Independent Software Vendors Practice€¦ · §Consulting §ERP §Middleware §Content Management Consulting Active Product Support §End of Life (EOL) §Globalized Life Cycle Services

Practice HCL Medical Device

Concept to Market Transformation Partner

Reliance - HCL works with 7 of the top 10 global medical device OEM’s

One stop shop – HCL has end-to-end capability – from Concept, Design, Analysis, Prototyping, Testing to Manufacturing

Experience – HCL believes in experience over expertise and has case-studies to show for areas where it wants to engage in

Flexibility – Various business/operating models to choose from

Quality - HCL Medical Quality Management System (MQMS) certified as per ISO 13485-2003 as well as ISO 14971 risk management standards

Compliance - Successfully audited multiple times in our development centers for CSV and 21CFR Part 11 compliance expertise strengthened by Regulatory Affairs Certified (RAC) Consultants

Proven Product Development Process - As per US-FDA as well as MDD

Successful launch of products (510K and IDE)

Tested & verified component & vendor base

Why should you partner with us?

?The largest Medical Device Practice in Indian Outsourcers?19 out of top 40 Global Medical Device OEM are HCL

customers?Quality & Innovation DNA

Mic

ro -

Ver

tical

s

ecitcarP erachtlaeH & secneicS eifL

Pharmaceutical

Clinical Research Organizations

Healthcare

Providers

Payers

Independent Software Vendors

Medical Device Companies

Talk to [email protected]

Hello there. I am from HCL Technologies. We work behind the scenes, helping our customers to shift paradigms and start revolutions. We use digital engineering to build superhuman capabilities. We make sure that the rate of progress far exceeds the price. And right now, 55,000 of us bright sparks are busy developing solutions for 500 customers in 18 countries across the world.

HOW CAN I HELP YOU? www.hcltech.com

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©Increased focus on reducing cost and time to market while mentioning the innovation and quality edge

©Developing low cost products to penetrate fast growing developing markets like India©Medical Devices companies are now increasingly looking at outsourcing to kick-start

Innovation©Business Partners are emerging as the #1 source of Innovation©Dis-connected devices which functioned in isolation to internetworked devices. Integration

using techniques like unified medical devices bus is becoming a common theme.©Smart devices coming in the market.©From being used by only a smaller section of the society to a larger populace – this is being

driven by lower prices, more consumer friendly interfaces and device companies launching newer and more innovative products.

©From being pre-dominantly being present in hospitals to being ubiquitous i.e being more a part of peoples regular life in homes, while at work etc.

HCL can reduce the time and cost to market by 50% while kick-starting the innovating program

Medical Device Industry Challenges

The Medical Device industry is at an interesting and exciting juncture in it’s history of evolution. Some of the changes we are seeing are -

HCL Medical Device Practice – A Pioneer & Leader

HCL is a recognized leader in the medical device outsourcing space, providing fast and cost effective end-to-end solutions across a variety of Class 1, 2 and 3 devices, across embedded, hardware, software, manufacturing, sales and marketing , regulatory compliance, product risk management, etc.

Being an organization with significant product engineering strength, we can participate right from the requirements definition to the end, or in any specific stage of the product lifecycle.Worldwide, we are one of the few vendors to offer end-to-end services for medical devices.

Our partnership with Celestica enables us to deliver end-to-end solutions in the Medical Devices area adding further value to our clients. Therefore, a combination of world-class experience, customer-centric processes and best practices, allows us to deliver high-quality solutions to our clients "on time and in budget".

“ To be an enabler in enriching the quality of patient lives through innovative technology solutions”

HCL Medical Device Practice Credo

HCL Medical Device Practice

Concept, Design , Prototype & Validation

Manufacturing IT Sales & Marketing Enterprise ITObsolescence

Mgmt. & Legacy

§Concept /Idea Generation

§Design & Develop.?Architecture?HW?SW?Imaging?Prototyping?I V & V?System Bring Up

§NPI / Implementation / Manufacturing

§Clinical Trial Management

§Clinical Data Management

§Data Analysis

§Factory Solutions§Enterprise Solutions§Automation

Solutions§Consulting§PDM/PLM

§Marketing Management

§Sales Force Management

§Sales Support Solutions

§Consulting

§ERP§Middleware§Content

Management§Consulting

§Active Product Support

§End of Life (EOL)§Globalized Life Cycle

Services§Compliance - RoHS

Design & Blueprint

Implementation & Rollout

Application Deve.& Management

Application Support & Enhancement

ConsolidationHL7

bas

ed Int

egra

tion

: UM

DB

Embedded RFID

Inventory Management Patient Management Disposables Authentication & Configuration

Reg

ulat

ory

§CGMP §GCP§GLP§GHTF§DHF/TCF/DMR§503(g)(1) §21 CFR Part

210,211,820

§21 CFR Part 812 : IDE

§Clinical Literature Review

§cGMP§Hazard Analysis §Critical Control

Point System §21 CFR Part

210,211,820§E-pedigree

§21 CFR 50, 54, 56, 312, 314,

§510 (k) §21 CFR Part 814:

PMA§Post Marketing

Surveillance§Adverse Event

Reporting

HCL Medical Device Outsourcing Service Offerings

Clinical

Concept to Market Services

©Largest Dedicated Medical Devices practice in Indian Outsourcers©Proven track record: Works with 7 out of the Top 10 global device OEM’s©First Indian service provider to be ISO 13485 certified©HCL Medical Quality Management System (MQMS) complies to ISO 13485 ©HCL compliance Lab is certified for ISO 17025©19 Top Medical Device customers©HCL has worked on 80+ Medical Devices

What makes us the leader and pioneer?

§Blood Glucose Meter§Sterilization System§Disinfection System§Sedation Delivery System§Nerve stimulator§Dialysis Equipment§Infusion System§Blood chemistry Analyzer

§Patient Monitoring System§Ablation and Sensing Unit§MEMS – Imp. Pressure Sensor§Diabetes Management S/W§Implantable Drug Delivery system§Computer Radiography System.§X-Ray cartridge readers§X-Ray Systems§ICD

§Breast Biopsy System§Catheter Connecter§Needle Holder§Orthopedic implants§Catheters§Surgical Disposables§Cardiovascular implants§Laparoscopic Device …and many more

Selected Medical Devices HCL has worked on...

