Case History Feature
Case history feature for Integrated Software Design
on Johnson & Johnson, written by Richard StewartMedical Device Manufacturer
Manages Labeling Details In-houseLabeling Software Helps Johnson & Johnson Design, Print High-Quality Labels on Demand
Nothing appetizing comes in Bob Nelson's "pizza box." The manager
of package development for Johnson & Johnson Interventional
Systems Company designed the flat, thin box to hold a coiled stent
delivery system — one of a variety of sterile medical devices the
company manufactures for the treatment of arterial blockages and
diseases of the vascular system.
Inside the box is a balloon catheter, fitted with an expandable,
stainless-steel stent. Once positioned inside the artery, the balloon is
filled with liquid, expanding the stent, which is similar in design to a sort
of tubular, chain-link fence. The implanted stent remains in place after
the catheter is withdrawn. Cardiologists and radiologists around the
world use them in cath labs to hold open diseased or blocked arteries.Packaging Challenges
From a start-up operation eight years ago, Interventional Systems has
taken a leadership role in stent technology. Its line has grown to more
than 100 product codes of its patented Palmaz™ and Palmaz-Schatz™
balloon-expandable Stents and delivery systems. Packaging requirements
range from a small packet to hold an unmounted coronary stent, to long,
narrow boxes for large-diameter, stent-mounted catheters.
But even more of a challenge to Nelson than packaging these products
is labeling them. Label requirements for sterile medical devices are
extensive and have to follow strict FDA guidelines, as well as Johnson &
Johnson corporate policy. Dating and batch information is included on
each label, along with bar codes, graphics, and detailed product
descriptions (in seven languages). In some cases, as many as four
different labels are used for a single product. This requires "on-demand,"
small-quantity printing.
Product labeling could have become a dilemma that would grow as fast
as the company's product line. Did the answer lie in stocking hundreds of
different preprinted labels? Buying them in small quantities meant paying
high prices. Plus, storage and tracking of the labels would create more
problems.Finds Software Solution
"I recognized that I was going to have to do something about labeling four
years ago," Nelson recalls. "I did some legwork to find out our options and
what other people were doing. It was obvious that producing our own
product labels, with a computer program developed specifically for that
purpose, was the way to go."
Nelson selected a program from Integrated Software Design (ISD) that
was the forerunner of the software he uses today, called Barney Ellis™. The
program facilitates the design of labels and manages the labeling operation.
It combines variable bar codes, text files and graphic files — storing them
on a PC in multiple databases (486/66 DX2 with 240 MB hard drive is
used for the labeling operation).
The integrated software includes scalable type fonts and all the standard
bar code symbologies. (Johnson & Johnson has required bar coding on its
products since 1989.) And Barney Ellis can access data stored in other
software programs, such as spreadsheets, word processing files, and
databases. Plus, it has its own database program for storing, cross-referencing
and retrieving information, and a paint program for handling graphics.
Adhesive-backed blank label stock is preprinted in a variety of formats
and sizes by an outside label printing company near Interventional Systems'
Warren, N.J. facility. The labels are imprinted with company ID, address,
and other generic information that's common to a family of labels. The
blanks are fed through high-speed thermal transfer printers from Zebra
Technologies to produce high-quality product labels as they are needed.Learning the Software
Kay Ronan, Interventional Systems documentation specialist, experimented
with the Barney Ellis software for two years before tapping the full potential
of the program's powerful database control. "We were using a separate label
file for each product code, and a lot of the information was repeated, with
just a very few things changing on the labels," she remembers. "I wanted to
start using the database control to save file space — and time — but I
needed help in setting it up."
At a three-day training course on Barney Ellis that she attended at ISD's
headquarters in Mansfield, Mass., Ronan got the answers she needed. "We
were able to talk one-on-one with the trainers; they helped me figure out how
to start working with databases. The course was great. It was three full days
of training. You really came out saturated."
Just by reading the Barney Ellis software manual, Ronan was able to pick
up enough information, initially, to begin designing labels. But she highly
recommends the training. "The classes helped me understand the full power
of the software program. I picked up a lot in a very short time and learned
how to work faster with Barney and more efficiently."
For an annual fee, ISD provides very good telephone support, Ronan
reports. "I get answers to any questions or problems right away. They'll call
me back to make sure I've figured out the problem. They're really good
about following up." She uses an assigned priority code to speed up response
time.Printing Labels On Demand
To print, a technician selects a label file by its item number and enters the
desired product code. Product-specific information is pulled from the
database. Then the technician is prompted to enter lot and dating information,
which is combined with the database fields to create primary and secondary
bar codes.
A WYSIWYG (what you see is what you get) representation of the label
appears on screen, complete with text and bar codes, just as it will appear
when printed. Health Industry Bar Code (HIBC) is used. The technician
enters the number of labels needed, and Zebra Z-140 printers go into action,
producing a thousand or more labels in a matter of minutes.A multi-level password security feature of the Barney Ellis software prevents
access to the program and databases by unauthorized personnel. Ronan
considers this to be an important feature, considering all the data that is
required on the company's labels. "Our technicians can change printers and
set up features without actually getting into the label files or the databases,"
she explains. "There's no chance that any data can get changed or deleted
by unauthorized users."Computer Graphics Next
Nelson is planning to add another dimension to the labels this year — actual-
size graphics of the products, in both collapsed and expanded views. The
graphics will be stored in the computer as PCX files and linked to Barney
Ellis. These product-specific illustrations will replace drawings of generic
stents that are now preprinted.
Interventional Systems Company has come a long way from the original,
manual labeling system Nelson had devised in the early, "make-do" days: a
word-processor, laser printer and paper cutter. Then the company was just
beginning to get FDA approvals for its products. Most of them were being
used in clinical trials, not commercially. So the complexity of the labels was
not as great.
Today, however, Nelson feels that a manual operation could not meet
the company's demands for sophisticated, high-quality label printing that
Barney Ellis and the Zebra printers provide. And having all the labels
printed outside is totally out of the question, he says. "Barney gives me the
capability to do everything we need to do, including validation. It keeps
the records and files straight and makes labeling a cleaner operation for us."
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