Initially specialising in solar panel cleaning robots, Noccarc pivoted to ventilators during the COVID-19 pandemic. Co-founder Nikhil Kurele explained to EFY’s Yashasvini Razdan how the startup gained recognition for its cost-effective, high-quality, in-house designed medical devices.
Q. Please tell us how you shifted from developing solar panel cleaning robotic solutions to ventilators.
A. From very early on, Harshit and I were interested in developing products with a unique selling proposition (USP) that addressed specific needs. While exploring opportunities, we identified the issue of cleaning solar panels and created a robotic solution for cleaning solar panels. After developing the product, we commercialised it within eight months, receiving our first order from Adani. Subsequently, we onboarded Adani, Mahindra, Tata Power and Renew Power as early adopters, and in 2019, we raised investment from the Indian Angel Network (IAN)Fund. Initially operating from an 18.58 square metres (200 square feet) room at IIT Kanpur, we moved to Pune to leverage its advanced manufacturing ecosystem. However, just as we were gaining momentum, the COVID-19 pandemic hit, posing operational challenges. Despite the uncertainties, we took a risk and developed a comprehensive ICU ventilator to contribute to the healthcare sector.
Q. How did this shift become a full-fledged startup business?
A. During the lockdown, we remotely connected with investors and experts who assisted us in navigating approvals, regulations, and operations challenges. We established a full-time ICU ventilator in less time than expected and received certification from the Ministry of Health. Encouraged by this success, we established our manufacturing facility in Pune. We faced sourcing issues during the pandemic, with one vendor being based in China. To address this, we identified alternative sources and resumed manufacturing by December 2020.
Recognising the looming second wave of COVID-19, we decided to establish a better-equipped facility, enabling us to supply over 2,200 ventilators during India’s more lethal second wave. Our team immersed themselves in hospitals, working with ICU and nursing staff to understand the real pain points and ultimately pivoted to medical devices focusing on comprehensive care. We launched our smart ventilators in June 2023 with over 90 units already sold in the market. We aim to sell around 12 to 15 ventilators this month.
Q. What do you mean by “the real pain points?”
A. Observing that many existing products in India were not designed for the domestic context, we identified three core problems: the impracticality of having multiple devices for treating multiple patients, high running costs due to device and consumable expenses, and the limited availability of information when doctors are not inside the ICU.
Q. Has there been any difference in the sales during and after the pandemic?
A. Yes, there is a significant difference. One notable change during COVID-19 was the fear hospitals had of losing revenues and patients. Premier hospitals urgently sought ventilators due to the necessity of saving lives, not driven solely by the companies selling them. The outcome would have been the same for any company. This reflects a shift that will persist post-COVID.
Q. What are the products that you are selling in the market currently?
A. Currently, we offer two distinct products to the market. The first is V730i, a high-end advanced ventilator recently introduced, incorporating aspects of machine learning. The second is V130+, an evolution of a product designed during COVID-19. V730i comes with a digital platform that allows access to patient information from anywhere at any time on mobile phones.
Q. How many units have you sold till now for the V730i?
A. We have already sold 90 pieces since June 2023.
Q. What is unique about your product?
A. We utilise high-end materials for our products, allowing us to deliver at a much lower cost. Since we source raw materials instead of pre-assembled solutions, we integrate and design in-house daily. For instance, our six-layer PCB board for the product’s internal computer is developed in-house. We get it assembled in China, send some components there, and then receive the completed PCB, enabling us to maintain a more cost-effective approach.
During COVID, we introduced a new ventilator with a four-hour battery backup, a feature not readily available at an affordable cost. Noccarc aims to bring this accessibility through lower costs and advanced electronics. We stand out as the only ventilator company globally, with an OTA feature for software upgrades to end customers, without the need for on-site personnel, a capability not present in competitors.
Q. Could you explain the hardware architecture for this complex device?
A. Our work could have been done with a smaller processor but given the complexity of our ventilator – being a first-of-its-kind product – we opted for a 1.4GHz quad-core processor. The ventilator comprises multiple PCB boards, with around 21-22 boards in total. Various processors, including one akin to a computer, are employed in different sections. Our display screen is comparable to a computer, as we’ve developed our own operating system. The electronic components, including ICs, are chosen to sustain our evolving software for 5 to 10 years. With RAM consumption below 20%, we’ve maintained room for future enhancements.
We’ve incorporated expansion ports into the device for potential upgrades or additional modules, so existing customers can integrate new technologies as they are developed. This allows us to introduce advancements such as sensing electrical signals from the brain for patients with neurological disorders. These capabilities are anticipated to be available within the next two-to-two-and-a-half years. The multiple expansion ports serve as connectors for these future developments, akin to USB ports in a laptop.
