Case Study: Hologic First to Meet UDI Requirements for Medical Device Manufacturers

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. WhatisUDI (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 • UDI at Hologic OOW 2014

9. UDI Compliance Timeline • UDI at Hologic OOW 2014

10. GUDID – the FDA Database Manufacturer submits device identifier and device information for each product • UDI at Hologic OOW 2014

11. Device Identifier Data Attributes 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 Support Contact Support Contact Phone Support Contact Email 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 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

12. UDI Information - FDA Database and Product Label • UDI at Hologic OOW 2014

13. How The Customer Obtains Product Information • 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 • 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=54200455) • I – Item number (product identification) • C – check digit • Example: 35420045507429 • 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 • UDI at Hologic OOW 2014

17. Hologic UDI Project Highlights • 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 at Hologic OOW 2014

20. Hologic UDI Process DI Created & Assigned in Agile Centrally Managed Product DI Data AGILE PLM Product Device Identification Data ECO Release – Device Identifier Information FDA Automated Confirmation GUDID ORACLE EBS ECO Release – BOM + GTIN Labeling Customers • 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 • Generate & Store (PI) Attributes • DHR (Lot, S/N and Labeling history) • UDI at Hologic OOW 2014

21. System Overview and Data Flow FDA/EBS Send FDA/EBS Send DI Preliminary ECO ECO/MCO DI DI Production Prototype/Preproduction Oracle • UDI at Hologic OOW 2014

22. Hologic UDI Dashboard (as of 9/19) • UDI at Hologic OOW 2014

23. NovaSure Devices UDI Example DI (01) Hologic ID=54200455 Product ID = 01284 Check Sum=2 PI (10) Lot (17) ExpDate

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% • Insert Presentation Title Here

27. Join Hologic and Oracle in the Fight Against Breast Cancer … Early Detection Saves Lives!

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