Medical OEMs Can Achieve Commercial Manufacturing Efficiency

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Medical OEMs Can Achieve Commercial Manufacturing Efficiency

Medical device manufacturers struggle to achieve the efficiency of high volume commercial manufacturers while adhering to stringent regulatory quality and traceability requirements. This presentation will demonstrate how to implement an automated manufacturing process control system that meets and surpasses ISO 13485 and FDA requirements in a lean manufacturing environment. With limited modifications to commercially available software, manufacturers can recognize benefits including: expedited new product introduction (NPI); reduced production costs; improved operating efficiency; and increased quality & traceability.

Presenter: Luis Alvarez, Vice President of OperationsDTx Inc.

Responsible for overseeing and managing all operations, production, manufacturing engineering, and product introduction activities. Luis holds a Bachelor of Science degree in Electrical Engineering from Florida Institute of Technology and a Master in Business Administration degree from Centenary College.

In 2005, Luis Alvarez lead the implementation of DTx’s proprietary Production Control and Traceability Software (PCTS) program in support of DTx’s award of ISO 13485 in 2007. DTx is an Original Design Manufacturer (ODM) specializing in the unique needs of Medical device manufacturers.

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Our History & the “Change Catalyst”

• 2004 Hurricane Season

• DTx Started To Develop The Manufacturing Execution System (MES) In September 2004

• Implementation Of Lean Manufacturing

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Challenges Faced

• Regulatory

• ISO 13485

• FDA

• Quality (Best In Class)

• Cost

• Life Cycle Management

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Achieve the speed of the commercial

manufacturing world but meet the regulatory

requirements of the medical device industry.

The Goal

…all with Minimal Capital Investment.

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Benefits of Meeting Goal

• Expedited New Product Introduction (NPI)

• Reduced Production Costs

• Improved Operating Efficiency

• Increased Quality

• Implemented Real Time Data Collection

• Achieved Comprehensive Traceability

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Tools Used

• C Programming Language

• National Instruments CVI GUI interface

• SQL Database Management

• Demand Flow Technology

• “The Goal: A Process Of Ongoing Improvement” (Dr. Eliyahu M. Goldratt)

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Results: Cell Based Lean Manufacturing Facility

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Assembler 2Install 2nd Set of

Components; Power Up Units; Quality Control

Assembler 1Install First

Components

Assembler 2QC Installation

of First Component

Assembler 1Verify Quality

of Parts at Installation

TechnicianQC Assembly

Work, Test Unit, Burn-In

QualityFinal QC

Unit

Two Person Cell

Operation

Results: Quality Control

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Results: MES Software

Manufacturing Executing

System

(MES)

Manufacturing Execution

System

(MES)

SQL:Database &

Data on Demand

(DoD)

FunctionalTest

Automation

ProductMonitoring

Board

Enterprise Resource Planning

(ERP)

Product Control

Tracking System (PCTS)

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MES Modules: SQL Database / Data-on-Demand (DoD)

• Utilizes Data From PCTS & Test Automation To Generate Reports

• Updates Product Monitoring Board

• Provides Real Time Communication & Information To Engineering, Suppliers, And Customers

Product Control

Tracking System (PCTS)

Manufacturing Execution System

(MES)

SQL:Database

&DoD

FunctionalTest

Automation

ProductMonitoring

Board

Enterprise Resource Planning

(ERP)

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MES Modules: Data-on-Demand (DoD)

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MES Modules: Enterprise Resource Planning (ERP)

• Provides Automatic Links To PCTS And Data Collection

• Facilitates Real Time Planning On Production Floor

• Enables Company Wide Visualization Of Inventory Moves.

Product Control

Tracking System (PCTS)

Manufacturing Execution System

(MES)

SQL:Database &

Data on Demand(DoD)

FunctionalTest

Automation

ProductMonitoring

Board

ERPERP

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MES Modules: Product Control Tracking System (PCTS)

• Enables Lean Manufacturing Process

• Interfaces with Company ERP System for Material Flow Management & Scheduling.

• Serial No. Mapped to: Product Assembly Requirements, BOM, Part No., Operator, Assembly Instructions, Test Requirements, & Customer Order.

