Originally Published June 2000
INDUSTRY NEWS
- Company Installs Cleanroom for Servicing Medical Tubing
- Puncture-Resistant Angioplasty Balloons Developed
- Software Facilitates Implementation of Medical Device Standard
- Machine Solutions Makes a Bid for Attention
- MD&M Conference Explores Internet Strategies for Device Manufacturers
Company Installs Cleanroom for Servicing Medical Tubing
Texloc (Fort Worth, TX) has installed a Class 10,000 cleanroom for inspecting and packaging medical-grade fluoroplastic tubing. According to Dan Rodriguez, Texloc general manager, "Our ability to inspect and package in a Class 10,000 cleanroom enables us to offer tubing that is ready for the high standards of the medical industry. Texloc has made a commitment to servicing the medical industry, and this cleanroom is the first step toward accomplishing that."
Microwall and heat-shrink tubing is available in sizes beginning at 0.006 in. in diameter. It is manufactured to custom specifications and precision tolerances. Processing methods include flaring, forming, convoluting, corrugating, and cuffing. The heat-shrink tubing is available in shrink ratios from 1.25:1 to 4:1 and can withstand all common methods of sterilization, including autoclave, radiation, and EtO. —Karim Marouf
In moves to increase safety for high-pressure angioplasty and stent delivery procedures, Advanced Polymers Inc. (Salem, NH) has developed puncture-resistant high-pressure angioplasty balloons. This development has been made possible by a coating that virtually eliminates the chance of an angioplasty balloon being punctured or damaged during stent delivery or after stent dilatation.
The coating also increases the coefficient of friction between the stent and the balloon surface and provides good stent retention, eliminating movement or slippage during delivery and deployment. This is a critical issue for high-pressure balloon stenting procedures, as many previously unaddressed concerns about stent slippage are coming to the forefront.
The coating, which can be produced from a variety of polymers depending on the application (polyurethane is typical), is applied to a balloon after a proprietary surface treatment by dipping the balloon into a liquid form of the chosen polymer, followed by oven drying. The drying process allows for cross-linking of the coating to occur, which helps to strengthen the coating and provide more durability, a better bond, and increased resistance to solvents and other chemicals.
The balloons can be produced in a variety of sizes, configurations, lengths, and burst pressures (up to 27 atm/400 psi). Wall thicknesses typically range from 5 to 50 µm, offering minimal invasiveness and the smallest possible profile. Some of the manufacturer's custom capabilities and configurations include unlimited tapered angles, varying diameters, and tapered diameters along the length of the balloon.—Karim Marouf
Help is on the way for medical device designers implementing the IEEE 1073 Medical Information Bus standard. The Medical Device Communications Industry Group (MDCIG), a branch of the Institute of Electrical and Electronics Engineers (IEEE; Piscataway, NJ), recently released a protocol data unit (PDU) software tool to facilitate adoption of the standard. The software can be downloaded free of charge from the MDCIG Web site at http://www.ieee-isto.org/mdcig.
The PDU software is being offered to the medical device industry as a development tool to assist in the design, development, and testing of medical device communications software in compliance with the IEEE 1073 standard. Adoption of the standard will allow clinicians to link patient-connected bedside medical devices to a bedside patient-monitoring device or a computer network. The standard will permit comprehensive data capture from devices such as infusion pumps, ventilators, and patient monitors, with the goal of improving patient safety and reducing medical errors.
"Our intent is to target intensive-care applications, where clinicians have several devices operating in a critical setting and plug-and-play capability is absolutely vital," explains Bob Kennelly, executive director of the MDCIG. "Clinicians need to be able to capture data across a range of devices," he says.
The most recent version of the software is focused on infusion pump applications and was designed by Agilent Technologies (Andover, MA), one of five sponsor members of the MDCIG. The other members are Alaris Medical Systems, Baxter Laboratories, GE Marquette Medical Systems, and Siemens Medical Systems. The MDCIG was created to accelerate, promote, and support the adoption of the IEEE 1073 standard. The group was formed as a program of the IEEE's Industry Standards and Technology Organization.—Benjamin Lichtman
Medical technology will meet the Internet this June during the Medical Design & Manufacturing (MD&M) East 2000 Conference and Exposition. Machine Solutions Inc. (Flagstaff, AZ) plans to auction the Torminator stent-crimping machine on the eBay Web site. The auction will coincide with the MD&M trade show in New York City, June 6–8.
Machine Solutions specializes in custom machine design for the catheter industry. Daniel Kasprzyk, president of Machine Solutions, came up with the idea for auctioning the Torminator in January at MD&M West in Anaheim, CA. The company received many requests for the product at the show. As a small company, Machine Solutions typically builds units only after an order is received, resulting in a manufacturing lead time of four to six weeks. By building the machine and then auctioning it off, the company can shave weeks off of delivery time, satisfying requests for the Torminator at a faster rate.
The eBay auction also provides another avenue for the company to inform OEMs about the Torminator. "We were looking for creative ways to get the word out on the product," explains Kasprzyk. Between the MD&M shows and the Internet, it looks like Machine Solutions will achieve its goal. —Jodi Triplett
Each day brings fresh news of manufacturers forming on-line alliances or Internet companies springing up to service end-to-end healthcare needs. Clearly the Internet continues to alter the medical device industry. How to meet that challenge is the main focus of one of the sessions at the Medical Design & Manufacturing (MD&M) East Conference being held June 5–7 in New York City.
Richard Cohen, principal of The Walden Group and chair of the session titled The Internet: Essential Strategies for Device Manufacturers, sees medical device companies implementing Internet capabilities in three ways: internally, through alliances, or by acquiring or being acquired by an Internet company. This last option may be a strategy reserved for larger companies, Cohen believes, as "buying a dot-com company would put a medical device manufacturer beyond the scope of its core competency." He finds most manufacturers confident they can develop a strategy within their own companies or through an alliance.
Jim McFarlane, president and CEO of Entelx Inc., addresses the issue of partnership relationships in the e-business environment. "In today's world, the customer is in charge," he says, adding that this has led many manufacturers to increase the number of distributors. "Manufacturers have recognized that distributors still bring huge value to the equation," McFarlane explains. "The value [they bring] has to shift, however, from being just an inventory supply to providing knowledge about the service side." He notes that e-marketplaces like a Web "exchange" or Neoforma.com will take a portion of the revenue, but will not make the traditional supply chain obsolete. In today's market, all facets of the chain bring some value to the table by finding unique solutions for the customers.
"One of the advantages of the Internet is the ability to collaborate," observes McFarlane. The focus has shifted from concentration on the quality of the product to quality and customer service, he maintains. Selling partners must collaborate in order to meet the needs of the customer. "Customer loyalty is [based on] who makes it easiest to do business," says McFarlane, "and by who brings me the greatest value." This value can include product collaboration where the customer can log on and personalize a product.
The ways in which the Internet can increase efficiency in traditional business strategies and create opportunities for entirely new ones will also be discussed by speakers from Medibuy, Manhattan Associates, Mallinckrodt-Nellcor, and Neoforma.com at the MD&M East conference.—Linda Nugent
Puncture-Resistant Angioplasty Balloons Developed
A puncture-resistant coating can be produced from a range of polymers.
Software Facilitates Implementation of Medical Device Standard
Machine Solutions Makes a Bid for Attention
This stent-crimping machine will be auctioned on eBay during the MD&M show in June.
MD&M Conference Explores Internet Strategies for Device Manufacturers
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