Retractable Technologies Inc. has played the underdog in an epic David-and-Goliath story that’s spanned the last 15 years. The Little Elm, Texas-based firm has fought loudly for its technology to be available to healthcare workers at risk for needlestick injuries.
Now the company is about to release a new product, one that could revolutionize the safety of healthcare workers. “That is, if they can only get it on the market,” says Richard Meyst, president & CEO of Fallbrook Engineering, a medical device design & development consulting firm.
RTI is no stranger to controversy. Its battles with the leading global syringe supplier, Becton Dickinson, have been marked with Pyrrhic victories: Injunctions and court orders have been enacted, all without any real change in the marketplace or an increase in RTI’s access to hospital buyers.
It’s the healthcare workers that really lose out. The Centers for Disease Control & Prevention conclude that, even with the presence of safety devices, needlestick injuries (NSIs) have not been reduced despite OSHA regulation.
These confluences are why Meyst believes that RTI’s latest technology needs to succeed. His team conducted research to analyze the new product, called EasyPoint, for safety, efficacy and design. “There are several features worth mentioning,” Meyst told Medical Design & Outsourcing.
EasyPoint is designed to be efficiently manufactured and meet user safety and clinical needs, with a unique safety mechanism. The EasyPoint is the first device to move the needle sideways as part of its retraction. When activated, the mechanism automatically retracts the needle into a sealed chamber outside the barrel and the fluid path.
“All plastic parts are designed for manufacturing by injection molding,” explains Meyst, meaning that the EasyPoint can be made at a fraction of the cost of competitive safety devices, using a fully automated, high-speed assembly process. “Less material means lower cost,” he notes. Meyst says the EasyPoint has fewer parts and is lighter and easier to make than even RTI’s predecessor safety syringe, the VanishPoint device. “This innovative design is more forgiving than previous designs, so manufacturing tolerances are less stringent (larger). This results in further lower manufacturing costs,” according to Meyst.
On the user side, RTI’s design team considered trends that are ongoing in the industry. Research shows that the market for pre-filled syringes is growing. The compound annual growth rate is expected to exceed 10% globally until 2020, until it reaches the $6.6 billion mark, in 2020 according to a report from Smithers Rapa. The EasyPoint fits on pre-filled glass syringes as well as standard syringes. The activation mechanism is perpendicular to the syringe barrel, eliminating the forward vector of force during activation. The design of the EasyPoint is such that it seals the syringe as soon as the needle is retracted, preventing medication leakage and airflow.
Meyst says the new design has no predecessor. “This is an entirely new concept and there have been essentially no previous research reports or precedent patents prior to RTI’s new patents for the EasyPoint,” he says. “As far as we know, nothing like the EasyPoint has ever before been submitted to the U.S. Patent & Trademark Office.”
RTI seems focused on protecting the design, although success in the market is still an uphill battle. But the company is hoping that EasyPoint’s low cost, patent-protected, unique design and market flexibility, (e.g., fits on the barrels of standard syringes) will tell a compelling story that industry will not be able to ignore – this time.