The Marriage of The Marriage of Lean and MESin Medical Device

Manufacturing

June 25, 2015

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 

worldp y g

skill processes used for ImplantUtilize pilot line concept withconcept with development to speed time to market

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Operations’ Mission Statement

Providing Quality Implant Systems

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Manufacturing

~200 Direct Labor Employees

13 Supervisory/Support Employees

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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

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Product:  Implant

Contains a communication coil, signal processing electronics, and anl t d (16 t t ) i l t d i id th ti t’ hl

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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 CoilRemovable Magnet RF Receiver Gold Coil 

Antennag

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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

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Product:  Sound Processors

Speech Processors and Headpieces are worn externally and houseSpeech Processors and Headpieces are worn externally and housethe 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 

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Patient Priority

Focused on Quality to Improve Patients’ Lives

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AB, Putting Patients First

Carter Activation

LeanLean MESMESLeanLean MESMES

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

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

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

Naida Operational Efficiencyp y

Efficiency

123.73%

MS Electrode Defect Rate

Total Defect Rate Projects Begin

35.63%

Scrap, Scrap & Replace, & Rework

MS Electrode Operational Efficiencyp y

Efficiency Projects BeginBegin

72.19%

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

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

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

LeanLean MESMESLean +LeanLean MESMES+

MES

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

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

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

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

eDHR Camstar Reportp

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

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

The Future of Lean & MES at AB

Performance DashboardAbility to instantly track container 

movement throughout an assembly line

Idle times− Idle times

− Cycle times

− Throughput

NC ti− NC reporting

Training ModuleTraining ModuleTraining compliance

− Only certified assemblers can perform operations

Questions?