Medical Design Briefs - July 2022 - 8

Manufacturing System Upgrade
How to drive value?
Quality
Value =
Cost
* Process management
* Performance metrics
* Actionable insights
* Automation
Fig. 1 - Elekta's equation for MES value focused on quality and cost improvements
* Adherence to guidance
* Outcome measurement
* Automation and standardization
Mark Kaak, Elekta's vice president
of global manufacturing, says, " We reviewed
several MES suppliers. We selected
Critical Manufacturing, [an MES
provider based in Portugal], because
they have excellent reporting. The company
is flexible and willing to partner
to ensure we get the solution we need
over the long term. It also scored highest
overall in our evaluations. "
Other requirements Elekta specified
for the MES included:
* Internet accessibility.
* User-friendly, configurable graphical
user interface (GUI).
* Ability to interface with other business
systems, including enterprise resources
management (ERP), product life cycle
management (PLM), and customer
life cycle management (CLM).
* Data flow to Elekta data warehouse.
* Easy updates to system programming
that could be performed by Elekta personnel
for rapid changes.
MES Integration Rollout
Because of the MES, Elekta can now make products to order, optimize inventory, and readily share
best practice business processes. (Credit: iStock/Nikolai Mentuk)
produced 1,200 folders a year that the
company needed to store for 21 years.
Further, manual methods and paper
records did not provide visibility into
processes and inhibited data analysis for
continuous process improvements. As a
result of these inefficiencies, products
had long lead times.
Evaluating Modern MES Options
Elekta envisioned a new MES to support
its business priorities. Specific improvements
were needed in quality control,
manufacturing lead times, supply
chain performance, lean manufacturing,
and employee engagement (see Table 1).
Elekta's " must have " criteria for MES
solutions included:
* Rapid and faultless execution of
production processes.
8
* Electronic device history records
(eDHR).
* FDA compliance.
* Complete tracking and traceability.
* Flexible and configurable process/
line setup with easy adjustments.
* Copying of configurations.
* Digital work instructions in multiple
formats, not just PDF.
* Integration of employee certification.
* Manufacturing process records.
* Localization, such as the ability to
use Chinese characters for the plant
in China.
* A single solution and interface for one
way of working across all sites.
Elekta conducted a thorough evaluation
of several MES providers to the
medical device market to meet these
requirements.
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Elekta rolled out the new MES across
three sites: Veenendaal in the Netherlands,
Crawley in the UK, and Elekta Beijing
Medical Systems in China. As part of
the project requirements, the implementation
needed to be agile for phased introductions.
The modularity and scalability of
the MES allowed Elekta to deploy a single
instance at the three sites over time at a
rate to suit the company's business goals.
The total elapsed time from specifications
to the third site's go-live date was one year.
" We started with Veenendaal because
it has a complex, job-shop-style production
layout with 1500 different products
moving across 50 stations. The project
went exceptionally well. Critical Manufacturing
met all of the project sprints
on time. We implemented the first plant
in eight months, the second in nine
months, and the third plant in China in
12 months. In fact, it was hard for us to
keep up with testing all the deliverables, "
says Kaak (see Figure 2).
Engineers spent over a year configuring
the system for each product, including
entering all the work instructions
into the MES. However, maintaining
those configurations in the MES requires
less than two people who also have other
responsibilities, so those employees reported
a noticeable decrease in frustration
and improved user experience with
the new system.
Medical Design Briefs, July 2022

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Medical Design Briefs - July 2022

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