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  5. Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration - 06/07/2022
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Workshop

Event Title
Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration
June 7 - 9, 2022

Date:
June 7 - 9, 2022
Day1:
- ET
Day2:
- ET
Day3:
- ET


The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled "Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration." The purpose of the public workshop is to discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). The RSCP aims to build upon a foundation of strong partnerships to improve supply chain resiliency through proactive communication, collaboration, and engagement with patient advocates, health care providers, distributors, group purchasing organizations, manufacturers, as well as key component and material suppliers.


BACKGROUND

The Resilient Supply Chain Program (RSCP) is currently being established within the Center for Devices and Radiological Health (CDRH). The RSCP's mission is to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to help prevent and mitigate shortages of medical devices. The purpose of the public workshop is to introduce the RSCP, explore opportunities to collaborate on enhancing resilience within the medical device supply chain, and solicit public feedback. 

Topics for discussion include:

  • Resiliency in the medical device supply chain 
    • Perspectives across the medical device ecosystem 
  • Methods to measure resiliency
  • Collaboration with government, private sector, and non-governmental organizations to build and sustain resilience 
    • Novel pre- and post-market mitigation strategies 
    • Measures to identify and prevent potential supply chain disruptions to prevent shortages
    • Potential response structures to mitigate future challenges

The FDA hopes to use the learnings and key takeaways from the panel discussions, breakout sessions, and comments received to further develop the RSCP, and may use such learnings in future activities, including discussion papers.

DATE and TIME

This public workshop will be held June 7-9, 2022, from 1:00 PM to 4:00 PM (ET) by webcast only. 

WEBCAST

The virtual public workshop will be a live webcast and the link will be provided in your confirmation email once you have registered. The link for the archived webcast will be posted to this webpage for viewing after the public workshop. 

AGENDA

This agenda is preliminary and subject to change.
 

Time

Subject

Name of Speaker / Panelist
Day 1: June 7, 2022 – Resilience Defined and Measured 
1:00-1:10 PM Welcome & Introduction Tammy Beckham, DVM, PhD
Associate Director, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
1:10-1:20 PM Keynote Address Suzanne Schwartz, MD, MBA
Director, Office of Strategic Partnerships & Technology Innovation (OST), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
1:20-1:30 PM Point of Care: Impact of Supply Chain Challenges Mary Beth Kingston, PhD, RN, FAAN
Chief Nursing Officer, Advocate Aurora Health Care
1:30-2:35 PM Panel Discussion: "Resilience Defined and Measured"

Moderator:
Robert Handfield, PhD
Executive Director of Supply Chain Resource Cooperative and Bank of America University Distinguished Professor of Operations and Supply Chain Management, North Carolina State University

Panelists:
Eric Gascho

Senior Vice President, Policy and Government Affairs, National Health Council

Deborah Haywood
Vice President, Government Solutions, McKesson Medical Surgical

Erin Kyle, DNP, RN, CNOR, NEA-BC
Editor in Chief, Guidelines for Perioperative Practice, Association of periOperative Registered Nurses (AORN)

Andrew Lam
Vice President, Procure to Pay, Kaiser Permanente

Linda Rouse O'Neill
Vice President of Supply Chain Policy & Exec. Branch Relations,
Health Industry Distributors Association (HIDA)

Soumi Saha, PharmD, JD
Vice President of Advocacy,
Premier Inc.

2:35-2:45 PM Break  
2:45-3:30 PM *Breakout Group Session: "Defining Resilience" N/A
3:30-3:55 PM Key Takeaways from Breakout Group Sessions Carl Newman, PhD
Senior Technical Advisor, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
3:55-4:00 PM Thank You and Close Carl Newman, PhD
Senior Technical Advisor, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
Day 2: June 8, 2022 – Building and Sustaining Resilience
1:00-1:15 PM Welcome and Recap Day 1 Frank Block III, PhD, PE
Senior Health Scientist, All Hazards Readiness, Response, and Cybersecurity (ARC), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
1:15-2:10 PM Panel Discussion: "Innovative Methods for Mitigating Future Challenges"

Moderator:
Linda Ricci, MME, MPH

Director, Division of All Hazard Response, Science and Strategic Partnerships (DARSS), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA) 

