Agile Lean Product Development

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Medtronic Neruomodulation at a Glance

 Minneapolis HQ

 $1.5 billion (FY2010) revenue

 10% of Medtronic‟s revenue

 140 suppliers

 Developed from Medtronic‟s expertise in heart electrical stimulation

 Key products: o implantable neurostimulators send mild

electrical impulses to the spine, masking

pain messages

o implantable drug pumps deliver pain medication directly to the fluid around

the spinal cord at a fraction of an oral

dose.

 Implantable treatments are reversible; a doctor can turn off or remove the system.

Patients can try therapies temporarily to test

effectiveness before getting a permanent

implant.

Lean management case studies series

Using Plan-Do-Check-Act as a Strategy and Tactic for Helping Suppliers Improve

Lean Thinkers are familiar with the scientific process of plan-do-check act (PDCA) as a method

that guides problem solving on the shop floor or office. But Medtronic‟s Neuromodulation

business not only uses PDCA for shop-floor problem solving, it also uses the process to guide

overall strategy for selecting and developing key suppliers.

As a maker of surgically implantable medical devices, such as electrical stimulators and drug

pumps, that alleviate pain, Neuromodulation (Neuro) depends on suppliers, many of whom

deliver critical components or finished goods. Continuously improving their performance is vital.

“Medtronic is on a lean journey and we‟d

like our strategic suppliers to be on that

journey with us,” said William Hooper,

Medtronic vice president of operations and

supply chain. “We can‟t be successful

unless our strategic suppliers are

successful.” For example, he noted that

analyses of field reliability problems

showed that “a quarter to a third” were

attributable to supplier quality issues.

“Not only do we have to lift our capability

in quality and field performance, but we

need to lift our suppliers‟ performances,”

Hooper said.

Besides improving supplier performance, a

strategic PDCA approach helps Neuro:

 Align supplier development activities with business

requirements as defined by Neuro‟s

director of global supply chain.

 Create a standard approach to the selection, status, and tracking of supplier development activities.

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Plan-do-check-act is

often illustrated as a

continuous cycle.

 Deliver real-time visual status of activities to Neuro stakeholders.

The approach is “modeled after the Toyota Production System strategy of treating suppliers as

partners,” said Jeff Hans, director of Neuro‟s global supply chain. Before adopting a strategic

PDCA methodology two years ago, engineers developing suppliers worked in a “heads-down,

fix-the-fire-of-the-day manner,” said Hans. “We just didn‟t feel that was a very proactive

approach.”

Hans said Neuro had to overcome some initial reluctance about advising suppliers to launch lean

transformations. “We felt a little presumptuous going out to help our suppliers become lean

when we realized that we have a long way to go internally. We had a lot of discussion around

that and decided, okay, we‟re not perfect but let‟s not let that get in the way of progress.”

Progress has included Neuro as well as its suppliers. As change agents work on a variety of

manufacturing applications at suppliers, they build skills. This unexpected benefit is helping

them transform existing Neuro production systems and develop new “born lean” systems for

product launches.

Strategic PDCA “PDCA is a strategic, methodical approach,” said David Errico, Neuro‟s senior principal supplier

development lean change agent.

“It‟s a whole operating system approach,” said

Errico, who spent three years with Toyota‟s

Operations Management and Development

Division, a special unit that helps implement the

Toyota Production System (TPS) in the

automaker‟s facilities. “We‟re using PDCA with the emphasis on developing a strategy for

improvement. The strategy is the Plan in the cycle where lean concepts become an actionable

and measurable blueprint for improvement. We act on the plan, continually measure and evaluate

the targeted metrics, make adjustments to achieve the target, or set the next level of

improvement.” (See a chart summarizing the supplier development process as a PDCA cycle.)

Errico noted that compared to other approaches to supplier development, the PDCA method

requires an investment of time at the beginning of the process in order to thoroughly understand

and define what has to be done. But execution goes very quickly. “Plan is where time is invested

for deep thinking, strategizing, and assessment,” he said. “But Do is lightning fast.”

The approach is particularly effective for the medical device manufacturers because process

changes have to be well-planned when seeking FDA approval, then implemented quickly and

accurately when approval is received. “Failure is not an option,” said Errico.

