Phloton

Phloton targets the inadequate vaccine cold chain in the developing world, making it difficult for people, especially expecting mothers and infants, to protect themselves from preventable life-threatening diseases. According to WHO, globally, 50% of all vaccines manufactured get spoilt, and 1.5 million infants die before their first birthday due to the lack of immunization. Covid-19 further highlighted these existing inefficiencies, resulting in inequitable vaccine delivery. 

Phloton vaccine carrier targets the broken last-mile vaccine delivery (Primary Health Centre onwards) to provide an ergonomically designed holistic system. Phloton, with its 14-hour power backup, integrated solar panel, and 2 to 8 degrees Celsius temperature range, is powered by AI to maximize accountability, minimize vaccine wastage, and encourage best practices in inoculation-related biowaste disposal.

Globally, the Phloton system can help 19.7 million immunization-deprived infants get vaccinated. Phloton will also support the process of reaching inoculation-driven global herd immunity for Covid-19.

Vaccine spoilage due to a broken cold chain is a significant challenge in India, where over 75% of vaccines show evidence of spoilage before being administered. (https://www.who.int/bulletin/volumes/91/12/13-119974.pdf).

Administration of a spoilt vaccine leads to two problems

• The individual develops no antibodies, susceptible to infection from life-threatening diseases
• The individual suffers from an adverse reaction from the administration of the spoilt vaccine, leading to local abscesses

Though spoilage can occur at any stage in the cold chain, it is especially prevalent at the last mile, where dumb boxes (without data loggers, data sharing, and active cooling) cause temperature fluctuations.  

The solutions using insulated containers with ice packs are bulky and hard to carry over long distances. These containers also provide limited temperature data. Phloton vaccine carrier assists frontline health workers and offers intelligible data to data analysts at vaccination programs. Phloton also promotes best practices for waste disposal in inoculation activities through integrated frontline health worker and administrator apps.

End beneficiaries are individuals in rural regions of the developing world. Supporting inoculation programs run by governments and others, Phloton aims to include 27 million under-vaccinated infants in the developing world and support Covid-19 vaccination for millions in rural India. 

Phloton team has a novel design that incorporates modern insulation materials and constrains the cooling chamber to precisely the required temperature of vaccines. A PID (Proportional Integral Derivative) controller accurately maintains the temperature of the contents, thereby preventing repeated freeze/thaw. In addition, the design includes active cooling achieved through the Thermo cooling effect in semiconductors.

Connected to the user phone through Bluetooth, the device keeps sharing live data to the cloud. Data analytics create intelligent data, and AI converts this data into preventable actions to enhance the product's efficacy.

There are three software interfaces developed in the product

-       Vaccine carrier

-       Frontline health worker app

-       Admin app (Medical Supervisor app

The primary health worker in the developing world currently does not have the necessary technology-enabled tools to effectively engage rural and hard-to-reach communities with life-saving interventions such as vaccines. By empowering the primary healthcare system with Phloton, we aim to reduce 1.5 million infant deaths, create a more inclusive Covid-19 vaccine drive and reduce the vaccine spoilage cost, which the taxpayer or philanthropic funds primarily bear.

Through the Tata Trusts network, we understood the pressing needs of the rural primary healthcare system through secondary research with frontline health workers (ASHA and ANM) in rural Jharkhand and Odisha. Direct healthcare workers gave valuable design /feature inputs; accordingly, we have augmented the last mile vaccine carrier system. For instance, rural primary health workers in India are primarily females who prefer a shoulder sling carrier rather than a traditional backpack design. Similarly, weight is a crucial decision point as it is difficult to carry heavy systems on foot over long distances. Therefore, we have incorporated the aforementioned suggested features. Additionally, during our planned field trials in collaboration with Accredited Social Health Activist(ASHA)/Auxiliary Nurse Midwife(ANM)/Angan Wadi Workers(AWW) workers, feedback on the product will be used to create the next build.   

The Phloton vaccine carrier system supports equitable access to preventive healthcare via augmented delivery of vaccines. Thereby controlling disease spread and eradicating vaccine-preventable communicable diseases. 

Our secondary feedback research was held with frontline health workers in Jharkhand and Odisha to assess product acceptability. As a result, a field-level pilot study of Phloton will begin in the last week of June. We have identified field partners and study objectives. 

