How Can You Quickly Adopt  Data Standards for  Unique Device Identification? Christopher Piela Director Healthcare Solutions
UDI Webinar Agenda <ul><li>Loftware Credentials </li></ul><ul><li>Critical Pressures to your Business </li></ul><ul><li>A ...
Loftware Credentials <ul><li>23 Years in business with more than 25,000 Customers </li></ul><ul><li>31 out of top 50 Fortu...
How do you view  data standard  adoption? GS1 5 Minutes UDI  7 Minutes
Critical Pressures  to Your Business Regulatory Market FDA Amendments  Act of 2007 Unique Device Identification (UDI) Data...
Problem Definition <ul><li>The FDA has not mandated  which data standard to use  for  Unique Device Identification.  They ...
The Great Debate:   GS1 vs. HIBCC HIBCC GS 1
The Great Debate:   GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul>HIBCC GS 1
The Great Debate:   GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Heal...
The Great Debate:   GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Heal...
The Great Debate:   GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Heal...
The Great Debate:   GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Heal...
Market Driven Labeling  Nearly 70% of GPO’s Demanding GS1 Less than 50% of the Manufacturers Adopting GS1
 
Barrier to GS1 Adoption Waterfall Hospital –  Demanding Data Standards GPO –   Carries Demands  to Manufacturers Manufactu...
Why GS1 Adoption is Important to You Recent conversation with a major medical device manufacturer: “It took us more than  ...
Critical Pressures  to Your Business Regulatory Market FDA Amendments  Act of 2007 Unique Device Identification (UDI) Data...
FDA Amendments Act of 2007: UDI <ul><li>The label of a device to bear a unique identifier , unless an alternative    locat...
The FDA UDI Law:  60 Words Which Mean… <ul><li>Manufacturers have to change the labels on thousands of products  </li></ul...
Adopting Data Standards Quickly and Efficiently A Proven Methodology
Methodology Step 1: Consolidate <ul><li>Label Consolidation </li></ul><ul><ul><li>Select a single way to drive label print...
Methodology  Step 2: Integrate <ul><li>Integration with Existing ECM / PLM Applications </li></ul><ul><ul><li>Systems alre...
Methodology Step 3: Automate <ul><li>Incorporate Label Print Services into Existing ERP Applications </li></ul><ul><ul><li...
Methodology Step 4: Validate <ul><li>Validation of System Performance </li></ul><ul><ul><li>Test per Quality System Regula...
Methodology Attributes <ul><li>No Silos  </li></ul><ul><li>No Swivel Chair Applications </li></ul>
Methodology Attributes <ul><li>Leverage Existing Infrastructure </li></ul><ul><li>Minimize Opportunity for Error </li></ul>
Sample Solution Overview Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Conten...
Step 1: Consolidate Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Sto...
Step 2: Integrate Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Store...
Configurable Workflow
Content Stored Enterprise Content  Management
Content Stored Enterprise Content  Management
Step 3: Automate Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored...
Loftware Connector Series <ul><li>An  enterprise solution   that serves as  a high-speed, bi-directional  ‘connectivity br...
Why is the Connector a Critical Business Component? <ul><li>From a Single Print Request , you can perform the following: <...
Gather Approved Template & Content
Loftware Print Server <ul><li>Supports Enterprise Environments </li></ul><ul><li>Centralized and Decentralized Control of ...
Print Management
Sample Solution Overview Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Conten...
Loftware Professional Services 12/15/09 Copyright © 2009 Loftware, Inc All Rights Reserved Page  Project Management
Loftware Professional Services Address the #1 Barrier to Data  Standard Adoption
Enterprise Printing Lifecycle Management Content Creation Print Request Global ERP Template Creation Configurable Approval...
Summary: Quickly Adopt Data Standards for Unique Device Identification? <ul><li>Consolidate: Webinar #2  </li></ul><ul><li...
Questions and Answers
Thank You
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Loftware UDI Webinar 1

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This presentation covers the issues around integration, the global preponderance of GS1-compliant markets and the up-coming US Food and Drug Administration regulations on Unique Device Identification.

