11 - 12 November, 2020 | Westin Grand Munich, Munich, Germany

Workshop Day

9:00 am - 1:00 pm WORKSHOP A - Master Data Management: Processes, Systems and Standardisation

Who’s it for?
Open to all levels of learning

Required/Prerequisite Knowledge
Basic understanding and/or previous experience with UDI

What do I need to bring?
Just an interest in learning about Master Data Management!

Introduction 
New UDI requirements continue to rapidly develop globally. UDI and the Master Data accompanying it are no longer considered a project but a long term process. 

Session Objectives
This session will focus on Master Data Management processes, systems and standardization to achieve global compliance.   It is open for all - beginners to those with prior experience.

What will be covered? 
•Development of governance and strategy on ensuring your data is the “Source of Truth”
•Understanding, evaluation, selection and implementation of Internal/External Master Data system solutions
•Integration strategies for new global regulatory and logistics data mandates
•Industry lessons learned and how to leverage them to your advantage

Key Take-Homes 
•Understanding of new global UDI & Master Data requirements (including EU MDR)
•Tools for developing long term solution(s) for your data

Workshop Leader
Dawn Fowler, Director UDI and Master Data Management, Masimo

Dawn Fowler, Director UDI and Master Data Management at Masimo

Dawn Fowler

Director UDI and Master Data Management
Masimo

1:00 pm - 2:00 pm Networking Lunch

2:00 pm - 6:00 pm WORKSHOP B - Leveraging Master Data Management and Multistakeholder Collaboration to Improve Business, Clinical and Product Performance


Key Topics
·         Overview of European Medical Device Regulation (MDR) and corresponding US regulations requiring provider UDI adoption
·         Current State: Pilots and Implementations in Supply Chain, Clinical and Research areas
·         Value of Learning Communities to Overcome Key Adoption Challenges
·         Use Cases:  How master data management (MDM) improvement efforts advance adoption and value
 
Who’s it for?
All stakeholders and all levels (including manufacturers and healthcare delivery organisations)
 
Required/Prerequisite Knowledge
Basic understanding of UDI regulations and an interest in working across disciplines to achieve value through UDI adoption
 
What do I need to bring?
Nothing
 
Introduction
Both the European Medical Device Regulation (MDR) and regulations in the U.S. require the inclusion of UDI in patient records, while the European regulation includes additional requirements on ‘operators’ to provide clinical data on the performance, safety and risk of products across their lifecycle.  As other countries adopt UDI regulations, similar requirements for both providers and manufacturers are expected.  This workshop will explore how master data management (MDM) and collaborative communities can identify and address adoption challenges that yield value to multiple stakeholders by generating improved operations and better clinical evidence on product performance.
 
Session Objectives
·         Learn how master data management and UDI compliance efforts can help improve manufacturer-customer working relationships and healthcare delivery
·         Recognise the importance of multistakeholder collaboration and learning communities to increase the effective use of UDI
·         Increase understanding of the key data and workflows that present the greatest opportunities for improvement across the healthcare ecosystem, (e.g. device classification, contact field, recall information)
 
What will be covered?
·         Master data management strategies to improve UDI data usability across the healthcare ecosystem
·         Multistakeholder engagement structures to generate improvements in data quality and improve operations for all involved
·         Learnings from other regions, including the U.S. and U.K., to inform MDM strategies and UDI compliance
 
Key Take Homes
·         Understand the importance of the connection between manufacturer MDM, product performance research, improved patient care and lower costs of doing business
·         Realise the value of engaging in multistakeholder learning communities to reduce MDM errors and increase UDI adoption and value
·         How to achieve value across the medical device ecosystem for all parties, most importantly patient care
Karen Conway, Vice President, Healthcare Value at GHX

Karen Conway

Vice President, Healthcare Value
GHX

Terrie Reed, Principal Consultant at Reed McCullough, LLC

Terrie Reed

Principal Consultant
Reed McCullough, LLC