• Step 1: Determine the facts in the situation – obtain all of the unbiased facts possible. Clearly state the ethical issue. 
• Ten researchers traveling to Lesotho
• Traveling for two weeks
• Several publications expected from this research
• Need locals to show them water sources/methods
• Lesotho is an LMIC
• The specific pathogen only exists in this region of Lesotho
• This research could lead to the development of chemical additives to treat the drinking water

 

It is ethical to conduct this research.

The primary ethical issue is whether to pay the community members for their work in enabling the research.

• Step 2: Define the Stakeholders – those with a vested interest in the outcome 

 

1. Researchers
2. Community members
3. Residents of the region at large
4. Academic institutions or other funding organizations
5. National and regional government organizations
6. Water purifying companies / NGOs
7. Scientific community

• Step 3: Assess the motivations of the Stakeholders 

 

1. 1. Researchers (primary stakeholders)
      1. Academic interest: understand the lifecycle and characteristics of a specific pathogen
      2. The desire for publications and academic prestige
      3. Implications for future work (sharing knowledge with the scientific community)

• Altruism/humanitarianism (helping the community members)––Khanjan disagrees; the researchers are unlikely to be the same people developing the solution

1. Community members (primary stakeholders)
   1. Curiosity about the researchers and their work
   2. Hope for better living conditions (safe drinking water)
   3. Want the pathogen to be understood
   4. Desire to draw attention to the issue
   5. The desire for financial compensation
2. Residents of similar settings (the region at large; other places with related diseases)
   1. Hoping for better living conditions (safe drinking water)
   2. Possible transferability of results
   3. Safe drinking water makes real estate more appealing
3. Backing organizations, even if not funding (secondary stakeholders)
   1. The desire for prestige/reputation
   2. Stability and safety of researchers
4. Funding organizations (secondary stakeholders)
   1. Publications and prestige
   2. High-quality results
5. National or regional government organizations (secondary stakeholders)
   1. Possibility of improved public health
   2. Networking opportunities and personal or organizational prestige
   3. Improved view of country/region on the world stag.
6. The scientific community (secondary stakeholders)
   1. Understand the lifecycle and characteristics of the pathogen
   2. Implications for future work
   3. Altruism (helping community members)

• Step 4: Formulate (at least three) alternative solutions – based on information available, using basic ethical core values as a guide 

 

1. Approach 1: Pay the community members offering assistance
   1. Ethical Principle or code: Consequence-based thinking or duty-based thinking
   2. Pros:
      1. Recognizing the value that locals bring to the research
      2. Respecting locals’ time and efforts
   3. Cons:
      1. How to decide how to pay
      2. Expense
      3. Some cultures may be offended by a money offering
2. Approach 2: Recruit community assistance as a volunteer opportunity
   1. Ethical Principle or code: Ethics of care 
   2. Pros:
      1. Find people with the right motivations to assist you
      2. You will not offend anyone by offering money
      3. Volunteering is rewarding to them and will create trust
   3. Cons
      1. Can be time-consuming to find volunteers
3. Approach 3: Compensate in a non-financial way
   1. Ethical Principle or code:  Duty-based thinking
   2. Pros
      1. Exercising appropriate virtue by recognizing locals’ value
      2. Non-financial compensation may be more valuable to locals
      3. May incur fewer expenses 
   3. Cons 
      1. What is honest or virtuous depends on social traditions, history, etc.
      2. Deciding what the compensation will be
      3. Money is the easier option

 

The best approach would be Approach 2: Recruit community assistance as a volunteer opportunity.

 

Bypassing it to well-developed organizations in the country with interest that might align with the researcher’s goal, there is a chance of getting the help they need for free. By putting together an application site where people of interest get to learn about the true mission and what is going to be expected of them gives the venture a chance at getting the right person at no additional cost as long as they clearly state that it is a volunteer position. Part of this option creates a long-standing relationship with the institute that could prove useful later in the long run. This decision has no hindrance to the current plans for the researchers when executed well in advance of time.

Below is the poem based on an English 002 essay 1.

Am I just a cook to you

Conner Calzone, Roy Ndebvudzemene, Tiffany Pang

 

 

• Refine the detailed income statement for your venture for two years (at six-month intervals) or a more appropriate time scale. Explicitly state the assumptions that underlie your financial model.