Product Product Control Control

Tracking Tracking System System (PCTS)(PCTS)

Manufacturing Executing System

(MES)

SQL:Database &

Data on Demand(DoD)

FunctionalTest

Automation

ProductMonitoring

Board

Enterprise Resource Planning

(ERP)

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MES Software: PCTS

• PCTS Tracks:

Assembly Times

Yields

Component By Serial And Part Number, Assembler, And Dates

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• Electronic Router & Traceability Process For Each Product Created

• Develops Sequence Of Assembly Events, Quality Checks & Requirements For Product Build

MES Software: PCTS

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1

4

2 3

5 6

9

8

10

7

1

4

2 3

5 6

9

8

10

7

1

4

2 3

5 6

9

8

10

7

1

4

2 3

5 6

9

8

10

7

• Each Products Sequence Of Events & Scanning Requirements Configured

• Expedites New Product Introduction Process & Engineering Development Documentation

MES Software: PCTS

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• Work Instructions Customized To Each Product Specifications

• Linked To Product Control Tracking System Software

• Links ERP System, Parts Control, And Process Control

MES: Paperless Work Instructions

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• Quality Checks TQCS, Verification

Process Also Traced

• Quality Steps Included In Traceability Process & Electronic Router To Comply With En ISO 13485:2003 Quality Requirements

MES Software: PCTS

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• Automatically Verifies BOM Accuracy, And Serial No. Digit Sequence Per Supplier

• Component Matches The Product BOM & Alerts User

• Controls Revision & Configuration Of Products

MES Software: PCTS

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• Flexible Configuration

• Work Order Links Automatically To Configuration Table And Instruction

• Reduces Engineering Time And Improves Accuracy Of Documentation Process

MES Software: PCTS

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MES Software: PCTS

• Tracks Cycle Time & Takt

• Monitors & Reduces Labor Costs

• Promotes Accuracy & Quality

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MES Modules: Functional Test Automation

• Fully Automated & Simulates Test Equipment Automation

• Interfaces With Company Developed Software & Off-The-Shelf Product Test Software

• Linked To Customer & Product Requirements

• 100% Verification Of Product Functionality, SW/FW Updates, & Subassembly Performance

Product Control

Tracking System (PCTS)

Manufacturing Execution System

(MES)

SQL:Database &

Data on Demand(DoD)

FunctionalFunctionalTestTest

AutomationAutomation

ProductMonitoring

Board

Enterprise Resource Planning

(ERP)

• Generates First Pass Yields And Failure Analysis Reports

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• Device History Includes Test Results & Component Traceability At Every Change

• 100% Traceability Of Operations, Time & Assembly Cell Stations

• Tracks Test Times & First Pass Yields

• Controls Quality & Reliability Without Added Overhead

MES Modules: Functional Test Automation

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• Tests Up To 30 Units Per Cell Concurrently

• Identities Test Time Pass Under Test Fail Factory Test

• All Stations Backed Up With UPS, & Standardized Equipment & Software

• Significantly Reduces Labor Cost

MES Modules: Functional Test Automation

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• Real Time Monitoring Of Product Performance & Process Control

• Main Control Test Board Identifier Status For Each Unit Green – Pass

Yellow – Testing

Red – Fail

MES Modules: Functional Test Automation

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• Remote Monitoring & Troubleshooting Of Product

• Monitors Cell Location & Operator

• Utilized By Repair Techs, Field Techs, And Customers.

• Reduces Repair Tech Time.

MES Modules: Functional Test Automation

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MES Modules: Functional Test Automation

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MES Modules: Product Monitoring Board

• Tracks All Assembly, Test, QC, Pack Steps And Fail/Pass Criteria Results

• Generates Automated Online Reports

• Also Tracks Time And Flow In The Production Floor

• Data Displayed At Any Station To Communicate Planning To Sales And Customers And As Needed

Product Control

Tracking System (PCTS)

Manufacturing Execution System

(MES)

SQL:Database &

Data on Demand(DoD)

FunctionalTest

Automation

ProductProductMonitoringMonitoring

BoardBoard

Enterprise Resource Planning

(ERP)

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• Monitors Each Work Order for Fast & Accurate Progress Status Information

• Updates Every 1 Minute

• Real time process control and performance communication

MES Modules: Product Monitoring Board

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Results

• Increased Capacity By 500% (Throughput)

• Improved Inventory Turns From 3 To 16 (Investment)

• Reduced Product Cycle Time By 40%. (Throughput)

• Improved On Time Delivery 98% (Throughput)

• Reduce Labor Requirements More Than 70% In Technical Labor (Investment)

• Establish Real Time Product Tracking Communication With Customer (Quality)

• Real Time Process Control Linked To Material Planning, Complete Understanding Of Material Flow (Quality)

• Quality Return Rate Less Than 0.39% (Quality)

• Improved First Pass Yields, Implemented Real Time Product Test Quality Monitoring (Quality)

• Reduce New Product Introduction (NPI) Time