Future questions

We have come up with the general idea of how our product should look like as seem in previous posts. We however did to figure out how it would work.
One idea is to coat the needles with the necessary allergen by having the needles be the opposite charge as the allergen. This will help the coating stay in the body when the needles are removed.

Are we able to have the same concentration and dose on the needles that are being used with current allergy tests?

Will having microneedles remove the reaction of the control meaning the only reaction will be the body reaction to the present allergen?

If not, how will be judge if there is an allergic reaction or not?

These are questions that need to be researched and answered moving forward.

Next Steps for the Project

So far this semester, we have come up with some great ideas for designing our allergy stamp test. We have an idea of what the device as a whole should look like and how it should function, as seen in previous blog posts. Our next steps will be to figure out the technical aspects of the device, such as the concentration of allergen we need to observe a meaningful result (reaction or no reaction). We also need to decide how much allergen each microneedle could contain, so we can figure out how many needles would be necessary to have the proper concentration for each allergen. The last major technical aspect we need to figure out is how the reactions will be detected; whether we will get bumps that can be seen through a lens (like a magnifying glass), or whether an automated system needs to be used. All of these things will be addressed over the next week, with the hopes of hashing out the final technical details of our device.

Another Reference

Last week I found another reference for our project. I talked to Pediatrician Dr. Elias Milgram this is his website: < http://www.drmilgram.com/Home > Dr. Milgram offered himself to help us in our further development of the product by giving feedback on the medical point of view of our product development. He is an extremely talented and a well known doctor among the Pediatric community. Dr. Milgram currently works in Miami, FL. In my last interview with him, Dr. Milgram claimed to be interested on our product and believed on the feasibility of our idea. Nonetheless, he stressed on the importance of having the right pressure for the needles to reach the skin deepness required. Moreover, he also pointed the relevance of having a way of standardizing the test in some way so that allergologists can actually make diagnostics based on the wheal size.   

Pitfalls of Skin Prick Testing in Food Allergy Diagnosis

Here's a paper on skin prick testing (SPT) and its pitfalls: http://www.ncbi.nlm.nih.gov/pubmed/20922509
 (be sure you're on BU network or VPN)

It explores the process of food allergy diagnoses and therapies in detail and concludes that the placebo-controlled oral food challenge is the gold standard in food allergy diagnosis. We should consider the merits of their arguments against our product and determine which food allergens are compatible with the skin prick test. Because our product works within the same theoretical framework as the skin prick test, we can evaluate our method with the same lens. However, we must also consider the improvements we make, such as the claim of increases specificity due to careful control of the application. Perhaps we can address their claims that current uses of SPT and serum food-specific IgE are insufficient without careful medical histories. Maybe we can knock some gold standards out of place!

First time trying out CAD

I've spent my entire day trying to figure out something with CAD, and this is my first very very very rough sketch.

Device Design

Last week, I took some time to consider how some basic characteristics of the device's design would be carried out. In addition to looking to create a microneedle patch, our team aims to develop a way to apply the patch. By shifting contexts and investigating things like stamps and clickable pens, we can get some inspiration. I've sketched some possible designs based that are based off a similar mechanism that clickable pens use. While developing possible ideas, it is important to keep the design as simple and as easy to implement as possible. I'll post some sketches soon when I have the means to scan them.

Preliminary Designs

After attempting to do a sequence drawing schematic of how our device would be used during class, we all decided that we need to have a clear understanding of how our device functions. We also need to figure out whether or not we will use biodegradable microneedles, whether we will inject the allergen through these microneedles, or whether we will just coat the microneedles with the allergen. We also have to figure out the most common allergies we should test for using this stamp.

According to this Mother Nature Network article, the 9 most common allergies are the following:

1. Wheat

2. Penicillin

3. Eggs

4. Pet Dander (for cats and dogs)

5. Mold

6. Milk

7. Pollen

8. Peanuts

9. Sun

Obviously, we won't be able to test for some of these allergies, such as milk, by using a test like ours, but this list is a start. As an example, our device could have a matrix containing 8 allergens and 1 control. Below are some preliminary designs I have created on the basic shape of the stamper and allergen matrix. 

