From concept to commercialization
Sil-Pro’s full design, manufacturing
and assembly capabilities create a
unique blend of a molding company
which provides Medical Device
Manufacturers with the performance
to make their products excel.
Design & Development
Tooling Design & Build
Silicone Molding & Extrusion
Fluortek’s new PTFE Micro-Bore System, for example, extrudes PTFE tubing (not
just monofilament) with as small an outside diameter as 0.006 inches—roughly two
times the diameter of a human hair.
Natvar recently opened a global tech center in Holland, Ohio. The $4 million
facility is equipped with the latest analytical and product-performance testing laboratories and staffed with a team of professionals from a variety of science and engineering disciplines with deep industry experience. There are large custom pilot scale
extrusion, co-extrusion, extrusion coating, extrusion lamination and lamination capabilities to support product development. OEMs also go there to work with Natvar
engineering teams on new designs and processes.
“Rapid development is essential for meeting the new demands within the industry, along with solid validation plans to meet and exceed the customer expectations,”
said Donohue. “The global tech center and our fully validated engineering labs provide faster speed to market. FDA requirements are changing fast for controlling the
supply chain and organizations have to stay on top of what’s required to provide
true product validation to satisfy these needs.” Forefront Medical Technology has developed new product capabilities of specialty stainless and nitinol wire reinforced
flexible tubing for high-performance catheters and other unique delivery systems.
Tubing constructions are available with medical grades of silicone, polyurethane or
di(2-ethylhexyl)phthalate-free polyvinyl chloride. Standard construction ranges are
5 to 20 millimeters outside diameters and up to 75 centimeter lengths. Custom constructions are available for unique application requirements. The material is ideal for
flexible, non-kinking tubing used for airways, drug delivery systems and proprietary
“This new tubing extends product shelf life and also provides tighter tolerances,
multiple durometers and specialty designs and a more durable exterior, which improves the user experience,” said Lilly.
Duke Extrusion is responding to the market’s desire for immediately available tubing that can be purchased in discrete lengths in a variety of materials, sizes, configurations and durometers by expanding its stock catheter tubing product offerings, which
now include both PEBA and nylon resin. In the near future, Duke will launch a PebaSlix single-lumen product line.
“We understand that our customers are seeking faster iterations for R&D of new
products,” said LaDuca. “By providing the opportunity to try materials in their preferred size range and material type quickly, we improve our customer’s ability to custom specify their exact product, with more assurance the tubing design will perform
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OEMs must be certain their complete supply chains are in compliance with the FDA,
which has been placing more stringent controls on suppliers. This has compelled OEMs
to demand more from their extrusion suppliers. Risk management always has been a
constant part of developing devices and choosing suppliers, but now it is especially at
the forefront of the OEM decision-making process.
“OEMs are demanding that suppliers use medical grade/FDA-compliant materi-
als, and extrusion houses are becoming more heavily involved in the device design
process,” said Botti. “Additionally, OEMs are requesting suppliers share in biocom-
patibility costs. OEMs have shifted to becoming comfortable with proven, next-gen-
eration devices and technologies that were developed outside of their companies
and have been pre-proven and tested.”
As medical devices continue to push manufacturing limits with smaller and more
complex products, extruders will have to work very hard to find creative ways to
make these devices without compromising quality, or driving up costs. Concerns at