BME100 f2017:Group9 W0800 L2

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OUR TEAM

Name: Ricardo Avila Person
Name: Erik Sandoval-Ansel
Name: Rayan Alnami
Name: Nadene Hubbard
Name: Irene Zhang
Name: Renee Chao

LAB 2 WRITE-UP

Device Image and Description

Aesthetic needle.JPG


This is the pneumatic model of the auto-injector with a spring loaded release mechanism. It has a combination of pistons that regulate the order of the mechanism so that the needle will release most easily (and therefore first) and for the retraction of the needle to be done last. The device is being powered by a mild chemical reaction that will occur once the activation mechanism (i.e. a button) breaks a capsule. This will release non lethal gas at a rapid rate which will power the pistons. Once the reactions are complete, there are exhaust areas that will release the pneumatic pressure which will in turn retract the needle through the spring mechanism. This model will also disperse alcohol at the injection site in order to sterilize the site before the large injection. This is facilitated by the pneumatic pistons and the one way inlet valves that will spray out said alcohol.

The chamber that hold the gas will be mildly fortified in order to withstand the initial pressure of the reaction.

The preferred version of this device would be a non-pneumatic model will be spring based and will be slightly heavier, but will still be able to perform the same function at a *lower* cost

It is composed of mostly plastic with a bit of metal for the capsule breaking mechanism and the needle. There will be some sort of fragile material for the capsule (i.e. glass), and some rubber used to increase the integrity of the piston systems and the valves.




Technical and Clinical Feasibility

Technical Feasibility
a. What are the technologies needed?
The pneumatic device will require a rapid gas releasing compound that will release with a single push of a button which will power a sequence of piston based events that will provide an initial sanitation and the injection of the needle. The spring based device will utilize a spring contraption which is activated with the simple push of a button. Both versions of the device will implement a two-stop button system which will provide the initial sanitizing feature with the first press; then it will release the needle with the rest of the button press. There will be a ‘click’ to indicate each stage of the button. The sanitation will be triggered through a piston and will be released through holes residing next to the opening for the needle. The needle will also be able to retract. The vaccination will be triggered through the same way as the sanitation, but will be transferred through the needle into the blood flow.
b. What are the challenges?
The challenges with the production of the device would be finding the balance between making it cheap enough to produce and sell to less affluent regions while also making it durable enough to withstand overseas transportation.
c. What could go wrong?
The pneumatic model can rarely have its chemical based system degrade, which could result in the lack of the injection occurring or the system releasing too slowly to fully activate.

The spring based model could get jammed; however, the consequences are negligible. Other things that could go wrong could include the button not correctly triggering the spring and piston, the sanitization and vaccine not being properly pushed out of their housings within the auto-injector, the needle not retracting properly post-injection, which could lead to needle sticks, and the vaccine being wasted and trapped within the auto-injector as a result of any trigger mechanism issue, which could cause some clinical risks as people might try to take the auto-injector apart, exposing the inner-workings.

Clinical Feasibility
a. Given the technical feasibility it work in the clinic?
The device should work in the clinical field based on the technical feasibility, as the device being developed is grandfathered by many proven devices in the field of auto-injectors. This includes the EpiPen, and other self-administered vaccine devices currently on the market.
b. What are the clinical risks?
The clinical risks of this device could include improper disposal or dismantling of the auto-injector leading to potential sanitation, hygiene, and needle sticking issues for the general community in which these are administered. There could also be risks from using the auto-injector in the wrong place for the vaccine or parts of the body that are damaged or injured in some way, leading to the potential for various health issues. Other clinical risks could include those that usually come with vaccinations in general such as inflammation, soreness, fatigue, and bruising.
c. Have similar products been in a clinical trial? How long was the trial?
There have been similar products in clinical trials, such as commercial epinephrine auto-injectors, as well as vaccine auto-injectors for ailments like influenza, and a single-use auto-injector for multiple sclerosis treatment. The trials’ durations ranged from 3 to 10 years on average. The auto-injector for the vaccine’s trial was withdrawn before enrollment, but before that it lasted 3 years.[1] The single-use auto-injector for multiple sclerosis treatment lasted 5 years in trial. The EpiPen does not seem to have a record on the clinical trial website, but it most likely fell within the 5-10 year long average for length of clinical trials. In the multiple sclerosis treatment, there was an 89% success rate in the use of the single-use auto-injector called Avonex, as well as that in the main subset of participants studied, with 70 participants analyzed, 94% of participants preferred the auto-injector over a manual pre-filled syringe.[2]



Market Analysis

Value Creation
The device will be more convenient to use in third world countries, due to its small size. It will be easy to pack many devices and ship them over because of this, and also as it should be a more durable way of housing vaccinations. In addition the functions will be easy to use: at the touch of a button, the device will allow people to vaccinate others or themselves in a simple, hygienic, and easy way. Also, the simplicity of the device will reduce the need for professionals to operate it, which will be helpful in third world countries that have a limited amount of health professionals available. The device will thus improve patient care in third world countries and allow for reliable treatment for diseases that may otherwise spread without resistance. This means that the customers for the prototype are not limited to health-related humanitarian outfits, but instead allow any charitable organization that sends people and goods to third world countries, to buy and distribute the device. This means more work that charities can do, which can help them get more donations to help more people, and more people in third world countries being immunized.