Innovating “care” since 2000

* To be achieved in 6 months

SEI - CMM Level 4, ISO - 9000, ISO - 13485, BS 7799, ISO 20000, ISO - 14971

21 CFR Part 11, 21 CFR Part 820, SW:68/ IEC 620304*, IEC - 60601 - 1- 2- 3 - 4

HL - 7, HIMSS, DICOM, CDISC, ACDM, SCDM, WBF, OPC

According to risk profile - Class 1, 2, & 3

CrosSView (Computer System Validation), ELM & PAT

Oracle Clinical, GVK Bio (CRO), FAST Search, Day Software, Visiprise (MES), Human Factors International

776 + strong team of domain and technical consultants

Leading Industry Standards

Process Compliance

Classes of Devices

Solution Accelerators

Best in Breed Partnerships

Strength in Numbers

Key Clientele

Quality DNA

7 out of the top 10 global medical devices companies

21 CFR Part 11

©Increased focus on reducing cost and time to market while mentioning the innovation and quality edge

©Developing low cost products to penetrate fast growing developing markets like India©Medical Devices companies are now increasingly looking at outsourcing to kick-start

Innovation©Business Partners are emerging as the #1 source of Innovation©Dis-connected devices which functioned in isolation to internetworked devices. Integration

using techniques like unified medical devices bus is becoming a common theme.©Smart devices coming in the market.©From being used by only a smaller section of the society to a larger populace – this is being

driven by lower prices, more consumer friendly interfaces and device companies launching newer and more innovative products.

©From being pre-dominantly being present in hospitals to being ubiquitous i.e being more a part of peoples regular life in homes, while at work etc.

HCL can reduce the time and cost to market by 50% while kick-starting the innovating program

Medical Device Industry Challenges

The Medical Device industry is at an interesting and exciting juncture in it’s history of evolution. Some of the changes we are seeing are -

HCL Medical Device Practice – A Pioneer & Leader

HCL is a recognized leader in the medical device outsourcing space, providing fast and cost effective end-to-end solutions across a variety of Class 1, 2 and 3 devices, across embedded, hardware, software, manufacturing, sales and marketing , regulatory compliance, product risk management, etc.

Being an organization with significant product engineering strength, we can participate right from the requirements definition to the end, or in any specific stage of the product lifecycle.Worldwide, we are one of the few vendors to offer end-to-end services for medical devices.

Our partnership with Celestica enables us to deliver end-to-end solutions in the Medical Devices area adding further value to our clients. Therefore, a combination of world-class experience, customer-centric processes and best practices, allows us to deliver high-quality solutions to our clients "on time and in budget".

“ To be an enabler in enriching the quality of patient lives through innovative technology solutions”

HCL Medical Device Practice Credo




Mgmt. & Legacy

§Concept /Idea Generation

§Design & Develop.?Architecture?HW?SW?Imaging?Prototyping?I V & V?System Bring Up

§NPI / Implementation / Manufacturing

§Clinical Trial Management

§Clinical Data Management

§Data Analysis

§Factory Solutions§Enterprise Solutions§Automation

Solutions§Consulting§PDM/PLM

§Marketing Management

§Sales Force Management

§Sales Support Solutions

§Consulting

§ERP§Middleware§Content

Management§Consulting

§Active Product Support

§End of Life (EOL)§Globalized Life Cycle

Services§Compliance - RoHS

Design & Blueprint

Implementation & Rollout

Application Deve.& Management

Application Support & Enhancement

ConsolidationHL7

bas

ed Int

egra

tion

: UM

DB

Embedded RFID

Inventory Management Patient Management Disposables Authentication & Configuration

Reg

ulat

ory

§CGMP §GCP§GLP§GHTF§DHF/TCF/DMR§503(g)(1) §21 CFR Part

210,211,820

§21 CFR Part 812 : IDE

§Clinical Literature Review

§cGMP§Hazard Analysis §Critical Control

Point System §21 CFR Part

210,211,820§E-pedigree

§21 CFR 50, 54, 56, 312, 314,

§510 (k) §21 CFR Part 814:

PMA§Post Marketing

Surveillance§Adverse Event

Reporting

HCL Medical Device Outsourcing Service Offerings

Clinical

Concept to Market Services

©Largest Dedicated Medical Devices practice in Indian Outsourcers©Proven track record: Works with 7 out of the Top 10 global device OEM’s©First Indian service provider to be ISO 13485 certified©HCL Medical Quality Management System (MQMS) complies to ISO 13485 ©HCL compliance Lab is certified for ISO 17025©19 Top Medical Device customers©HCL has worked on 80+ Medical Devices

What makes us the leader and pioneer?

§Blood Glucose Meter§Sterilization System§Disinfection System§Sedation Delivery System§Nerve stimulator§Dialysis Equipment§Infusion System§Blood chemistry Analyzer

§Patient Monitoring System§Ablation and Sensing Unit§MEMS – Imp. Pressure Sensor§Diabetes Management S/W§Implantable Drug Delivery system§Computer Radiography System.§X-Ray cartridge readers§X-Ray Systems§ICD

§Breast Biopsy System§Catheter Connecter§Needle Holder§Orthopedic implants§Catheters§Surgical Disposables§Cardiovascular implants§Laparoscopic Device …and many more

Selected Medical Devices HCL has worked on...

Innovating “care” since 2000

* To be achieved in 6 months

SEI - CMM Level 4, ISO - 9000, ISO - 13485, BS 7799, ISO 20000, ISO - 14971

21 CFR Part 11, 21 CFR Part 820, SW:68/ IEC 620304*, IEC - 60601 - 1- 2- 3 - 4

HL - 7, HIMSS, DICOM, CDISC, ACDM, SCDM, WBF, OPC

According to risk profile - Class 1, 2, & 3

CrosSView (Computer System Validation), ELM & PAT

Oracle Clinical, GVK Bio (CRO), FAST Search, Day Software, Visiprise (MES), Human Factors International

776 + strong team of domain and technical consultants

Leading Industry Standards

Process Compliance

Classes of Devices

Solution Accelerators

Best in Breed Partnerships

Strength in Numbers

Key Clientele

Quality DNA

7 out of the top 10 global medical devices companies

21 CFR Part 11

Client: Leader in manufacturing Implantable drug delivery systems targeted for patients suffering from Cancer / Chronic pains.

