M&E (Monitoring & Evaluation) Plan and the Social Return on Investment for Our Project

Our inputs include a variety of people and materials. Specifically, we as the GSIF team are working with our advisor, Prof. Cheng, and a TE capstone group to contribute bioengineering expertise towards the development of a low-cost, point-of-care, sickle cell anemia screening device. For this development, we are utilizing Lehigh University lab resources and funding (which will hopefully be expanded by health-related grants). Additionally, we will be getting local and healthcare system expertise from community members in Sierra Leone established through our partnership with World Hope International. In the future, we also hope to include business students, in order to get expertise on distributing the final product.

In addition to these inputs, our team focuses on several activities. Currently, our activities involve designing the device, and learning about the local context so that we can best implement our device. In the future, our activities will focus on distributing the test strip, training healthcare workers on using the device, and working with other NGOs to make sure our device is implemented alongside a treatment regime.

With these inputs and activities, we will create several outputs. Our primary output will be a physical test strip product. Additionally, we will develop jobs for locals in Sierra Leone who will be charged with distributing the device. Finally, our outputs will also include the participants we reach, specifically the healthcare providers who are conducting the testing, and community members who are getting tested. These outputs are directly measurable. We will determine the number of test strips that need to be developed and shipped/distributed to the healthcare providers and ultimately the community members by the amount of funding we receive and projected number of people who will be seeking the test. Once one shipment has been sent out, more concrete numbers for the amount of test strips that need to be delivered at one and how frequently to specific locations will be determined after statistics on the number of people tested and where they got tested have been collected. These statistics will be provided by the medical professionals stationed in different locations throughout the country who will be offering and administering the test.

Finally, our project will also have several short-term, intermediate, and long-term outcomes or impacts. Within a few years, we will hopefully have created a new and usable product which can be used to diagnose people in Sierra Leone with sickle cell anemia. After that, we hope to make a direct impact on community members by allowing individuals to get screened for sickle cell anemia at an early age, and access those potentially life saving preventative treatments. In the intermediate, we also hope that this product can also be expanded in to other low-resource settings, particularly throughout sub-Saharan Africa, where sickle cell anemia is prevalent. These intermediate impacts then have the long-term potential to reduce child mortality due to sickle cell anemia. Once we are able to implement screening for sickle cell anemia with our device at birth or at a young age (before 5) we will be able to take/track statistics around child mortality and determine if child mortality due to sickle cell anemia is going down. If the child mortality, due to sickle cell anemia, rate does not decrease this could be due to the lack of people getting screened or the lack of treatment after being diagnosed. We do not foresee the lack of treatment being a problem for there are cheap penicillin based treatments available. If the child mortality rate does not go down we will need to rethink where and how we have implemented the device and try/decide if it’s possible to make sickle cell screening mandatory at birth.

Additionally, we hope that by working with other NGOs, this product can be used to help bring about policy and social action changes. For example, although hydroxyurea is proven to reduce the symptoms of sickle cell anemia, and has been used successfully for patients in the US for years, it is not currently available in sub-Saharan Africa (original due to concerns that this treatment could increase the risk for malaria, which has recently been disproven). With the effective implementation of a low-cost, point-of-care sickle cell anemia diagnostic tool, we can hopefully initiate a push for health NGOs to make policy changes, getting this treatment to individuals in Sierra Leone. The data stating the number of people being screened and the information around how people are being treated for sickle cell anemia after being diagnosed can and should be presented to NGOs funding medical treatments. Once presented the data these NGOs will hopefully push for policy changes to allow for more options for treatment, like hydroxyurea, that will hopefully reach and affect more people positively.

In order to estimate the social return on investment of our project requires several assumptions. The value of every person who is screened will be equated to the average cost of sickle cell screening in the United States ($50 will be used as a very rough estimate of this price). We would also have to know what the value of each strip would be. To estimate this we would have to assume that one strip accounts for all labor, transportation, materials and other costs associated with eventually delivering the test. For the purpose of this estimation let us say that the total cost per test strip is $0.50. If we make these assumptions, then we can say that for every dollar that is given to the project we generate $100 dollars of social value. One dollar would equate to two test strips which would be used to screen patients. These two screenings in turn would equate to the value of being screened in the United States.

Making the assumption that the $50 test value is the only social value created by our project is false. In reality, the ability to understand and get treatment for sickle cell is very valuable but is not able to be monetized.