Panelists:
L. Paige Ezernack

Chief, Defense Production Act - Emergency Response Authorities Office, HHS Office of the Assistant Secretary for Preparedness and Response

Anoush Frankian, MSc, RAC
Senior Manager, Regulatory Affairs, FUJIFILM Sonosite, Inc., Representing Medical Imaging Technology Association (MITA)

Monica Gorman, PhD
Deputy Assistant Secretary for Manufacturing, Industry & Analysis, International Trade Administration, U.S. Department of Commerce (DoC)

Deborah E. Kramer, MS
Acting Assistant Under Secretary for Health for Support, Veterans Health Administration, Department of Veterans Affairs

Heather Mallinckrodt
Associate Vice President, Contract and Program Services, Vizient, Inc.

Abby Pratt
Senior Vice President, Global Strategy & Analysis, Advanced Medical Technology Association (AdvaMed)

2:10-2:25 PM Keynote Address Tammy Beckham, DVM, PhD
Associate Director, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
2:25-2:40 PM Break  
2:40-3:25 PM *Breakout Group Session: "Innovative Mechanisms for Promoting Resilience" N/A
3:25-3:55 PM Key Takeaways from Breakout Group Sessions Frank Block III, PhD, PE
Senior Health Scientist, All Hazards Readiness, Response, and Cybersecurity (ARC), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
3:55-4:00 PM Thank You and Close Frank Block III, PhD, PE
Senior Health Scientist, All Hazards Readiness, Response, and Cybersecurity (ARC), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
Day 3: June 9, 2022 - Collaboration and Engagement Opportunities
1:00-1:15 PM Welcome and Recap Day 2

Kausar Riaz Ahmed, PhD, RAC
Senior Science Health Advisor, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)

1:15-2:20 PM Panel Discussion: "Opportunities for Effective Collaboration in the Supply Chain"

Moderator:
Michelle Tarver, MD, PhD
Deputy Director, Office of Strategic Partnerships & Technology Innovation, Program Director for Patient Science, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)

Panelists:

Paul T. Conway
Chair, Policy & Global Affairs,
American Association of Kidney Patients (AAKP)

Nancy Foster
Vice President for Quality and Patient Safety Policy,
American Hospital Association (AHA)
Mark Leahey
President & CEO, Medical Device Manufacturers Association (MDMA)

Paul E. Petersen, PharmD, CEM
Director, Emergency Preparedness Program, Interim Director, Vaccine-Preventable Diseases and Immunization Program, Communicable and Environmental Diseases & Emergency Preparedness Division, Tennessee Department of Health, Representing the Association of State and Territorial Health Officials (ASTHO)

2:20-2:35 PM Break  
2:35-3:20 PM *Breakout Group Session: "Achieving Effective Collaboration: Forums, Tools & Mechanisms for Partnership" N/A
3:20-3:50 PM Key Takeaways from Breakout Group Sessions Kausar Riaz Ahmed, PhD, RAC
Senior Science Health Advisor, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)
3:50-4:00 PM Thank You and Close Tammy Beckham, DVM, PhD
Associate Director, Resilient Supply Chain Program (RSCP), Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration (FDA)

*Breakout participants only

REGISTRATION

If you wish to attend this Workshop, you must register by 4:00 p.m. on June 6, 2022.

There is no fee to register for the Workshop.  Registration will be on a first-come, first-served basis.

FDA is seeking interested stakeholders to participate in the breakout sessions during this event. If interested, please note (Yes) in the registration field (#7). Space is limited for the breakout sessions, so FDA may limit the number of participants from each organization. If you wish to participate in the breakout sessions, registration must be completed by 4:00 p.m. on May 17, 2022. 

There is no fee to register for the workshop or breakout groups.

Register for This Event

Registrants will receive confirmation when requests for participation have been accepted, if applicable. Registrants who have requested to participate in breakout sessions will receive a separate notification confirming acceptance with details on how to access the breakout sessions.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2022-N-0593 by July 11, 2022.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.  

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.  

CONTACT

For questions regarding workshop content please contact:

Tammy Beckham, DVM, PhD
Associate Director, Resilient Supply Chain Program (RSCP)
Office of Strategic Partnerships and Technology Innovation (OST)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Email: RSCPWorkshop@fda.hhs.gov

ADDITIONAL RESOURCES

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