DTx medical OEMs Can Achieve Commercial Mfg Efficiency
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DTx medical OEMs Can Achieve Commercial Mfg Efficiency

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Medical device manufacturers struggle to achieve the efficiency of high volume commercial manufacturers while adhering to stringent regulatory quality and traceability requirements. This presentation ...

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.

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    DTx medical OEMs Can Achieve Commercial Mfg Efficiency DTx medical OEMs Can Achieve Commercial Mfg Efficiency Presentation Transcript

    • Medical OEMs Can Achieve Commercial Manufacturing Efficiency
    • 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 Operations DTx 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. 2
    • Our History & the “Change Catalyst” • 2004 Hurricane Season • DTx Started To Develop The Manufacturing Execution System (MES) In September 2004 • Implementation Of Lean Manufacturing 3
    • Challenges Faced • Regulatory • ISO 13485 • FDA • Quality (Best In Class) • Cost • Life Cycle Management 4
    • The Goal Achieve the speed of the commercial manufacturing world but meet the regulatory requirements of the medical device industry. …all with Minimal Capital Investment. 5
    • 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 6
    • 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) 7
    • Results: Cell Based Lean Manufacturing Facility 8
    • Results: Quality Control Assembler 1 Install First Components Assembler 1 Two Person Assembler 2 Technician Quality Install 2nd Set of Verify Quality Cell Components; QC Assembly Final QC of Parts at Power Up Units; Work, Test Unit, Unit Installation Operation Quality Control Burn-In Assembler 2 QC Installation of First Component 9
    • Results: MES Software Enterprise Resource Planning (ERP) SQL: Product Database & Control Data on Manufacturing Tracking Demand System Executing Execution (PCTS) (DoD) System (MES) Product Functional Monitoring Test Board Automation 10
    • MES Modules: SQL Database / Data-on-Demand (DoD) Enterprise Resource • Utilizes Data From PCTS Planning (ERP) & Test Automation To SQL: Product Control Database Generate Reports & Manufacturing Tracking System DoD (PCTS) Execution System (MES) • Updates Product Monitoring Board Functional Product Monitoring Test Board Automation • Provides Real Time Communication & Information To Engineering, Suppliers, And Customers 11
    • MES Modules: Data-on-Demand (DoD) 12
    • MES Modules: Enterprise Resource Planning (ERP) ERP • Provides Automatic Links To PCTS And Data Collection SQL: Product Control Database & Tracking Data on System Demand Manufacturing • Facilitates Real Time (DoD) Execution System (PCTS) (MES) Planning On Production Floor Product Functional Monitoring Test • Enables Company Wide Board Automation Visualization Of Inventory Moves. 13
    • MES Modules: Product Control Tracking System (PCTS) Enterprise Resource • Enables Lean Manufacturing Planning (ERP) Product Process SQL: Control Database & Data on Tracking Demand Manufacturing System • Interfaces with Company ERP (DoD) Executing System (PCTS) (MES) System for Material Flow Management & Scheduling. Product Functional Monitoring Test • Serial No. Mapped to: Board Automation Product Assembly Requirements, BOM, Part No., Operator, Assembly Instructions, Test Requirements, & Customer Order. 14
    • MES Software: PCTS • PCTS Tracks:  Assembly Times  Yields  Component By Serial And Part Number, Assembler, And Dates 15
    • MES Software: PCTS • Electronic Router & Traceability Process For Each Product Created • Develops Sequence Of Assembly Events, Quality Checks & Requirements For Product Build 16
    • MES Software: PCTS • Each Products Sequence Of Events & Scanning 22 33 99 Requirements 11 Configured • Expedites New Product Introduction 88 Process & 44 10 10 Engineering 55 66 77 Development Documentation 17
    • MES: Paperless Work Instructions • Work Instructions Customized To Each Product Specifications • Linked To Product Control Tracking System Software • Links ERP System, Parts Control, And Process Control 18
    • MES Software: PCTS • Quality Checks TQCS, Verification Process Also Traced • Quality Steps Included In Traceability Process & Electronic Router To Comply With En ISO 13485:2003 Quality Requirements 19
    • MES Software: PCTS • Automatically Verifies BOM Accuracy, And Serial No. Digit Sequence Per Supplier • Component Matches The Product BOM & Alerts User • Controls Revision & Configuration Of Products 20
    • MES Software: PCTS • Flexible Configuration • Work Order Links Automatically To Configuration Table And Instruction • Reduces Engineering Time And Improves Accuracy Of Documentation Process 21
    • MES Software: PCTS • Tracks Cycle Time & Takt • Monitors & Reduces Labor Costs • Promotes Accuracy & Quality 22
    • MES Modules: Functional Test Automation Enterprise Resource • Fully Automated & Simulates Planning (ERP) Test Equipment Automation SQL: Product Control Database & Tracking Data on System Demand Manufacturing • Interfaces With Company (DoD) Execution System (PCTS) (MES) Developed Software & Off- The-Shelf Product Test Software Product Monitoring Functional Test Board Automation • Linked To Customer & Product Requirements • 100% Verification Of Product Functionality, SW/FW • Generates First Pass Yields Updates, & Subassembly And Failure Analysis Reports Performance 23
    • MES Modules: Functional Test Automation • 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 24
    • MES Modules: Functional Test Automation • 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 25
    • MES Modules: Functional Test Automation • Real Time Monitoring Of Product Performance & Process Control • Main Control Test Board Identifier Status For Each Unit  Green – Pass  Yellow – Testing  Red – Fail 26
    • MES Modules: Functional Test Automation • Remote Monitoring & Troubleshooting Of Product • Monitors Cell Location & Operator • Utilized By Repair Techs, Field Techs, And Customers. • Reduces Repair Tech Time. 27
    • MES Modules: Functional Test Automation 28
    • MES Modules: Product Monitoring Board Enterprise Resource • Tracks All Assembly, Test, Planning (ERP) QC, Pack Steps And SQL: Product Control Database & Fail/Pass Criteria Results Data on Manufacturing Tracking System Demand (PCTS) (DoD) Execution System (MES) • Generates Automated Online Reports Functional Product Monitoring Test Automation Board • Also Tracks Time And Flow In The Production Floor • Data Displayed At Any Station To Communicate Planning To Sales And Customers And As Needed 29
    • MES Modules: Product Monitoring Board • Monitors Each Work Order for Fast & Accurate Progress Status Information • Updates Every 1 Minute • Real time process control and performance communication 30
    • 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 31