Duoject Design Team
Duoject Medical Systems
VaccJect is a safe, simple and cost effective cartridge-based alternative to a prefilled syringe. Its unique passive retraction mechanism never exposes the needle, either before, during or after injection. The drug is contained in a standard 1ml ISO cartridge and is kept separate from the device until point of use. This greatly reduces cold-chain shipping and storage costs and eliminates the need for secondary packaging at the pharmaceutical facility. VaccJect takes advantage of the numerous benefits of a cartridge over a syringe: Low cost, high speed filling, baked silicone, no tungsten, etc.2. The Brief: Summarize the problem you set out to solve. What was the context for the project, and what was the challenge posed to you?
The need for effective needlestick protection is well established. According to OSHA, in United States there are 385,000 needle stick injuries per year. This alarming situation pushed authorities to address this major socio-economic problematic by passing into law the US Needlestick Safety and Prevention Act in November 2000 and the recent EU Sharps Directive. With those directives in place, the need for safe injection device is now clear. In early 2009, Duoject Medical Systems examined the current device development trends and set out to try to develop a better solution. In particular we wanted to answer the question, does the inclusion of a needlestick prevention device have to increase the cost of a delivered dose of vaccine or parenteral drug? The prefilled syringe has long been accepted as the preferred container for supplying and delivering a ready to use injection. However, syringes are relatively expensive and adding a safety system has considerable technical challenges and doesn't always result in an elegant solution. We did not want to develop a new primary container with all the regulatory hurdles and difficulties that would entail, so we restricted ourselves to well established proven packing systems. The obvious choice to us was the standard glass cartridge.3. The Intent: What point of view did you bring to the project, and were there additional criteria that you added to the brief?
Cartridges are being used in huge volumes throughout the industry. Production capacities are freely available, high speed filling and handling equipment is highly developed, and it’s a reliable, effective, low cost drug container. Convincing pharmaceutical companies to switch to a new drug delivery container is a fairly complex task due to all the regulatory hurdles and cost usually associated with this kind of change. As mentioned above, it is proven that cartridges offer many advantages over syringes, it just needed to be packaged the right way. From the outset we wanted to ensure that the needle was never seen: not before, during, or after injection. VaccJect had to be low cost, the safety feature passively activated and the device permanently disabled as soon as the injection was complete. As the development progressed, we saw clear advantages in separating the drug container (the cartridge) from the delivery device. Keeping the two parts separate until the point of use greatly simplifies the production process at the drug filling facility, eliminating all secondary packaging and letting the facility focus on the critical task of compounding and filling the drug cartridge. It also has a significant financial and environmental impact on cold chain storage as only the drug container (cartridge) needs to be kept refrigerated.4. The Process: Describe the rigor that informed your project. (Research, ethnography, subject matter experts, materials exploration, technology, iteration, testing, etc., as applicable.) What stakeholder interests did you consider? (Audience, business, organization, labor, manufacturing, distribution, etc., as applicable)
Observations and a profound understanding of the injectable drug delivery ecosystem was central to this project because it was really important for us to fully consider all the different stakeholders involved the product's life cycle. The revelations from these activities helped us determine where we could add value. As an example, our studies of drug delivery systems in third world countries indicated that the lack of cold storage availability was a big issue. As a matter of fact, we quickly realized that our solution could provide a financial and environmental advantage that any market could benefit from, not only third world countries, as a decrease in required cold chain storage space would undeniably save energy costs. After this first research phase of our design process, we were confident that we would bring something new and necessary to the table. At this point, our focus moved towards the end-user needs which are those of the patients and practitioners. By observing patients on site, it became obvious that we could have a significant impact on the negative perception associated with injection devices and needles. Combining absolute safety, absolute simplicity and soothing aesthetics, without transferring functional complexity from the device to the user, was the next important objective for us to achieve. However, the fundamental paradigm-shift proposed by the VaccJect needed to be embraced by pharma companies, nurses and doctors who, as discovered from our industry observations, are more reluctant to change than non-experienced users. In order to answer the previously mentioned challenges, we came up with an intuitive device that, conceptually speaking, was based on the way a ball-point pen is used, which is something that everyone can relate to. Push on a button to expose the ball-point, push again to retract it. Simple, efficient. After several concept and prototype iterations in order to optimize end-user experience and overall mechanical performance, we were ready to submit the VaccJect to user studies, allowing us to verify and validate our design assumptions. These studies were highly successful and surpassed our expectations, enabling us to offer the device to the market with a high level of confidence. Many pharma companies now see the advantages offered by this innovative proposition and we're proud to say that the device will soon be in FDA clinical trials.5. The Value: How does your project earn its keep in the world? What is its value? What is its impact? (Social, educational, economic, paradigm-shifting, sustainable, environmental, cultural, gladdening, etc.)
We see great value in introducing Vaccject to the pharmaceutical industry. Keeping the drug cartridge separate offers significant benefits where drugs must be kept at reduced temperatures. The cartridge takes up approximately 10% of the volume of a typical 1mL syringe, thus providing substantial savings in the cold chain storage and distribution systems. According to the 2011 BioPharma Source Book (Pharmaceutical Commerce), the pharmaceutical industry was expected to spend $4.6 billion on cold chain transport and storage in 2012. Just a 1% reduction would equate to a $46 million saving to the industry. Clinic and hospital healthcare workers also told us that refrigerated storage space is at a premium and, when questioned in a study, saw a significant benefit in being able to store the drug separately, especially as cartridge insertion into the device is so simple, “like inserting a battery in a remote control”, as one experienced nurse reported. During user evaluation trials, other key points became clear: 1. Seasoned healthcare professionals found VaccJect very easy to use and expressed no reservations about switching to the device. They particularly loved that the needle was never exposed, neither before nor after the injection. 2. Pediatric professionals particularly liked that the device does not look like a syringe and that the needle is always covered. They felt that their patients would be more at ease receiving their injections from VaccJect rather than from a standard syringe. Our observations demonstrate that the VaccJect responds successfully to socio-economic and ecological challenges.