 

https://docs.google.com/spreadsheets/d/1UtqK6RgJZu4CY-PxDmE8mOEYOrnFLLXNnSJtWPgsFM8/edit?usp=sharing

 

Assumptions:

• Sierra Leone and other developing countries may not have the ability to afford the device, so these costs will be taken up by the following partners, potential donors and organizations who have innovation fund programs that could fund our project for several years. 
• Our goal is to make an IMPACT, and national screening program for all newborns. It is not about making a profit. Therefore, profits from bulk sales are reinvested in the project and SCD relief efforts, such as patient support, education, penicillin therapies and into families. Profits from Direct Sales can also be reinvested to organizations like Sickle Cell Society and others
• The venture will operate with economies of scale and we expect most sales to be from bulk pricing. Current estimations are unit prices of $4.50 for bulk pricing and $5.50 for direct consumer channels. 
• Our plan is to have the health care systems in Sierra Leone well equipped to use the test strip directly and advocate to diagnose 75% of newborns for SCT/SCD in the third year after introducing our device. By year 3, 330,000 units will be sold and distributed to hospitals in the country.

 

 

• Refine the Business Model for your venture based on your revenue model. You may use the Osterwalder BMC to refine your business model but prepare one or more visuals that explain how your venture will work and accomplish your BHAG.

 

 

• Develop an M&E plan for your venture.

• Clearly list all assumptions

 

• We are planning to launch our product in Sierra Leone in Summer 2023. By cross-referencing a population density map and a map of all the public hospitals in Sierra Leone, we have constructed an ordered list of hospitals where we will introduce our device. One year after launch, we expect to be implemented in 10 densely populated hospitals encompassing many areas of the country. Two years after launch, we expect to be in 25 hospitals, and three years after launch, we expect to be in at least 50 hospitals diagnosing 75% of the newborns.
• To fund our venture, we will need $1.25 million over the next 5 years. Donor Spending on Child Mortality in Sierra Leone will total to $75 million over the next five years. Our venture can eliminate 4% of child mortality in Sierra Leone, so it is well worth the investment from donors.
• Our staff includes: hiring a project manager, relationship manager, and training expert. Managers will have access to transportation, internet, and networking budgets. Additionally, we will use an advertising budget to raise awareness of the severity of SCD as well as the newborn testing options available. The venture will operate with economies of scale and we expect most sales to be from bulk pricing. Current estimations are unit prices of $4.50 for bulk pricing and $5.50 for direct consumer channels. 
• The newly born infants in Sierra Leone are our target users, yet we plan to sell the devices in bulk to donors such as WHO or UNICEF, who will help distribute them to the public hospitals. Additionally, we have accounted for some direct sales to pharmacies in our sales projections.

 

• Identify short-term and long-term success metrics.

 

Short-term: We are planning to launch our product in Sierra Leone by the Summer of 2023. The newly born infants in Sierra Leone are our target users, yet we plan to sell the devices in bulk to WHO or UNICEF, who will help distribute them to the public hospitals we prioritize. Our plan is to successfully screen about 75% of newborns in Sierra Leone for SCT/SCD after three years of introducing our device. 

 

Long-term: 5 years from now, our metric for success is the venture being sustainable and autonomous from our input. The operations of the project are to be absorbed into the Sierra Leone Ministry of Health which will continue screening for SCD/SCT in infants. Then from our launch, our goal of about 90% of newborns being diagnosed will be reached.

 

• Identify specific methods to measure any metrics.

 

• Our profits from direct sales could be reinvested into organizations such as Sickle Society and education efforts while profits from bulk sales would be reinvested into the project and penicillin prophylaxis treatments, which costs $184 per each saved year of life for SCD patients.
• Five years from launch, the venture will be sustainable and autonomous from our input as we will shift our focus to look at the intellectual side: strategic gaps, false positives/negatives. The project will be absorbed into the Sierra Leone Ministry of Health which will continue screening for SCD/SCT for newborns because they have the authority and funds to sustain our venture.

Conner Calzone, Tiffany Pang, Roy Ndebvudzemene

 

• Develop a detailed income statement for your venture for two years (at six-month intervals). Explicitly state the assumptions that underlie your financial model.

 

https://docs.google.com/spreadsheets/d/1UtqK6RgJZu4CY-PxDmE8mOEYOrnFLLXNnSJtWPgsFM8/edit#gid=972430196

 

• • Device Pricing: There is currently no SCD diagnostic device established in Sierra Leone. One of our competitors are the SickleSCAN device, which is still under pilot study. 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. Another SCD program includes 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). 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). 
    • Yet, because the DBS program is the only one that has been tested in high-risk areas, we are looking to sell our device at $10.00 per unit, which is $5 cheaper than the average DBS tests.