AREA OFENGAGEMENT

Product re-engineering to come out with a new product based on a modular design, which allows easier future enhancements to the product

BUSINESS PROBLEM

Client’s existing Implantable pain relief system, is a non-programmable mechanical system. The client’s business requirement was to come out with a completely programmable pain relief system with new technology using new components and based on a modular design, which allows easier future enhancements to the product

©Feasibility, Prototyping and Product development phases for the H/W and S/W Development

©Development of complete Electrical and S/W for the Implantable pump and Hand held unit

©S/W development including: Application S/W, Diagnostics, Calibration, Boot loader, PC based protocol simulator, Image down load software and MMI simulator

©Requirements Specification & High level design for Electrical and Software

©Electrical and S/W implementation & verification

©FMEA, SHA analysis and Traceability©Support customer during Validation

testing©Development Process Conforming to

FDA guidelines ©Design Compliant to IEC60601-1-4

SOLUTION CHALLENGES

©Extremely low power consumption requirements

©Driving the complete Implantable device from RF Power

©Long Battery Life ©Battery inrush current constraints©Direct printing support©C o n c u r r e n t H / W a n d S / W

development

Selected Case Study



Mgmt. & LegacyRegulatory Clinical

Concept, Design , Prototype & Validation Offerings

NPIConcept/ Idea Generation

§Market Requirements§User, Market & Tech

Research §Feasibility Studies§Concept Directions§Functional Specs§Feature Benchmarking§Human Factors

Consideration§Mock-Ups§Preliminary Proof of

Concept

Design & Dev

§Architecture Design§H/W Design§S/W Design§Imaging§Mechanical§Electronic Packaging§Full Design Implementation§H/W and S/W integration §Prototyping§IV & V

Implementation Manufacturing

§Design Transfer§PCM Layout, DFX & DMEA§Diagnostics§Compliance Testing§Reliability & Analysis§Mechanical Design, Analysis

& Prototyping§Environment Screening

§Transfer of Technology§In-House Low Volume

Manufacturing§EMS Tie-ups for Medium &

High Vol Mfg.§IQ/OQ/PQ/DQ

§Humidity , Vibration, Leakage, Altitude

§Environmental tests - Hot & Cold cycling, Rain Chamber, Dust Chamber

§EMI/EMC Testing§Electrical Safety

(Pre-Compliance)

Compliance Testing

§FEA – Structural. Dynamic Thermal, CFD

§Reliability Plan & Approach§Reliability Allocation &

Prediction§Design Verification§Functional Hazard Analysis

(FHA)§Fault Tree Analysis (FTA)§FMEA / FMECA§Design , Functional , Process

& Maintenance FMEA§Common Mode Analysis§Cascading Failure & Zonal

Safety Analysis§Maintainability & MSG 3

Analysis§Reliability Estimation from

Failure Data§Warranty Analysis§Reliability Test –ESS & ALT

§Software Verification§Mechanical Verification§Electrical Verification§Systems Verification§Systems Validation§OTS/COTS/Tools§Particular Std Testing

§Patient and Clinical Information

§Compliance -HL7, IHE & DICOM (Networking & Image Retrieval)

§PACS Implementation & Support

§Sheet metal§Plastic Jigs & Fixture§Tool design – plastics, sheet

metal, casting, mould flow analysis

§Jigs/ Fixture design §Tooling support, first article

inspection, component qualification

§Assembly process development

§Soft tooling

§Detailed Mechanical Design§Design of Compo. &

Assembly§Material Selection §Design for Manufa.&

Assembly §Manufa. Drawings§Tolerance analysis

Reliability & AnalysisImaging Prototype Development MechanicalIV & V




Client: Japan based global top 5 Medical and Graphics major

Selected Case Study

AREA OFENGAGEMENT

New Products Introduction- Market focused Computed Radiography (CR) Solution Suite - (X-Ray Suite)

BUSINESS PROBLEM

Develop a Market / Segment focused specific Product Suite

©Product Engineering Services Covering – New Product Development

©Product Functionality Definition ©Software architecture and

implementation©Development of simulators to enable

automated testing of the software ©Software and System validation

SCOPE CHALLENGES

©Collaborative Development effort across multiple stake-holders

RESULT

©Improved Time to Market cycles©Capability to simultaneously work on

two new product development projects

Client: Leading Medical Device Manufacturer

Selected Case Study

AREA OFENGAGEMENT

Validation Testing

BUSINESS PROBLEM

Development of an automated regression suite executed when there is a requirement change or a bug fix or upgrade to the gold database.

SOLUTION RESULT

©Portfolio Study and Gap Analysis.High Level study of the existing Test Processes and Test Environments and understanding of the CPR Applications

©Proof of Concept,A business scenario was identified by client, where they were unable to achieve complete automation using standard industry tools. HCL consultants developed a solution using tools.

©Development of a scalable automated regression pack

©Reverse Knowledge Transfer to the team©Enhanced technical support from

Mercury – A benefit through HCL’s partnership

©Development of Winrunner patches by HCL’s test engineers for unrecognized objects

©Effective resource utilization through ramp-up and ramp-down

©Provided expertise on Winrunner test automation tools

©Product discounts and expertise from Mercury

RESULT

©As per customer’s historical product development data there is a 50 % reduction in time and 30% cost saving achieved.

Increased Speed to Market

Client: Leader in manufacturing Implantable drug delivery systems targeted for patients suffering from Cancer / Chronic pains.

AREA OFENGAGEMENT

Product re-engineering to come out with a new product based on a modular design, which allows easier future enhancements to the product

BUSINESS PROBLEM

Client’s existing Implantable pain relief system, is a non-programmable mechanical system. The client’s business requirement was to come out with a completely programmable pain relief system with new technology using new components and based on a modular design, which allows easier future enhancements to the product

©Feasibility, Prototyping and Product development phases for the H/W and S/W Development

©Development of complete Electrical and S/W for the Implantable pump and Hand held unit

©S/W development including: Application S/W, Diagnostics, Calibration, Boot loader, PC based protocol simulator, Image down load software and MMI simulator