Plan Strategic supplier development at Neuro begins at regular monthly meetings attended by a team

that includes Hans plus the unit‟s sourcing manager, quality manager, and a supplier

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development lean change agent. The team selects suppliers, who are segmented into four groups,

for development activities based on an analysis of their potential impact on quality and revenue.

The sourcing manager and quality manager identify a supplier‟s business problem. The trouble

usually falls into one or two of several buckets, including delivery, capacity, quality, cost, lead

time, product launch delays, or financial troubles. After getting the supplier‟s agreement for a

lean project, Medtronic‟s sourcing manager, quality manager, and change agent visit the supplier

to sharpen the project‟s focus and begin training a supplier manager who will lead the lean effort.

If the Neuro sourcing manager wants shared cost savings as a project goal, it is discussed with

the supplier before launching the transformation project. “We want to build and establish a

partnership of candor, honesty, and trust through the change process,” Errico explained. “The

supplier becomes the Medtronic change agent‟s customer.”

In the subsequent Do phase, the Medtronic change agent works on the shop floor with the

supplier‟s improvement team to further investigate the problem‟s current condition, establish a

goal, and provide training to the supplier‟s lean team as needed.

This phase can take several days to several weeks to thoroughly understand and “grasp the

current condition,” according to Errico. The Medtronic lean change agent and supplier team will

develop a “scope A3” defining the problem, targets, strategy, implementation timeline, and

needed resources. The scope A3 is supported by data the team acquires through observation and

measurement as it works to understand current conditions. This document becomes the business

case and instrument of accountability that Neuro and the supplier use to continue through the Do,

Check, and Act/Adjust phases.

The Neuro change agent and supplier team implement the improvements, which are reviewed by

the project stake holders, including quality engineers from Neuro and the supplier. The engineers

coordinate the quality system requirements, regulatory requirements, and notifications regarding

the improvement prior to implementation. “Quality and safety are top priorities and can‟t be

compromised,” Errico said.

The supplier and lean change agent must agree on a reporting method to Neuro along with

follow-up actions that will be done in the Check and Act/Adjust phases. As part of the

Act/Adjust phase, the supplier works with sourcing and quality managers from Neuro to monitor

the continuing effectiveness of the improvements and determine if additional help is needed from

the change agent. This review takes place during the periodic business review process.

Errico recently let LEI join him as he worked with two suppliers. One was moving from Plan to

Do; the other was in the Check phase.

Do Located a short drive from Medtronic‟s headquarters in Minneapolis, STI Surgical

Technologies, Inc. in St. Paul assembles surgical components into kits. Surgeons use the kits to

implant Medtronic devices in patients suffering from chronic pain. The company makes six

different varieties of kits, but three dominate the production schedule.

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A surgical kit containing 16 components.

STI orders components from suppliers. Associates working in a clean room assemble parts into

kits, built to Medtronic specifications. A typical kit includes instruction sheets, gloves, syringes,

needles, filters, gauze pads -- as many as 28

different components. Associates wearing hair

nets and clean room suits place components

into wells in a plastic molded kit tray, which

is covered by a sealed lid. Kits are sterilized,

then sent to an outside lab that verifies them

as sterile.

Following a strategic supplier development

meeting (Plan phase), Medtronic approached

STI about quadrupling kit volume. Medtronic

wanted to shift assembly from another supplier to STI, which would become the primary source.

The business problem for Errico and STI was how to handle the big jump in demand without

expanding the expensive 1,800-square-foot clean room or adjacent warehouse, and without

increasing the workforce of associates or managers. To become a strategic supplier, STI would

have to launch -- with Medtronic‟s help -- a lean transformation.

Lots of Lots “Our production was completely a batch-and-queue process,” recalled Jesse Scanlan, STI

manufacturing manager and project manager for the implementation team. Kits were built in

batches to customer forecasts, based on how many units STI‟s sterilizer could handle. Thus, if

the sterilizer could process 2,000 kits of a particular size every 10 days, the production batch size

was 2,000 kits.

The old process required one-and-a-half weeks of preparation followed by a half-week of

assembly. So, two weeks before a production run, associates picked components from a small

on-site warehouse. That meant 2,000 filters, syringes, needles, etc. had to be kept on carts in

warehouse staging areas and often in aisles. To prevent dust from entering the clean room with

the parts, warehouse associates put the waiting components in plastic bags then bagged them

again. The outer bag was removed just before employees brought the parts into the clean room.

