Originally Published EMDM November/December 2001
PRODUCT UPDATE
Automation
Eliminates Guesswork in Catheter Processing
Catheter manufacturers can benefit in many ways from recent advances in production equipment.
Jamie Graham
To err is human,
to automate, divine. Automation simplifies catheter manufacturing processes,
reducing operator error, shortening production times, and, ultimately, cutting
costs. Most areas of catheter processing have been affected by the automation
trend, from leak testing to hole punching to coating. Although many small catheter
manufacturers cannot afford to automate all of their processes, mechanizing
even a small segment can prove economical.
Interface Associates
Inc. (Laguna Niguel, CA, USA) provides OEMs with a wide variety of catheter
processing equipment, and company president and CEO Josef Stupecky notes that
automation is a primary concern for both large and small OEMs. “We are
continually adding new devices to our product line, at an approximate rate of
three to four new projects per year. The technology aims to mechanize or automate
a variety of production or assembly steps that are currently performed manually,”
says Stupecky. “Our combination of equipment supply and technology transfer
even helps start-up companies with minimal experience in the catheter field
to shorten the whole cycle of development.”
 |
|
Operating
on compressed air and electricity, the 2000XL adhesive dispenser from
EFD International is suited for use in balloon attachment. The unit can
be preprogrammed with up to eight different dispensing settings.
|
The company recently
introduced several new devices, including a marker band swager, balloon wrapping
fixture, multistation burst tester, multistation leak tester, and tubing cutter
and splitter. “All of these devices are highly specialized and designated
only for use in balloon catheter production,” says Stupecky. “We want
to provide a drastic reduction in production times; substantially improve the
quality, performance, and appearance of the finished product; provide high production
yields; and reduce the number of rejects.”
Eliminating, or
at least reducing, human error has always been a goal in catheter manufacturing,
but it was not feasible until automation moved to the forefront of product development
trends. Steve Royce, president of Crescent Design (San Diego, CA, USA), a burst
and leak tester manufacturer, says that he, too, has noticed a heightened interest
in automation in the last few years. “Our customers appear to be looking
for ways to fully integrate and automate their product testing in an effort
to improve testing efficiency and reduce data collection errors,” he says.
The company’s hydraulic burst/leak tester uses water as the working fluid,
which makes the tester extremely sensitive to small leaks. There is no stored
energy in the system, so a burst lesion in simulation looks the same as it would
in actual patient use.
Likewise, EFD International
(Dunstable, Beds, UK), a supplier of adhesive dispensers for balloon attachment,
recently developed an eight-memory dispenser to take the guesswork out of dispensing
adhesives. “We designed the 2000XL to have enough automation to reduce
the instances of human error,” says Gary Cordier, technical manager at
EFD International. The dispenser uses microprocessor circuitry to remove variability
from critical adhesive-dispensing processes, so that catheter assemblers can
apply identical dots or neat, controlled beads.
As catheter applications become smaller and more complex, SEBRA marketing representative Judi Laurel says OEMs need equipment that has precise, repeatable, and consistent process controls. SEBRA (Tucson, AZ, USA) supplies RF welding systems that can be used to tip and weld thermoplastics into finished catheters. “As represented by our customers, the trend in the industry is to equipment that has process controls, is reliable and quantifiable, and provides the highest quality end product,” says Laurel.
Streamlining Production
Despite the allure
of error-free production, many companies cannot afford to fully automate all
of their systems. For these companies, semiautomation makes more sense, according
to Daniel Fowler, general manager of S-Y-M Products Co. (Stamford, CT, USA).
“Many times the wish for sophisticated automation cannot be cost justified
until high production levels are reached, so semiautomation is used to increase
production,” says Fowler. S-Y-M’s Mini-Winder is semiautomated. The
newest model has computer preprogramming so the user does not need to reprogram
the machine for each of its products. Also, variable speeds and “pause
and resume” functions assist the operator and speed the packaging process.
Companies unable
to automate all of their processes are still searching for machinery and services
that will facilitate catheter production. For catheter producers with limited
resources, Søbygaard Machine Design (Naestved, Denmark) provides equipment
that allows smaller companies to be self-reliant. “We see a growing demand
for simple and reliable tip-forming and punching equipment, making it possible
for the producers in many countries to go into the catheter market with a relatively
low investment and a low-skilled labour force and obtain high quality and output,”
says Henrik Søbygaard, managing director.
Manufacturers looking for equipment and services to streamline catheter production should consult the following pages, which feature the newest products and services from some of the top suppliers in the medical device industry.
Copyright ©2001 European Medical Device Manufacturer
