University of Minnesota,
Faegre Baker Daniels
Rosemarie Hakim
Centers for Medicare & Medicaid Services
Joachim Hassenpflug, MD
University Hospital of Schleswig-Holstein, Germany
John Hernandez, PhD
Abbott Vascular
Ajay Kirtane, MD
Columbia University Medical Center
David Kong, MD
Duke University
Mitchell Krucoff, MD
Duke University
Harlan Krumholz, MD, PhD
Yale University
Gerold Labek, MD
Medical University Innsbruck, Austria
John Laschinger, MD
U.S. Food and Drug Administration
Russell Leftwich, MD
Tennessee Office of eHealth,
Health Level Seven
Michael Mack, MD
Baylor Healthcare System
Bill Maisel, MD, MPH
U.S. Food and Drug Administration
Danica Marinac-Dabic, MD, PhD
U.S. Food and Drug Administration
Brian McCourt
Duke University
Jose Morales, MD
U.S. Food and Drug Administration
Robert Nelissen, MD, PhD
Leiden University, Netherlands
Graham Nichol, MD, MPH
University of Washington
Sharon-Lise Normand, PhD
Harvard University
Marc Overhage
Siemens Healthcare
Elizabeth Paxton, MA
Kaiser Permanente
Pamela Plouhar, PhD
DePuy Synthes
Terrie Reed, MSIE
Duke University
Frederic Resnic, MD, MSc
Lahey Hospital and Medical Center
David Rutledge, PharmD
Abbott Vascular
Jeffrey Secunda, MBA
AdvaMed
Art Sedrakyan, MD, PhD
Cornell University
Joe Selby, MD, MPH
Patient-Centered Outcomes Research Institute
Murray Sheldon, MD
U.S. Food and Drug Administration
Vahan Simonyan, PhD
U.S. Food and Drug Administration
Julia Skapik, MD, MPH
Office of the National Coordinator for Health Information Technology
Kenneth Stein, MD
Boston Scientific
James Tcheng, MD
Duke University
Robert Thatcher, MBA
Cardiovascular Systems, Inc.
Kimberly Trautman
U.S. Food and Drug Administration
Mark Turco, MD
Covidien
Jing Xie, PhD, MS
Biomet

 

* Supported by FDA cooperative agreement #1U01FD004964 *

FDA-WhiteOak-800x150

White Oak Campus, FDA Headquarters
10903 New Hampshire Avenue, Silver Spring, MD

Contact info@MDEpiNet.org  for additional details or comments

Manuel Gomes FDA Presentation May 20, 2014

Handling missing data in meta-analysis of individual participant data with mixed outcomes

M Gomes, LA Hatfield, S-LT Normand

Abstract

Meta-analysis of individual participant data (IPD) is increasingly utilized in combining data from both randomized trials and observational studies. IPD meta-analysis has several advantages over meta-analysis based on aggregate study-level data, such as standardization of analysis across studies, analysis of multiple outcomes, and adjustment for additional potential confounders. IPD meta-analysis hosts, however, particular features making inferences challenging; the hierarchical structure of individuals within studies, the multiplicity of outcomes – often consisting of a mixture of continuous and discrete variables, and the missing data. Missing data typically arise because outcomes may be partially observed across studies (sporadically missing), or may not be collected in a specific study (systematically missing). We illustrate a multivariate Bayesian approach that accounts for the correlation among the (mixed) outcomes, between-study heterogeneity, and missing data.

Multiple imputation (MI) offers an alternative approach for addressing missing data as this approach also recognizes the hierarchical nature of the data and the correlation among the multiple outcomes. An important advantage of MI involves its relative ease of implementation through the availability of standard software. In this talk, we illustrate approaches in a meta-analysis of randomized controlled trials comparing the effectiveness of implantable cardiac devices (ICD vs CRT-D) to treat heart failure, with both sporadically and systematically missing mixed outcomes (mortality, 6-minute walk, NYHA class and quality of life). A simulation study characterizes the relative performance of alternative methods across different settings in IPD meta-analysis.
This work is supported by the MDEpiNet Methodology Center (Drs. Hatfield and Normand) and by funding from UK MRC Early Career Fellowship (Dr. Gomes).

Learning objectives

  1. Understanding the specific challenges posed by missing data in meta-analysis of individual-participant data.
  2. Illustrating different methods for meta-analysis of mixed outcomes with missing data.
  3. Assessing the relative merits of alternative methods for addressing the missing data in IPD meta-analysis, across a wide range of circumstances.

