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Electronic Medical Device Reporting (eMDR)Presented to

Team 4 – Melissa Guerrero, Andre McMillan, Carine Melhorn, Kevin Wang May 10, 2014

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About Us

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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.

Presenters:

Melissa GuerreroTechnical Architect

Andre McMillanDirector, eMDR Product Manager

Carine MelhornSr. Engagement Manager

Kevin WangImplementation Engineer, Sr. Developer

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MDR Background Information

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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.

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.

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Business Overview

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The ChallengesLack of Preparedness for the Upcoming FDA Mandate$1MM in Penalties Due to Non-Compliance (Late Submissions)

Inconsistent Reporting Across the OrganizationMissed DeadlinesInadequate training

Low Visibility on Reports Submitted

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Goals/Success CriteraMeet the Upcoming FDA Mandate: 100% E-SubmissionsEliminate FDA Sanctioned Monetary PenaltiesReduce the Staff Involved in the MDR Process by 30%Increase Product Quality by 5% Through Decisions and Corrective Actions Derived From MDR Dashboard Analytics

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RequirementsCentralize the Process and DataTie into the Incident Management SystemSimplify Data-Entry (Auto-populate Forms, Context Help)Leverage the Enterprise Portal (SSO, Security, UX)Report MDR Submission MetricsAll Submission Electronic (Regulatory Requirement - FDA)

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“As-Is” vs. “To-Be” Business Processes

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Phone

Fax

Internet

Service Desk

Phone

Fax

Internet

Service Desk

Fax

E-Submit

HL7

Fax

Departments As-IsTo-Be

eMDR System

BI

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Technology Overview

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IT

eMDR Software Solution

eMDR System

eMDR DB

SOA

Service Bus

CRM

Incident Mgmt

Product InfoPersistent Data Layer

Integration Layer

Users(Internal & External)

XML

Electronic Submission

Gateway HL7 ICSR Layer

Enterprise Portal

eMDR Pagelets SSO

UI Layer

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IT

eMDR BI Integration

BI SystemUsers

Enterprise Portal

SSOBI Dashboards

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Data warehouse

ETL

BI Reporting Engine(SQL)

Databases

eMDR DB

Other Repositories Data Marts

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Architectural Context

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Implementation Overview

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Solution Customization Portal Integration (UI design, SSO)FDA ESG Electronic SubmissionCRM Integration

Asset Management WorkflowIncident Management Workflow

Data Migration Planning and Data TransformationETL/ BI Integration

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Deployment Approach

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Phase 1 eMDR system Internal Users

Phase 2 eMDR systemExternal Users

Phase 3BI Dashboard

eMDR Deployment – 3 Phases

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Deliverables Inception

5/12/14 - 6/9/14Elaboration6/9/14 - 8/1/14

Construction8/4/14- 6/15/14

Transition6/8/15 - 7/20/15

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Project kickoff Customization eMDR system integrated

MDR data migrated

FDA ESG tested

UAT

Internal Training

External User Training

eMDR Dashboard Training

Post Implementation

Sunset previous MDR Process

Go-Live 1

Go-Live 2

Go-Live 3

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Project Timeline

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Start5/12/14

Finish7/20/15

July September November January March May July

Phase 1 Phase 2Phase 3

eMDR system integration to

Portal and CRM completed

9/11/14 MDR data migration completed11/10/14

FDA ESG test submission completed 11/18/14

UAT Completed1/23/15

Go Live 1 1/27/15

Internal training 3/10/15

Go Live 23/17/15

External users training

completed4/7/15

Go Live 3 6/8/15

Post implementation

review completed 7/20/15

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Operational GovernanceICT CIOSponsor

ICT CFO

ICT COO

VP EnterpriseArchitecture

VP Application Delivery

VP Information Security

VP Corporate Systems

VP Operations

CAB PMO

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ITS eMDR Director

ITS Sr. PM

ITS Implementatio

nTeams

ITS Integration

Teams

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Stakeholder /Key Roles

CIO SponsorCompliance TeamHelp Desk Agents/ TrainersProduct TeamGLOCO Medical Device Users, Clinical Staff

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User Enablement: Communication Plan

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Briefing to Stakeholders as approved by CABEnd-users training and help documentation resourcesRoll-out schedule, testing schedule information

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User Enablement : Training Plan

Training Groups

Training Methods

• Service Desk/ Trainers• Management /Compliance

team• Device users/Clinical staff

• Traditional classroom/Web• How-To Videos for external

users• Standard Operating

Procedures

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Financial Metrics

Cost Analysis

Savings Costs

Total Costs of Ownership (1st year) $780,000

FDA Late Penalties Savings $1,000,000

Staff Cost Reduction $195,000

Total Cost-Avoidance $415,000

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Product Demonstration