The document discusses the integration of lean methodologies and MES (Manufacturing Execution Systems) in Class 3 medical device manufacturing to improve operational efficiency and product quality. It outlines various processes, product details, and manufacturing locations while emphasizing the importance of continuous improvement and key performance indicators (KPIs) to track progress. The future direction focuses on further analysis of current and desired states to enhance data visibility and streamline processes in production.

1. The Marriage ofThe Marriage of
Lean and MES
in Medical Device
Manufacturing
June 25, 2015

2. AB Profile
Provide the
Build to
All products manufactured
d Cl 3 M di l
Products are
highest level
of product
availability
Build to
forecast, ship
from stock
under Class 3 Medical
requirements and regulations
Proprietary and high
distributed
throughout the
world
p y g
skill processes used
for Implant
Utilize pilot line
concept withconcept with
development to
speed time to market
2

3. Operations’ Mission Statement
Providing Quality Implant
Systems
3

4. Manufacturing
~200 Direct Labor Employees
13 Supervisory/Support Employees
g
13 Supervisory/Support Employees
Implant and Externals Manufacturing
Final PackagingFinal Packaging
2 Manufacturing Locations:
ValenciaValencia:
2 shifts, 5 days/week
New products
S lSylmar:
1 shift/5 days/week
Legacy Products
4

5. Product: Implant
Contains a communication coil, signal processing electronics, and an
l t d (16 t t ) i l t d i id th ti t’ hl
p
electrode (16 contact array) implanted inside the patient’s cochlea
16 C t t16 Contact
Electrode Array
Implant
El t iElectronics
Housing
RF Receiver Gold Coil
Removable
Magnet RF Receiver Gold Coil
Antenna
g
5

6. Implant
Implantable manufacturing consists of over 140 processes involved in
making a HighRes90K device
p
making a HighRes90K device
Standard Operations
44%
25%
Inspection
11% Test
20% Critical/High Skill Operations
6

7. Product: Sound Processors
Speech Processors and Headpieces are worn externally and houseSpeech Processors and Headpieces are worn externally and house
the microphone, electronics, communication coil, and battery
Harmony™ Behind the Ear
Sound Processor (BTE)
Naida™ Behind the Ear
Sound Processor (BTE)
Neptune™ Off‐Ear Sound
Processor
7

8. Patient Priority
Focused on Quality to Improve Patients’ Lives
y
8
AB, Putting Patients First

9. Carter Activation

10. LeanLean MESMESLeanLean MESMES

11. Lean
Where AB’s Lean Journey Began
Started in Manufacturing
− Where value is created
− Initial vertical functions that touch the Value Stream
Manufacturing, Quality, Engineering, Planning
Engaged in process of Continuous Improvement

12. AB’s Lean Journeyy
Improve Process & Develop Capabilities Together
− Developed a Historic/Current State Value Stream Maps
− Developed Process Maps for each process touching the Value Stream
− Analyzed the maps for improvement opportunitiesy p p pp
− Began implementation of Total Production System tools
− Determined 4 categories of KPIs

13. 4 Areas Measured via KPIs
1. Team Development
L t i i− Lean training
− Expanded process training
Ensuring there is a cross‐trained & engaged Workforce
2. Quality
− Ensuring appropriate Quality for Class 3 Medical Device
3. Lead Time & Flow
− Improving Operational Efficiency
− Reducing Cycle Time through processReducing Cycle Time through process
4. Cost & Waste Reductions
− Eliminating waste & non‐value added activities to control costg

14. Naida Operational Efficiencyp y
Efficiency
123.73%

15. MS Electrode Defect Rate
Total Defect Rate Projects
Begin
35.63%
Scrap, Scrap & Replace, & Rework

16. MS Electrode Operational Efficiencyp y
Efficiency Projects
BeginBegin
72.19%

17. Camstar MES Systemy
eDHR Project Timeline
Scope Definition
– Phase 1 (Dec 2012 – Nov 2013)
Non‐Sterile Device, Sterile Device
Phase 2 (Mar 2014 April 2015)– Phase 2 (Mar 2014 – April 2015)
Complete Implant areas and applicable reworks
– Phase 3 (May 2015 – est. Sept 2015)
New Product Introduction, Externals

18. Currently Deployedy p y
110 Work Stations On‐line
5 Scanners
10 ATE Systems Interfaced
Interfaced with Document Control Systemy
− AP Updates automatically to MES
Interfaced with ERP System for TraceabilityInterfaced with ERP System for Traceability

19. Initial Benefits
Benefits
– Reduction of Device History Records pagesReduction of Device History Records pages
Original DHR has 100 pages
Eliminate copying & paper handling
– Reduction of Non‐Conformances
Eliminates 80% of documentation errors
– Ensures 1 piece flow through Manufacturing

20. LeanLean MESMES
Lean
+LeanLean MESMES+
MES

21. How Lean Supports MESpp
– Lean creates Value Stream MapsLean creates Value Stream Maps
Allows everyone to see and connect the supporting business
processes to the Manufacturing process
– Lean identifies Waste & Value
Within the MES process waste can exist in theWithin the MES process, waste can exist in the
processing/modeling steps
– Allows us to focus on what’s important in Modeling
– Lean disciplines are incorporated in product flow

22. How MES Supports Leanpp
− Single‐piece flow
Native MES functionality supports 1 piece flowNative MES functionality supports 1 piece flow
− MES data for Lean
A f b fA common set of numbers for measurement
− MES supports the increased visibility of Data and Process
Formalizes Product movement in Manufacturing

23. MES Data for Lean Initiatives
1. Team Development
b l h f d h– Ability to show # of operators trained on each operation
» Measure gaps in training
2 Quality Perspective2. Quality Perspective
– Easier calculation of defect and rework reasons & percentages
» Identify areas of improvement
3. Operations Perspective
– Able to capture actual output vs. observed best performance
» Measure gaps in flow» Measure gaps in flow
4. Cost Perspective
– Able to determine the amount of labor in each unit producedAble to determine the amount of labor in each unit produced

24. Lean & MES at AB
MS Electrodes
– Consolidate KPI tracking in one system
Defects, Defect Rate, Cycle Time, Lead Time
– Before MES
» Pull paper travelers, review dates & times, manually enter
data in Excel for analysis
– After MES
» Device History Report
One click button for reporting output into Excel

25. eDHR Camstar Reportp
S l f DHR R t h i Th h t R d tiSample of eDHR Report showing Throughput Reduction

26. The Future of Lean & MES at AB
Continuing a Culture of Continuous Improvement
Determine gaps between the current state and desired state
− Value Stream Map Analysis
» Current state vs. Planned Fiscal Year‐end State
Data Analysis from MES
» Gather data to support the Gemba‐based facts from MES
» Use charts & graphs to easily convey the information
» Once the root cause is determined, apply countermeasures
» Able to visually verify and confirm countermeasure
effectiveness
» MES will allow you to monitor long‐term effectiveness

27. The Future of Lean & MES at AB
Performance Dashboard
Ability to instantly track container
movement throughout an assembly
line
Idle times− Idle times
− Cycle times
− Throughput
NC ti− NC reporting
Training ModuleTraining Module
Training compliance
− Only certified assemblers
can perform operations

28. Questions?