Warehouse associates printed labels bearing kit lot numbers, contents, and use-by dates a week

ahead of production then staged them in the warehouse too. “We had multiple processes batching

up in preparation for our kit production,” said Scanlan.

Inside the clean room, employees broke down the 2,000-piece batches into lots of 50. They put

the 50-piece lots into plastic bins then moved them to a line of tables for picking and placement

into kits.

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Before: Associates prepared kit components in

batches, top, for batch assembly, bottom.

The 50-unit lots served as

quality control. For a kit

packager, the “number one”

defect is to ship a kit missing a

component, Scanlan explained.

If, for instance, assemblers

packed 50 plastic trays only to

discover a package of gauze

pads remaining in the bin where

there had been 50 packages, then

the lot of 50 kits -- instead of

2,000 -- would be inspected.

“We didn‟t have any escapes to

Medtronic for defects,” said

Scanlan, “but our internal

statistics showed that we were

catching things on the line so our

potential for an escape was

there.”

Overprocessing Shawna Pearson, a Neuro

supplier development lean

change agent, noted that STI

achieved “built-in-quality” in

batches of 50 kits which resulted

in significant handling waste and

lost production when an

abnormality was identified. A

key challenge the team faced

was how to transform quality verification from lots of 50 to lots of one in order to make kits in

one-piece flow. The new production system would have to verify that the right part was placed in

the right kit at the point of use.

The implementation team identified other wastes during this phase, which is the strategic Do step

for Neuro but a tactical Plan phase for STI. Much of the waste was caused by overprocessing.

For example, the time needed to stage components in the warehouse, double bag them, prep

labels and lids, remove outer bags before assembly, and other nonvalue-added activities added

up. The current-state analysis on the team‟s A3 showed that more than 75% of production time

was spent in nonvalue-added activities. In addition, associates viewed this work as burdensome.

The team identified much of the overprocessing waste by observation after receiving training in

lean basics from Errico and Todd Heeringa, also a Neuro supplier development lean change

agent.

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The STI lean team tested single-piece flow in a

basic simulation of a U-shaped cell, top. Later,

team members checked walk paths in a more

complex simulation, bottom.

But the first lesson for the STI

transformation team and senior

management wasn‟t a “how-to” session

on implementing lean concepts. It

focused on the need for leaders and

team members to create a culture of

continuous improvement.” This

commitment is required to sustain the

dramatic changes in manufacturing

practices and behaviors that were about

to occur.

The first lesson taught leaders and

associates the TPS philosophy:

 The customer is our top priority

 Respect for humanity

 Continuous improvement and kaizen

 Shop-floor focus

The philosophy is the foundation of the

TPS business model and management

system that Errico had experienced. It‟s

a key part of the training with all

supplier improvement teams because it

informs basic lean thinking elements

that guide every project. Elements

include “develop real-time problem

solving” or “build in single-piece flow.”

In turn, the interlinked elements form an

operating system.

Teams learn that the basic thinking is

driven by what should be the goals of a

competitive company. These objectives collectively become the team‟s perpetual goals or True

North:

 Highest quality

 Shortest lead time

 Lowest cost

The team received additional training as needed for analyzing current conditions and designing a

leaner future-state. The objective of current-state analysis is to gain a deep understanding of the

process and improvement opportunities so training included studying videos of team members

working.

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In a third simulation, many quick kaizens occurred

as operators offered more suggestions.

“Many lean practitioners will look at

every process and every work element

in a process by first-hand observation

10 times to get such key data as lowest

repeatable time and they‟ll run with

that,” said Errico. The video analysis

takes observation a step deeper.

For example, say the lowest repeatable

time on an operation is 60 seconds. But

during shop-floor observations, one

cycle takes 68 seconds. That difference

is called fluctuation. “What happened?”

Errico asked. “We can‟t ignore the

fluctuation regardless of the frequency.

“Statistically the reoccurrence may be

minimal, however, these abnormalities

are critical because they often create

opportunities for potential breeches in standardized work as operators work to recover time lost

to fluctuation. This may result in safety or quality issues. We can‟t bring those conditions into

the new process.”

