Conner Calzone, Roy Ndebvudnemene, Tiffany Pang

 

1. List five compelling takeaways from the Art of the Start (the video we watched).

• Intent to make an impact and to change the lives of people and that way, you will make money in the process. 
  • The best way to guide this is to have a three-to-four-word mantra.
    • FOR the employees or the team
  •  Keep it simple: “Cost a $1, sells for $5 and gross margin is 20%”
• Do something unusual. The best place to be is to create something that people desire and with something that only you might be doing.
  • In other words, get going, think differently, and don’t do better sameness. Do things 10x better.
  • Aim for the top right corner:
    • X-axis: Value to the customer
    • Y-axis: Ability to provide unique product or service
• Don’t try to encapsulate a wide range of people as the target customer/consumer or you will end up making something of mediocrity. Don’t be afraid to polarize people.
  • Every idea, product, or subject in the world will always have polarizing views.
  • Be specific: Who is my customer? And how do I get the money out of their purse?
  • At the same time, find a few soulmates, partnerships or people to balance you off.
• Compete on value rather than on price.
  • Work with people who are “infected” with the love of your product, idea or goal
  • If you truly want to change the world, the best reason is to start something to make meaning, which will collect people who see the same meaning:
    • Increase the quality of life
    • Right a wrong
    • Prevent the end of something good
• For the pitch, try to apply the 10, 20, 30 rule. 
  • 10 slides
  • 20 minutes 
  • Font size 30
    • Core information = a lot less text, meaning you must know your material

 

2. Articulate your value propositions for your diverse customer segments. 

Sickle cell anemia (SCA) is a common, life-threatening, but largely neglected inherited blood disorder which results in red blood cells becoming sticky and sickle shaped. Neonatal screening and early detection have been shown to significantly reduce mortality rates by allowing for several potentially life-saving interventions, including penicillin prophylaxis, pneumococcal immunization, education on symptom management, and hydroxyurea treatments. However, in LMICs like Sierra Leone, families do not usually have the luxury of early intervention in testing for Sickle Cell Disease. Hence, under-5 mortality rates are still very large for Sickle Cell Disease patients in Sierra Leone. Our venture aims to be low cost, accessible and usable for all newborn births in Sierra Leone. This set of attributes will allow our venture to make an impact on many lives in Sierra Leone. Hence, our full value proposition is that for all children 5 years or younger, our diagnostic device is capable of identifying whether you have healthy blood, Sickle Cell Disease or Sickle Cell Trait, so their families can take the necessary steps to receive treatment as soon as possible.

 

3. Discuss your Total Available Market and Total Addressable Market. List all your assumptions and hypotheses.

The long term objective of our venture is to screen all newborns for Sickle Disease and Sickle Cell Trait shortly after birth. We aim to do this with a low cost, point of care diagnostic test strip. The point-of-care testing market has been developing rapidly over recent years. This market includes all detection devices that are able to rapidly diagnose patients. The global point-of-care testing (POCT) market is expected to grow up to $36.96 billion in 2021. This expansion of the market is validated by the importance of POCT in global health. These devices are intended to simplify the diagnosis of many diseases and are especially useful in low-resource areas. Hence, our Total Available Market would be the children under 5 years old and their families that would benefit from early Sickle Cell Disease testing. Therefore, our venture has a diverse range of clients that would make up the Total Addressable Market. 

Several non-profit organizations, such as the World Health Organization, also distribute these diagnostic devices to low-resource areas as a step towards reducing world health care issues. This point-of-care device will likely be distributed by a non-profit organization to be utilized by health care professionals and patients in low and middle resource countries. The patients and medical professionals who come in contact directly with the device are the product’s end users. The product’s targeted customers are non-governmental organizations (NGOs) and other healthcare organizations that will be investing in the device. In Sierra Leone, there is a Free Healthcare Initiative (FHCI) funded by other governments (especially the UK Department of International Development), the UN, and financial NGOs. This initiative provides free, basic healthcare services to pregnant women, lactating mothers, and children under 5. Once the utility of the product in Sierra Leone is proven this device could become a part of this initiative as a free, commonplace screening device among all newborns.  

Currently, a pilot study of the Sickle SCAN device conducted by Dr. Cheedy Jaja has been put into place in an effort to create change in SCD diagnostic processes through introducing their product. However, this diagnosis is not significantly accessible in countries of low resources due to the requirement of performing a 200-fold blood dilution step and a costly charge of $4.50 per test. Other programs include collecting dried blood spot (DBS) samples from newborns in high-risk areas, and sending them to centralized laboratories for isoelectric focusing analysis. Two such programs were initiated in Angola and Uganda; however, these initiatives were time-consuming and expensive (with costs estimated to be $15.36 and $9.94 per test, respectively).

To address these problems, our current understanding of the healthcare system and distribution of diagnostic devices in low and middle-income countries leads to the belief that this test strip must be considered inexpensive. The intended novel device configuration, the “E-Junction”, allows the device to run using a whole drop of blood, eliminating a dilution step. The device takes approximately 15 minutes to run. The estimated lateral flow diagnostic device prototype and production bills of materials is currently $2.98 however, further optimization of the device will reduce the cost ideally less than $1.00 (US). Therefore, if our research is supported by the FHCI, the device’s direct customers would be the groups behind the funding of the FHCI. This kind of screening device will be of value to customers as it will reduce other medical costs by improving initial diagnosis of individuals with sickle cell anemia. Until this device proves it’s utility, other NGOs will be purchasing the product. 

