Dental Trade Alliance Workshop
October 8, 2014 – San Antonio, TX
Grant Hodgkins
VP of Commercial Practice
Office: 805.259.1227; Mobile: 817.691.2271
ghodgkins@usdm.com

• Introductions
• UDI Defined
• Business Context
• Q&A

Grant Hodgkins
VP of Commercial Solutions and Services at USDM Life Sciences
Grant assists USDM Life Sciences clients with Pharmaceutical Track and Trace, Medical Device UDI, GS1 standards adoption, ERP, MES,
PIM/PLM, and other enterprise solutions. Grant has three decades of life sciences industry experience designing, implementing and managing complex global programs and operations. Grant also served on key industry action committees driving adoption of GS1 standards and solutions across the end-to-end supply chain from manufacturer to provider.

• Exclusive Life Sciences Industry Professional Services Firm
• Compliance and Strategy partner for Life Sciences Companies,
Industry Organizations, and best of breed solution Vendors
• We help clients improve business value through technology
• Recognized Industry thought leaders in all relevant and emerging
Life Sciences Topics
• Healthcare Provider service offerings based on, and consistent with, service offerings across the entire Healthcare Value Chain
PROFILE
• Services and solutions for the emerging, mid-tier, and large Life
Science companies
• Multi-national client engagements
Founded in 1999
• Strategic and tactical delivery models
Headquartered in Santa
Barbara, CA
• Leader in the life sciences cloud
• Solve Compliance Issues o Assist clients under regulatory distress
• Over 1,000 projects in over 300 life sciences organizations

• Introductions
• UDI Defined
• Business Context
• Q&A

• Provide standardized granular identification of medical devices and associated meta-data to support public health initiatives
• Most notably to support FDA’s postmarket surveillance activities:
– adverse event reporting/aggregation
– recalls
– device and disease specific registries
– EHRs
– large population-based data sets, e.g., claims data
– others
6

Device Identifiers
-GS1 GTIN
-HIBCC LIC
-ICCBBA
Text + Barcode
DI + PI **
Direct Part Mark
Label
Carton
Inner Pack
Case
GUDID
MDR
QSR
Post-Market
Surveillance
Other Uses
** UDI = DI + PI
DI = Device Identifier (static industry-standard product identifier)
PI = Production Identifier (variable info, such as Lot, Expiry)
Printed in Text and in a Barcode, on every fixed-quantity packaging level

• UDI Assignment and Marking
– Key compliance dates for product marking and GUDID entries
24-Sep-2014
Class III
24-Sep-2015
FDASIA Implants
(Class I and II)
24-Sep-2016
Class II
24-Sep-2018
Class I
Class II DPM
24-Sep-2020
Class I DPM
– UDI assigned to in-scope packaging levels
– UDI marked in a barcode on those packaging levels
• Including DI + PI data: DI, Lot, Expiry, Manufacturing Date, and/or Serial Number
– Standard Date Format marked on all packaging levels (YYYY-MMDD )
– Manage new items / changes per applicable standards
• UDI Attribute Data loaded into FDA GUDID
– Share master data elements related to every DI
8

• Work with one (or more) FDA accredited issuing agencies –
GS1, HIBCC, and ICCBBA/ISBT-128
• Assign Device Identifiers to all devices – including kits, complex systems, combination products
A new DI is required whenever:
• A change to a device results in a new version or model
• Create a new device package (including changes to #)
• Various other situations

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11

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Manufacturer
(Labeler)
The Medical Device Label:
Device Identifier (Device XYZ123)
Production Identifier (Lot #ABC)
Expiration date (YYYY-MM-DD)
For each Device Identifier
Commercial
Distribution
Web based tool or
HL7 SPL
3 rd Parties (e.g., GDSN)
Business
Rules
FDA’s GUDID
Public User
Interface
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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 characters)
Commercial Distribution
– DI Record Publish Date (mm/dd/yyyy)
– Commercial Distribution End Date
(mm/dd/yyyy)
– 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 Email
Direct Marking (DM)
– Device Subject to Direct Marking (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 (21
CFR 801.437)
– Device labeled as "Not made with natural rubber 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
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• Introductions
• UDI Defined
• Business Context
• Q&A

