M&E Plan and Social Return on Investment

(Written with Jaro Perera and Maria Lancia)

M&E plan

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.

Social Return on Investment

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.

Funding & Partnerships

1. Identify two SPECIFIC funding sources for the design phase of your project and two SPECIFIC funding sources for the dissemination (implementation/distribution/commercialization) phase of your project. For each funding source, explain why this is a good fit for your project, and what SPECIFIC aspect of your project might the funding source support.

We have identified several funding sources for the design and dissemination phases of our projects.

Right now, our group is applying to the Phase 1 of the VentureWell E-Team grant (https://venturewell.org/e-team-grant-program/?utm_source=EOEmailFeb19&utm_medium=email). This grant provides $5,000 in funding as well as training and mentoring during a workshop. This is a great opportunity for our team as it will provide us with non-dilutive funding and give us invaluable knowledge on company building and market analysis. Additionally, we are a great fit for this grant as it is designed for engineering based teams which are creating innovations with social impact. Finally, if we are successful with the phase 1 application, we will become eligible to apply for the phase 2 grant, which will provide us with an additional $20,000 in funding and further mentoring and networking opportunities.

Once we have a working prototype, we will then apply for the DEBUT (Design by Biomedical Undergraduate Teams) grant (https://venturewell.org/debut/?utm_source=EOEmailFeb19&utm_medium=email). This grant is sponsored by the NIH National Institute of Biomedical Imaging and Bioengineering and VentureWell to provide up to $20,000 in funding for biomedical research projects focused on solving real-world problems in healthcare. This grant requires a working prototype, and is awarded based on the significance of the problem being addressed, and the impact the proposed solution has on end users. This grant would be a great opportunity for our team since it would provide funding towards the optimization and testing of a working test strip prototype. This grant application would be due May 31st, 2020 (and is only for undergraduate teams, so would have to apply after I graduate).

For the dissemination phase of our project, we will first focus on grants which support proof of concept operations. One grant which may be a great fit for this purpose is the USAID Development Innovation Ventures (DIV). This grant focuses on supporting innovative solutions to any global development challenge, and includes three phases. The first phase provides up to $200,000 for proof-of-concept stage projects, and could help support our work piloting the test strip in Sierra Leone. The second phase provides up to $1,500,000 in funding to support testing and positioning for scale, which could support our project as we test new ideas and build evidence on implementation parameters so that we can scale our product to other countries. Finally, the third stage provides up to $5,000,000 for scaling initiatives, and would help support our work as we expand successful solutions into other countries in sub-Saharan Africa.

Once we have evidence supporting the utility and impact of our device, we can also target funders of the Free Healthcare Initiative (FHCI). The FHCI in Sierra Leone provides free, basic healthcare services to pregnant women, lactating mothers, and children under 5. This initiative is funded by other governments (especially the UK department of International Development, the UN, and financial NGOs). Therefore, once we prove the impact, cost-effectiveness, and viability of our product, we can target these funders of the FHCI in order to find a sustainable funding source for the commercialization phase of our project.

2. Identify five specific partnerships that you need to forge to advance your project forward with the ultimate goal of positively impacting atleast one million people. Describe exactly how that partnership might help you achieve scale and why that entity might be willing to work with you.

In order to advance our project forward and positively impact at least one million people, our team will have to make many strategic partnerships.

The first partnership we will have to make is a with a manufacturing company to which we can outsource the production of our device. Like the Ukweli team, we will probably need to contact multiple companies and choose the cheapest/best option. Some companies which are known for producing lateral flow devices, and which we may consider, include Abingdon Health, BBI solutions, and Atomo Daignostics.

Another partnership we will have to establish is with the Pharmacy board in Sierra Leone. In order to get device approval for use in Sierra Leone, we will have to work with them. We will have to start working with this partner soon, so that we can make sure that we consider their regulatory requirements in the design process.

A third partnership we will have to establish is with the funders behind the FHCI. Since the funders of the FHCI (including the UK department of International Development, the UN, and financial NGOs) will be responsible for choosing what services and products they pay for, it is essential that we develop good partnerships with them early on so that we can make sure our device meets their specifications.

