UDI: Where Do We Go From Here?

Healthcare
Greg Bylo, GS1 US
UDI: Where Do We Go From
Here?
GS1 US Supply Chain Visibility
June 15, 2016

© 2016 GS1 US All Rights Reserved
Antitrust Caution
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GS1 standards are voluntary and not mandatory.
Please review the complete GS1 US antitrust policy at:
http://www.gs1us.org/gs1-us-antitrust-compliance-policy
2

Legal Disclosure
GS1 US, Inc. is providing this presentation, as is, as a service to interested
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GS1 US employees are not representatives or agents of the FDA, and the
content of this presentation has not been reviewed, approved or authorized
by the FDA.
3

Agenda
4
• Anti-Trust Caution / Legal Disclosure
• Standards in Action
• UDI – The Basics
• Holistic Approach to UDI
• Leveraging Your Investment

Standards in Action
5

GS1 Standards in Action
• The following link provides a basic review of the
GS1 standards for Healthcare and how they can
improve operational efficiency and patient
safety.
• http://www.gs1us.org/industries-
old/healthcare/standards-in-action-video
6

The Global Language of Business
7
Identify GS1 Identification Numbers
Companies, Products, Locations,
Logistics, Assets, and Services
Capture GS1 Data Carriers
Barcodes and EPC-enabled RFID
Share GS1 Data Exchange
Master Data, Transactional Data,
and Physical Event Data

GS1 Standards
8

Implemented GS1 Standards in the
Supply Chain
9

GS1 Interface Standards for Electronic
Commerce
10

GS1 Interface Standards for Electronic
Commerce
11
Data Flow for the Global Data Synchronization Network
Select one data pool as a
SINGLE point of entry to the
GDSN
The GS1 Global Registry® is a single repository
where basic data is registered. The GS1 Global
Registry identifies the data pool location of
source data.
Data Pools provide data that is standards
conformant, and interoperable in the GDSN®.
The data pool performs the transactions of
sending
and receiving validated product information
between partners inside or outside the data
pool.
Step 1 : Load Data
Step 2 : Register Data
Step 3 : Subscription Request
Step 4 : Publish Data
Step 5 : Recipient Confirmation
1
2
5
5
5
4
4
3
3
3
FDA GUDID
4

UDI Basics
12

Meeting UDI Requirements
• Step 1 - The Device Identification
(DI)
- Identify your devices
- Adhere to one of issuing agencies –
GS1, HIBCC, or ICCBBA
13
• Step 2 – Select Bar Code
(AIDC) and design label and
packaging
• Step 3 – Identify the
Production data
•GTIN – Global Trade Item Number
•Expiry Date
•Lot
Number
•Serial Number
UDI =
Device Identifier (DI) + Production Identifiers (PI)
GTIN + Application Identifiers (AI)

Meeting UDI Requirements
Step 4 – The GUDID
• Global Unique Device Identifier Database (GUDID)
- Operated by the FDA to collect information on Medical Devices
- Will have public facing website to share data with anyone
- Some information submitted to the GUDID will be private (for FDA only)
• All medical devices which are regulated under the UDI regulations will be
required to be listed in the GUDID
- Sunrise for each class is the same for GUDID as assigning a UDI
• Class III devices- 1 year from final rule publication (September 24, 2014)
(complete with extensions)
• Class II “life sustaining” devices- 2 years from final rule publication
(September 24, 2015) (GUDID extended to October 24, 2015) (complete with
extensions)
• Class II remaining devices- 3 years from final rule publication (September
24, 2016)
• Class I devices- 5 years from final rule publication (September 24, 2018)
14

Holistic Approach to UDI
15

Implementation & Integration
Implications to Consider
16
1
• MDM business process needed to maintain UDI attributes
• UDI Rule provides data definitions for each attribute
• Need BP Owners for each attribute
2
• Incorporate UDI into it Labeling/Packaging process
• Address both global & local UDI requirements
• Impacts all product labels– unit of use through case
3
• Create ECR BP to meet UDI Requirement
• 48 hour requirement for design change notification
• Product Design incorporate GTIN assignment process
4
• Identify all SOPs which need to be updated & include in project plan
• Document integrated process in SOPs
• SOPs need to be completed before project is completed
5
• Update the systems to utilize the UDI GTIN (DI)
• Map product attributes from source to GUDID
• Identify GUDID process & owner
• Validate automated GUDID transfer process
6
• Determine sharing strategy–GDSN?
• Integrate ECR process with data update process
• Integrate data sharing with GUDID update process
• Global and Local Approach
1
2
3
4
6
5

