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

Case Study: Hologic First to Meet UDI Requirements for Medical Device ManufacturersSeptember 30, 2014

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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

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Hologic is a $2.5B global Medical Device companyWe 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.

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Hologic is The Science of Sure in action


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Platform for Success: Our Enterprise Solutions Architecture


Oracle Exadata, Oracle Database

Siebel CRM Sales

MFG

HR

SCM

FINANCIALS

CRM Servic

e

Agile PLM

Oracle eBusiness Suite R12

OBI OPLA

Hyperion

Oracle Fusion Middleware

ODI

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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.


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Means Product Labels Must Include UDIThe 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.


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Why UDI?


Reduce Medical Errors• Standard

scanable barcode • Rapid and Precise

Identification of a Device

Increase patient safety• More accurate

adverse event reports

• More rapid development of solutions

Identify Device Through Distribution and Use• More effectively manage recalls• Support a secure global

distribution chain to address counterfeiting

To Provide a Single, Global System for Identification and Traceability of Every

Medical Device

UDI Compliance Timeline

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Class III devices compliant by Sept 24, 2014• Hologic Examples: Blood Screening, HPV (Aptima and

Cervista), MTDClass 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


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GUDID – the FDA Database


Manufacturer submits device identifier and

device information for each product

Device Identifier Data AttributesDevice Identifier (DI) InformationIssuing AgencyPrimary DI NumberDevice CountUnit of Use DI NumberLabeler DUNS NumberCompany NameCompany Physical AddressBrand NameVersion or Model NumberCatalog NumberDevice Description (max 2000 chars)Commercial DistributionDI Record Publish Date (mm/dd/yyyy)Commercial Distribution End DateCommercial Distribution StatusSecondary DISecondary DI Issuing AgencySecondary DI NumberPackage DIPackage DI NumberQuantity per PackageContains DI PackagePackage TypePackage Discontinue DatePackage Status

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Support ContactSupport Contact PhoneSupport Contact EmailDirect Marking (DM)Device Subject to DM, but ExemptDM DI Different from Primary DIDM DI Number Device StatusHuman Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)KitCombination Product FDA Product CodeProduct Code/Product Code NameFDA ListingFDA Listing NumberPremarketDevice Exempt from Premarket SubmissionFDA Premarket Submission NumberSupplement NumberGMDN (Global Medical Device Nomenclature)CodeNameDefinitionDevice CharacteristicsFor Single-Use

Production Identifier(s) on LabelLot or Batch NumberManufacturing DateSerial NumberExpiration DateLatex InformationDevice required to be labeled as containing natural rubber latex or dry natural rubber Device labeled as "Not made with latex"Prescription StatusPrescription Use (Rx)/Over the Counter (OTC)MRI Safety StatusIs the device labeled for MRI Safety? Clinically Relevant SizeSize Type/Size ValueSize Unit of MeasureSize Type TextStorage and Handling Storage and Handling TypeHigh Value/Low ValueUnit of MeasureSpecial Storage ConditionsSterilization MethodDevice Packaged as SterileRequires Sterilization Prior to Use

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UDI Information - FDA Database and Product Label


Device Identifier (DI) Information

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How The Customer Obtains Product Information


Components of a Unique Device Identifier (UDI)

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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 attributesA 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


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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)

1. P=Packaging Level

2. M=Manufacturer (Hologic=54200455)

3. I – Item number (product identification)

4. C – check digit

Example: 35420045507429


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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


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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


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Hologic Project at a glanceSteering Committee, Central core team, Global site-based teams – 60+ members for 10 months

Key partners: Inspirage, Oracle and USDM


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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


Hologic UDI Process

20UDI at Hologic OOW 2014

GUDID

Labeling

ORACLEEBS

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

AGILEPLM

• 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

DI Created & Assigned in Agile

ECO Release – BOM + GTIN

System Overview and Data Flow


Oracle

PreliminaryPre-Production ProductionFDA/EBS

SendFDA/EBS

Send

DI DIECO/MCO

ECO

DI

Prototype/Preproduction

Preliminary

Production

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Hologic UDI Dashboard (as of 9/19)


NovaSure Devices UDI Example

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DI (01)Hologic ID=54200455Product ID = 01284Check Sum=2

PI(10) Lot(17) Exp Date

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Ready to ship with UDI labels!


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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


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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

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

28Insert Presentation Title Here

Documents

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