Blackfrog Technologies Pvt. Ltd. is a Manipal, Karnataka-based technology Start-up Company that seeks to improve the efficiency of immunization supply chains. We have developed patented technologies for precision cold-chain and vaccine traceability systems with support from BIRAC (DBT) and leading impact investors in the nation including Venture Centre (NCL, Pune) and Social Alpha to provide logistical support in the last-mile delivery of vaccines.

Amid surging cases and an acute shortage in the supply of COVID-19 vaccines, the emerging economies certainly cannot afford vaccine wastage. However, since our immunization drive relies heavily on bringing vaccines to the people, rather than vice-versa, there is scope for vaccine wastage in transit during the ‘last mile’ (from healthcare centre to location of administration), due to exposure to non-optimal temperatures. Despite varying storage temperature and requirements, every drug currently being administered as part of the immunization drive across nations, including Pfizer, Moderna, Covaxin (BBL) and Covishield (AZ) require temperature between 2 and 8 ^oC (35-40 ^oF) during the last-mile of transport. More importantly, most vaccine candidates (BBL, AZ etc) are even freeze-sensitive. Therefore, in order to ensure their efficacy, exposure to temperatures outside the optimal range must  be minimized.

Unfortunately, iceboxes, the predominant mode of last-mile vaccine transportation for COVID-19 vaccines, are not equipped for this task. Since they have no mechanism for temperature control and regulation, there exists the risk of accidental freezing and/or thawing, rendering the temperature-sensitive vaccines inefficacious. This is especially likely when vaccines are to be transported to distant and remote locations with harsh weather conditions. As a result, even when vaccines reach their destination in time, there exists the prospect that they have been compromised. Additionally, the lack of reliable temperature monitoring capabilities in iceboxes makes it challenging to determine the efficacy of the vaccines in advance. It is possible, then, that a proportion of the population receives inefficacious vaccines, significantly impeding immunization efforts.

Product overview

Emvólio is a portable, battery-powered refrigeration device that will strictly maintain any pre-set temperature for over 12 hours for the last-mile transport of vaccines. Emvólio’s 2-litre capacity enables it to carry 30 - 50 vials, which is standard for a daylong immunization campaign. Further device capabilities include continuous temperature monitoring, location tracking, state-of-charge  indication,  communication with headquarters via live tracking, and vital statistics for improved coverage. This system has been helping remote hospitals relieve the economic burden of wasted vaccines. Further, it helps optimize human resources in vaccine delivery by removing the need for repeated immunization visits to account for the administration of unviable vaccines. Most importantly, our battery-powered device stands apart from the competition with its unmatched portability and ease of charging. Blackfrog is an ISO 9001 and ISO 13485 certified manufacturer of medical devices and Emvólio has been designed under WHO-PQS E003 standards.

Deployments

A group of researchers from the UK and Thailand conducted a study in 2017 on the ‘Cost, health impacts and cost- effectiveness of iceless refrigeration in India’s vaccine cold chain’[1] to better understand the economic benefits of using a battery-operated device as a replacement for conventional iceboxes. The team concluded that the costs of wastage in the context of just rural India alone of the ice based cold chain system is USD 7,512,930 and that even at a unit

cost-price of USD 2000 for an iceless, battery-powered vaccine carrier, the cost-benefit ratio that avoids this wastage would be 0.28, indicating that this is cost-beneficial.

We have around 322 devices that have been currently deployed for human vaccination in around 10 states and 1 union territory of India with a majority in Assam, Manipur, Meghalaya and Tamil Nadu. Around 1,06,197 vaccination doses have been administered in the very hard to reach areas across different regions i.e., in the mountains of the north east, the coastal region of the south and deserts of Rajasthan. A consolidated table of the state wise deployment and vaccination data  is as shown below which was received from January, 2022 until July, 2022.

Post-deployment, the Blackfrog team visits the deployment sites and provides comprehensive hands-on training on the usage of Emvolio. The team usually trains the Cold Chain Technicians (CCTs) and Vaccine Cold Chain Managers (VCCMs), who then go to their respective districts and train the end-users (ASHAs/ANMs/VHNs). Apart from this, we also ensure regular follow-ups with the end-users to obtain feedback on the device. We also provide refresher training so the users are familiar and comfortable with the device and the new technology. We have received both positive and negative feedback from different places since adapting to new technology can take some time and people may have apprehensions about the same. This also gives us opportunities to constantly improve our product and  service based on user feedback.

Apart from these domestic deployments, we have 3 units live at Gulf Advanced Trading, Kuwait that are currently being used by various organisations on trial basis. With the help of USAID through IPE Global, we will be soon deploying 100 units in Kenya in the counties of Isiolo and Samburu.

Use case

One of Blackfrog’s stakeholders, SVYM Hospital in Sargur, near Mysore (Karnataka) have used Emvólio for a full year now which was donated by SELCO foundation. They report saving USD 174 every month as a direct consequence of not having to discard unused vaccines at the end of the day’s field trip. The field doctors report  that with Emvólio’s battery performance, they are now able to immunize twice as many children in tribal regions as they were previously able to with ice-based systems.

From our general feedback, we were notified that the vaccination drives could be done for a longer duration as compared to before introducing Emvólio into the last mile supply chain. During COVID-19 vaccination drive, from our internal data, we noticed a savings of about USD 1800 from 2 devices in a period of 45 days. We have noticed that some of the PHCs that do not have an ILR are using Emvolio as a stand-alone refrigerator. There are cases where Emvolio was used to transfer rare blood bags to remote locations.

Regulations and compliance

Blackfrog Technologies is an ISO 13485 certified company (accredited by MTIC) and we have recently received our ISO 9001 certification too (accredited by TUV, Rheinland). Our device Emvolio has cleared the highest standards of electrical safety for medical devices of IEC 60606-1 that has been tested at TUV Rheinland and ICAT. We have also cleared the PQS testing for E003 TS01.1 category of transportable, battery powered vaccine storage appliances. This testing was conducted at a WHO certified lab in Intertek, Delhi.

Production facility

Our batch production facility is in place with a capacity of nearly 1500 units per month that can be assembled and manufactured which was previously of about 300 units per month. The photographs of the facility are as shown below. The facility is completely ESD proof with air conditioning in all the three assembly lines, inventory and pre-processing area. There is a burn-in chamber in which the devices are tested for about 4 days in extreme conditions.

Compiled By: Dr. Elton Dylan Nazareth, Senior Program Manager, Blackfrog Technologies Private Limited

References

[1] Panarasri Khonputsa MSc PhD, Katherine Plewes MD PhD, Nicholas P.J. Day MD PhD, Yoel Lubell PhD. ‘Cost, health impacts and cost-effectiveness of ice-less refrigeration in India’s vaccine cold chain’. Center for Tropical Medicine and Global Health, Oxford, UK and Mahidol-Oxford Tropical Medicine Research Unit, Bangkok, Thailand.