(as of August 1, 2022 – subject to change)
FDA UDI Program Update
Speaker: Indira Konduri, Deputy Director, Division of Surveillance Support (DSS), Office of Regulatory Programs (ORP), Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health, US FDA
The Panorama: The Evolving Global UDI Landscape
Speaker: Jay Crowley, Vice President Medical Device Solutions and Services; Dennis Black, UDI Program Director, Global Regulatory Affairs, BD; Angela Fernandez, VP, Community Engagement, GS1 US
As global regulators, purchasers and other stakeholders begin to develop and implement country or regulator-specific UDI or UDI-like systems – they are not only trying to address device identification – but also support specific national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement). These new regulatory, commercial, and patient-safety use-cases create novel and complex challenges for device manufacturers, who now must establish, maintain and submit the ever-growing (and changing) broad set of global device attribute information to these various robust global systems, processes and stakeholders. This session will review the current global climate and outline the trends and the direction of the international UDI activities to address the question of how companies might manage distribution at a UDI level.
Auto ID: The Key to Traceability Efficiencies
Moderator: Patti Blessing, Chair, UDI Workgroup, AIM North America
Panelist from UDI Workgroup to be announced
Join us as we detail the leading Auto ID technologies supporting the UDI community. Whether your needs are based on regulatory requirements, or you are looking to the future, these technologies enable visibility and traceability throughout the supply chain from raw materials to point of consumption. This panel of leading technologists and industry experts will walk you through direct part marking, RFID, the migration to 2D, and other critical enabling technologies.
Getting Specific on the EU MDR
Facilitator: Jay Crowley, Vice President Medical Device Solutions and Services, USDM
Panelists: Lionel Tussau, Market Unit Healthcare – Global Lead, atrify; Wendy Jackson, Fellow QA Engineer, Global UDI Program, Boston Scientific Corp.; Olga Van Grol-Lawlor, Manager Global Regulatory Intelligence & Advocacy, Boston Scientific Corp.
The EU MDR regulation includes significant UDI requirements, some of which are new and different from the US regulation. We will cover these differences and highlight major new challenges, allowing ample time for audience discussion. The session will cover:·
Facilitated Conversation on Hot Topics / Issues
Speaker: Dennis Black, UDI Program Director, Global Regulatory Affairs
Panelists to be announced
New DI triggers; lack of harmonization on data attributes & definitions; list of values; confusion on what needs to be done, when globally; short implementation periods for some regulations; migration to 2D; and more will be discussed. Bring your issues / hot topics to share in this audience-engaged session facilitated by industry thought leaders.
UDI: Unlocking the Value
Speaker: Karen Conway, Vice President, Healthcare Value, GHX; Natalia Wilson, MD MPH, Executive Director, Center for Healthcare Delivery and Policy, Arizona State University
This level-setting, thought-inspiring session will explore how UDI regulations fit in the global movement toward value-based healthcare, and why that matters to multiple stakeholders, including manufacturers. Understanding the bigger picture can help answer questions around WHY, HOW and WHAT to do to leverage your investments in UDI compliance to meet evolving market demands. With this knowledge, you can better position your organization for success in a healthcare system that rewards the delivery of high quality, safe and cost-effective care to support optimal patient outcomes.
Data Quality & Data Management
Speakers: Jay Crowley, Vice President Medical Device Solutions and Services, USDM; Indira Konduri, Deputy Director, Division of Surveillance Support (DSS), Office of Regulatory Programs (ORP), Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health, US FDA; Ann Ferriter, Acting Associate Director, Postmarket Programs, Office of Product Evaluation and Quality, US FDA; Terrie Reed, Chief Strategy Officer, Symmetric Health Solutions; Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
There are many new, expanding, and evolving global medical device regulations – many of them focused on improving our visibility into and control over the global supply chain – and the understanding of the safety and effectiveness of devices over their lifecycle. This – in combination with the digital transformation of healthcare – is challenging many medical device manufacturers in new ways. There is an urgent need to collect, manage, submit, and (importantly) maintain an expanding list of data attributes to a growing number of regulatory (and commercial) databases globally. Concurrently, more customers and other stakeholders (including trading partners, researchers, hospitals, clinicians, patients, payors) are requesting more information about the devices they purchase and use. This session will discuss ways for device manufacturers to identify the best way to manage data attributes across their various regulatory, commercial, catalog, sales, and distribution systems.
The Elephant in the Room: UDI for Non-Sterile Implants
This lively conversation will discuss the current lack of requirements for non-sterile implants in the U.S. market which contradicts the EU MDR Requirements. This issue has been rearing its head time and time again and is being pushed even further with hospitals sharing their concerns. This panel will talk through the current activities, identify where we are seeing gaping needs, review the impacts, and outline some future steps that the industry is suggesting in order to address this issue.
Working Through the Chaos to Build a Sustainable Framework
Speaker: Jay Crowley, Vice President Medical Device Solutions and Services, USDM
You will gain an understanding of why and how to envision a robust strategic approach to establishing a foundation for addressing the unfolding UDI-related requirements around the world. Knowing the critical pillars and how to work with industry stakeholders (health-care providers, researchers, patients, purchasers, insurers, and regulators) will help achieve the shared goals of improving device safety/effectiveness, healthcare quality/patient safety, and reducing risks and healthcare costs. The appropriate initial development, maintenance and re-use of information is central to establishing and supporting a sustainable framework.
UDI Community: Current Activities & Future Landscape for UDI
Moderator: Patti Blessing, UDI Work Group Chair, AIM North America
Panelists: Mike Schiller, Senior Director, American Hospital Association, Association for Health Care Resource & Materials Management; Linda Rouse-O’Neill, Director, Healthcare Supply Chain Collaborative, Health Industry Distributors Association; Indira Konduri, U.S. Food and Drug Administration; Dr. Barry Daniels, Clinical Lead, GMDN
This session will provide industry reports from the leading trade organizations on the current work being conducted on UDI-related activities covering multiple stakeholder positions. You will hear what industry organizations are teaching and learning about UDI adoption, and programs being implementation through their member constituents representing the healthcare providers, medical device manufacturers, distributor organizations, and others. Gain an understanding of the strategic UDI priorities creating the collaborative communities both here in the United States as well as other countries for the benefit of global trade and device evaluation. Understand how these organizations are supporting each other in a cooperative community fashion, and how you, too, can become involved.