 

Conner Calzone, Roy Ndebvudzemene, Tiffany Pang

 

1. Summarize and report out on the results of the SKS exercise.

 

During Tuesday’s class, we completed a series of exercises meant to affirm our own and our teammates’ skills and assets with regards to our project. One of these exercises was the Start, Keep, Stop (SKS) exercise. In this exercise, our three team members wrote two things under each of the three sections (SKS) that would help improve our project. One “Start” we all agreed on was to make a larger effort to become knowledgeable in all facets of the project. We all look up to Maria, Jannah, Ashleigh and the other senior members because of their wide ranging knowledge of the project. We are on our respective subteams, and we have been putting in work in the labs and working on the concept paper, but there are parts of the project that we are not as familiar with. Participating in events like the Lehigh EXPO, DEBUT and even our GSIF presentations will help us in furthering our knowledge, but we agree we can do more. We should take advantage of our senior members’ knowledge while we still have it, so we can continue the process of creating strong, intelligent and passionate team members. Once again, our team independently wrote that we should continue acting inquisitively and proactively in the “Keep” section. In our seminar, Khanjan has repeatedly stressed the importance of asking any and all questions. No question is a stupid question any questions help in advancing our project in some way. In our meetings, and in the lab, we have made a consistent effort in asking questions often. Finally, we had some differing opinions on what we should stop doing. Two of the most worthwhile results from this section include “stop being short-sighted and using more foresight for problems/solutions” and “Realizing the purpose of everything we do, executing everything with perfection”. Sometimes, our group may not realize the purpose in doing a specific activity, but I feel we sometimes need to look at things in not only a short term sense, but also a long term sense. Our team is very smart, cohesive, fun and intelligent, but we still learned a lot from this SKS exercise.

 

2. Develop a detailed Collaboration Plan for your team clearly articulating your Goals (Small g and Big G), Roles, Procedures, and Relationships.

 

Roles:

Our team’s role is to successfully develop and administer a lateral flow immunoassay test strip in order to diagnose sickle cell disease (SCD) in Sierra Leone. The organizations and individuals (listed in “Relationships” below) identified the absolute need for a low-cost, screening device and have shown interest in what our solution proposes.

 

Relationships:

The project has gone through multiple stages of prototype designs to the design we have today with our PI, Professor Cheng, and GSIF coordinator, Khanjan Mehta. The team has also validated this device and has received feedback through the connections we have established with World Hope International and Sickle Cell Care Awareness Network (SCCAN) together with partnerships within Sierra Leone including Masanga Hospital and Dr. Cheedy Jaja.

 

Procedures/Work in Progress as of Now:

So far, the team has a successful diagnostic test strip established. The novel device schematics, the “E-junction”, is capable of running on only a single drop of blood without a dilution step. The process is efficient and only takes 15 minutes to run.

However, before the actual field testing, the team must prioritize creating an IRB for obtaining and testing on HbA and HbS blood samples. Currently, the diagnostic device is being tested using purified HbA and HbS, and also HbA blood samples from a local blood bank in Bethlehem. In addition, the team is in the process of acquiring an Institutional Review Board (IRB) approval to receive HbS blood samples from the Lehigh Valley Hospital.

 

Current Goals and Milestones:

As our lateral flow device is improved and developed over time, our team plans to write publications. To do so, we are looking into journals to understand what our targeted audience wants to see from our research. For instance, in-depth concepts about our diagnostic device’s design, outcome, specificity, and sensitivity. Our experiments will be planned based on our target journal and two main focuses discussed in our publication will be design versus clinical tests versus field considerations. Some publications the team is considering as of right now are IEEE for review, Lab on the Chip, and the Journal of Hematology. 

Another goal the team is looking at is quality control. As a team, we must figure out the shelf-life and storage of the test strips (by itself or with the blood sample + running buffer + antibody). Possible storage we are looking into is the development of a casing. Other aspects to consider are also the effects of humidity, temperature and other possible constraints (dehydration). 

After establishing quality control, we are currently working on is optimizing the production of test strips. An automated repetitive system for the printing mechanism has been slowly developed alongside the diagnostic device. The system will consist of a conveyor belt and functionality programmed by an Arduino with Matlab. The goal is to create a motor-driven belt in which it could transport the strips of Nitrocellulose membranes down the conveyor. The Nitrocellulose membrane strips will reach a point, where it will trigger a light sensor (Photocell or Light Dependent Resistor Sensor), causing a chain reaction to enable an attached syringe press (propped up by a 3D printed stand) to pump the antibody solution onto the strip.

 

Next Steps and Larger Goals:

In August of 2020, the team will be returning to Sierra Leone to conduct the alpha testing phase of the diagnostic device. To conduct this testing, we aim to collaborate with Dr. Jaja who has IRB approval to run studies on current SCD screening devices, SickleSCANⓇ. As we work under his guidance, an estimate of 10-20 devices will be tested to validate its usability. 

By July of 2021, the team will focus on receiving IRB approval to start beta testing the diagnostic device. Under the IRB, the team plans to test around 100 test strips. Alongside the testing, our goal is to provide an educational system that will teach the Sierra Leone locals to be conscious of SCD symptoms. In order to do so, we have recognized the indigenous knowledge, traditional beliefs, and practices, so our device can be accustomed to being non-disruptive to the current Sierra Leonean lifestyle. Therefore, the educational curriculum will focus on providing locals with information on where and how to receive treatment.