 

• Manufacturing Pricing: Production costs would be estimated around $0.10 ~ $0.20 if we compare our device to the common pregnancy test, which can be manufactured in China for $0.02 each. Each unit will be priced according to cubic meter. Additional costs of ~$0.15 will be derived from shipping, handling and packaging. We are looking to package each unit individually to prevent damage or contamination. Within each package will consist of directions on how to use the device.

• Fixed Expenses:

 

• • • Hiring a Project Manager/Relationship Manager: Salary of $30,000
    • Networking budget of $10,000, which will encompass the travelling expenses that both will need in order to visit communities, partnerships, meetings, and conferences to network about promoting the significance of diagnosing SCD.
    • Operating Expenses of $10,000, which will encompass resources that both individuals will need including: internet, insurance, laptop, and Top-Up (Phone service).

 

• Advertising Expenses:

 

• • Broad spectrum education/advertising help educate people across the country and creates demand: (posters & bulletin boards on highways, capital cost), health programs, and radio announcements

 

• 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.

 

For the design phase of our project, due to the Corona Virus delaying our focus in the lab area, as a team we have decided to shift our focus to applying to more grant opportunities and competitions for our research for the remainder of the semester. One of the submissions is the NIH Tech Accelerator Challenge for Global Health that focuses on developed prototypes of Non-invasive diagnostic devices and the other is a collaboration of NIH, NIBIB, and VentureWell offering a DEBUT competition that will recognize undergraduate biomedical design and innovation. As of now applying for grants and competitions are our only source of funding the development of the diagnostic device. In addition, as our lateral flow device continues to be developed, the 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 discussions in our publication will be addressing the differences between design, clinical tests and 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. Successful publication of our research in these mentioned articles can help to publicize our plan of impact, while at the same time garnering attention of potential funding sources/partnerships. 

The World Health Organization (WHO) is one of the major organizations our team has decided to establish a partnership with. Their resolution or value proposition aligns with ours: to ensure the surveillance of birth defects and provide support for prevention of common genetic disorders (this includes haemoglobin disorders and ethics). They have been expanding their developing services, and  need to initiate in order to prevent birth defects in low and middle income countries (LMICs). Based on their experiences gained in LMICs from the implementation of medical services for haemoglobin disorders, they recognize services are fundamentally different compared to industrialized nations, due to the differences in both culture and relative incidences of specific genetic diseases. They understand that the aspects of educational and tertiary care services within industrialized countries are translated into a more holistic community-based strategy when incorporating public health approaches (primary health care) into low-resource communities. Since they are an organization that seeks to create impact, strategies of development of health systems, improving education, classical public health approaches to disease control and prevention and health promotion are welcomed. 

Similarly, UNICEF’s, a non-governmental organization (NGOs), mission is to create change for children and young people every day, across the globe. We also plan to partner up with them once our device is at stable state because they have works in over 190 countries and territories in order to save children’s lives, defend their rights and to help them fulfil their potential, from early childhood and throughout adolescence. They have helped to reduce child mortality all over the world by working to reach the most vulnerable children, everywhere. 

In this case, WHO/UNICEF will most likely support the distribution or initiation of the implementation process. Let’s say we have our device be likely manufactured by a Chinese manufacturer, producing our request of 1000 devices. These devices will get shipped (exported?) to Sierra Leone, where WHO/UNICEF personnel can retrieve the shipments at the port, which will be distributed to all the targeted hospitals. Since WHO/UNICEF already has existing systems within Sierra Leone’s primary health care, distribution of our diagnostic device becomes efficient. Based on the March of Dimes Global Report on Birth Defects, there are approximately 7.9 million infants born every year affected with a serious birth/genetic defect. Of these births, 94% (or 7.4 million) happen within LMICs. In Sierra Leone specifically, there are 700,000 child births annually, but 400,000 of 700,000 are born with Sickle Cell Disease (SCD). That’s about 57% of newborns born annually, contributing significantly to the country’s toll of birth defects. If the product is planned to be launched by the Summer of 2023, that’s where our revenue model begins and will be dependent on this “57%” of SCD affected newborns. In other words, if 57% of deaths are SCD-related, then WHO/UNICEF’s funds can be convinced to 57% addressed on SCD. 

