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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
GS1 US is committed to complying fully with antitrust laws.
We ask and expect everyone to refrain from discussing prices,
margins, discounts, suppliers, the timing of price changes,
marketing or product plans, or other competitively sensitive topics.
If anyone has concerns about the propriety of a discussion, please
inform a GS1 US representative as soon as possible.
Please remember to make your own business decisions and that all
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
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© 2016 GS1 US All Rights Reserved
Legal Disclosure
GS1 US, Inc. is providing this presentation, as is, as a service to interested
parties. GS1 US MAKES NO REPRESENTATIONS IN THIS REGARD AND
DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO, ANY WARRANTY OF ACCURACY OR RELIABILITY OF
ANY CONTENT, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
GS1 US shall not be liable for any consequential, special, indirect,
incidental, liquidated, exemplary or punitive damages of any kind or nature
whatsoever, or any lost income or profits, under any theory of liability,
arising out of the use of this presentation or any content herein, even if
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could have been reasonably foreseen.
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.
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© 2016 GS1 US All Rights Reserved
Agenda
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• Anti-Trust Caution / Legal Disclosure• Standards in Action• UDI – The Basics• Holistic Approach to UDI• Leveraging Your Investment
© 2016 GS1 US All Rights Reserved
Standards in Action
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© 2016 GS1 US All Rights Reserved
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
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© 2016 GS1 US All Rights Reserved
The Global Language of Business
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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
© 2016 GS1 US All Rights Reserved
GS1 Standards
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© 2016 GS1 US All Rights Reserved
Implemented GS1 Standards in the Supply Chain
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© 2016 GS1 US All Rights Reserved
GS1 Interface Standards for Electronic Commerce
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© 2016 GS1 US All Rights Reserved
GS1 Interface Standards for Electronic Commerce
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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
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FDA GUDID
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© 2016 GS1 US All Rights Reserved
UDI Basics
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© 2016 GS1 US All Rights Reserved
Meeting UDI Requirements
• Step 1 - The Device Identification
(DI)
- Identify your devices
- Adhere to one of issuing agencies –
GS1, HIBCC, or ICCBBA
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• 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)
© 2016 GS1 US All Rights Reserved
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)
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© 2016 GS1 US All Rights Reserved
Holistic Approach to UDI
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© 2016 GS1 US All Rights Reserved
Implementation & Integration Implications to Consider
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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
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• 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
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• 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
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• Determine sharing strategy–GDSN?
• Integrate ECR process with data update process
• Integrate data sharing with GUDID update process
• Global and Local Approach
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© 2016 GS1 US All Rights Reserved
Leveraging Your Investment - Supply Chain Visibility using GS1 Standards
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© 2016 GS1 US All Rights Reserved
Critical Tracking Events
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© 2016 GS1 US All Rights Reserved
Critical Tracking Events
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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.
© 2016 GS1 US All Rights Reserved
Key Data Elements
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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 DepletionKey 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.
© 2016 GS1 US All Rights Reserved
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 )
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© 2016 GS1 US All Rights Reserved
How do we Share this data?
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© 2016 GS1 US All Rights Reserved
Visibility Data Content
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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
© 2016 GS1 US All Rights Reserved
The “What” Dimension
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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)
© 2016 GS1 US All Rights Reserved
The “Where” Dimension
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• 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
© 2016 GS1 US All Rights Reserved
The “Why” Dimension
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• 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 #23Tue 10:05Rent Shop
CheckoutRented
Ski #23Tue 10:15Base Rack
Observe
Ski #23Tue 10:20
Lift #1
Observe
Ski #23Tue 10:23Summit #1
Observe
Ski #23Tue 11:05Rent Shop
CheckinAvailable
Ski #23Tue 13:08
Repair
BeginRepair
Ski #23Tue 13:10Rent Shop
DoneRepair
Ski #23Tue 13:06Base Rack
Observe
Ski #23Tue 13:07Rent Shop
Problem
Ski #23Tue 13:05Rent Shop
CheckoutRented
RentalContract#1235
John Doe
RentalContract#1325
Jane Roe
© 2016 GS1 US All Rights Reserved
Visibility in the Supply Chain
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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
© 2016 GS1 US All Rights Reserved
Visibility Architecture
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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
© 2016 GS1 US All Rights Reserved
Example – Forward Deployed Inventory
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Implant #1Tue 10:05
Mfg. Plant 1
GoodsReceipt
Implant #1Tue 1:05
Mfg. Plant 1
Shipment
Implant #1Tue 4:30DC #1
GoodsReceipt
Implant #1Wed 12:10ReplenishStore #2Goods
Receipt
Tray #10Thur 12:05Replenish Store #2
Aggregate
Implant #1Wed 8:30
DC #1
Shipment
Tray #10Thur 3:00ReplenishStore #2
Shipment
Tray #10Sat 9:00Hospital#1234
Shipment
Tray #10Fri 9:15Hospital#1234Goods
Receipt
Tray #10Tue 1:05Hospital #1234Goods
Receipt
Implant #1Fri 3:30Hospital#1234
Consumption
© 2016 GS1 US All Rights Reserved
Scenario – Leveraging the Data
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Implant #1Tue 10:05Mfg. Plant
GoodsReceipt
Implant #1Tue 1:05
Mfg. Plant
Shipment
Implant #1Tue 4:30DC #1
GoodsReceipt
Implant #1Wed 1:05ReplenishStore #2
GoodsReceipt
Tray #10Thur 12:05ReplenishStore #2
Aggregate
Implant #1Wed 8:30
DC #1
Shipment
Tray #10Thur 3:00ReplenishStore #2
Shipment
Tray #10Sat 9:00Hospital#12345
Shipment
Tray #10Fri 9:15Hospital#12345GoodsReceipt
Tray #10Tue 1:05Hospital#12345GoodsReceipt
Implant #1Fri 3:30Hospital#12345
Consumption
Inventory Management
Supply Consignment Management
Accounts Payable
© 2016 GS1 US All Rights Reserved
Data Sharing with Known Trading Partners
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Supplier Retailer
Factory Distribution Ctr Distribution Ctr
Retail Stores
EPCIS Database
EPCIS Database
1. Visibility data
collected during
tagging and shipping2. Visibility data
collected as product
moves3. Retailer data shared
with supplier via
retailer’s network
4. Combined data used
to gain business benefits
© 2016 GS1 US All Rights Reserved
Focus on Data Interfaces –Maximum Flexibility
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Visibility-Driven Business Applications
Visibility Data Hub
Visibility Data Capture (1 or more sites)
Visibility Data
Definitions (matrix)
Govern
ance
Master Data
Configuration
© 2016 GS1 US All Rights Reserved
Macy’s Inc. - Driving Inventory Accuracy & Omni-Channel Fulfillment
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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).
© 2016 GS1 US All Rights Reserved
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”
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© 2016 GS1 US All Rights Reserved
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
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© 2016 GS1 US All Rights Reserved
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
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© 2016 GS1 US All Rights Reserved
T
E
www.gs1us.org
GS1 US Corporate Headquarters
Princeton Pike Corporate Center
1009 Lenox Drive, Suite 202
Lawrenceville, NJ 08648 USA
Contact Information
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Greg Bylo
VP Healthcare
Office (609) 620-8073, Cell (609) 216-4346