Leveraging Your Investment - Supply
Chain Visibility using GS1 Standards
17

Critical Tracking Events
18

Critical Tracking Events
19
CRITICAL TRACKING EVENT DEFINITIONS
TRANSFORMATION-TYPE EVENTS are those events that typically support internal traceability within
the four walls of a supply chain company.
TRANSFORMATION INPUT (T1) EVENT: The event where one or more materials are used to
produce a traceable product that enters the supply chain.(NOTE: Materials used to produce
products for immediate consumption by consumers are reported as Consumption events)
TRANSFORMATION OUTPUT (T2) EVENT: The event where a traceable product is packaged and
labeled for entry into the supply chain.
TRANSPORTATION-TYPE EVENTS are those events that typically support external traceability between
supply chain companies.
SHIPPING (S) EVENT: The event where traceable product is dispatched from a defined location to
another defined location.
RECEIVING (R) EVENT: The event where traceable product is received at a defined location from
another defined location.
DEPLETION-TYPE EVENTS are those events that capture how traceable product is removed from the
supply chain.
CONSUMPTION (C) EVENT: The event where a traceable product becomes available to
consumers.
DISPOSAL (D) EVENT: The event where a traceable product is destroyed or discarded or otherwise
handled in a manner that the product can no longer be used as a food ingredient or become
available to consumers.

Key Data Elements
20
Shipping Receiving Input Output Consumption Disposal
Event Type R R R R R R
Event Owner R R R R R R
Date R R R R R R
Time R R R R R R
Event Location R R R R R R
Item ID Type R R R R R R
Item ID R R R R R R
Batch/Lot/Serial# BP* BP R R BP BP
Quantity R R R R R R
Unit of Measure R R R R R R
Batch/Lot Relevant Date C^ C C C^ BP BP
Activity Type C C R R
Activity ID C C R R
Supplier Identity C C C C
Trading Partner Location R R
R = Required Data
BP = Best practice is to capture the batch/lot number for transport and depletion events whenever possible;
however, if not feasible, Batch/Lot Relevant date or Activity ID must be provided.
* Batch/lot/serial numbers should be reported by Suppliers for Shipping events.
Transport Transformation Depletion
Key Data Element
C = Conditional Data; The need for this data would be determined by business circumstances;
^ Relevant Date should be reported by Suppliers for Shipping Events and for Transformation Output events.

GS1-128 barcode information for
Visibility
• When using a GS1-128 barcode, Application Identifiers (AI’s) are
encoded for scanning purposes. AI’s are flags that precede each piece
of data in a barcode to identify its meaning and format.
• GS1-128 provides the ability to string together additional fields of
information:
− (01) precedes a GTIN ( 00614141987658 )
− (11) precedes Production Date (YYMMDD) (120715)
− (10) precedes Batch/Lot Number ( ABC123 )
21

How do we Share this data?
22

Visibility Data Content
23
Visibility data consists of events,
each of which records something
that happened in the real world
triggered by reading a barcode
or an RFID tag.
An event has four dimensions:
- What: what physical objects were
involved (EPC)
- When: when the event took place
(timestamp)
- Where: where the event took place
(location identifier)
- Why: what business process step
was being carried out
Where and Why are what
distinguish visibility data
useful to a business
application from raw RFID
or Bar Code data

The “What” Dimension
24
1732050807+
Company Code Product Code Lot/Batch or Serial Number
• Tells you:
- What product (GTIN / U.P.C.)
- What instance (lot/batch or serial number)

The “Where” Dimension
25
• A location identifier that says
- Where the event took place; and/or
- Where things are following the event
• Understood by applications
- Master data synchronization  important!
• Meaningful
- E.g., two rooms separated by a door, report which room,
not the location of the door
• Not necessarily the name of the reader
- E.g., for a bar code / RFID-enabled forklift, indicate into
which bin the load was dropped, not which forklift did it
• Location sensor, location tag, etc – not the reader
identity
Room 1 Room 2

