Originally published in the Proceedings of the SMTA International Conference, Orlando, Florida, October
7 - 11, 2007.
SUPPORTING A FULL PRODUCT LIFE CYCLE IN THE MEDICAL
INSTRUMENTATION MARKET
Kevin Stokes and Paul Plante
Kimball Electronics Group
Jasper, IN USA
kstokes@kimball.com
ABSTRACT
Medical equipment manufacturers face unique challenges in
outsourcing projects both because of the regulatory
environment and also because of product life cycles which
often can be up to 10 years in length. This presentation
looks at some of the key challenges electronics
manufacturing services (EMS) providers specializing in this
area must routinely address:
ƒ Significant variance in volumes over the life cycle
of the product
ƒ Periodic specialized engineering support needs
ƒ Extensive test support capabilities
ƒ Procurement strategies which support both cost
competitive sourcing of “commodity” materials
plus very specialized custom parts or third-party
hardware
ƒ Proactive identification of component obsolescence
issues, and requirements for end-of-life buys
and subsequent stocking of that material for several
years
ƒ Fast response time in product development and
repair depot activities
ƒ Extensive documentation support capabilities and
required third-party quality certifications
ƒ Ability to support fairly long end-of-life cycle
requirements with limited ability to cost effectively
redesign the product
ƒ Product validation requirements which limit both
the Approved Vendor List (AVL) and the ability to
change processes and/or equipment on the
manufacturing floor
ƒ The ability to retain and disseminate traceability
and manufacturing quality data on request as long
as the product remains in use in the field.
Additionally, several project examples illustrating ways that
an EMS provider and its OEM customers have teamed to
address these issues will be discussed.
Key words: Medical product outsourcing, EMS, lifecycle
management, contract manufacturing.
INTRODUCTION
The challenges for medical equipment manufacturers
continue to increase. There are several key market trends
which are increasing the complexity of product lifecycle
management (PLM) including healthcare cost reduction
focus and the impact of RoHS legislation on component
availability. At the same time, the core drivers of product
development and manufacturing complexity, regulatory
compliance considerations and healthcare provider
purchasing processes are not changing.
While outsourcing can tap the expertise needed to address
these issues, it is important to recognize that not every EMS
provider business model adequately addresses the PLM
challenges inherent in medical device manufacturing. This
paper will look at key service requirements which should be
considered in selecting an EMS provider, discuss key
processes that can help address these issues and then
provide examples of ways these processes have been
applied to support specific medical equipment
manufacturing needs.
KEY SERVICE REQUIREMENTS
Areas where medical products tend to vary from consumer
electronics include:
ƒ Volumes over the life of the product
ƒ Engineering support
ƒ Obsolescence management
ƒ Product test requirements
ƒ Post-manufacturing response time
ƒ Regulatory compliance.
In selecting an EMS provider, it is important to determine
whether or not the systems and processes in place are
aligned with these service requirements.
Production Volumes
While consumer medical devices may have relatively high
volumes, there are many products which run in the low-to-
medium volume ranges. The regulatory qualification
process and healthcare service provider procurement
practices often create a product demand pattern that runs at
low volumes for an extended introduction period, ramps to
volume and then has an extended low volume end-of-life
period. The low volume portion of the product cycle doesn’t
fit well in every EMS business model and the variances in
demand need to be carefully monitored to ensure that ramps
to volume are supported and that any inventory issues that
evolve from varying volumes are adequately addressed.
Engineering Support
Engineering support can also be more complex. As the
product is developed there is a need for Design for Success
engineering support, which includes Design for:
• Manufacturability (DFM)
• Testability (DFT)
• Six Sigma (DFSS)
• Life Cycle Management.
While most EMS providers don’t actually manage the
product qualification process, there may be requirements for
greater detail in support documentation related to design
improvement recommendations. Over time, sustaining
engineering support becomes important as long product
lifecycles can generate significant obsolescence
management issues.
Obsolescence management
It is not unusual to see lifecycles of up to 10 years in
medical capital equipment. This presents significant PLM
challenges as consumer product lifecycles typically run less
than two years and off-the-shelf component lifecycles are
driven by these higher volume electronic products. As a
result there is often a need to either specify and support
custom components or manage the inventory costs
associated with lifetime buys of critical components as they
enter end-of-life. From an EMS provider selection
standpoint it can be valuable to understand how the
contractor’s business model addresses extended PLM
requirements. Another growing area of complexity is driven
by RoHS legislation. Although medical devices are
exempted from EU RoHS requirements, many component
manufacturers are discontinuing leaded parts. Additionally,
different regions of the world are creating different types of
legislation. For instance, China doesn’t exempt medical
devices from its RoHS requirements. As a result, it is
important to select a contractor who has both a robust
procurement system capable of identifying component
obsolescence or availability issues early, and the ability to
support conversions as required over time.
Test Support
Medical products have a range of test challenges. There is
growing use of RF technology in medical devices and this
drives a need for RF test expertise in product development,
production and post-manufacturing support services.
Additionally, large-scale capital equipment may have
complex functional test requirements. When repair depot
and refurbishment are required, often the production
contractor represents the most cost effective choice for
repair depot as volumes may not justify two sources or
duplicate sets of specialized test equipment. As a result it is
important to understand EMS providers’ ability to support
both production test requirements and the technically more
complex troubleshooting and test requirements driven by
long-term repair depot activities.
Post-Manufacturing Support Response Time
Post-manufacturing support is a different skill set from
production support. There is both a logistics and a customer
service element. With medical products, there is often a
contractual commitment on repair depot response time.
While technical support capabilities in this area are
important, it is also important to evaluate a contractor’s
