integware medical devices, plm, and the fda
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Graciella BeyersDirector of PLM
May 2013
Medical Devices, PLM, and the FDA
2Integware, Inc. Confidential. © 2013. All Rights Reserved.
Quick EXERCISE
3
Topics
Transforming Medical Device Companies with PLM
Case Examples
Aras PLM for Medical Devices
Integware, Inc. Confidential.© 2013. All Rights Reserved.
Life Sciences Customers
4
Integware, Inc. Confidential.© 2013. All Rights Reserved.
How do you see the World?
Business Dimension
Product Development Dimension
Quality Management System Dimension
Technology/Research Management Dimension
5Integware, Inc. Confidential.© 2013. All Rights Reserved.
Prod
uct L
ifecy
cle
Dim
ensi
ons
Med
ical
Dev
ice
Com
pani
es
Enterprise Product Lifecycle – Backbone
Concept
Design Controls
Prototype
Production
Sell
Service & Quality Issues
Phase out & Disposal
PLM
It’s just like the human body!
ERP
MES
PLM
Business Intelligence
CRM
Business Intelligence
PLM
CRM
MESERP
ManagementPortfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
ResearchMarket Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
DevelopmentDesign Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
ProductionDevice History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
QualityCAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
PLM Maturity
ManagementPortfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
ResearchMarket Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
DevelopmentDesign Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
ProductionDevice History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
QualityCAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
CAPA
Management Review
Device Master Record
Complaints and eMDR
Quality Documents
10
FDA Heat!!!
Integware, Inc. Confidential.© 2013. All Rights Reserved.
IDNumber of Citations
% of Total Subsystem Ideal Solution
1 453 12% Design Controls PLM2 402 11% Complaints PLM3 378 10% Corrective and Preventive Action [CAPA] PLM4 215 6% Purchasing Controls PLM + ERP5 191 5% Production and Process Controls PLM + ERP +MES
6 189 5%Receiving, in-process, and finished device acceptance PLM
7 167 5% Management Controls PLM + BI8 166 5% Non-Conforming Products PLM9 163 4% Quality Audit PLM
10 153 4% Process Validation PLM
ManagementPortfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
ResearchMarket Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
DevelopmentDesign Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
ProductionDevice History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
QualityCAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
Device Master RecordBill of Materials
Product Documents Change Control
ERP Integration
Management Review Verification and Validation
Design History File (Docs)
Project Management
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
99% improvement in time to generate
Routers
Supplier Quality
Quality Documents
Process Validation
Design Planning
Requirements
Specifications
Regulatory Documents
56% improvement in on-time periodic reviews – ease of reporting
48% reduction in volume of COs75% reduction in CO creation time 41% reduction in time to process a change
75% reduction in validation documents processing time
Mature PLM Scenario
Verification and Validation
Supplier Quality
CAPA
Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
Mature PLM Scenario
Verification and Validation
Supplier Quality
CAPA
Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
Customer Calls with a Complaint
Product is failing unexpectedly
The PLM’s analytics tool automatically identifies a trend
Mature PLM Scenario
Verification and Validation
Supplier Quality
CAPA Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
The system sends an alert to a quality analyst on her mobile device
She opens a CAPA - (CAPA is a quality process used to overcome or prevent serious problems)
Mature PLM Scenario
Verification and Validation
Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk ManagementA root cause investigation implicates supplier inconsistencies
A critical parameter had been assumed to be consistent between suppliers
The PLM tool easily illustrates this gap due to advanced traceability
The system helps the user link together the relevant information
The system also helps identify which suppliers are qualified
CAPA
Supplier Quality
Mature PLM Scenario
Verification and Validation Supplier Quality
Complaints Management
Bill of Materials
ERP Integration
Change Control
The PLM tool reveals the complaint code indicates a new type of failure mode that was missed in the original risk analysis
The CAPA is used as a central hub to manage the information
CAPA
Risk Management
Mature PLM Scenario
Verification and Validation Supplier Quality
Complaints Management
ERP Integration
Change Control
The control plan NOW includes reviewing critical parameters of the part during incoming inspection
CAPA
Risk Management
Bill of Materials
Mature PLM Scenario
Verification and Validation
ERP Integration
A change is invoked and evaluated to update incoming inspection procedures
The change impact tool in PLM looks across affected data to determine the risk of change and appropriate actions
Supplier Quality
Complaints Management
CAPA
Bill of Materials
Risk Management
Change Control
Mature PLM Scenario
The change is tested and validated and pushed to production
Supplier Quality
Complaints Management
CAPA
Bill of Materials
Risk Management
Change Control
Verification and Validation
ERP Integration
20
PLM Maturity Model ® 2013r2 Interfaces Grid - Draft
Integware, Inc. Confidential.© 2013. All Rights Reserved.
