FACILITATING LEAN MANUFACTURING WITH MPM (MANUFACTURING

PROCESS MANAGEMENT) IN THE MEDICAL DEVICE INDUSTRY

Eric Vermillion
Tecnomatix Technologies
Keller, TX USA
eric.vermillion@unicam.com

ABSTRACT The result of this paradigm is the intense pressure faced by

Manufacturing Process Management, or MPM, is a
discipline widely recognized by industry analysts and
consultants as a key part of a successful product
development strategy. MPM allows companies to
effectively manage all of the resources, operations, and
components that go in to the production process. By doing
so, companies are able to effectively communicate between
all stakeholders in the process, including product designers,
engineers, and even contract manufacturers, and suppliers.
This helps to ensure that products are delivered to market as
fast as possible and at the highest possible quality.
In the Medical Device Industry, documenting process is
important both for regulatory approval and for facilitating
lean. MPM enables lean manufacturing by providing the
tools necessary to create an optimal assembly process and
flow, automatically calculate kanban sizes, and easily
transfer processes from line to line or factory to factory. In
today’s complex product development environment, the
ability to electronically document and archive this is
paramount to the success of an ongoing lean initiative.
In many cases, companies rely heavily on the services of so
called "lean consultants" that typically help with only a
single project or map the value stream in a static
environment. Because products and technology rapidly
change, the lean initiative often ends as time passes. By
using MPM in your manufacturing strategy you are able to
document, re-use, and automate the change process
inevitable in every manufacturing environment and Lean
initiative.
those responsible for manufacturing to expedite production,
improve quality, and improve efficiency. These are
daunting tasks that can be likened to giving someone only a
hammer and nails and asking them to build you a house. It
can be done, but there are much better tools and technology
available to make it faster and more efficient.
The challenges faced by manufacturing have driven the
need for a new methodology in managing all of the systems
and information used in bringing a product to fruition on the
manufacturing floor. This methodology is known as MPM,
or Manufacturing Process Management. MPM is a
mechanism for tying all the information involved in
effectively planning, simulating, optimizing, and executing
the manufacturing process and allowing for it’s share and
re-use throughout the manufacturing value chain, extending
not only from the shop floor, but to other factories within
the enterprise as well as trading partners such as suppliers
and even customers.
The illustration below describes where MPM lives within
the enterprise environment:

Key words: MPM, Lean, process documentation

BACKGROUND
For years, companies have invested heavily in enterprise
systems to control product information and to control
financial information and order flow. These systems,
known commonly as CAD, PDM, MRP, and ERP systems
address only the top-level need.

Typically the production environment relies on the groups

in control of these enterprise systems to share bits of
information with those responsible for the manufacturing
process. The systems they use for manufacturing are
typically incompatible, standalone, and non-scaleable.
 “what” “How to build the product?”
“How well are we doing it?”
E-BOM
MPM
CAD/
PDM
Managing
Define Simulate
CHALLENGES OF THE MEDICAL DEVICE
INDUSTRY
The manufacturing challenges faced in the medical device
industry are multiplied relative to other industries.
Regulatory restrictions, shorter product lifecycles,
competition, and intense time to market pressures are just
some of the drivers.
Lean initiatives have grown in popularity as Medical Device
manufacturers strive to get the product to market faster and
eliminate costly and error-causing waste throughout the
product lifecycle.
CORE PRINCIPLES OF LEAN
The root of Lean strategy is to get the right things to the
right place at the right time, the first time, while minimizing
waste and being open to change.
Lean manufacturing objectives are historically:
–Reduce response time to customer demand
–Reduce capital investments – and inventory
–Eliminate waste – in material and activities
This is a daunting task when viewed at the enterprise level
because there are so many stakeholders in the development
of each product. In the medical world, where product
lifecycles are often short and innovation is high, the
problem is exacerbated. Often adding to the challenges are
the inherent, often non-value added tasks, imposed by
regulatory agencies.
“when + where”
M-BOM
ERP
Optimize Execute
MPM CONNECTION TO LEAN
Historically, it was believed that software was not an
important part of Lean. Early advocates of Lean believed
software would become a non value add piece of a lean
initiative. Times have changed and technology has
changed. This way of thinking is rapidly dwindling and
many are finding that the use of software tools that map to
the Lean methodology are of great benefit and actually help
not only to effectively implement a Lean strategy, but
perhaps even more importantly, to sustain one.
A recent AMR Research report detailed the importance of
adequate software tools in Lean. “Companies outgrow the
approach of using Microsoft Excel to support lean
programs, and are increasingly searching for lean-specific
software” 1
The AMR report goes on to detail the key elements of Lean
software tools:
–Model: The ability to graphically represent a value
stream, perform simulations, and instantiate product family
tracking
–Calibrate: The ability to calculate and adjust appropriate
lean control points, including TAKT time, Kanban sizes,
supermarkets
–Operate: Support of the requisite data collection, as the
actual product flows through the value stream
–Improve: The ability to identify points of high variability
and the root causes in order to adjust and improve
Fundamentally, it is clear that a cornerstone to Lean is the
ability to effectively create, document, and execute an
efficient, demand driven, process. These are key elements
of MPM also.
1
“Lean Software Application: The Market is Finally Catching Up to the
Demand” AMR Research’s Bob Parker