Additionally, we will need to build partnerships with hospitals in Sierra Leone. Since we will be piloting distribution and implementation parameters there, it is essential that we have close partnerships with healthcare workers and facilities so that we can get feedback on this process and choose the best parameters for scaling up the project.

Finally, we will want to establish partnerships with SCD-focused organizations, such as the Sickle Cell Disease Coalition. The SCDC is composed of public health and research organizations, patient groups, and industry representatives with special interest in sickle cell disease. Their goals include finding stable funding for SCD programs, developing reliable approaches to adult SCD care, and establishing feasible solutions for bringing diagnostic devices and therapies to low-resource setting. Because this coalition has connections with many powerful stakeholders in the SCD community, they will be a great resource for our team. Specifically, in addition to putting us in contact with funding sources, they may be able to help us connect with organizations who focus on the therapy or education side of SCD, so that our device can be implemented as part of a bigger outreach effort.

One Acre Fund

One Acre Fund Business Model:

Value Proposition

One Acre Fund provides value to farmers by allowing them see large improvements in their incomes. This increase in income allows farmers to afford healthy food, attend school more often, and focus on building their futures and communities. Currently, more than 50 million farmers in sub-Saharan Africa go through annual cycles of hunger, resulting in child malnutrition and underperformance in school. However, within one year of joining One Acre Fund, farmers see a 50% average increase in income, allowing them to avoid these cycles of hunger.

Key Activities

In order to deliver this value to its customers, One Acre Fund has an adaptive and comprehensive set of activities.

Their services are adaptive in that they adjust their activities based on the individual country’s needs. Additionally, instead of coming in and teaching farmers how to make money with “cash crops,” they focus on preserving the particular culture of the country and only recommended simple differences which unlock harvest potential.

This increase in harvest potential is accomplished through a comprehensive set of activities. First, One Acre Fund provides flexible-repayment loans in order for farmers to invest in themselves. Second, they provide accessible and reliable deliveries of required materials, including seeds, fertilizers, and non-agricultural products such as lights. Next, they train farmers on sustainable farming practices which align with the current culture, such as introducing intercropping, crop rotation, and planting trees. And finally, they provide market facilitation in order to help farmers time crop sales to maximize profits.

Key Resources

The key resources that the One Acre Fund require include the physical agricultural and non-agricultural products that they provide to the farmers, the indirect products used to provide those materials, and the knowledge that the enterprise brings to the farmers. The physical products which are provided to the farmers include seeds, fertilizer, and non-agricultural products such as solar-powered lights and crop storage bags. The resources needed to provide these products to the farmers include trucks, warehouses, and offices where growth research and distribution plans are optimized. Finally, the intellectual resources include the knowledge provided to the farmers through training which allows them to optimize their productivity.

Distribution Channel

The main customers, the farmers, are primarily reached directly. Specifically, One Acre Fund utilizes a “Farmer’s First” approach, stressing the importance of trucks dropping the supplies off within walking distance from the farmers and training them directly. Other players are reached electronically. For example, potential donors can be reached via the website.

Revenue Stream

The One Acre Fund has two primary sources of revenue. 75% of expenses are funded through farmer loan repayments, meaning that the primary source of revenue is from interest obtained off loans. The remainder of revenue comes from donations.

Customer Segment

The primary customer segment receiving value from these products are the farmers. Although the One Acre Fund began with only 38 farmers in Kenya, it has since grown to serve 809,800 farmers (in 2018) throughout six sub-Saharan African countries including Kenya, Burundi, Malawi, Rwanda, Tanzania, and Uganda.

Additionally, this business provides value to several other groups. First, the One Acre Fund provides employment opportunities for locals in rural areas, with 95% of their 7,400 full time staff being locals. Furthermore, the One Acre Fun provides value for the respective governments by improving the health of their populations.

Customer Relationship

The most important customers for One Acre Fund are the farmers. With their “Farmers first” philosophy, the company focuses on building a good relationship with their customers by providing reliable deliveries, delivering the products within a walkable distance, and providing a comprehensive group of services including training. Additionally, they provide flexible repayment formats and allow the farmers not to repay if they aren’t happy.

The One Acre Fund also builds relationships with other customer segments, for example with the government by negotiating import permits, and working with them to provide background support for farmer outreach programs.

