Auto-injector devices have been around for decades, yet they have not kept up with the technological improvements that much of the medical device industry has made. The design has essentially been the same over the last twenty years, with the latest improvements only being created to help combat the exorbitant price increases of the devices. Despite this lack of technological improvements, companies have continued to raise prices for auto-injector devices without adding additional functions, a longer shelf-life, or better user interface. Auto-injectors currently are mainly used for the administration of epinephrine, meaning that are entire classes of medicine which are unavailable for use in an auto-injector device. Auto-injectors require some basic functions such as: releasing medication at a specific depth, being able to be used through clothing, relatively portable, administers a consistent dose, and must be able to be used by a wide age range. These functions are the basic necessities of a functioning auto-injector, but many additional features would create a superior product.
Some of the additional features that would improve on current auto-injector designs are: a device that is compatible with multiple drug types, has replaceable cartridges for additional doses, smaller unit size, and additional safeties to prevent unintended injections or needle exposure. An auto-injector having any of these features would drastically improve upon existing products. A new product that is able to incorporate all of these features would save more lives, create less waste, and cost consumers less money, would undoubtedly become preeminent auto-injection device.
The Novo-ject belongs strictly to the auto-injector medical industry. Currently, this market is dominated by two main devices called “Epipen” and “Auvi-Q” made by Mylan and Kelo Pharmaceuticals respectively. Team 19 is ready to enter this market by creating solutions to many complaints and problems associated with current auto-injectors. One issue associated with auto-injectors is that they are very wasteful devices when it comes to the use of epinephrine due to the small shelf life of the medication. When the medication expires, the entire device needs to be replaced. Novo-ject overcomes this by allowing users to replace a small cartridge which contains the medicine and needle. This cuts down on yearly cost and reduces waste. Currently, there are no auto-injectors on the market that will work for two different medications. Novo-ject will work for two drugs, epinephrine which is used for allergic reactions, and naloxone which is used to prevent an opioid overdose. Since the FDA recently called an opioid overdose crisis within the United States, this directly allows Novo-ject to be ready for this industry.
At this time in the United States, an epinephrine auto-injector has to be prescribed by a doctor. Consequently, the foremost distributors of these devices are pharmacies. In some countries such as Australia and Canada, a prescription is not needed. Considering the highly strict medical laws in the U.S., not needing a prescription does not seem to be a near future possibility; therefore, the distribution pattern will likely stay fairly consistent. Because having these devices is life-or-death for some people, there has not been a huge decrease in the buying patterns of auto-injectors. However, there has been a notable increase in the number of people opting for alternative devices. In fact, prescriptions for alternatives to EpiPen increased from 14.8 percent of the market share in January 2017 to 28.9 percent in February 2017 . This trend looks very promising for Novo-Ject to become a new competitor.
Proof of Concept
In order to prove the validity of the Novo-Ject, Team 19 must first ensure that the mechanism used will be able to produce enough force to complete an injection successfully. For the design to be successful, Team 19 determined that any design that could be considered for the embodiment design would need to be able to produce a force equal to or greater than 16 pounds. Sixteen pounds is the force that can be generated in an EpiPen and therefore an appropriate benchmark for determining the validity of other designs.
Additional concepts that Team 19 is attempting to validate in this design is the feasibility of replaceable cartridges. By having successfully designed an auto-injector with replaceable components, the Novo-Ject looks to revolutionize the auto-injection market. The use of the replaceable components in a real-world application in that the device can be quickly adapted to administer different medications and it allows smaller components to be replaced after the medication has expired. The replaceable components will serve to reduce cost to consumers, increase the use of auto-injectors to other applications, and reduce the waste associated with current product options.
The Novo-Ject is an optimized auto-injector device which has the potential to revolutionize the auto-injector market. With its groundbreaking removable cartridge the Novo-Ject will allow users to replace the medication when it expires rather than having to replace the entire device. Not only does this drastically reduce the cost to consumers, but is also a more responsible, environmentally friendly solution to other more wasteful products. Additional safety features on the Novo-Ject reduce the chance of missed or unintended injections helping to improve the overall user experience.
Other product design specifications integral to the function of the Novo-Ject are standard for all auto-injector devices including: the ability to release a liquid medication into the human body, the ability to penetrate thick clothing, portability of device, and the consistency of injection depth and volume. The product design specifications that make the Novo-Ject unique are the most important to consider when determining how it is useful for the consumers.