Q. What do you mean by a compressor-based ventilator?
A. There are two types of ventilators: compressor-based and turbine-based. The new one is compressor-based, while the old one is turbine-based. The choice contributes to clinical outcomes. A compressor-based ventilator is a medical device that helps people breathe by using a built-in compressor to generate airflow. The compressor takes in surrounding air, compresses it to the necessary pressure, and then delivers it to the patient’s lungs through a patient tube. This process helps ensure the patient gets enough oxygen and removes carbon dioxide from their body.
Q. How do you ensure safety in the OTA feature for a medical device holding sensitive data about patients?
A. Our mobile devices including smartphones or laptops, which are typically connected to Wi-Fi, have numerous applications to fetch data, acting as a bridge between the cloud network and the device. While there are chances for this connectivity model, we do not insist on constant connection. Even when connected, we ensure there is only one channel for data communication. We intentionally avoid making everything online, maintaining a level of control. Technically, it is possible to remotely control, but on the hardware side, we’ve implemented measures to prevent certain commands from being sent to specific hardware boards, enhancing both digital security and hardware safety. We use a HIPAA-compliant server, meeting medical-grade international compliance standards.
Q. How do you utilise AI in your decision making and what algorithms are you employing?
A. Currently, our devices are equipped with AI algorithms, but we have not rolled them out to customers yet due to the need for additional testing and validation. We have addressed the first layer of the problem in the Indian market, which revolves around the availability of data outside the ICU. Using AI and machine learning, we have applied these technologies to monitor the health of the product, allowing the device to automatically alert users if any issues arise.
On the clinical side, our focus has been on solving the challenge of data availability. In an ICU, approximately 1200 data points are collected within a 24-hour window. Managing and analysing this data manually is impractical. We have built capabilities into our devices to address this issue. By bringing data to our cloud platform, we can correlate information from various devices. This approach enables us to provide better insights to healthcare professionals.
Looking ahead, we aim to leverage the accumulated data to enhance predictive capabilities. To illustrate, integrating ECG information from patient monitors could enable us to predict potential cardiac issues. Similarly, in ventilators, we are exploring the possibility of predictive analysis based on multiple parameters. While these capabilities are in progress, our devices are already equipped to handle such advancements. The ongoing digitisation efforts have laid the foundation for these developments.
Q. What kind of data does this device collect and what action does it take based on the data collected?
A. It is a fairly complex process as it measures how the lungs respond to the ventilator. The accuracy of these measurements is crucial, and it determines the effectiveness of the device. For instance, you could have the same specifications on paper, but the device could cost 150% more than our competitively priced product.
The body essentially creates suction to breathe, and the ventilator provides pressure. There are many intricacies involved in this process. The accuracy and ease of use in clinical settings are where our product shines. We have demonstrated that our modes yield better results regarding spO2 oxygenation, and our pressure support is more effective for complex patients. These aspects have been validated across hospitals, including successful runs in Apollo Jubilee Hills, CMC Vellore, and Royal Care Coimbatore. Renowned ICU doctors nationwide are using our products and evaluating their performance.
Q. Does India have advanced facilities required to manufacture medical electronic devices?
A. In India, we have the necessary manufacturing facilities; however, they are primarily used for automotive development rather than medical devices. Facilities focused on electronics for automobiles are well-equipped for manufacturing. The challenge lies in their small number geared towards medical device manufacturing. These facilities are reluctant to engage with us as vendors due to the significant difference in production volumes between automotive and medical devices. While we encounter such challenges, there is a positive shift as people are beginning to consider and support companies in the medical device sector. This marks a changing trend with more companies coming forward to assist in overcoming these obstacles.
Q. Do you also white-label your products for other entities?
A. We sourced a patient monitor product from Science, which we white-label under our brand name Fourier, not Noccarc. We made this choice because we have developed a remote monitoring platform that we believe will be a game-changer in the ICU, and we wanted to test that thesis. Since our digital platform was ready, we decided to white-label a product under the Fourier brand name. However, we plan to discontinue the white-labelled patient monitor in the next four to five months as we are in the final stages of introducing our own monitor.
Q. What does this monitor do?
A. One part is diagnostic, where you measure the patient’s basic parameters at any given point to assess the health of the human body, such as blood pressure, SPO2 level, heart rate, ECG, and body temperature. For complex patients, additional features like invasive blood pressure are considered. Invasive blood pressure involves placing a catheter inside the body to measure real pressure, especially when muscles are weak. Another diagnostic parameter is End-Tidal CO2 (ETCO2), which assesses the percentage of CO2 expelled when breathing air, providing insights into lung function.
