The heart of the matter
Source : The Manufacturer
Published : 26 Sep 2005 17:32
Medical device manufacturer Boston Scientific uses a unique approach to deploy lean manufacturing throughout the product lifecycle. Linda Seid Frembes reports
Many manufacturing operations are labeled “mission critical” by company managers, but rarely does that term take on life or death meaning. That is, unless you’re Boston Scientific, a worldwide developer, manufacturer, and marketer of medical devices with approximately 16,000 employees and revenue of $5.6 billion in 2004. At the company’s Maple Grove, MN, plant, the focus is on cardiovascular devices known as stents, devices used to treat and relieve blocked arteries.
“Most of Boston Scientific’s 13 plants have a certain specialty; ours is cardiovascular. Our plant specializes in less invasive treatments using stents, balloon catheters, and guide catheters,” explains Terrance Brick, vice president of operations for the Maple Grove campus, who has been with the company for eleven years. “Our drug-coated stent is the most popular and widely used in the medical community. Only two companies have FDA approval for drug-coated stents-us and Johnson & Johnson.”
The Maple Grove operations include two buildings, one in Maple Grove and another building six miles away in Plymouth. The Maple Grove campus is the second largest manufacturing site for Boston Scientific. The largest plant is in Galway, Ireland, which is also a frequent partner in manufacturing and product development since both plants manufacture the same products. The Maple Grove campus is 850,000 square feet which includes a new 150,000-square-foot facility dedicated solely to research and development. Production takes up 110,000 square feet with 2,000 of the total 3,500 employees in manufacturing. The campus is a three-shift operation with most people serving as product builders.
The Plymouth operation uses high tolerance stainless steel tubing in its manufacturing process. The company partners with steel suppliers on dimensions, purity, and specific tolerances. The tubing is cleaned and electropolished before shipping to either the Maple Grove building or to the sister plant in Galway for its drug coating. Functional and analytical testing as well as documentation for FDA regulation is all done in Maple Grove.
At Maple Grove, the laser processing of plastic into balloon catheter and guide catheters are some of the lowest profiles in the industry. The finished product catheters are then crimped onto the end of a stent and prepared for packaging. Included in the end product are directions for use and a sterilized sealed pouch with a stent crimped on the end. “It is packaged so it can be rapidly deployed in a sterile environment,” explains Brick. “The catheter and stent can be taken directly from the package and quickly inserted into the patient’s femoral artery (a common pathway to the heart).”
Maple Grove has been lean since the 1990s but only over the last five to seven years have they honed their lean techniques. Brick adds: “Lean means something different to every company. The most important step is to determine what lean is and isn’t to your company. Lean to Boston Scientific is a production operating system.”
The company’s strategy to excel at lean was to create “islands” of lean in the production area. That meant taking one small piece of the production process and concentrating on simple systems done with discipline. There was regular use of 5S and kaizen events, all with a very simple focus. The next level in the lean strategy was to connect those islands and branch lean outside of production and into business systems. “We used a formula of 40/20/25 and a sense of entitlement. Each island was expected to achieve 40 percent space utilization, 20 percent production improvement, and 25 percent lead time improvement. This metric came from reviewing our own data and seeing that those averages existed. Once you present that expectation and the data to support it, it becomes almost an entitlement to achieve the goal,” says Brick.
In another unique approach, the company pushed lean upstream in development process with the idea to get lean into the new product before it comes into production. This concept, titled “Born Lean,” meant a new product could easily fit into a lean environment without any re-engineering once production began. At Boston Scientific, the industrial engineers are the lean gurus. The “Born Lean” initiative placed one engineer on every product development team to bring in a lean culture to the process.
The lean expectation has moved upstream to the supply chain. Boston Scientific uses kanban for day-to-day replenishment or supplier-managed consignment of materials. Suppliers to Boston Scientific are constantly audited and certified.
“The results speak for themselves: 50 percent reduction in lead times, 15 percent production increase, and 15 percent scrap reduction each year,” says Brick. Maple Grove has had the same square footage since 2000, yet have doubled its production output, thanks to focusing on lean manufacturing.
Company managers aren’t the only ones recognizing the effort. In 2005, the Maple Grove facility received the Shingo Prize for Excellence in Manufacturing and was voted one of the Top 10 Plants in North America in 2003. In 2002, it also won the Minnesota Manufacturer of the Year award.
In addition, Boston Scientific was named the top company in Massachusetts for 2004 in the Boston Globe’s annual “Globe 100” report. Boston Scientific was ranked on a variety of criteria, including return on equity, change in revenue and change in profit margin. Boston Scientific Corporation also received the 2005 Best Practices in Logistics Management Gold Award from Logistics Management magazine.