processes and track record in supporting the logistics side of
this requirement.
Regulatory Compliance
Regulatory compliance drives two evaluation issues. First, it
is important to understand whether or not the contractor has
a cost effective and robust process for meeting medical
history recordkeeping and traceability requirements. Third-
party registrations such as FDA or ISO 13485 demonstrate a
commitment to understanding and meeting these
requirements. However, companies without these
registrations may also have robust support systems. This
drives the second point of evaluation. In long-lifecycle
products the scope of work often grows over time. A
contractor building PCBAs today who doesn’t need
medical-specific registrations may see the scope of project
grow to a point where these registrations are necessary,
particularly if post-manufacturing services are added.
Evaluating the contractor’s commitment to medical industry
business can be valuable in determining whether or not the
company is the best choice for a long-term project.
SYSTEMS WHICH ADDRESS THESE CHALLENGES
Kimball Electronics Group (KEG) Medical Solutions has
seen these challenges within its customer base. Addressing
the challenges has involved a combination of core processes
which are used with all customers and medical-specific
support tailored to the needs of low-to-medium volume
customers.
Two core processes which support medical product
manufacturing are New Product Introduction (NPI) and
Transfer of Work (TOW).
The NPI process addresses the issues which arise as a new
product is entering the facility. Its goal is to ensure that all
issues associated with project start-up are addressed and
that longer-term PLM issues are identified early. It can
encompass product development support or simply address
the issues associated with launch of a new project.
The NPI process actually begins during the bid phase which
includes both a feasibility review and identification of
potential design support issues. Once a bid is won, there is a
design concept review which may include design
improvement recommendations or simply validate
documentation and quote assumptions, depending on the
project requirements. The production launch phase may
include a product verification review and/or a product and
process validation review. Key points addressed in this
phase can include:
ƒ Design Failure Modes and Effects Analysis
(DFMEA)
ƒ DFT/DFM review and recommendations
ƒ Identification of special product or process
characteristics
ƒ Material specifications
ƒ Concept Verification (CV) testing
ƒ Highly Accelerated Life Testing (HALT)
ƒ Production of engineering samples
ƒ Design intent prototypes
ƒ Design Verification (DV) testing
ƒ Preliminary capability testing
ƒ Engineering drawing release
ƒ Approved Vendor List review
ƒ Bill of Material (BOM) review
ƒ Process Failure Modes and Effects Analysis
(PFMEA)
ƒ Development of a control plan
ƒ Validation testing
ƒ Manufacturing feasibility studies
ƒ Capacity verification
ƒ Supplier tooling
ƒ Pilot build
ƒ Process Validation (PV) testing
ƒ Intellectual Property (IP) security.
The degree of complexity is typically driven by project
requirements and customer preferences. The key focus is on
analyzing project requirements and planning appropriately.
Once the project enters production startup the focus is
placed on executing and controlling production. There is a
focus both on creating systems which monitor internal
metrics and customer feedback which tie to a corrective
action process. There is also focus on measuring quote to
actual costs, and in measuring progress towards jointly
agreed upon cost reduction goals. Once in volume
production, the emphasis expands to include a focus on field
performance and continuous improvement.
The TOW process is designed to support transition between
KEG facilities to support product needs such as volume
changes, cost reduction, etc. Its starts with an internal
analysis by the program manager which defines costs, risks,
needed team members and action plan. Once the analysis is
approved, the team is identified and strategy meetings
begin.
TOW is a pull process with the program manager at the
receiving facility driving the TOW. There is a kickoff
meeting to make initial assignments. A color-coded (red-
green-yellow) action register is used to monitor activities.
The register is available via the Company’s intranet to all
project personnel. There is a formal weekly, and in some
cases daily, review depending on project requirements.
Typically the receiving plant will send key personnel to the
sending plant to drive knowledge transfer. These personnel
normally include engineering, quality, program management
and others as needed. During these visits the team will also
witness production, review prior corrective actions and
document potential issues.
Once assumptions are validated a safe launch plan is
created. This plan defines a product validation process used
for a 500 piece production run. The customer receives the
safe launch plan and qualification units for their analysis.
TRANSLATING CAPABILITIES INTO SPECIFIC
PROJECT BENEFITS
Example 1 – NPI Support
A developer of physical therapy products needed
manufacturing support.
The product is built in KEG’s Tampa, Florida facility and
shipped to the customer’s distribution center in Texas. It
includes both a PCBA and a unit build. The build facility is
both FDA registered and ISO 13485 certified.
Initially, DFM/DFT recommendations were made. Over
time, other areas have been identified for improvement as
both production metrics and field data have been analyzed.
The component engineering team actually studied the
product in the field prior to making recommendations. The
keypad was redesigned to improve durability. This has been
designed as a staged improvement. Currently, the pad is
reinforced with a molded plastic support plate, but in the
next product generation the full set of redesign
recommendations will be implemented. A switch
substitution has also been recommended to improve
performance in the field. Additionally, specific parts have
been targeted for cost improvement opportunities.
The program team has also identified several potential
component obsolescence issues. To support PLM analysis,
the Company uses Part Miner as an internal tool and
discusses projected lifecycle issues with critical component
suppliers. The product currently contains lead, but is
scheduled for conversion to RoHS compliance in 2008.
A key benefit of this relationship to the customer has been a
smooth ramp to volume and the ability to tailor the use of
engineering resources. The customer sees product
development and marketing as a core competency. EMS
engineering resources have been integrated as needed to
support design improvements for subsequent generations of
product, identify cost reduction opportunities and support
market-driven requirements such as RoHS conversion. The
project started out with lower volumes as it was qualified in
various markets for insurance coverage. As this volume now