RESEARCH FUNDING SOURCES

Currently the sickle cell anemia group is working on the application for VentureWell E Team Program – Stage 1: Market Validation application for $5,000 in funding and a three day workshop. At the workshop teams learn how to better describe and identify the markets they plan on implementing there innovation in. Most of the $5,000 will be used for travel expenses to the workshop however the rest can be used for research material expenses. If we receive the Stage 1 grant we can apply for the Stage 2 and eventually the Stage 3 grants that are $20,000 and $50,000 (up to). The research materials we are currently using in the lab are extremely expensive, the most expensive materials are the antibodies that are used for printing the test line. We are currently paying approximately 7 dollars to make and test each test strip. The Stage 2 and 3 grants could help fund our research tremendously and the first step in applying for those grants is to complete Stage 1.

Another possible source of funding is a research grant from the NIH, National Institute of Health. Three programs we could possibly apply to are the NIH Research Project Grant Program (R01), NIG Small Grant Program (R03), NIH Research Enhancement Award (R15). Each of these programs are for early stage projects and the grant money is to go toward the materials and resources needed to complete the research. The main part of the application is the proposed budget for the next year or two of research and the proposed research strategy.

NIH Research Project Grant Program (R01): https://grants.nih.gov/grants/funding/r01.htm

NIG Small Grant Program (R03): https://grants.nih.gov/grants/funding/r03.htm

NIH Research Enhancement Award (R15): https://grants.nih.gov/grants/funding/r15.htm

DISSEMINATION FUNDING SOURCES

The DEBUT grant run by VentureWell and the NIH (National Institute of Health) is for undergraduate biomedical design and innovation teams that have a working prototype that solves a healthcare problem and is ready to be tested in the field (clinical trials) or implemented. The largest grant that we could receive is $20,000 with additional funding/prize money if our device/application shows a large market potential and economic feasibility or patentability. Once we have a working prototype and lab results this would be a great grant to apply for to fund a clinical trial in Sierra Leone that would lead us into the path of implementing the device.

Another possible grant that could aid us in the dissemination process of the project is UNICEFs Innovation Fund. We could receive an investment up to $100,000 for our device that improves child development. Before we are able to apply for this grant that could again aid us in running a clinical trial we first must meet their criteria. We have to be registered as a private company and registered in a UNICEF programme country (Sierra Leone is one of them). We have to be working on open source technology solutions or willing to be open source. Similar to the DEBUT grant we must have a working prototype and promising lab results, and identify how our device has the potential to positively impact the lives of children. The application for this grant is a little bit different than others and does not require a full formally written proposal/report, instead this grant is based off of a 2 minute video that provides all of the information above.

FIVE POSSIBLE PARTNERSHIPS

• Free Healthcare Initiative Figureheads/Leaders: The FHCI is ultimately the program we see our device being funded/bought by. By creating a partnership early on and explaining to the program what we are planning/working on developing they will already know the basics about the device when we come back and start implementation (need funding). Also, by forming an early relationship with the program we will be building trust and credibility by keeping in contact with them and giving them updates on the device, its impact and its cost.
• NGOs, UN, other governments (especially the UK Department of International Development) who provide the funding to the FHCI: Along with forming a partnership with the figureheads/leaders of the FHCI we should also be talking to the funding sources of the FHCI directly. If the funding sources support our device directly the device will most likely be accepted/supported by the FHCI.
• Sierra Leone Pharmacy Board: Once we have a working device we will have to receive permission to conduct a clinical trial with the device and then the certifications to have it on the market as a medical device. Again, by forming relationships with the Pharmacy Board early on we can ask very specific questions about the application process in person and keep in contact with our connections over the phone/email if we run into problems when filling out the applications. Sickle cell anemia is very prominent in Sierra Leone and having a diagnostic device on the market would greatly benefit the society, therefore, I believe the Pharmacy Board would be willing to work with us once we are able to provide a working device.
• Hospital Figureheads (head doctors, medical directors): Our medical device will be used primarily in hospitals and clinics and will have to be administered by a nurse or a “higher” medical professional. When we are in Sierra Leone we will be interviewing the medical professionals who would be administering the device and receiving feedback on the usability of the products. We will also be interviewing the head doctors and medical directors to discuss how a large group teaching session would be planned/carried out once the device is ready to be administered. The head doctors and medical directors can also give us feedback on if they believe the device is beneficial to the system and where in the system the device would be most beneficial. As of right now we believe the device should be used to screen for sickle cell anemia at birth, however, the medical professionals in Sierra Leone may have other ideas and reasons to do screen at a different time. In short, it is important that we have a strong relationship with the administrative side of the hospitals as well as the medical professionals themselves because they will be the people ultimately informing and administering the device for the people of Sierra Leone. If they believe the device will benefit the society, the more likely they will insist people get tested when they come to them.
• Sickle Cell Disease Coalition: This coalitions mission is to amplify the voice of the sickle cell disease stakeholder community to improve outcomes for individuals with SCD. The coalition helps bridge public health organizations with research and provider organizations to deliver advances faster, more economically and more efficiently to patients suffer from SCD. This coalition would want to partner with us because we are developing a device that is inexpensive and that will allow hundreds of people to be diagnosed with SSD and ultimately be treated in a timely manner that could greatly increase their quality of life. With the backing and partnership from the SCDC we will have a connection (“a in”) to other organizations that could help us with funding, production of the device, implementation, excetera. Having the support from the SCDC will also build our credibility tremendously which will help us build connections with all the above mentioned organizations and more.

