1. Case Study: Hologic First to Meet UDI Requirements for Medical Device Manufacturers
September 30, 2014

2. Session Overview Hologic and The Science of Sure!
Platform for Success: Our Enterprise Solutions Architecture
Our UDI Story
National Breast Cancer Awareness Month
UDI at Hologic OOW 2014

3. Hologic is a $2.5B global Medical Device company
We use The Science of Sure to improve lives!
By innovating and bringing to market the best diagnostics, detection and surgical technology in the world.
We integrate The Science of Sure into everything we do To help healthcare professionals discover, diagnose and treat their patients with progressive certainty… …and ever-greater peace of mind.

4. Hologic is The Science of Sure in action
UDI at Hologic OOW 2014

5. Platform for Success: Our Enterprise Solutions Architecture
Oracle eBusiness Suite R12
Agile PLM
MFG
SCM
CRM Service
OBI
OPLA
ODI
Siebel CRM Sales HR
FINANCIALS
Hyperion
Oracle Fusion Middleware
Oracle Exadata, Oracle Database
UDI at Hologic OOW 2014

6. What is UDI (Unique Device Identifier)?
The US Food and Drug Administration (FDA) issued a final rule on September 23, 2013 to establish a system to identify medical devices through distribution and use. FDA mandated (CFR 830 UDI Requirements) that the manufacturer (aka Labeler) assign a unique number to its devices in order to sell those products in the US. Unique Device Identifier (UDI): A unique number assigned to medical devices by the manufacturer of the device.
UDI at Hologic OOW 2014

7. Means Product Labels Must Include UDI
The label of EVERY medical device (including IVDs) must have a UDI
Plain Text
Barcode
EVERY device package must have a UDI.
However, not every component of a kit requires a label
Individual single-use devices that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution are exempt.
The Packaging level labels – such as 4 boxes of 25 filters or a case of 3 NovaSure products – also displays the UDI.
UDI at Hologic OOW 2014

8. Why UDI?
To Provide a Single, Global System for Identification and Traceability of Every Medical Device
Increase patient safety
More accurate adverse event reports
More rapid development of solutions
Reduce Medical Errors
Standard scanable barcode
Rapid and Precise Identification of a Device
Identify Device Through Distribution and Use
More effectively manage recalls
Support a secure global distribution chain to address counterfeiting
Why would the FDA make this requirement? Having a unique identifier on medical devices benefits everyone.
For physicians, it will
Reduce medical errors –
The device or label will winclude a scanable barcode that will allow the physician to rapidly identify a device and information about its safe and effective use. The physician can obtain descriptive information about the device, preventing confusion with similar devices.
* It will also provide a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries.
UDI will Increase Patient Safety :
In addition to the reduction of medical errors, UDI will ensure more rapid identification and reporting of medical devices with adverse events or for recalls or other corrective actions,
More effective FDA Safety Communications, eliminating confusion with similar devices and a more rapid responsive action
More rapid development of solutions to reported problems
For manufacturers of devices,
UDI will allow Identification of the device through its distribution and use
Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
UDI at Hologic OOW 2014

9. UDI Compliance Timeline
Class III devices compliant by Sept 24, 2014
Hologic Examples: Blood Screening, HPV (Aptima and Cervista), MTD
Class II devices to be compliant within 3 years (2016)
Hologic Examples: AccuProbe, InPlex, Eviva (Costa Rica)
Class I devices to be compliant within 5 years (2018)
Hologic Examples: Invader Products
The implementation date is based on the class of device.
Class III products must have a UDI by 9/24/14, Class II devices must be compliant by 2016 and Class I devices must be compliant by 2018.
Here you can see some examples of Hologic products within each class.
UDI at Hologic OOW 2014

10. GUDID – the FDA Database
Manufacturer submits device identifier and device information for each product
In order to track medical devices sold in the US, the FDA has created a database – the Global Unique Identifier Database or GUDID. This database contains the device information – manufacturer or labeler, device model and device attributes.
is a publicly searchable database administered by the FDA that will serve as a reference catalog for every device with an identifier
UDI at Hologic OOW 2014