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  • Discovery Phase: Project Planning – A detailed understanding of timelines, scope and objectives, project phases and resources. Current State Assessment - A documented current state that should include: Inventory all processes, applications, tools and data Inventory of all business process flows Detailed review of all requirements Definition of the existing infrastructure (including all environments; DEV, TEST, PROD, FAILOVER) Outline of the number of environments that will be necessary The project team will develop a prioritized list of needs that identify how the requirements will be addressed; which requirements will be accomplished through Loftware, Customer, or a combination Approval to proceed with Analysis Phase Analysis Phase: Validation of business needs and proposed business flows Validation of proposed environments Validation of legacy systems details; data and integration points Proposal for promoting legacy system components to new solution Validation of implementation approach and refinement of project plan Project scope and plan finalized Approval to proceed with Design phase Design Phase: During Design we are building out the DEV environment Finalize the Solution Design Install and configure the Development environment Build the new Business Process Flows and Integration points between Loftware and Host System Design the appropriate Training Plan. This will include formal classroom training as well as over the shoulder knowledge transfer. Loftware’s training includes administration, operation and design training. Design the complete testing plan; integration, validation and end user training Design the promotion plan; a plan that identifies how to move configurations, integrations and designs from DEV to TEST to PROD Approval to proceed to the Delivery Phase Delivery Phase: We are delivering the approved DEV environment to TEST Delivery of a fully functioning TEST environment Execution of the training plan Performing Validation Testing according to the approved plan Providing Integration support Transition Phase: We are delivering the approved TEST environment to PROD/FAILOVER Validation of the Production and Failover environments Launching Phase 1 Formal close out of Phase 1 Transition of Phase 1 to Production Support teams (Loftware and Customer) Begin Phase 2 of the project if necessary
  • Loftware UDI Webinar 1

    1. 1. How Can You Quickly Adopt Data Standards for Unique Device Identification? Christopher Piela Director Healthcare Solutions
    2. 2. UDI Webinar Agenda <ul><li>Loftware Credentials </li></ul><ul><li>Critical Pressures to your Business </li></ul><ul><li>A Proven Methodology for UDI Adoption </li></ul><ul><li>Sample Solution Overview </li></ul><ul><li>Summary </li></ul><ul><li>Question & Answer </li></ul>
    3. 3. Loftware Credentials <ul><li>23 Years in business with more than 25,000 Customers </li></ul><ul><li>31 out of top 50 Fortune 500 Companies are Loftware customers </li></ul><ul><li>Leader in Enterprise Barcode Labeling Solutions and Printing Lifecycle Management </li></ul>
    4. 4. How do you view data standard adoption? GS1 5 Minutes UDI 7 Minutes
    5. 5. Critical Pressures to Your Business Regulatory Market FDA Amendments Act of 2007 Unique Device Identification (UDI) Data Standards Adoption
    6. 6. Problem Definition <ul><li>The FDA has not mandated which data standard to use for Unique Device Identification. They have left this decision up to the market… </li></ul>
    7. 7. The Great Debate: GS1 vs. HIBCC HIBCC GS 1
    8. 8. The Great Debate: GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul>HIBCC GS 1
    9. 9. The Great Debate: GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Healthcare and Retail </li></ul><ul><li>Supports Healthcare Products Only </li></ul>HIBCC GS 1
    10. 10. The Great Debate: GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Healthcare and Retail </li></ul><ul><li>Supports Healthcare Products Only </li></ul><ul><li>Required by multiple Hospitals </li></ul>HIBCC GS 1
    11. 11. The Great Debate: GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Healthcare and Retail </li></ul><ul><li>Supports Healthcare Products Only </li></ul><ul><li>Required by multiple Hospitals </li></ul><ul><li>Required by multiple Group Purchasing </li></ul><ul><li>Organizations </li></ul>HIBCC GS 1
