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Personalized Medicine’s Path from Concept to Reality: How Our Lab Uses Lean to Speed the Transformation

Anthony Carter, Ph.D.Director of OperationsADx LaboratoriesNational Jewish Health

National Jewish Health and ADx Laboratories

Mycobacteriology

Pharmacokinetics

Immunology

Beryllium

ComplementMolecular Diagnostics

Microbiology

Core

ADx

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The Road to Personalized Medicine

• Multi-disciplinary approach

• IS-intensive

• R&D-intensive

Lean Concepts

5‐SAndonBottleneck AnalysisGemba (The Real Place)Heijunka (Level Scheduling)Hoshin Kanri (Policy Deployment)Jidoka (Autonomation)Just‐In‐Time (JIT)Kaizen (Continuous Improvement)Kanban (Pull System)Key Performance Indicator (KPI)Muda (Waste)

PDCA (Plan, Do, Check, Act)Poka‐Yoke (Error Proofing)Root Cause Analysis (RCA)Single Exchange of Die (SMED)Six Big LossesSMART GoalsStandardized WorkTakt TimeTotal Productive Maintenance (TPM)Value Stream Mapping (VSM)Visual FactoryOveral Equipment Effectiveness (OEE)

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Achievements

1.What we have accomplished in ~6 months

2.Alternate Lean approach

3.Development and creative use of Lean tools

4.Creating operational control and transparency

5.Driving continuous improvement

6.Do’s and Don’ts

Our journey begins.

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Once upon a time…..

Core

Mycobacteriology Complement Microbiology Beryllium

Immunology Pharmacokinetics MDx

Anthony Carter, Ph.D. Director of Operations

• Older LIS• Manual processes• Little automated metric collection• Individualized processes• No centralized operational visibility• Limited scalability• Limited resources

ADx Growing Pains

PRODUCTION PROBLEM

Problem: Current processes and systems lack sufficient scalability (malleability).Solution: Implement more automation….focus on LIMS.

R&D PROBLEM

Problem: R&D resources taxed at the expense of production.Solution: Devote more staff resources to R&D efforts.

Roadblock: Fixed FTE capacity….so, we can’t hire.

R&DProduction

$$

Deliverables

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Approach of LEAN

Non-value added25-45%

Value added

Non-value added

Step 3Step 2Step 1 Step 4 Step 5 Step 6

Process X

High Impact Primary Goals

1. Gain operational visibility

2. Find 10-15% FTE capacitya. Find in Productionb. Fuel the R&D engine

3. Create control systems and operational transparency

4. Drive quality and service through development of KPIs

5. Drive kaizen (continuous improvement)

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Our approach.

Traditional DMAIC Approach

Project Charter

Collect Data

Analyze DataPilot Studies

Control System

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Novel MADIC Approach

Measure, Analyze, Define, Improve, Control

• Shotgun approach • High impact in short time• Multiple areas involved• Gain quick operational visibility• Use data to target low-hanging fruit• Involve entire staff

MADIC Approach

Measure: VSM, Process Map, SWCS, Spaghetti diagram, DOWNTIME

Analyze: Analyze data to find targets

Define: Define project charter based on all data

Improve: Design pilot studies, calculate and truly understand delta

Control: Develop control systems and develop transparency

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Evolutionary stages of introduction of Lean

Measure

Spaghetti Map-motion waste-transportation waste-feet=seconds=t=$

Process Map-process flow-touchpoints-redundancies-problem areas-IS variability

SWCS-time spent/step-time bottlenecks

VSM-cycle time-queue time-lead time-FPY% (reruns)-bottlenecks-% capacity

DOWNTIME -Categorizes waste

Metrics-TAT-Failure rate/batch/sample-Control failures-Reasons for failures-Root cause for reasons-Equip, vendor, person-Operational transparency