Instant Replay To keep them out, Errico and the STI team watched videos frame-by-frame of operators

preparing and assembling kits. Studying the videos allowed the STI team to spot fluctuations not

identified by observation alone. This current-condition analysis included appropriate training

such as how to capture data and how to design standardized work. “I teach as we do it,” Errico

said.

He noted that a lot of fluctuation is eliminated simply by going from batch to flow production

because batching tends to cause variability. For instance, fluctuations in the time needed to break

components into lots of 50 will go away when assembly shifts to one-piece flow. But the

improvement team also focused closely on fluctuations in the time team members needed to pick

a part and place it into the kit. The picking and placement will still be part of the new process so

it must be understood in detail.

“That‟s the fluctuation that we really want to home in on and eliminate,” said Errico.

After analyzing current conditions in assembly and the warehouse, the team decided the future-

state process would have to follow this basic thinking:

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A pick-to-light system uses a green

light (top) to show operators what kit

component to pick. A red light and

alarm indicate if a wrong part is picked.

 Create and run an assembly cell to a level schedule and build every part every day.

The cell would have to be capable of

building all kits in single-piece flow to a

leveled demand of an estimated 400 kits

per day. Each of the three most popular

kits would be built daily by leveling

(averaging) demand by type and quantity

over a fixed period of time to eliminate

spikes. STI would hold the kits in

inventory then sterilize and ship them as

needed. Cell walk paths and operator

balance charts were created at three

different takt times for each kit the

company assembles.

 Develop visual indicators of production performance using standard work in

process, a heijunka system, hourly production status boards, real time Pareto charts of

abnormalities, min-max inventory levels by component, and real-time sterilization order

status.

 Develop real-time problem solving. The visual indicators would tell operators and managers where there were problems. But the team also called for installing a pick-to-light

system as a pokayoke (error-proofing) device. The system, one of the few capital costs of

the project, would signal operators what part to pick then confirm that the part was picked.

This would eliminate the pre-assembly sorting and prevent shipment of a kit without a

component. If the light system signals that an incorrect part was picked, an operator

summons the team leader by hitting an andon buzzer. The kit is taken from the line, parts

are reloaded into bins, and the leader investigates the error‟s cause. (In early runs, two

components were picked incorrectly more than others. The problems were fixed by a

change in component packaging.)

 Deliver components by tugger based on a kanban signal and a 60-minute delivery route to reduce the amount of parts needed line side and identify improvement opportunities.

 Create a first-in, first-out (FIFO) warehouse system by developing a Plan for Every Part (PFEP) and installing, FIFO flow racks, min-max levels, and an overflow area to visually

indicate if there was too much inventory.

Besides the pick-to-light system, the only other capital spending was for FIFO storage racks in

the warehouse, a right-sized sealing machine that could seal kits one at a time, and a pipe-and-

joint system for building new assembly cells.

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After: The Do phase at STI transformed clean room

kit assembly from batch to a single piece flow cell

with three walk paths.

Launch and Buy-In “The Do phase is like launching a rocket,” said Errico. “Before the actual launch date many tests

and simulations are conducted in stages to achieve a flawless launch.”

The improvement team built the first simulated assembly cell using cafeteria tables, lunch trays,

and cardboard. But real parts were used to prove the concept. Then operators ran the simulated

cell, offering improvement ideas.

“When we run these simulations, people are

buying in,” said Scanlan. “They are having a

a say in the process with their ideas

and suggestions.

The first simulation used people and

parts. The infrastructure of operator

walking paths, bins, and fixtures

wasn‟t incorporated until the second

simulation, which used a pipe-and-

joint system to construct a working cell

with actual workstations. “We build

the cell with the intent of using the

stations for production but we‟re not

production ready,” said Errico. “We

build it and run another simulation.”

Once again, team members had the

opportunity to run the cell, offer

improvement ideas, or raise

concerns. “Operators realized right

away they were going to have to

stand in the new cell to walk from

station to station,” Errico recalled.

“It was a major worry for them.” He

said operators accepted the new way

of working as they saw the

ergonomic design of the cell. In fact, operators noted that time went faster when moving through

the cell.

At this stage, operators made suggestions to improve station dimensions, part container flow, and

scrap handling. “Because of team member suggestions, we eliminated three workstations in the

cell,” Errico noted. “That reduced the cell footprint by 25% which is a huge cost savings due to

the expense of clean room square footage.”

