Originally Published EMDM
Originally Published EMDM
Med-Tech Finds a Place in the
Sun in Central Florida
Mention Florida, and thoughts invariably turn to perpetual sunshine, Miami Beach, Walt Disney World, and surreal voting practices. Medical technology isn’t on most people’s radar. And yet, the Sunshine State is home to the second-largest number of medical device companies in the United States. According to economic development organization Enterprise Florida, 1021 US FDA–registered companies have set up shop in the state.
One of them is Cordis, a Johnson & Johnson Co., maker of the first drug-eluting stent on the world market. Another is Smith & Nephew, which is headquartered in London and maintains a wound management facility in Largo. The firm has developed Dermagraft, a dermal substitute that is used to treat diabetic ulcers. And Swedish firm Gambro recently opened a new plant in Daytona Beach for its renal-care products. The facility will produce dialysis fluids for markets in the United States, Canada, and Mexico. Not surprisingly, numerous suppliers to medical device OEMs have also flocked to the state. Companies settle in Florida for a number of reasons, not the least of which is the lure of sun, surf, and fun.
“Florida is a destination for many of our customers,” says Ray Johnson, president of
Doyen Medipharm (Lakeland). Headquartered in Barton, Cambs, UK, Doyen manufactures medical packaging machinery and provides contract packaging and gamma sterilization services. “People visit on a regular basis, either for business or pleasure. Thus, we are able to encourage a high frequency of visitors to our facility, where we can most effectively demonstrate our equipment and contact manufacturing capabilities,” says Johnson. “The natural draw of the state has certainly been a competitive advantage for us,” he adds, “especially in the winter months!”
|Pacing leads, introducer systems, and associated parts are manufactured by Florida-based Oscor Inc.|
Florida’s natural charms may entice companies to come, but the state works hard to ensure that they stay. It has no personal-income or property tax, there is no corporate income tax on limited partnerships, and raw materials that are incorporated into a final product for resale are exempt from sales tax.
The state’s strategic geographic location is also a key benefit for companies with global ambitions. For many years running, the state has held a commanding share of US trade with Latin American and Caribbean nations, as well as between those regions and the rest of the world, according to Enterprise Florida. Europe is Florida’s second-largest trading partner, and the state’s trade share with the European Union has been steadily rising year on year.
High-tech industry in the state benefits from strong research and academic support. Florida’s universities are active in the development of vascular and cardiac devices, lasers, and nanotechnology. Internationally recognized Scripps Research Institute is set to open a facility in Palm Beach County in 2006. It will focus on biomedical research, technology development, and drug design.
Mapping the Corridor
Although the medical device industry is growing statewide, one of its primary hubs is the so-called High-Tech Corridor.
The High-Tech Corridor stretches across 21 counties in the central part of the state, from Greater Tampa Bay on the west coast to Volusia County in the east. It is home to more than 180 medical and biomedical technology firms, as well as numerous suppliers. The proximity of customers and partners has been a winning combination for Doyen Medipharm. “The High-Tech Corridor allows us to have local access to experienced engineers, a broad selection of quality subsuppliers, and specialized services such as plasma coating, titanium nitrate plating, rifle drilling, and sterilization,” says Johnson.
On the other coast, David Slick Sr., founder of Command Medical (Ormond Beach), also cites easy access to customers and partners as a regional benefit. “Our ability to communicate with other suppliers in the region is a main reason for locating here,” he explains. Command Medical offers full-service manufacturing of disposable medical devices.
Meeting and sometimes even anticipating customer needs gives many suppliers a competitive edge in Florida as elsewhere. While the rush to outsourcing shows no sign of abating at every level of the supply chain, some companies in the corridor are finding renewed interest in some form of vertical integration. Command Medical has consolidated manufacturing operations under one roof, says Slick, to improve quality control and productivity and to reduce costs. Oscor Inc., a maker of pacing leads based in Palm Harbor, recently decided to bring all of its manufacturing processes in-house for similar reasons. Integrating machining and mould-making divisions, which were necessary to perform two key processes, proved to be challenging. Operations manager Ernest DeBella explained to
EMDM how the firm overcame these obstacles to better serve its clients.
