“Find the right questions. You don't invent the answers, you reveal the answers." -Jonas Salk

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Vision and Approach

Mission

Numbers for context

Our focus

Current scenario in India

What Sanjivani does

Under the hood

Why Sanjivani over the alternatives?

Technology deliverables

Interference test results

Next steps

Credits

Reference

Table of Contents

VISION AND APPROACH

At Blackfrog Tech, we believe in harnessing the power of Science & Technology to make the world a

safer place to live in – this is our vision. Our approach is to identify and bridge critical service delivery

gaps in the humanitarian and social impact sectors

through innovation grounded in deep, context-

driven interdisciplinary research. We prioritize

understanding the complexities of humanitarian

problems in order to be able to deal with them

responsibly, over the pursuit of engineering

gratification. That is, innovation for its own sake does

not excite us; we believe innovation must help fix

significant problems in the material world.

MISSION

Our flagship product, ‘Sanjivani’, is a concerted effort towards fighting this humanitarian crisis. With

it, our mission is:

To ensure every child in India and her subcontinent receives appropriate and efficacious

immunization against disease;

To manufacture high-quality products for our clients and healthcare partners, while creating

employment opportunities in the local business ecosystem.

Immunization Saves 2-3 million children every year

Use of frozen water packs is standard practice

NUMBERS FOR CONTEXT Vaccines keep children alive and healthy by protecting them against disease. A 2016 report from UNICEF [1] claims that approximately one-fourth of deaths among children under 5 were from pneumonia, diarrhea and measles, and could have been mostly prevented by vaccines. The Immunization Technical Support Unit (ITSU) of Health Ministry (Govt. of India) claims around 25% of all vaccines go to waste due to poor cold-chain management. Ice-based products and technologies exposing vaccines to sub-zero temperatures is potentially endemic. A recent study found that ~65% of vaccine vials showed evidence of freezing in vaccine stores and peripheral health facilities across 10 states in India [2].Low immunization coverage compromises gains in all other areas of health for mothers and children. The poorest, most vulnerable children who need immunization the most continue to be the least likely to get it.

OUR FOCUS We have identified a critical gap in the last mile cold chain vaccine delivery system. In a nutshell, the

efficacy of vaccines deployed from Healthcare Centres to be administered to patients in distant and

remote geographical areas is often compromised due to lack of temperature control in extant ice-

based systems. Since most vaccines are temperature-sensitive, and require to be maintained at

specific temperature ranges (for example, 2-8 degrees Celsius as per the Indian & European

Pharmacopeia guidelines; WHO guideline for effective vaccine storage), ice-based technologies lead

to significant amounts of wastage.

CURRENT SCENARIO IN INDIA A group of researchers from Center for Tropical Medicine

and Global Health, Oxford, UK and Mahidol-Oxford

Tropical Medicine Research Unit, Bangkok, Thailand

conducted a study on ‘Cost, health impacts and cost-

effectiveness of ice-less refrigeration in India’s vaccine

cold chain’[3]to understand the economic benefits of using

a battery-operated device as a replacement to

conventional ice-boxes. The following are the results from

the study:

The costs of wastage in the context of rural India of the ice-based cold chain system is

7,512,930 USD, as detailed in Table 1.

Table 1. Vaccine cost/dose, wastage rates, coverage and costs of wastage using ice-based delivery

*Includes $0.25 program costs per dose [4]

The incremental cost per vaccine dose delivered with an iceless, battery-powered carrier is USD

0.026. On average, a health center serves a 4,554 target population for routine vaccination for

about 18,358 doses of vaccines. The total cost of an iceless, battery-powered carrier per 5 years of

use is USD 2,375, equal to USD 475 per year (Table 2). When compared with an annual wastage of

USD 1,726 per health center, the cost-benefit ratio for an iceless, battery-powered cold chain that

avoids this wastage would be 0.28, indicating that this is cost-beneficial.

Target

population

Individuals/

center

Doses/

vaccine

Subtotal of

Doses

Cost of iceless carrier (USD)

At birth

705

3

2,116

Unit cost (5 year est. shelf

life)

2,000

In 1 year

677

4

2,708

5 year maintenance cost

375

In 5 years

2,397

5

11,983

Cost per year

475

Pregnant women

776

2

1,551

Cost per dose:

0.026

Total

4,554

18,358

Table 2. Incremental costs of vaccine delivery using iceless, battery-powered device

Vaccine Cost /dose

(USD)

Wastage

rate

Current

Coverage

Cost of avoidable vaccine

wastage (USD)

Total cost of

wastage (USD)*

BCG

0.05

25%

95%

22,1417

1,328,499

DPT

0.04

25%

100%

1,900.868

13,781,292

TT

0.02

25%

85%

237,731

11,760,383

Hepatitis B

0.05

25%

100%

233,070

1,398,420

OPV

0.06

25%

90%

1,831,964

9,465,150

Measles

0.16

25%

95%

3,087,880

7,912,693

Total

7,512,930

45,646,891

Using the current ice-based cold chain, the vaccines were cost-effective with a cost per DALY

