ALLERGY ALLY
GROUP PAPER B
Students Commented [PH1]:
Engr 190W Paper Grade: 19.5/20
Lecturer: Patrick Hong --Critical thinking & analysis: 4.0/4
--Use of evidence & research: 4.0/4
4 June 2018 --Development & structure: 4.0/4
--Generic disciplinary conventions: 3.5/4
--Visuals: 4.0/4
Table of Contents
1. Introduction……..…….……………..…………………………………………………….2
2. Proposal Statement…….......................................................................................................4
3. Work Product/Technology…………...................................................................................4
4. Target Customer……...........................................................................................................6
5. Competition……………......................................................................................................7
6. Method of Approach……………........................................................................................9
7. Risk Management…………..............................................................................................11
8. Conclusion…….................................................................................................................13
9. Table of Contents………………………………………………………………………...14
List of Figures
1. Peanut Protein Visual Representation………………………………………………….....3
2. Diagram of Probe-Tip Construction………………………………………………………5
3. Allergy Ally……………………………………………………………………………….6
4. Allergy Ally Accompanying App…………………………………………………….…...6
5. Disposable Probe Tip……………………………………………………………………...6
6. Nima Allergy Sensor……………………………………………………………………....7
List of Tables/Charts
1. Nima vs. Allergy Ally…………………………………………………………………….9
2. Material Costs…………………………………………………...……….…….……...…..9
3. Timeline………………………………...…………………………………….……… Deleted: ….10
2. Introduction
According to Food Allergy Research and Education (FARE), over 200,000 people per
year require emergency medical care for allergic reactions to food in the United States. In
particular, children are a higher risk for having a food allergy due to their immature digestive
systems and inability to digest complex proteins. The Centers for Disease Control and Prevention
reports that almost half of the 15 million Americans with food allergies are children under 18
years old, and the number of children with food allergies has also increased over 50% in the last
twenty years [1].
Current solution to this problem requires the use an EpiPen. It is expensive, emotionally Deleted: In addition,
Deleted: having to
and physically traumatizing, and an after-the-fact remedy to food allergies. Common safety Deleted: solution
precautions advised by doctors instruct people who are highly sensitive to various allergens to
carry an EpiPen with them at all times. The pharmaceutical company that makes EpiPens,
Mylan, recommends users to always have access to at least two devices for safety just in case
one does not work properly [2]. This device is held in reserve and is only used after a reaction Deleted: work
has begun to occur. Each EpiPen costs between $50 to $300, and to make matters worse, the
device expires after one year. This forces people with food allergies to purchase more units on a Deleted: constantly
yearly basis, which is a financial burden.
Allergies are caused by the body’s immune system reacting to a non-threatening Commented [PH2]: You mean perceived as
threatening, but really not?
substance. The body senses the presence of a specific protein or substance that it deems
dangerous by the way of antibodies. Antibodies are created by the immune system to detect and
bind to a specific protein [3]. When an antibody binds to its specific antigen (foreign substance),
it activates a chain of events that results in the entire body attempt to fight the perceived threat.
For example, the active protein in peanuts is what induces the bodily-reaction called anaphylaxis.
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The symptoms include difficulty of breathing, rapid heart-rate, and when gone untreated, can Deleted: is has
Deleted: of
cause death [4]. People with severe peanut allergies only need to consume 0.25mg of peanut Deleted: it
protein to have this reaction, and as seen in Figure 1, this is an extremely small quantity. This is
equivalent to 1mg of a peanut, or 1666 ppm.
Figure 1: Visual Representation of Milligrams of Peanut Protein [3]
Furthermore, issues such as unskilled employees, cross contamination, or simplified
labelling are still risks for foods that may appear to be safe to consume. Individuals with allergies Deleted: concerning
must rely on restaurant staff to properly prepare allergen-free meals, but that still does not
completely eliminate the possibility of having an allergic reaction. Commonly, the waitstaff will
not consult with chefs to ensure that a dish is devoid of an allergen when asked by the customer
and will make an incorrect assumption about an ingredient. Unskilled or careless chefs may also
prepare an allergen-free dish in the same workstation that he or she prepares food that contains
an allergen, which causes cross contamination. According to an Environmental Health
Specialists Network study from 278 randomly selected restaurants, more than 10% of managers
and staff believed that a person with a food allergy can safely consume a small amount of such
allergen [5]. And when it comes to packaged foods, the Food Allergen Labeling and Consumer
Protect Act does not regulate advisory labelling. Therefore, precautions such as “may contain” or
“in a facility that also processes” are often-times left off packaging [6], which can be life-
threatening to people with severe food allergies such as Celiacs disease.
