SMALLPOX WORRY A BIG CHALLENGE
18 Apr 2003
Source: Hartford Courant, April 18, 2003
Smallpox Worry A Big Challenge
By BARBARA NAGY, Courant Staff Writer
Had the smallpox vaccine yet?
Here's a suggestion: Don't look at the needle. It's a mean-looking thing, about 3 inches long with a tip that flattens into two tiny pitchfork-like prongs.
There's a reason for the design. The gap between the tines holds exactly one dose of vaccine, and the tips are sharp enough to pierce your skin - but just lightly - when it's jabbed a few times.
Figuring out how to turn out millions of these delicate things on short notice was the challenge of a lifetime for F.W. "Frank" Dworak, president of Hobson & Motzer Inc. in Durham.
Needles stamped out at his 150-person shop are being shipped around the world for vaccinations that health officials say could thwart the spread of smallpox by terrorists. The company, which does about $25 million a year in sales, has added 10 people to its payroll in the past year - while many other manufacturers in the state are laying off workers.
After the 2001 terror attacks, Becton, Dickinson & Co. of Franklin Lakes, N.J., the world's largest manufacturer of hypodermic needles, asked the Durham company if it could quickly produce millions of needles for the smallpox vaccine. Becton, Dickinson is a longtime customer of Hobson & Motzer.
Dworak and his tooling designers were intrigued. One day early last year a Becton, Dickinson team armed with photos of smallpox victims, drawings of needles and detailed design specifications arrived in Durham to brief a dozen Hobson & Motzer people. The topics included the history of smallpox, how the virus attacks the body and, of course, the role of the needle in making sure the vaccine is administered correctly.
"Consistency. That's the trick," said Espen D. Kateraas, senior manager for worldwide marketing at Becton, Dickinson. "It looks very straightforward, but it's an overwhelming task to ensure 100 percent geometric accuracy" for every needle when millions are being produced, he said.
The size of the gap between the two prongs is critical because it ensures that the needle picks up the correct amount of vaccine - 1 microliter, a fraction of a droplet.
"Everything's got to be just right," Dworak said, "to make that slotted point and to make it consistently."
The two-pronged - or bifurcated - needle was developed in 1965 by Benjamin A. Rubin, a Wyeth Laboratories microbiologist, according to the World Health Organization. The battle against smallpox had shifted to Third World countries. Authorities were looking for a cheap, efficient way for the vaccine to be administered by workers with minimal training.
The needle was the answer. Workers dipped it in a vial of vaccine, then lightly jabbed the patient's upper arm to push the fluid under the skin. The vaccine created a lesion that scabbed over and healed in a couple weeks.
Smallpox was essentially eradicated by 1979, and Rubin's needle went out of production. But with new worries about terrorism, a handful of manufacturers are now making the needles again. Becton, Dickinson, apparently the largest of them, made several changes to Rubin's design and handed the specs to Hobson & Motzer.
Dworak's team, working 12-hour shifts around the clock for two months, designed a system that could turn out perfect needles by the millions. They used computers to test their ideas and plan the layout of the manufacturing process. They built the machine piece by piece as components were ready, and tested prototypes on the backs of their hands. The prongs, after all, had to be sharp enough to draw blood.
"It was smoking around here," Dworak said with a grin. "It was a fun project." In June, the Food and Drug Administration gave its approval and production started.
The secret to consistency, Dworak said, is precise tooling. The details of the manufacturing process are proprietary, but the needles start as rolls of stainless steel wire. In a few swift motions the machine cuts the wire to length and stamps out the tip.
Workers use a computerized laser to inspect samples from the production line through each shift. Sensors are also embedded in the manufacturing equipment to warn of any problems.
After the needles leave Durham, they go to other Becton, Dickinson suppliers to be polished, cleaned, sterilized, packaged and labeled.
In Durham, Dworak hopes to use the same manufacturing technology for other projects. The 90-year-old company has done well by concentrating in the growing medical industry during the past 15 years, said Lauren DeLisa, executive director of the Connecticut Tooling and Machining Association. She said Dworak has worked to streamline his shop floor, be more innovative and pursue new types of work.
"They have great vision," DeLisa said. "They know their market and they know their industry." That gives managers a better idea of which work to pursue, she said. The company is fairly large, which gives it a bigger marketing staff and broader capabilities than many of the state's smaller manufacturers.
Frank Johnson, executive director of the Manufacturers' Alliance of Connecticut, said the medical-equipment business has been largely unaffected by the economic downturn.
Many of those manufacturers have little foreign competition, the federal regulatory process creates a more orderly system of supply and demand, and sales are rising as Baby Boomers age.
Johnson said many Connecticut companies are looking to get into the field. "They see it as recession-proof," he said.
Dworak said Hobson & Motzer was fortunate. It had the equipment and staff to do what Becton, Dickinson needed, he said.
"We were just in the right spot at the right time," he said. "It's more luck than skill, but I'll take luck over skill any day."