Balancing Device Innovation and Evaluation to Advance the Regulation and Health: In context of Urgent and Routine Public Health Needs

Balancing Device innovation april 3, 2014

Meeting Agenda
Balancing Device Innovation and Evaluation to Advance the Regulation and Health:
In context of Urgent and Routine Public Health Needs
April 3 & 4, 2014
Meeting Location: Cornell Club, 6 East 44th St, New York, NY

Day 1, April 3, 2014

  • 8:30 am Continental Breakfast and Introductions
  • 8:45 am Setting the Scene/Goals: Art Sedrakyan and Peter McCulloch, Cornell University and Oxford
    University

    • 8:45 am Overview of IDEAL: Peter McCulloch, Oxford University
    • 9:00 am Potential gaps in IDEAL for devices: Art Sedrakyan, Cornell University
  • 9:15 am – 12:00 pm Current FDA Pathways, Guidance(s) on innovation and Total Product Life
    Cycle- opportunities for advancement

    • Moderator: Art Sedrakyan, Cornell University
    • 9:15 am – 10:00 am General Overview of Innovation at FDA: Murray Sheldon, CDRH/FDA -A
      summary of the major processes from science and policy perspectives
    • 10:00 am – 10:45 am Pre-post market balance, other opportunities for improvement in
      partnership with manufacturers and IDEAL: Danica Marinac-Dabic, Division Director, Division of
      Epidemiology and Surveillance
    • 10:45 am – 11:00 am Break
    • 11:00 am – 12:00 pm Questions to Presenters and Moderated Discussion (including Reflections
      from EU and Canada)
  • 12:00 pm – 1:00 pm Working Lunch and Key Questions for the Afternoon:
    a. Are regulatory evidence requirements different for emergencies? Can IDEAL help in
    developing methods for devices filling an urgent need?
    b. General context for innovation: If regulation is changing how can IDEAL methods address
    new needs and promote different thinking within surgical innovator community
  • 1:00 pm – 5:00 pm Opportunities for change: IDEAL and pragmatism
    • 1:00 pm – 2:00 pm: Strategic/Regulatory and Methodological Opportunities for Civil
      Emergencies and Related Devices: Hemostasis device and Extracorporeal membrane oxygenation
      (ECMO) presentation and discussion. Moderator: Murray Sheldon, CDRH/FDA
    • 2:00 pm – 3:00 pm: Strategic/Regulatory and Methodological Opportunities for Devices filling
      known critical public health gaps (PMA and 510K examples): Transcatheter Valve Technologies
      (TVT) and LARIAT device presentation and discussion. Moderator: Michael Mack, Chair of TVT
      Registry, Cardiothoracic Surgery at Baylor
    • 3:00 pm – 3:10 pm Coffee break
    • 3:10 pm – 4:45 pm: Current Realities in the USA and Europe. Policy and Methodology
      Facilitated Discussion- Moderator: Bruce Campbell, NICE
      Starting with Perspectives for a discussion (5 minutes each): Danica Marinac-Dabic, FDA; Tammy
      Clifford, Canadian regulator; Richard Kuntz, Medtronic, Jesse Berlin, Johnson and Johnson
      General discussion: All participants but focus on manufacturer needs and regulatory advancement
      Discussion to provide early thinking about new vision: IDEAL evolution for devices.
    • 4:45 pm – 5:00 pm Closing Remarks
  • Dinner 7:00 pm (TBD)

Day 2, April 4 (IDEAL specific discussion- others are welcome)

  • 8:30 am Continental Breakfast
  • 9:00 am – 12:00 pm Mapping Regulatory Evidence Needs to Circumstances
    Discuss the importance of the public health emergency and urgent gaps (e.g. emergencies and incurable
    conditions). Is there a need for development of IDEAL stage 0 (preclinical) standards? Are the current
    IDEAL Recommendations in need of modification to fit the needs of the device innovation pathway?
    What should IDEAL recommend around the use of Registries as a balance for accelerated innovation?
    Facilitated Discussion

    • 9:00 am – 10:00 am
      Defining circumstances: emergencies, urgent gaps and routine care: Split into two groups in the
      same room (Moderators for the groups: TBD)
    • 10:00 am – 11:00 am
      Development of recommendations for each circumstance, focusing on the role of IDEAL: Split
      into two groups in the same room (Moderators for the groups: TBD)
    • 11:00 am – 12:00 pm: Summarize the discussions (moderator TBD).
  • 12:00 pm Lunch
  • 1:00 pm – 4:00 pm: Guidelines for IDEAL Development and Exploration Stage Studies
    • 1:00 pm – 1:20 pm Explanation of the draft guidelines and the need for them (Riaz Agha, The Mid-
      Yorkshire Hospitals)
    • 1:20 pm – 2:30 pm Group Discussion on draft Guidelines (TBD)
    • 2.30 pm – 2:45 pm Coffee break
    • 2:45 pm – 3:45 pm Group Discussion on PES draft Guidelines (TBD)
    • 3:45pm – 4:00 pm Summarize the Session (Peter McCulloch)

4:00 Close (Art Sedrakyan)