Manufacturing Cost
The spring device itself will cost around five dollars each in materials. The cost of labor would either be wrapped into that or add on around 5 dollars after being distributed throughout the entire batch of devices, as it is important to keep all costs as low as possible to make the product affordable enough for the humanitarian groups acting as customers, and so that the device can be profitable for the company as well. We will use recycled plastic for the outside casing, a small amount of metal for the needle, spring, and piston, and some thicker plastic and glass to house the vaccine and sanitization liquid. The goal is to create the device so that it is simple yet durable and reliable enough to transfer over to third world countries. However, the cost will go up once we add the vaccine for malaria to the product, as all vaccines, especially one as new as this one, are expensive. It should cost $10 to $20 for one dose of the vaccine. As a result, the total cost of the product will range from 25 to 30 dollars.

Due to the vague market on gas releasing compounds, the material costs will be assumed to increase significantly, but the design of it will drop production costs by a mild amount. There will also need to be more physical tests for the device in comparison to the spring based design.
Sales Price
We plan to sell the device for $50 each. The plan is to sell in bulk to organizations and not individually to people. This is because the people who are going to benefit from our device have no way to pay. However, we can sell to the humanitarian organizations who help and distribute goods to these people. Therefore, because they are humanitarian groups, we can’t mark up price that high because non-profit groups have limited funds that are carefully allocated and organized, as the people they are providing to can’t pay them back. Along with that, the price of the product compared to the current vaccines and auto-injectors is much cheaper thus making it a more attractive option for humanitarian groups as far as price for a reliable product goes, which should help with the transition from using health workers to administer vaccines, to using the prototype to administer vaccines.

Market Size

$50 x 0.05 x 300,000,000 annual patients =$750,000,000/year
Through a market size of $750 million per year, this gives the prototype a score of 3 on the fundability worksheet. This makes sense, as although we are not selling directly to the people in third world countries who are affected by disease, in this case malaria, we are selling to the organizations who will distribute the products to them. According to UNICEF, “an estimated 300-600 million people suffer from malaria each year.” [3] This does not even include the number of people who are at risk to suffer malaria each year. As a result, with our sale price multiplied by 5% penetrance of the market multiplied by the amount of people suffering from malaria per year, the result is a huge market size that can be reached through selling the product to humanitarian organizations.




Fundability Discussion

The technical feasibility of the device is most likely a score of 3, as while there are some newer ideas that add to the auto-injector that make it different from pre-existing ones, such as the self-sanitization and pneumatic piston, the auto-injector otherwise is a completely proven concept and device and should be easy to develop and build.
The clinical feasibility of the device is most likely a score of 2 because the use of auto-injectors to administer vaccines is proven, but it is not a commonplace practice, especially when concerning the fact that the vaccine housed inside the auto-injector is one for malaria, which is a very new vaccine. Therefore, to be on the cautious side due to the self-administering aspect of this device and the most likely general lack of skilled supervision, the device gets a two. However, successful injection technique can be easily taught and would require only a few people to teach.
The prototype should be funded because although the current calculated score would be 27, the score for regulatory pathway should be set a 2 or 3 rather than the 1 that was automatically set due to the fact that the technology is not necessarily anything hugely unique or unfeasible to build today, as it has essentially been grandfathered in by previous technology with only slight additions. Therefore, the true fundability score should be a 54 or 81 rather than a 27 when changing the regulatory pathway score. Along with this, the technical feasibility as previously stated is there: it is ranked as a 3 due to the simplicity of the design and how user friendly it is. Adding on to the reasons as to why the prototype should be funded, the clinical feasibility is high at a score of 2 as this is simply a new way to administer vaccines that are already being administered, just in a more efficient and cost effective manner. The humanitarian groups that this device would be sold to would no longer need to spend money on intensive training for volunteers, because if needed, they can simply administer the prototype with a basic instruction manual, or the groups can administer them at local healthcare facilities in third world countries at minimal cost. The money not spent on intense volunteer training can then be used to buy even more of the device. Finally, the market size for this prototype has a score of 3, with a size of approximately $750 million/year due to the cost of the prototype which is tremendously cheaper than current ways to administer vaccines, thus making it more attractive and affordable for charitable groups to buy in bulk. While the competition and IP position scores are low, the competition score only stems from that up until now, there has only been one way of administering vaccines in third world countries: by doctors and skilled workers. The IP position score comes from the many auto-injector patents, which is something uncontrollable, though our design is slightly modified, allowing for a patent to be filed. However, the prototype pushes forward a way to immunize the population that is much more efficient and generally cost effective than having doctors or skilled workers, and is an auto-injector more suited for shipping and use in third world countries. The huge population in third world countries that would benefit from the accessibility to these vaccines through our prototype should make this device worth being funded.

Sources

[1] "Pharma-Pen (Formerly Innoject) Auto-injectory TIV." Pharma-Pen (Formerly Innoject) Auto-injectory TIV - Full Text View - ClinicalTrials.gov. ClinicalTrials.gov, n.d. Web.
[2] "Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects." Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects - Full Text View - ClinicalTrials.gov. ClinicalTrials.gov, n.d. Web
[3]"The Reality of Malaria." UNICEF. UNICEF, n.d. Web.