©Requirements Specification & High level design for Electrical and Software

©Electrical and S/W implementation & verification

©FMEA, SHA analysis and Traceability©Support customer during Validation

testing©Development Process Conforming to

FDA guidelines ©Design Compliant to IEC60601-1-4

SOLUTION CHALLENGES

©Extremely low power consumption requirements

©Driving the complete Implantable device from RF Power

©Long Battery Life ©Battery inrush current constraints©Direct printing support©C o n c u r r e n t H / W a n d S / W

development

Selected Case Study




Concept, Design , Prototype & Validation Offerings

NPIConcept/ Idea Generation

§Market Requirements§User, Market & Tech

Research §Feasibility Studies§Concept Directions§Functional Specs§Feature Benchmarking§Human Factors

Consideration§Mock-Ups§Preliminary Proof of

Concept

Design & Dev

§Architecture Design§H/W Design§S/W Design§Imaging§Mechanical§Electronic Packaging§Full Design Implementation§H/W and S/W integration §Prototyping§IV & V

Implementation Manufacturing

§Design Transfer§PCM Layout, DFX & DMEA§Diagnostics§Compliance Testing§Reliability & Analysis§Mechanical Design, Analysis

& Prototyping§Environment Screening

§Transfer of Technology§In-House Low Volume

Manufacturing§EMS Tie-ups for Medium &

High Vol Mfg.§IQ/OQ/PQ/DQ

§Humidity , Vibration, Leakage, Altitude

§Environmental tests - Hot & Cold cycling, Rain Chamber, Dust Chamber

§EMI/EMC Testing§Electrical Safety

(Pre-Compliance)

Compliance Testing

§FEA – Structural. Dynamic Thermal, CFD

§Reliability Plan & Approach§Reliability Allocation &

Prediction§Design Verification§Functional Hazard Analysis

(FHA)§Fault Tree Analysis (FTA)§FMEA / FMECA§Design , Functional , Process

& Maintenance FMEA§Common Mode Analysis§Cascading Failure & Zonal

Safety Analysis§Maintainability & MSG 3

Analysis§Reliability Estimation from

Failure Data§Warranty Analysis§Reliability Test –ESS & ALT

§Software Verification§Mechanical Verification§Electrical Verification§Systems Verification§Systems Validation§OTS/COTS/Tools§Particular Std Testing

§Patient and Clinical Information

§Compliance -HL7, IHE & DICOM (Networking & Image Retrieval)

§PACS Implementation & Support

§Sheet metal§Plastic Jigs & Fixture§Tool design – plastics, sheet

metal, casting, mould flow analysis

§Jigs/ Fixture design §Tooling support, first article

inspection, component qualification

§Assembly process development

§Soft tooling

§Detailed Mechanical Design§Design of Compo. &

Assembly§Material Selection §Design for Manufa.&

Assembly §Manufa. Drawings§Tolerance analysis

Reliability & AnalysisImaging Prototype Development MechanicalIV & V




Client: Japan based global top 5 Medical and Graphics major

Selected Case Study

AREA OFENGAGEMENT

New Products Introduction- Market focused Computed Radiography (CR) Solution Suite - (X-Ray Suite)

BUSINESS PROBLEM

Develop a Market / Segment focused specific Product Suite

©Product Engineering Services Covering – New Product Development

©Product Functionality Definition ©Software architecture and

implementation©Development of simulators to enable

automated testing of the software ©Software and System validation

SCOPE CHALLENGES

©Collaborative Development effort across multiple stake-holders

RESULT

©Improved Time to Market cycles©Capability to simultaneously work on

two new product development projects


Selected Case Study

AREA OFENGAGEMENT

Validation Testing

BUSINESS PROBLEM

Development of an automated regression suite executed when there is a requirement change or a bug fix or upgrade to the gold database.

SOLUTION RESULT

©Portfolio Study and Gap Analysis.High Level study of the existing Test Processes and Test Environments and understanding of the CPR Applications

©Proof of Concept,A business scenario was identified by client, where they were unable to achieve complete automation using standard industry tools. HCL consultants developed a solution using tools.

©Development of a scalable automated regression pack

©Reverse Knowledge Transfer to the team©Enhanced technical support from

Mercury – A benefit through HCL’s partnership

©Development of Winrunner patches by HCL’s test engineers for unrecognized objects

©Effective resource utilization through ramp-up and ramp-down

©Provided expertise on Winrunner test automation tools

©Product discounts and expertise from Mercury

RESULT

©As per customer’s historical product development data there is a 50 % reduction in time and 30% cost saving achieved.

Increased Speed to Market

Clinical Trials Management

§Hosting§Investigators & Site Management§Patient Life Cycle Management§Adverse Event Monitoring &

Management§Clinical Trials Supplies

Management§COTS Implementation§Application development,

maintenance & support§Data Integration

Clinical Data Management

§Hosting §Paper & EDC§CRF Design§Data Management Plan§Database Design & Build§Data Entry§Data Validation Plan§Data Review & Validation§Query Management§Medical Coding§AERS/SAE Reconciliation§Database Lock§Quality Control§Review for Protocol Adherence§Clinical Data Migration§Standards Adoption§Application development,

maintenance & support§COTS implementation/

validation

Data Analysis

§Statistical Analysis Plan§Bio-Statistics§Development of SAS programs §Validation of SAS programs§Statistical Reporting - Safety,

Efficacy and PK§Quality control of statistical

reports

§CTMS – Siebel, Oracle, ClinPhone,Legacy

§CDMS – Oracle, PhaseForward, MediData, ClinPhone, Legacy

§AERS – Oracle, Relsys, ArisGlobal

§Data Analysis - SAS

Client: Global Top 10 Lifesciences Company

Selected Case Study

AREA OFENGAGEMENT

BUSINESS PROBLEM

RESULT

CDMS - Configuration, Customization and Maintenance of data capture screens. Business User Interaction and gathering Requirements from the end user, Deployment of the views and Data Entry Screen to production, UAT for clinical studies.

