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.