GS1 Standards Implementation have a logical order of chronology and complexity GDSN GLN GTIN

Transcription

1 Covidien Data Standards Status Healthcare Transformation Group (HTG) Meeting St. Louis, MO May 2, 2012

2 The real long-term objective Supply Chain Data UDI Clinical Data 2

3 GS1 Standards Implementation have a logical order of chronology and complexity GDSN GLN GTIN 3

4 UDI Program Objectives Scope As a world class medical device manufacturing company, the implementation of UDI will drive compliance to global / regional regulations and conformance to customer and industry requirements, while maximizing operational efficiencies leading to enhanced patient care and safety Objectives Establish Unique Device Identifiers using GS1 Data Standards Establish quality standards for Data Quality and Product Marking Establish Master Data Management and Data Governance Application of Unique Device Identification to packaging 4

5 The Covidien Data Standards Team Three Key Members David Brooks, GS1 Business Owner Steve Capel, GS1 Global Tri-Chair Corwin Hee, GS1 US Leadership Team UDI Program Manager Global data standards issues US standards Covidien created a complete program dedicated to UDI compliance and the adoption of GS1 data standards. The program includes staff members allocated solely to the design and implementation of these activities. 5

6 Covidien Data Standards Achievements Full membership in GS1 Global and GS1 US Healthcare groups Elected members on both GS1 Global and GS1 US Healthcare Leadership Teams Participation in all relevant GS1 Workgroups Active projects with HTG members, GS1, and SMI focused on business implementation of the standards Using GLN in GPO reporting GTINs allocated to the Covidien rebranded products; many are beginning to appear in the supply chain 6

7 Covidien GTIN Example Mfg Reorder Code UOM QOM GTIN Covidien 2230 RL Covidien 2230 BX Covidien 2230 CA

8 Master Data Management GHX Health ConneXion will be our data pool MDM selection currently in progress Developing internal and external staff requirements Initial attribute focus is on a verified set of products and their full packaging strings 8

9 GS1 Standards Implementation have a logical order of chronology and complexity GDSN GLN GTIN 9

10 HTG Supplier Summit Tom Werthwine Global Process Owner May 2012

11 HTG Questions Summary Question Subscribe to the Global Location Number (GLN) registry and integrate into your operations Continue your Global Trade Item Number (GTIN) enumeration of prioritized products and apply it to the appropriate unit of use Ensure attributes required for enabling transactions with trading partners are available in the GDSN Label both your products and shipping packages using the GS1 identification keys GTIN and Serial Shipping Container Code (SSCC) respectively Commit to working with the HTG group to resolve issues and move forward quickly with full adoption Yes Yes Answer Yes; attributes vary per product Yes; GTINs for products SSCC on pallets not applicable Yes

12 Global Trade Item Number Status

13 GS1 Bar Code Adoption Medical Devices

14 Global Location Number Status

15 GS1 US GLN Registry Usage Johnson & Johnson Health Care Systems Inc. GLN

16 Systems and Software Status SYSTEMS and SOFTWARE

17 Upgrading U.S. Order-to-Cash Modifying our U.S. Region Order-to-Cash System to use GS1 Standards Advanced Sterilization Products, Division of Ethicon Inc. (ASP on next slide) Biosense Webster, Inc. (BWI on next slide) Codman & Shurtleff, Inc. Cordis Corporation DePuy Mitek, Inc. ETHICON, INC. Ethicon Endo-Surgery, Inc. (EES on next slide) Ortho-Clinical Diagnostics, Inc. (OCD on next slide) GLN Reconciliation is a manual process

18 GS1 Conversion Timeline Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Master Data & Prep. ASP BWI Cordis DePuy Mitek and Codman DePuy EES Ethicon GLN & GTIN Order To Cash GTIN - Franchise Label Conversions OCD U.S. OTC

19 Project Ice Auger A resounding success!

20 Ice Auger Learnings for all Stakeholders Global Trade Item Management and Ownership requires expertise and communication Acquire Divest Communicate

21 GS1 Standards Adoption Current Status Johnson & Johnson Family of Medical Devices & Diagnostics Companies are implementing GS1 Standards. See JOHNSON & JOHNSON GATEWAY Commerce website at: Medical devices and diagnostics products will be labeled with GS1 bar codes at the appropriate levels of packaging. The bar codes will contain the Global Trade Item Number (GTIN) as well as other appropriate identifiers: expiry, lot number and/or serial number. GTINs and other product data will be made available through the GS1 Global Data Synchronization Network (GDSN ) to authorized distributors and endcustomers when system, data quality and business criteria are met. Johnson & Johnson Family of Companies supports the use of the GS1 U.S. GLN Registry for Healthcare and will cross-match the appropriate customer global location numbers to account numbers when system, data quality and business criteria are met.

