The. six. principles. of. cLEAN®. harken. back. to. the. basic. principles. of.
Lean.Thinking,.as.Jim.Womack.articulated.in.his.book,.Lean Thinking,.
first.published.in.1998..Womack.characterized.the.principles.of.Lean.
thinking.as.value,.the.value.stream,.flow,.pull,.and.perfection..Novo.
Nordisk. interpreted. these. principles. for. themselves. and. added. one.
more.(Figure.10.1):
•. Value/waste:.Understanding.what.value—and.waste—look.like.in.
the.context.of.pharmaceutical.development..The.sheer.number.of.
customers.creates.a.complex.picture.of.value:.Patients,.doctors,.hos- pitals,.national.health.services,.insurance.companies,.and.pharma-cists.all.have.differing.views.of.value..While.everyone.wants.to.put.
the.patients’.needs.first,.there.is.a.lot.of.disagreement.about.what.
the.patients.need.the.most..At.the.same.time,.an.outsider.would.
look.at.a.process.with.a.less.than.10%.success.rate.and.claim.that.it.
must.be.inherently.wasteful..Pharmaceutical.companies.recognize.
this.and.they.rapidly.adopt.new.methods.of.modeling.and.testing.
to. screen. out. molecules. before. they. reach. clinical. trials.. At. the.
same.time,.the.best.thing.that.a.pharmaceutical.company.can.do.to.
increase.chances.of.success.is.to.increase.throughput.and.capacity.
in.the.processes.that.are.bottlenecks..It.could.be.that.the.failure.
rate.for.preclinical.testing.may.need.to.go.up.so.that.the.number.
of. successful. drugs. can. increase.. At. the. same. time,. it. is. equally.
important.in.the.early.phases.to.ensure.optimal.ideation.and.deci-sion.processes.to.make.sure.that.the.right.things.(drug.candidates.
and.projects).are.pursued.
•. Value streams:. Visualizing. the. flow. of. value. through. pharma-ceutical. development,. especially. the. interdependencies,. so. that.
everyone.has.a.common.picture.of.the.process..The.processes.in.a.
pharmaceutical.company.are.inherently.complex.and.heavily.regu-lated..The.teams.working.on.drug.development.find.that.they.get.a.
lot.of.value.from.simply.visualizing.the.processes.in.ways.that.help.
them. to. understand. how. the. different. parts. of. the. organization.
work.together..In.such.a.large.process,.it.is.easy.for.people.to.focus.
on.only.their.own.work.because.the.overall.goal.of.the.project.is.so.
uncertain.and.so.distant..By.making.one.person’s.part.in.the.value.
Improvements Customer real needs
Agreements Value/
Waste Value
Streams Common pictures Interdependencies Process families
Predictability Robustness
Clarity Variation analysis A basis for planning!
Levelling Balancing No stops Coordination WIP control Readiness
Calling in tasks Fast feedback No queues Kaizen
Continuous improvements
Sustainability
cLEAN Principles
The Six Basic Principles of cLEANR
R
FIGURE 10.1
The.Novo.Nordisk.cLEANÒ.framework.
Novo Nordisk: Metrics to Drive Change • 125 stream.clearer,.it.helps.build.stronger.commitment.to.the.goals.of.
the.overall.program.
•. Stability:.Ensuring.that.processes.are.robust.and.predictable.so.that.
plans.are.reliable..This.is.especially.important.in.a.process.that.has.so.
many.dependencies.among.transactional.processes..In.this.environ-ment,.fast.is.good,.but.it’s.better.to.be.predictable.than.fast..At.the.
same.time,.improvements.in.shared.processes,.such.as.the.ones.that.
coordinate.clinical.testing,.are.shared.among.all.of.the.drug.develop-ment.programs,.compounding.their.benefits.