Complete legacy support for Phase I – III clinical studies helping customer transition to EDC environment

INPUTS

©Protocol Document,CRF, Trial set up specification documents that include tie-breakers, treatments and phasing related information

,SMS/visit design,Allocation schedule header document,Local & Central lab meta data mapping,List of Site/Investigators

©Data entry interfaces ©Standard & Protocol specific database

views©Data validation sheet & Pick list sheet©External Data load capability (central

labs)©Documentation and Validation evidence©Data collector/views tested on CDE

System, DM Application and DTS©Application support (production data).©Reporting & QA/QC©Clinical Data Migration©Data flow from legacy to Janus based

CDR

OUTPUTS

©30% reduction in data management costs©Efficiency gains of 20%©Outsourcing gains of 35%©Independent handling of legacy support

leading customer to focus on strategic transition to EDC

©100% SLA compliance

Client: Top 5 Medical Device Manufacturer

Selected Case Studies

MES implementation

AREA OFENGAGEMENT

SCOPE

BUSINESS PROBLEM

©Implementation of COTS MES©Automation of the execution of

medical devices manufacturing process ©Capture the manufacturing data

electronically ©Integration with the ATE and

store/retrieve test results/steps

©Implemented MES©E l i m i n a t e d t h e p a p e r b a s e d

manufacturing process©Ensured traceability

RESULT

©Ability to view manufacturing and device data from remote location

©Control and simplify business processes©Regulatory compliance©Improved efficiency in operations at

manufacturing sites©Interfacing with ATE systems to collect

device assembly and test data

Increased efficiency with compliance at lower TCO

Factory Solutions

§MES/ FCS§Statistical Process Control§Process Analytical Technology§Dispatching§Regulatory

Enterprise Solutions Automation Solutions Consulting Solutions

§Enterprise to Plant Integration§Partner Integration§PDM / PLM – Design to

Manufacturing§Risk Management§Asset Management

§Equipment to MES Integration§QC tools Integration§Data Acquisition & Reporting

§Plant Performance benchmarking

§Product Selection & Implementation Best Practices

§Migration Frameworks§Manufacturing Informatics



Mgmt. & LegacyRegulatoryClinical

CAPA solution

AREA OFENGAGEMENT

©An Intranet web based solution supporting standard CAPA features such as:nManufacturing plant, Internal Audits, External Audits, Supplier Quality

nExternal Manufacturer, Management Action Plan and Customer complaints.

SOLUTION

©Helped to achieve cGMP compliance

RESULT

Need for a CAPA solution to comply with cGMP requirements

BUSINESS PROBLEM

Client: Fortune 500 Medical Device Manufacturer




HCL Clinical Offerings

Reduction in Clinical Trial & Data Management Costs

HCL Manufacturing & Plant Automation Service Offerings

Packaged Applications

§Camstar Insite

§Brooks Factoryworks

§Visiprise

§AMAT Work Stream

§Flexnet

§FAB 300

§Windchill

§eMatrix

§TeamCenter

§Agile

§SmarTeam

Clinical Trials Management

§Hosting§Investigators & Site Management§Patient Life Cycle Management§Adverse Event Monitoring &

Management§Clinical Trials Supplies

Management§COTS Implementation§Application development,

maintenance & support§Data Integration

Clinical Data Management

§Hosting §Paper & EDC§CRF Design§Data Management Plan§Database Design & Build§Data Entry§Data Validation Plan§Data Review & Validation§Query Management§Medical Coding§AERS/SAE Reconciliation§Database Lock§Quality Control§Review for Protocol Adherence§Clinical Data Migration§Standards Adoption§Application development,

maintenance & support§COTS implementation/

validation

Data Analysis

§Statistical Analysis Plan§Bio-Statistics§Development of SAS programs §Validation of SAS programs§Statistical Reporting - Safety,

Efficacy and PK§Quality control of statistical

reports

§CTMS – Siebel, Oracle, ClinPhone,Legacy

§CDMS – Oracle, PhaseForward, MediData, ClinPhone, Legacy

§AERS – Oracle, Relsys, ArisGlobal

§Data Analysis - SAS

Client: Global Top 10 Lifesciences Company

Selected Case Study

AREA OFENGAGEMENT

BUSINESS PROBLEM

RESULT

CDMS - Configuration, Customization and Maintenance of data capture screens. Business User Interaction and gathering Requirements from the end user, Deployment of the views and Data Entry Screen to production, UAT for clinical studies.

Complete legacy support for Phase I – III clinical studies helping customer transition to EDC environment

INPUTS

©Protocol Document,CRF, Trial set up specification documents that include tie-breakers, treatments and phasing related information

,SMS/visit design,Allocation schedule header document,Local & Central lab meta data mapping,List of Site/Investigators

©Data entry interfaces ©Standard & Protocol specific database

views©Data validation sheet & Pick list sheet©External Data load capability (central

labs)©Documentation and Validation evidence©Data collector/views tested on CDE

System, DM Application and DTS©Application support (production data).©Reporting & QA/QC©Clinical Data Migration©Data flow from legacy to Janus based

CDR

OUTPUTS

©30% reduction in data management costs©Efficiency gains of 20%©Outsourcing gains of 35%©Independent handling of legacy support

leading customer to focus on strategic transition to EDC

©100% SLA compliance

Client: Top 5 Medical Device Manufacturer

Selected Case Studies

MES implementation

AREA OFENGAGEMENT

SCOPE

BUSINESS PROBLEM

©Implementation of COTS MES©Automation of the execution of

medical devices manufacturing process ©Capture the manufacturing data

electronically ©Integration with the ATE and

store/retrieve test results/steps

©Implemented MES©E l i m i n a t e d t h e p a p e r b a s e d

manufacturing process©Ensured traceability

RESULT

©Ability to view manufacturing and device data from remote location

©Control and simplify business processes©Regulatory compliance©Improved efficiency in operations at

manufacturing sites©Interfacing with ATE systems to collect

device assembly and test data

Increased efficiency with compliance at lower TCO

Factory Solutions

§MES/ FCS§Statistical Process Control§Process Analytical Technology§Dispatching§Regulatory

Enterprise Solutions Automation Solutions Consulting Solutions

§Enterprise to Plant Integration§Partner Integration§PDM / PLM – Design to

Manufacturing§Risk Management§Asset Management

§Equipment to MES Integration§QC tools Integration§Data Acquisition & Reporting

§Plant Performance benchmarking

§Product Selection & Implementation Best Practices

§Migration Frameworks§Manufacturing Informatics




CAPA solution

AREA OFENGAGEMENT

©An Intranet web based solution supporting standard CAPA features such as:nManufacturing plant, Internal Audits, External Audits, Supplier Quality

nExternal Manufacturer, Management Action Plan and Customer complaints.