With this in mind, our partnerships with WHO and UNICEF will begin the implementation process of the immunoassay device in targeted hospitals across Sierra Leone. Our target hospitals will answer the question of, “Where is the centralized number of babies that are born?” There are about 80 hospitals in the public and private sectors of Sierra Leone. Of the 80 hospitals, Ola During Children’s Hospital and Bo District Hospital are some of the few larger hospitals that have higher success in their birth rates for neonates. Looking at GIS data, in order to equally spread the distribution of devices, large cities such as Freetown, Makeni, Koidu-Sefadu and Kenema would be our priorities because larger cities are more likely to have one or two healthcare systems implemented. In addition, the geographic proximities of the large cities could expand distribution in the long-run. For example, Freetown is located in West Sierra Leone, Makeni near the center, Bo near south, Koidu-Sefadu in the east and Kenema near south-east. If these five larger cities implement the screening of SCD with the device in their healthcare routines at the hospitals, over time distribution will begin to expand to smaller hospitals in the large cities, and then continuing to expand to hospitals within the smaller cities. The process will be gradual where the first year will only involve 10 hospitals that will be acquainted with the device. Then year 2 would be 20 hospitals, year 3 would be 30 hospitals and so on. Through these hospitals, the number of locations determines how much babies can be tested. Once the is acquainted in the first 10 hospitals for the first year, we will hire designated individuals to oversee the device implementation process.

 

 

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

 

• • WHO
    • *mentioned above
  • UNICEF
    • *mentioned above
  • User Communities (our patients)
    • We must build ethical and highly patient-centric management with a system that supports it and instill faith, create ownership in the Sierra Leonean community to the problem and engage with them as a partner.
  • Hospitals/Healthcare Systems:
    • Full-time project manager (based in sierra leone)

 

• Grant writing, advocacy, relationship building, training the hospital staff, coordination of all the entities

 

• • • Second person to hire: Relationship Manager

 

• For everyone that tests positive, this person will work with all the different service provider and gets these patients to the right places. 

• This helps organizations to build their own capacity. 

• This person is the one actually collecting the data, using the data for grant writing advocacy, relationship building and etc. 

• We can implement an educational program through this person right when the baby is born.

 

• Sickle Cell Society
  • Supports and represents people who have been affected by SCD to improve their overall quality of life
• Ministry of Health and Sanitation (Pharmacy Board of Sierra Leone)
  • Their vision is to ensure that a functional national health system is delivering efficient, high quality health care services that are accessible, affordable and equitable for everyone in Sierra Leone with the overall goal to maintain the health of their citizens.
  • An approval from the Pharmacy Board will further the implementation of the device. As the device grows successful in many hospitals across the country, the process can be absorbed into the Ministry of Health, where the significance of diagnosing SCD can be promoted continuously.

Conner Calzone, Roy Ndebvudzemene, Tiffany Pang

 

1.Refine your Business Model Canvas:

• Include a Visual Canvas
• Extremely specific notes for each block
• Explain how exactly you will deliver an end-to-end solution.

 

Some specificities to the Business Model:

• For Customer Relationships, we have to ensure to create trust with the entities buying the devices (WHO, Hospitals etc…) and the end consumers of the product. We have to keep in contact with entities through the whole value chain and ensure that they have sufficient devices and that the newborns are consistently being tested.
• Additionally, we should be developing bonds with NGOs like UNICEF and UKAID as we are selling our device as a huge markup and we will have to overcome development and implementation costs in order to sustain our venture
• We must sell the same product with the same service, but must keep variation in quality and in service. To design a delivery system, we need to constantly “innovate”
• Once the device is developed, we also may have additional fixed costs of paying employees to be trained and delivering the devices as well as paying an outsourcing fee to a manufacturing company. 

