MPO: What technology or service are you emphasizing at Medica this year?
Anthony Feng: The company will highlight its NuSil brand biocompatible silicone adhesive technology, designed to help medical device manufacturers improve their production processes and device performance. We have an extensive product selection, plus our adhesives can be customized to satisfy unique device design, substrate, and manufacturing processes.
MPO: What’s the most common challenge customers inquire about and how do you address it?
Feng:One of the most common challenges that medical device customers ask is, “How can we improve productivity without sacrificing quality?” These companies have relied on silicone adhesives for decades. As they scale up for larger production volumes, manufacturers are always seeking ways to enhance their processes. They want to increase throughput and improve device performance, while at the same time achieve better reliability and durability.
Selecting the right silicone adhesive can help address some of these concerns. As formulation and production experts, we collaborate with customers to understand the specific medical device application along with the substrates used to create the device, and even their manufacturing process. Given these considerations, we can help identify the right adhesive formulation, recommended primers, or other surface treatments to improve adhesion. We definitely consider factors such as cure rate as much as possible to help make the manufacturing process more efficient.
MPO: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Feng: Given the possible variations in premium silicone adhesive formulations and different application demands, it’s helpful to collaborate early in the design stage with a silicone adhesive manufacturer that offers a wide range of customization and product development services to meet specific device and manufacturing requirements, and can offer support during the regulatory process.
Besides achieving the optimal adhesion requirements, a device maker can save valuable time in getting the final product to market by working with an adhesives supplier that uses quality manufacturing processes and can provide Master Files to the U.S. Food and Drug Administration and international authorities—documenting product details about ingredients, manufacturing, processing, packaging, and storage.
MPO: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Feng: Our product development processes, customer service capabilities, and proprietary equipment are engineered to deliver customization even at a mass scale. Rapid, highly scalable customization is fundamental to our workflow. We can create unique products in small batches, or larger commercial quantities, and we can customize from physical properties, to processing characteristics, to packaging.
From start to finish, we offer access to a team of chemists, engineers, regulatory experts and technical application specialists. This collaboration allows us to quickly meet customers' distinct needs for the tightest specs, keeping them ahead of competitive market demands.
For example, as today’s medical devices continue to get smaller in size, applying adhesives requires more precision. We understand the adhesive properties needed to accommodate thin sections or small intricate areas where an adhesive must reach a location that might otherwise be hard to access. Using our expertise in applications like this, a device manufacturer can save time upfront in the design process, as well as production time and costs in the actual device manufacturing.
MPO: In what ways is your company able to aid in getting a product (project) to market faster?
Feng: There are intense pressures to speed up time-to-market, regulatory approval, and market acceptance for new medical devices.As a result, medical device designers have discovered that working with a company with deep experience in the science of silicone and its medical applications can provide the support needed to overcome obstacles on the way to market. Our work in the most challenging environments necessitated a systematic approach to achieving consistent quality.
With our quality system, we go beyond what you would normally expect, combining the best of key ISO standards and select cGMP standards. The combination of our quality system, scalability and global regulatory expertise results in an operational mastery that takes our products from the lab to commercial scale with speed and dependability.
NuSil is located at Medica/Compamed in Hall 8A, Booth/Stand L15.