| intern summary |
|
 |
Endocardial
Solutions Saves $15,000 through Waste Reduction
| Company |
Endocardial Solutions,
Inc.
St. Paul, Minnesota |
| Results |
Reduces 1.4 tons
of solid waste per year. The payback is less than
a year with first year savings of about
$15,000. |
|
Process
Background
Endocardial Solutions, Inc. (ESI) produces diagnostic technologies
for tachycardia arrhythmia, a heart abnormality. One component
of the technology is a catheter that is inserted into the
patient’s heart, via the leg, to detect abnormal cell
reactions when the heart is stimulated. ESI employed 96 people
at the start of the project.
Advanced medical technologies often have
a short market life. Competition maintains a high rate of
product innovation. ESI anticipates that their catheter will
only be in production three years before they replace it with
an improved technology.
Incentives for
Change
The company anticipated producing catheters at a rate of 3,120
per year by the end of 1998. By the end of 1999, they expect
to increase production by 250 percent.
In developing the catheter, engineers over
designed the packaging. They wanted to ensure product safety
and to prevent problems with getting the product on the market.
The project’s goal was for the MnTAP
intern to optimize packaging. The intern needed to ensure
that packaging would provide the same performance while using
less material and saving ESI money. Savings in this summary
are based on producing 3,120 catheters a year.
Considerations
The catheters are delicate instruments and are expensive to
produce. Packaging could not be a cause for product failure.
Because ESI is ISO 9001 certified and is manufacturing a medical
device all of their products and processes must be strictly
documented and validated.
ISO certification requires ESI to document
every step of the assembly process and verify that procedures
are reasonable. Each catheter must be tracked via a history
record. If anything is wrong with a device, the problem can
be traced back to the manufacturing process to determine the
cause of the problem.
The U.S. Federal Drug Administration (FDA)
must approve all medical devices for use in the United States.
Any significant changes to a product would require ESI to
submit the modified catheter for FDA approval.
Packaging the
Catheter
The catheter looks like a three-foot long tube with a thick
handle on one end and a small balloon on the other. Each catheter
is laid out at full length in a plastic tray, then enclosed
in two Tyvek pouches and a chipboard box.
Catheters must be sterilized before being
delivered to customers. Each batch of catheters sent out for
sterilization must be verified as sterile. This was done by
including a dummy catheter—known as a simulant—inoculated
with pathogens, along with the actual catheters.
Five catheters and one simulant were placed
together in a shipping box. Full pallets were sent out for
sterilization. After treatment, the simulant is checked for
complete sterilization. When returned to ESI, the catheters
were individually placed in inventory. The six-pack boxes
and simulants were discarded.
Options Implemented
Package Labeling
Instead of putting product information stickers on each shipping
carton then inspecting them for accuracy, ESI now has the
information printed on the boxes. An extra step is eliminated
from the process, saving labor costs and the opportunity for
error. The change cost roughly $1,040 to create the printing
plates.
Savings: Labor savings were
not calculated.
Lightweighted Trays
The individual catheter trays were made thinner and design
features were added to give more structural support to the
tray. Reducing the thickness from 0.07 to 0.062 inches decreased
the weight of the polystyrene by 12 percent. It cost $2,100
to retool the tray mold and to verify the structural integrity
of the new tray design.
Savings: Plastic use is reduced
by 431 pounds a year, saving $1,480.
Sterilization Packaging
Step 1: Simulant Substitute
The sterilization company sells "test packs"
that can substitute for the simulants. Using these smaller
and less expensive test packs eliminates the need for ESI
to build simulants, allowing for increased catheter production.
The test pack is placed on the pallet instead of being packaged
with the catheters.
In order to switch, ESI had to prove that
the test packs were equal or better indicators of sterilization
than the simulants. The test cost $12,830.
Savings: The cost difference
between the simulant and test pack yields a savings of $27,700
per year.
Step 2: Packaging Reduction
Once the simulants were replaced by test packs, the catheters
could be packaged directly into their five-catheter shipping
cartons. These boxes do not have to be reopened and inspected.
The six-pack box used only for shipping between ESI and the
sterilization company was completely phased out at no cost.
Switching to test packs also provided more
space on the pallets for catheters, allowing ESI to sterilize
larger loads.
Savings: This option eliminates
2,350 pounds of solid waste per year and saves $1,440 annually.
Additional savings from increasing sterilization throughput
was not calculated.
Results
ESI will be reducing 1.4 tons of solid waste per year. Their
implementation costs were approximately $16,000. The payback
is less than a year with first year savings of about $15,000.
When production reaches anticipated levels in 1999, the project
will be saving ESI $76,500 a year.
Additional Options
Reviewed
Single Catheter Shipping Boxes
ESI determined that they will only sell their products
in multiples of five. This marketing decision helped to avoid
the need to store boxes of various sizes.
Catheter Tray Design
Improvements
The current catheter tray is very long and bulky. Coiling
the three-foot long catheter tube would make it much more
manageable for shipping and reduce the packaging required.
Coiling the catheters would allow more of them to fit into
a sterilization chamber, further reducing the cost of sterilization.
Tests would be needed to determine the minimum
radius that the catheter can be coiled before it begins to
retain a permanent curve. However, revalidating all of the
processes and testing done on the catheter and tray would
be costly. This option will be pursued when the catheter technology
advances with the next generation of product. The new technology
must be tested and FDA approved and the coiling can be verified
for minimal extra cost at that time.
More Information
MnTAP has a variety of technical assistance services available
to help Minnesota companies reduce and manage their industrial
waste. If you would like assistance or more information about
MnTAP’s Intern Program, call 612.624.1300 or 800.247.0015
from greater Minnesota.
This project was conducted in 1998 by MnTAP
intern Steve Miller, a mechanical engineering senior at the
University of Minnesota.
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