Electronic Medical Device Reporting (eMDR) Presented to

1. Team 4 – Melissa Guerrero, Andre McMillan, Carine Melhorn, Kevin Wang May 10, 2014 Electronic Medical Device Reporting (eMDR)Presented to Confidential

2. About Us Presenters: Melissa Guerrero Technical Architect Andre McMillan Director, eMDR Product Manager Carine Melhorn Sr. Engagement Manager Kevin Wang Implementation Engineer, Sr. Developer Founded in 1995, Integrated Technology Solutions (ITS) is a leading healthcare information technology (HIT) consulting firm dedicated to helping organizations design and implement business-driven HIT solutions. Core competencies of ITS include: Business Intelligence and Analytics, Information Exchanges, Regulatory Compliance, Healthcare System Interoperability, Patient Centered Medical Home (PCMH), Healthcare CRM, eMDR, Health Insurance Portability and Accountability Act (HIPAA) Security, and more. We are privately held with 900+ employees nationwide, and headquartered in Cambridge, MA. Confidential

3. MDR Background Information On February 14, 2014 the FDA released a final rule, superseding the “Medical Device Reporting for Manufacturers” regulation dated March 1997. Among other things, the new ruling mandates that all MDR submissions to the FDA be in electronic format. Manufacturers and importers have until Aug. 13, 2015 to comply. The Food and Drug Administration (FDA) has established specific reporting and recordkeeping requirements for manufacturers of medical devices. These requirements are covered under the Medical Device Reporting (MDR) regulation. MDR provides a mechanism that allows the FDA, as well as device manufacturers, to identify and monitor adverse events (deaths, serious injuries and malfunctions) involving medical devices. The goal is to detect and correct problems in a timely manner. Confidential

4. Business Overview Confidential

5. The Challenges • Lack of Preparedness for the Upcoming FDA Mandate • $1MM in Penalties Due to Non-Compliance (Late Submissions) • Inconsistent Reporting Across the Organization • Missed Deadlines • Inadequate training • Low Visibility on Reports Submitted Confidential

6. Goals/Success Critera • Meet the Upcoming FDA Mandate: 100% E-Submissions • Eliminate FDA Sanctioned Monetary Penalties • Reduce the Staff Involved in the MDR Process by 30% • Increase Product Quality by 5% Through Decisions and Corrective Actions Derived From MDR Dashboard Analytics Confidential

7. Requirements • Centralize the Process and Data • Tie into the Incident Management System • Simplify Data-Entry (Auto-populate Forms, Context Help) • Leverage the Enterprise Portal (SSO, Security, UX) • Report MDR Submission Metrics • All Submission Electronic (Regulatory Requirement - FDA) Confidential

8. “As-Is” vs. “To-Be” Business Processes Phone Phone As-Is Service Desk Service Desk Fax Fax Internet Internet Departments E-Submit HL7 Fax Fax eMDR System BI To-Be Confidential

9. Technology Overview Confidential

10. eMDR Software Solution IT Enterprise Portal CRM eMDR System eMDR Pagelets SSO Users (Internal & External) Incident Mgmt Service Bus UI Layer Product Info Integration Layer XML Electronic Submission Gateway HL7 ICSR Layer Persistent Data Layer eMDR DB SOA Confidential

11. eMDR BI Integration IT Enterprise Portal SSO BI Dashboards Users BI System Databases BI Reporting Engine (SQL) Other Repositories Data Marts ETL Data warehouse eMDR DB Confidential

12. Architectural Context Confidential

13. Implementation Overview Confidential

14. Solution Customization • Portal Integration (UI design, SSO) • FDA ESG Electronic Submission • CRM Integration • Asset Management Workflow • Incident Management Workflow • Data Migration Planning and Data Transformation • ETL/ BI Integration Confidential

15. Deployment Approach - 15 - Confidential Confidential

16. Deliverables • Sunset previous • MDR Process • eMDR system integrated • Projectkickoff • Customization • MDR data migrated • Post Implementation • FDA ESG tested • UAT • Go-Live 1 • Internal Training • Go-Live 2 • External User Training • Go-Live 3 • eMDRDashboard Training Confidential

17. Go Live 36/8/15 FDA ESG test submission completed 11/18/14 Go Live 23/17/15 Go Live 11/27/15 July September November January March May July Phase 1 Phase 2 Start5/12/14 Finish7/20/15 Phase 3 eMDR system integration to Portal and CRM completed9/11/14 UAT Completed1/23/15 Internaltraining 3/10/15 Post implementation review completed 7/20/15 MDR data migration completed11/10/14 External users training completed4/7/15 Project Timeline Confidential

18. Operational Governance Confidential

19. Stakeholder /Key Roles • CIO Sponsor • Compliance Team • Help Desk Agents/ Trainers • Product Team • GLOCO Medical Device Users, Clinical Staff Confidential

20. User Enablement: Communication Plan • Briefing to Stakeholders as approved by CAB • End-users training and help documentation resources • Roll-out schedule, testing schedule information Confidential

21. User Enablement : Training Plan Confidential

22. Financial Metrics

23. Product Demonstration Confidential