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:: Tue, Jun 7 1:00 PM - 4:00 PM ET
Day2:: Wed, Jun 8 1:00 PM - 4:00 PM ET
Day3:: Thu, Jun 9 1:00 PM - 4:00 PM 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
Date and Time
Webcast
Agenda
Registration
Comments
Contact
Additional Resources

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

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	Supply Chain Disruption: Perspective at the Point of Care	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
1:00-1:05 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)
1:10-1:25 PM	Advancing Critical Medical Supply Chain Resiliency	Tim Manning Former White House COVID Supply Coordinator
1:25-2:10 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, MBA, 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) Clayton Hall Executive Vice President, Government Affairs, Medical Device Manufacturers Association (MDMA) Paul E. Petersen, PharmD, MPH, 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, MBA, 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

Online registration is now closed.

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, [email protected].

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: [email protected]