11/12/2012 1 Personalized Medicine’s Path from Concept to Reality: How Our Lab Uses Lean to Speed the Transformation Anthony Carter, Ph.D. Director of Operations ADx Laboratories National Jewish Health National Jewish Health and ADx Laboratories Mycobacteriology Pharmacokinetics Immunology Beryllium Complement Molecular Diagnostics Microbiology Core ADx
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11/12/2012
1
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)
• 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
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