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.

1. Medical OEMs Can Achieve Commercial
Manufacturing Efficiency

2. 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

3. 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

4. Challenges Faced
• Regulatory
• ISO 13485
• FDA
• Quality (Best In Class)
• Cost
• Life Cycle Management
4

5. 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

6. 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

7. 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

8. Results: Cell Based Lean
Manufacturing Facility
8

9. 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

10. 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

11. 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

12. MES Modules: Data-on-Demand (DoD)
12

13. 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

14. 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

15. MES Software: PCTS
• PCTS Tracks:
 Assembly
Times
 Yields
 Component
By Serial
And Part
Number,
Assembler,
And Dates
15

16. MES Software: PCTS
• Electronic
Router &
Traceability
Process For
Each Product
Created
• Develops
Sequence Of
Assembly
Events,
Quality
Checks &
Requirements
For Product
Build
16

17. 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

18. 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

19. 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

20. 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

21. MES Software: PCTS
• Flexible
Configuration
• Work Order
Links
Automatically To
Configuration
Table And
Instruction
• Reduces
Engineering
Time And
Improves
Accuracy Of
Documentation
Process
21

22. MES Software: PCTS
• Tracks Cycle
Time & Takt
• Monitors &
Reduces Labor
Costs
• Promotes
Accuracy &
Quality
22

23. 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

24. 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

25. 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

26. 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

27. 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

28. MES Modules: Functional Test Automation
28

29. 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

30. 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

31. 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