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
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: Panelists: Deborah Haywood Erin Kyle, DNP, RN, CNOR, NEA-BC Andrew Lam Linda Rouse O'Neill Soumi Saha, PharmD, JD |
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: Panelists: Anoush Frankian, MSc, RAC Monica Gorman, PhD Deborah E. Kramer, MS Heather Mallinckrodt Abby Pratt |
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 |
1:15-2:20 PM | Panel Discussion: "Opportunities for Effective Collaboration in the Supply Chain" |
Moderator: Panelists: Paul T. Conway Mike Schiller Clayton Hall Paul E. Petersen, PharmD, MPH, CEM |
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, 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
- Speaker Biographies (PDF - 1MB)
- Resilient Supply Chain Program
- Resilient Supply Chain Program Workshop Keynote - June 7, 2022
- Resilient Supply Chain Program Workshop Keynote - June 8, 2022
- Resilient Supply Chain Program Workshop Keynote - June 9, 2022
- Collaboration May Foster a Resilient Supply Chain