Takeaways from Guy Kawasaki’s Speech on “The Art of the Start”:

Guy Kawasaki’s speech on “The Art of the Start” walked through the main components/concepts that need to be met and understood in order to create/develop a business from a great idea. The first point that really stood out to me was that he believed once a person has a general idea they should “Get going?”. That there should not be a large amount of time dedicated to planning because he believes you will be more successful if you start doing. The subpoint that got me thinking about this main point was that an entrepreneur, engineer, or designer (etcetera) should aim to polarize people with their idea. That an idea will be more successful if people immediately have an opinion on it and that it’s okay if not everyone is a fan or your idea. I believe the sickle cell anemia project has really embraced the idea that once an idea is established, get going. We have jumped into research and are working to get our device up and running. After only a semester and a half we have already had huge success; the control line has been created and the test line is close to being spotted. Kawasaki’s second point that resonated with me was that one’s product needs to be “high and to the right”, aka one must be able to provide a unique product or service and the value to the customer must be high. Kawasaki gave examples of products that met every other category (high and to the left, low and to the left, excetera) and explained how they failed. Going over examples made it easier to understand the concept and helped me figure out how our project met the “high and to the right” criteria. As of right now we are working on our ability to provide a unique product however, the value to the customer is high because the device will be cheap and will help screen/diagnose a disease that highly impacts the customers quality of life.

The next point that Kawasaki mentioned stood out to me because it directly correlates with a process we are currently going through. His 10/20/30 rule for presenting or pitching ones product or service is incredibly important because you want to correctly present our idea to stakeholders so that you can receive the funding and support to continue on your venture. The 10/20/30 rule guidelines for presenting are 10 slide, a 20 minute presentation and 30 point font. This rule can help us plan out our class presentations but will also help us during future presentations at conferences and for potential stakeholders. These guidelines will help us get our message across that sickle cell test strips are necessary in the Sierra Leone health care system in a timely and concise manner. Kawasaki mentioned directly after this point that teams should hire better than themselves and that new hires should be “infected” with love for the product or service. By hiring better than yourself the momentum of the project will continue in a productive way. As our project continues and students graduate new students will be brought onto the team. These students need to be as passionate about the test strips as we are and must be able and willing to put the time in the lab as well as doing research to continue improving the test strip. The final point that really stood out to me was “don’t let the bozos get you down”. I feel like a teams ability to bounce back from being criticized can really make or break the project. Being college students people might not take us as seriously as professionals with accredited degrees however, that should not affect our ability to produce incredible work. No matter what one person thinks our project will be as successful as we make it.

 

Business Model Canvas: Sickle Cell Anemia Test Strips (I can’t get the lines on the table to show up)

Key Partners – World Hope, will help us financially and will also help accredit us (people trust World Hope so in turn they will trust our device) – We will need to have a relationship and partnership with the NGOs/government sectors that will be funding the production of the test strips – We will eventually need a company that will be able to mass produce our test strip	Key Activities – We must develop a low cost test strip that can diagnose sickle cell anemia; we are currently in the research phase trying to get the test strip to work – We will have to figure out our supply chain management. Who will be producing the strips? Where will they be shipped? Who will distribute them?	Value Propositions – Provide a screening device (test strip) for sickle cell anemia; a disease that impacts a person’s everyday life and can result in death		Customer Relationships – Get: pitch the device as a screening device that needs to be administered at birth; goal: will be a typical test done at birth – Keep: To reach out and keep in contact with the hospitals buying and providing the test strips to the population; insure the supply of devices is the correct amount in relation to the number of people being tested – Grow: Build relationships with NGOs, organizations and the government to figure out who will be funding the development of these devices	Customer Segments – Our customers are going to typically be from developing countries where sickle cell anemia is prevalent – These developing countries typically have free health care services therefore our customers will be the NGOs, organizations and the government who fund medical care services – We will start implementing the device in Sierra Leone a country in Africa (75% of the children out of the 300,000 children born each year with SCA are born in Africa)
	Resources – Need access to medical professionals and CWH in Sierra Leone in order to receive feedback on the device and support from them when the device is implemented and administered – Need World Hopes support financially as well as their connections with the FDA and Pharmacy Board of Sierra Leone, doctors in the local hospitals and other medical professionals that will aid us in implementing the device			Chanels – Hospitals; the device should be used to screen for sickle cell anemia at birth – Community health workers; to distribute and administer the device in local villages
Cost Structure – As of right now the supplies needed to conduct our research is our greatest cost (we are seeking out funding from different grants) – once the device is developed fixed costs will be paying the employees we will need to deliver the devices and paying the manufacturing company to produce the devices			Revenue Streams – These test strips will be as cheap as possible and will be sold for a little bit more than their actual production cost in order to keep the business running (paying employees, continuing to develop and improve the test strip, to pay for costs that arise when trying to implement in other countries)