SOLUTION

©Helped to achieve cGMP compliance

RESULT

Need for a CAPA solution to comply with cGMP requirements

BUSINESS PROBLEM

Client: Fortune 500 Medical Device Manufacturer




HCL Clinical Offerings

Reduction in Clinical Trial & Data Management Costs

HCL Manufacturing & Plant Automation Service Offerings


§Camstar Insite

§Brooks Factoryworks

§Visiprise

§AMAT Work Stream

§Flexnet

§FAB 300

§Windchill

§eMatrix

§TeamCenter

§Agile

§SmarTeam




Regulatory Compliance at lower TCO

Selected Case StudyClient: Leading Lifesciences Company

AREA OFENGAGEMENT

BUSINESS PROBLEM

SOLUTION RESULT

Regulatory – Validation Services

©Gap Analysis of Existing Application – 60+

©Application Revalidation - Functionality C o n fo r m a n c e i n t h e n ewe r environment

©Validation Methodology definition

©Work on an onsite-offshore model ( Validation onsite, Migration offshore)

©Perform Scope Study & Gap Analysis – creation of retirement plan of un-used application

©Validation Plan creation©IQ/OQ/PQ Definition©All documents created in Accordance of

the SOP©Successful Migration of application

©Significant reduction of time – 60 Application validated /revalidated and migrated in 8 calendar weeks

©Helping client to discover unused application and retiring them – Significant cost reduction and value add in project portfolio management

©Creation of all required documentation according to 21 CFR PART 11 AND OR 21 CFR 820 (QSR) predicate rules.


AREA OFENGAGEMENT

BUSINESS PROBLEM

SOLUTION RESULT

Equipment Qualification & Process Validation

Validation of the medical device manufacturing process and qualification of the equipment with complete automation.

Equipment Qualification©Helped the client in performing the FAT,

Instal lat ion, SAT and complete qualification of the equipment with Engineering studies by factorial analysis and DoE.

©Effective & Pragmatic validation process established

©Time to market is considerably reduced by the on-site off-shore model opted for this engagement

Validations

§Computer System Validation§Manufacturing process Validation§Design SOP’s, Protocols and

Reports§Quality Manuals, Policies,

Training§Qualification - IQ/OQ/PQ§Prospective / Retrospective /

Concurrent§Validation testing & verification

services§SCADA / DCS / PLC /

Automation systems

Submissions Consultancy

§510 (k)§PMA§IDE (21 CFR Part 812)§503(g)(1) §e-Submissions tools e-CTD.§Labeling – SPL/PIM§Customized solutions to

enhance submission quality

§GxP Compliance (USFDA/TGA/EMEA/JMHA)

§Quality Management Systems§Change management for

effective compliance§Process Consultancy§LIMS / eLNB§CAPA Management Solutions§Facility Management Solutions§Training and Document

Management Solutions

§Vendor Qualification / Third party audits

§GxP compliance audits§Internal Audits/surveillance

audits§CE Audit & Certification§REACH Disclosures

Audits Packaged Applications

§QMAS

§Liquient

§First Docs

§Synagoge – Lean 6s .

§Cambridge Soft – eLNB

§CIMQUEST - LIMS

HCL Regulatory & Compliance ServiceOfferings




Risk Mitigated Rapid Offshore for efficiency & effectiveness gains

ERP

§SAP - mySAP, ABAP, CRM, HCM, Netweaver / ESA

§Oracle Universe - Oracle ebusiness, Siebel, Peoplesoft , JDE Edwards, Fusion, DW / BI

§Microsoft Dynamics – Axapta, MS CRM 3.0

Middleware Content Management Consulting

§SOA driven Integration§EDI§EAI§Tibco§Cisco §AON§Webmethods§Biztalk §Websphere

§Documentum§Filenet§Humming Bird§IBM§Open Text§Microsoft§Vignette§Interwoven§FAST§DAY Software

§Business Transformation – Legal Compliance, CRM, SCM

§Technology Transformation – IT Strategy, Governance, Security & quality

§Application Transformation – Legacy Modernization & Testing

§Data Transformation – MDM, DW/BI

Consulting

§IT Consulting§Information Management /

Metrics§Business Processes

Sales SupportSolutions

Sales Force Management Marketing Management

§Customer Interaction Hub (Contact Centers, Feedback Management Systems, Samples Management systems)

§Customer Contract Management

§Account Management

§Sales Force Planning & Alignment

§Sales Force Automation§Physician Targeting, Profiling &

Detailing§Incentive Compensation

Management System§Territory Management§eLearning & Training

Management

§Marketing Automation (DW/BI, Campaign Management, Customer Lifetime Value, email and online Marketing, etc)

§Brand Management (Physician/ Payor/ Patient)

§Strategic Planning & Control§New Product Launch§Promotional Events§Knowledge Management





§Siebel

§SAP

§Filenet/ Documentum

§Dendrite

§I-many

§Siperian

§Aprimo

§Unica

Reduction in S & M spends by using analytics and permissive marketing

HCL’s Enterprise Service Offerings

HCL Sales & Marketing Service Offerings

Services

§Blue Printing

§Development

§Deployment/ Global rollout

§Upgrades/ Migrations

§Helpdesk Support

§Infrastructure Support

§Application Maintenance




Regulatory Compliance at lower TCO

Selected Case StudyClient: Leading Lifesciences Company

AREA OFENGAGEMENT

BUSINESS PROBLEM

SOLUTION RESULT

Regulatory – Validation Services

©Gap Analysis of Existing Application – 60+

©Application Revalidation - Functionality C o n fo r m a n c e i n t h e n ewe r environment

©Validation Methodology definition

©Work on an onsite-offshore model ( Validation onsite, Migration offshore)

©Perform Scope Study & Gap Analysis – creation of retirement plan of un-used application

©Validation Plan creation©IQ/OQ/PQ Definition©All documents created in Accordance of

the SOP©Successful Migration of application

©Significant reduction of time – 60 Application validated /revalidated and migrated in 8 calendar weeks

©Helping client to discover unused application and retiring them – Significant cost reduction and value add in project portfolio management

©Creation of all required documentation according to 21 CFR PART 11 AND OR 21 CFR 820 (QSR) predicate rules.


AREA OFENGAGEMENT

BUSINESS PROBLEM

SOLUTION RESULT

Equipment Qualification & Process Validation

Validation of the medical device manufacturing process and qualification of the equipment with complete automation.

Equipment Qualification©Helped the client in performing the FAT,

Instal lat ion, SAT and complete qualification of the equipment with Engineering studies by factorial analysis and DoE.