Key Partners

The One Acre Fund has several key partners from an organizational scale. For example, the organization has several key funding partners including the Global Innovation Fund, Children’s Investment Fund Foundation, USAID, and Pershing Square Foundation. These partnerships have included providing funding and working towards specific goals, such as working to improve nutrition.

Additionally, the One Acre Fund has many key partners which vary from country to country. Because the specific products and services vary in each country depending on the local conditions, the suppliers of seeds and other products vary between countries.

Cost Structure

The primary costs of this business include labor, supplies, and distribution. Labor costs include the salaries of local and non-local workers, such as drivers, warehouse managers, trainers, and office workers. Supply costs include the costs of seeds, fertilizers, and non-agricultural products which the One Acre Fund must purchase. And finally, distribution-associated costs include those for vehicles, warehouses, and maintenance. Additionally, costs include covering the small percentage of farmers (1-3%) who are not satisfied and do not repay their loans.

Sources:
1. http://nextbillion.net/one-acre-fund-empowering-the-one-acre-farmer
2. http://pershingsquarefoundation.org/case-study/one-acre-fund
3. http://www.thelifeyoucansave.org/where-to-donate/one-acre-fund
4. http://www.emersoncollective.com/articles/2016/04/5-questions-with-one-acre-fund
5. http://www.oneacrefund.org

Business Model

Guy Kawasaki Take-Aways

There are many take-aways from Guy Kawasaki’s talk on the “Art of the Start” which our team will integrate into our sickle cell anemia project.

First, I was really inspired by his point to make a mantra instead of a mission statement. I think having a mantra that explains to the employees why they work there is especially important to make sure everyone in the company stays focused on the big goal. As we progress through our project, and employee other individuals, we will definitely incorporate a meaningful and memorable mantra in order to help our employees stay motivated.

Additionally, our project will definitely incorporate Guy Kawasaki’s concept of “weaving a MAT.” By prioritizing milestones, assumptions, and tasks, I think we will all be able to stay focused and motivated on the big goals and how to accomplish them. For example, our group considers our current milestones to be having a fully functioning test strip, proving that our test strip is better than other options on the market, getting our test approved for use, establishing production, distribution, and funding partners, and getting the test strip accessible to individuals in Sierra Leone. In order to accomplish these big goals over the next 5-10 years, our team will also need to write down and test assumptions (such as those seen in last weeks blog), and tasks (such as how we are currently working on small sub-steps of making a functioning test strip).

Next, our project will also incorporate the strategy of thinking differently, instead of just doing things better. Already, with our test strip, we are trying to incorporate different aspects of low-cost devices, instead of simply improving the isoelectric focusing method which is currently used in the US. Additionally, in the future, we will try to incorporate this strategy when we begin organizing production and distribution. For example, instead of relying on slow, traditional distribution methods seen in rural Sierra Leone, we might try partnering with an organization trying new ideas, such as utilizing drones.

In order to accomplish and incorporate all of these goals and strategies, we will also need to follow one of Guy Kawasaki’s most important points: “hire infected people.” Already, I have found that because everyone in our group is really excited by the project, we are getting a lot accomplished and coming up with unique and creative ideas. Having seen how positively working with “infected” people can be on the project, our group will definitely have to continue focusing on this concept in the future as we partner with more individuals and organizations.

Finally, our group will definitely have to incorporate Guy Kawasaki’s 10/20/30 rule. As we try to secure funding and partners, we will have to make sure to impress people with our presentations. Because of this, by limiting our presentations to 10 slides, 20 minutes, and 30 point font, we will be able to ensure that we keep our audience engaged and excited about joining our project.

Business Model Canvas

1. Value Proposition: We deliver value to our customers by allowing healthcare workers to better treat their patients through sickle cell anemia diagnosis. Although at this point we are unsure whether our customers will be healthcare facilities directly or local/global health NGOs, either of these customers would receive value from our product through the health improvements in the patient populations they are trying to serve.

