Employee engagement through Lean driven innovation

Himanshu Parikh, Ph.D. VP, Manufacturing Operations

Roche Diagnostics Ventana Medical Systems, Inc.

The foundation of Ventana Medical Systems, Inc. (Ventana)Ventana was founded in 1985 by, Thomas Grogan, MD., Professor of Pathology at the University of Arizona.

Dr. Grogan had a vision for single, automated pathology test covering all aspects of a patient’s case and therapy to improve survivability

Created a passion for improving diagnosis and patient outcome

Developed a Culture of Accountability focused on improving the lives of all patients afflicted with cancer

Ventana at a glance• Over 1,200 employees across North America• Fully integrated commercial operations, manufacturing, research and

development in Tucson, AZ• 249 granted patents worldwide and 219 pending patents worldwide• Over 250+ diagnostics tests; world’s largest ready-to-use assay menu• 10,000+ systems installed worldwide• Products in over 80 countries with 14% annual target growth• Acquired by F. Hoffmann-La Roche in early 2008, the largest biotech

company in the world • Began Lean journey in 2001

Roche goal:One-stop shopping for anatomical pathology (AP) labs

Advanced Staining

Special Stains

Order Entry

Microtomy

Embedding

Tissue Processing / Record Time

Gross Cassette

Verification

Accessioning

Sample Transportation

Patient InPatient Out

Tele-Pathology

Advanced Image Analysis

Pathologists Review

Case Assembly

AP Labs operate an integrated workflow

1023

1023

Digital Slide

Scanning &

Analysis

AP lab workflow today

H&E

Sample Collection

Ventana goal: One-stop shopping for AP labs

Advanced Staining

Special Stains

Order Entry

Microtomy

Embedding

Tissue Processing / Record Time

Gross Cassette

Verification

Accessioning

Sample Transportation

Patient InPatient Out

Tele-Pathology

Advanced Image Analysis

Pathologists Review

Case Assembly

AP Labs operate an integrated workflow

1023

1023

Digital Slide

Scanning &

Analysis

Ventana solutions in the AP lab today

H&ERTD’s offerings today

Primary Staining StingingHE 600

BenchMark

Digital Slide Scanning &

Advanced Image Analysis

iScan HT

BenchMark

Sample Collection

Vantage

The Ventana portfolioDelivering testing efficiency and medical value

Pre-analyticaltissue preparation

Primary stainingH&E stain

Advanced staining SS, IHC, ISH

Workflow managementconnectivity

Customer care and consultative services

Imaging/reportingimage analysis

Single Minute

Exchange of Dye(SMED)

Total Preventativ

e Maintenanc

e(TPM)

Jidoka

Just in Time(JIT)

Visual controls

Production

Planning Process

(3P)

Process monitori

ng

5s Kanban Standard work

Heijunka

Process smoothi

ngKaizen

Lean Enterprise

The Ventana journeyBegan May 2001

> 70% of management team participated in Lean training and events

Held more than 130 Kaizen events

> 65% of employees participated in Kaizen

Reorganized Manufacturing by product teamso Self-directed work teams utilizing

Group Lead/Team Lead methodology

Kaizen-( 改善 ?), Japanese for "improvement" or "change for the best“.

Designed layout and material replenishment for XT/LT Line

Designed in Quality at the source

Implemented one piece flow for assembly

2002New product cell

Implemented Managing for Daily Improvement Tools for Manufacturing

Developed metrics; engaged team leads and team members

Applied Lean principles to the development of new products from Voice

of Customer to Manufacturing to market release

2003 to 2004Managing for daily improvement

2008 to 20105S and Value Stream

2011 to 2013Kaizen and SS introduction

AfterBefore

Lean recognition2014 awards and accomplishments

Winners of the 2014 Roche Germany Innovation Award

Winners of the 2014 AME Manufacturing Excellence Awards

Vorne Board with OEE(Overall equipment effectiveness)

Lean Journey exampleDispenser Build and Test Process

Dispenser uses Automated & Manual Fill

Antibodies Detection Molecular

Prep Kits User fillable kits

Kits for BenchMark

Dispenser automation journey

Dispenser manual assembly

Manual build: Right to left with 2 operators1st Operator: Build dispenser & coupler2nd Operator: Assemble & test

Manual prime to semi-automated

Dispenser test methodsDrop measurement and pressure decay testing

Single Minute

Exchange of Dye(SMED)

Total Preventativ

e Maintenanc

e(TPM)

Just in Time(JIT)

Visual controls

Production

Planning Process

(3P)

Process monitori

ng

5s Kanban Standard work

Heijunka

Process smoothi

ngKaizen

Lean Enterprise

Jidoka

Introducing dispenser automation

DVM - Dispenser Verification Module

Scale: technical details• resolution: 0.1 mg/µl• accuracy: ± 0.5mg/µl• settling time: ~1s

DM Drop Measurement Specification

• 5 drops from each dispenser • 5 volume measurements• Average ≥ 88µl but ≤100µl• Standard deviation ≤ 2.00

3 dispensers tested at once 3 scales in parallel 3 scale related dripping cup

(150ml) 3 evacuating nozzles

Data concept / traceability/ Remote access concept

puck RFID+ cell-no

Dispenser ID puck RFID

Dispenser ID+ cell-no

Dispenser ID-PDT values+pass/fail result-drop values+pass/fail result-final result+deposited bin type

Case of change management

Employee involvement in the project

Ergonomically designed work stations

Improved workflow

Automated test station reducing physical stress

Drop in productivity

Fully automated reagent dispenser assembly concept

Barrel

Plug

Duckbill

Insert

Filter

Coupler

Balls

Ball Seat

Lower Seal

Quad SealStopSpring

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Fully automated reagent dispenser assembly concept

Summary

Building a Lean Enterprise is a Journey not the destination

Conceptual training needed at every stage with ongoing refresh is key to

success

Employee involvement and clear communication critical at every stage

Management must be receptive to the ideas generated on the floor – some of

the best ideas come from there

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Questions?

Employee engagement through Lean driven innovation

Himanshu Parikh, Ph.D.VP, Manufacturing Operations

Roche DiagnosticsVentana Medical Systems, Inc.

Thank You!Please complete the session survey at:www.ame.org/survey

Session: (i.e. TP/16 - # will be advised)Employee engagement through Lean Driven InnovationHimanshu ParikhRoche DiagnosticsVentana Medical Systems, Inc.himanshu.parikh@roche.com

Confidential and proprietary to Ventana Medical Systems, Inc. For internal use only. Do not copy. Do not distribute.

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