1st Edition

Creating a Lean R&D System Lean Principles and Approaches for Pharmaceutical and Research-Based Organizations

By Terence Barnhart Copyright 2013
    267 Pages 13 B/W Illustrations
    by Productivity Press

    The ability to find and remove barriers between people and their systems in R&D can almost guarantee a doubling in performance, and often delivers multiples of that. R&D teams that have smooth handoffs deliver 100 percent of the required knowledge at those handoffs. As a result, such teams do not lose critical information, have unexpected knowledge gaps appear in their projects, or have uncoordinated knowledge transfers that waste minutes, days, and even months every year.

    Creating a Lean R&D System: Lean Principles and Approaches for Pharmaceutical and Research-Based Organizations lays out the logic of why Lean implementation isn’t strictly for manufacturing and describes why it can be just as effective in R&D organizations. Terence Barnhart, former senior director of continuous improvement at Pfizer R&D, describes the theoretical and physical underpinnings of creating a Lean transformation in any R&D organization, as exemplified by the Lean transformation initiated within the R&D division of a global pharmaceutical company.

    Describing how to merge Lean principles with the cultural virtues inherent in R&D, the book presents Lean approaches that can be easily applied in pharmaceutical and research-based organizations. It takes a strategic approach to solving two problems unique to the Lean field. The first is in noting the key distinctions between R&D and manufacturing, and developing a Lean approach specific to the R&D environment. The second is that it proposes a systematic middle-out (merger/maneuver) strategy to help you initiate and sustain a Lean culture within your pharmaceutical R&D organization that will help you immediately engage all stakeholders involved.

    Seeing and Removing Barriers in the R&D Environment
    Mental Models
    Removing Barriers to Innovation
    Impact on R&D Innovation
         Physical Barriers 
         Emotional Barriers 
         Observational and Thinking Barriers
    Lean and the Removal of Barriers

    Lean in Research and Development
    Purpose
    Continuous Improvement in Manufacturing and R&D
    The Purpose of Lean
    What Lean Is
    Lean R&D
    Implications
    Connection with People
    Conclusions

    The Individual in the Lean R&D Community
    The Individual/Community Continuum in R&D 
         An Example of the Lean R&D Community
    Qualities of the Individual in a Lean Environment 
         Commitment
         Commitment to Craft
         Commitment to the Team
    Awareness of the Community
    Skill at Learning
    Pulling It Together

    Lean Exercises for the R&D Professional
    Seeing
         Skill-Building Exercise 1: Seeing without Prior Mental Context
         Skill-Building Exercise 2: Seeing Beliefs
    Reframing to Innovate
         Deconstruction and Synthesis to Increase Value Content
         Making Snowmobiles
         The Role of Language in Reframing for Innovation
         Skill-Building Exercise 3: Reframing by Converting Statements into Questions
         Skill-Building Exercise 4: Seeing and Reframing through Value Stream Mapping
         Skill-Building Exercise 5: Reframing by Making Snowmobiles
    The Value of Experience in Innovation
         Skill-Building Exercise 6: Improving Innovation Experience through Daily Experimental Practice
    Growing Yourself and Your Environment
         Practice to Grow
    Pulling It Together—Seeing, Reframing, Experiencing, and Growing: A Learning Loop for Innovation
    Integrated Exercises
         Skill-Building Exercise 7: The A3 Format
         Skill-Building Exercise 8: Good-Better-Best
         Skill-Building Exercise 9: Mapping
         Apply Liberally
         Apply in Your Work, Start Small, Grow in Scale, and Spread Outward

    The A3 in Developing R&D Thinking
    Description of the A3
    Purpose of the A3
    Section 1: Problem Statement, Business Value, Performance Goals—Defining the Problem and the Terms for Its Successful Resolution
         The First Step in Creating Thought Clarity—Separating Problem and Solution with a Well-Constructed Problem Statement or Valuable Question
         Business Value—Creating a Stage for Buy-In
         Goals—Defining Criterion for Successful Completion, a.k.a. "When Do I Stop?"
         Other Types of Stop-Gap Goals
         Section 1 Summary
    Section 2: Current State
         Section 2 Summary
    Section 3: Analysis/Synthesis—Finding the Root Cause of a Problem and Developing      Countermeasures to Address Root Cause
         Considerations in Analysis/Synthesis
         Section 3 Summary
    Section 4: The Learning Plan
         Learning Plan Structure
         Predicting Plan Timing
         Building Fast Learning into Our Planning Process
         Thinking and Cadence in the Learning Plan
         Thoughts on the Learning Plan
         Section 4 Summary
    Section 5: Results and Future Considerations
    Pulling It Together to Get the Most from the A3