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3. Proposal Statement
The proposed Allergy Ally will take the stress and guesswork out of eating for those with Deleted: For people with food allergies, the
food allergies. By placing the probe-tip in contact with any food, Allergy Ally analyzes and
determines if there are ingredients that may cause an allergic reaction, including gluten, dairy,
soy, and various nuts. It is a small, easy-to-use, and portable device that connects with any
smartphone. This device acts as a preemptive safety measure to avoid an allergic reaction
altogether, unlike the EpiPen meant as a device for after the life-threatening reaction has already Deleted: that is
begun. Allergy Ally also allows users to circumvent the necessity to rely on other entities, such
as the aforementioned unskilled waitstaff, chefs, and food labels.
Now, users will be able to increase their quality of life for they will no longer have to
skip out on birthday dinners, work meetings at restaurants, or socializing with friends. More
importantly, parents will no longer have to worry about their child being in a life-threatening
situation when eating food not prepared at home, such as a school cafeteria. Thus, people with
food allergies can eat with a sense of security and independence, and having an allergy will no
longer limit people to only eating food prepared in their own kitchen. Commented [PH3]: This can be moved to the
conclusion.
4. Work Product/Technology
The Allergy Ally utilizes this antigen-antibody specific binding system to determine the
presence of a potentially harmful protein. As seen in Figure 2, the stainless steel probe-tip is
coated in the specific antibody for the given allergen. Below the surface mounted proteins lies a
semiconductor with variable resistance based on the activation states of the surface proteins [3].
As more allergy-causing proteins bind, the resistance to voltage flow increases. The sensitivity of
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the transducer allows the Allergy Ally to reach the 20 ppm sensitivity goal, which is a detectable
quantity of allergens about 100 times smaller than 1mg (previously shown in Figure 1). Deleted: the
Figure 2: Diagram of Probe-Tip Construction [3]
The smartphone auxiliary port is capable of sending and receiving low voltage signals,
which is how the buttons on headphones communicate back to the phone. Therefore, this
transducer allows Allergy Ally to turn a biological process into an electrical signal. If the
resistance passes a specified threshold, the app will alert the user that the substance being tested
contains a significant trace of the specified protein. The process from probe insertion to the app
displaying the results should take no longer than 30 seconds. Moreover, the auxiliary port is a
universal input port for any smartphone, which resolves the limitation of types of users’ type of
smartphone.
Allergy Ally is a device similar to a voltmeter. As seen in Figure 3, it has a probe at the
end of a cord that plugs into the user’s smartphone through the auxiliary port. The accompanying
app will allow the user to select the allergy they want to avoid: gluten, dairy, soy, or various nuts,
seen in Figure 4. Once plugged in and the allergen selected, the user simply puts the probe-tip in
contact with the food they wish to test, and the users will receive results through the app within
30 seconds. The final analysis will report the contents of proteins in food to 20 ppm at a 99.5%
accuracy, due to this unique antibody detection technology. After testing one item on their plate,
the user disposes the used probe-tip and replaces it by unscrewing it and screwing on a new one
(Figure 5). This will combat any cross-contamination that may occur by using the same tip twice.
4
Due to the nature of the bio-reactive semiconductor device, the user will be able to test various
substances by changing the style of tip on the probe. Each probe tip will be built with the specific
surface proteins for that allergy.
Figure 3: Allergy Ally [14] Figure 4: Phone Application [15] Figure 5: Probe and Disposable Tip
[16] Commented [PH4]: This should be at the start of the
section. Then the details of how it works then come
after.
5. Target Customer
Allergy Ally targets children under 18 years old with a food allergy. According to FARE,
up to 15 million Americans have a food allergy, and 6 million of those are children under 18
years old. Also, children under 5 years old are more susceptible to food allergies than adults due
to an immature digestive/immune system, and the inability to digest complex proteins [7]. While
most children outgrow their allergies beyond 5 years of age, “[allergies] appear to be resolving
more slowly than in previous decades” [6]. Therefore, not only will the need of the Allergy Ally
for children be sustainable, but also this device will be able to give parents peace of mind when
they are not with their children, such as when their children are at school.
Since Allergy Ally requires a smartphone and has a sharp probe-tip, it may be less
convenient and less safe for children under 5 years old to operate themselves. However, parents
can easily check their child’s food for them and ask for a teacher’s assistance when at school. For
more independent children aged 5-18, parents may need to stress the dangers of food allergies
and the need to test questionable food products.
5
6. Competition
The biggest competitor to the Allergy Ally is the Nima Gluten Sensor. Nima has already
begun commercialization as a handheld device that tests for the presence of gluten in various
food products. It plans to expand into other allergens such as soy, dairy, and nut based products.
