udi implementation - medconf · craniomaxillofacial shoulder, elbow and wrist arthroplasty thoracic...

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

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


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


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


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


UDI experiences and approach UDI attributes in customer-specific fields


UDI experiences and approach

Definition and understanding of single attributes

Clarify the meaning and appliance of each attribute before starting data collection!


UDI experiences and approach Data maintenance in SAP

manual SAP LSMW Customer specific upload


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



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


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.


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



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

http://www.fda.gov/


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

http://www.fda.gov/


Reaching the Goal…

Lessons Learned


•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


Juergen Troendle

IT Manager EMEA SAP Logistics

Zimmer GmbH

CH-8404 Winterthur

[email protected]

www.zimmerbiomet.com

Contact details

Stefan Temps

Ext. Project Manager ZUDI Systems

DHC Dr. Herterich & Consultants AG

CH-8180 Bülach

[email protected]

www.dhc-ag.ch

mailto:[email protected]

http://www.zimmerbiomet.com/




http://www.dhc-ag.ch/



udi implementation - medconf · craniomaxillofacial shoulder, elbow and wrist arthroplasty thoracic...

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