MARKETPLACE: OUTSOURCING OUTLOOK
Finding a Qualified Extrusion Vendor
Experience in the medical market and knowledge of current manufacturing trends and regulatory issues are
among the most important criteria to look for in a contract extruder.
Yvonne Klöpping
WHEN LOOKING FOR an extrusion supplier, always begin with
the end application in mind, advises Richard Jokinen, Sales Manager EMEA, Creganna-Tactx Medical (Galway, Ireland; www.
cregannatactx.com). Then identify step by step what is needed to
get there. The extruder you ultimately choose should offer capabilities that meet your needs as they change throughout the production cycle, he says. For instance, when a project is in the early
development stage, the supplier should be able to provide quick
turnaround of prototypes. In steady-state production, however,
consistent quality and delivery performance are critical. Another
consideration is the extrusion vendor’s ability to manage safety
stocks and consigned inventories when the product is in steady-state production, Jokinen adds.
Medical device experience required
Experience in the medical market is probably the most crucial
criterion for a vendor. “Long-term experience in the medical
device arena is required because of the specific documentation
and product quality requirements,” says Ralf Ziembinski, Head of
Application Technology Business Team Extrusion/Tubing at Rau-
medic AG (Helmbrechts, Germany; www.raumedic.com). “For
most medical tubing applications, high precision is required when
it comes to tubing dimensions, but also for the material param-
eters of the polymers,” he adds. A number of factors challenge the
expertise and resources of extruders serving the medical device
market. These include
the increasing spe-
cialisation of extruded
parts, ever-tighter tol-
erances of medical tub-
ing, growing demand
for micro-tubing and
multilayer extrusions
and increasingly strict
regulatory oversight.
“Device manufac-
turers rarely have the
time to educate vendors
that lack prior [medi-
cal] experience on the
criteria for qualifying
Micro-extrusions, ever-tighter tolerances and
increasingly complex designs of sections are
among the current trends in medical extrusion,
says Mark Ostwald of Helix Medical.
Increasingly tight tolerance requirements are pushing engineers to “think
outside the box,” says Kenneth Koen of Creganna-Tactx Medical.
as a supplier of parts or assemblies for this industry,” Creganna’s
Jokinen says. Conversely, the ability to proactively assist device
manufacturers in the development process can save time and
money for both parties.
Keep it clean and safe
When manufacturing medical devices, it is important that the level
of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapours are kept to a minimum. Hence,
producing medical devices under cleanroom conditions is almost
a given these days. “Cleanroom production, generally under Class
10000 conditions, is obligatory for medical extrusion, and specific
monitoring of the biological and particle contamination of the
product is essential,” says Raumedic’s Ziembinski. He adds that
it is vital to guarantee cleanliness and purity in the production
process as well as in the materials used.
Another important consideration is the certification required
to produce for the medical device industry. “A prospective supplier should have an understanding of the regulations and quality
systems involved in manufacturing medical device components,”
says Mark Ostwald, General Manager, Helix Medical Europe KG
(Kaiserslautern, Germany; www.helixmedical.com). He recommends looking for a supplier with the necessary ISO certifications
