JULY 10, 2014

MEDICAL DEVICE MANUFACTURING

UDI REGULATION

Zebra Confidential

AGENDA

• Medical Device Manufacturer Overview• UDI Overview• Buying Center• Zebra Solution• Zebra Supplies Positioning and Value• Supplies Competition• Sales Tools and Resources• Demand Generation

MEDICAL DEVICE MANUFACTURER OVERVIEW

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US MEDICAL DEVICE MARKET

• 32 of 46 $1B+ companies are based in US

• Serve 40% of world market• US largest Healthcare market• Global leadership of FDA• Unparalleled venture capital (VC)

infrastructure

• Globalization• In the next 5 years:

• China - 15% growth• India – 23% growth

• Highly regulated• Swaying investments in new products• Medical device tax effective Jan, 2013• Lack of permanent R&D Tax Credit

ThreatsOpportunities

Strengths Challenges

• Growing and aging population• Emerging markets – Brazil, India &

China

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MEDICAL DEVICE MARKET CHALLENGES

Source: Emergo Group

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MEDICAL DEVICE

• What is a Medical Device?– An instrument, apparatus, implant, in vitro reagent, or similar or

related article– Used to diagnose, prevent, or treat disease or other conditions– Does not achieve its purposes through chemical action within or

on the body (which would make it a drug)

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MEDICAL DEVICE CLASSIFICATIONS

• Class III devices: – Support or sustain human life– Are of substantial importance in preventing impairment of human

health– Present a potential, unreasonable risk of illness or injury– Examples: implantable pacemaker, pulse generators, HIV

diagnostic tests, automated external defibrillators, etc.

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MEDICAL DEVICE CLASSIFICATIONS

• Class II devices– General controls alone cannot assure safety and effectiveness

– Existing methods are available that provide such assurances

– Examples: powered wheelchairs, infusion pumps, surgical drapes and an implantable radiofrequency transponder system for patient identification and health information

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MEDICAL DEVICE CLASSIFICATIONS

• Class I devices: – Not intended to help support or sustain life – Not intended to be substantially important in preventing

impairment to human health– May not present an unreasonable risk of illness or injury– Examples of Class I devices include elastic bandages,

examination gloves, and hand-held surgical instruments

UNIQUE DEVICE IDENTIFIER (UDI) OVERVIEW

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UDI OVERVIEW

• Food and Drug Administration (FDA) rule

• Requires most medical devices distributed in the United States carry a unique device identifier, or UDI.

• Also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act (e.g., donor screening assays).

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BENEFITS OF UDI

• Accurate reporting, reviewing and analyzing of adverse event reports to enable quick identification and correction of problem devices

• Enable clinicians to quickly obtain important information on devices, reducing medical errors

• Enhance analysis of devices

• Provide a standard and clear way to document device use in HIT systems.

• Increase effectiveness of management of medical device recalls

• Enable a global, secure supply chain, helping to address counterfeiting and diversion and prepare for medical emergencies.

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UDI REQUIREMENTS

• Device label and package must bear a UDI, 21 CFR 801.20

• Devices intended to be used more than once and devices intended to be reprocessed before each use must be directly marked with a UDI, 21 CFR 801.45

• Data for these devices must be submitted to GUDID, 21 CFR 830.300

• Dates on the labels must be in the correct format (YYYY-MM-DD), 21 CFR 801.18

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UDI LABEL REQUIREMENTS

• Create a UDI (a unique numeric or alphanumeric code)

that consists of two parts:

– a device identifier (DI), a mandatory, fixed portion that identifies

the labeler and the specific version or model of a device

• GTIN

– a production identifier (PI), a conditional, variable portion that

identifies one or more of the following when included on the label

of a device:

• lot or batch number

• serial number

• expiration date (date format must be YYYY-MM-DD)

• date of manufacture (date format must be YYYY-MM-DD)

• distinct identification code required by §1271.290(c) for a human

cell, tissue, or cellular and tissue-based product (HCT/P) regulated

as a device.

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UDI LABEL REQUIREMENTS

• Use of Device Identifier (DI) and Production Identifier (PI)

– Class I: Device Identifier (DI) ONLY

– Class II and III: Device Identifier (DI) + Production Identifier (PI)

• The UDI must be presented in two forms:

– (1) Easily readable plain-text

– (2) Automatic identification and data capture (AIDC) technology

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ISSUING AGENCIES CURRENTLY ACCREDITED BY FDA FOR UDI

• GS1• HIBCC• ICCBBA

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MEDICAL DEVICE LABEL ELEMENTS

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UDI LABEL EXAMPLE

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UDI LABELING LEVELS

• UDI does not have to be on shipping container (ie. skid or tote)

• What is marked depends on how the device will be consumed and if it is reusable

Inner Carton

Outer CartonDevice PackagingDirect Marking

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LABEL QUALITY REQUIREMENTS

• Title 21, Chapter 1 FDA, Subchapter H

– Label Integrity

• Remain legible and affixed during processing, storage, handling,

distribution, and where appropriate use

– Labeling Inspection

• Need to verify info on the label is correct.