 

End-End Solution:

1. We have an optimized test strip assembly compatible with large scale manufacturing practices. 
   1. In terms of any changes or development, our goal is to reduce the costs of both manufacturing and selling of this product. Our aim is to not accumulate a large profit, so we hope the low cost of production will allow for a low purchasing price as well. Ideally, our price is set equal to the marginal cost of producing a single device to ensure we break even. 
2. We have a functioning immunoassay lateral flow device, where a single drop of blood will allow the device to be capable of identifying individuals with normal blood, sickle cell disease and people who carry the trait for sickle cell disease.
   1. Because the test strip is derived from a similar nature as current pregnancy tests, causing our team to translate this technology to our needs, this must require an intellectual property to patent the design. Our test strip is different than a standard straight test strip and the current design advances its performance: no dilution step and no hook effect. The patent will prevent others from using our invention for commercial purposes for up to 20 years. We are the deciding factor of who will be allowed to produce, sell or import the invention.
3. Transporting/expanding the device from the U.S to Sierra Leone.
   1. The device will be approved by the U.S. Food and Drug Administration (FDA) through a 510k pathway to demonstrate legal marketing. Although the device will not be focused on being used in the U.S, FDA approval will make it much easier to receive an ethics board approval from the Ministry of Health and Sanitation (Pharmacy Board) together with an established service level agreement in order to implement the device in other LMICs, like Sierra Leone.
4. Once our devices are approved and can be implemented, they will be sold to large organizations such as the WHO, FHCI, UNICEF and UKAID who have widely known distribution practices. Government health sectors, healthcare services, including hospitals, clinics and medical professionals within Sierra Leone will be more inclined to receive the device to utilize on their patients.  
5. Then, with our user communities, we must build ethical and highly patient-centric management with a system that supports it. We must instill faith, create ownership in the Sierra Leonean community to the problem and engage with them as a partner.
   1. Consultations
   2. Education
   3. Training for residents/fellows, technicians and healthcare workers, while prioritizing those who will become future staff

 

2.Ten practical lessons from the business (revenue) models of ventures we reviewed today (or others you research) as they relate to your venture.

 

• A value proposition should be about solving or fulfilling a specific need. It should be about creating value for the people.
• People don’t care about technology. They want to know exactly how buying your product will be of benefit to their day to day lives directly.
• One must build strong customer relations to sustain a successful venture. This can be accomplished by using customer feedback in order to further act upon your value proposition
• A new invention is not a requirement for social entrepreneurship. Any methods of creating added value for a group of people can be the basis of a venture.
• Ventures can be sustainable without insane markup pricing. A small, but sustainable profit after making up an initial investment will allow our venture to be sustained in Sierra Leone.
• For social entrepreneurship ventures, social capital is very valuable and it can make the difference between your business succeeding or failing. 
• Building and maintaining that strong relationship with customers is key to getting the trust a business needs.
• The pricing model of the product you are selling is very important as it addresses who can afford it and thereby detects your possible market. Offering Flexible payments and pay-as-you-go options can make your business as successful as well.
• Thinking about how everything will be paid for is very useful to evaluate the likelihood/validity of the business model. 
• A very good business model must be very logical and realistic. From looking and examining it, it needs to be clear of how everything from key resources to revenue streams allows for the customer segments to get the value that you are proposing without a hiccup. It needs to flow and link up everything as to how they will all come together to create the value that you intend it to in the value proposition

Conner Calzone, Roy Ndebvudzemene, Tiffany Pang

 

 

• Develop a business model for your venture using the Osterwalder business model canvas

 

 

Value Proposition: 

• For all children of 5 years and younger who have sickle cell disease, our SCA diagnostic device is capable of identifying between normal blood, sickle cell disease and sickle cell trait, in order to take the necessary steps for treatment.

 

Distribution Channels:

• Clinics through a screening program
• Hospitals
• Non-Governmental Organizations
• Government Health Sector

 

Key Resources:

• Retrieval of blood
• Data of who are diagnosed with SCD or SCT
• Management of how the blood will be taken from patients
• IRB Approval

 

Cost Structure:

• Fixed Costs: Utilities, Community Health Worker Salaries
• Variable Costs: Direct Materials, Indirect Materials, Taxes

 

How should the device be paid for? Government health sector or individual patients?

• Things to think about: If the government, how realistic is that for the government to pay? There could be political problems and for the most part, not always successful. If the individual patients, they may struggle to pay and may choose not to use the diagnostic device at all if the financial burden falls on them.

• Current: Receiving funds from grants and competition
• Distribution & Approval: Pharmacy Board, Hospitals, Clinics in Sierra Leone
• Possible Plan: If healthcare workers are already there, we may not have to pay them and hence we can save money. The money from the grants could be used in manufacturing and transporting the device. The money gained from the devices will be injected into the program to keep it running and perhaps expand it as well.

