Focus: MedicalIMM Plant Tour: Leaders in pacing leads

Building a clean facility involves much more than a few Hepa filters.

A pacemaker “listens” to a heart’s natural electrical signals. When a heart beats too slowly or (heaven forbid!) stops, a pacemaker generates electrical signals at a prescribed frequency to keep the beat. Silicone- or polyurethane-insulated platinum wires called “pacing leads” carry the electrical signals between the heart and the pacemaker.

About 26 years ago, an electrical engineer in Germany saw that the most crucial component in a pacemaker is the pacing lead. He concentrated his efforts on advancing the state of that art.

Today, his son is the president and CEO of Oscor Inc. (Palm Harbor, FL), a small, privately owned company that designs and manufactures more than 80 different models of its own pacing leads, including the world’s smallest. Oscor also produces other medical devices, including temporary pacemakers and lead adapters.

Oscor became a vertically integrated captive manufacturer just two years ago after finding the quality of outsourced parts wanting. It reportedly experienced a 500% increase in OEM sales alone in 2003. To pace such growing demand, Oscor is now putting the finishing touches on a manufacturing and assembly plant expansion in the Dominican Republic.

If Swiss lathe machining makes your heart skip a beat, or if molding and micromolding extremely precise, lifesaving parts out of implantable materials in Class 10,000 cleanrooms on all-electric molding machines stops your heart (heaven forbid!), let’s tour.

Family Ties

Thomas Osypka, Oscor’s president and CEO, is our host and tour guide. He greets us in a conference room adjoining his office on the second floor of the first of the company’s two wholly owned buildings in Palm Harbor that we’ll see today.

Building 1 houses administrative offices, design engineering, QA, and parts inspection/assembly. Its two-year-old manufacturing operations are in Building 2.

Thomas’s father, Peter Osypka, started a company called Dr. Osypka GmbH in Germany in 1977 after seeing the need to develop safe and secure pacing leads. He founded Oscor Inc. in 1982 to supply U.S. markets. In 1996, both companies were sold. However, three years later his father bought back Dr. Osypka GmbH and Thomas Osypka bought Oscor Inc.

“Even though we are still the same loving family, we are two, 100% independent privately owned companies, producing competitive products,” says Osypka.

Family-friendly

Oscor invests more than 15% of its revenues into product R&D. It sells its high-margin products through indirect sales reps and distribution channels to OEM customers, purchasing groups, and directly to hospitals.

“Our specialties are quality and quick turnaround. But we do not do mass production,” Osypka says. “Our products are made in a carefully controlled, step-by-step process even though all of our in-house operations work in parallel.”

Then we ask one of the dumbest questions ever: Why did you settle in Palm Harbor, FL?“Well, the weather here was a major factor,” Osypka says, smiling. “It’s easy to attract talented people from other states to work here. It’s also a calm area that’s family-friendly and affordable.”

Osypka says a spirit of enthusiasm pervades Oscor. Some employees have 15 to 20 years with the company. All know their ultimate mission is saving lives.

“People are where the value is added,” Osypka says. “Machines are a necessity.”

$10K LSR—10K Cleanrooms

After passing design engineering cubicles, one of our first stops is a small room housing Oscor’s new high-performance liquid chromatograph (HPLC). HPLC separates, identifies, purifies, and quantifies compounds.

It’s being used to analyze a fully validated, proprietary, implantable Oscor product in which a drug solution is mixed with the LSR A and B components. HPLC accurately analyzes and documents the plastic and the drug content of each molded piece.

“We buy extremely expensive LSR for applications like this. Five gallons can cost more than $10,000,” says Osypka. “Outsourced HPLC testing takes too long—anywhere from eight to 10 weeks.” He says Oscor also will soon install its own ETO sterilization system to improve turnaround times—the closest one’s in Georgia.

We pass Oscor’s server, its document control center, and its new international sales office before arriving at a Hepa-filtered parts inspection/assembly area. Oscor operates a total of six Class 10,000 and Class 100,000 cleanrooms for everything from molding to laser welding. All are regularly certified by outside sources.

An Oscor Standard

After a quick ride in Oscor’s golf cart, we arrive at Building 2, its injection molding, CNC machining, and moldmaking facility. We’re met by Ernie DeBella, manager of operations.Oscor runs Nisseis. Period. Why? DeBella says Oscor’s Nissei machines are reliable and precise. That’s what they need in injection molding machines. “We’re not molding rubber rabbits to put in magicians’ hats,” DeBella says.