(Disability-Adjusted Life Year) of USD 216 averted, slightly higher than prior estimates due to

the lower incidence in the current model. Switching to the iceless, battery-powered device

would avert a further 0.03 DALYs per child with cost savings of USD 0.80 per child

vaccinated. The sensitivity analysis suggested that even at a much higher incremental delivery

cost of, for instance, USD 2 per vaccinated child and with higher wastage rates in the iceless

device of up to 20% (as compared with 25% in the ice-based system) the iceless, battery-

powered cold chain would still be cost-effective.

The study conclusively shows that vaccine wastage in ice-based cold chains incurs high human

and economic costs, whereas the per-dose incremental delivery cost for an iceless, battery-

powered device to reduce or eliminate such wastage is negligible. Compared with a scenario

in which compromised vaccines are identified and replaced, the use of an iceless, battery-

powered device would result in large cost savings. Also, compared with a scenario where

compromised vaccines are administered to children, the iceless, battery-powered device

would help cut costs and provide additional health gains.

WHAT SANJIVANI DOES

Above all else, Sanjivani is a portable, battery-powered controlled refrigeration device that strictly maintains any preset temperature (error of 0.1 0C ) for up to 12 hours.

Ergonomic and weighs 3.8 kilograms Compatible for Online monitoring of live-data

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Blackfrog Tech’s portable carrier syncs with LoggFiTM dashboard online for monitoring

vital data. Beyond portability and controlled refrigeration, Sanjivani offers continuous

temperature monitoring, location tracking, battery-level indication, and real-time

communication capabilities with the healthcare facility. With these features, Sanjivani

generates valuable usage

data from the field, which

can be taken as feedback

for further calibration and

enhancements as per

necessity.

Sanjivani is adaptable for other

biological materials and for use

EXTREME COLD WEATHER

(as a controlled heater)

The device operating ambient

temperature is between -20 0 C to

43 0C

Over-ordering of vaccines is one of the leading

problem in the distribution chain, and causes the

majority of wastage. Thus vaccine wastage is an

important factor in forecasting vaccine

requirements and while placing vaccine orders.

Sanjivani provides a platform for collecting crucial

inventory-data of Vaccines.

(https://dashboard.loggfi.com/login)

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UNDER THE HOOD Sanjivani compactness and low weight owes to its solid-state cooling system. While multiple

innovation teams have, in the past, attempted to integrate solid-state cooling into a portable

solution for the transport of biological substances, they have been unsuccessful due to low

power efficiency, and insulation issues. We, at Blackfrog Tech, have overcome this challenge

with a novel design that constrains the cooling chamber to precisely the temperature-range

requirement of day-to-day delivery of vaccines.

Solid-State Refrigeration principle PID controller

A single-stage 24 W Peltier assembly with an appropriate performance curve (for micro-refrigeration) has been employed by our system. Powering the Peltier is a 200Wh Li-ion battery pack along with battery protection and safety circuits. The device is optimized to ensure that a batch of vaccines can be cooled for 8-12 hours. Quick refrigeration and efficient battery usage has been prioritized while selecting manufacturers and designing electronics to drive the Peltier. To sense the temperature of the chamber, DS18B20 is used and housed inside a weatherproof sensing probe. The accuracy of this sensor is 0.5°C in the sensing range. System Block diagram

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At the brains of the system is an Atmega2560, a microcontroller capable of controlling the whole system. The Chamber temperature is maintained digitally using a Proportional Integral Derivative (PID) algorithm on-chip which uses continuously modulated control on the Peltier to attain and maintain the set point seamlessly. The secondary function of the electronics subsystem is to provide a user interface and data logging capability. A custom Liquid Crystal Display (LCD) displays the temperature and other vitals. Using the tactile buttons on the panel the device lets the user change the setting temperature of the cooling chamber. A Global Positioning System (GPS) module embedded on-board helps with tracking the device. The temperature information and the GPS coordinates are sent to a remote server for cloud monitoring using a Global System for Mobile communication (GSM) based module connected to the internet. A small backup secondary battery is on board for continuous transmissions even after draining the primary battery.

The system works on a 12V source, and therefore, in the event of a power outage, it can be

plugged directly into an automobile (motorcycle/car/auto rickshaw) engine with the help of

an adapter that comes as part of the package. There is also potential for the device to be

charged via an external solar panel.

WHY SANJIVANI OVER THE ALTERNATIVES?

The need of the hour is an affordable, easy-to-charge, battery-operated, controlled

refrigeration device that will ensure the efficacy of vaccines through a daylong

immunization deployment, a.k.a Sanjivani.