The safety features that are integrated into the Novo-Ject significantly decreases the chances of a missed injection particularly an injection into the thumb. These safeties help to make the needle of the device evident to the consumer just by holding the device rather than needing to read labels or instructions. This is especially useful when using auto-injector devices because time to treatment is usually critical. For consumers, another priority is their cost of the device.
The Novo-Ject aims to reduce the cost to consumers with its replaceable medication cartridge. Specifically with epinephrine which has a shelf life of only a year, the long term cost of the device would be lower to the consumers. Epinephrine also has a very limited temperature range that it remains effective in, in the event that the epinephrine is exposed to a temperature outside of that range, the user would be able to swap just the medication cartridge. The purpose of the Novo-Ject is to create a safer, effective product that will cost consumers less money so that patients that need to carry them as a last resort are able to more easily afford their auto-injectors.
The assembly process to the final prototype of the Novo-Ject is very similar to our teams proof of concept (PoC). All of the materials being used in the prototype test need to be acquired and laid out. These materials are: upper and lower housings, upper drive plunger components, safety release springs, safety release button, safety release handle, syringe and needle, syringe holder components, needle sheath components, and springs 1, 2, and 3.
Assembly of the upper housing:
- Glue together the 3 components of the upper drive plunger.
- Glue the springs for the safety releases to the safety releases.
- Insert springs 1 and 2 into drive plunger.
- Insert safety releases into upper housing.
- Slide upper drive plunger and springs into upper housing.
Assembly of the lower housing:
- Glue syringe into the top of the syringe holder.
- Insert lower syringe holder and spring 3 into the two halves of the needle sheath and glue the two halves together.
- Insert the above completed sub assembly into the lower portion of the lower housing.
- Insert the syringe and syringe holder into the top of the lower housing and glue to other half of the syringe holder.
Simply screw the upper and lower assemblies together to complete the unit.
Majority of the parts used in the Novo-Ject prototype were machined to spec using the machine shop in palmer engineering at the University of Nevada, Reno. Initially, the stock material of 1.5” diameter delrin rod was cut to length in order to get the material into a machinable size. These stocks were then put onto at least one of three different machines in order to manufacture the parts. The majority of the machining process was turning parts on the lathe. This completed the majority of the steps and several of the parts. Many of the parts required additional machining or were entirely made on either the mill or CNC. While the lathe is a fast and very accurate way to turn parts with round features, milling and the CNC is required to generate some of the more complex geometries of the parts. Once parts were completed, going through and breaking edges of the parts where possible ensures that parts move freely without sharp edges to get caught on. Since delrin is a plastic, there is little to no surface treatment that needs to be done. Simply ensuring that all parts are made to spec and fit together as desired was the final step to the fabrication process.
Testing and Results
The initial test plan was to perform 25 tests with the finished prototype. We conducted the tests by filling the syringe in the prototype with .3 mL of a colored saline solution that has similar density to the actual epinephrine solution. The saline solution was then injected into gelatin to simulate muscle tissue. The team was able to test the product 12 times before a part failure that prevented continued testing. In terms of results, the prototype hit all the marks the team had laid out for it except the goal for the number of tests. The product failed this test because some parts had to be 3D printed due to a time constraint. These 3D printed parts were considerably weaker than the machined plastic parts we had anticipated using resulting in the failure of these parts. The team will fix this issue by making sure to plan the timing of machining parts better for the next iteration of the prototype so that 3D printing parts is unneeded. Our product solves a number of current problems in the auto-injector industry. Currently, if the medicine inside a competitors auto-inject were to expire after a year, the consumer would have to buy an entire new product. With the Novojects groundbreaking replaceable cartridge, this allows users to replace the medicine when it expires as opposed to needing to purchase an entire new device. Not only does this drastically reduce the price for consumes, it is a more responsible, environmentally friendly solution to other, more wasteful products. While no one has actually tested our prototype on themselves, the general reaction we received when presenting out prototype was that this was a good idea and a much needed change to the current stagnation in the industry. The design of the product matches its purpose.
Meet the Team
James grew up in Concord, California, where he attended Concord High School, graduating in the Spring of 2013. In high school was where James found his passion to become an engineer as he took classes like physics and robotics. He the started at the University of Nevada, Reno in the Fall of 2013. James has always had a passion for baseball and classic cars. He grew up playing baseball in his backyard with his family. He grew into the classic car scene when he got a 1966 Mustang in high school. James has learned a great deal about engineering through his experience working on his own cars, learning how suspension, brakes, and motors work. He also has a fair amount of experience working in the engineering field, with over two years of experience as an intern for the Hamilton Company, aiding other engineers with their work designing benchtop lab equipment. These experiences, along with many others, have helped James progress as a person and an engineer when he graduates in the Spring of 2018.