Seen in Figure 6, Nima utilizes pre-packaged disposable capsules in which the user places a pea
sized portion of food for testing. After three minutes, the user is notified as to whether the
sample contains gluten on a 20 ppm concentration at 99% accuracy. These results are obtained
by using specific antibody binding in conjunction with an optical sensor [8]. Though Nima does
not disclose the method in which it detects gluten, it can be assumed that when activated, these
antibodies cause a photoluminescence effect, also known as light radiation. This effect can then
be captured by the optical sensor and processed by the onboard computer. Upon receiving Deleted: ,
results, the user then disposes of the test capsule.
Figure 5: Nima Allergy Sensor test container loading procedure [8]
The Nima device’s shortcomings include the inability to detect gluten in liquids such as
alcohol, soy sauce and vinegars; this is due to the preparation methods used when producing the
liquid [8]. Specifically, the processing technique used in brewing causes the gluten to denature in
such a way that the Nima constructed antibodies cannot detect, but this denatured protein is still
detrimental to those with Celiacs disease [9]. The technology in Allergy Ally’s probe will be able
to analyze these harder-to-test substances, such as liquids.
6
The Nima also encounters issues with other types of food. The design of their capsule
requires that the sample be of a specific size to fit through the opening. This requires foods to be
crushed up or torn apart before testing. Some dry or flakey substances such as crackers and
cereal require the user to break up the substance and add water to create a pulp before inserting it
into the testing capsule. For patients that experience allergic reactions from merely touching the
allergen, this can be inconvenient and potentially life-threatening. Since Allergy Ally utilizes
probe technology, users will not have to touch the food in order to test if an allergen is present.
The Nima is also an independent device with an onboard rechargeable battery. No one
would want to be caught in a situation where they do not know if they can eat a meal because
their gluten monitor ran out of battery; it is inconvenient to charge the Nima separate from one’s
other devices. Thus, the Allergy Ally circumvents this issue by utilizing the user’s phone as the
processor and display for the device. Since smartphones have transitioned from a tool to a
necessity in the modern world, their batteries are rarely completely drained. Also, many people
with smartphones have additional plug-in battery packs that can be used to keep phones charged
long-term. As the Nima’s design adds another battery for the user to monitor and another Deleted: Since
changing cable to keep track of, by comparison Allergy Ally utilizes an existing device which Deleted: and
makes it more convenient for users. Deleted: ,
Deleted: makes the Allergy Ally much
The Nima device itself costs $289, with disposable capsules costing an additional $72 for
a package of 12 [8]. Many users may feel this is too an expensive, because not only is the device
itself expensive, but the recurring charge of additional capsules will add up over time. Allergy
Ally aims to market the product at $150 with an additional 10-pack of disposable probe-tips for
$10, which is clearly more affordable to users.
7
As seen in Table 1, Allergy Ally is clearly the preferred product over the Nima, based on
cost per use, accuracy, portability, a wider range of testing capabilities, and more.
Table 1: Nima vs. Allergy Ally
Less Portable Fast Results Higher Users Don’t Can Test Not Battery
Expensive Accuracy Have to Liquids Operated
Touch Food
Nima X X X X X X X
Allergy ✓ ✓ ✓ ✓ ✓ ✓ ✓
Ally
7. Method of Approach
The Allergy Ally probe exterior will be made of various plastic polymers and a stainless
steel tip, with the internals of the probe being made of the proprietary bio-reactive semiconductor
assembly. The cord insulation and shielding will all be made out of the industry standard silicone
plastic with copper core wires carrying the electrical signal. Stainless steel is the preferred Deleted: prefered
material to utilize for the probe-tip because it is tough and has a high resistance to corrosive
elements.
Table 2 shows the cost of materials to manufacture the Allergy Ally. In addition, Allergy
Ally as a startup company would need initial funding to pay employees to develop the product.
Table 2: Material Costs
Materials/Components Cost Per Unit Source
Stainless Steel (Probe-Tip) $0.50 [10]
Semiconductor Assembly $45.00 [11]
(Probe)
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Integrated Circuits $10.00
Silicone Plastic Cord with Wire $3.00 [12]
Total Materials Cost $58.50 -
Final Product Starter Kit $150.00 -
Cost
(With 10 Probes Included)
Probe Replacement $10.00 for 10 pack -
Table 3 shows the schedule timeline for the Allergy Ally development. The biggest
obstacle in creating the product is the semiconductor hardware testing. This is what the entire
product depends on as it tests the food for the presence of the allergen. The entire development
would be about 45 weeks (approximately 10 months) and would need teams working in
software, hardware, app creation, and commercialization. This separation of tasks allows the
various teams to work in parallel. The main functions would be to test the hardware to ensure
Allergy Ally does not fail, achieving gluten detection results at 20 ppm at 99.5% accuracy. At
around week 31, the final software and hardware should be almost complete, with finalization
concluding at week 40. The app will take 15 weeks to create and debug, and the finished product
will go on the market at week 45.