These basic parameters can be expanded to include numerous diagnostic parameters. Monitors and other diagnostic devices are used to assess these parameters. On the therapeutic side, ventilators and syringe pumps are employed to improve these parameters based on monitor readings. Ventilators, as therapeutic devices, play a crucial role in decision-making. The information ventilators provide helps determine the necessary actions for patient care and understand how the patient responds to interventions.
Q. How large is your team?
A. We are a team of around 70 individuals, with approximately 24 to 25 people comprising our core team. In addition to our core team, we also have a separate assembly team. Our organisation functions with various teams, including service, sales, production, marketing, and finance teams.
Q. Are there any partnerships or collaborations that you have undertaken to develop this product?
A. Everything in our product is designed and solely owned by Noccarc. We are currently looking at almost 23 patents, with thirteen already granted. These granted patents cover the technologies incorporated into our ventilator, including the breath delivery method, component design, and internal structure. Through these innovations, we have brought down costs without compromising on quality and enhanced accuracy.
Q. How do you manage quality control and comply with global standards?
A. Early in our journey, we recognised the importance of consistency to be compared with global brands. Designing a product in R&D is different from manufacturing it in quantity. Ensuring the right set of components, maintaining tolerance limits, and proper assembly are crucial. We have eliminated manual quality checks by designing tools and electromechanical systems. These systems automatically perform quality checks on the 21 PCB boards and over 2000 electronic components in the new ventilator, preventing potential issues in the market.
To further enhance quality control, we implemented automated checks for every component entering the factory, minimising manual judgment and relying on machine assessments. Additionally, we digitised our manufacturing facility, making it paperless. This transition aligns with international guidelines, specifically ISO 13485 compliance, with nearly 170,000 documents digitised in the past year. The digital approach allows us to identify bottlenecks, address repeated issues, respond more effectively, and exercise better control over manufacturing processes. While such practices are not entirely new, they are uncommon for a company of our scale.
Q. Are there any specific regions or markets that you are targeting?
A. We will first target Germany and then the US, followed by the Middle East in the second phase. The Middle East is more accepting of European certification, which is relatively easier to obtain. Large markets in European countries like Germany and the Netherlands are our focus. Compliance regulations mandate the replacement of devices every five years, and there are replenishment test requirements. This applies not only to new hospitals but also to existing ones that are replacing their devices. Globally, there is a trend toward favouring better-priced products, as countries aim to minimise investments in devices. While we’ve exported minimal quantities to African countries, all new products, especially the new ventilator, adhere to USFDA and CE guidelines, signalling our intent for international markets. Although approached by multinational partnerships, we aim to gain more installations for better command before international expansion. Around 1.67% of the global medical device market is our target.
Q. How many ventilators are you producing every month?
A. We are currently producing approximately 20 to 25 ventilators per month. Our target is to reach 100 to 250 ventilators within a span of one and a half to two years, focusing on the rapidly growing Indian market. The post-COVID scenario has witnessed significant growth in tier two and tier three cities, with increased investments in the hospital sector. Private equity involvement and mergers and acquisitions are contributing to the changing standard of care. This has led to a surge in demand for more affordable ventilators without compromising clinical quality. The global market for medical devices is substantial, estimated at around5 to 7 billion dollars per minute.
Q. Can you give me an overview of your recent financial performance and how do you see your growth trajectory?
A. As of this year, we are set to close at around ₹120 million in this financial year, an increase from the approximately ₹100 million achieved last year. With the introduction of new products, we anticipate revenue to be in the range of ₹300 to ₹350 million next year. Regarding our revenue model, currently we sell our products to distributors who, in turn, sell to hospitals. The distributors handle financial aspects, including payment collection, mitigating our involvement in credit profiles and related matters. While we are considering experimenting with new revenue models like the leasing model and subscription-based software in the future, this is not being implemented at present.
Q. How are you lowering the total cost of ownership for your end customer?
A. Due to our patented expiratory cassette and circuits, our product operates without the need for special consumables. Everything can be run using generic consumables readily available in the market, reducing the hassle for users. Additionally, since everything is designed in India, our costs remain significantly competitive.
Q. What trends are you looking at in the market to capitalise on?
A. As mentioned, people are now aware that a high-quality ventilator can yield excellent clinical results, and this awareness is a trend we aim to leverage. Buyers are increasingly concerned about the clinical accuracy of ventilators, and there is a growing trend of evaluating products before making a purchase, especially in critical care settings. Despite being priced higher than Chinese products, we see this as a reflection of the superiority and differentiation of our ventilators. Another vital aspect we plan to focus on is the cost of ownership for ventilators. Despite the growth in healthcare facilities in India, the paying capacity of patients and insurance amounts has not increased proportionally, emphasising the need for a low cost of ownership for ventilators.
