Medical Design Briefs - July 2022 - 13

costs, and ensuring easier, ongoing
compliance with future regulations.
Costs. The system has dramatically
reduced the overhead associated with
manual actions needed for regulatory
compliance. With eDHR and easily
searchable data, Elekta can prepare for
and go through audits with far less time
and effort. The company also enjoyed
archiving cost savings from the first day.
Elekta estimates archiving cost savings
from printing, internal, and external
storage to be $85,000 after four years
and over $850,000 over 20 years.
Kaak says, " This is the start of a new
future for Elekta. The payback on the
MES is already coming from cost savings,
increased efficiency, and easier
compliance. We also benefit from freeing
up resources to enable our business
to innovate more and greater agility to
respond to our customers' demands. "
Coherent device data. Creating the
DHR is not that different in terms of
time and effort. However, in the previous
approach using folders, not everything
from a manufacturing order was in the
same folder. So, the team had to find
them in an external warehouse Besides,
it's far easier to check a label now that it's
attached to the eDHR than when it was
separate.
Unexpected benefits. Elekta expected
to reduce production lead times with
the MES, but according to Eweg, " That's
not where we found the real benefits.
Those are shaping up to be projects
that are not directly for MES but use
data from MES. The big benefits and
cost savings are in improving the quality
of our processes. "
MDRs and Labeling
Medical device records (MDRs) requirements
have become dramatically
more complex since the implementation.
Country-specific labeling and
translations for equipment manuals,
once needed only for China, are now
required for shipping to an ever-growing
number of countries (see Figure 7).
Checking the volume of specialized labels
for lot and serial numbers could
have led to improperly labeled items in
the field. Each month, Elekta's process
triggers 2,000 label print jobs, most of
them automatically, and the number is
growing.
As that was not a requirement pre- implementation,
the benefits are difficult
Medical Design Briefs, July 2022
As part of the project requirements, the implementation needed to be agile for phased product
introductions. (Credit: iStock/izusek)
Objective
Increase
Compliance
Improve Quality
Description
* Ensure using correct work instructions, trained people and
calibrated tools
* Use electronic (fire resistant) DHR
* Reduce inflow non-conformances (NCs)
* Force processes/procedures
* Force calibrated tools and trained people
* Ability to trace back issues and improve quality/reduce human error
Increase Efficiency * No paper (1200 folders a year reduced )
* Use data to reduce waste in process
* Improve accuracy and remove checks
Reduce Lead Time * Reduce actual lead time for Linac by 50 percent (33 CDs to 15
CDs) through visibility and process optimization
Reduce Cost
Compliance
* No physical signatures anymore
* Automatic checks
* MES is FDA proven, so audits are much easier and more cost-effective
* Improve readiness to adapt to future regulations
Table 1. Elekta expected the MES to help meet its operations performance objectives in various ways.
to measure. Eweg says, " We could never
have done it without MES. We connected
the label solution to the MES so we
can no longer make mistakes. "
Remote Work
Another unexpected event was the
COVID-19 pandemic. With MES in place,
the engineering and operations teams
have been able to collaborate seamlessly,
even when working from home. This ease
of working has also supported Elekta
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through a surge in demand for new smaller
applicator products.
MES has already supported Elekta's
healthy growth. By radiating the MES
data throughout the business, Elekta is
gaining benefits not only in the three
plants using it but across disciplines and
the enterprise.
This article was provided by Critical Manufacturing,
Austin, TX, an MES provider headquartered
in Portugal. For more information,
visit http://info.hotims.com/82323-342.
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Medical Design Briefs - July 2022

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