Production RecordProduct Information File
Design History File (Approximate)
Product Lifecycle Maturity Model® Chronology
21Integware, Inc. Confidential. © 2013. All Rights Reserved.
Portfolio Management
Research
Market Analysis
Personnel Training
Design Planning
Requirements Product Design
Verification and Validation
Regulatory Approval
Supplier Quality
Retirement
ServiceComplaints
CAD Design
RATE O
F C
HA
NG
E
Design TransferERP IntegrationResource Planning
Ideation Changes(Recorded to DHF)
Process Design
Packaging &Labeling
Production
Extreme Innovation Occurs EarlyMinimum control needed or desired
Best “Right to Market” Opportunities75% Product Cost Determined Here
Risk Management File
Quality Issues
Risk Planning Risk Analysisand Control
Risk Re-evaluation
SafetyChange
New Product Lifecycle
Promotion
RiskEvaluation
Release
Disciplined Innovation Occurs HereControlled Changes
Sustaining Changes – Very Tightly Controlled
ImpactAssessed
Riskier Changes
Trending and Analytics
EarlyConceptualization
Integware Enterprise “System of Record” Recommendation (R=System of Record, A=System of Access)Medical Device Process FDA QSR ISO 13485: 2003 PLM ERP MES CRM BI
Quality Manual All All (4.2.2) RDocument Control 820.25(b), 820.40 4.2.3 R A
Control of Records 820.180, 820.186 4.2.4R
(Part)R
(Part)
Management Review & Responsibility 820.5, 820.20, 820.25(b), 820.2504.1, 5.1, 5.2, 5.3, 5.4.1, 5.4.2, 5.5, 5.6, 6.1, 6.3, 6.4, 8.1, 8.4
R
Training 820.25 6.2 R APreventive Maintenance 820.70(g) 6.3 RContract Review 820.25(b) 7.2 R
Design Control, Risk Management 820.25(b) & (b)(2), 820.30, 820.72 (use) 7.1, 7.2.1, 7.3 (See also ISO 14971:2007) R A
Purchasing & Supplier Control 820.25(b), 820.50 7.4
R (Part)/
A (Part)
R (Part)/
A (Part)
A
Receiving
820.25(b), 820.60, 820.65, 820.70, 820.72 (use), 820.75, 820.80, 820.86, 820.90, 820.120, 820.140, 820.150, 820.180(b), 820.250
6.4, 7.1, 7.4.3, 7.5.1.1, 7.5.1.3, 7.5.3, 7.5.4, 7.5.5, 8.2.3, 8.2.4, 8.3
R
Receiving Inspection
820.25(b), 820.60, 820.65, 820.70, 820.72 (use), 820.75, 820.80, 820.86, 820.90, 820.120, 820.140, 820.150, 820.180(b), 820.250
6.4, 7.1, 7.4.3, 7.5.1.1, 7.5.1.3, 7.5.3, 7.5.4, 7.5.5, 8.2.3, 8.2.4, 8.3
R
Manufacturing, Kitting, Product Release, Production Control, Process Control, Quality Planning, DHRs
820.25(b), 820.60, 820.65, 820.70, 802.72 (use), 820.75, 820.80(c), (d), (e), 820.86, 820.90, 820.120, 820.130, 820.140, 820.150, 820.180(b), 820.184, 820.250
5.4.2, 6.4, 7.1, 7.5.1.1, 7.5.3, 7.5.4, 7.5.5, 8.2.3, 8.2.4, 8.3
A R
Labeling (product, material, marketing literature) 820.40, 820.120 7.5.1.1 g R A
Shipping 820.130, 820.140, 820.150, 820.160 7.5.5 RCalibration 820.72, 820.25(b), 820.180(b) 7.6 R ?Complaints, MDRCorrections & RemovalsHeath Hazard Evaluation
803/804, 820.25(b), 820.100, 820.180(b), 820.198, 820.250 8.2.1, 8.5.1
R (Part) A A R
(Part) A
Device Master Record 820.181 8.2.1 R A AInternal Auditing 820.22, 820.25(b), 820.180(b) 8.2.2 R ANonconforming Product 820.60, 820.86, 820.90 8.3 R A ? ACorrective and Preventive Action 820.100, 820.250 8.4, 8.5 R A
ManagementPortfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
ResearchMarket Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
DevelopmentDesign Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
ProductionDevice History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
QualityCAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
PLM Maturity
ManagementPortfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
ResearchMarket Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
DevelopmentDesign Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
ProductionDevice History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
QualityCAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
Potential for Aras These are things that are getting us excited
Open platform
Advanced reporting
Better fundamental building blocks
Services
Product
Full business process flows