2. Customer Segments: At this point, we are not sure exactly who will be purchasing our product. Although we will primarily be creating value for our patients and healthcare workers by allowing them to receive and give better treatments, we have not determined who will be paying for the devices. Right now, there is a Free Healthcare Initiative (FHCI) in Sierra Leone, which provides free, basic healthcare services to pregnant women, lactating mothers, and children under 5. This initiative is funded by other governments (especially the UK department of International Development), the UN, and financial NGOs. Because of this, if we are able to prove the utility of our product in Sierra Leone, we could hopefully get our product to become a part of this initiative as a free, commonplace screening device among all newborns. If we are able to accomplish this, our direct customers would be those funders of the FHCI, who we would create value for by hopefully reducing other medical costs due to the better treatment of individuals with sickle cell anemia.

3. Channels: Our customers will be reached through several different channels. Specifically, our patients will receive the test strips from healthcare workers in healthcare facilities. These healthcare workers and facilities will receive the device through on the ground partners, who will deliver the devices. The on the ground partners will receive the devices from a production partner in the US who will produce the test strip. Finally, each of these units will receive money through our funding partners.

4. Customer Relationships: We will have to maintain different relationships with each of our customer segments. For example, we will have to educate NGOs financing the strips and train healthcare workers administering the test.

5. Revenue Streams: Our customers will be paying for the better treatment of the patient populations they are responsible for. Because sickle cell diagnosis is currently symptom-based and unreliable, healthcare facilities have to spend a lot more money on treating patients for the wrong condition (ex. Malaria, which has similar symptoms), and the side-effects of sickle cell anemia which can be prevented through cheap, penicillin prophylaxis treatments (ex. Pneumonia infections). In this way, by paying for the test strips, our customers will also be getting cost-saving value.

6. Cost Structure: The most important costs in our business model are those attributed with making our test strip, distributing it (transport and employees), and outreach (advertising, education, spreading awareness, and pushing for our test to be included as a standard screening device). Our business will be cost driven, with the goal of creating a low-cost device to ensure maximum utilization.

7. Key Partners: Our key partner currently is World Hope International, who will allow us to learn more about the health system and needs in Sierra Leone. Additionally, we have several key suppliers where we get materials for the test strip. In the future, we will have several additional key partners who will be responsible for mass producing the strip and distributing it.

8. Key Activities: Our value proposition requires several key activities, including test strip production, distribution, and education.

9. Key Resources: Our value proposition requires several key resources, including the physical test strip components (nitrocellulose membrane, antibodies, beads, etc), packaging for the test strip, the intellectual design of the test and its possible patent, and the human resources required to distribute and do outreach with the strip.

Assumptions, Hypotheses, and Assets

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

Since our goal is to design a sickle cell anemia test strip which can be used for screening newborns, we will need to validate several assumptions. Some of these assumptions include that:
1. Mothers give birth primarily in health centers (not at home).
2. Mothers stay in healthcare clinics after giving birth long enough to have their child get tested.
3. If mothers do give brith at home, they still go into healthcare centers for “well-baby” checkups.
4. Mothers will be open to testing their child using a Western device.
5. Mothers will want to get their newborn tested.
6. Mothers will want to know if their child has sickle cell anemia or sickle cell trait.
7. Mothers have the power to give permission for testing (for example, father’s, who may or may not be involved in the birth process, are not required to give consent).
8. Health workers will have the work capacity to initiate sickle cell anemia screening protocols.
9. Healthcare workers are open to implementing “Western” medical products
10. Healthcare workers have the capacity to take care of patients who are diagnosed with sickle cell anemia (for example, they can educate them and provide penicillin prophylaxis treatments).

List ten hypotheses about your project that you need to test during fieldwork.
1. Our test is easy to use.
2. Our test has easy to understand readouts.
3. There is room in healthcare facilities to store our test
4. The storage environment (ex. Humidity and heat) supports our test strip.
5. Our test can reach healthcare facilities around the country (for example, there are mechanisms in place which we can utilize in the future to help deliver our test).
6. Testing both sickle cell anemia and sickle cell trait is desirable
7. Our test will allow newborns diagnosed with sickle cell anemia to receive penicillin prophylaxis treatments (for example, penicillin is readily available and there are no procedural guidelines which would prevent it from being used for this cause)
8. There are people in Sierra Leone who we can hire to promote the test strip, train how to use the test strip, and distribute the test strip.
9. There are no religious or cultural beliefs against using blood for medical testing
10. There are global or local to Sierra Leone NGOs which can help with paying for the test.

What do you think you bring to your team? How has your perception of your own strengths and weaknesses changed over the course of the class? Please be specific.