doubles or triples a scalable process is in place to ensure
demand is met.
Example 2 – Extended Product Life Cycle
In this example, the customer is a manufacturer of medical
imaging equipment and the products are image resonator
units used with CAT scan equipment. The project has been
in place at the Tampa facility for more than a decade. The
customer operation has been acquired by larger medical
manufacturers twice during that period and the cost
justification for continued outsourcing has remained viable
during post-acquisition cost analysis.
Project complexity drives a range of cost challenges. Each
product type has a top level Bill of Materials (BOM)
averaging 200 line items and contains four complex printed
circuit assemblies whose BOMs each average 400-500 line
items. The project currently supports six different product
types which have a varying range of volumes at different
stages in the life cycle. Initially, each model runs 5-10
units/month during the product introduction which may last
over a year. Once the market accepts the new product,
typical volume increases to 30-50 units per month. Long
unit life spans also drive a requirement for extended end-of-
life production support in lower volumes.
The Tampa facility supports new product development,
assembles and tests the printed circuit assemblies, and then
builds the image resonator unit. Elevated temperature burn-
in is provided on certain products. This is integrated with
the final product at the customer’s Midwest manufacturing
facility. During the first year of production, it is not unusual
to see as many as 100 engineering change notices (ECNs).
Installed units must be supported over the entire life of the
product. When replacement part stock is no longer
manufactured or available in end-of-life inventory supplies,
KEG acts as the emergency repair depot, accepting returns
directly from the hospital and troubleshooting the failed part
until repaired.
As mentioned in the previous example, the facility building
the project is both FDA registered and ISO 13485 certified.
This level of quality system focus is not required for this
project from a regulatory standpoint, since the product is
integrated into a larger unit elsewhere. However, having a
highly compatible quality environment has made it easy for
this customer to add additional product to the project and
has also supported growth of repair depot support activities.
The large component count, typical production volumes and
long life cycle make clustering common projects extremely
cost effective from both a total cost and an inventory
management standpoint. The high service/high quality/fast
response environment of the medical imaging equipment
market makes co-locating prototyping, production and end-
of-life support advantageous because it supports improved
response speed and communications efficiency.
Example 3 – Sustaining Engineering Support
The customer is a medical imaging equipment manufacturer
who wanted assembly support in close proximity to its
Silicon Valley location to augment its lean manufacturing
philosophy in final assembly. The end product is an
intravenous ultrasound system for which KEG’s Fremont,
CA facility performs assembly of intelligent data acquisition
and display subsystems.
The Fremont facility represented a cost effective option
because it is located in the same general area as the
customer’s manufacturing complex, its assembly services
are focused on mid-volume complex builds, it has
developed LCD display technology expertise for medical
and industrial markets, and it provides dedicated
engineering support.
The facility’s initial role in the end product lifecycle was to
support the customer in redesign of the display subsystem,
which included conversion of the original off-the-shelf CRT
monitor to a 17” SXGA LCD display. Industrial design
(aesthetic blending with the end product), electrical and
mechanical compatibility with the original monitor, and
best-in-class image quality were the key project
requirements.
All goals were accomplished, resulting in a highly
compatible LCD monitor in a cast aluminum housing with a
unique tilt/swivel mechanism. This solution also provided
the customer with extended lifecycle for the end product,
and design control of the display subsystem. As a result, the
customer subsequently outsourced projects to manufacture
additional computer-based data acquisition subsystems in
the same end product.
A few years later when an electronic video board in the
display became unavailable, the facility provided sustaining
engineering services by identifying the OEM offshore
manufacturer and securing the limited number of the boards
remaining directly from their factory to keep customer
production deliveries on schedule. During this period while
the offshore boards were being depleted, the engineering
team designed and qualified an electrically and
mechanically comparable replacement with image quality
improvement and domestic hardware/firmware control to
minimize overall display assembly redesign.
The team also assumed responsibility for agency re-
certifications, minimizing the involvement of the customer’s
engineering staff who was engaged in next generation
product development. Migrating to a custom, domestic
board design minimized costs and provided a reliable, long-
term component supply line for the life of the customer’s
end product.
The facility continues to supply the customer’s final
assembly operation with 3-piece subassembly kits on
demand. Although the associated computer assemblies
were originally build-to-print, KEG’s engineering team now
assumes the sustaining engineering role to address
proactively periodic component end-of-life situations with
critical supply line management and engineering support.
This includes identifying possible replacement components,
qualifying supplier sources, qualifying component
performance and compatibility via engineering tests and
reports, securing inventory, and managing engineering
change processes both internally and with the customer as
needed.
Benefits to this customer include a smaller manufacturing
footprint and a minimal raw inventory storage space
requirement in their facilities. Additional benefits include
high quality assemblies, on time deliveries, quick reaction
time to customer special needs, and minimization of
customer engineering time related to component life cycle
management. A key challenge that the team has been able
to address is the obsolescence issue caused by use of off-
the-shelf components with lifecycles much shorter than that
of the medical product.
CONCLUSION
Outsourcing long lifecycle medical equipment is not
without challenge. However, a foundation of robust core
processes combined with an understanding of this segment
of the medical market’s unique regulatory and market
dynamics can result in teaming efforts which support
customer goals for market entry, product sustainability and
continued cost reduction. To achieve the optimum outcome,
both the OEM and EMS provider need to carefully analyze
project scope and long-term requirements.