11. Device Identifier Data Attributes
Device Identifier (DI) Information Issuing Agency Primary DI Number Device Count Unit of Use DI Number Labeler DUNS Number Company Name Company Physical Address Brand Name Version or Model Number Catalog Number Device Description (max 2000 chars) Commercial Distribution DI Record Publish Date (mm/dd/yyyy) Commercial Distribution End Date Commercial Distribution Status Secondary DI Secondary DI Issuing Agency Secondary DI Number Package DI Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date Package Status
Support Contact
Support Contact Phone
Support Contact
Direct Marking (DM)
Device Subject to DM, but Exempt
DM DI Different from Primary DI
DM DI Number
Device Status
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Kit
Combination Product
FDA Product Code
Product Code/Product Code Name
FDA Listing
FDA Listing Number
Premarket
Device Exempt from Premarket Submission
FDA Premarket Submission Number
Supplement Number
GMDN (Global Medical Device Nomenclature)
Code
Name
Definition
Device Characteristics
For Single-Use
Production Identifier(s) on Label
Lot or Batch Number
Manufacturing Date
Serial Number
Expiration Date
Latex Information
Device required to be labeled as containing natural rubber latex or dry natural rubber
Device labeled as "Not made with latex"
Prescription Status
Prescription Use (Rx)/Over the Counter (OTC)
MRI Safety Status
Is the device labeled for MRI Safety?
Clinically Relevant Size
Size Type/Size Value
Size Unit of Measure
Size Type Text
Storage and Handling
Storage and Handling Type
High Value/Low Value
Unit of Measure
Special Storage Conditions
Sterilization Method
Device Packaged as Sterile
Requires Sterilization Prior to Use
We’ve already talked about the DI containing the manufacturer ID and product ID. When the manufacturer submits these two pieces of information to the FDA, they also submit the device attributes to the FDA database.
These attributes vary by product and this slide lists the types of device attributes for each product that are included in the FDA database.

12. UDI Information - FDA Database and Product Label
In addition to submitting the DI information to the FDA database, the manufacturer puts the Device Information on the product label.
UDI at Hologic OOW 2014

13. How The Customer Obtains Product Information
Now, let’s complete the picture.
We started out this presentation with talking about how UDI would benefit the customers, whether they are doctors, patients or manufacturers.
If the customer wanted to get information about the product – perhaps to identify a device to prevent a medical error or a device that has been recalled, that person can use the UDI information on the product label to search the FDA database for information on that product. They can identify the manufacturer, device model and device attributes for that medical device.
UDI at Hologic OOW 2014

14. Components of a Unique Device Identifier (UDI)
The UDI is composed of two parts: DI + PI
A device identifier (DI) – static identifier which identifies the device manufacturer (aka labeler), the specific device version or model, and device attributes
A production identifier (PI) – dynamic identifier with specific control/production identifiers such as:
Lot / batch number
Serial number
The expiration date
The date of manufacture
NOTE: Only the DI portion is submitted to the FDA
The Unique Device Identifier must be placed on the each medical device, device label and packaging.
It is composed to two pieces of information:
The first part of the UDI contains the Device Information or DI. The DI is a static or unchanging number that identifies the manufacturer, device model and device attributes.
The second part of the UDI contains the Production Identifier or PI. The PI is dynamic or changing number that provides specific production information such a the lot/batch or serial number, the expiration date and the date of manufacturer.
On the DI portion of the UDI is submitted to the FDA.
UDI at Hologic OOW 2014

15. Device Identifier (DI)
Hologic uses the Global Trade Identifier Number (GTIN) numbering scheme for our Device Identifiers.
Components of GTIN (DI)
The GTIN is a fourteen-digit number composed of four sections (PMMMMMMMMIIIIC)
P=Packaging Level
M=Manufacturer (Hologic= )
I – Item number (product identification)
C – check digit
Example:
You will also hear the term GTIN – which stands for Global Trade Item Number. The GTIN is a numbering scheme that identifies the company, product and product attributes – the Device Identification or DI portion of the UDI.
Hologic uses the GTIN numbering scheme for its products.
A number that uniquely identifies trade items as they move through the global supply chain to the end user. Each type of GTIN provides unique numbers that correspond to specific company and product information.
UDI at Hologic OOW 2014

16. Production Identifier (PI)
Can be one or a combination of any of the following:
Lot / batch number
Serial number
The expiration date
The date of manufacture
Product Specific / each site responsible for its PI
Generated in Oracle EBS during the manufacturing process
Added to product label
The other component of the UDI is the Production Identifier or PI.
The PI is the device control companies use to provide traceability to their product (lot number, mfd date, exp date, serial number). The PI is product specific and generated in Oracle EBS during the manufacturing process.
The PI information is also added to the product label, and each site is responsible for how that information gets added to its product labels.
UDI at Hologic OOW 2014