• Need to document the release in the DHR, including the date and

signature of the individual(s) performing the examination

– Labeling Storage

• Ensures proper ID and prevents mixups

– Labeling Operations

• The label and labeling used for each production unit, lot, or batch

shall be documented in the DHR.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.120

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UDI DATA SUBMISSION REQUIREMENT

• Submit product information into Global Unique Device Identification Database (GUDID)

– that users of a medical device can easily look up information about the device.

Source: UDI Implementation Workshop

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DATA SUBMISSION FLOW

Source: AIM North America

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ISV’S OFFERING GUDID SUBMISSION SOLUTIONS

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KEY COMPLIANCE DATES

Date Device Type Labeling RequirementsSept. 24, 2014 Class III & Licensed

under PHS (Public Health Service) Act

• Labels and packages must bear a UDI

Sept. 24, 2015 Class II –implantable devices and life-supporting and life-sustaining devices and software

• Labels and packages must bear a UDI• Devices intended to be used more than

once and reprocessed before each use must a bear UDI as a permanent marking on the device itself

Sept. 24, 2016 Class III

Class II

• Devices intended to be used more than once and reprocessed before each use must a bear UDI as a permanent marking on the device itself

• Labels and packages must bear a UDI

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KEY COMPLIANCE DATES

Date Device Type RequirementsSept. 24, 2018 Class II

Class I & Non Classified Devices and Software

• Devices intended to be used more than once and reprocessed before each use must a bear UDI as a permanent marking on the device itself

• Labels and packages must bear a UDI

Sept. 24, 2020 Class I • Devices intended to be used more than once must a bear UDI as a permanent marking on the device itself

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UDI COMPLIANCE WORKSTREAMS

• Assign UDI’s to devices and place UDI on the devices label (and packaging) [and standardized date format]

• Identify, collect, validate and submit required data to GUDID

Workstreams should be done in parallel

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ZEBRA UDI MARKET RESEARCH LEARNINGS /FINDINGS

• Label is a critically important component for Med Device manufacturers

• Medical Device labels contain a lot of regulated information

• Minimal new hardware opportunities driven purely by UDI regulations

• There are opportunities to improve labeling operations for Medical device manufacturers, regardless of UDI influences.

• Operations people looking for label solutions and application advice

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MEDICAL DEVICE MANUFACTURER NEEDS

• Solution that: – Meets regulatory and compliance standards– Will remain readable during the products life– Can print small text and graphics – Is easy to apply, to maximize efficiency in the plant

• Supplier that:– Offers high-quality, consistent material and ribbon combinations– Can recommend the right material and ribbon combination

based on the medical device, it’s use and expected life– Lowers total cost of ownership and reduces downtime

• Printhead Protection• ZebraCare• Pre-tested materials

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PAIN POINTS

• UDI Labeling Pain Points– Re-design of all label formats to include UDI

• General Labeling Pain Points– Labeling errors are a cause of recalls

– Want to move from distributed printing to on-demand printing

– Hard to determine the right label and ribbon combination to use• Sterilization

• Chemicals

• Abrasion

BUYING CENTER

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MEDICAL DEVICE BUYING CENTER

Director of Regulatory Compliance and Quality

Needs:-UDI remains

readable during the products life-Label contains

all required information

Director of Engineering

Needs:-UDI remains

readable during the products life

Product Marketing/

Management

Needs:-Branding on

label-The use of

color enables user to do their

job more efficiently (i.e. highlight size,

etc)

Labeling and Document

Control

Needs:-Label contains

all required information

-UDI remains readable during the products life

Materials Mgmt/

Purchasing

Needs:-Reliable and

consistent solutions at competitive

prices-Easy to do

business with

Operations Manager

Needs:-Reliable

solutions that help alleviate and reduce

burden on his current

resources -Reduce error

rates-Help

implement best practices

ZEBRA SOLUTION

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RECOMMENDED PRINTERS

Xi4300 or 600dpi

ZT410300 or 600dpi

Desktop300 dpi

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ZEBRADESIGNER

• Label Design Made Easy– Wizard Driven / WYSIWYG

– Quick access to frequently needed tools

– Windows Certified drivers

– Supports RFID, database connectivity ("Pro" edition)

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UDI PACKAGING LABELING SOLUTIONS

• Product Packaging• Carton Labeling

Material Name Key Features

Sterilization Resistance

Chemical Resistance

Use with Applicator

(Y/N)Z-Select 4000T

Paper label with a high-tack permanent acrylic adhesive. Temperature exposure up to 200°F.

-Gamma Radiation -Ethylene Oxide

Minimal resistance to moisture and chemicals.

Y

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UDI DIRECT PRODUCT LABELING SOLUTIONS

Material Name Key Features

Sterilization Resistance Chemical Resistance

Use with Applicator

(Y/N)UL

RecognitionPolyPro4000T

Matte Kimdura® polypropylene label with a permanent acrylic adhesive. Offers some flexibility for labeling curved surfaces. Temperature exposure up to 250⁰F.