The Nisseis run in two Class 10,000 cleanrooms, one for LSR molding and one for molding thermoplastics. Literally speaking, Oscor’s LSR molding machine capacity includes U.S. industry firsts.

It runs two custom-built 20-ton parting liners from Nissei, Model TH20-2E2 LIM presses. Each is equipped with two of Nissei’s latest innovations: a high-kneading screw specially designed to prevent LSR drooling, and a compact meter/mix/dispensing unit with a static mixer mounted directly on the molding machine’s injection unit.

DeBella says it’s ideal for precision molding small parts.

Micromolding, Overmolding

Oscor’s only hydraulic press is a 20-ton Nissei Model ST20, an all-vertical equipped for LSR molding. DeBella calls it “our entry-level machine.”

Microparts and the implantable LSR/drug solution product mentioned above are molded on a 7-ton Nissei Denkey all-electric. It’s fed by meter/mix systems from Fluid Automation Inc., as is the ST20.

Two 20-ton model TH20-2E2 parting-line all-electrics run thermoplastic parts in a cleanroom next door. Thermoplastic components often are overmolded here onto tubing processed from exotic materials such as FEP, a melt-processible fluoropolymer.

The tubing is extruded by one of Oscor’s two single-screw extruders from American Kuhne Inc. Both have coextrusion capabilities. All of Oscor’s machines are networked for remote monitoring.

Swiss-made Solutions

Oscor machines production parts and components to within ±10-µm tolerances out of titanium, nickel-cobalt-chromium-molybdenum alloys, and stainless steel. The CNC machining room occasionally machines parts for Oscor’s molds, too, like ±3-µm-diameter core pins. Like its molding rooms, Oscor’s CNC machining shop is equipped almost exclusively with 21st century vintage machines. It has, for instance, a bank of SA-16R Series CNC Swiss-type automatic lathes from Star CNC Machine Tool Corp., U.S. distributors for Star Micronics Co. Ltd. (Shizuoka, Japan).

These multiaxis machines can mill, tap, cross-drill, and completely machine parts in a single setup. “Deburring for a finish—that’s all that’s needed when we remove the parts,” says Doug Duncan, CNC machining supervisor. “As far as the mold components go, we build a lot of LSR tools. LSR easily flashes, so the shutoffs have to be perfect.”

One-week Lead Times

Oscor makes about 30 to 35 cold runner molds a year next door in its mold room. It builds cores, cavities, and graphite electrodes. Tolerances are held to within ±.0002 inch.

“We only build low-cavitation molds, molds up to four cavities,” DeBella says. “We find that we can hold part tolerances more consistently in fewer cavities. Besides, our part volumes are not always high.”

Its cores and cavities are mostly done in 420 stainless steel; P-20 is used for some molds running thermoplastics. It purchases bases from D-M-E and Progressive Components. The mold room also does some repairs and refurbishes molds built elsewhere.

“Our lead times are only about one to two weeks to build molds and start molding. We also build steel and aluminum prototype tooling,” says DeBella.

Its moldmaking machinery is impressive. We see a Mori Seiki NVD 5000—a 20,000-rpm contouring mill with 30 tools. There’s a Weiler Lathe here, too, and Charmilles 20 ZNC sinker EDMs with diamond cutting tools.

Caribbean Bound

After golf-carting back to Building 1, we return to the conference room. Osypka smiles when we ask if capital investments are his biggest challenges.

“No, our biggest challenges are product liabilities and potential lawsuits,” he explains. “Our insurance costs are extremely high. You’re never fully protected when you’re working with implants.”

We interrupt him with another question that’s been bugging us about his expansion plans: Why the Caribbean? Why not China?

“I don’t speak Chinese,” he says, smiling. “Seriously, though, China is too far. I can’t waste the weeks of travel time involved. The D.R. [Dominican Republic] is less than 2 hours away.”

As a beneficiary country covered in the Caribbean Basin Initiative, merchandise can be shipped to the U.S. duty-free from the Dominican Republic. Oscor is building a 16,000-sq-ft plant there and expects to employ 20 initially—up to 80 in a year. It will be a high-volume/low-cost production plant with LSR and thermoplastic molding, extrusion, and assembly operations in Class 10,000 cleanrooms.

“We did not take this initiative to satisfy customer requests. We did it all on our own to remain competitive,” Osypka says.