BigDIL ReWork

0.00%

0.50%

1.00%

1.50%

2.00%

2.50%

3.00%

3.50%

4.00%

1 /26/ 20

10

1/ 27/ 2

010

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% BigDIL ReWork

avg= 2.09%

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Analyze

BigDIL ReWork

0.00%

0.50%

1.00%

1.50%

2.00%

2.50%

3.00%

3.50%

4.00%

1 /26/ 20

10

1/ 27/ 2

010

1 /28/ 20

1 0

1/ 29/ 2

010

1 /30/ 20

1 0

1/31/ 2

010

2/1/2 0 10

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0

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0

2 /4/2 0 10

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0

2/ 6/2 0 10

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2/ 8/2 0 10

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2/16 / 20

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1 0

2/25/ 2

0 10

% BigDIL ReWork

avg= 2.09%

Define (and begin Control)

D O W N T I M E

Project Charter(s)

Option: Categorize each PC according to Waste – similar teams and approach

Develop operational transparency and design Quality and Control Boards

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Improve

Current State Future State

vs. = ROI

Control and Quality Dashboards

Control Board: Centrally located manual magnetic board that contains a snapshot of all WIP (Work In Progress). Huddles are held.

Quality DashboardElectronic KPI board that has both leading and lagging indicators.

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Control Board – Example

Pre-Analytical Analytical Post-Analytical

Test Step 1 Step 2 Step 3 Step 1 Step 2 Step 3 Step 1 Step 2 Step 3 Metrics

1

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐Ct‐Rerun‐Reasons‐Equip issues‐FTE issues

‐TAT‐Rerun‐Reasons‐Equip issues‐FTE issues

2

3

4

5

VALUE STREAM MAPs

TB/PK Lab

MDx Lab

Control Boards

Beryllium

Complement Lab

Immunology

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Quality Dashboards

Immunology

Core

Client Services MDx

MycobacteriologyMicrobiology Beryllium

Primary Operations Dashboard

Control Board

VSM

Process Gauges

Dashboard

Control and Transparency

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How we use our Lean tools.

KPI’s, Process Maps and Root Cause Analysis

Track Frequency and Root Cause

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Process Map Permutations

And the winner is…

4 Levels of Information

1. Who is involved with the step2. What software each step touches3. Where the process takes place4. Steps/decisions in the process

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Capacity Planning….use VSMs

Total FTE Time Total Equipment

Time+ =

Total Resource Time

FTE TimeClin Process 1

FTE TimeClin Process 2

FTE TimeClin Process 3

FTE TimeClin Process 4

Equipment TimeClin Process 1

Equipment TimeClin Process 2

Equipment TimeClin Process 3

Equipment TimeClin Process 4

FTE TimeR&D

Equipment TimeR&D

+ =Total Resource Time devoted

to Clinical

+ Total Resource Time left over

for R&D

=

VSMs

-Reruns (FPY%)-Cycle Time-Queue Time-Automation

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Development of complete operations picture using VSMs will allow for appropriate resource allocation to R&D projects and drive scheduled innovation

Production: 80%

R&D: 20%

ETA on deliverables

Buy

HireBuy Buy

Hire

Operations and Innovation Initiatives

Operational Control/Process Improvements

Quality Control/Operational 

Transparency

Continuous Improvement Cultural Change

Lean Six-Sigma Initiative

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LEAN Six-Sigma CultureTB

PK

MDx

Micro

Ber

Immuno

Phleb

CS

Complement

# Projects

Time

$$ Savings

Time

Mission

Vision

Strategy

Tactics

Goals

Targeted, Quantifiable, Time-Bound Goals

Departmental MAPs -time bound-measurable ROI-sets accountability

Overall Operations MAPs

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v

Do’s and Don’ts.

Things we learned

Do1. Allow creativity to flow and find new ways to use your Lean tools2. Pick and choose your metric collection wisely…don’t tax the group 3. Create timelines for delivery4. Quantitate ROI5. Perform Gemba walks6. Find your stars

Don’t1. Think of DMAIC steps as completely uni-directional (MADIC)2. Underestimate entropy3. Limit personnel involvement in Lean4. Lose momentum…celebrate small victories5. Get hung up on jargon

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Thank you very much.