 

Key Partners:

• World Hope International
• Dr. Cheedy Jaja
• World Hope Organization
• Sickle Scan Society

 

Key Activities:

• Educating individuals on the stigma and effects of Sickle Cell Disease
• Testing children under 5 for Sickle Cell Trait and Sickle Cell Disease
• Directing SCT and SCD patients to the most effective treatment types
• Directing SCT and SCD patients to how and where they can be treated

 

Customer segments:

• Children under the age of 5
• Newborn babies
• Sierra Leoneans with SCD or SCT

 

Customer Relationships: 

• User Communities: The targeted customers/consumers will benefit more by getting involved more with the program for sickle cell screening, advisory services, and educational services.

 

Future Addressable Markets:

• Point of care testing market (POCT)
  • 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.
• World Health Organization (WHO)
  • 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. 
• Non-governmental Organization (NGOs)
  • Because Sierra Leone and other developing countries do not have the ability to purchase the test strips from us as they would cost too much money, these costs would be taken up by large organizations such as UKAID, and UNICEF who have programs such as the innovation fund which could fund our project for several years
• 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. 

 

1. 1. List ten lessons from the business and operations model of the Aravind eye hospital

 

• Recognize the problem

 

1. 1. 1. 1. State the problem
            1. “Today, we’re reaching not even 10% of them”
               1. This sentence speaks “why” we should even consider this
         2. Ex: Recognize what it is like to be blind

 

• Sharing a real-life person’s story

 

1. 1. 1. 1. The woman talks about her struggles, depravity of their livelihood and their dignity, their independence and their status in the family

 

• State the statistics

 

1. 1. 1. 1. “One amongst the millions”
         2. Numbers or percentages show the severity of how many are affected by blindness
         3. Numbers/percentages/facts also indicate “possibility”, “success”, “validity” and the “power” of the project (encompassing how many can be cured and given sight)
            1. “A simple procedure-will give sight to 7.5 million”
            2. “Last three decades we have done about  3 ½ million surgeries”
            3. “A typical day we perform about 1000 surgeries and see about 6000 patients”

 

• Discuss how the project all started/The History or Founding of the Project

 

1. 1. 1. 1. Start with meaning
         2. “Started with no money. He had to mortgage all his life savings.”
         3. Building blocks
            1. Value system
            2. Efficient delivery process
            3. Fostering culture of innovation

 

• Show the growth of the project/implemented system

 

1. 1. 1. 1. “Over time, we have grown into a network of fie hospitals”
         2. Mention “where” it is predominately established
         3. Mission centers: hub-and-spoke model
         4. Management or hospitals in-country and down the line, in other parts of the world

 

• State Target Customers 

 

1. 1. 1. 1. “Who” is this project for?

 

• State Your Approach or Solution

 

1. 1. 1. 1. “Send out teams into the villages to examine, bring back patients” (Transportation)
         2. Consultations
         3. Training for residents/fellows, technicians and healthcare workers (prioritizing those who will become future staff) 

 

• Establish meaning in your project

 

1. 1. 1. 1. Build an ethical and highly patient-centric management with a system that supports it
            1. “Implicit faith in you. Here is an old lady who has got so much faith in me, I must do my best for her.”
            2. “When we grow in spiritual consciousness, we identify ourselves with all that is in the world, so there is no exploitation. It is ourselves we are helping. It is ourselves we are healing.”

 

• Marketing Strategy

 

1. 1. 1. 1. McDonald’s franchise is available all over the world, selling the same product with the same service
            1. Consistency and Convenience is Key
         2. “The eyeball is the same, the problem is the same, the treatment is the same. Yet, why should there be so much variation in quality and in service?”
            1. The design of delivery systems need to constantly “innovate”

 

• Creating a Step-By-Step Execution Strategy

 

1. 1. 1. Create ownership in the community to the problem and engage with them as a partner
      2. Community-organized camp
         1. Organize volunteers, Bring in doctors/healthcare workers, Determine next steps (what further testing/treatment should be done), Diagnosis (prescribes a line of treatment), If needed glasses (immediately available at the camp site), patients get glasses with frames by “their choice” (fashion statement they’re willing to pay for), those who need surgery are counseled (buses waiting to transport them to the base hospital), they receive surgery the following day, stay for a day or two to recuperate, then they are transported back to where they came from…..

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.

Conner Calzone, Roy Ndebvudzemene, Tiffany Pang                                                    

2/28/20

 

• Does your work require IRB approvals?

• If Yes, articulate your detailed IRB strategy.