-Steam Autoclave -Gamma Radiation -Ethylene Oxide

Excellent resistance to moisture and chemicals, such as isopropyl alcohol, bleach and additional healthcare cleaning agents.

Y

Z-Ultimate 4000T

Gloss polyester label with a high performance permanent acrylic adhesive. Temperature exposure up to 302⁰F.

-Steam Autoclave -Gamma Radiation -Ethylene Oxide

Excellent resistance to moisture and chemicals, such as isopropyl alcohol, bleach and additional healthcare cleaning agents.

Y UL 969 and UL/IEC 60601-1 when paired with 5100 resin ribbon

Z-Xtreme 4000T

Matte polyester label with a high performance acrylic adhesive. Temperature exposure up to 300⁰F.

-Steam Autoclave -Gamma Radiation Ethylene Oxide

Provides unparalelled resistance to moisture and harsh chemicals. Provides excellent resistance to isopropyl alcohol, bleach and additional healthcare cleaning agents.

Y UL 969 when paired with 5095 resin ribbon

Includes Electronics and Reusable Products

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UL CERTIFICATION

• UL 969

• UL/IEC 60601-1 3rd edition

– Requires that both internal and external markings be clearly

legible and that all required external markings be durable

– Specifies rubbing external markings with water, methylated spirit,

and isopropyl alcohol

– Verifies that the external markings are clearly legible and that

labels do not fall off or curl after the rub treatments

SUPPLIES POSITIONING & VALUE

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SUPPLIES POSITIONING STATEMENT

• Medical device labels are now viewed as a as a critical mechanism for:

– Maintaining compliance– Ensuring brand consistency– Improving operational efficiency– Supporting business growth

• They are the final link between your company and key stakeholders including customers, care givers, patients and regulators.

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SUPPLIES VALUE

• Not all thermal labels are created equal. It is critical that labels you utilize are:

– Readable and scannable when they leave your operation and throughout the products safe and appropriate use and disposal

• Purchasing genuine Zebra supplies means you have access to:

– A large selection of quality, pre-tested supplies

– Manufactured by a thermal industry expert

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SUPPLIES VALUE

• Offer specific label and ribbon combinations for Medical

Device Product Identification

– Withstand sterilization

– Withstand cleaning agents used in hospitals

– Our expects can help with material and ribbon selection

• Pre-tested, consistent materials and quality processes

ensure consistent print quality, reducing the need to re-

print labels due to poor readability and scannability

– Do not substitute materials

– ISO 9001:2008 certified

– Zebra’s Supplies R&D Team tests all materials in Zebra printers

for print quality and printer wear and tear.

– One of the largest thermal convertors in North America

SUPPLIES COMPETITION

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OVERVIEW - MAIN SUPPLIES COMPETITORS

Brady

• OEM Printers• UDI-specific solutions?• Large synthetic stock

offering• Strong Supplies Brand• R&D focus

CCL

• No Printers• UDI-specific solutions?• Focus on prime labels

and packaging

SALES TOOLS AND RESOURCES

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KEY QUESTIONS

• What classes of Medical Devices do you manufacture?• How are you preparing for the UDI compliance that is coming up for

Medical III devices in September?• Who is on project team to implement UDI?

UDI

• Is the label going to be applied manually or with an applicator• Can I see your current label format? (600 dpi?)

• What is the size of the text and logos being printed?Printer

• Are you running into any challenges from a labeling perspective? • Are you in need of a packaging label, a direct device label or both?• If a direct device label, is the device reusable?

• If yes, will it be sanitized with healthcare cleaning agents or sterilized?• What sterilization method(s) will be utilized?

Supplies

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COMMON OBJECTIONS

• Buying Zebra Supplies for your Zebra ensures you receive a high-quality solution, maximizing up-time. Zebra extensively tests all materials in Zebra printers. Testing includes: • Print quality• Printer wear and tear. • Chemical, abrasion resistance• Adhesive strength

We already have a supplier

• Zebra utilizes the highest quality of materials that are pre-tested in Zebra printers.

• We never substitute materials so the performance will be consistent from run-to-run.

• If you decide to exclusively use Zebra Supplies you are eligible for our Printhead Protection Program, which offers you free replacement printheads.

Zebra Supplies are more expensive

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SALES AND MARKETING TOOLS

• UDI Medical Device Product Identification Label Datasheet

• UDI Medical Device Product ID Sales Guide

• UDI Medical Device Supplies Customer Presentation

• Supplies Video

• White Paper: Selecting the Right Label to Identify your Finished Product

• UDI Q&A

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SUMMARY

• UDI labeling compliance for Medical Devices starts September 24, 2014 and extends until September 24, 2020.

• The labels are the simplest part of the requirement, but the most time consuming as Medical Device Manufacturers must update all their labels.

• Engage with the Buying Center to understand their needs and pain points.

• Zebra’s Supplies Value: Quality + Pre-tested + Reliable

• Leverage the Sales Tools and Marketing Assets