There are several strengths which I bring to my team. First, I have a lot of bioengineering lab and global health fieldwork experience. While working on two previous bioengineering research projects, I was able to develop basic lab skills, understanding, and the ability to organize a project using current literature. Additionally, while studying abroad in Vietnam, South Africa, and Argentina, I was able to develop skills interviewing people from different cultural and socioeconomic backgrounds while working on a maternal and child health research project.

Additionally, the main personal trait which I believe I bring to the team is being a good listener. As a good listener, I tend to be good in group settings since I am open to other people’s opinions and ideas. Additionally, since I tend to closely hear what other people are saying, I am good at facilitating compromise between different interests or conflicts.

My perception of my strengths and weaknesses has also changed a little over the course of this class (and I believe will change a lot more during the field work). Specifically, because I am leading the sickle cell anemia GSIF team in the lab, I have really been able to develop leadership skills, and the ability to take initiative. I have also identified areas which I need to continue working on, for example, making sure to give team members more opportunities to ask questions, instead of just assuming that they will come to me if they need help.

IRB Strategy and Logic Model

IRB strategy:

Our research in Sierra Leone this summer will require an IRB approval (which we will need to prepare and submit by middle of June). We determined this since we will be conducting research with human subjects. Specifically, we will be obtaining information through interactions, such as interviews. Since our research will not include any interventions or collection of identifiable information, our research should be considered low risk, and be classed as exempt.

In order to submit this IRB application, we will have to complete several things. First, we will have to consider the IRB application requirements, as well as those posed by the Sierra Leone Ethics and Scientific Review Committee (required for all health-related research). For both of these applications, we will have to include a research proposal and plan for obtaining consent. Additionally, for IRB approval we will have to complete an ethics training tutorial.

For the research proposal, our team will have to work together to come up with a detailed plan for our in-country interviews. Specifically, we have to consider our goals, who we will talk to, and what sorts of questions we will ask. Since we hope to speak to community members about the local experience of sickle cell anemia, and since sickle cell anemia is a leading cause of maternal and child mortality, some of our interviews may be with pregnant women. Since pregnant women are considered a vulnerable population, we would have to specifically include this information in our IRB proposal.

Finally, we will also have to include a detailed plan for how we will obtain consent from our research participants. Although IRB approvals usually require signed consent waivers, since cultural norms are different in Sierra Leone, we may find it more appropriate to prepare a verbal consent agreement. (Sierra Leone Ethics and Scientific Review Committee does not accept verbal consent, however, so we will have to double check the requirements for our research.) Regardless of whether we decide to get verbal or written consent, we will have to prepare a consent form in advance to submit to the IRB committee.

Logic Model:

Our logic model is broken up into four parts: context, inputs, outputs, and impact.

Our context includes the situation and priorities. In Sierra Leone, there are currently no diagnostic tools available for sickle cell anemia. Because of this, diagnostics are symptom-based and unreliable (since symptoms can often be mistaken for other conditions such as malaria). This is a huge problem since early diagnosis of sickle cell anemia can allow preventative prophylaxis treatments (specifically penicillin, which is locally available) which have been shown to reduce one of the common deadly side effects of sickle cell anemia, an increased risk for infection. This problem is especially critical since sickle cell anemia is a leading cause of maternal and child mortality in Sierra Leone. With this background, our mission is to create a low cost-point of care, sickle cell anemia test strip which will allow early screening and identification of individuals with sickle cell anemia, allowing them to get the helpful preventative treatments.

In order to accomplish this, 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 the 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.

With these inputs, we will create several outputs. Our primary output will be a physical test strip product. Additionally, we will develop jobs for individuals in the US who are creating the product, and 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.

Most importantly, our project will also have several short-term, intermediate, and long-term 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 long term, we 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. Additionally, we hope that this product can 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. With long-term goals like this, our product has the potential to significantly reduce the maternal and child mortality due to sickle cell anemia in Sierra Leone, as well as hopefully throughout other low-resource countries.

Design Process, Validation & My Philosophy of Engagement

Design Process

I believe that my background in bioengineering and global health will allow me to establish a design process which is both unique and effective. Specifically, my previous experiences doing bioengineering research have given me the skills to evaluate current products and research, and identify weaknesses and areas for improvement. Additionally, my time studying community health while studying abroad has allowed me to appreciate some of the cultural, distribution, and education challenges which we may encounter as we try to implement our product.

