Boston Scientific Corp.: IW Best Plants Profile 2005

Boston Scientific Corp.: IW Best Plants Profile 2005

In Good Hands: Employees take their work personally because they know lives are at stake.

Boston Scientific Corp., Wayne Operations, Wayne, N.J.

Employees: 270, non-union

Total square footage: 282,145

Primary products: abdominal and thoracic grafts

Start-up: 1961

Achievements: In 2004 employee suggestions led to cost savings of $1.4 million. On-time delivery is 99.8% based on customer request date.


Manufacturing at the Boston Scientific, Wayne, N.J., plant can be intensely personal: David Delgado's parents were in a serious car crash in which his father, Joseph, died and after which his mother, Rose, had an emergency arterial graft. After talking to the surgeon that performed the aortal graft, Delgado was content and assured in the knowledge that the graft was made by the people he has lunch with every day. The graft saved her life. Dave is a senior manufacturing engineer at the Boston Scientific Wayne plant. Now, two years after the operation, the 270 workers at the plant remember that they contributed to keeping Dave's mother alive.

IW's 2005 Best Plants

See the other winners of IW's 2005 Best Plants award and find out how they made the top ten.
Boston Scientific Wayne is a leading producer of highly engineered surgical grafts and fabrics that are used to replace and patch human blood vessels and -- this is the reason Delgado was comfortable knowing that his company's product would be used for his mother -- the 270 employees at the facility work with the knowledge that lives are in their hands.

The northern New Jersey facility originally was a producer of decorative fabrics used in upholstery but, since 1954, when it first developed a synthetic artery for the treatment of vascular occlusive disease, it has shifted its focus to work exclusively on medical devices, and has made significant contributions to advance the uses of synthetic grafts and patches for the repair of vascular diseases. The facility's work is done with the surgical precision expected from a medical device producer whose products literally save and lengthen lives, and the company is managed to foster that precision in every way.

Most of the plant's nearly 51,500-square-feet of manufacturing space is devoted to clean-room operations, in which surgical grafts are produced in cutting, sewing, collagen-impregnating and finishing operations. Packaging also is done under strict clean-room conditions. The company operates its own knitting and weaving looms to control production of the fabrics it uses; and it is moving toward production of its own medical-grade of yarns from which those fabrics will be made. It also operates a production line for making plastic tubing from DuPont's Teflon, a material that is notoriously challenging to work with but which is preferred for a line of peripheral arterial grafts.

Lee Weatherwalks and Jose Guirales work to improve performance of a loom used to make vascular grafts.
Without a moment of hesitation, Patrick Walsh, vice president of operations for the Boston Scientific Wayne plant, says the most important asset and aspect that ensures his facility's success is its people. Walsh has led the plant to streamlining its production operations, and has incorporated total quality management (TQM), lean manufacturing and Six Sigma techniques, and manufacturing benchmarking and kaizen methodologies, but he says those techniques are meaningless without the personnel at the facility.

"People. That's what it comes down to," Walsh says, adding that Boston Scientific Wayne has a significant program dedicated to ensuring that it will have the high quality personnel it needs into the future.

In an analysis of operations in 2004, the plant found that it was not readily prepared if the vital managers and professional employees who were responsible for its success were to suddenly leave. In fact, Boston Scientific Wayne's replacement readiness for critical management and professional positions was at 22%, which meant that it had fewer than 25% of its essential employees backed-up by others who could fulfill their responsibilities on short notice. "To address this, we have taken several actions, including pre-recruiting for several critical positions for which we assessed a relatively high turnover risk, and targeted development plans for employees to accelerate toward replacement readiness," Walsh says. The company's goal is to improve replacement readiness to 40% this year, and to 50% in 2006 for those critical positions. Additionally, Boston Scientific Wayne initiated an apprenticeship program to ensure that it will have people with the critical skills necessary for its key production areas, such as knitting, weaving and yarn warping. The company's goal is to have complete replacement readiness for those positions by 2006.

Svetlana Filipovic hand sews branch grafts onto the main aortic vascular graft.
Boston Scientific Wayne launched its lean manufacturing program in 2002, and eliminated $500,000 of costs associated with excessive labor and inefficient space utilization in its first year. In 2003, the company focused on continual improvements in manufacturing and added several new products with the use of lean manufacturing tools, and in 2004, it shifted the focus of those streamlining techniques toward its office and support functions.

Throughout the process, Walsh says, he has kept an eye on the asset he most values -- people. "We have never lost or let anyone go through the use of lean manufacturing procedures," he says. Although he acknowledges that production jobs have declined by 11.8% in the past three years, he says that people who left the company departed on their own or were let go because of typical performance issues. People who held production jobs that streamlined manufacturing reduced the need for were shifted to other areas at the Wayne facility. A combination of growth and the introduction of new products are expected to lead to a 7% increase in production jobs in the coming months, he adds.

Well-trained people and their dedication to quality are helping the Boston Scientific Wayne facility to address recent quality issues that led to a product recall in June. (Editor's Note: The product recall put into question the inclusion of this plant as one of IndustryWeek's Top 10 Best Plants. However, the editors at IndustryWeek feel that this issue was unfortunate, but was addressed in a timely and straightforward manner and, although investigations are not complete, at this time it has not put into question the integrity of the manufacturing processes at the facility.)

Dorota Zwolinski fills equipment that she worked closely with engineers to help design.
James Malloy, director of quality assurance for the plant, said the product recall was launched after the company's complaint system highlighted an uncharacteristic number of comments on its "Vantage" arterial graft. Seven complaints were directed at minor fraying that doctors saw at the edges of the Vantage grafts. Six of the complaints came from doctors in Germany, and four of those complaints were from doctors at one hospital, Malloy says. While patients who received the graft are being monitored, Malloy said Boston Scientific is confident that any problems with the use of the products would become evident within seven days after they were used on a patient, so the company is confident that they pose no threats to patients. The line of products is more than 10 years old and contributes less than 1% of sales for Boston Scientific Wayne.

Boston Scientific Wayne used the Kepner-Tregoe product and process review methodology to address the product recall. Malloy says 60 people at the Wayne facility are trained in Kepner-Tregoe practices, and that the training gives them the ability to use a common language and a common problem-solving approach to investigate such problems. A Kepner-Tregoe team was formed, and the investigation followed two paths -- one looked at the demographics of the complaints, while the other addressed characteristics of the products involved, he said.

2006 Nominations

IndustryWeek is now accepting nominations for the 2006 IW Best Plants Program.
On July 28, the date of the IndustryWeek editor's visit to confirm information about the plant, the investigation was continuing, and Malloy provided the following thoughts: "The investigation showed that we had some uncharacteristic products that had the potential for problems ... (and) that the circumstances had to be addressed." However, he added, the company is "still exploring the root cause of the problem."
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