With the costs of research and
development escalating, and
talented staff in short supply,
the challenge to remain competitive is
a difficult one for medical equipment
companies. Which is why an increasing
number of firms are adopting a
business strategy that involves handing
over the burden of the development
and manufacturing to a third party.
This frees the business up to focus on
its high-level research and marketing
efforts, says Carl Lidén, corporate sales
manager at PartnerTech.

“Medical equipment companies put a
lot of capital, time and other resources
into developing research, but a contract
manufacturer can take care of the
development of a complete system, from
involvement in writing the
specifications, through certification and
production,” he says. “It can deal with
the entire range of activities involved,
including development, prototyping,
production, service in the field and
maintenance; it is a one-stop shop. That
leaves clients to concentrate on the core
aspects of their business such as
research and marketing activities.”

Advantages of contract
manufacturing

There are a number of benefits from using
a contract manufacturer. One is a tight
control of costs. “We understand the
customer’s requirements and the cost
drivers,” says Lidén. “In medical products
the cost drivers are set at the very
beginning of development. Because of our
production experience, we know what will
cause cost and quality issues over the entire
product life cycle. So we involve customers
early on in the process to discuss
manufacturing costs and hit their targets.

Another advantage is that the contract
manufacturer is free from internal
departmental pressures to cut corners in
order to get to market on time.

“When a firm designs a medical
equipment product it always has a
marketing date in mind for introducing
that product,” says Lidén. “All the
initial development steps aim at
meeting that deadline. But, because of
the focus on a particular date, it is easy
to make the wrong decisions for the
product in the long term. Marketing
demands push the design and the
regulatory fulfilment in a way that can
have negative implications for the long-term
production.

Functional silos are not a problem at
the contract manufacturer, either. “Many
of our bigger customers have to contend
with functional silos, ‘walls’ between
departments, from marketing, to
development, to production and so on,”
says Lidén. “That doesn’t happen in
contract manufacturing, we have just one
interest; having the best product finished
on time. There is no question, for
example, of different departments being
concerned about who is going to get the
most prestige for a particular project.”

Excellence and experience

Medical device firms are unlikely to hand
over development and production without
being satisfied that the contract
manufacturer can deliver on a number of
levels, including regulatory issues, technical
expertise, and global distribution and after-sales
service. PartnerTech takes particular
care with all three aspects of the medical
equipment production process, says Lidén.

“We have a highly experienced team
with the technical skills and knowledge to
deal with quality issues, and understand
and meet the regulatory demands of the
various authorities,” he explains.

“PartnerTech has centres of excellence
based in Scandinavia, for example, with
expertise in system integration, electronic
components and enclosures, and which
focus on meeting worldwide regulatory
demands, such as QSR, PAL and CE.”

The firm also offers lower-cost
solutions for high-volume manufacturing
at production units in Poland and China.
The majority of the company’s units are
certified according to the ISO 13485
medical device standard – a regulatory
requirement for medical devices
distributed in a number of international
markets, and necessary for CE mark
approval in the EU.

In today’s global economy, perhaps one
of the most important aspects of
PartnerTech’s service is its worldwide
reach. ‘We take care of distribution of
products all round the world, working with
the customers’ ERP systems,” says Lidén.
“Through our customer centre concept and
our locations across the globe, our
customers can communicate with a contact
locally, and still have access to the whole
range of activities within PartnerTech.”