A Plan for Every Part Building every part every day in the clean room meant the warehouse would have to deliver

every part every day to the clean room production cell. The first step was to create the PFEP

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(Plan for Every Part), a spreadsheet showing where every part came from, where it went, and

how it was used (See part of a PFEP from STI). A typical PFEP database contains these

categories:

Description Point of Use Location Standard Container Quantity Order Frequency Carrier Container Type

Length Width Weight

Daily Usage

Storage Location

Supplier Name

Supplier City Supplier State

Delivery Frequency

Transit Time

Using information in the PFEP, the team made changes to improve storage and retrieval,

including:

 More frequent deliveries in smaller quantities from selected suppliers

 Minimum and maximum levels marked on shelves and racks

 Parts storage in three levels from low density (larger parts) on the lowest level to high density (such as needles) on the highest

 One side of shelves or roller racks designated for retrieval only

 Parts stored in FIFO sequence

 Tugger delivery every two hours to a clean room interlock

The next step calls for creating additional cells in the clean room, using the same PDCA

STI Scorecard

Goal: Improve productivity, quality, and floor space utilization to handle 4x increase in demand

Improvements Comments

Assembly Team Members >50% reduction Freed team members were redeployed at STI

to help with demand growth.

Lead time from warehouse

to clean room

Before: 2 weeks

After: 2 hours

Components were double bagged and held for

2 weeks in the warehouse in lots of 1,500 to

2,000 per component. Now components are

delivered when needed based on kanban and a

60-minute delivery frequency. Warehouse

inventory is being reduced, by as much as 50%

on some components.

Rejected components per

month

50% reduction Achieved by real-time notification of rejects to

drive immediate problem solving.

Next Steps Create additional cells to handle 4x increase in

volume without increasing clean room or

warehouse space.

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Screener production went from a straight line with

eight operators, top, to a one-piece flow cell with

four.

approach. “What I appreciated with the Medtronic partnership,” said Scanlan, “is that they didn‟t

come in and say, „Hey supplier this is what you need to do.‟ A lot of companies will do that.

Medtronic said this is what we‟ve done; this is how it works. Then they teach us how to fish so

it‟s not just me leading the project. People on the shop floor have to be involved.”

Check A two-hour drive southeast of STI, is TSE where the process for making a kit component, a

cable used by surgeons to program implanted devices, has entered the Check phase. Located in a

small industrial park set among the farmland of Jackson, MN, TSE‟s plant builds the cables,

called screeners, along with other electrical components used in medical products.

TSE built the Medtronic cables, which

come in two lengths, on a traditional

production line, 33 feet long, five feet

wide, and occupying 175 square feet.

Raw cable arrived from suppliers in a

big coil, was cut to length, then

transported to the line where eight

team members performed 12

operations, including trimming,

soldering, and attaching contacts and

pins, to create the screener cables.

The line layout and batch processing

led to a number of wastes. For

example, operators left stations to get

materials and spent time untangling

cables passed from station to station

in batches. Work-in-process (WIP)

between each station fluctuated

between 20 to 80 cables. Work

content at each station varied greatly.

Operators often struggled to keep up

and felt overwhelmed as batches of

cables in WIP grew larger as the day

went on.

“Everyone was always busy, but they

were doing a lot of non-value added

work and resources were often

reallocated to address the moving

bottleneck,” said Errico.

The screener line was selected as the

initial lean project because

Medtronic‟s demand for the two

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cables was significant in volume and fairly level over time. After three months of analysis,

simulations, and redesigns, Errico and a TSE team had converted the line into a U-shaped cell,

following the same tactical PDCA process used at STI.

Leadership Involvement Errico checked performance in person weekly and in daily phone conversations with the team.

Three weeks into cellular production, he was accompanied on the weekly visit by two Medtronic

senior leaders: Bill Hooper, the operations and supply chain vice president, and Jeff Hans, the

global supply chain director.

