‘We are also the first manufacturer dedicated solely to engineering custom made, medical-grade fibers’
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.”
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 Torgerson, textile manufacturers in Central America originally made most of the fibers used in implantable medical devices, but they did not have traceable quality systems that met U.S. medtech manufacturer standards.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.
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.
Dr. King and Dr. Chris Pastore, professor and co-director of the engineering and design institute at Philadelphia University, are collaborating with RxFiber in an ongoing research, testing and analysis program comparing RxFibron HT with PET and UHMWPE alternatives.
They will present their findings before the Society of Biomaterials 2014 annual meeting in Denver this spring.
“RxFibron HT is the first released product of its kind to deliver this lower profile product potential,” Dr. King said.
Mr. Torgerson, spent three years studying the fiber market and once considered moving to North Carolina to set up their business and to be close to university and commercial colleagues.
“We assembled a high caliber board of advisors in the North Bay who recommended that we stay in Sonoma County and establish the company in an area with a growing biotech and medical device community. This is a great group of experts and executives helping to guide us, including a retired CEO with related manufacturing experience,” Mr. Torgerson said.
He observed that the town of Windsor was extremely helpful. “Their concierge level of service helped fast track us through the permit process, making it a seamless process to get started.”
RxFiber operates with a lean staffing model that includes the founder, a quality director, and several highly qualified contingent employees serving as production technicians and preventive maintenance personnel. RxFiber’s new RxFibron HT product will be featured as a finalist in the Golden Mousetrap Awards event held at MedTech World’s MD&M West conference, the largest OEM medical device design and manufacturing conference in the U.S..
Mr. Torgerson also has been selected to deliver a presentation at the Techtextil North American Symposium in Atlanta on research and applications of novel materials and innovative structures in developing new healthcare products spanning a wide range of clinical uses.
”We are becoming one of the fastest-growing fiber manufacturers in the U.S. focused on medical-grade fiber for the medical device industry,” he added.
“Our goal is to provide the medtech industry with a sustained supply of high-quality fiber and continue to innovate next-generation fibers and biomaterial device designs.”
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