©Effective & Pragmatic validation process established

©Time to market is considerably reduced by the on-site off-shore model opted for this engagement

Validations

§Computer System Validation§Manufacturing process Validation§Design SOP’s, Protocols and

Reports§Quality Manuals, Policies,

Training§Qualification - IQ/OQ/PQ§Prospective / Retrospective /

Concurrent§Validation testing & verification

services§SCADA / DCS / PLC /

Automation systems

Submissions Consultancy

§510 (k)§PMA§IDE (21 CFR Part 812)§503(g)(1) §e-Submissions tools e-CTD.§Labeling – SPL/PIM§Customized solutions to

enhance submission quality

§GxP Compliance (USFDA/TGA/EMEA/JMHA)

§Quality Management Systems§Change management for

effective compliance§Process Consultancy§LIMS / eLNB§CAPA Management Solutions§Facility Management Solutions§Training and Document

Management Solutions

§Vendor Qualification / Third party audits

§GxP compliance audits§Internal Audits/surveillance

audits§CE Audit & Certification§REACH Disclosures

Audits Packaged Applications

§QMAS

§Liquient

§First Docs

§Synagoge – Lean 6s .

§Cambridge Soft – eLNB

§CIMQUEST - LIMS

HCL Regulatory & Compliance ServiceOfferings




Risk Mitigated Rapid Offshore for efficiency & effectiveness gains

ERP

§SAP - mySAP, ABAP, CRM, HCM, Netweaver / ESA

§Oracle Universe - Oracle ebusiness, Siebel, Peoplesoft , JDE Edwards, Fusion, DW / BI

§Microsoft Dynamics – Axapta, MS CRM 3.0

Middleware Content Management Consulting

§SOA driven Integration§EDI§EAI§Tibco§Cisco §AON§Webmethods§Biztalk §Websphere

§Documentum§Filenet§Humming Bird§IBM§Open Text§Microsoft§Vignette§Interwoven§FAST§DAY Software

§Business Transformation – Legal Compliance, CRM, SCM

§Technology Transformation – IT Strategy, Governance, Security & quality

§Application Transformation – Legacy Modernization & Testing

§Data Transformation – MDM, DW/BI

Consulting

§IT Consulting§Information Management /

Metrics§Business Processes

Sales SupportSolutions

Sales Force Management Marketing Management

§Customer Interaction Hub (Contact Centers, Feedback Management Systems, Samples Management systems)

§Customer Contract Management

§Account Management

§Sales Force Planning & Alignment

§Sales Force Automation§Physician Targeting, Profiling &

Detailing§Incentive Compensation

Management System§Territory Management§eLearning & Training

Management

§Marketing Automation (DW/BI, Campaign Management, Customer Lifetime Value, email and online Marketing, etc)

§Brand Management (Physician/ Payor/ Patient)

§Strategic Planning & Control§New Product Launch§Promotional Events§Knowledge Management





§Siebel

§SAP

§Filenet/ Documentum

§Dendrite

§I-many

§Siperian

§Aprimo

§Unica

Reduction in S & M spends by using analytics and permissive marketing

HCL’s Enterprise Service Offerings

HCL Sales & Marketing Service Offerings

Services

§Blue Printing

§Development

§Deployment/ Global rollout

§Upgrades/ Migrations

§Helpdesk Support

§Infrastructure Support

§Application Maintenance

! HCL is the top choice for embedded systems engineering and product development work! HCL offers a range of product development services as part of their wide offshore service lines bouquet! HCL provides the full spectrum of R&D services, for which economy of scale is the prime differentiator! Most of their clients use them for product extension, management, porting, and maintenance as well as for

core product development in select verticals! For companies that want to form a Joint Venture in India...HCL is a Top Choice. It is also a Top Choice for

embedded systems engineering and product development work! HCL has demonstrated capabilities in Lifesciences vertical in:

+Pharma solution providers like HCL Technologies now offer browser-based tools as part of their conversion services to pharma customers. As part of its conversion service, for example, HCL Technologies offers a Web-based tool that copies the look and feel of the EMC/Documentum user interface, but it automatically generates the XML code and tags in the appropriate sections of the SPL schema.

HCL Technologies is ranked as Strong Positive on Technology, R&D and Product Engineering Services

AMR Research

FORRESTER

! HCL has demonstrated capabilities in Lifesciences vertical in:+Plant-level data collection (better than Infosys, Satyam & TCS)+MES/Shop floor Control Systems Development (tied top position with TCS)+Quality Management (including CAPA) (tied top position with Satyam)+Shop floor ERP Integration (HCL has demonstrated capabilities)+Mftg Strategy/Technology Selection (HCL has demonstrated capabilities)+Custom Application development (tied top position with Satyam)

The World is talking about us…

“ Technology collaboration with HCL accelerates our market entry in India; by working with a strategic technology partner, we have been able to leverage our strengths and turn our ideas into action.”

- Surya N. Mohapatra, Ph.D., Chairman and CEO of Quest Diagnostics

"HCL is our key partner for medical devices development. Several of our projects are conducted at their design center located in Chennai, India. For us, India represents much more than those aspects of IT. Today, we rely on our partner for critical, real-time control software, as well as complex hardware design encompassing digital and analog electronics.“

- Al Chopeena, Vice President, Research and Development Worldwide, a Johnson & Johnson company

Johnson & Johnson

A leading provider of high-value diagnostic products and services to the global health care community. For more than half a century, customer has been providing accurate, timely and cost–effective solutions for screening, diagnosing, monitoring and confirming diseases.

Selected Case Study

BUSINESS PROBLEM

AREA OFENGAGEMENT

SOLUTION

To continue with altitude gains in technology, our customer felt the need to reengineer the legacy product for RoHS-compliance

©The device was redesigned for RoHS-compliance , funct ional compatibility and component obsolescence-prevention.

©HCL prepared a Techn ica l description document justifying the selection of components for which direct RoHS compliant replacement parts are not available.