Table 3: Timeline
Week Week Week Week Week Week Week Week
1-5 6-10 15-20 21-25 26-30 31-35 36-40 40-45
Software
9
Design
Testing
Improve-
ments
Retesting
Finalizing
Hardware
Design
Failure
Testing
Production
App
Creation
Creation
Debugging
Commer-
cialization
Advertising
On Market
8. Risk Management
The majority of risks associated with Allergy Ally involve user error.
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Probe contamination is the one of the biggest issues that Allergy Ally users may face. To
overcome the sanitary and consistency problem, Allergy Ally will use replaceable probe-tips. By Deleted: Nima uses disposable cartridges for each trial. To
reduce cost to the user as well as bulkiness, the
doing so, it ensures that each test utilizes a fresh set of antibodies to prevent contamination Deleted: will be about one third the size of the Nima, and
between foods and false readings caused by residue from the previous test. Additionally, having Deleted: Therefore
an exposed tip allows for the possibility of human contamination or mishandling of the
replacement probes during installation. To avoid contamination during tip replacement, the tip
will be packaged in a sanitary cap, and users will be instructed to have the cap remain on the tip Deleted: will
until the user is ready to conduct a food test.
In use, Allergy Ally’s probe may submerged too deeply into a liquid sample (which could Deleted: Additionally
Deleted: users
damage the probe), not deep enough into the sample, or not replacing the probe tip between use, Deleted: the probe
which could all result in false analysis. Allergy Ally would need to clearly outline how the
device should be used and under what conditions are additional steps required. This includes
easy-to-follow instructions to inform users to emulsify foods such as crackers, cereal, candy, and Commented [PH5]: Wasn't this mentioned as a con for
Nima? Meaning the user will have to touch it? In you
cereal example I think.
other hard foods to ensure sufficient contact between the probe and the substance in question.
Though this could cause a slight inconvenience for people who have severe conditions that
prevent them from even directly contacting substances that contain the allergen in question.
In addition to user error, antigen protein degradation is also a real threat to the device.
Allergy Ally would have to ensure proper packaging to ensure advertised accuracy up to a
specific date. The design of this product requires the antibodies to come into direct contact with
the food in question. This will require that the antibodies be attached to the probe surface, where Deleted: adhered
they will also be susceptible to other environmental factors. Antibodies are susceptible to
degradation over time and require specific environment parameters to work properly. The device
packaging will have to account for these needs.
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For probe tip disposal, detailed procedures will need to be determined once final Deleted: Also, exact
materials selection has occurred. Though it is very likely that disposal into landfill will be
acceptable since antibodies in this state will simply degrade when exposed to a nonideal Deleted: as
Deleted: the
environment. Other expected materials within the disposed unit are commonly found in other
disposed products: metal conductor, semiconductor elements, and a plastic housing.
Lastly, Allergy Ally ensures 99.5% accuracy in testing allergens at 20 ppm. This may
seem to pose a threat to those with severe food allergies, but as stated in Work Product, this is a
quantity 100 times smaller than the 1/600th of a peanut that induces anaphylaxis. Thus, there is a
clear factor of safety built into the probe’s accuracy thus minimizing the risk. Deleted: in regards
Deleted: to
Deleted: , so this risk in infinitesimal.
9. Conclusion
Not only will Allergy Ally take the stress and guesswork out of eating, but it will save
lives and reduce the likelihood of one being in a life-threatening situation due to an allergic
reaction. Within 30 seconds, Allergy Ally analyzes and determines if any food contains
ingredients that may cause an allergic reaction with a high level of accuracy. It is a small, easy-
to-use, and portable device that conveniently connects with any smartphone. Most importantly,
Allergy Ally acts as a preemptive safety measure to avoid an allergic reaction altogether, unlike
the EpiPen that is meant as a device for after the life-threatening reaction has already begun.
According to a pediatric allergists survey with National Jewish Health, seventy-five
percent of participants said their child’s social activity is limited by their food allergy [13]. So,
Allergy Ally will also be able to improve the quality of life for all users, especially children.
Children with allergies will no longer need to avoid social settings or feel outcasted by their fear
12
of having a reaction. With this new device, users will regain control of their health, and live life
as normally as anyone without an allergy would.
13
10. Table of Contents Deleted: ¶
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