1. List ten non-obvious assumptions about your target customers (or organizations) that you need to validate. 

• Assume the organization we will be working with (World Hope) has connections to specific, well respected medical professionals that can evaluate our device
• Assume the organization (World Hope) has connections to CHW training facilities that we can visit and receive feedback from the CHWs about if think the device is easy to use/practical for local village medical visits
• Assume the people of Sierra Leone will want to be screened for sickle cell anemia
• Assume the people of Sierra Leone believe there is a benefit to knowing if they have sickle cell anemia/carry the trait for sickle cell anemia
• Assume when interviewing prospective customers (the local people) they will be honest about how sickle cell anemia affects their lives and the community as a whole
• Assume the organization sees our medical device as a device that will help improve the society and will have a lasting benefit
  • If the organization does not see the benefit of the device they will be less likely to help us implement it into the medical system
• Assume there is not a stigma behind sickle cell anemia
• Assume the people of Sierra Leone do not have an issue with having blood samples taken
• Assume seeking medical treatment or medical advice is free will of everyone in the society
  • That the husband does not have complete control over his wife and children when deciding if they should go get screen for sickle cell or any other medical treatment/medical screening
• Assume the organization we will be working with has connections to outlets that will help us advertise the device

2. List ten hypotheses about your project that you need to test during fieldwork.

• Is the structure of the test strip device understood by local CHWs, is it easy to use?
• The results (lines on the test strip) are easily understood, directions that will be provided are clear.
• The test will be administered by CHWs and they will be storing the test strips when not in use.
  • We need to figure out if test strips need to be kept in a controlled environment and what the environment is (needs to be figured out before fieldwork)
    • How they react to humidity, heat, light
• The test strips will be delivered in bulk shipments to hospitals/CHW centers (meeting places) one a month (or once every few months).
• Test strips will be available at doctor offices/hospitals, could/should be used as a screening device at birth.
• The test strip will be advertised throughout the community so that the people know to go see a CHW to get tested.
• The test strip will be recommended by medical professionals (doctors) when patients go to see them at their offices/hospitals.
• Patients will understand what the test does, what their results mean and what the next steps should be
  • Will be educated by CHWs/doctors/other medical professionals
• Patients will allow the CHWs/doctor/other medical professionals to take a small blood sample that will be needed for the device
• Patients will actively seek the test and will want to be screened for sickle cell anemia

I think I bring strong communication skills to the team. I believe I am able to talk and build a connection with almost anyone in a short amount of time; a skill I have developed being a camp counselor for the past four years. A strength I think I have developed more while being apart of the sickle cell anemia project is knowing when we should just go for it even if we aren’t exactly sure what the outcome will be or if we don’t know exactly what the process will be. To be specific, a lot of our work is based on previous research but slightly modified therefore our procedures are not the same and we are working to develop our own. A weakness I knew would affect the project and still effects the project is my lack of lab skills. I have already learned so much from working in the lab these past 3 months however, my background in basic chemistry is not enough to help contribute and understand the exact process. I have been working to overcome this weakness by researching articles that are similar to our research as well as going through the slides and adding comments and questions so I learn and understand exactly what we are doing to improve our device.