This randomized, open-label, controlled, multicentre field study aims to evaluate the efficiency of Phloton. A novel vaccine vial carrier meant to transport vaccines from site to site under a steady temperature of 2-8°C by Accredited Social Health Activist (ASHA) workers. Third-party supervisors evaluate the Phloton vaccine carrier system with three comparative carriers (AVC 44, Styrofoam Boxes, and "Sanjeevni"). The study will include 15 - 20 literate frontline health workers who travel from primary health center to session site with typical travel times between 1 to 4 hours.

Following the Pilot, we will develop a commercial prototype by mid-August 2021.

Over the last four decades, immunization programs have been transporting vaccines in insulated containers, which contain frozen water packs to maintain suitably cold temperatures. However, these conventional methods have resulted in large annual wastages (vaccine, causing substantial financial losses and economic burden to the patient. On average, in India alone, the wastage rate in ice-based vaccine carriers is conservatively 25% for all types of vaccines. The cost of Disability Adjusted Life Years (DALY) is up to 45 Million USD (2018).

The innovation is in the integration of design (inclusive of UI & UX), technology (Peltier-based cooling), and software (SaaS, AI, IoT). The integration of the three provides for absolute accountability through assured temperature maintenance, and thus, has the credibility to replace standard-issue iceboxes and other cruder devices like thermos flasks.

Key features of the innovation

• Ability to regulate the internal temperature at any ambient conditions ranging between -15°C to +43°C
• Day Long Battery Life of 8-12 hours, integrable with solar panel
• Ergonomic design and weighs 2.6 kilograms
• It has an accessible Plug-In mode to act as a standalone refrigerator
• Continuous temperature, battery, and location monitoring
• Predictable software response for identifying system failure
• Bio-waste collection integrated into the software

Because of this, Pholoton will be able

• To improve the immunization coverage, by reaching the remotest geographies
• To safeguard vaccines' potency: Prevent freezing or heating of the vials To provide extra cold chain points, improving supply chain efficiency

Currently Serving: None

In one year: 5 intervention sites in different parts of India and one each in Afghanistan and Rwanda. In India, our presence will be in 15 Primary Health Centres, 45 front-line health workers, administering 3000 vaccine doses to 500 children week on week under the universal immunization program. Total children and expecting mothers inoculated in the first year – 26,000 in India. Vaccine carriers in field: 100 units.

In 5 years: Reach 8.2 million session sites in India, 50% of which are in rural India, two vaccine carriers per rural session site will serve 1.3 million front-line health workers, helping them inoculate, through 180 million doses, 30 million infants year on year. In Africa, we plan to support 100,000 front-line health workers to reach 5 million children. Numbers are a ball-park figure as resource mapping for Africa remains a challenge.

Indicators:

• Number of vaccine carriers in operation
• Number of front-line health workers utilizing the device
• Strengthening of the cold chain for the last mile, percentage of geographic area covered via vaccine
• Reduction in DALY calculated over five years, from regions having poor availability to readily available vaccines
• Behavior change, if any, in rural population due to augmented cold chain delivering vaccines to remote areas safely
• In process support SDG 3
  • 3.2 - By 2030, end preventable deaths of newborns and children under five years of age, with all countries aiming to reduce neonatal mortality to at least as low as 12 per 1000 live births and under-5 mortality to at least as low as 25 per 1000 live births
  • 3.3 - By 2030, end the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, water-borne diseases, and other infectious diseases
  • 3.b Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines under the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all

The consortium of Social Alpha, Design Alpha, National Physical Laboratory, KnowYourMeds & Enhanced Innovations has 20 active participants consisting of core 6 members highlighted in the image. Others include scientists, research assistants, lab operators, design associates, accountants, and mentors.

The core team of Phloton has decades worth of experience in R&D, design, innovation, social development, and product commercialization. The project lead of Phloton, I, Prerit initiated the project after understanding the vacuum in the cold chain leading to the wastage of vaccines. Dr. Mahesh at NPL had already worked on thermo-cooling devices and suggested a solution. Kishore has systems communication experience which helped identify Bluetooth as a power-efficient communication relay mechanism. Also, Dr. Rajiv’s extensive experience in renewable and battery systems helped us identify the right li-ion battery system. Meanwhile, Shwetika helped design AI software and technology platforms. Dr. Suresh is helping us design and manufacture a world-class commercial prototype. Ankita is the CEO of Enhanced Innovation and is leading communication and commercialization engagements for the Phloton project.

