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Since the passage of the Federal Needlestick Prevention Act of 2000, healthcare facilities in the U.S. are required to use safety syringes; syringes designed to prohibit accidental injury, misuse or reuse of syringes. Unilife, a medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable safety syringes is working to create safety syringes that are easier to use, cheaper to manufacture and, above all else, safer for healthcare workers. MedHealthWorld recently talked to Daniel Ziroli, Unilife’s Director of Information Technology, about the Company’s product offerings, how they are designed to change the medical device industry and their innovative company culture.

Unilife has two main product lines, Unitract and Unifill, both of which feature passive (automatic) safety features fully integrated within the syringe. Unitract is a safety syringe that is targeted for use in healthcare facilities or by patients that self-administer medication.  In 2010, the Company received 510K clearance from the U.S. Food and Drug Administration for two 1mL versions of the Unitract syringe, an insulin version and a tuberculin version.  The second product line, Unifill, is a glass barrel prefilled safety syringe. Unifill acts as a primary drug container for pharmaceutical companies’ drugs and vaccines and is designed to integrate into the fill-finish systems used for equivalent products, and supplied as per standard handling processes.

Safety syringes are designed to include mechanical features that reduce the risk of a needlestick injury to a healthcare worker or patient.  Ziroli explains that the inherent stress of the healthcare environment can lead to potential hazards that can be preventable through the use of Unilife’s devices. Ziroli says, “If you think about the hectic environment that a healthcare worker is working in when you add that much chaos to the healthcare environment, wielding a syringe with possibly infected blood, it’s an unnecessary danger.”

Moving beyond the traditional healthcare environment, Unilife’s products also work to address the harms of using traditional needles in the third world healthcare environment. Unilife’s website elaborates on the dangers, writing, “Injecting drug use is estimated to account for nearly one-third of new HIV infections outside sub-Saharan Africa. With many syringes re-used and shared multiple times before disposal, Unilife estimates that billions of unsafe injections occur globally each year.” Single-use safety syringes ultimately combat the spread of infection and disease by eliminating the syringe’s ability to be reused. Ziroli explains, “With the advent of the new safety syringe technology, none of our syringes can be reused after the needle has been retracted, it’s basically a dead mechanism at that time.”

“We are a company that really wants to look out, see what healthcare workers are dealing with, see what manufacturing companies are dealing with, and be there to provide a solution.”

The Unitract and Unifill products have characteristics that distinguish them from competing medical syringes and make them particularly beneficial to healthcare workers and manufacturers alike.

For healthcare workers and self-administering patients, Unilife’s syringes are designed to be user friendly and familiar to workers and administrators versed in working with traditional syringes. While the Unitract and Unifill syringes are designed to build upon the inherent flaws and safety issues of using non-safety syringes, they are also physically designed to be as faithful to the design of traditional syringes as possible.  Ziroli explains, “the motions that a person goes through to utilize a Unilife syirnge are the exact same as with normal syringes. It’s offers truly passive safety features integrated into the syringe itself. The health care worker is not performing an extra activity to engage the safety capabilities.”

Secondly, deviating from central trait of safety syringes, the needle’s retraction into its barrel is user controlled rather than automatic. Depending on how quickly the syringe’s user releases pressure on the plunger, the needle will retract accordingly. Ziroli explains that the instantaneous retraction of many competitors’ syringes can present a different set of risks to workers and patients simply due to the surprise and energy of many of these mechanisms’ retraction rate.

Third, Ziroli notes that Unilife’s products, particularly the Unifill syringe, are simply designed to be smaller and less bulky than competitors’ products.

For pharmaceutical companies and the associated manufacturers, the Unifill syringe offers a competitive advantage in that it eliminates many of the extra steps currently necessary due to the design of competitors safety devices for prefilled syringes.  This includes steps in the prefilling process and in the installation of third party secondary safety mechanisms. Ziroli explains, “From a manufacturer perspective, it’s more cost, more assembly, and, frankly, the more times you handle a prefilled syringe, the more opportunity you have to break it. The manufacturers are looking to us as bringing a competitive advantage. When they go to the market, being able to do that with our syringe gives them an edge up.”

While Unilife is currently focused on developing the Unitract and Unifill safety syringes, the Company is not limiting its focus to these two product lines, but rather, they are looking at the bigger picture. As Ziroli explains, “When we look to define ourselves, we are trying today as a company to not only look at syringes, but also to ask philosophically what are improvements that the Company can help bring other devices and other ideas that will either help patients or healthcare workers or help manufacturing companies.”

Unilife is forecasting significant growth for itself and is already planning accordingly. In one example, the Company recently turned to SAP’s Business-All-in-One solution software; software designed to help growing companies with all facets of management. Ziroli is optimistic that SAP’s software is going to be of a great benefit to Unilife as it scales up its production and grows in size and capability. He expects great results in areas like inventory control, staffing, pricing, and compliance. He says, “You know we have an expectation of where we are going to be in three years, and at that time we are really going to need a world class system like SAP.”

Ziroli attributes the Company’s success to its can-do attitude. Citing a recent exclusivity agreement with sanofi-aventis as an example, he explains that the Company continues to set and meet goals as it grows. He says, “We have a staff of very intelligent people that are united around a common cause and that is really helping us get things done. We have an incredible ability to continuously meet the milestones that we have ahead.”

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