Bringing It All In-House
|Oscor Inc. uses a microblasting device supplied by Comco Inc. to deburr small parts, retexture the inner surface of moulds, and clean extrusion dies.|
Oscor Inc. has been in the business of manufacturing pacing leads in a variety of shapes and lengths for 26 years. It also produces associated parts and the transvenous introducer systems that are used to place cardiac pacing leads. In addition to self-branded product lines, the firm has rapidly expanding lines of OEM products.
A pacing lead carries the electrical signals between a pacemaker and a human heart. Complementary parts include tips, coverings, and fixation devices such as small, flexible silicone tines that attach the lead directly to the heart muscle. Tines can be as small as seven French (2.3 mm).
In 2003, the firm decided to bring all manufacturing processes in-house to improve quality control and reduce lead times. By integrating manufacturing capabilities that had been outsourced, the company eliminated fluctuations in quality and production delays that were restricting its ability to respond quickly to the rapidly growing OEM market.
DeBella was put in charge of integrating machining and mould making into the company’s overall production flow. “We have two thermoplastic and four silicone molders,” explains DeBella. “We also have two extrusion lines, and four Swiss-style lathes for making metal parts. Our machining facility makes the metallic portions that we overmould into electrical connectors, and we have a shop that makes the moulds,” says DeBella.
Several aspects of mould making caused DeBella concern. The mould’s inner surface must have the precise texture required to form the part and easily release it. Through repeated use, the surface tends to become smooth, causing material to stick to it. Reconditioning is required to solve this problem.
Finally, the extrusion machines need to be torn down and cleaned of residue periodically to keep the equipment from “gumming up” and to meet quality control specifications.
“The sizes we're working with and the accuracy required leave no room for error,” says DeBella. “We'll take a 1-mm-diam pin that is 5 mm long and overmould it with silicone. To do this, you need a shut-off mould. By that, I mean the cavity has to end against that pin. That requires hitting numbers very, very closely on each pin. We're talking about minute standard deviations,” says DeBella. “Surface retexturing can’t cause a deviation in the mould dimensions,” he adds.
|By sending a jet of dry air and abrasive media through a nozzle, microblasting equipment cleans and textures parts without altering their dimensions.|
DeBella did his research on the Internet and learned about the use of microblasting technology in the mould-making and machining industries. A refined version of sandblasting, microblasting is designed to clean, texture, deburr, or otherwise process very small parts and hard-to-reach areas with extreme accuracy. The variety of abrasive media that are available and the capability to adjust the blast pressure offer users a great degree of process control. Microblasting can achieve precise close-tolerance cleaning and texturing without altering the part’s surface dimensions.
DeBella chose a microblaster designed and built by Comco Inc., located in Burbank in an- other sunshine state, California. Consisting of a control unit and a well-lit work chamber, this compact equipment blasts a jet of dry air and abrasive media through the nozzle of a pencil-like stylus. Nozzles can have openings from 0.018 up to 0.060 in. “We use a Comco MicroBlaster Model MB1000-1 with 25-µm glass-bead abrasive media. We set our air pressure at 60 psi, and it gets the job done perfectly,” says DeBella.
Although Oscor purchased the unit specifically for mould cleaning and texturing, the firm soon discovered that it had other applications. “We also found that we could clean our extrusion dies with it,” says DeBella. “We frequently change plastics between runs. That requires a teardown of the extrusion lines. The pin and die set is pulled and the crosshead is disassembled. We burn old residue off in a furnace and then blast it with glass beads to completely clean it off,” he explains. “We are also using the blaster to deburr parts in the machine shop,” adds DeBella. “It has turned out to be a great tool with a lot of versatility.”
Oscor’s standard line includes more than 20 different leads, plus associated introducers and related products. The OEM side is growing daily, and many large, long-term OEM projects are in process. It comes down to manufacturing in the tens of thousands of units using costly US FDA–compliant materials such as implantable silicone, 316 L stainless steel, titanium, and platinum meridian. Tolerances are very tight, and all production machines are top of the line. Keeping that equipment and its working assemblies in good condition ensures a perfect product every time, the firm explains.
In the following pages, you will find profiles of Oscor and other leading suppliers to device OEMS located in the High-Tech Corridor. All of them share a commitment to providing world-class services and products. And if you’re looking for a reason to escape the concrete sky this winter by combining business with sunshine, the welcome mat is out.
Copyright ©2004 European Medical Device Manufacturer