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The systems employed by Blackfrog Tech are tested, reliable technologies, with the added

advantage that most components are commercially available, which means manufacturing

becomes cheaper and easier.

Further, we conducted primary research in order to better understand user experience with

our device, in order to optimize its design. This involved:

1. Protocol analysis (a research method where respondents describe their thought processes

and experiences in real time, as they are performing a particular task): We shadowed primary

healthcare workers as they went about their vaccine administration job, and encouraged

them to talk us through the entire process as descriptively as possible.

2. Semi-structured interviews: Building on certain insights garnered from protocol analysis

and observation, we explored important user-experiential themes in open-ended

conversations with the healthcare workers. For example, we discussed in depth how they felt

about having to improvise and troubleshoot in the face of the variability that ice-based

cooling systems present.

3. We also asked the healthcare workers to physically examine and test our prototype in order

to get real time usage feedback, which has significantly contributed to our design process.

Ice-boxes are a century-old method of refrigeration

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Pictures from a local Vaccine-Outreach Centre where we conducted simulated trials (Kapu, Udupi district- Feb 2019)

Overall, from our research, we have gathered that Sanjivani does plug important gaps in the

cold chain immunization system. The device was

perceived by healthcare workers to be ergonomic

and efficient in its operating principle, but it also

took away the burden of improvisation and

troubleshooting from them. This latter point is

significant because improvisation often leads to the

vaccines being compromised, and blame is most

often placed on the healthcare workers, because

they represent the penultimate human link in the

immunization cold chain system. Therefore, we believe that Sanjivani is suited to cater to the

Indian last mile cold chain immunization system better than any other device in the global

marketplace.

$ 7,512,930

is the annual cost of wastage in

the context of rural India of ice-

based cold chain system.

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TECHNOLOGY DELIVERABLES Following are results from a simulated field-trial for Sanjivani against current practice of using

Ice-boxes in a Vaccine outreach programme (Routine immunization campaign) held at Kapu

RMCW (Rural Maternity & Child-Welfare) home in February 2019.

Ambient Temperature: Ranging from 27° C to 34° C

Temperature Sensor used (for both systems): Berlinger Q-tag Wireless (WHO PQS Certified)

Clearly, Sanjivani performs significantly better than the ice-based option in terms of temperature control. Our device is able to maintain a stable 4 degrees Celsius platform, with a 0.1 degrees Celsius error margin. On the other hand, the temperature within the icebox is radically variable (often freezing the samples), and this is potentially the single most serious threat to the efficacy of temperature-sensitive vaccines. Sanjivani’s stable temperature platform ensures absolute accountability for the efficacy of vaccines, and minimizes human error, thanks to the novel design that does away with repeated freeze/thaw cycles.

INTERFERENCE TEST RESULTS When vaccines are taken to the field for administering, the device is opened multiple times

to retrieve the vials. This is usually when the temperatures shoot above the recommended 8

degrees Celsius higher limit and thus degrade the efficacy. It is absolutely imperative for any

refrigeration mechanism to bring the temperature down to the safe-limits in the least

possible amount of time.

We simulated these human-interference by opening both the systems (ice-box and Sanjivani

containing same volume and density of load) for a period of 3 minutes (as per WHO PQS

guidelines for testing refrigeration). The temperatures went above the set-temperature and

they were placed back inside the respective devices for stabilization. Temperature versus

Time curves were plotted for both the systems and compared.

SANJIVANI Temperature Chart UNICEF (Blue Plastic Ice-box) Temp

Chart

Ta = 34.03 °C is the Average Ambient Temperature during Test

T0 = 4.6 °C is the Set-temperature / optimal temperature for cold-chain

Parameters Ice Box Sanjivani

Peak Temperature (T1)

9.3°C

10.4°C

Temperature change brought about by Refrigeration (dT)

4.7

5.8

Time taken to reach 4.6°C (T0) in minutes (dX)

35

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Rate of cooling R = dT/dX

0.13429 °C/min

0.26364 °C/min

Table 3. Interference test results

Improvement in rate of cooling = (Rsanjivani – Ricebox )/ Ricebox

= (0. 26364 - 0. 13429)/0. 13429 = 96.33%

Sanjivani is able to refrigerate (stabilize temperature to recommended levels) at a rate of

96.33% faster than the ice-box

NEXT STEPS We aim to conduct user-experience research in an iterative manner, until we have designed

the most viable product for the purpose. That is, we intend to incorporate our respondents’

feedback into our design, and take it back to them for more feedback, until we have checked

all the important boxes. We are almost there. An important step that remains to be taken to

test the device under extreme weather conditions. This is part of our ambition to take

Sanjivani global.

CREDITS

Agung Pandit Wiguna from Pexels

Harryarts - www.freepik.com

Hush Naidoo on Unsplash

Pasja1000 from Pixabay

REFERENCES

NOTES

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