Leveraging UDI Database Requirements to Drive Data Governance

1. May 21, 2014 Leveraging UDI Database Requirements to Drive Data Governance Rene Zoelfl Business Development Manager Medical Devices

4. 4MEDICAL DEVICES “This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States for safe and effective use… The rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use” Class II, Implantable (9/2015) UDI (Unique Device Identification) Regulatory Timeline PTC UDI solution released (9/2013) Class I, All (9/2018) Congress Mandates the unique identification of medical devices PTC R&D begins with the FDA and major device manufacturers FDA UDI proposed ruling Class III devices (9/2014) Class II, Other (9/2016) FDA UDI ruling published (9/2013) 2014-18: Enforcement begins for… FDA UDI Ruling Worldwide UDI regulations in work (April 2013, IMDRF) 2005 2007 2009 2011 2012 2013 2014 2015 2016 2018 492,000 adverse event reports / year 283,000 involved an injury 17,700 involved a death © 2014 PTC

5. 5MEDICAL DEVICES 5 Agenda © 2014 PTC • A checklist for FDA UDI compliance • Data management as lever for streamlined submissions – Current Situation – Challenges – Best Practices • How PTC solutions support UDI and data governance

6. 6MEDICAL DEVICES Executive Scorecard for a UDI Submission Solution © 2014 PTC Requirements, Should-Have’s, & Better to Have’s Compliance by the deadline System available to meet compliance deadline System supports 21 CFR Part 11 compliance* HL7 SPL (XML) Formatted submission Communicated to ESG (electronic submissions gateway) Capture acknowledgements from FDA Triage accept / reject / delayed status (7 days to correct**) High-level reportability for compliance across all products Collect and aggregate regulatory data centrally Templates / workflows / bulk load and approve Create, review, and approval permissions Connect to product development so GUDID data is current / UDI referenced in DHF (per 21 CFR Part 820.184) Connect to CAPAs/Complaints/NCs/Adverse Event reports (21 CFR Part 820.198) Architecture to accommodate future global regulations 124 days left to comply with the rule for class III devices

8. 8MEDICAL DEVICES Problem Definition: Market and Regulatory Submissions Our observation: multiple systems house the 65 data points required by FDA © 2014 PTC FDA GUDID DB2 DB1 DB4 DB3 GDSN Future Global UDI Databases Global Providers US Providers Group Purchasing Org’s Product Changes New Geographies Internal processes / approvals .CIN .SPL .??? Market / eCommerce Data Regulatory Submissions .??? .???

9. 9MEDICAL DEVICES Our Recommended Approach for Streamlined Submissions © 2014 PTC SYNCHRONIZE CENTRALIZE HARMONIZE FDA GUDID DB2 DB1 DB4 DB3 Global Providers US Providers Group Purchasing Org’s GDSN Future Global UDI Databases Workflows/ Approvals .CIN .SPL .??? Changes / History Submissions/ Output Future Regulations submissions with unique market / regulatory needs data as changes are made upstream AGGREGATE REVIEW / CLEAN GOVERN

11. 11MEDICAL DEVICES • Transparency about all devices falling under the rule – How many devices are affected at what deadline? • Clarity on – Which data are available? – Where are the 65 data points required for FDA UDI Submission housed within the organization? – Which data are electronically accessible? – Which data are correct for submission? – Are the data available in the required format? – Can the data be stored centrally? • What do the FDA required attributes mean? – i.e. what is brand name or the catalogue number in the context of the customer Where are all the data stored? Critical questions at the beginning © 2014 PTC

12. 12MEDICAL DEVICES • Who within the organization can validate the data? • Who is responsible for the program? • Need people in place that are dedicated to UDI – It isn’t just about submission, it is all about validation and maintenance – It isn’t solely an IT topic, but a regulatory challenge • How do I setup the account structure for communication with the FDA. Who is responsible within the Organization? Many stakeholders in many organizational units © 2014 PTC

15. 15MEDICAL DEVICES STAY COMPLIANT AND REDUCE THE RISK OF NEGATIVE AUDIT FINDINGS Best Practice I Data Governance ensure Accuracy and Uptodateness Automatically stay compliant as product data changes upstream, as required by the UDI rule. • Submissions Stay Current as Products Change – Live synchronization of UDI submissions with upstream data source(s) – As product data changes in upstream system(s), the system creates new or updated submissions • Available UDI Data Management – Centralized storage and management of UDI in a purpose-built UDI data model – Route to the right organizational roles via create/edit/review/approval workflows – Template and bulk-load capabilities for creation / approval of submissions – History and change/configuration management of UDI data to aid in future compliance with worldwide UDI regulations – Pre-submission validation using the same FDA algorithms used post-submission W H Y IT MATTER S W H AT IT MEA N S © 2014 PTC

16. 16MEDICAL DEVICES • Ensure data quality, integrity, and security – Capture and manage all required UDI information from multiple systems into a single data model • A single, centralized data model for e- commerce and UDI (starting with FDA GUDID) submissions – Scalable to future requirements while preserving data integrity and ease-of-use – Strong Integrations with other systems to rapidly pull UDI data into a single source • Centralize workflows, edits, reviews, and approvals – Pre-configured workflows route UDI information to the correct roles for review and approval • Keep business processes and roles aligned with e-commerce and regulatory data management needs REDUCE TIME AND EFFORT, IMPROVE ACCURACY OVER MANUAL METHODS Best Practice II Centralize Product and Regulatory Data Improve Efficiency and Reduce Risk with a single source of truth for product and regulatory data W H Y IT MATTER S W H AT IT MEA N S © 2014 PTC