The morning started in a training room off the shop floor with short presentations by plant

managers and cell team operators, who reviewed the cornerstones of TPS philosophy:

 The customer is our top priority

 Respect for humanity

 Continuous improvement and kaizen

 Shop-floor focus

Team members took turns presenting, based on the project‟s Scope A3. (See a sample A3

template.). First they described the problem: batch production was causing long lead times and

higher than optimal labor, burden, and material costs. They reviewed their basic thinking and

strategy:

 Run to a level schedule

 Develop real-time problem solving

 Develop visual status of production

 Build in single-piece flow.

They reviewed targets, current conditions, improvement strategy, a diagram of the new cell, and

the implementation timing schedule. Then the TSE team and Medtronic visitors headed to the

shop floor to see the current shift of operators run production.

Changing Behaviors Despite the presence of all the visitors, cell operators performed without a hitch. While they

worked, Medtronic managers focused on two clear plastic boards (“the glass walls”) attached to

the cell‟s metal structure on either side of its “U” bend. Performance charts posted on the boards

were “see-through” so they didn‟t block sight lines, an important consideration as the lean

system is deployed to other areas of the plant.

The charts tracked not only production output, but incorporated lean management practices into

the cell‟s daily operation, a key element of creating a lean culture, which is critical to sustaining

the cell‟s new way of working.

Depending on type, charts were filled out hourly by team leaders, supervisors, engineers, or

managers. They tracked hourly production, daily production, defects by type and station,

problems and corrective actions. But one, called a kamishibai board, showed how well

management was supporting the cell team.

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Cell operators drape any defects on horizontal posts that

are labeled by type.

The kamishibai board makes the lean management concept of genchi genbutsu or “go see what's

really happening” part of management‟s standardized work. It gives leaders from team leader to

plant manager a schedule for when to visit the cell and what to check. The board shows whether

or not the required audits occurred along with the results of the audit and, if necessary, notes

about abnormalities and countermeasures.

“The goal is to act right now if there is an abnormality,” said Errico. “If the team can‟t solve it,

engineering is notified about the need for a countermeasure.”

The left side of the board listed

five tasks to be checked every

hour, beginning at 6:30 a.m:

 Real time defect Pareto review

 Hourly count and countermeasure tracker

 Line review (check standardized work at each

station)

 Raw material and standard work in process status

 Review that all required support has performed

required reviews

The top row listed who is

responsible for performing the

check. The cell team leader does

every check, but at 7:30 a.m. and

Paper charts on a

prototype “glass

wall” …

… become transparent charts when the cell

begins production

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A heijunka post loaded by the team leader levels

production through the cell. Each section is an hour‟s

worth of work.

1:30 p.m. the production manager accompanies her. A representative from manufacturing

engineering and quality join her at 11:30 a.m. and 3:30 p.m. respectively.

A triangle in the box means an abnormality was observed and corrected. An X means that

corrective action is needed to fix an observed abnormality, which is noted on the corrective

action sheet hanging on the plastic board. A circle indicates that the right quality and right

quantity was being produced and the right standardized work was being followed. An empty box

means that team support didn‟t occur.

Sounding the Andon In its first week of operation, the cell hit 74% of targeted production, exceeding the 60% rate that

was anticipated. In a few days, output was at 98.7% Then it plunged to 87% when spattering

solder at one station contaminated cable contacts. “It wasn‟t‟ happening all the time, just some of

the time,” Errico recalled.

The cell team summoned its leader, who also supervised a nearby line, by ringing a bell. She

stopped production for a quick problem-solving discussion. Team members knew that spattering

is usually caused by cold solder, so they replaced the existing solder. But soon, the team member

at the station next to solder had rejected another cable for spatter. The team tried a different

solder gun, but the problem soon reappeared. Then a team member noticed that a small fan at a

neighboring station was blowing

towards the solder station. The air

stream was cooling the solder,

which spattered when it hit the hot

iron used to join contacts. The fan

was redirected; problem solved.

“It really is a paradigm shift from

where we were,” said Gary

Roberts, TSE plant manager.

“You have a cell that can compete

globally,” Hooper told TSE

managers and associates after the

cell inspection. “If you can

compete, we can compete.”

Adjust

In the Adjust phase, Medtronic‟s

Purchasing group will review

continuous improvement

performance with TSE as an

agenda item during periodic

business reviews. The review will

include a discussion on the

effectiveness of the improvement

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activity to determine if the supplier is sustaining and spreading the improvements or if it needs

additional support.