    12. 12. The Great Debate: GS1 vs. HIBCC <ul><li>Supports UDI </li></ul><ul><li>Supports UDI </li></ul><ul><li>Supports both Healthcare and Retail </li></ul><ul><li>Supports Healthcare Products Only </li></ul><ul><li>Required by multiple Hospitals </li></ul><ul><li>Required by multiple Group Purchasing </li></ul><ul><li>Organizations </li></ul><ul><li>Required by multiple Countries </li></ul>HIBCC GS 1
    13. 13. Market Driven Labeling Nearly 70% of GPO’s Demanding GS1 Less than 50% of the Manufacturers Adopting GS1
    14. 15. Barrier to GS1 Adoption Waterfall Hospital – Demanding Data Standards GPO – Carries Demands to Manufacturers Manufacturer – Lack the Resources to Implement Data Standards
    15. 16. Why GS1 Adoption is Important to You Recent conversation with a major medical device manufacturer: “It took us more than four years to adopt GS1 data standards.” Examples of GPOs Mandating GS1 by 2012! $780 Million Plexxus - Canada $73 Million under contract (device only) NHS PASA (UK) $670 Million under contract Sisters of Mercy ROi – US IDN $31 Billion under contract Novation – US GPO $30 Billion under contract Premier
    16. 17. Critical Pressures to Your Business Regulatory Market FDA Amendments Act of 2007 Unique Device Identification (UDI) Data Standards Adoption
    17. 18. FDA Amendments Act of 2007: UDI <ul><li>The label of a device to bear a unique identifier , unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices, </li></ul><ul><li>The unique identifier to be able to identify the device through distribution and use, </li></ul><ul><li>The unique identifier to include the lot or serial number if specified by FDA </li></ul>
    18. 19. The FDA UDI Law: 60 Words Which Mean… <ul><li>Manufacturers have to change the labels on thousands of products </li></ul><ul><li>Labels need to be modified within the rules of cGMP – versioned, reviewed, approved, validated system </li></ul><ul><li>Data required for the label must be provided at print time from various systems (no pre-printed labels) </li></ul><ul><li>Adoption will impact every department of a business: </li></ul><ul><ul><li>Sales </li></ul></ul><ul><ul><li>Manufacturing </li></ul></ul><ul><ul><li>Supply Chain </li></ul></ul><ul><ul><li>Information Systems </li></ul></ul><ul><ul><li>Regulatory Compliance </li></ul></ul>This Needs Immediate Attention
    19. 20. Adopting Data Standards Quickly and Efficiently A Proven Methodology
    20. 21. Methodology Step 1: Consolidate <ul><li>Label Consolidation </li></ul><ul><ul><li>Select a single way to drive label printing </li></ul></ul><ul><ul><li>Use a Template-Based solution to minimize label layouts </li></ul></ul><ul><ul><ul><li>Covered in UDI Webinar #2 </li></ul></ul></ul><ul><ul><li>Benefit: Minimizes the Workload for Modifications </li></ul></ul>
    21. 22. Methodology Step 2: Integrate <ul><li>Integration with Existing ECM / PLM Applications </li></ul><ul><ul><li>Systems already deployed and in use </li></ul></ul><ul><ul><li>Systems support 21 CFR Part 11(electronic signature) </li></ul></ul><ul><ul><li>Approval workflows already in place </li></ul></ul><ul><ul><li>Existing applications already contain product information </li></ul></ul><ul><ul><ul><li>Covered in UDI Webinar #3 </li></ul></ul></ul><ul><ul><li>Benefit: All auditable product information consolidated under a single enterprise secure database </li></ul></ul>
    22. 23. Methodology Step 3: Automate <ul><li>Incorporate Label Print Services into Existing ERP Applications </li></ul><ul><ul><li>Systems already deployed and in use </li></ul></ul><ul><ul><li>Users already trained on application </li></ul></ul><ul><ul><li>Eliminate manual label data entry </li></ul></ul><ul><ul><ul><li>Covered in UDI Webinar #4 </li></ul></ul></ul><ul><ul><li>Benefit: No new applications to learn or deploy in order to drive enterprise labeling </li></ul></ul>
    23. 24. Methodology Step 4: Validate <ul><li>Validation of System Performance </li></ul><ul><ul><li>Test per Quality System Regulations </li></ul></ul><ul><ul><ul><li>IQ, OQ, PQ qualification </li></ul></ul></ul><ul><ul><ul><li>Covered in UDI Webinar #5 </li></ul></ul></ul><ul><ul><li>Benefit: Ensures solution is running as designed </li></ul></ul>