Identify ten specific things you will do to strengthen your next presentation (and responses)

1. Finalize our slides earlier.
2. Reach out and receive feedback earlier.
3. Since we know who the judges are, base our presentation off what they are more interested in.
   1. Talk less about the science behind it and more about the results we’ve collected.
   2. Talk more about the implementation of the device, cost, production plan, excetera.
4. Switch up who talks about what aspects of the project (background vs. research results)
   1. Become more well versed in the technical part of the project not just the logistics and statistics of why we are conducting this research
5. Prepare general backup slides.
   1. Our slides were very specific, we prepared for very specific questions however, it would have been nice to have general slides that could be connected to lots of different questions.
6. Answer the questions with more confidence and trust that my fellow teammates know what they are talking about.
7. We could try a different flow/order: start with our research and then talk about why it is important compared to talking about the background and then out research
8. Have a stronger ending
   1. I feel like we ending in the middle of a thought; we should have a closing statement that sums up the entire presentation.
9. Include pictures/videos of our research and lab work on the slides, show the judges what we have done so far.
10. Provide numbers/data on the slides (even if it’s just expected cost – all we have so far) to build credibility

Our research and work requires IRB approvals. Our research requires obtaining biospecimens (blood) from patients and interacting with them to administer the test. For our device a blood sample will be taken through a finger prick and then placed on the test strip, the patient will be present for the entire procedure. Our first task will be to write out and develop an informed consent document, to be approved by the IRB, that will be easily understood by the patients in Sierra Leone. The patient’s identity must also say anonymous and their results, medical history, etcetera must stay confidential. This may be difficult to accomplish in Sierra Leone because there is a different medical system in place and consultations are normally not in private. We will have to be very specific with who we want in our patient population. The test strip we are developing will hopefully be used to screen all ages and all people. This means that we will be including minors and pregnant women in our inclusion criteria that will have to be approved by the IRB. While a majority of people speak english in Sierra Leone we should also provide waivers explaining the test and consent forms in their native language.  Conducting research internationally will add another level of approval that needs to be given by the IRB. In order to conduct research in Sierra Leone we also need to receive approval from the Sierra Leone Ethics and Scientific Review Committee. In order to conduct research specifically for a medical device we will also have to receive approval from the Pharmacy Board of Sierra Leone. In order to receive approval from the Lehigh IRB we will first have to secure and submit evidence of international IRB approval. We need to get started on the applications for the IRB in Sierra Leone because it is said to take a while for everything to be finalized.

Our application to the IRB will be sent through IRBNet and should be sent at least six weeks in advance of anticipated start date. Our research will most likely be reviewed by a full committee because our research will involve intervention and we will be working with protected populations. We should start and submit our application as soon as possible because we do not want to get to Sierra Leone and not have the approval to conduct our research because we waited till the last minute.

Logic Model

Inputs: The funding provided by Lehigh, the Global Social Fellowship and outside sources support the project and allow it to get up and running. tThe time and effort from Lehigh faculty, undergraduate students, graduate students and outside resources are also all inputs for the project.

Activities: The work we are doing in the lab and the time we are spending researching projects that have already happened are the activities that make up this project.

Outputs: A fully functioning sickle cell anemia screening rapid diagnostic test is our proposed outcome. We plan on developing the device; from the test strip to the casing/packaging to the training behind administering the test.

Outcomes: After a device has been developed we will need to do a number of trails ensuring correct screening results. After all of the research done in the lab the device should be outputting correct readings and successfully identifying sickle cell anemia.

Impact: To provide Sierra Leone with these test strips, allowing for early diagnosis and early treatment that will result in a greater quality of life.

For me personally, a design process that is both uniquely mine as well as effective would begin with a verbal brainstorming session or “word vomit”. I believe the fastest way to think if a bunch of different ideas is to bounce the idea off of other people. The more people, the better because then we will have more versions of peoples take on the idea (main subject). The next step would be to narrow down the number of ideas and specifically identify them by writing them out in words. The words would then need to be translated into a visual design. I would again ask as many people as I can to implement their take on the visual design so that there is not a shortage of ideas and possibilities. I would then take the time to reflect and decide logically which design or which combination of designs would solve the problem the most efficiently and which design or combination of designs would be the most feasible. The next step would be to execute the design, either testing, prototyping or both would then begin. After a concrete design is chosen and executed, we would need to reach out for opinions and reviews from experts in the field. They could give us tips and suggestions in order to make the design better before implementing the design into its proposed location/environment. For me, the main part of a successful design process is getting a number of different opinions. I believe there can never be too many ideas.

Our idea that a sickle cell anemia test strip can be designed to diagnose sickle cell anemia as well as identify if a person has the sickle cell trait is a valid concept because similar test strips have already been designed. This means that technology/science has already been proven to check out and we are not on a journey that has no hope. Our design is different from current sickle cell test strips because we are proposing a strip that uses a slightly different kind of binding that will ultimately make the test more accurate and reliable. Our test strip project will also be different because the end goal is to implement it into Sierra Leone’s health care system. We are not sure if the other companies have attempted to implement their devices in developing countries health care systems but if they have, they have obviously not been successful. It would be worth looking into if the other companies have attempted to implement their devices and if they have, we can learn from how they failed. As of right now we plan on gathering a lot of different people’s opinions while in Sierra Leone. We plan on asking medical professionals, community health works as well as the local people what they think about our device (if we don’t have a working device by then we plan on bringing a prototype). They will provide insight on if the design is easy to use, if they believe it is appropriate for solving the problem and if they believe it will even be used. By getting the local people’s opinions and taking them into account we are increasing the chance that this device will be successful in Sierra Leone.