• If No, explain why you don’t need IRB approval and identify situations when you might need IRB approval

 

The Institutional Review Board (IRB) plays a significant role in research if it involves working with human subjects. They are responsible for approving, reviewing and protecting the rights and welfare of human subjects through informed consent procedures. A student or faculty research advisor determines if a project is research when it meets the three following criteria: the research contributes to an identifiable knowledge, the research is designed in advance, and the research encompasses a systematic approach. These projects indicate a need for an IRB approval when the research involves collecting private data from interacting with one or more persons. Our research involves a medically invasive method of drawing blood or requesting blood, but it is of minimal risk so we hope to go through an expedited review process rather than a full board review. In this case, the level of review will be determined by the degree of potential risk or vulnerability of the human subjects.

Therefore, our work requires an IRB approval. Our IRB strategy must overall encompass the human subject’s consent, clear objective, possible risks and entire research process. The IRB written protocol must include a Table of Contents, in the beginning, to categorize the information efficiently for the IRB reviewers. After the Table of Contents, the objective of the project and the background will be discussed in detail. The objective will briefly state the purpose of this study (comparing our lateral flow diagnostic device for the Sickle Cell Disease (SCD) to current clinical diagnosis), state specifically what we need to conduct this study (blood samples from human subjects) and state why we are seeking the IRB’s confirmation. The background can be an overview of past/current experiences that have contributed to this project, such as fieldwork, partnerships with hospital leaders, physicians, and sickle cell advocates in Sierra Leone. The background must also include how our team plans to address the SCD problem by mentioning current clinical practices versus our team’s clinical tests, quantitative data of how SCD has affected populations of LMICs, and the costs of diagnoses. Ultimately, these two portions of the IRB protocol will explain to the reviewers our scope of the research project. The next steps will involve more in-depth evaluation of the many processes that make up the entire project, which will prove the team’s level of knowledge on the research. Therefore, the remaining protocol must include:

• Inclusion/exclusion of “who” fits the criteria to participate 
  • If certain populations are unable to provide consent, they will be excluded
•  The study of a broad range of subjects (sample size of who will be admitted and screened)
• Recruitment methods (current patients from our partnerships)
• Timelines and Deadlines
• End Goal
• Procedure of the Diagnostic Device
• Confidentiality and How Private Information will be Handled
• Professional Supervision of the Research Team
• Withdrawal of Subjects
• Potential Benefits/Risks (Informed Consent)
• Resources Available
• Compensation if a Research-Related Injury Occurs
• Funding/Financial Burden to Subjects
• References

 

1. Develop an outline for your mid-semester presentations. 

• What supporting evidence will you provide for each point? 
• How will you boost your credibility every step of the way?

 

 

• The first bullet point is the evidence for the outlined point. It is what the speaker will talk about and the pictures on the slide will support what the speaker is saying.

• The second bullet point talks about how we will establish our credibility throughout the presentation.

 

 

• Slide 1: Problem/Opportunity from a Macro Perspective

• We will very briefly talk about the background of Sickle Cell Disease
• We will start the presentation by introducing the team and the problem.

• Slide 2: Problem/Opportunity from a Micro Perspective.

• Keep talking about the disease, but now explaining the devastation it causes, using statistical figures as evidence for why this is a problem/opportunity for development. Show that there are not any good options for this currently on the market.
• The statistical figures show credibility if they are from credible sources. We could also use first hand accounts from Sierra Leone if the travel group has any.

• Slide 3: Our approach/solution on a micro-scale

• Introduce the possibility of having a diagnostic device that can tell who has sickle cell, who doesn’t and who is a carrier.
• The presentation is meant to sell the product’s benefits, not the product itself; personalize the situation. Talk about the product’s benefits/researchers we have worked with.

• Slide 4: Device design 

• We’ll go into detail about the dream device and explain how the lateral flow of the device would work and explain how it would distinguish Sickle Cell Disease, Sickle Cell Carriers and Healthy patients. (Using 6th grade language)
• Mention the tests we have done with antibodies on this design and show a picture of the product with the active test lines

• Slide 5: Our Approach/solution on a macro scale

• Talk about how this device will be a game-changer for the people of Sierra Leone and how it would help the people with a low cost, point of care diagnostic device.
• Having a passionate clear vision on a macro and micro scale will show the potential benefits of our project

• Slide 6: Past work/Work done before we joined the team

• Talk about the past progress on the project and how this is a whole team effort. 
• To establish our credibility, we can have pictures of all the people who were on this project before we were.

