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MEDCONF 2015
Munich, 15.10.2015
UDI Implementation A pragmatic approach
• Combined annual revenue of ~$8 billion
(estimate based on latest public
financial disclosures)
• Serving approximately 100 countries
• Global manufacturing network, with
facilities in the U.S., Europe, and Asia
• Building on a portfolio of more than
3,700 patents and applications
Zimmer Biomet Your Progress. Our Promise.
2
History of Tradition and Innovation
1927 J.O. Zimmer establishes Zimmer Manu-
facturing Co. in Warsaw, Indiana (USA)
1972 Bristol-Myers acquires Zimmer
2001 Spin-off Bristol-Myers and Zimmer
Sulzer Brothers Co. is founded
Sulzer Medizinaltechnik
becomes an autonomous division
Sulzer Medica is formed
Spin-off: Sulzer Medica becomes
Centerpulse
1834
1970
1989
2001
Sulzer Zimmer
2003 Zimmer acquires Centerpulse
1977
Dane A. Miller establishes Biomet in
Warsaw, Indiana (USA)
2007 Consortium of private equity firms
purchases Biomet
2008 - 2012
Biomet
Zimmer acquires Abbott Spine, Beijing
Montagne, SoPlus, ExtraOrtho, Synvasive
Technology, and Normed
2015
Zimmer and Biomet combination
Total focus on musculoskeletal health:
The broadest portfolio of patient solutions
Dental reconstruction
Craniomaxillofacial
Shoulder, elbow and
wrist arthroplasty
Thoracic
Spine: cervical,
thoracic, lumbar
Partial, primary, revision
and salvage knee
arthroplasty
Primary, revision, and
salvage hip arthroplasty
Upper and lower
extremity trauma
Foot and ankle fixation
and arthroplasty
Allograft service
Bone Healing
Intelligent Instruments
and Computer-Aided
Surgery
Bone cements and
accessories
Oncology and
specialized implant
solutions
Surgical Products
Sports Medicine
Early Intervention
and Biologics
Blood management
4
DHC AG in CH – Buelach
Strategy and Implementation from the same Source
DHC AG: Since 1999 focussed on the needs of the
pharmaceutical and medical device industry
www.dhc-ag.ch
UDI
Information Technology
Introduction to UDI
What is UDI?
• UDI = Unique Device Identification
• Law passed by the U.S. Congress, implemented by the FDA
• Mandatory for medical devices sold in the USA
• Primarily consisting of two elements, namely:
– UDI number
– Global UDI database
UDI-number
Information Technology 9
Introduction to UDI
UDI Timeline
Information Technology 10
Introduction to UDI
UDI number
• DI Device Identifier “GTIN”
• PI Production identifiers
– Serial number
– Lot number
– Manufacturing date
– Expiration date
Device Identifier (DI) Production Identifiers (PI)
ZUDI Project
Information Technology 12
Program Overview Map
ZUDI
Labels Systems Direct Part Marking
Configuration Management
Layout / Content
Supplier Impact
Configuration Management
Etch Content
External Interfaces
Logistics
Attributes
Supplier Impact
Regulatory Affairs
13 Information Technology
Project plan SAP EMEA
ZUDI
Attributes
SAP
DEV
SAP
PRD
SAP
QUA
JAN
ZUDI attributes per SKU
Manual data collection in xls
Design & Development
Idocs, Data, Upload Prg.
Te
stin
g
PTQ
Build up
SAP QUA
UAT and
Val.testing
Test run 01 Bu
g F
ix
UAT/Val.
Testing
run 02
ZUDI attributes
improvements
CA
B
PTP
Build up
SAP PRD
Interface running
ZUDI Attributes
Bu
g F
ix
Go
Live
FEB MAR APR MAY JUN JUL AUG SEP
UDI attributes in SAP
Information Technology 15
Introduction to UDI
UDI attributes
UDI experiences and approach UDI attributes in SAP classification
• All UDI attributes are recorded by
the material master in SAP
• Audit trail is secured
• Access rights are controllable
Information Technology
UDI experiences and approach UDI attributes in customer-specific fields
Information Technology
UDI experiences and approach
Definition and understanding of single attributes
Clarify the meaning and appliance of each attribute before starting data collection!
Information Technology
UDI experiences and approach Data maintenance in SAP
manual SAP LSMW Customer specific upload
Information Technology
UDI experiences and approach Possible overview of the UDI attributes in the system
• Reporting of the UDI attributes, maintained in SAP
Customer-specific fields
Classification
….
Maintenance status by organisational unit
Information Technology
Information Technology 21
Maintenance in SAP
Data Mass Upload
Data Mass Upload Process
Create an Excel
template
Upload the Excel
and verify the data
Review and
approved the data
Fill data in the
Excel template
22 Information Technology
Default status when new
data is uploaded to SAP
Review and Approval of Data in SAP
Status Network
Data is checked & correct.
The data owner released
his data.
Data is in review process
Each Department has its own Data Approval status
Change in approved data results in status
withdrawal of the corresponding department.
Information Technology
Being Prepared for the EC…
How ZUDI Attributes come to
the FDA GUDID
Overview: What is UDI?
Data transmission to the GUDID Database (FDA)
.xml
FDA
ESG
GUDID
GUDID HL7 SPL
Submission GUDID Web Interface
GUDID Submission Options
FDA Electronic
Submissions Gateway
Global Unique Identification Database
GUDID Search & Retrieval
Options
Public
Users
Search &
Retrieval
Future
System to System
Search & Retrieval
Information Technology
Information Technology
UDI System Landscape
Zimmer USA
Zimmer EMEA
SAP
GUDID FDA
ESG HL7 xml
UDI-Mass
Upload
Program
Manual
Entry
MDM Material Master
Labelling
Default Tabelle
IDOC ZUDI
GTIN
Upload
Program
Reporting
IDOC Confirm
Integration
Platform
Information Technology 27
ZUDI EMEA Submission Progress
Version: NN MMM YYYY
SAP
MDM
GUDID
1 2 3 4 5
SAP
sent out
MDM
received
MDM
Approved
FDA
submitted FDA
passed
100 %
NNNN *)
*) Number of SKUs which will be submitted until Oct 24th 2015
Information Technology
Reaching the Goal…
Lessons Learned
Information Technology
•UDI is more than just an IT project
•Creation of a project handbook with all important definitions regarding UDI
attributes and project scope
•Calculate enough time for data collection and data verification
• Involvement of all related departments from the very beginning
• Transferring first data sets to UDI test data base at the earliest point
UDI experiences and approach
Lessons Learned
31 Information Technology
Juergen Troendle
IT Manager EMEA SAP Logistics
Zimmer GmbH
CH-8404 Winterthur
www.zimmerbiomet.com
Contact details
Stefan Temps
Ext. Project Manager ZUDI Systems
DHC Dr. Herterich & Consultants AG
CH-8180 Bülach
www.dhc-ag.ch