Barcodes and handheld computers ensure quality assurance for MED-EL ear
4 August 2009
Tyrol-based manufacturer MED-EL and its subsidiary Vibrant-Medel
develop, produce, and market the high-technology ear implant hearing
devices. Strict US and European regulations require seamless product documentation and
traceability of every individual part throughout the life cycle of the
product. This process has been streamlined by a system integrated by B&M
that uses Datakey ERP middleware and Honeywell Dolphin wireless mobile
computers with data capture by 2-D barcodes. The system reduces manual errors, eliminates paper
documentation, and increases the security of all logistics processes.
In 1975, two Austrian scientists and the founders of MED-EL, Prof.
Erwin Hochmair and Dr Ingeborg Hochmair, developed the first hybrid
multi-channel ear implant. Since then, the university spin-off has
developed into a globally active enterprise that offers a broad range of
ear implants for various types of hearing loss. The MED-EL product range
comprises the cochlear implant system Maestro, the EAS hearing system
for combined electric acoustic stimulation, and the Vibrant Soundbridge,
the world's first approved middle-ear implant.
The challenge of FDA-compliant quality assurance
"The Medical Devices Act requires us to document every single
implantable part from production to the entire life cycle of the implant
as well as the patient’s life,” explains Dr Walter Fimml, IT Manager at
MED-EL. “As more than 25 digits needed to be entered manually in some
instances (5 or 6-digit S/N), errors were unfortunately introduced
during the input of serial numbers.
"According to the Medical Devices Act, we must be certified according
to ISO EN 13485, which is a lot of work. Currently, more than 20 people
work in MED-EL's Quality Management (QM) department alone. In addition,
there are QM officers in the individual departments. Almost ten percent
of our staff members are responsible for quality management and quality
"Every year, FDA officers conduct audits that take several days,”
explains Werner Goth, Warehouse Logistics Manager at MED-EL. “For us,
this means that we have to prepare documentation and take numerous audit
steps, all of which ultimately serve the security of the patients."
Cross-sectional drawing of the ear showing
the position of the ear implant.
Tracing goods logistics at MED-EL
An ear implant system consists of implantable and external parts.
Implantable parts require sterile packaging, which is a challenging base
for printing barcodes. The miniature component groups and parts must
bear the serial number and be labelled in the appropriate local language
to enable the patient to identify the package contents. The systems are
shipped to hospitals and physicians in handy cases along with software
and documentation. Logistics therefore play a key role in the
distribution of these highly sensitive products.
The components are transferred from the incoming goods department to
the main warehouse, where they are either directly selected for
production or for external partners. The products are prepared for
dispatch in the warehouse. "Unlike conventional warehouses, the
requirements for our warehouse are very high," adds Goth.
"An advanced degree of responsibility and precision is vital for our
shipping staff. Our warehouse team is made up of specialists who conduct
customer-specific configuration, assembly, and electronic adjustment
tasks for each order. In this context, they now benefit from the support
of the B&M wireless data system."
MED-EL first contacted integrator B&M at a professional
trade show. "We were looking for a wireless data system that would meet
our advanced security requirements,” recalls Dr Fimml. “The B&M team
understood our needs and was able to meet these to provide a practical,
functional, and secure solution."
MED-EL already had an encrypted high security wireless local area
network (WLAN) installed, and only needed additional access points for
the warehouse area. The company chose a system using 2-D barcodes and Honeywell
B&M delivered Honeywell Dolphin 7850 wireless computers and connected
them to the Navision Enterprise Resource Planning (ERP) system via
DATAKEY middleware. From the DATAKEY control station, the warehouse
manager can selectively issue picking orders, for example in order to
release specific orders to particular individuals, depending on the
qualification of the team members.
Screenshots of the ERP system on the Dolphin 7850
Apart from facilitating administration, this approach is more secure
than the previous system which used printed order slips which virtually
anybody could take. "We did not encounter any major problems during the
project rollout and we were very satisfied with the project flow," explains Dr Fimml, IT Manager at MED-EL.
"We have eliminated manual errors and the process has become
faster and more secure."
Barcode scanning using the Dolphin 7850 mobile
Serial number tracking
The mobile data collection begins with incoming goods. Most of the
supplied parts arrive in cardboard boxes that are already marked with
barcodes or are labelled at the company upon arrival. MED-EL uses code
39 for box labelling. Boxes that are not already labelled are equipped
with barcode labels after registration. The label printing is triggered
directly from the mobile computer.
One of the most outstanding features of the MED-EL warehouse is the
great variety of products, most of which are stored in Rotomat systems.
Currently more than 6,000 different products are kept in stock for the
production of MED-EL ear implants. There is also a storage area for
auxiliary supplies and one for packaging and marketing material.
When the implant leaves production, it already has a serial number
and a documented manufacturing history. Before an ear implant customer
set is assembled, the serial number is scanned. The scanning of the
serial number plays a significant role in minimizing documentation
"The Honeywell mobile computers are now directly connected to
Navision ERP system over the DATAKEY middleware, and all tasks can be
performed on site using the mobile computers such as querying orders,
scanning goods, correcting quantities, etc,” explains Alois Greiderer,
ERP Manager at MED-EL. “This saves the team a lot of time and reduces
"The mobile data collection mainly serves the following objectives:
the error rate during data collection should approach zero, part of the
paper documentation will be eliminated, and the security of all
logistics processes will be increased," adds Dr Fimml.
Except for China and Turkey, no other country explicitly demands
barcodes on medical devices — even in the USA, no standard is expected
to be adopted before 2015. "Naturally, we want to have a system that is
sustainable and internationally recognized,” says Dr. Fimml.
“Therefore, we currently use the DataMatrix code for all small parts.
Should this code not be adopted as the standard in 2015, we will have to
change it. Nevertheless, we will be able to draw on our long-standing
experience and get started on the basis of an operable system."
"Due to the high quality requirements, every change to our system is
very time-consuming,” adds Werner Goth. “For instance, changes to the
sterile packaging of the implants are subject to elaborate approval
processes. Therefore, we expect the full migration to paperless picking
to take at least three years. Until then, to be on the safe side we will
use both methods, ie wireless computers and order slips."
At any rate, the introduction of the B&M wireless system forms the
basis for consistent, seamless data, batch, and serial-number input and
paperless logistics handling. In keeping with MED-EL's traditional
style, this will be followed by further steps on the road to perfection.
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