17. Hologic UDI Project Highlights
Implementation across 5 global sites, 105 Class-III products
147 Device Identifiers submitted to GUDID (Global UDI Database)
100% UDI compliant as of 9/24 deadline
First company to process automatic submissions to the GUDID via FDA’s Electronic Submission Gateway
UDI at Hologic OOW 2014

18. Hologic Project at a glance
Steering Committee, Central core team, Global site-based teams – 60+ members for 10 months Key partners: Inspirage, Oracle and USDM
UDI at Hologic OOW 2014

19. Hologic Agile Solution
UDI solution is fully integrated into existing Agile PLM workflows
UDI rule requirements embedded into Agile’s intelligence. Users don’t have to know UDI in depth!
Device Identifier defined as a new Item Type in Agile
Agile auto-generates 14-digit GTIN (Global Trade Identification Number) numbers
UDI information is automatically submitted to FDA upon ECO release. No additional steps needed!
Team never logs in to GUDID. All work done in Agile!
UDI information is transferred to Oracle EBS for transaction processing
UDI at Hologic OOW 2014

20. Centrally Managed Product DI Data
Hologic UDI Process
DI Created & Assigned in Agile
GUDID
Labeling
ORACLE
EBS
ECO Release – Device Identifier Information
Generate & Store (PI) Attributes
DHR (Lot, S/N and Labeling history)
Customers
FDA Automated Confirmation
Product Device Identification Data
Centrally Managed Product DI Data
AGILE
PLM
ECO Release – BOM + GTIN
UDI (DI) Data captured within DMR data (product BOMs)
Standard ECO process for approval of DI data.
ECO release triggers automatic submission to FDA
Automated acknowledgement from FDA to confirm successful transfer
Here’s the process in more detail:
Hologic has been assigned a unique nine (9) digit sequence ( ) that identifies products it manufacturers.
Agile generates and assigns a unique number (Device Identifier) for each Hologic device or product.
After the DI has been assigned, an ECO is created to add this information to the product BOM in Oracle.
The approval of the ECO automatically triggers submission of the DI date of the FDA databse.
The PI information is also in Oracle, and the DI + PI information are combined to create the UDI, which is printed on the product label.
UDI at Hologic OOW 2014

21. System Overview and Data Flow
Preliminary
Pre-Production
Production
FDA/EBS
Send
FDA/EBS Send DI
Preliminary
ECO DI
ECO/MCO DI
Prototype/Preproduction
Production
Oracle
This is a system overview of how DI data is added and processed in Agile thoroughout the product lifecycle and how the data is submitted to the FDA.
The DI is created when the product is at the preliminary stage.
When the product is added to an ECO to move it a prototype/pre-production status, the DI information is submitted to the FDA and to Oracle. This submission is a critical component of the process, since it tests if the information provided will be accepted by the FDA database.
When the product is ready for production status, it is placed on the ECO to move it to that status in Oracle. The DI information is again submitted to the FDA database and the product is now ready for sale.
UDI at Hologic OOW 2014

22. Hologic UDI Dashboard (as of 9/19)
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23. NovaSure Devices UDI Example
Hologic ID=
Product ID = 01284
Check Sum=2 PI
(10) Lot
(17) Exp Date
Here’s an example of label for a NovaSure Device.
The barcode is a linear barcode.
Beneath the barcode, you can see the UDI in a text format.
The (01) indicates that the device identifier information follows.
Following the (01), you see the DI. The first digit indicates the packaging level, then there is the Hologic ID
Next is the product ID number
The (10) indicates the batch or lot number
The (17) indicates the the expiration date.
Following the (10) you see the PI. On this label, the PI consists of the Lot Code and the Use by Date

24. Ready to ship with UDI labels!
UDI at Hologic OOW 2014

25. Next Steps EU and other jurisdictions likely to release requirements
Upcoming FDA deadlines:
Life sustaining Class-II devices by September 2015
All Class-II devices by September 2016
UDI at Hologic OOW 2014

26. October is Breast Cancer Awareness Month
Please spread the word… 3D Mammography Saves Lives! Hologic 3D technology is proven to increase the detection of invasive breast cancers by 41% and reduce the recall rate by 15%
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27. Join Hologic and Oracle in the Fight Against Breast Cancer … Early Detection Saves Lives!

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