With these skills, I have spent a lot of time with my team looking at other sickle cell anemia diagnostic tools. By observing their strengths and weaknesses, we have been able to start the design process for a test strip. For example, two products, Alibaba and Sickle Scan, are low cost but are also difficult to interpret due to subtle color changes indicating a diagnosis. With this in mind, we were able to decide on a lateral flow test strip, since the absence or presence of a line leaves less room for user error. We were also able to find two other lateral flow test strips for sickle cell anemia. One, Sickle Dex, is commercially available, but utilizes a direct binding method, and therefore requires a dilution step in order to work. A different lateral flow test, a competitive test still in the research phase, is easier to use than the Sickle Dex product since it does not require a dilution step; however, its utilization of a competitive binding method also makes it less specific. By analyzing these two sickle cell anemia lateral flow tests, our team was able to think of a solution which incorporates the specificity of a direct binding test, without the need for blood dilution. Specifically, by incorporating a T-Junction shape, and having the sample and colored beads travel from separate directions, we can theoretically avoid pre saturation of the beads, preventing the need for a dilution step.

Despite that three of these products are commercially available, none of them are available in lower and middle income countries. By decreasing the training required, increasing the specificity, and specifically utilizing our on-the-ground partners, we hope to use our unique backgrounds to complete an effective design process, and actually get the product to the community.

Validation

As we continue with this design process, we will utilize several resources in order to validate our progress. For example, in order to validate our project concept and technology, we will hopefully be able to get feedback from people in industry. Our advisor, Prof. Cheng, has a few contacts who work on commercial lateral flow tests, and will hopefully be able to connect us with them to learn more about what works well, and what doesn’t, with our technical design. Furthermore, we will hopefully be able to validate the usability of our product during our fieldwork this summer. Specifically, we hope to have a working prototype prepared by the time our team goes to Sierra Leone, and will be able to get feedback from community healthcare workers on what is easy and difficult about using our test. Finally, we also hope to start looking at how our product will fit into the Sierra Leone health system during the field work. Although our team is currently very bioengineering focused, we hope to eventually recruit business students to work on the operational/business model, and that they will be able to use our experiences in Sierra Leone, as well as their own expertise with business, to start validating the operational aspects of our project design.

My Philosophy of Engagement

There are several reasons why I am excited about this project, and why I specifically chose to engage with communities in low-income countries.

Although I know that there are socioeconomic and health challenges locally as well as globally, I love learning about cultural differences. Being born in Germany, an English citizen, and an American resident, I have always been very aware of the different cultures surrounding me. Because of this, I have always aspired to work with people from diverse backgrounds.

Furthermore, I love learning. I believe that working to solve challenges in low-income countries presents several unique challenges. Figuring out how to work through these obstacles presents unique learning opportunities, and allows for exciting problem solving.

Finally, I want to make an impact, and to help the communities that I am working with. Coming from a high-income, powerful country, I understand that I have opportunities and resources which are unavailable to many others. Because of this, I want to be able to take my privilege and turn it into something beneficial.

By combining my interests and aspirations, I believe that my philosophy of engagement will help to keep me focused and excited as I continue to work on this project.

Circle of Life

Biomimicry

While watching the TED talk on biomimicry, I was especially fascinated by the comment that “there [are] organisms out there that [have] already solved the problems that [others have] spent their careers trying to solve” (3). One interesting example of this is with renewable energy. Although scientists all over the world are trying to come up with good solutions, plants have always been able to produce their own.

Our design for a sickle cell anemia test strip has included this concept without our intention. Specifically, for our test, we are creating a lateral flow test device, which uses a nitrocellulose membrane to run blood samples over test lines. This concept of capillary action, where water is passively moved along a membrane by molecular attractions, is actually seen all over nature. For example, the thorny devil or moloch, an Australian lizard, uses capillary action to collect moisture and funnel it into its mouth (1).

This concept is also something that may impact our product in the future. For example, drones are being considered for the delivery of many medical products to remote villages. If other organizations find success with this method, we may want to consider using drones for our test strip distribution as well. Current drone research is using biomimicry to solve the problem of navigation in the dark, by looking at bat sonar. In this way, biomimicry could serve as a model for our test strip in multiple ways in the future (2).