The UDI system provides global visibility and supports:
• Medical device recalls
• Adverse event reporting
• Track and trace
• Supply chain security
• Anti-counterfeiting/diversion
• Disaster/terror preparation
• Shortages/substitutions
• Reduction of medical errors (e.g., bedside scanning)
• An easily accessible source of device information for patients and clinicians
16

Provides foundation for (but requires enabling changes):
• Documentation of use/implantation in EHRs/PHRs
• Claims/reimbursement – CMS and private payors
• Internal efficiencies in supply chain, clinical, other areas
• Stage 3 Meaningful Use
• Value Analysis
• Consignment management
• Others?
But how will this be done…?
more questions that answers
17

Now
Many US Medical Products marked with barcodes, limited data content, multiple standards
2015-2016
Virtually all US medical products marked with UDI barcodes, with extended data content
GUDID and other product catalogs available to synchronize product master data
Extended transaction information available for
Pharma products (DSCSA)
Recommendation
Providers can now begin investments with confidence
UDI Barcodes will become readily available
Data to drive business systems already available

• Providers facing significant pressures to be more efficient
– Declining top-line revenue due to Affordable Care Act (ACA) provisions
– “Meaningful Use” provisions coming soon
– Robust “Value Analysis” solutions becoming more urgent
– High sense of urgency to address these needs quickly (i.e., NOW)
• Current provider business models are fragmented and further split into “supply chain” and “clinical” operations
– Insufficient coordinated actions across operations
– Inability to share information across Provider systems – supply chain through point-of-care clinical systems
– Difficult to quantify benefits to convince Provider management to invest

Supply Chain Operations
• Requisition to Pay Automation
• Barcode scanning across enterprise
• Master Data synchronized with Suppliers
• Replenishment automation
• Consignment management optimization
• Recall enhancements
Clinical Operations
• Interface Supply Chain information into Clinical Operations systems
• Point of Care barcode scanning into EHR
• Advanced logic to detect expiry product, wrong product, wrong time, wrong dosage, drug interactions
• Value Analysis, Meaningful Use, other outcomes-based solutions

• A continuing dialogue about UDI application and use
– Specific, documented use cases (yes, it is a chicken and egg discussion – you can’t
“prove”/demonstrate UDI benefits until you have them)
• Understanding the costs of different UDI applications – and discussion of the trade-offs for “more” UDI
• Manufactures need to talk to each other – and to their customers
• Customers need to engage – adoption of UDI internally will help drive manufacturers towards providing more capabilities
• Jointly develop a path which allows and encourages manufactures to iteratively change/evolve their UDI programs to meet changing market demands
21

• End-to-End Visibility using UDI
• No-Touch ‘Perfect Orders’ and ‘Perfect Payments’
• EHR Bedside Scanning of Items and Services
• Implant Registries tied to EHR and other systems
• Value Analysis by UDI and GMDN categories
• Low-Touch incoming receiving
• Auto-replenishment of consignment inventory triggered by consumption
• And the list goes on and on…

• Real-Life Business Cases
– Financial-based, confirmed value of UDI adoption for Providers and Suppliers
• Build the Foundation – Drive UDI Adoption
– Strategy, master plan, solutions design, deployment and implementation
– Supply Chain, Clinical, Pharmacy segments of Provider business
– Barcodes – adoption of UDI barcodes, scanner selection, integration into systems
• Improve the Foundation – Integration and Data Sharing
– Strategy, solution design, and deployment across Provider systems
– Integration of master data between Suppliers and Providers and other trading partners
• Build the House – Business Process Renovation
– Define and implement 1 improvement from the previous slide
– Capture and quantify benefits
– Use the savings to fund the next project, then repeat

• Introductions
• UDI Defined
• Business Context
• Q&A

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(888) 231-0816 ext 161