I have engaged with all core team members in a professional capacity before. One of the things that really stand out for me with the team is the complementary skill set of individuals. 

Additionally, the project has been blessed by well-wishers and mentors who help broaden our network.

Being inclusive and driving social equity are a part of the essence of Phloton. We endeavor to create products that individuals can use across all societal strata, including different gender identities and physical capacities, including the elderly and the differently-abled.

We are a team of diverse people, and we firmly believe that we will continue to learn and grow from imbibing various viewpoints and perspectives. Expanding the team and bringing on-board new talent will be done without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, or age. We strive to build an organization that can provide a fair, participatory, enjoyable, and safe working environment without bias.

Our leadership team currently has balanced male and female representation with varying ages, experiences, and expertise. We will continue to ensure that this is maintained and improved upon over time.

Apart from access to funds and global networking opportunities for our Indian-based program, I am excited to learn from my peers at Solve. One of the goals that we seek to achieve at Phloton is to have a global presence of our solution. election in Solve program will give us the brand and impetus to reach newer geographies. 

Additionally, the Phloton vaccine carrier system is one of the many health care technologies that the partners and I envision deploying for equitable access to healthcare. As part of the Solve community, our ears will remain plugged to the ground to collaborate and create effective community-driven solutions. 

To sell internationally, all countries have their own laws and best practices. ISO 13485 and WHO-PQS are two important certifications that will open the global market for us. To achieve and maintain the same, it is essential to understand international regulations. Also, as we are creating a medical-grade device, it is essential to remain cognizant of laws associated with the delivery of the project.

One of the aims of the project is to build local capacities by enabling social entrepreneurs across geographies. The blended distribution model requires both human capital and product distribution support at the local level, especially in markets outside of India. 

MIT Hacking Medicine, Harvard Health Innovation Network, Bill and Melinda Gates Foundation, The Global Alliance for Vaccines and Immunizations are some of the organizations that we seek to collaborate for our solution. 

Nevan Clancy Hanumara, a research scientist at MIT, is passionate about solving pressing social problems through technology. He has initiated multiple projects in healthcare technology and teaches MIT Medical Device Design course. In short his mentoring will provide unparalleled insight into our solution.  

Disability, lack of knowledge, or remote position are some of the key reasons a person cannot reach a vaccination center. In such cases, inoculation has to be performed at the patients' residence or place of convenience. Covid-19 has highlighted the need for product solutions such as those provided by Phloton to help public healthcare systems conduct an equitable vaccination drive. 

We also license our technology in different geographies to help create social entrepreneurs. Empowering individuals to create community-first business acumen. 

One of the most affected communities by the onset of the pandemic has been the refugees in different parts of the world. Best practices such as washing hands with soap, social distancing, wearing masks, etc., are mostly unviable for refugees to follow. Vaccination is one the most cost-effective method to help ensure economically and politically vulnerable individuals can continue to make progress for a better life. 

Phloton vaccine carriers have been designed to work in rugged regions with power backup of up to 14 hours in 34 deg Celsius ambient temperature. We help support initiatives by WHO, GAVI, UNICEF, other international foundations, and institutions to deliver vaccines in remote conditions. the phloton vaccine carrier covers the temperature requirements of all necessary infant and maternal vaccines. Plus, AI helps create an efficient system to improve cold chain decision-making.

Maternal Tdap vaccination helps protect infants. Newborn babies are at the greatest risk for developing pertussis and its life-threatening complications. Flu vaccination during pregnancy is safe and helps protect babies from flu for several months after birth. This is important because babies younger than 6 months of age are too young to get a flu vaccine. HPV vaccines against cervical cancer are administered to adolescent girls. All these vaccines are temperature sensitive between 2 to 8 deg celsius. 