The “Why” Dimension
26
• Identify the business context of the visibility event:
- What business step was taking place at the time of the event
- What is true from a business perspective after the event
- Any associated business transactions
• Purchase Order, Invoice, BOL, etc
Ski #23
Tue 10:05
Rent Shop
Checkout
Rented
Ski #23
Tue 10:15
Base Rack
Observe
Ski #23
Tue 10:20
Lift #1
Observe
Ski #23
Tue 10:23
Summit #1
Observe
Ski #23
Tue 11:05
Rent Shop
Checkin
Available
Ski #23
Tue 13:08
Repair
Begin
Repair
Ski #23
Tue 13:10
Rent Shop
Done
Repair
Ski #23
Tue 13:06
Base Rack
Observe
Ski #23
Tue 13:07
Rent Shop
Problem
Ski #23
Tue 13:05
Rent Shop
Checkout
Rented
Rental
Contract
#1235
John Doe
Rental
Contract
#1325
Jane Roe

Visibility in the Supply Chain
27
Pack
Line
Ship
Door
Ship
Door
Rcv
Door
Interior
Door
Trash
Compactor
R1 R2 R3 R4 R5
R6
R7
DC1 - Mfr DC2 - Retailer
Store1
Rcv
Door Back Front
Promotion
/ NPI
Tracking
Supply
Routes
Analysis
Real-time
Inventory
Correction
EPCIS Visibility Data
Product
Recall
Execution
Demand
Planning
Response

Visibility Architecture
28
EPCIS Visibility Data
Business Applications
Data Capture
Infrastructure
R
R
R
R
Single Most
Important
Design
Decision:
This
Interface
Key “hinge”
between
different worlds
Enterprise
Software
Factory
Automation
Overall
Business
Process
Single
Material
Handling
Step
IT/LOB
Operations/
Labor

Example – Forward Deployed Inventory
29
Implant #1
Tue 10:05
Mfg. Plant 1
Goods
Receipt
Implant #1
Tue 1:05
Mfg. Plant 1
Shipment
Implant #1
Tue 4:30
DC #1
Goods
Receipt
Implant #1
Wed 12:10
Replenish
Store #2
Goods
Receipt
Tray #10
Thur 12:05
Replenish
Store #2
Aggregate
Implant #1
Wed 8:30
DC #1
Shipment
Tray #10
Thur 3:00
Replenish
Store #2
Shipment
Tray #10
Sat 9:00
Hospital
#1234
Shipment
Tray #10
Fri 9:15
Hospital
#1234
Goods
Receipt
Tray #10
Tue 1:05
Hospital
#1234
Goods
Receipt
Implant #1
Fri 3:30
Hospital
#1234
Consumption

Scenario – Leveraging the Data
30
Implant #1
Tue 10:05
Mfg. Plant
Goods
Receipt
Implant #1
Tue 1:05
Mfg. Plant
Shipment
Implant #1
Tue 4:30
DC #1
Goods
Receipt
Implant #1
Wed 1:05
Replenish
Store #2
Goods
Receipt
Tray #10
Thur 12:05
Replenish
Store #2
Aggregate
Implant #1
Wed 8:30
DC #1
Shipment
Tray #10
Thur 3:00
Replenish
Store #2
Shipment
Tray #10
Sat 9:00
Hospital
#12345
Shipment
Tray #10
Fri 9:15
Hospital
#12345
Goods
Receipt
Tray #10
Tue 1:05
Hospital
#12345
Goods
Receipt
Implant #1
Fri 3:30
Hospital
#12345
Consumption
Inventory
Management
Supply
Consignment
Management
Accounts
Payable

Data Sharing with Known Trading
Partners
31
Supplier Retailer
Factory Distribution Ctr Distribution Ctr
Retail Stores
EPCIS
Database
EPCIS
Database
1. Visibility data
collected during
tagging and shipping
2. Visibility data
collected as product
moves
3. Retailer data shared
with supplier via
retailer’s network
4. Combined data used
to gain business benefits

Focus on Data Interfaces –
Maximum Flexibility
32
Visibility-Driven Business
Applications
Visibility Data Hub
Visibility Data Capture (1 or more sites)
Visibility
Data
Definitions
(matrix)
Governance
Master
Data
Configuration