•. Flow:.Balancing.and.controlling.the.work.in.process.to.avoid.over-loads.and.bottlenecks..This.is.the.ability.to.understand.the.whole.
process.and.its.subprocesses.well.enough.to.recognize.bottlenecks.
and.other.flow.problems,.and.then.to.put.countermeasures.in.place.
to.remove.them..Drug.development. has.the.potential. for.transac-tional.process.flow.problems.that.result.in.backlogs.and.long.lead.
times,.as.well.as.knowledge.flow.blocks.that.make.it.more.difficult.
to.leverage.the.organization’s.knowledge.among.teams.working.on.
similar.classes.of.molecules.
•. Pull:.Eliminating.backlogs.and.ensuring.that.downstream.teams.
are.prepared.when.the.time.comes.for.them.to.take.things.into.the.
next.phase.of.development..This.is.also.about.ensuring.that.hand-offs.from.one.team.to.another.work.smoothly..Given.how.long.this.
process.is.and.how.much.of.it.is.bound.up.in.experiments.that.take.
time.to.perform,.the.teams.don’t.have.any.time.to.waste.on.missed.
handoffs. or. bottlenecks.. Pull. is. also. the. enabler.of. fast. feedback.
ensuring. that. resources. are. being. used. on. the. right. things—the.
best. and.most.promising.hypotheses,.drug.candidate.series,. and.
projects.
•. Perfection:.Committing.to.continuous.improvement. and.sustain-ability..This.is.a.common.focus.of.Lean.programs.throughout.the.
enterprise,.but.at.Novo.Nordisk,.this.is.not.just.a.slogan..It.is.the.
way.that.the.company’s.Lean.teams.break.down.the.massive.work.
it.would.take.to.overhaul.such.a.large.process.into.smaller.chunks,.
and.then.ensure.that.the.changes.stick.after.an.improvement.project.
is.finished.
MetRicS: A BALAnceD VieW oF oRGAniZAtionAL PeRFoRMAnce
All.product.development.organizations.need.a.mechanism.to.assess.
their.ability.to.meet.their.multifaceted.mission.of.delivering.value.
through.new.products..This.is.a.distinct.activity.from.the.tactical.
measurements.that.a.program.manager.must.use.to.assess.a.specific.
program’s.performance.against.its.objectives,.schedule,.and.budget..
Dave.Packard,.founder.of.HP,.often.said,.“What.gets.measured.gets.
done.”.Metrics.focus.a.group’s.attention.on.the.things.that.are.most.
important.to.the.company’s.leadership,.and.the.right.metrics.drive.
progress.toward.achieving.the.organization’s.strategic.objectives.
It.is.better.to.manage.a.critical.few.metrics.than.it.is.to.create.a.
complex.set.that.requires.a.lot.of.time.to.collect,.report,.and.inter-pret..From.a.Lean.perspective,.the.time.spent.managing.metrics.is.
“necessary.waste”—non-value-added.activity.that.should.be.mini- mized..Each.metric.will.need.an.owner.who.is.responsible.for.col-lecting.data.and.reporting.the.results.
MeASURinG SUcceSS AcRoSS PRoDUct PRoGRAMS AnD tiMe HoRiZonS
In.product.development,.we.have.two.challenges.to.consider.before.
defining. metrics:. variability. across. programs. and. lag. time.. Each.
product. development. program. differs. in. the. amount. of. technical.
and.market.risk,.the.effort.required.for.completion,.the.amount.of.
reusable.knowledge.that.is.available.to.the.team,.and.the.ease.of.inte-gration.into.the.organization’s.existing.operations..When.the.goal.is.
faster.time.to.market,.how.does.one.measure.across.such.wide.vari-ances.in.complexity?
We.address.this.challenge.by.seeking.out.predictive.metrics.that.
are. independent. of. the. type.of. program.. For. example,. we. cannot.
meaningfully. measure. reduced. cycle. time. across. products. unless.
we.have.many.of.them.to.smooth.out.the.variation..We.can.mea-sure.estimated.time.between.phase.gates.versus.actual.time..We.can.
also.measure.actual.time.to.market.(often.from.concept.approval.to.
launch).for.programs.of.similar.size,.scope,.and.risk..Some.groups.
develop. categories. (research,. breakthrough,. platform. extension,.
Novo Nordisk: Metrics to Drive Change • 127
TRANSACTIONAL VERSUS KNOWLEDGE