The Nitty Gritty

After getting through intensive ideation and finally making an idea, we have been dealing with the specific details of our product. We decided to keep a running list of issues and topics that need to be dealt with in more detail, and we have been volunteering to take on individual research goals. The idea is that each person will naturally be familiar with the project as a whole, but each task calls for more care than six people could efficiently offer. So, while we are taking new developments as they arrive--and they arrive quickly--we are simultaneously trying to bring structure to our work. 

David gathered our ideas in a list on our Facebook page, and we each elected to focus on one of following:

1. Determine the size of our prototype and concentration of allergen required.

2. Do a rough sketch of the product by hand and possibly in CAD

3. Determine how the needles will be distributed and spaced

4. Do a logo and pick colors for the product

5. Determine how to insert the allergen in the needles/patch

6. Determine the material of the stamp, patch, and which microneedles to use. Also how to adhere the stamp     to the patch.

7. Determine which lens to use or what technology to use to capture the size of the skin reaction.

The list is incomplete, representing a snapshot of what seemed urgent at the time, which has changed and continues to change. I think that the list has a lot of potential as a living document that grows alongside our project. The more we learn, the our answers to problems, as well as problems themselves, develop and take on new form. By the end of the project, we will have an extensive list of problems and researched solutions, and presenting the work to others will hopefully be trivial.

Weekly Update

So... time to post again for the weekly update. While Natlia's previous blog entry addressed some of the questions from Design Review presentation, I will focus on some of the comments/suggestions given in the feedback.

This summarizes some of the comments/suggestions

Convincing Need?
1) More stats.
     - How many people have un-diagnosed allergies?
2) Pain reduction doesn't seem to be that pressing of a need.

Reasonable Specs?
1) In addition to cutting down on test duration, aim to cut down on diagnostic time as well.
2) Specificity/Sensitivity?
3) Don't necessarily limit testing to children, as some allergies don't develop until later

Creative Ideas?
1) Use microneedles to draw blood - then use lateral flow test
2) Microfluid device to collect and analyze blood samples

Likable Features?
1) Reduced pain
2) Quickly tests multiple allergens

Potential Challenges?
1) maintaining structural integrity
2) producing prototype of accurate proportions (on micrometer scale)
3) interpreting results - ie diagnosing correct allergens (avoid contamination)
4) determining amount of allergen necessary to deliver

Other Comments/Questions? -
1) Could this ever be safe for at home testing? What if allergic reaction occurs?
2) Make table of each allergen being tested and method of testing
3) Use input from contacts to find out feasible needle density

Suggested Contacts?
1) Kristine Krol - Allergy Specialist
2) People with allergies - feedback on comfort, hesitations, etc
3) Check Boston Children's and Harvard Vanguard
4) Johnathan Rosen - BME technology commercialization

We'll look into these and try to better address our solutions!

Resource for learning CAD

In response to Lauren, I agree that our current primary contacts are very solid. One of them is an allergist, who has intensive experience with allergy testing. I believe that David did a good job listing out the aspects that we should prioritize on.

I would like to recommend lynda.com to any of you who wants to learn solidworks, their tutorials are super informative and helpful, and you can essentially learn every software/ programming language from it. It costs $25, BUT you can use it for free if you have a friend/family member who goes to a college that has free access to lynda and is willing share with you. These colleges include northeastern,  Emory, columbia, carnegie mellon, american university, and tons of others. Just search for the schools' name followed by lynda.com to see if that college has access to the site. Annoyingly, BU doesn't have it.

Things to do:

After receiving feedback from the class, professor, and doctors. We are looking forward to improve our product. For now, these are some of the things we have to do next:

1. Determine the size of our prototype and concentration of allergen required.
2. Do a rough sketch of the product by hand and possibly in CAD
3. Determine how the needles will be distributed and spaced
4. Do a logo and pick colors for the product
5. Determine how to insert the allergen in the needles/patch
6. Determine the material of the stamp, patch, and which micro needles to use. Also how to adhere the stamp to the patch.
7. Determine which lens to use or what technology to use to capture the size of the skin reaction.