17. 17MEDICAL DEVICES HELP ENSURE COMPLIANCE TO PROTECT FROM RISK Best Practice III Regulatory Compliance reducing risk and effort Extend compliance to include related industry requirements – with no additional effort • 21 CFR Part 11-Supportive Training – Completely pre-built, documented training developed and delivered by industry experts via eLearning and instructor-led options – Gain compliance faster by eliminating the need to create and conduct training internally • 21 CFR Part 11-Supportive Technology – Audit trail technology, electronic signatures, and secure review of electronic data – Complete solution validation package facilitates required validation process – Speed and streamline the audit process; help to reduce uncertainty and risk during audits • Accommodate Future UDI Regulations – Robust software architecture anticipates UDI regulations from future worldwide markets – Prepare to meet future global UDI rules and future changes to FDA UDI W H Y IT MATTER S W H AT IT MEA N S © 2014 PTC

19. 19MEDICAL DEVICES DB4DB3DB2DB1 We designed our solution to facilitate data governance Lower the risk of noncompliance with accuracy, efficiency, traceability and scale  21 CFR Part 11- supportive technology  21 CFR Part 11- supportive training  21 CFR Part 830 – supportive solution  Solution technology facilitates validation  Accommodates future global UDI rulings Regulatory compliance Centralized Data Management Data Governance - Dynamic connections ensure changes flow down - Available centralized UDI regulatory data management with: - Bulk-load capabilities - Collection, control of data from disparate sources - OOTB workflow to create, review, approve submissions - Pre-built templates to bulk-create and bulk-approve - Pre-submission data validation with FDA algorithms - Change/configuration management of UDI data - Automatic data transformation - Human-readable PDF - Monitor and track FDA responses - Rejections/exceptions flagged for correction - High-level graphing and reporting - Historical record of submissions UDI data Centralized data if pre-existing OR… © 2014 PTC

20. 20MEDICAL DEVICES Revision control and data stewardship 5.0 PTC’s Unique Device Identification Solution ► Process Overview Collection of Data Review & Approvals e-signature Start Creation FDA Submission End Ongoing Change & Configuration Mgmt Regulatory Affairs 2.0 3.0 4.0 1.0 5.0 PLM Systems ERP Systems Home Grown Systems MDM Systems Doc & Labeling Systems Product “Specs” Collection of Products & key UDI attributes from Disparate systems – Automatic bulk Creation of UDI Objects & Initiation of Workflows 1.0 © 2014 PTC UDI Creator applies final edits to refines UDI submission then submits for approval 2.0 Generate HL7 SPL, submit to FDA Electronic Submissions Gateway (ESG) – Monitor Acknowledgments 4.0 E-Signature and review/approval workflows 3.0

21. 21MEDICAL DEVICES Technical Architecture Overview The PTC UDI Complete Solution Includes Services and Software Components. • PTC Core UDI Submission Engine – Manages Inputs, Workflows, Approvals, Configuration and Change • PTC Submission Cartridges – Manage formatting, communication & monitoring for Agency Submission Doc / Labeling Regulatory PLM ERP/MDM Spreadsheet Import UDI Database Create Wizard UDI Algorithm PTC Core UDI Submission Engine UDI Templates “Populate from Source Method” Calls Data Populators if used Wizard or Spreadsheet US FDA Cartridge © 2014 PTC

22. 22MEDICAL DEVICES Vision: Centralized Data Management © 2014 PTC Product Based Information – Design, BOM, Parts, Variants etc.. Document Based Information – SOPs, Policies, Quality Manual Quality Records Based on Products & Documents – CAPA, NCs, Complaints, Audits etc.. Design Manuf. Distribution & Use Support & Service Concept • A Documents Backbone - Manage & Control all key documents / Document Control • A Products Backbone - Provide Control of Product information / Design Control, DHF, DMR, BOM and BOO• A Quality Backbone – Quality Activities & Processes interact with the Anchor Points for Products and Processes Requirements Design Inputs Risk & Hazards Failure Modes Design Validation Design Reviews Regulatory submissions Material Compliance CAPA Nonconformance Manufacturing Process Plans Manufacturing Instructions CAPA Complaints CAPA Complaints Service Issues FDA Market Approval Enable streamlined data governance over the entire product life cycle

23. 23MEDICAL DEVICES Summary Corner Stones for a product data centric UDI implementation © 2014 PTC • UDI as regulatory must have or opportunity to drive future data quality and governance • Communicate and win stakeholders Develop Strategy and Scope • Systems and Owners • Gaps to UDI requirements • Inconsistencies Identify Data Sources • Data preparation and evaluation • Iterative approach; build, evaluate, define process • Review data quality at each iteration of test load Evaluate Data Quality • Improve process and data; solidify submission process • Be clear on ownerships Define Cleansing and Governance Process • Submission handling, and approval concept • Integration strategy Define submission procedure and triage concept