Engaging with the community, partners and markets is the most important aspect of making sure our device is successful. If we can get our device to work then the only thing holding us back from implementing the device into the community is our relationship with the community, our partners and the market. Our relationship with the community, our partners and the market has the ability to make or break our device. If we do not have a relationship with them we will not have the connections to get our device out there and implemented into the healthcare system. If we do not have a good relationship with them we will not have people who are willing to do fast and meaningful work and ultimately the local people will not believe in our product. How companies and partners support us will affect how the local people react to our device. If they actively support our device the locals will trust our work and are more likely to seek out our device. The local peoples perception on our device is highly dependent on how the community, our partners and how the market supports us.

Nature can be used as a model for our own designs, for example, Janine Benyus who did a Ted Talk about Biomimicry talked about the skin of a shark repelling bacteria. She talked about how the shape/architecture of the cells keep bacteria from landing on the surface of the sharks skin. Nowadays this type of architecture is being used to design surfaces in hospitals. Learning from nature we are now able to create surfaces that are resistant to bacteria that does not include dowsing the surface in antibacterial chemicals that could ultimately cause a greater issue (bacteria resistance). Learning about this architecture I have learned that there are ways to solve chemical problems without using a chemical solution. Figuring out what these ways are might take a little longer but it will be worth it in the long run. Another example of a product being based off nature that is a little bit more basic, is the design of racing swimsuits. From fish, sharks, dolphins (excetera) and birds we have learned how having a streamline body/coating one can travel much faster and with ease through water. From this information designers have created swimsuits/speedos that are completely skin tight in order to allow for a more streamlined effect in the water, compared to board shorts. Our sickle cell research project is trying to design a test strip that is not the general, one flow strip design, instead we are looking to do more of a tee shape design. Learning how things flow naturally in nature might be worth looking into and we could possibly apply that information to our project. It might streamline/solve issues for our flow device. One final example is how a leaf stores and absorbs energy from the sun. If we could harness a leafs solar system like cell we could learn how to power machines more efficiently and improve devices that already use this technology, solar panels. Solar panels are generally very large and need to be very large in order to power anything. If we get a better grasp on this technology we could possibly use this technology to power smaller devices that could be used in developing countries that don’t necessarily have reliable power sources.

The Life Principle that stood out to me the most was resilience. I believe we start to learn about resilience at a young age. While the situations we face as a child might not be as serious we learn how to handle adversity and adjust from those small moments. How one responds to a tough situation can really show how resilient a person is and being able to bounce back is a very important skill in any field and in life in general. As a student I feel like my resilience is always being tested. It is very easy to give up in a class and believe you will never be able to understand the material but you have to push yourself to work harder to overcome those thoughts/ideas. Having resilience when it comes to research is also very important. I have only been working in the lab a few weeks and it is already very hard to stay motivated when all your tests have been failing. One has to be incredibly resilient but also motivated to do work like this and I am learning a lot about myself being exposed to this type of research. As of right now I don’t really know where I stand with considering research as a career path but I’m really trying to give this research my all and I am being driven by the fact that our research might be able to help someone in the future.

The Cradle to Cradle Design concept takes into account the entire life cycle of the product. For example, take into consideration a plastic child’s toy. The toy will give a child joy for a little bit of that kids life, then maybe the toy gets passed down to their sibling or donated. If the toy keeps getting passed down and down it is still fulfilling its purpose, however, what if this toy starts to release toxic chemicals from the plastic wearing down and causes cancer later on in life for the kids who use the toy after it’s 5th year. On the other hand, what  if the toy takes another direction and instead of being past down gets dumped in a landfill where it will take years to disintegrate. I have completely made up this example but those are all things one has to think about when designing a product; what will this product amount to in 5, 10, 15, 20 years? The device my research group is trying to design is meant to be a one time usage type product. Taking that into consideration we need to figure out ways our device can be disposed of safely and if it is possible to reuse and recycle any part of the project. The one part of the project I can imagine being recycled is the casing the strip will be held in. If we are able to resanitize the casing I believe it could be reused.