Microneedle Technology Article

Just last year, the Discovery channel had an article about a microneedle patch for delivering vaccines. It is just an example about how our idea is plausible and is in line with current emerging technologies. Click here for the Discovery News article.

In other news, I finally got a response back from my dad's cousin, who is a doctor at Beth Israel Deaconess Medical Center, but she said she does not have much experience with allergy testing. She also does not have experience getting her children tested for allergies, so she couldn't attest to the pain children experience. It was worth a try, but I think our other contacts are pretty solid.

- Lauren

After Progress Presentation

These are the main aspects people asked about after the presentation:

How do we put multiple needles without affecting the reactions?
     We're going to need to see if there is a ratio to how close the needles can be to each other in terms of concentration of the allergen.

What if a microneedle breaks in the body?
     We can consider making the microneedles biodegradable for disposal and if the needles get stuck in the body.

Is it painful?
     While the aspect of having multiple needles in the body seems painful, products having microneedles have said they aren't painful.

How will the reaction be detected?
     There are detection devices with other microneedle allergy tests which scan the area and determine if there is a reaction. The doctor could maybe measure the reaction by using a magnifying glass. Maybe since the needles are smaller, the only bumps that form will be from allergy reactions. Maybe we could use a lotion or something depending on the heat of the reaction or antibodies from the small wound. We need to consider and discuss further how the detection will be determined.

 Other than these concerns, the product seemed to be well received. We will now need to wait for the evaluations from our peers.

Explaining our Idea

As Natalia previously mentioned, our idea combines a micro needle patch that administers the drugs and the stamp that avoids the idea of having the patch attached to our skin for many hours. The combination of the patch and stamp enables the patients to test for different allergens without having the painful and invasive procedures of nowadays allergy tests. The VACC-STAMP injects the drug in a very subtle way by exposing its micro needles that are attached to the patch. The patch contains a matrix of different allergens and a mixture of anti-inflammatory/disinfectants that administer the drug and prevent infection. This new product is convenient for doctors and patients because:

- It administers the drug easier and faster
- It can be used in any kind of patient
- It replaces the painful and invasive current allergy tests
- It is cleaner and prevents infection
- It extremely easy to use
- It is portable

These are some of the characteristics that describe our product and that make us believe that this patch & stamp technology can have a great impact on the health diagnostics market.

Our next step is to consult doctors and professionals about the feasibility of the product.



    

Finding a plausible idea!

While looking for diagnostic problems, we decided to focus on a less painful way of diagnosing allergies.
Currently, there are three ways to diagnose allergies: skin prick test, interdermal test, and skin patch test. To do a skin prick test a drop of an allergen solution is placed on the skin and then a needle prick is applied allowing for the solution to enter the skin. Similarly, an interdermal test is done by injecting an allergen solution into the skin. A skin path is when a pad with an allergen solution is placed on the skin. For all there are two ways to determine an allergy, a blood test where the concentration of antibodies is calculated and a skin reaction test where the size of the reaction is measured.

Our first idea was to create a microneedle interdermal patch that attaches to the skin and after a certain time period is removed and the results can be seen on the skin. This idea however was found to be currently patented.

Our second and current idea is to combine the patch idea with a stamp. Therefore the allergen can be injected into the skin using microneedles on a stamp. This will take less time to administer and can be used on children. A similar idea currently in testing is called a Vacc-Stamp which uses microneedle vaccines on babies.

We are currently still developing this idea more.

Nebulizing Creative Hurdles

Tuesday's group breakout exercise, rapidly prototyping an electricity-free and child-friendly nebulizer, helped me realize a lot of deficiencies in my approach to creative problems and underlined some important issues in operating effectively as a team. From the start of the workshop, it was clear to me how we were going to get the nebulizer to work: pump connects to tubes connects to inhalation device, throw in connecting pieces, plug holes, get out the door in under two minutes. For the most part, that is what happened, but it was just as straightforward for everyone else. I was too focused on the idea of jumping in and getting the thing to work period that I missed out on some really simple ideas to make our product approachable and fitting for its application.

