[caption id="attachment_86958" align="alignright" width="360"] Robert Torgerson, president of RxFiber, uses a tensile tester to measure the mechanical properties of the company's new RxFibron HT medical-grade fiber.[/caption]
WINDSOR -- A local, small manufacturing startup RxFiber, LLC, launched its first commercially available medical-grade fibers.
RxFiber produces custom medical grade fiber used by the medical device industry that is ideal for a wide range of clinical applications, including: endovascular, vascular, orthopedic devices and valves, suture, and biomaterial fiber for other associated uses.
The market for medtech devices that can contain medical-grade fiber is estimated to be $61.42 million within the U.S. alone, according to industry sources.
"We are also the first manufacturer dedicated solely to engineering custom made, medical-grade fibers for the medical device industry, using polyester biomaterial to produce both absorbable and nonabsorbable properties," said Robert Torgerson, a biomaterial engineer, founder and president of RxFiber with 30 years of experience in the medical device industry.
"Our high quality, next generation fiber products are available in both small or large quantities."
[caption id="attachment_86959" align="alignleft" width="302"] Resin pellets are the first stage in the manufacture of custom medical-grade fiber devloped by RxFiber.[/caption]
According to Mr. Torgerson, textile manufacturers in Central America originally made most of the fibers used in implantable medical devices, but they did not have traceable quality systems that met U.S. medtech manufacturer standards. When these firms went out of business, they left a supplier gap for the medtech industry.
As manufacturing materials evolved, fibers were made from ultra high molecular weight polyethylene (UHMWP) and polyelthelene terephthalate (PET) polyester resins, but still lacked the flexibility and the tensile strength -- high tenacity (HT) factors -- suitable for creating today’s lower profile devices.
As an innovative alternative and a substantial upgrade over traditional industrial polyester (PET), RxFiber manufactures high quality medical-grade mono- and multi-filament fibers in a wide variety of custom sizes and variations using unique thermal melt and extrusion processes.
This process complies with ISO 13485-2003 international quality management guidelines for the manufacture of medical device components.
[caption id="attachment_86960" align="alignright" width="259"] Spools of medical-grade fiber are personally inspected by RxFiber's founder and president, Robert Torgerson, before being shipped. Each spool can contain thousands of feet of fiber.[/caption]
However, today there is an emerging demand for more stringent standards due to an increase in lawsuits involving alleged failures of earlier industrial-grade products.
"We want to serve as a catalyst in helping to bring together biomaterial experts to create a comprehensive industry standard," Mr. Torgerson said.
Individual fibers are extruded onto large spools (packages or bobbins) and can be weaved, knitted or braided into a fabric structures.
The company’s new release is a next- generation fiber called RxFibron HT, a product giving it double the strength of regular PET fiber and with the biocompatibility needed for advanced device integrity for small form factor devices -- and as an upgraded solution to other materials on the market.
The firm also has commercially released 40/27 PET, a fiber product that enables customers to replace their aging fiber supplies previously produced by industrial manufacturers with FDA equivalent material.
The mission of RxFiber goes beyond developing material specifications to focus on device outcomes and patient benefits.
"Physicians are looking for smaller and smaller systems to deliver devices in transcatheter applications inside narrow blood vessels that mitigate trauma to the patient," said Martin W. King, PhD, professor of biotextile technology at North Carolina State University.