Says AMR: “In terms of supporting, as opposed to
constraining, lean manufacturing principles, this is where
software applications really shine. The ability to model,
promulgate, monitor, and manage workflows is vital to
capturing the benefits of better process planning.”
HOW MPM FACILITATES LEAN
Administers CPR
Not CPR in the context that the Medical industry may
envision, but a Central Process Repository. Crucial to Lean
success is establishing a CPR as a means for archiving
knowledge, making it readily available and useable to all
stakeholdersas part of a persistent waste reduction strategy..
Often the CPR today is a person or series of people that are
subject matter experts on various facets of the production or
product lifecycle process. Lean does not teach us this is
wrong, but one caveat that is rarely accounted for by this
reliance on subject matter experts is basic attrition and the
unpredictable accessibility a live body poses in a global
workplace. Decisions can be made quickly and effectively
based on readily available, real-time information from a
CPR.
Most companies today would not consider doing business
without the help of a PDM (Product Data Management) or
Bill of Materials centralized control system. These tools are
viewed as mission critical elements in providing consistent
access to product data. Yet, oddly, the vast majority of
manufacturers choose to do business without a central
control system for production process information. If you
consider the fact that each piece of product data yields a
multiple of associated process data, it would appear that our
priorities need to be reviewed. After all, the best product
design in the world is nothing more than a wasteful data file
unless it can be manufactured. And the ability to
manufacture it effectively, on time, and at a reasonable cost
is the difference in that great product design becoming a hit
or miss. Again this is the domain of MPM.
Value Stream Mapping is a fundamental practice of Lean.
Many companies and consultants today make this a key part
of Lean training and Lean documentation. It often becomes
something of an art project that shows very well hanging in
the corporate hallways or at the side of the boardroom. The
inherent problem with this is the fact that the information is
outdated by the time the double-sided tape is applied to the
back of the masterpiece and hung on the wall. The factory
is, and for good and desirable reasons, a rapidly changing
place. Frequent changes occur to products, as well as
changes to the technology available to assemble them. This
is especially true in the medical device world.
The ability to effectively map the Value Stream is
important. The ability to rapidly adapt this model to
product and process changes is more important. The
inability for companies to adapt to these changes after the
Lean consultants have left is one of the primary reasons
Lean initiatives die on the vine, lacking proper care and
feeding. MPM gives companies that have Lean initiatives
the tools needed to not only effectively implement a Lean
strategy, but more importantly, to make it live on.
How do we know it’s Lean?
After the Lean initiative has begun and Value Stream has
been mapped it is time to try it in a real-life scenario. A
manual “guess and check” method is the most common way
to test and validate the new initiatives. This is an inherently
wasteful process.
Another key element to MPM is the ability to tie the Lean
production plan directly to a simulation tool. The ability to
not only plan for a Lean process, but to validate and test it
via simulation is critical in the effort to implement changes
quickly and at the lowest cost.
Integrated tools are key
MPM seeks to improve the implementation of Lean
strategies by providing an integrated set of process planning
and collaboration tools. One of the challenges most
companies face today is the disparate systems and groups
that each have their own level of subject matter expertise
and their own unique set of tools for accomplishing their
tasks.
Any Lean initiative should include the following integrated
MPM capabilities to:
ƒ Analyze throughput and bottlenecks
ƒ Map/Improve factory/line layout and production
flow
ƒ Reduce set-ups via better process analysis
ƒ Analyze workplace design
logistically/ergonomically
ƒ Calculate and optimize Kanban sizes, supermarkets
etc.
ƒ Analyze drivers of process cost
ƒ Optimize movement and placement of all resources
ƒ Create and publish electronic work instructions that
meet CFR part 11 specifications.
ƒ Optimize throughput via simulation and task
management
Having an integrated set of tools for modeling and
calibrating Lean functions is itself a reduction of waste and
very much Lean thinking.
CASE STUDY
In one example of how MPM has helped with effectively
implementing a Lean strategy, let’s look at a major multi-
billion dollar, multi-national, global manufacturer of
industrial electronics controls. While the proprietary nature
of the processes we will analyze, prohibits using the
company’s name, it should allow a good representation of
how MPM can be used as part of a Lean strategy.
The project initially began with the company defining the
need to find a way to both increase productivity and
improve performance in their global factories. It was
determined that Lean manufacturing principles, if deployed
properly, could help to achieve these goals. Based on the
global reach and complexity in terms of the number of
factories and products it was determined that an effective
way to design, communicate and deploy a standard
company production system was needed. The company
determined after thorough benchmarking that utilizing an
integrated MPM solution would be the best way to
accomplish this. This standard production system would:
ƒ Be based on Lean manufacturing principles in
order to focus on customer needs and avoid all
activities without added value.
ƒ Define global guidelines with which to design
industrial processes.
ƒ Include a panel of standards to encourage re-use
and best of breed activities.
Let’s look at the areas that this particular manufacturer
choose to include as part of their Lean initiative and how
MPM was able to help them accomplish these goals.
Lean Design
The company sought a way to, earlier in the product
lifecycle, evaluate different product/process architecture
scenarios in order to:
ƒ Help simplify the industrial processes
ƒ Reduce the number of components used
ƒ Take into account product variants as late as
possible.
ƒ Validate assembly feasibility and simplify
assembly sequence before designing fixtures and
manufacturing equipment
ƒ Convert full assembly sequence into short
assembly sequences, eliminate all operations
without added-value and simplify fixtures
definition
Virtual Product Representation
MPM was able to help them accomplish these goals by:
ƒ Enabling product visualization throughout the
enterprise without need to know or learn complex
CAD systems
ƒ Facilitate web-based graphical product
communication among manufacturing, design, and
marketing.
ƒ Easily simulate different scenarios during the pre-
production phase.
ƒ Optimizing the impact of product variants on
process planning.
ƒ Reduce the number of fixtures modifications
needed before manufacturing.
ƒ Visualize very early the real assembly sequences of
the product and assign them to the appropriate
factories or lines.
ƒ Better collaborate with fixture suppliers
Lean Manufacturing
This company also knew that improving techniques used in
process planning and layout needed to be accomplished. As
part of the lean initiative, they sought a better way to
optimize process design and line layout during the design or
re-engineering phases. They believed in order to
accomplish this, they needed to have an effective way to:
ƒ Easily define all components to build an effective
bid for a new product (time, costing, quality
requirements)
ƒ Easily define value-add operations, time waiting,
transportation and logistics, sequence of orders,
check points.
ƒ Easily define design of workcells and lines by
using standard libraries and rules, enabling re-use
and best practices replication.
ƒ Validate effectiveness of line design and run
various “what-if” scenarios by using simulations
tools.
MPM helped them to accomplish these things through:
ƒ Enable effective value stream mapping
Value Stream mapping