    The Lean R&D Manager
    Skills a Lean Manager Must Possess
    Seeing Exercises
         Skill-Building Exercise 1: Seeing Group and System Dynamics in an External Setting
         Skill-Building Exercise 2: Letting the Environment Tell You Its Problems
         Skill-Building Exercise 3: Observing the Internal Environment (Walking the Gemba)
         Skill-Building Exercise 4: Seeing and Reframing through Mapping
    Reframing Exercises
         Skill-Building Exercise 5: Disbelieving Your Own Beliefs
         Skill-Building Exercise 6: Identifying Other Possible Beliefs
    Experience
         Skill-Building Exercise 7: Small-Scale/High-Velocity Experimentation
    Growth
         Skill-Building Exercise 8: Setting Targets
         Skill-Building Exercise 9: Assessing Performance and Reflecting on Results
    Pulling It Together

    Removing Barriers within the R&D Community
    Noninnovation Work
         Supporting Basic Work Requirements
         Supporting Interfaces
         Supporting Management Systems
         Seeing the Noninnovation Work
         Creating Purpose
    Seeing without Prejudice
         Group Exercise 1: Seeing without Prejudice, the Current-State Value Stream Map
    Issues in Value Stream Mapping in R&D
         Group Exercise 2: Seeing Team Assumptions
         Group Exercise 3: Bypass Assumptions Entirely—Critical Question Mapping
    Reframing Exercises
    Building Group Experience
    Pulling It Together to Remove Barriers

    Critical Question Mapping
    The Emergence of Critical Question Mapping
    Developing Critical Question Maps
         Step 1: Defining a Strategic Problem
         Step 2: Brainstorming
         Step 3: Arranging the Questions and Flow
         Steps 4 and 5: Review and Iteration
    Managing Creative and R&D Projects Using Critical Questions
    CQM in the Real World

    Value Stream Mapping in the R&D Space
    Scoping to Define Direction and Performance Level
    The Design (Value Stream Mapping) Workshop
         Current-State Mapping (Day 1)
         Analysis (Day 1)
         Analysis (Day 2)
         Future-State Mapping (Day 2)
         Creating the Learning Plan (Day 3)
    Management Intervention during Design and Planning
    Implementation and Fast Learning
         Learning and Review
         Fast Learning and Strategies for Fast Learning
    The Next Level: Linking the Project to Lean Strategy and the Learning Process

    Implementation Strategy
    Using a Critical Question Map to Define a Strategic Thinking Structure
         Flow and Learning Loops
         Filling Gaps in the Questions
         Methodology/Philosophy (Barrier Removal) Section of the Map
         Converting the Critical Questions into a Strategy
    Design of the First and Subsequent Projects
         Selecting Lean Practitioners
         Identifying That First Project
         Spreading Lean through Fast Learning: The Wildfire Strategy
    Learning as Its Own Strategy
         The Implications of a Learning Strategy
    Implementation Strategy Summary

    The Formation of Lean R&D Communities: A Case Example
    Case Study: Formation of a Lean Community
    The SPOT Project
    Project Management in a Lean R&D Community
    The Value of Point-to-Point Communication
    Results of the SPOT Experiment
    Conclusions

    Reflections

    Index

    Biography

    Dr. Terence Barnhart has worked as an academic and industrial research scientist, a strategy consultant, a plant engineer, and a project manager for some of the largest and best-known companies in the world, including Pfizer, McKinsey and Company, and General Electric. His professional passion is researching, developing, and implementing strategies to help people create environments in which they and others can flourish.

    Dr. Barnhart holds a PhD in inorganic chemistry from the University of Wisconsin and a bachelor of science degree and post-doctoral fellowship in chemistry from the University of Michigan.