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

Detailed Income Statement: https://docs.google.com/spreadsheets/d/1UtqK6RgJZu4CY-PxDmE8mOEYOrnFLLXNnSJtWPgsFM8/edit#gid=798007029

 

Project Action Plan: 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.

 

Visual Business Model: Business canvas visual.pptx

 

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

 

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.

 

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…..