The presentations showed how a few simple creative ideas could really set the product apart from its competitors and cater the way it is used by the user. Something as simple as making the mouthpiece less intimidating for the child with a an animal shape, as one group did with a dragon, or, as another group did, using the T-junction and a second pump to create a continuous stream could greatly enhance the user experience and even make it more attractive than the electrically-pumped device.

Moreover, I realized that those simple ideas would be a lot easier to come across if we made better use of each other as a team. We could definitely use some practice in decreasing friction and letting ideas flow more freely. I feel as if we squelch ideas a little too quickly, and we sometimes abandon ones that, in hindsight, may have been promising leads or at least a route to later branch off from. A major part of why I am in this course is to gain those skills, especially in the context of engineering, and to get into the groove of getting the most out of group projects like this. Let us hope we do that!

Brainstorming - The Ideas that Didn't Make It

Brainstorming can be tough... Especially when attempting to implement a novel diagnostic device. Over the last week or so, I've been trying to think of innovative ideas. I've tried several strategies: combining existing technologies, thinking back to previous projects or labs I've worked on, evaluating existing diagnostic protocols, shifting contexts... Despite coming up with several ideas they all had their flaws and didn't seem to catch on with the rest of the group. Here's a couple examples.

Building off of previous lab experience, I considered a sleep monitoring device. After all, there are many easy to measure and informative biological signals during sleep. These include ECG, EMG, EEG, and EOG data. These signals vary through the night in each shift of sleep cycle. With careful monitoring of such signals, one could see if anything was irregular in their sleep pattern. For instance, too long or too short of time spent within REM can greatly affect mood, alertness, memory, and many other conditions. Our device could monitor one or more of a subject's biological signals and be programmed to analyze and interpret the data and present its results in a useful, user-friendly form.

Another idea came to me when considering a semi-neglected problem: HPV in men. HPV is very common and most sexually active people will have it at some point in their life. High risk types of HPV can cause cervical, anal, penile or throat cancer. Lower risk types which don't cause cancer can cause genital warts. Overall however, symptoms are rare, and the virus will typically go away on its own within a couple of years. Women after the age of 30 are recommended to get tested regularly: a pap test and an HPV test. The HPV test tells whether the patient has the virus. Having the virus alone is not considered overly problematic, as it typically goes away on its own without symptoms. The pap test checks for irregular cell morphology that could lead to cancer. Having a positive pap test is more reason for concern. There's no recommended test for men, due to how rare symptoms are. However, as rare as it is, due to the large number of people that get HPV, approximately 8,400 people within the US are diagnosed with oropharyngeal cancer that may be caused by HPV. Men are approximately 3 times more likely than women to get this type of cancer. Thus, despite the fact that oroparyngeal cancer is "rare," it still affects a great amount of people. In addition to men having no regular screening, there is no approved test (for men or women) to find HPV in the mouth or throat. Since over screening is an economic concern, a cheap, perhaps self/home test could have potential.

Weekly update from Tim.

We've come up with many different ideas from brainstorming. I have experience with App development, so our original brainstorming revolved around making an app that helps diagnose something. But we later ended up choosing to tackle allergy testing, because we found it more fitting to the group as a whole. We made a pugh chart comparing widely adopted allergy testings with two other testing methods that we came up with.

Thoughts on Brainstorming

Hey everyone! I have been working on brainstorming ideas for the project and am stuck on creating some sort of saliva test strip. Since there are already test strips that test different things in saliva already, like pH, I was thinking we could create a comprehensive saliva test strip. Maybe we could combine each of those strips together so they can be tested for all on one strip. Another idea I had was to somehow modify an instrument that dental hygienists use when cleaning teeth, like the mirror; It is one of the only simple instruments I could think of that can be probably be physically modified somehow. Anybody have thoughts on this or other ideas?

- Lauren Kalfin