Macy’s Inc. - Driving Inventory Accuracy
& Omni-Channel Fulfillment
33
Macy’s, Inc. is one of the
nation’s premier omni-
channel retailers. As of
February 23, 2016, the
company operates about
870 stores in 45 states,
the District of Columbia,
Guam and Puerto Rico.
Macy’s, Inc.’s diverse
workforce includes
approximately 166,900
employees.
macysinc.com
Situation Approach
In late 2011, Macy’s embarked on a 3-year omni-
channel excellence journey. Looking to increase
color/size inventory visibility and to drive sales in
their high replenishment categories, They began
using EPC-enabled RFID technology to execute
more frequent cycle counts and improve sampling
compliance in women’s and men’s shoes.
GS1 Standards support:
• GS1 EPC Radio-Frequency Identity Generation-
2 UHF RFID Protocol (GS1 SGTIN-96 coding
schema for these tags)
• GS1 US Apparel and General Merchandise
Initiative membership
• Workgroup participants - Macy’s has
collaborated with industry trading partners in
developing industry best practices and driving
industry adoption.
Since 2011, their adoption of RFID has evolved from
a transformational technology to a foundational
requirement for inventory optimization and has
grown to all 800+ Macy’s and Bloomingdale’s
stores.
They expanded RFID use from replenishment to
fashion areas and saw their sales volumes increase
more than 200%. In 2014, they completed their
single view of inventory system upgrades. Macy’s
now has one “view” of inventory— accurate
inventory through RFID—with a focus on optimizing
in-stock inventory to satisfy customer demand.
Converting to a single view inventory was enabled
by leveraging many GS1 Standards including, but
not limited to: GTIN, SSCC-18, EDI, and EPC/RFID.
Results & Benefits
3-Yr Results:
• Inventory optimization in their omni-channel fulfillment processes (freeing up the last one (GTIN) for
sale … instead of working with thresholds and minimum units/location before making it available for
sale via their e-com channel)
• Sustaining a 95% item accuracy at the size/color level (improved from 75%)
• Selling floor shoe sample compliance growth (from 70% style representation to 95%+)
• Sales trends increases in RFID tagged product categories (increasing in the high single digits to low
double digits vs the non-RFID comparable control groups)
Benefits ~ Previously, store and online assortments were bought and marketed by separate organizations
at Macy’s and at Bloomingdale’s. These changes enable Macy’s to:
• Continue to support organizational growth & the enhanced unified shopping experience
• Have an accurate inventory file to drive customer demand & better business decisions
• Increase sales & customer satisfaction through improved in-store availability and enhanced omni-
channel fulfillment (e.g., buy online and ship from / pick up in store).

Macy’s Inc. - Driving Inventory Accuracy
& Omni-Channel Fulfillment
• Their RFID-enabled departments outperformed controls by 10%
(between Sept. 2013 and May 2014) and their display rates
improved from 70% to 95%. 1
• Further, demonstrating that RFID enables better “last-item” visibility
and the ability to sell that item at the higher full margin price point,
Macy’s CEO, Terry Lundgren reported that their “buy online/pick-up
in-store results totaled 125% of intended order.” 2
1. Retail Touch Points Webinar, Sept 16, 2014, “Omni-channel Leaders Reaffirm The Value Of RFID”
2. Marketing Daily, Sept 3, 2014, “Macy's Focused On Mobile, Gen Y, Private Label”
34

Wrap Up
• Determine what “challenges” visibility can solve in your
organization
- Inventory Utilization?
- Supply Management – shortages?
• Validate process flows are really what is happening
• Do a risk analysis of the events in the process flow to
determine when to capture the data and how long to
maintain it
• Are all systems enabled for the process?
• Apply learnings to other parts of your business
35

Supply Chain Visibility Workshop
• The below link takes you to a GS1 US website dedicated to supply
chain visibility. Additional information and workshops are available
to support an organization who wants to pursue this further.
- https://www.gs1us.org/about-gs1-us/events/supply-chain-
visibility
36

T
E
www.gs1us.org
GS1 US Corporate Headquarters
Princeton Pike Corporate Center
1009 Lenox Drive, Suite 202
Lawrenceville, NJ 08648 USA
Contact Information
35
Greg Bylo
VP Healthcare
Office (609) 620-8073, Cell (609) 216-4346

UDI: Where Do We Go From Here?

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