Danielle was born and raised in Anchorage, Alaska and graduated from West Anchorage High School in 2013. She started school at the University of Nevada, Reno in the fall of 2014 to pursue a bachelor degree in mechanical engineering as well as complete the necessary prerequisites for medical school. The most challenging engineering project that Danielle has been directly involved with was a project in bioinstrumentation that required Danielle to create a lab setup that could measure and analyze electrical impulses from muscles compared to the muscles mechanical strength. This was particularly challenging due to the advanced circuit and programming knowledge that Danielle had to acquire to have a successful experiment. During Danielle’s academic career she has gained a working knowledge of the engineering design process and has been able to apply the process to her premedical courses. Outside of academics Danielle enjoys skiing, racing snowmobiles, and golfing. The accomplishment that Danielle is most proud of is her private helicopter pilot’s license that she obtained at the age of 18 and she is currently working towards her commercial helicopter pilot’s licence. Her current goals are to finish her engineering bachelor’s degree and to get accepted into medical school. Danielle’s goal after graduation is to pursue her medical doctorate and become a practicing physician.
Nick was born and raised in Anchorage, Alaska and graduated from South Anchorage High School in 2013. In fall of 2014, he came down to Reno, Nevada to start his bachelor degree in Mechanical Engineering. The most challenging engineering project Nick encountered in his academic career was measuring the thermal insulation properties of vacuum insulated devices. This posed a challenge since he was unfamiliar with heat transfer modeling computer programs. During Nicks academic career he has acquired great problem solving skills for school problems and other hands on issue at his job. Nick enjoys being outdoors with his dog Roper and traveling to new places. A few accomplishments that Nick is proud of is being an Eagle Scout and having an internship the past two summers for the natural gas company Norgasco in Deadhorse, Alaska. The drive and determination Nick held onto during his undergrad career has left him fortunate to graduate this May 2018. Nick’s goal after graduation is to find an entry level engineering job on the west coast.
Maddi is an accomplished, energetic Mechanical Engineering student who was born and raised in Carson City, Nevada. In 2013, she graduated from Carson High School as salutatorian, which was one of her academic accomplishments she is most proud of. Additionally, she has been awarded numerous academic merit scholarships to completely pay for her higher education expenses. Since high school, she has continued to grow her skills as a leader of engineering teams and has greatly improved her critical thinking throughout her college career. During college, her most challenging engineering project was using electromyography sensors to control a small robot through an obstacle course. This project required her to learn some LabVIEW coding that she was not previously familiar with. Maddi has recently been an intern at her family’s engineering business and uses analytical techniques to define problems and design solutions to HVAC and plumbing systems in commercial buildings. Outside of academics and work, she is a talented athlete and has a passion for working with youth leadership through Rotary International. Her short term goal is to graduate in the Spring of 2018 and start working full time in her family’s business as a consulting engineer. Eventually, she wants to settle down and start a family right here in Nevada.
Wade is from Danville, California and graduated from San Ramon Valley High School in the spring of 2014. He started school at the university in the fall of 2014 working towards his bachelor of science in mechanical engineering. In his time at the university, the most challenging engineering project he faced was using an evolutionary algorithm to train an artificial neural network to act as a nonlinear controller for a model physical system. He needed to apply all of his brief learning of C++, as well as seek outside sources for help, to successfully program a learning and adaptive model to the proposed real world scenario. Some of his most improved upon engineering skills are a desire to learn and viewing the world with a more analytical lense. Wade’s analytical skills are often tested when he returns home, having to diagnose and fix many different problems, from small things like having to fix the internet by resetting the router, to much larger tasks such as replacing an engine in a car when the old one failed. One of his proudest accomplishments outside of work and school stem from his athletic career in high school. He was a very capable sprinter in track and field and made it to the state track meet multiple times in his career. His goal after graduating is to land an engineering job somewhere along the west coast.
Thank you to the following people for the immense help and guidance throughout this rigorous project:
Capstone Professors: Dr. Nick Maus, Dr. Daichi Fujioka, Dr. Saul Opie
Team Mentor: Dr. Larry Levine
Everyone else who helped make this project possible