For more information contact: Slideshare@marcusevans.com. The Marriage of Lean and MES in Medical Device Manufacturing - Presentation delivered by Speaker James Robinson, Vice President, Operations, Advanced Bionics, at the marcus evans Medical Device Manufacturing Summit held on June 25-26, in Las Vegas

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?