BiliSURE

Jaundice affects nearly 70% of term and 80% of preterm neonates during the first week of their life and in severe cases, if not monitored and treated timely, leads to Kernicterus, a neurological disorder characterized by excessive levels of bilirubin in the blood (hyperbilirubinemia) during infancy. Bilirubin is an orange-yellow bile pigment that is a byproduct of the natural breakdown of hemoglobin in red blood cells (hemolysis). Hemoglobin is rapidly broken down into bilirubin after birth, the rapid breakdown can lead to toxic levels of bilirubin and can accumulate in the brain. This potentially results in a variety of symptoms and physical findings.  The metabolic capacity of the liver in a neonate is immature and is less able to process large amounts of bilirubin. Kernicterus impacts the quality of life, and in several cases may also lead to mortality in infants. The evidence-based studies conducted by Newman TB, Maisels MJ indicate that there is a possibility of re-emergence of hyperbilirubinemia as a disease in infants even in developed countries like the US.

At present, the level of bilirubin in neonates is measured using invasive methods by drawing blood (1-2ml). This process is time taking (ranges between 4-24 hours) and causes discomfort in neonates, which makes it difficult to regularly monitor bilirubin levels. It also requires a trained professional to draw blood and a trained technician to operate the analyzers. However, the availability of trained professionals in low-resource settings and small hospitals is not certain. The following figures display the invasive procedure of sample collection in newborns.

Bilirubin can be measured non-invasively by expensive devices like Drager JM 105 and Bilicheck (Philips). The cost of such an instrument ranges from 70000 to 250000 INR. The non-invasive devices have been designed by European and American manufacturers targeting the European and American populations which have less melanin compared to the Indian and African populations. Hence the devices are inaccurate for the measurement in the Indian Scenario.

After the identification of the hyperbilirubinemia, the neonate undergoes the planned phototherapy sessions. These sessions are monitored after periodically drawing the sample from the baby and sending it back to the lab for testing. The data is reported in at least four hours where there is no in-house lab. According to the derived values of serum bilirubin, the intensity and duration of the phototherapy are planned.

There are several cases of readmittance because of neonatal jaundice around the globe. In a study conducted by Paul C Young, Kent Korgenski et al. 2,96,114 neonates were discharged after four days of delivery. Out of those 2,96,114 neonates, 35% had jaundice and 33% had respiratory distress which may or may not be linked with jaundice.

Our solution to this problem is an easy-to-use compact product BiliSURE which is capable of monitoring the bilirubin level in neonates non-invasively and instantly, saving the turnaround time that invasive methods take to churn out the diagnosis. This device is designed to take into account the level of melanin at the subcutaneous level and negate the same to account for accurate measurement of bilirubin, making it suitable for a population with high melanin levels in countries like India. We are compensating the melanin using the multi-detector method. These detectors identify all the interfering agents and negate the values of interfering agents. This device also provides the solution of an application where the regular measurement of bilirubin levels can be recorded and visualized, thus making it comparatively more efficient. BiliSURE enables the doctor to plan for the therapy in a more precise and targeted manner. Digitization of reports can also aid in efficient record-keeping for both the family and medical facilities. 

One of the merits of BiliSURE is that it can be used for multiple patients at the same time, without restricting its use to individual patients. This gives our product an edge as the data (findings) will still be getting recorded under specific unique IDs that are assigned to patients, with minimum chances of data loss and mix-ups.

Value Proposition:

For the Patient (neonate):

1. The diagnosis is painless accurate and time-bound
2. The chances and risk of the ineffectiveness of phototherapy are low
3. The neonate is completely treated
4. The tests can be done post-discharge
5. The chances of readmittance in the hospital are low
6. Adequate exposure to the blue light, avoiding over and under dosage

For the mother:

1. Less trauma in seeing the sample collection of the neonates
2. At mild jaundice, the baby can be with the mother
3. The presence of a baby in the vicinity can keep the oxytocin level balanced
4. Low chance of readmittance just after delivering the baby

For the family/finance:

1. Saves the cost of wet-lab testing i.e., 300 INR per sample
2. Saves the cost of readmittance
3. Saves the cost of excess dosage of bilirubin

For the Healthcare Professional:

1. Precise and accurate report generation
2. Opportunity to collect bilirubin data at a high frequency
3. Better control over phototherapy procedure
4. Suggestive measures to guide through the therapy by Kramer’s Scale
5. Better planning and management of the dosage
6. Remote support can also be provided to the PHC/ Low resource settings through the application