Example 4 - TOW
In this final example, the customer was a manufacturer of
medical patient monitoring devices. KEG’s Tampa facility
is producing the PCBAs. The project has a mix of product
families with varying degrees of market-driven margin
sensitivity. The customer saw value in migrating some
product offshore but was very concerned with the potential
for intellectual property theft.

The end result was that a large PCBA with some manual
assembly content was selected for migration to KEG’s
Thailand facility. It was a mature product with low ECN
requirements. Volumes are variable, but with the labor cost
reduction, maintenance of inventory buffer stock in Tampa
is cost effective. The functionality is still programmed in
Tampa and final functional test is in Tampa. From a
traceability standpoint, KEG will serialize the board in ways
that identify factory of origin. Thailand is FDA registered
and ISO 13485 certified.

KEG’s TOW process has been used for the migration

planning. The Thailand engineering team travelled to
Tampa to watch the board in migration prior to running a
qualification production run of 50 boards in Tampa. Tampa
provided the kits for that production run to minimize
variables. A 500-piece validation run followed the
qualification run. A logistics value stream map has also
been drawn up. In addition to analyzing logistics flow,
product handling requirements, shipment container and
packaging have been analyzed to determine if any potential
issues exist that may impact product quality given the
change in transport methods.

Once customer validation is complete, ramp-up begins and

Thailand will begin sourcing material to the AVL.

Customer benefits include the ability to smoothly transition

mature product to lower cost manufacturing regions as their
market cost dynamics change. The Thailand facility offers
the same level of regulatory compliance as the Tampa
facility. The TOW process ensures that there are adequate
qualification procedures and that all issues that could
potentially impact product quality are carefully analyzed
and addressed.