When I was growing up I was never exposed to Judaism. I knew the basic beliefs of the religion but nothing else. I didn’t know what Jewish services were like or the true meaning behind a bar mitzvah. About a year and a half ago, I met a friend who is Jewish and grew up in a predominantly Jewish town. I learned about synagogues, their services and the cultural aspects of the religion. I grew up in a place that was prodominatly Muslim and Christain and meeting my friend who was Jewish I learned a lot about how all the religions are very similar and how Judaism wasn’t as different as I thought.

I grew up overseas and attended private schools for most of my life. I had never attended an American public school nor had I ever visited one. Most of my friends here at Lehigh went to public school and a few attend public schools in the inner city. I understand that not all public schools are the same but they told me stories about how people would treat teachers and each other and I was shocked. I learned about how some public schools have metal detectors and how people would fight in the hallway. Hearing these stories I didn’t really know how to respond because those events would never happen at the school I grew up at. I feel like I learned a lot about my friends lives and their stories opened my eyes up to school in the US.

The last thing I’ve learned a lot about through my friends in the past year and a half here at Lehigh is, mental health. I grew up in a relatively small community and while it was a very open, respecting community, mental health was not a topic that was often discussed. I have met people here that are very open about their mental health issues and have no problem answering questions about mental health in general. The organizations here on campus about getting the help you need were also all new concepts to me before coming to Lehigh. It is really nice to know that if I do need the help there are facilities and people who will be there for me.

 

The five major stakeholders that affect the sickle cell anemia project are the suppliers, investors, regulatory bodies, society, and the employees/vendors. The suppliers will be our source to get the test strips developed and delivered after the research has been completed. Obviously the suppliers will be getting paid to produce and deliver these devices. By getting involved in this project they have the potential to be apart of a very successful business. If the test strips take off and are determined to be incredibly useful in Sierra Leone the product will be in high demand and the suppliers business will have increase ultimately making them more money. Similarly the investors, who will be providing money to get the product up in running, will want to see the product succeed because the more successful the device is the more money they will get back. The regulatory bodies in Sierra Leone are equivalent to the FDA in the US. Their job is to insure our device is safe to use, will produce the results the device guarantees and will truly benefit the community. The regulatory bodies have to be involved and are the ones who decide if our device gets out onto the market. If the regulatory bodies approve the sickle cell device they are putting their reputation on the line and trust in the device and that it will not harm anyone specifically or the society as a whole. People trust that regulatory bodies have their best interests in mind, therefore, if we get their approval we will be one step closer to implementing the device as a common medical test in Sierra Leone. Not only does the society trust that the regulatory bodies have their best interest in mind but they trust that we have their best interest in mind. They are trusting us to create and provide a device that works and solves the issue of not being able to test for sickle cell anemia easily. If the people of Sierra Leone accept the device and believe that the test is helping society the device will be very successful. If the people of Sierra Leone dont accept the device it will be incredibly difficult to implement the test into the society. The employees/vendors will be the final stakeholder that will be apart of the sickle cell anemia project. Like the regulatory bodies the employees (CHWs, doctors) who will be administering the test are putting their reputation on the line and their trust in our device (that it will work). If the employees/vendors believe in the device they are more likely to tell their patients that they need to get tested (using our device). Their patients, the people of Sierra Leone, trust and respect the CHWs and doctors and will generally follow their advice. By having the employees/vendors behind the sickle cell test strip, the device has the potential to be very successful. These five stakeholders, suppliers, investors, regulatory bodies, society, and the employees/vendors are crucial parts of the sickle cell anemia project. Without their backing and support the sickle cell test strip will not be successful.

The sickle cell anemia project will be validated and will build its credibility by laying out the benefits of having a diagnosis, receiving support from NGOs on the ground and telling true stories of people who could have benefited from a sickle cell anemia test strip. In order to lay out the benefits of having a diagnosis we must first explain how not having a diagnosis has affected society. By providing the statistics of the amount of people who suffer from sickle cell anemia (world wide and then specifically Sierra Leone) and ultimately die from the disease the numbers will establish a sense of urgency. Statistics around how many people die without knowing they had the disease and how many of those people could have survived if they had known and received the correct treatment should also be provided. These statistics will appeal to a person’s emotions and will ultimately validate the project. The next step in validating the project and enhancing our credibility would be to get established NGOs on board with the project. By receiving support from accredited, trusted companies their reputations will help our project gain respect and will give us credibility by association. Finally, by providing stories of people who could have benefited from a sickle cell test strip we will again establish a sense of urgency and will appeal to a person’s emotions. By appealing to one’s emotions a person gets more involved/attached to the project. By rallying support behind the project our credibility will build. In conclusion, we can validate our project and enhance our credibility by aying out the benefits of having a diagnosis, receiving support from NGOs on the ground and telling true stories of people who could have benefited from a sickle cell anemia test strip.