RESULT

©All components are RoHS compliant©Obtained certificate of compliance

from component vendors©Modified mechanical diagrams for

i n c l u d i n g R o H S c o m p l i a n c e requirement

©The customer benefitted from:§Extended PLC §Minimal changes to production requirements




Extending the Maturity Stage of PLC

Active Product Support

§Sustenance§L1/2/3 Technical Support§Field Implementation & Training§Engineering Change

Management§Globalization / Localization§Regulatory Compliance

(RoHS/WEEE)§Tech Pubs

End of Life (EOL)Globalized Life Cycle Services

Compliance (U.S, Europe & China RoHS)

§Re-engineering§Value Engineering§Porting§Migration§Modernization§End-Customer Support

§Strategic long-term Partnership Model

§Focused on enhancing revenues of Product

§Addresses a Global marketplace§Risk-Reward sharing model

§RoHS identification and Analysis§RoHS conversion for the whole

system (redesign)§Reliability Prediction§RoHS timing Sensitivity analysis§Manufacturing / Assembly

process analysis§Cost analysis (Cost analysis

against retention of existing design for replacement with a

Obsolescence Mgmt. & Legacy Offerings

Re-engineering the legacy product for RoHS - Environment compliance

Client:


! HCL is the top choice for embedded systems engineering and product development work! HCL offers a range of product development services as part of their wide offshore service lines bouquet! HCL provides the full spectrum of R&D services, for which economy of scale is the prime differentiator! Most of their clients use them for product extension, management, porting, and maintenance as well as for

core product development in select verticals! For companies that want to form a Joint Venture in India...HCL is a Top Choice. It is also a Top Choice for

embedded systems engineering and product development work! HCL has demonstrated capabilities in Lifesciences vertical in:

+Pharma solution providers like HCL Technologies now offer browser-based tools as part of their conversion services to pharma customers. As part of its conversion service, for example, HCL Technologies offers a Web-based tool that copies the look and feel of the EMC/Documentum user interface, but it automatically generates the XML code and tags in the appropriate sections of the SPL schema.

HCL Technologies is ranked as Strong Positive on Technology, R&D and Product Engineering Services

AMR Research

FORRESTER

! HCL has demonstrated capabilities in Lifesciences vertical in:+Plant-level data collection (better than Infosys, Satyam & TCS)+MES/Shop floor Control Systems Development (tied top position with TCS)+Quality Management (including CAPA) (tied top position with Satyam)+Shop floor ERP Integration (HCL has demonstrated capabilities)+Mftg Strategy/Technology Selection (HCL has demonstrated capabilities)+Custom Application development (tied top position with Satyam)

The World is talking about us…

“ Technology collaboration with HCL accelerates our market entry in India; by working with a strategic technology partner, we have been able to leverage our strengths and turn our ideas into action.”

- Surya N. Mohapatra, Ph.D., Chairman and CEO of Quest Diagnostics

"HCL is our key partner for medical devices development. Several of our projects are conducted at their design center located in Chennai, India. For us, India represents much more than those aspects of IT. Today, we rely on our partner for critical, real-time control software, as well as complex hardware design encompassing digital and analog electronics.“

- Al Chopeena, Vice President, Research and Development Worldwide, a Johnson & Johnson company

Johnson & Johnson

A leading provider of high-value diagnostic products and services to the global health care community. For more than half a century, customer has been providing accurate, timely and cost–effective solutions for screening, diagnosing, monitoring and confirming diseases.

Selected Case Study

BUSINESS PROBLEM

AREA OFENGAGEMENT

SOLUTION

To continue with altitude gains in technology, our customer felt the need to reengineer the legacy product for RoHS-compliance

©The device was redesigned for RoHS-compliance , funct ional compatibility and component obsolescence-prevention.

©HCL prepared a Techn ica l description document justifying the selection of components for which direct RoHS compliant replacement parts are not available.

RESULT

©All components are RoHS compliant©Obtained certificate of compliance

from component vendors©Modified mechanical diagrams for

i n c l u d i n g R o H S c o m p l i a n c e requirement

©The customer benefitted from:§Extended PLC §Minimal changes to production requirements




Extending the Maturity Stage of PLC

Active Product Support

§Sustenance§L1/2/3 Technical Support§Field Implementation & Training§Engineering Change

Management§Globalization / Localization§Regulatory Compliance

(RoHS/WEEE)§Tech Pubs

End of Life (EOL)Globalized Life Cycle Services

Compliance (U.S, Europe & China RoHS)

§Re-engineering§Value Engineering§Porting§Migration§Modernization§End-Customer Support

§Strategic long-term Partnership Model

§Focused on enhancing revenues of Product

§Addresses a Global marketplace§Risk-Reward sharing model

§RoHS identification and Analysis§RoHS conversion for the whole

system (redesign)§Reliability Prediction§RoHS timing Sensitivity analysis§Manufacturing / Assembly

process analysis§Cost analysis (Cost analysis

against retention of existing design for replacement with a

Obsolescence Mgmt. & Legacy Offerings

Re-engineering the legacy product for RoHS - Environment compliance

Client:


Practice HCL Medical Device

Concept to Market Transformation Partner

Reliance - HCL works with 7 of the top 10 global medical device OEM’s

One stop shop – HCL has end-to-end capability – from Concept, Design, Analysis, Prototyping, Testing to Manufacturing

Experience – HCL believes in experience over expertise and has case-studies to show for areas where it wants to engage in

Flexibility – Various business/operating models to choose from

Quality - HCL Medical Quality Management System (MQMS) certified as per ISO 13485-2003 as well as ISO 14971 risk management standards

Compliance - Successfully audited multiple times in our development centers for CSV and 21CFR Part 11 compliance expertise strengthened by Regulatory Affairs Certified (RAC) Consultants

Proven Product Development Process - As per US-FDA as well as MDD

Successful launch of products (510K and IDE)

Tested & verified component & vendor base

Why should you partner with us?

?The largest Medical Device Practice in Indian Outsourcers?19 out of top 40 Global Medical Device OEM are HCL

customers?Quality & Innovation DNA

Mic

ro -

Ver

tical

s

ecitcarP erachtlaeH & secneicS eifL

Pharmaceutical

Clinical Research Organizations

Healthcare

Providers

Payers

Independent Software Vendors

Medical Device Companies

Talk to [email protected]

Hello there. I am from HCL Technologies. We work behind the scenes, helping our customers to shift paradigms and start revolutions. We use digital engineering to build superhuman capabilities. We make sure that the rate of progress far exceeds the price. And right now, 55,000 of us bright sparks are busy developing solutions for 500 customers in 18 countries across the world.

HOW CAN I HELP YOU? www.hcltech.com

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Independent Software Vendors Practice€¦ · §Consulting §ERP §Middleware §Content Management Consulting Active Product Support §End of Life (EOL) §Globalized Life Cycle Services

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