In developing countries, preventive healthcare (vaccines) is essential for women and girls due to poor healthcare facilities and medical negligence by family and practitioners. Phloton vaccine carrier system helps deliver vaccines in remotest locations. With the integration of battery and solar power backup, the sleek and portable vaccine carrier is designed for women frontline health workers to carry it with ease over long distances. 

Phloton vaccine carrier system for last-mile delivery of vaccine uses artificial intelligence to predict the breakdown of vaccine carrier system by detecting temperature fluctuations, battery life, and overheating of the system. The software then instructs users to take adequate steps. 

Our initiative to use artificial intelligence for the last-mile delivery of vaccines is to reduce the spoilage of vaccines because of temperature fluctuation. The temperature fluctuation results in spoilage of vaccine, which results in either of the two situations:

• Vaccine spoilage is detected, and the vial is discarded, resulting in the wastage of precious resources. 
• The spoilt vaccine is administered leading to medical complications such as the death of infants

We take the support of AI to analyze the data in real-time and suggest changes to the user of the device.

The developing world faces supply chain challenges for vaccine delivery, especially in cold chain solutions. It is difficult for people, especially expecting mothers and infants, in rural settings to be protected against preventable life-threatening diseases. WHO estimates that globally 50% of all vaccines manufactured get spoilt, and 5.2 million children die annually, largely due to the lack of immunization. Covid-19 further highlighted these existing inefficiencies, resulting in inequitable vaccine delivery.

 The project targets the inefficient last-mile vaccine delivery (Primary Health Centre onwards), to develop a standalone and holistic system. The ongoing R&D is to develop a system with 14-hour power backup, solar charging support. The vaccine carrier will provide 2 to 8 degrees Celsius temperature range, powered by AI to maximize battery life.

The system we are aiming to develop will comprise of:

• Docking stations for charging multiple units of vaccine carrier, which can be:
  • plugged to grid electricity
  • solar powered supply
  • or a generator
• Vaccine carrier designed to carry 4 vials in one unit. It will include features for:
  • Bluetooth connectivity support
  • Location tracking
  • External power bank support for range extension
• MIS system for digitising the workflow, such as
  • Pick-up and return
  • Waste disposal tracking after vaccination
  • Repair and maintenance

-Globally, the technology has the potential to help 19.7 million immunization-deprived (WHO Fact Sheets) infants and support steps towards inoculation-driven herd immunity for Covid-19.

The project team has combined experience in social innovation development ecosystem of several decades and is uniquely placed to help identify critical problem areas and create optimum solutions for last mile delivery of vaccines and drugs.

The project team will utilise the support and resources from the Global Fund to cover cost of: 

• Research and development of prototype
• Design for manufacturing
• Procuring materials and consumables to create first 100 units for field work
• Fieldwork including survey and data collection and statistical analysis
• Consultancy fees for achieving international standardization: ISO13485, WHO PQS
• Expenses for conducting field trials with front-line health workers – participatory fees, travel, and enumerator expenses
• Development and administration of questionnaires, recruitment material, newsletters, etc for clinical, epidemiological, and qualitative research studies
• Public engagement materials of field research study and product performance under field conditions
• Project team members including recruitment costs and salary costs (for full-time or part-time staff, excluding founders)
• Applying for international tenders and supplying the product globally
• Applying for any eventual patents that may emerge during product development or enhancement

The project will cover the following specific diseases and vaccines:

• Tuberculosis: BCG Vaccine - XM8142
• Diphtheria Vaccine: XM8YP9, XM46V1, XM46V1, XM39K8
• pertussis (whooping cough) Vaccine: XM43M9, XM2CV8
• Tetanus Vaccine: XM5L44
• Poliomyelitis Vaccine: XM0N50
• Measles Vaccine: XM28X5, XM8TF3
• hepatitis B Vaccine: XM9V38
• Diarrhoea Vaccine: XM1CE0
• Covid-19 Vaccine:  XM68M6
• Rubella Vaccine: XM7PP1, XM8TF3
• pneumonia (haemophilus influenzae type B) vaccine: XM11V3
• Pneumococcal diseases (pneumococcal pneumonia and meningitis): XM9EM7
• PE88 Assault by exposure to or harmful effects of other or unspecified drug, medicament, or biological substance
• QC02 Need for immunization against certain specified single infectious diseases