 

I think the biggest cultural issue that is going to affect the sickle cell anemia project is that people in Sierra Leone believe in spiritual healing. If the people truly believe that the magical services offered by community organizations can heal them they will not feel the need to go get tested. Going off this point, the sickle cell device we are trying to create will also test for sickle cell trait. People carrying the sickle cell trait do not experience the symptoms of the disease and therefore will not go get tested because they believe that they are healthy and maybe that they are healthy because of the magical services.

Another cultural issue that may affect the people of Sierra Leone from using our test strip is the countries main religion and the traditions around that religion, Islam. I am not completely sure that statements I am about to make about tradition based off religion is a cultural issue for Sierra Leone but from my time spent overseas in the Middle East, which are also predominantly Muslium countries, (which I will explain later) I am making this assumption. There is a tradition that is based off religion, that could be described as a cultural ‘norm’, that the man of the house is the person in charge. The man of the house would have to sign off on and give permission for his wife and children to travel, drive, receive medical care, exetra. If this type of tradition is present in Sierra Leone it might be difficult to get mothers and children tested for sickle cell anemia and the sickle cell trait.

A third cultural issue that may affect our ability to provide a successful device is stigma around the disease, sickle cell anemia. The people of Sierra Leone might not want to be tested because their might be an unwritten rule that if you have an incurable disease (no matter the disease or maybe specifically sickle cell anemia) you will be treated like an outcast. People might not want to risk being shunned from the community and in order to guarantee that they just won’t be tested.

Growing up in the Middle East I have been exposed to a culture that is based around religion (Islam) in many ways. One experience that pertains to a cultural issue that we might encounter in Sierra Leone, a predominantly Muslim country, is that the man of the house tends (not always true now a day) to have the power. When I turned 18 I went to the Road and Transportation Office in Dubai, UAE to register for a driver’s license. Before I could even submit any of the paperwork I had to present a permission slip signed by my father that I was allowed to drive. This may seem minor but in Saudi Arabia, the country neighboring the United Arab Emirates, there is a rule that women can not travel without a male family member. If these types of rules are implemented in Sierra Leone we might have some issues with people who want to get tested or want their children to get tested but can’t because of the religious culture.

At home I have known people who believe that their trust in God is the best medicine that will heal them instead of modern medicine. I have also observed Jehovah Witnesses deny medical treatment because of their beliefs. This can be compared to the magical healing services in Sierra Leone. Another cultural issue I have experienced that is similar to what we might experience in Sierra Leone is the stigma behind being sick. Generally when someone is sick even if it is a common cold people tend to keep their distance. This is because they don’t want to get sick themselves. There’s a stigma behind sick people that they are always contagious even if the contagious period has passed or if they don’t even have a contagious sickness.

In Sierra Leone we might encounter community and market problems because of the cultural norms. In order to gain the communities trust and support around the test strip we should bring in doctors, who are generally well respected figures, to explain why they should get tested. In order to insure getting tested does not disrupt their day-to-day lives we need to figure out a way to bring the device to each specific community. If people have to change their social/cultural ways of life people will be less likely to go out of their way to get tested. Finally, having the organizations that run the spiritual services (that also offer other religious services) advertise the sickle cell test strip will encourage people to go get tested because the information is coming from a trusted source.

Implementing our sickle cell test strips in Sierra Leone will be difficult because as we discussed at the retreat processes tend to move slower there. If we want our devices to be delivered somewhere it might take twice as long as it would in the US because people don’t feel the need to get stuff done as quickly. In summary, work is completed at a different pace compared to the US.

Another challenge that we might face is getting our device delivered to rural places after it has been manufactured. The roads might not be suitable for trucks (which would be necessary if we needed to keep our device at a certain temperature) to travel on. Looking at the bigger picture it might be difficult getting our device into the country from the place of manufacturing. Sierra Leone is a developing country and does not have the resources to produce the device therefore we would need to find a place that could manufacture the devices and import them into the country, which would be another challenge.

On the other hand, getting our device out on the market after it works and we have the research behind it should be much easier than in the US. The FDA in the US is extremely strict, if our device was approved by the FDA it would have to go through clinical trials which could take years. There is a different system in Sierra Leone which should speed up the process of getting the device out onto the market.

Finally, in Sierra Leone we will also have the opportunity to talk to the people who would be administering the device and get their advice on how to improve it. In the US it would very difficult to access the people who would be providing and administering the device and could take a very long time to set up those meetings. Apart from the professionals, we will also have the chance to ask the local people about the test strips. By getting the locals opinions we will have the chance to figure out the best way to market our device.