For the Hospitals/ Maternity Centers:

1. Precise treatment plan
2. Opportunity to set up more phototherapy units as the cost of the diagnostic devices goes down
3. Opportunity to provide phototherapy services at a small scale too
4. Customer confidence translating into recurring business

The team has experience in medical devices innovation and manufacturing; the founding team comes with a collective experience of 27 years in the field.  I have 7+ years of experience in the innovation and implementation of medical devices in the government and state-sponsored ecosystem. I have also led the production, certification of the product ISO 13485 and IEC 61010, etc. 

 The co-founder of the company 3 years has experience in the Public Health domain. She has worked in maternal and child health in the remote areas of Uttar Pradesh India and Bihar. She was among the first few people in the state to establish the COVID 19 war room for contact tracing in 2020.

Vishal at present working as a consultant has 15 years of experience in embedded electronics and 5 years of experience in medical devices. He has deployed solutions at scale in high volumetric sales areas.

Hence I believe that our team posses sufficient talent and learning to make this project a success story.

In the past,  I have worked with a few research groups from international universities. The learning that I have had from such projects is that there are so many international teams who have worked a lot in multiple countries at a time in Public Health and Health Equity domain.

Hence my aim with solve is to have access to some kind of network so that we can scale up the product in the international market easily thereby solving the problem of Neonatal Jaundice in various other LMICs.

We have developed a novel method of measuring TcB (Transcutaneous Bilirubin), where we use a combination of optical modules. The optical modules split the broad source of light into the wavelength at which bilirubin has a distinct absorption peak. The source also emits light at different wavelengths, which enables us to isolate contributions from other analytes present in the dermal layers. A multispectral algorithm is implemented for a high level of accuracy for the quantification of Bilirubin. to differentiate between bilirubin and

In order to bring down the cost and reduce the complexities of a spectrometer, we perform the detection process through an integrated detector array with multispectral filters which is one of our Unique propositions and Intellectual property.

The device also has a supported application where it reads and records the previous values of bilirubin against Unique Patient IDs. The device learns the ethnic, geographical data, etc.

In the next 9 months, MedBlue Innovations will partner with government agencies such as NRHM, NHM who could procure our product in larger volumes,  including raising awareness and training healthcare workers. This will make an easier way for us to enter the biggest market and also create an on-ground impact saving millions of babies from tier 2 and 3 centers of India.

Partnerships with Pharma companies - co-sales with pharma companies and NGOs -  will result in screening more babies in less time. 

B2B: Tie-ups with private hospitals to sell the product directly 

Wearable: Our long-term goal is to make a wearable that can be prescribed for post-delivery discharge. This allows the healthcare practitioner to control the situation and treat it at the right time. 

Milestones:

1. First Prototype August 2021
2. Second prototype with calculation algorithms and live testing completed in February 2022
3. Third prototype - 10 Units are being produced (TBC - May 2022)
4. NIDHI PRAYAS grant of INR 4 Lakh in January 2022
5. IIT Kanpur & CITI Foundation’s CSR fund of INR 10 Lakh in March, 2022
6. BIG BIRAC Grant of INR 48 Lakh awarded in March, 2022
7. National Bio Entrepreneurship Award of INR 7 Lakh , awarded in December 2021 [C-CAMP]
8. Ongoing Clinical trials in collaboration with SGPGI , Lucknow and Kamineni Hospitals, Hyderabad (to commence from April, 2022).  

So far we have raised INR 62 Lakh through various grants ( to be disbursed in tranches). At the moment we want to raise an additional INR 35 Lakh to fund our Fastrack product development & trials, build our team, forge collaborations and reduce our time to the final product version. 

This investment will take the final approvals and certifications from the government bodies. Post which, we will raise follow-on funding, preferably pre-seed or seed funding to scale the production and market entry across India. 

To reduce the incidence of Kernicterus in neonates

To reduce the cases of re-admission in cases of neonatal Jaundice

To equip the doctors and medical staff with real-time data for precise and timely treatment of elevated bilirubin levels in neonates To reduce the dependency of trained staff in the measurement of bilirubin values

At present the Indian child mortality is around 16/1000 Live Births. We want to bring it to 12/1000 live birth which is in alignment with the SDG's goal.