22 7 Billion Reasons to Care Global Standards Will Benefit Patients and Consumers Around the Globe 13

23 Contact Tom Werthwine Global Process Owner Johnson & Johnson Health Care Systems, Inc. Telephone: Cell:

24 Smith & Nephew Healthcare Transformation Group May 2012

25 Smith & Nephew Healthcare Transformation Group 1) Strategy Standards Update 2) Challenges 3) Questions

26 Smith & Nephew Healthcare Transformation Group 1) Standards Strategy Update: a) SN multi Divisional Global Company: i) Advanced Wound Management AWM ii) Advanced Surgical Device ASD: - ENDO - Recon - Trauma b) SN is committed to using GS1 Standards c) SN is in varying stages of adoption of: - GLN - GTIN - GDSN

27 Smith & Nephew Healthcare Transformation Group 1) Standards Strategy Update: d) AWM uses GS1 bar codes e) ASD uses HBIC bar codes f) GTIN s assigned to all products in SAP g) GS1 Bar Code Labels are applied at GDC s in Memphis and Baar for certain countries that require it (Destination Labeling System) h) HTG GS1 Bar Code requirement by year end 2012 Destination labeling system can accommodate this requirement i) HTG GS1 Bar Code Destination Labeling System is manual today difficulty in identifying orders needing the labeling Volume potential is 4x s greater

28 Smith & Nephew Healthcare Transformation Group 1) Standards Strategy Update: j) GS1 Bar Code CER (Capital Equipment Request) covers updating all distribution systems to be capable of scanning and interpreting GS1 bar codes. k) GS1 Bar Code CER once completed production labeling can be converted to include the GS1 Bar Code l) Once Bar Coding is complete only electronic transmission of data will be needed to meet Standard Requirement

29 Smith & Nephew Healthcare Transformation Group 2) Challenges: a) Multi-Divisional Global Company b) New CEO, CTO, Senior Leadership Team c) Focused on European Integration of Multiple Systems - $40 mm FY 2012 d) No appointed leader to drive across divisions e) Cost of implementation vs. ROI f) Merging the two largest divisions into one Endoscopy and Orthopaedics

30 Smith & Nephew Healthcare Transformation Group 3) Questions

31 GS1 Implementation Status HTG Summit May 2, 2012

32 Zimmer World leader in musculoskeletal health headquartered in Warsaw, Indiana Annual revenue of $4.5 billion Divisions Manufacturing Locations Reconstructive Trauma Biologics Surgical Dental CAS Carlsbad, CA Warsaw, IN Dover, OH Minneapolis, MN Statesville, NC Parsippany, NJ Austin, TX Beijing, China Bordeaux, France Etupes, France Shannon, Ireland Ponce, Puerto Rico Winterthur, Switzerland 2

33 GS1 Sponsorship GS1 is jointly owned at Zimmer : Global VP of Operations is overall sponsor (Rick Stair) Global VP of IT is co-sponsor (Edwina Payne) Multiple departments also engaged in ensuring GS1 adoption is meeting the requirements of our customers and regulatory bodies Global VP of Regulatory (Shami Feinglass) VP of Sales Logistics (Dean Childers) Director of Packaging (Tim Early) Individuals across the Zimmer organization globally are involved as required 3

34 GS1 Journey Already in Place: Ability to transact with customers using GLN in US (November 2010) Basic 4 EDI transactions and paper purchase orders Intermountain Healthcare Mayo Clinic Central assignment of GTIN numbers for US and international usage (Spain, France, Germany, China, India and Australia) Activities Underway: Complete the GTIN assignment for all products. Review of GTIN assignment rules Awaiting the FDA UDI Regulations Key Enabling Activities: Elimination of duplicate Finished Goods numbers Master Data Management process and system Global Labeling System implementation 4

35 Upcoming Activities Continue to partner with key business customers and regulatory bodies on GS1 activities GS1 rollout in the US: GTIN transactional capabilities by December 31, 2012 GTIN to Zimmer Product# cross reference available (spreadsheet format) UDI compliance GDSN data synchronization Evaluate a 2013 implementation 5

36 Summary Zimmer s leadership team is developing the logistical plans to roll out this program across 37,000 active SKU s. GTIN available in EDI transactions end of year 2012 Compliant with FDA UDI Regulation Class III Products 2013 Class II Products

37 Addressing Your Questions 7 7