May 21, 2014

Leveraging UDI Database Requirements to Drive Data Governance

Rene ZoelflBusiness Development Manager Medical Devices

2MEDICAL DEVICES

FDA’s Regulation on Unique Device Identification

21 CFR 830 (UDI

regulation)

Not another FDA submission

process

FDA’s view on a product data

centric enterprise

Founded on the believe that there is only one truth

regarding product data

© 2014 PTC

© 2014 PTCMEDICAL DEVICES

How this journey developed…

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“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 UDIsolution

released (9/2013)

Class I, All

(9/2018)

Congress Mandatesthe unique identification of

medical devices

PTC R&D beginswith the FDA and majordevice manufacturers

FDA UDIproposed ruling

Class III devices (9/2014)

Class II, Other

(9/2016)

FDA UDIruling published (9/2013)

2014-18: Enforcement begins for…

FDA UDI Ruling

Worldwide UDIregulations 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

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Agenda

• 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

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Executive Scorecard for a UDI Submission Solution

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

© 2014 PTCMEDICAL DEVICES

Is there a single and reliable source of audit ready product data today?

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Problem Definition: Market and Regulatory Submissions

Our observation: multiple systems house the 65 data points required by FDA

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

.???.???

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

© 2014 PTCMEDICAL DEVICES

What are the challenging parts?

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• 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

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• 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 PTCMEDICAL DEVICES

Best practices learned from the field

How could the challenges be addressed?

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An approach to start with: UDI Requirements Assessment

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STAY COMPLIANT AND REDUCE THE RISK OF NEGATIVE

AUDIT FINDINGS

Best Practice IData 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 I T M AT T E R S

W H AT I T M E A N S

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• 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 IICentralize Product and Regulatory Data

Improve Efficiency and Reduce Risk with a single source of truth for product and regulatory

data

W H Y I T M AT T E R S

W H AT I T M E A N S

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HELP ENSURE COMPLIANCETO PROTECT FROM RISK

Best Practice IIIRegulatory 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 I T M AT T E R S

W H AT I T M E A N S

© 2014 PTCMEDICAL DEVICES

How did PTC reflect those best practices?

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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…

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Revision control and data stewardship

5.0

PTC’s Unique Device Identification Solution

► Process Overview

Collection of Data Collection of Data

Review & Approvalse-signature

Review & Approvalse-signature

StartStart

Creation Creation

FDA SubmissionFDA Submission

EndEnd

Ongoing Change & Configuration MgmtOngoing Change & Configuration Mgmt

Regulatory Affairs

2.0

3.0

4.0

1.0

5.0

PLMSystems

ERPSystems

Home Grown

Systems

MDMSystems

Doc & LabelingSystems

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 editsto 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

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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

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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

& UseSupport & 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

RequirementsDesign Inputs

Risk & Hazards Failure ModesDesign ValidationDesign ReviewsRegulatory submissionsMaterial Compliance

CAPANonconformanceManufacturing Process PlansManufacturing Instructions

CAPAComplaints

CAPAComplaintsService Issues

FDA Market Approval

Enable streamlined data governance over the entire product life cycle

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Summary

Corner Stones for a product data centric UDI implementation

• 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