Activities/inputs: provision and use of noninvasive bilirubin meter at healthcare facilities for the detection of jaundice in neonates
Output: timely detection and management of jaundice in neonates at facilities
Outcome: timely management and referral of sick children, decreased readmissions due to jaundice, decreased duration of hospital stay because of continuous and instant monitoring 
Long-term outcome: decrease in morbidity caused by jaundice in neonates decrease in financial strain on families caused by neonatal jaundice.

The core of the technology lies in two basic components i.e.

1. Hardware: The evolution of the camera sensor in the last decade along with the processing power attached to the camera has reached a level where a thumbnail size camera sensor can take images that are equally good to a DSLR camera. On similar notes CCD sensors have also become affordable, we are using the combination of such sensors and lenses that are affordable and have drastically reduced the cost of the product. This has made the solution affordable and accessible for less and underprivileged groups.

2. Software: We are using powerful but energy-efficient chips so that we can put a layer of AI to negate the errors in the reading. One of the core issues with non-invasive measurement techniques is that the sensor may take up the values associated with artifacts. We aim to negate such value with the advanced multispectral sensors and a software layer over it. This will ensure more accurate results.

At present, the founding team has one female and one male member. We aim to keep the diversity in terms of gender-equal in the team.

We also aim to include team members from various ethnicity, culture, and places so that the knowledge among various communities can be brought to one place for the collective good. 

Our mission is to make healthcare accessible to the population who do not have access to diagnostic facilities etc. Hence to keep moving on our mission we aim to include representatives from all parts of the society for a better understanding of the Mind frame of the individuals. This will ensure easy implementation of the solutions at scale and would also create greater impact.

Direct Competitors:

BiliCheck by Philips Respironics: Priced at USD 2500

JM 105 by Drager, priced between USD 1800-2000.

Our USP lies in both cost affordability and easy-to-use and extract data. Whereas our competitors use complex mechanisms making the product unaffordable and less reliable when used by inexperienced medical practitioners.

 Indirect competitors:

Lab Analysers: The lab analyzers are the capital instruments that may range from the price of INR 5000 to 25000 USD  -  require a sophisticated lab setup and operators to operate the machine. The readings shown by the analyzers are reported to the doctors at intervals of 4-24 hrs.

The neonatal Jaundice Market is expected to grow at 8-10% CAGR for the next few years. The incidence rate of premature birth is increasing across the globe. From the Indian market perspective, it is USD 150mn worth of market.

The serviceable market involves complex procurement agencies, like government, NGOs, Pharma companies, etc. hence the available market would be around USD 80 mn.

We aim to obtain 2-4% of the market in the next three years with the help of the sales strategy planned in stages. Our revenue model relies upon the sale of devices to government and private hospitals. 

Our customers are B2G and B2B: government bodies such as National Health Mission, National Rural Health Mission, state health centers, government hospitals, private healthcare practitioners,  NGOs, and private hospitals.

We will be attaining this number by selling the solution in the following manner:

1. Direct Sales: We will be doing direct sales to the big size customers like government agencies etc.

2. Pharma NGOs: We will be partnering with the pharma chains and NGOs to follow the process of co-sales and screening.

3. ICU, NICU, etc: We will be targeting the ICUs and NICUs in Tier-II cities to sell the product at an affordable cost.

4. Distributor Partnership: We will be partnering with distributors who are active in neonatal market segments.

At present we have been supporting our project through grants. As we have an aim to turn it into a profitable business. Hence will be selling the solution to the government first so that we can bring bigger chunks of cash at low cost. The reason to do so is that the cost of acquiring a B2G customer is quite lower compared to a B2C customer. Hence such transactions will bring positive cash flow to the company.

A similar model will be adopted in different regions of India where the distributors hold a more influential network. 

Our next step in the strategy is to identify the NGOs who can provide us with both national and international platforms for the implementation of the project.

As this will ensure enough flow of cash to finance the stringent regulatory approvals then will be targeting the international market.

We are also aiming for a long term approach that is we will be working closely with the doctor on a prescription based model where the doctor will prescribe a wearable to the baby and in case of any alert the doctor can call the baby back to ICU, this will free up the ICU and earn additional money to the hospital and also save ICU stay cost for the parents.

I have followed the same strategy with my team in a company. We were able to attain profitability within 4 years of launch by successfully raising VC rounds too.

The company now is aiming for different avenues and is a successfully growing business.