Life’s Principles

One of life’s principles that I thought was especially interesting is “optimize rather than maximize.” I believe that this concept could apply to our work in many different ways. For example, one concept of this principle is that “social enterprises are designed so that others can build on to them” (4). With our sickle cell anemia diagnostic tool, we are trying to develop a low-cost, easy to use lateral flow device that is sensitive, but does not require blood dilution. Once the basic technology for this goal is established, it could easily be applied to other tests by simply changing the test line antibody.

Cradle to Cradle

Similarly, the Cradle to Cradle design concept can also be applied to our test strip. This concept stresses that everything is a resource for everything else, and that a major goal should be a “healthy and just world, with clean air, clean water, soil, and power” (5). This concept will be especially important for our test strip when we start to think about a test strip case, packaging, and distribution. In each of these manufacturing stages, we should try to integrate clean and sustainable processes, such as by minimizing plastic use in packaging.

Interesting Facts

Over the years, I have learned many interesting facts from my friends. For example, while studying abroad, I spent a lot of time with people who were studying public health, gender studies, and anthropology. One interesting concept that they explained to me was positionality. Positionality is the practice of observing ones own relation to others, and understanding the implications this has on what we observe. This was an especially important concept to understand while studying abroad, since as a white westerner, my positionally gave me access to a lot of unique experiences, while also preventing some locals from ever completely opening up to me. Additionally, I have learned many fun facts about space from my friend, who is fascinated by astronomy. For example, she told me that the nearest major galaxy is 2.5 million light years away, but that the farthest a human being has ever gotten from earth is 1.3 light seconds. I found this fact especially interesting since it puts everything in to perspective, and highlights just how little humans actually understand. Finally, another friend once told me that Coca Cola tastes better in South America. I thought this was very interesting, since the difference in taste is due to different food regulations in South America, preventing some forms of sweeteners. I thought this was interesting since it puts into perspective how much of an influence governments have in our daily lives, and makes you think about just how many artificial ingredients are in everything we eat.

1. https://inhabitat.com/the-biomimicry-manual-what-can-a-thorny-devil-teach-us-about-water-harvesting/
2. https://techxplore.com/news/2018-06-team-biomimicry-drones-dark.html
3. https://www.ted.com/talks/janine_benyus_shares_nature_s_designs/up-next?language=en
4. Samir Patel & Khanjan Mehta; Life’s Principles as a Framework for Designing Successful Social Enterprises
5. https://www.ted.com/talks/william_mcdonough_on_cradle_to_cradle_design/up-next?language=en

Stakeholders & Project Credibility

Stakeholders

With the long-term goal of implementing a sickle cell anemia screening tool in Sierra Leone, there are several stakeholders with unique motivations which we need to keep in mind.

The most affected by our product will probably be the community members getting tested. Although our goal is to create a screening tests which will impact the entire population, ultimately those most impacted by our device will be the individuals with sickle cell anemia and their families. For these stakeholders, the priority is a highly sensitive test. Because early screening and detection can result in better treatments, the priority for these stakeholders would be to have an accurate test with as few false negatives as possible.

Another important stakeholder for our test strip would be the healthcare providers (doctors or community health workers) who are administering the test. In addition to desiring a highly sensitive test for the well-being of their patients, these individuals probably also prioritize an easy-to-use device. With this stakeholder in mind, one of our primary goals for this test is to make it point-of-care, meaning it is portable, quick, and non labor-intensive.

A third important stakeholder would be the person paying for the test strips. Since early sickle cell anemia diagnosis can improve treatment decisions, we would never want to limit people’s access to the test due to financial constraints. Because of this, we would want to make sure that the test was payed for by the government (if this sort of test is covered through a public healthcare system) or an NGO. Because of this, the primary motivation for these individuals is probably to keep the test as low-cost as possible.

A fourth important stakeholder would be the individuals involved in distributing our product within Sierra Leone. Since we would like to make this product as socially and economically sustainable as possible, the goal would be to hire locals to distribute the product. The primary motivations for these individuals would therefore be to make enough money to provide for their families. Because of that, we would want to make sure to provide reasonable compensation, taking into consideration the local economy (such as the practice of paying for small quantities of things at a time, instead of paying regular, larger bills).

