Medtronic UDI Implementation
Tim Boos and Jeffrey McVay
Medtronic PLC
SESSION CODE: 1337
Tim Boos
Global IT Program Manager
3
Project Management
Jeffrey McVay
Sr. Program Manager, Regulatory Affairs and Operations
5
LEARNING POINTS
 What UDI is and its role in improving patient
safety globally.
 UDI implementation required a solid master data
management strategy, processes, technology.
 The value we found using MDM as the record
collection repository and BPM as the
orchestration tool.
7
Global Leader in Medical Technology
85,000+
160+
Employees around the world
Number of countries
operating in
Our Mission
To contribute to human welfare by application of
biomedical engineering in the research, design, and
sale of instruments or applications that alleviate pain,
restore health, and extend life.
8
UDI = Unique Device Identification
What is UDI . . .
• A set of requirements to unambiguously identify medical devices in the
healthcare supply chain
UDI Requires …
• UDI requires that medical devices
• be assigned a unique device identifier,
• include that identifier on product packaging, and
• publish all UDI numbers and their attributes to a public database
• UDI is going global – it became law in the US in 2013 and other countries
are expected to follow in the following years.
UDI’s Future & Impact
• UDI data must be submitted to the FDA before manufacturers can market,
distribute, or sell product in the US
9
Why UDI?
 Current systems of product catalog numbers include duplicate identifiers for different products
across manufacturers
Manufacturer
Catalog #
Description
Medtronic
305905
Mosaic ® 305 Porcine Heart Valve ………….
BD
J&J
305905
305905
3mL BD SafetyGlide ™ Syringe ………..
Protectiv ® IV Catheter System ………..
 Product re-identification often occurs by every stakeholder in the supply chain, making
product tracking efforts extremely difficult
Manufacturer
Product # 305905
Distributor
Product # MT 305905
Hospital or Healthcare Provider
Product # M-5905
UDI requires All Stakeholders in the Healthcare Supply Chain to use the same Unique Identifier
1
UDI Core Requirements = Assign, Label, Publish
1
2
3
ESG*
1.Assign UDI (GTIN)
2. Place UDI on package labels
and direct mark where applicable.
3. Submit UDI and its
attributes to new public
database
* ESG = Electronic Submission Gateway
1
FDA’s Global UDI Database
a.k.a.The GUDID (The “Good ID”)
Provides a common source of
information for all medical devices
sold in the US
1
GUDID Attributes
Item
Master






Device Identifier Portion of UDI (GTIN or HIBC)
Trade/Brand Name
Device Model, Version No.
Quantity of devices in the package
Production Identifier Type: [Serial] [Lot] [Mfg. Date] [Exp. Date]
Commercial Distribution Status
Design /
Labeling






Size of Model / Version
Package Sterile, Need to be Sterilized Before Use , Sterilization Type
Labelled as Containing natural rubber Latex
Kit, combination, HCT/P *
MRI compatibility (safe, conditional, unsafe) *
Rx , OTC *





Market Authorization No. (510(k), PMA)
Manufacturer Listing No.
Nomenclature – GMDN *
FDA ProCode *
DUNs No. - Manufacturer Name and Address
Regulatory
13
UDI “Opportunities”
1. FDA false starts
 FDA missed several planned release dates of UDI Rule
 Delayed prioritization and dedication of resources
2. Interpretation
 Many attributes definitions left room for interpretation
 Reconciliation needed
FDA Definitions vs. Internal Definition vs. Industry Consensus
3. Time
 One year to meet first compliance milestone
14
Build vs. Buy
1. Use in-house applications?
2. Purchase 3rd party software?
3. Challenge of building internal consensus.
15
Systems – SAP in Organization Ecosystem
BPM
16
Process Overview – Systems Focused
GTIN Create /
Change
Process
ECC
Label Portal
Data Entry
MDM
FDA
UDI Submission
Process (via
Portal)
UDI GTIN
Assignment
Portal
RAD
UDI
GTS
System Driven
User Driven
17
Data Architecture
Design/Label Data
Size of Model / Version
Package Sterile, Need to be Sterilized Before Use ,
Sterilization Type
Labelled as Containing natural rubber Latex
Permanent Marking on the Device itself, Different
UDI from Label;
Kit, combination, HCT/P *
MRI compatibility (safe, conditional, unsafe) *
Rx , OTC
FD
A
PLM
UDI Submission
Records
Submission History
All Versions with Data
MD
M
ERP
UDI
Consolidation &
Verification
Material Master Core
Device Identifier Portion of UDI (GTIN or HIBC)
Trade/Brand Name
Device Model, Version No.
Quantity of devices in the package
Higher levels of packaging
Production Identifier Type: [Serial] [Lot] [Mfg.
Date] [Exp. Date]
Previous DI if New Model/Version
Commercial Distribution Status
RAD
Regulatory Approval Data
Market Authorization No. (510(k), PMA)
Manufacturer Listing No.
Nomenclature – GMDN *
FDA ProCode *
DUNs No. - Manufacturer Name and Address
Documents
Submission Tracking Documents
Submission Files
Ack 1
Ack 2
Ack 3
18
Process Overview – User Focused
Need to
Perform UDI
Work
GTIN
Create or
Change
No
Login to BPM Portal
Based on System Roles you can access one or more of the areas below
Yes
GTIN / ECC
Label
Please
Note: At
Fill Out GTIN
Data Sheet
Enter Label
Data
Select UDI
Records
times data may
need to be
updated in the
source system (ex:
RAD or GTS)
Enter
Regulatory
Data
Resolve
Errors (if
Needed)
Resolve
Errors (if
Needed)
Resolve
Errors (if
Needed)
Review Data
Save Data
Save Data
Save Data
Submit UDI
Records
19
GTIN
Assignment
UDI
BEST PRACTICES
 Invest in a foundational solution that can be
evolve and expand over time.
 Specifically identify your core competencies to
better understand the gap you need to fill.
 Strong corporate sponsorship and the value of
partnering with IT.
KEY LEARNINGS
 Eliminate Data Silos - UDI required a new way of
compiling and utilizing data across multiple
functional areas.
 Master Data governance and management
strategies are at the core of solutions like UDI.
 There were many SAP platforms already in our
system ecosystem that were leveraged to enable
global business process for UDI.
STAY INFORMED
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Tom Wailgum: @twailgum
Chris Kanaracus: @chriskanaracus
Craig Powers: @Powers_ASUG
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SESSION CODE: 1337
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