India is a global leader for technology embedded medical devices. As med-tech companies develop novel technologies and new business models, India’s large patient pool can maximise access to accurate diagnosis at a faster pace. There is considerable focus on enhancing the capability of medical devices with technologies that are safe and efficient, said Dr Ayelet Akselrod-Ballin, director of AI, Zebra Medical Vision, in an interaction with Nandita Vijay. Excerpts: Regulations are getting stringent across the world for medical devices. Please comment. The regulatory authority, FDA is constantly evolving now and is eager to see that approval of medical technologies are safe and effective for patients. This will enable companies to introduce the product faster in the market so the patient benefits with faster diagnosis and access to treatment. The US FDA insists that artificial intelligence/machine learning embedded medical device now need to come under its proposed regulatory framework for saMD (Software as Medical Device). There is considerable focus on enhancing the capability to approve technology embedded medical devices. In this regard, regulatory authority is also matching itself by training its teams to understand AI and the related algorithms.
Zebra Medical Vision has put in considerable high quality work to garner the FDA or EU regulatory approvals. With the advanced data infrastructure we are able to navigate the regulatory process.
Could you provide an overview of Zebra Medical Vision? Zebra Medical Vision was started in 2014 as an initiative to develop deep learning imaging analytics solutions to empower radiologists for providing detection, analysis of medical findings. Since then, we have solutions that have been approved and pending approval from the US FDA and European Medical Agency. Some of the products are AI1 Triage Solution for both CTs and X-rays which currently addresses two acute conditions: intracranial hemorrhages and pneumothorax. There are also solutions for faster detection of cardiac risk, TB, breast cancer, osteoporosis and bone compression fracture detection.
What is so unique about the technology that you have used to develop these diagnostic products? There are a few aspects of the products that make it unique. First of all, today this sort of technology is based on deep learning which in the past were computer vision or machine learning approaches based on feature engineering. Today, we have models and the architecture algorithms that learn high-level features from data. Now this sort of approaches rely on a lot of data which Zebra has. For example, in our chest x-ray product alone we accessed 2 million studies for references. This is similar for other applications too. It is the methodology that integrates multiple disciplines and domains that work together. The company has a large team comprising expertise in clinical, regulatory and product development along with a pool of excellent researchers who create applicable products to serve the population. Therefore, it is not just being adept in algorithms or engineering but to have an understanding of clinical needs.
Is Zebra Medical Vision looking at the Indian market? Yes, we are looking at the Indian market and have a collaboration with the Union government and Apollo Hospitals Group in India with a generous grant of $4.9 million. This came about during an Indo-Israel pact between Prime Minister Narendra Modi and Israel Prime Minister Benjamin Netanyahu. Here Israel identified Zebra Medical Vision to work with Apollo in India having over 70 hospitals. We looked at this as a big opportunity to work with such a large healthcare system. We are counting a lot on this collaboration for knowledge sharing and adoption of our expertise. Now India is home to a population with different diseases and so this will enable considerable data creation.
Are you looking at clinical trials from India to assess the patient data from this part of the world? Definitely it is on the cards because it is vital to expand our products reach and also to bring solutions that we have already developed for other parts of the world and now for India. We see our technology for chest x-ray which has considerable data and hence we would like to evaluate and see if it can be adopted for health problems here. It is here anything that involves population health, that we need to bring it to the attention of radiologists whose ever increasing workload can be minimised and with no compromise on quality.
Going forward, what is the next plan for 2020 in India? We want to make the different technologies that we already have to work for India. In this regard, the intent is also to understand the Indian market needs. Plans are underway to line-up products for this market next year. These products are for the general good of all humans. Now that we are working with the Indian government, there is immense scope to expand our reach here.
Specific to Apollo Hospital Group, what has Zebra Medical Vision collaborated for? The collaboration with Apollo Hospital Group started 3-4 years ago. The whole idea was Tuberculosis as a disease is not common in the West. India today accounts for 27- 30 per cent of TB incidence and so doctors do not know how to diagnose such a condition at scale. The current mode of diagnosis is sputum test where the sensitivity a low as 50 percent. We came up with the idea to detect TB with development of markers on a chest x-ray. In India, a chest x-ray is accessible, affordable and accurate. Apollo has access to a large data set across the country of chest x-rays indicating positive and negative for TB. Zebra can take this data to start fine tuning its existing algorithms that will start stacking patterns in the data of x-rays. The grant of $4.9 million will be partly used for data tagging and development. This will be offered to all government hospitals in India by Apollo so that TB is detected easily.
Are you looking at any other collaboration besides Apollo? We always look for good partners to help us accomplish our vision. In India, we also work with the Ayushman Bharat, the Modicare team because this is like a government sponsored biggest health coverage scheme in the world covering 500 million people. Specifically for cardiovascular diseases Zebra’s algorithms can detect the disorder. We feel given the Israeli-India collaboration it will automatically transfer to Zebra working with the government hospitals. In India, healthcare is expensive. It is here population health with AI from Zebra will make a big difference.
What led the Israel government to select Zebra Medical Vision for this project? There are several factors. First is the expertise in data and we have an advanced infrastructure for product development. Second it is the team with a broad range of expertise. Third is the high standards of quality enforced by the company that has enabled getting the FDA approvals. From an HR perspective, the company won an award recognising it as the top 5 ‘Best start-up places to Work’ and was also named as a Top-5 AI and machine learning company.
Funding is also important for governments. The company raised $52 million. We are one of the few AI companies globally with significant funds coming in from some of the best investors including Khosla Ventures, Marc Benioff, Intermountain Investment Fund, OurCrowd Qure, Aurum, aMoon, Nvidia, J&J, and Dolby Ventures. In addition, we received many government grants to help us take the technology to more and more patients.
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