The final major stakeholder would be the producers of the test strip. Although ideally we would produce this product in-country to provide additional employment opportunities and reduce distribution costs, this probably is not feasible. Because of this, we would need to find a company that can scale up our production of test strips for a low cost. Because this company will likely be in the US, their primary motivations will likely be profits. Although this could create challenges with balancing the motivations of different stakeholders, our priority as a team will always be to provide these test strips to as many people in Sierra Leone as possible.

Project Credibility/Validation over the semester

In order to validate our project progress throughout the semester, there are several things which we will try to accomplish. First, since the Ukeweli test strip team has a similar product to ours, but is at a significantly further stage, we should check in with them to see if they have any comments or suggestions on our product and ideas. Similarly, we would like to speak with individuals from industry who can give us feedback and advice on our test strip. Because our advisor, Prof. Cheng, knows people who work on lateral flow devices, these individuals may be able to help us as we optimize our test or overcome a particular challenge with the design. Finally, in order validate our work so far, and reflect on the next steps, our team would like to put together an abstract for the IEEE Global Humanitarian Technology Conference. Not only would an acceptance to this conference validate our accomplishments and ideas, but the process of putting together the abstract will also allow us to reflect on our project so far.

Cultural Challenges & Opportunities

As my team moves forward with designing and implementing a sickle cell anemia diagnostic tool in Sierra Leone, there are several cultural issues which we may have to be aware of; including religious beliefs, concepts of the good life, and gender roles. Specifically, religious beliefs could impact whether individuals choose to utilize our diagnostic tool due to a preference for traditional medicine, or a trust in “miracle services.” Additionally, the concept of a good life might not encourage individuals to seek out our diagnostic services. For example, since sickle cell anemia is not curable, individuals might not want to know their status. Finally, gender roles may impact the utilization of the test strip. For example, in some cultures, women are not allowed to be treated by men, or to go out without their husbands. Because of this, we should be aware of how gender roles and expectations could influence people’s access to our test strip.

I have also observed how these different religious beliefs, concepts of the good life, and gender roles can impact social situations at home in the US. Specifically, for example, religion can impact maternal health through abortion access, and with blood transfusion beliefs among Jehovah’s Witnesses. Additionally, the concept of the good life in the US stresses efficiency and profits. Coming from Germany, I have seen how this culture uniquely affects the work culture, such as through reduced vacation time and maternity leave. Finally, although there has been a huge social movement for increasing gender equality in the US, gender roles and expectations still affect every day life, for example with the gender pay gap.

In addition to these cultural challenges, I believe that there will be some unique challenges presented by the African context specifically. For example, because we are unfamiliar with the healthcare system, economy, and culture in Sierra Leone, there may be some unexpected challenges (such as the unforeseen consequences of the treadle pumps and hybrid corn). Additionally, although English is the primary language in Sierra Leone, the prevalence of different languages among different ethnic groups may create some communication difficulties. And finally, the economy in Sierra Leone, specifically with individuals typically only having small amounts of money at once and no steady salary, may present some unique challenges with figuring out how to pay distributers and getting reimbursed.

Although this unique context may preset some challenges, I also believe that there are some local practices which could be leveraged to address problems. For example, although the “gig economy” may be an adjustment for us, it could allow us to employ many more people for small tasks. Additionally, although the US is a very individualistic nation, a greater focus on community in the culture, for example, could allow for a more cohesive workforce. Finally, since learning is different depending on the cultural context, being in an environment where people learn through imitation instead of reading, for example, could allow us to make a bigger impact more easily.

Within the African context specifically, I believe that there may be several resources which could benefit the implementation of the sickle cell anemia test strip. For example, because Sierra Leone does have a large gig economy, I believe that finding individuals to help us distribute our product will be easy, and open up a lot of employment opportunities for locals. Additionally, because sickle cell anemia is the leading cause of child mortality, our product will be especially well received. And finally, because doctors are well respected in Sierra Leone, most people will choose to utilize our test if recommended.

In this way, I believe that there are many unique local challenges and opportunities we may be observe while trying to implement our test strip in Sierra Leone.