ƒ Standardizing the methodology to design processes
and lines
ƒ Standardized libraries for architecture definition
ƒ Simulation of differents scenarios and update
easily the changes
ƒ Reducing the cost of detailed studies by reusing
existing projects
ƒ Capitalizing the know-how by creating a
“knowledge database”
ƒ Simulation and effective analysis of ergonomics
concerns
Ergonomics Analysis and 3-D line Design
ƒ Improved shop floor and operator response through
improved ease of use and readability of work
instructions
Measurable Value Delivered
Some of the tangible results of the process were reductions
in the following areas:
ƒ Significant savings due to better fit between
customer need needs and capital investment.
ƒ 5% reduction in tooling costs related to less
modifications needed during design phase.
ƒ 33% reduction in product ramp costs related to
expensive prototyping and improper set ups.
The customer has successfully deployed an MPM solution
throughout much of their enterprise. It remains an on-going
initiative.
COMPLEXITY IS INCREASING
We are all certain that the medical device industry will
continue to fuel the need for Lean manufacturing and Lean
organizational focus.
1. Regulatory guidelines will not go away or
decrease. Having the ability to effectively
document processes, best practices, and work
instructions with necessary revision and change
control will remain and intensify as a need.
2. An aging populace will continue to fuel demand
and growth in our industry for the foreseeable
future.
3. Growth will force many challenges and changes to
medical device manufacturing such as outsourcing
challenges, globalization, M&A activity, and
others.
4. Time to market demands, increasing product
complexity, more new products, and shorter
development cycles will work together to make
production improvements critical to success of
many organizations.
All of these factors contribute heavily to the need for
effective tools to plan for change in a Lean environment.
WHO CAN BENEFIT FROM MPM
What types of organizations stand to benefit the most from
using MPM as part of their Lean strategy? Every
organization is different, but these types of organizations
will have the fastest return on investment in MPM
technology:
ƒ Organizations with Lean initiatives that lack
rollout tools (internally and across supply chain)
ƒ Organizations knowledgeable on Lean and about
to implement it
ƒ Organizations that are extending Lean principles to
product and process engineering activities
CONCLUSION
There is little question today that integrated software tools
are key to successful Lean implementations. The
methodology known as MPM is today the most widely
accepted and tested mechanism for addressing these
integrated software needs.
As Marc Halpern of Gartner put it, “We’re seeing
manufacturing process management tools playing a
significant role in reducing cost and time to
manufacturing.... It’s part of managing that product content
in such a way to deliver that maximum
return on investment.”2
Medical device manufacturers have an opportunity today to
be proactive and implement the tools that will enable and
fuel the growth of tomorrow or they can try to play catch up
later. In closing, I think Ken Brant of Gartner put it best:
“…Manufacturing Process Management is just a no-
brainer.”
2
Gartner’s Manufacturing and Supply Chain Summit June
2002, Chicago