    24. 25. Methodology Attributes <ul><li>No Silos </li></ul><ul><li>No Swivel Chair Applications </li></ul>
    25. 26. Methodology Attributes <ul><li>Leverage Existing Infrastructure </li></ul><ul><li>Minimize Opportunity for Error </li></ul>
    26. 27. Sample Solution Overview Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored Enterprise Content Management Gather Approved Template & Content Print Management Loftware Print Server
    27. 28. Step 1: Consolidate Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored Enterprise Content Management Gather Approved Template & Content Print Management Loftware Print Server
    28. 29. Step 2: Integrate Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored Enterprise Content Management Gather Approved Template & Content Print Management Loftware Print Server
    29. 30. Configurable Workflow
    30. 31. Content Stored Enterprise Content Management
    31. 32. Content Stored Enterprise Content Management
    32. 33. Step 3: Automate Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored Enterprise Content Management Gather Approved Template & Content Print Management Loftware Print Server
    33. 34. Loftware Connector Series <ul><li>An enterprise solution that serves as a high-speed, bi-directional ‘connectivity bridge’ between Enterprise applications and the Loftware Print Server(s) </li></ul><ul><li>Intelligent data filtering and decision-making tools that remove the complexities of high volume label printing from Enterprise Applications </li></ul><ul><li>‘ High Speed’ Queuing System supports label printing on a ‘large to massive’ scale – 100’s to 1000’s of printers </li></ul><ul><li>Seamless integration </li></ul><ul><li>Loftware products require no change to current production workflow </li></ul>Gather Approved Template & Content
    34. 35. Why is the Connector a Critical Business Component? <ul><li>From a Single Print Request , you can perform the following: </li></ul><ul><ul><li>Print Multiple Label Formats </li></ul></ul><ul><ul><li>Use Multiple Printer Types </li></ul></ul><ul><ul><li>Automatically determine which label or labels to print </li></ul></ul><ul><li>Connect to more than one Print Server </li></ul><ul><ul><li>Load Dividing </li></ul></ul><ul><ul><li>Automated Failover </li></ul></ul><ul><ul><li>Scale to an unlimited number of printers </li></ul></ul><ul><li>Dynamically retrieve label Content from the Enterprise Content Management solution </li></ul>Gather Approved Template & Content
    35. 36. Gather Approved Template & Content
    36. 37. Loftware Print Server <ul><li>Supports Enterprise Environments </li></ul><ul><li>Centralized and Decentralized Control of Large Scale Printing Operations </li></ul><ul><li>High-Volume Throughput </li></ul><ul><li>Fault Tolerance (Clustering) </li></ul><ul><li>Native Support for 500+ Barcode and Smart Label Printers </li></ul><ul><li>Native Support for Most Types of Printers </li></ul>Print Management
    37. 38. Print Management
    38. 39. Sample Solution Overview Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored Enterprise Content Management Gather Approved Template & Content Print Management Loftware Print Server
    39. 40. Loftware Professional Services 12/15/09 Copyright © 2009 Loftware, Inc All Rights Reserved Page Project Management
    40. 41. Loftware Professional Services Address the #1 Barrier to Data Standard Adoption
    41. 42. Enterprise Printing Lifecycle Management Content Creation Print Request Global ERP Template Creation Configurable Approval Workflow Content Stored Enterprise Content Management Gather Approved Template & Content Print Management Loftware Print Server Label Workflow Management Label Output Management
    42. 43. Summary: Quickly Adopt Data Standards for Unique Device Identification? <ul><li>Consolidate: Webinar #2 </li></ul><ul><li>Integrate: Webinar #3 </li></ul><ul><li>Automate: Webinar #4 </li></ul><ul><li>Validate: Webinar #5 </li></ul>Register for these webinars at www.loftware.com/udi
    43. 44. Questions and Answers
    44. 45. Thank You

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