• Slide 7: Work we have done thus far this semester

• Talk about our findings on the placement of the test lines and our optimization of resources to have the strongest and most accurate test lines. Also, talk about the printing machine which is a model for the scaling of the manufacturing process.
• Showing prototypes and explaining the benefits and the research we have done, we can show how we are continuing to evolve and develop our product and our goals.

• Slide 8: Work for the rest of the semester and summer

• Show our goals for the semester and summer during Mountaintop for making the project better and advancing it further. These goals are found in one of the spreadsheets in our team drive.
• Having an outlined plan that is reasonable, yet challenging to accomplish shows our determination and how we are set towards our vision

• Slide 9: Research/Design challenge and our solutions around them

• Talk about some of the challenges that we know we are going to face and strategize how we will tackle them. Talk about the design flaws.
• The referees understand we are not asking for funding. These projects are prototypes and there are flaws, problems we do not know how to solve and problems we do not even know exist. Being conscientious of our flaws, they could help us brainstorm solutions. Knowing everything is not the only way to establish credibility.

• Slide 10: End with a big happy overall impact/outcome with a happy slide

• Put a picture of our brand name and logo to burn that image into the minds of the referees. This will help them put an image to our team and the work we have done. 
• This picture, as well as the presentation as a whole, will show we are knowledgeable, passionate, and organized; showing credibility to the referees.

1. List ten things that make you feel human.

• Spending quality time with friends and family
• Eating good food
• Listening to music
• Mindfulness exercises
• Having an ultimate vision that I want to see come to fruition
• Working towards that vision
• Laughter
• Having the capacity to feel for myself and others – being emotional
• Playing music
• Having limitations

 

2. Articulate your philosophy of engagement as it pertains to your work with the GSIF / LVSIF. Specifically discuss 

 

1. Why should I engage?

There used to be a time when knowledge was power and ignorance was bliss: we are way past that time. Ignorance is a plague that kills and knowledge comes with a great responsibility for sustaining humanity at large. That is the set of lenses I view this world with. The work that GSIF does is that of impact and that can be used to help civilizations that are lagging behind; to give them a hand up instead of a handout. I engage with this work because I believe in the physically visible results that it produces. This belief stems from personal experiences growing up in Zimbabwe, my own morals and personal core values, my identity as a person and the knowledge that I have acquired in different spheres. It is all these that have driven me to develop a passion for the work that I do and make a well-informed decision to make decisions that I deem to be in support of better livelihood for people.

2. How must I engage? 

How I engage can validate the reason I am engaging. As such, gathering enough information about Sierra Leone enables me as part of a team to strategize and come up with the perfect angle into which the project system is co-created between us and the people of Sierra Leone. This can only and only if I am able to blend myself into the country and see things in the same way they do. This idea of co-creation gives the people of Sierra Leone a sense of drive to participate in for various personal/social reasons but it also gives us the opportunity to get the support we will need in order to make the launch of this a success. 

3. With whom must I engage? 

As mentioned above, the people of Sierra Leone are the primary target for this development agenda and hence it is important to start building trust and security with them. This, we can do through the field trips by immersing ourselves into their culture and treat them with such respect and hospitality they will show us. Secondly, we must engage with current existing NGOs working in the country. They will be very insightful about certain things or policies that we need to be aware of while proceeding with our project. At some point, it might prove to be useful to have such connections as we might need letters of recommendations from such at some point. The third party to engage with that will also validate the reasoning for engagement will be the potential sponsors for the projects. This will provide the funds to actually start the project and start planning accordingly. The fourth party would be team members on the project as this is where everything will be emerging. Effective communication and duty allocation can prove useful. The last group to engage with will be the government in Sierra Leone but this comes at a very later life of a project when we are ready to start implementing a system that we would have developed.

4. What kinds of challenges, opportunities, and approaches should I care about? 

Opportunities that will make this project move forward not only include lab work but funding as well. If there is any funding source that the project is eligible for, it is important to apply for it and get more resources to push the project forward. The challenge that is of essence is that of having to get paperwork approvals from Sierra Leone. Not all paperwork happens within the timed deadline in our plans and we have to factor that into our planning for the project. For example, for the field trip that we are going to do this summer, we need certain approvals in time for us to do tests that will change the pace and course of this research itself. 

5. What might my epitaph read?

“He lived, He loved and most of all, he will live on in his legacy he left behind”