TSE Scorecard

Goal: Improve productivity, quality, space utilization through flow and visual management

Improvements Comments

Screener Team

Members

50% reduction Freed members were

redeployed to other

jobs in the plant.

Work-in-Process Before: 320+

After: 6

Floor space Before: 175 sq. ft.

After: 99 sq. ft.

Defects 50% reduction

Assembly lead time Before: 3 to 5 hours.

After: 6 min.

Time for 1 cable at

start of line/cell to

final assembly

Next Steps Improve 3 more product lines then improve setup time on the next

process, which is molding, so the cell can be coupled to the molding,

test, clean, and inspect processes. This will incorporate downstream

operations in the single piece / small-lot production flow.

Links with Related Information

Medtronic Neuromodulation is the second-oldest and fourth-largest of Medtronic's business

units. It products include neurostimulation systems and implantable drug delivery systems for

chronic pain, common movement disorders, and urologic and gastrointestinal disorders. Learn

more.

 Learn more about the PFEP, tugger routes, and lean material handling in the LEI Lean Case Study, “Following Four Steps to a Lean Material-Handling System Leads to a Leap

in Performance”

 Read LEI‟s Lean Leadership articles: a continuing series of interviews with executives on how they changed the ways they managed and led during lean transformations.

 The Lean Enterprise Institute (LEI) teaches many of the lean management concepts described above in workshops, Lean Summits, books and workbooks, and on its web site.

Join LEI‟s Lean Community for access to case studies, webinars, newsletters, lean

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lean.org Lean Enterprise Institute 16

NEUROMODULATION - SUPPLIER DEVELOPMENT (SD)

PROJECT; SELECTION, STATUS & TRACKING PROCESS

Objective:

- Align SD activities with business requirements defined by Director of Global Supply Chain

- Standard approach to the selection, status and tracking of SD activities

- Provide real-time visual status of activities to Neuromodulation stakeholders.

Standardized Work

Standard ManagementVisual Control

DGSC

SM

QM

SDLCA

- Standard Monthly Planning Meeting, attendance:

Director Global Supply Chain (DGSC)

Sourcing Manager (SM)

Quality Manager (QM)

Supplier Development Lean Change Agent

(SDLCA)

- SM & QM select suppliers for target SD activity.

- SM & QM Define business priority:

Delivery/Capacity

Quality, Cost, Lead time

Launch, Financially troubled

- SM contacts Supplier, gets agreement on nature of assignment.

(If shared cost savings is goal, SM negotiates terms with supplier

prior to start of activity.)

SM,QM,

SDLCA

&

Supplier

- SM, QM, SDLCA visit supplier and determine the following:

Engagement Theme/Focus

Commitment of resources

Timing Estimate

Supplier Project Manager

- SDLCA to give Lean Principal Overview that drives Lean culture:

Customer is the Highest Priority

Respect for Humanity

Continuous Improvement

Shop Floor Focus

- SDLCA & Supplier Team investigate current condition (5 to 10 days)

- Current Condition goal is to gain deep understanding of process

and opportunities.

- SDLCA provides appropriate Lean training / coaching

- SDLCA coaches Supplier through the development of

"SCOPE A3" -> Define problem & targets

Set Strategy

Determine resources

Detail timing

- SDLCA reports out to Neuro stakeholders (i.e. Buyer,SM,QM,QE)

SDLCA

&

Supplier

- Activity Implementation:

Supplier Team & SDLCA, together solve problem

and implement Lean improvements (duration varies)

Supplier, Buyer, QE, SDLCA review proposed

improvements

Supplier,SDLCA,QE weekly review project KTM

(Key Task Monitor)

Neuro Quality Engineer coordinates requirements

for Neuro Quality System and Regulatory impact.

- Supplier and SDLCAdetermine temporary reporting to Neuro for

monitoring of targeted results. Post implementation

coaching is also planned.

P

L

A

N

D

O

C

H

E

C

K

A

D

J

U

S

T

/

A

C

T

P D

C A

SDLCA,

QE, Buyer

&

Supplier

SDLCA

&

Supplier

- Supplier, SM and QM review ongoing effectiveness at Business

Reviews's and determine if additional assistance is required.

SM,QM

&

Supplier

lean.org Lean Enterprise Institute 17

lean.org Lean Enterprise Institute 18