FILTERS
 |
Respiratory filters are among the applications of a 5-µm PTFE membrane that has been introduced by Gore.
|
Navigating a cost-conscious, highly competitive global business environment, suppliers of medical filtration products have few alternatives but to continue to innovate in membrane design and fabrication. "Industry must remain flexible and further invest in its core technologies," says Jim Rudolph, OEM sales manager at Whatman (Maidstone, Kent, UK). Forget the housings—"they cost less today than they did 20 years ago"—and focus on the membranes, says Rudolph, who works out of the company's US offices in Florham Park, NJ. Here is how Whatman and other leading suppliers of filtration technologies are helping medical device manufacturers to develop next-generation medical devices and to make existing products more efficient.
"The pressure on product cost and therapy effectiveness is pretty obvious in cardiovascular, says Tom Quinci, product specialist, medical membranes, at Gore (Newark, DE, USA). "It may be less obvious in other sectors, but it is present there, as well. In addition to cost pressures, there is a focus on safety," he adds. Satisfying those demands is a challenge, but the process can lead to innovative solutions.
"No one wants to compromise on safety, but everything has to fit within a business model," says Quinci. "Working from certain material sets, we inherently build safety and reliability into our products. To offset the cost implications and meet the objectives of cost control, for example, we'll focus on reducing cycle times in a diagnostic device. That can be an extreme lever on overall cost," he explains. Increasing throughput by 30% strips away almost one-third of the cost from a very expensive piece of capital equipment, says Quinci.
Gore is attuned to the need for clean, inert materials for lower extractable requirements, says Keith Fritsky, also a product specialist, medical membranes. "That is one general trend within industry. Another is having a reliable barrier to exposure to any toxic types of materials—drugs, chemotherapy products, and so forth," says Fritsky. How does the company juggle all of these requirements? By subordinating everything to meeting the end user's needs, says Quinci.
End user drives innovation
"Our core competency is a full understanding of material properties and how they affect the end user. That sort of vertical integration is important to us," he explains. "We approach membrane development at the microstructure level of the material, where its morphology, functionality, and so forth is carried forward to meet the requirements of the end user. The end user is the driver in application engineering, product development, product engineering, and manufacturing. The better we understand his needs, the better we understand what is really driving our customer's decisions," says Quinci. He cites two recent product introductions as successful illustrations of this approach: a high-flow 5-µm membrane and a tight-tolerance 0.03-µm product.
The 5-µm device is designed for medical gas filtration applications in which fibreglass-based materials are currently being used, says Fritsky. "The advantage, of course, is that a nonshedding microporous membrane made of PTFE will provide a better combination of particle retention and airflow," he adds. It is being commercialized this year.
The 0.03-µm membrane has been on the market for about one year, and has proven to be quite popular with end users. "It is for tough venting applications, where pressures can be quite high but you still need to eliminate air, as in IV filtration," says Fritsky. "We have improved the airflow on this product without sacrificing its liquid retention capability."
Accelerating diagnostic procedures
Controlling costs while maintaining—or improving—performance and safety is also a central concern at Pall Life Sciences OEM (Ann Arbor, MI, USA). "Our expertise is rooted in satisfying specific customer needs," explains Ricardo Alfonso, vice president, marketing and business development. "For example, we recently launched an amber IV filter for the filtration of light-sensitive drugs. We are also launching products with improved performance characteristics that facilitate drug delivery and offer increased comfort to the patient," says Alfonso.
The firm also is helping healthcare institutions to increase efficiency and reduce overall costs by applying its proprietary technologies to the rapid and safe delivery of drugs and therapies. "In the blood apheresis market, where speed is paramount, Pall is launching products with faster flow rates and throughput capabilities," he says. "Molecular diagnostics is also experiencing rapid growth, and Pall is introducing technology to simplify the separation of plasma from whole blood, enabling the development of faster and more sensitive IVD products."
The molecular diagnostics field also has Whatman's attention. "Our underlying technology for FTA and FTA Elute products for collecting, immobilizing, and archiving DNA and RNA have been very successful," says Rudolph. "We are at a point now that we can store DNA at room temperature for up to 18 years and still do a diagnostic. Even though they have been around for many years, our nitrocellulose membranes are still in great demand. People recognize the quality and consistency of the product."
