Startup India is an initiative of the Government of India. The campaign was first announced by Indian Prime Minister, Narendra Modi during his speech on 15 August 2015.The action plan of this initiative is focussing on three areas:
Simplification and Handholding.
Funding Support and Incentives.
Industry-Academia Partnership and Incubation.
India is now waking up to the call for Make IN India, Design IN India and naturally “Incubation in India”. Several Indian e-commerce or mobile app or service startups have made waves and become very successful. Interest in the medical sector is definitely growing and there are several notable start-ups and SMEs working on innovative solutions or already making an impact in the Indian context.
With the changing market dynamics caused by Covid-19, almost everything is in overhaul mode. Within the evolving health technology ecosystem, the medical device market is also witnessing a dramatic shift as policies change to meet high demand.
However, at the same time, it is also becoming essential for medical device manufacturers, hospitals, research institutions and regulatory bodies to thoroughly verify the safety, reliability and quality of medical devices, thereby adhering to strict testing protocols, safeguards and ethical approval processes. So the industry is currently balancing between the seemingly incompatible goals of releasing more devices and also give time for testing.
Many industry experts who spoke said that the medical device approval process in India is very time consuming but also rewarding as the market potential is huge. Apart from the obvious current rise in use cases such as screening, diagnosis and treatment of Covid-19, medical devices can also contribute to export earnings and support the healthcare ecosystem in long run.
The Covid-19 pandemic has just highlighted the importance of medical devices more than ever. Many startups, researchers and medical device manufacturers are currently focusing on improving the quality of care as well as developing affordable devices including ventilators, contactless wearables, UV sterilization chambers, test kits, PPE among others.
At the same time, the Indian government is supporting and facilitating a regulatory process for mass testing and manufacturing, pushing startups and SMEs to develop medical devices that will help India deal with the pandemic and other lifestyle and chronic diseases.
As part of the new Medical Devices (Safety, Effectiveness and Innovation) Act, the government has also proposed an improved regulatory framework to facilitate business by providing a healthy environment for innovation and approval of medical devices in the country.
According to GlobalData, the new proposed regulatory framework is to focus on the safety, efficacy and quality of medical devices and will operate under the Central Drugs Standard Control Organization (CDSCO), which will strengthen its expertise in regulating the safety and efficacy of medical devices. device. Previously, 34 categories of medical devices were regulated, the Ministry of Health is now planning to do so cover all medical devices sold under the new law.
In a speech last month, Prime Minister Narendra Modi highlighted India’s “vocal for local” initiative as a measure to promote local manufacturing of medical devices. Apart from announcing the INR 20 Cr stimulus package during his speech, PM Modi also talked about the medical device market and revealed India’s manufacturing capacity.
He said that India was not producing personal protective equipment (PPE) kits before the Covid-19 pandemic, but now it is producing more than 2 Lakh PPE kits per day. He further said that from less than 5.5 lakh ventilators in February 2020, India now has about 15 manufacturers producing more than 40 lakh ventilators to tackle the Covid-19 pandemic.
India on the other hand accounts for about 1.7% of the global market and the current market size of the medical device industry in India is estimated at USD 11 billion due to its heavy dependence on imports and also the current demand to offer a range in various product categories. Some of the raw materials that India imports from China include gloves, syringes, bandages, CT and MRI, etc.
India has an estimated 900-1000 domestic medical device manufacturers and only 15 companies have a turnover of more than INR 200 crore. In 2019, India imported equipment worth INR 38,837, nearly 66% (INR 25,624) worth of medical devices was in categories of electronics and appliances from multinational companies such as Philips, GE and Siemens, among others.
The Medical Devices Association also said that about 90% (INR 16,000) worth of medical devices are imported every year. And 40% of medical devices imported into India are either proprietary or obsolete.
It’s a completely different ball game for startups, Pritish Gupta, COO at Dozee.io said that unlike software companies, medical devices take longer to test and work with hospitals and healthcare facilities. “Since our product uses an AI-based application, accuracy increases with time and data collection,” he added.
Bengaluru-based Dozee.io claims to have developed India’s first contactless health device for stress management, better sleep, heart and respiratory health monitoring. Currently, the company is tied up with more than ten hospitals and healthcare institutes including NIMHANS, Jayadeva Hospital and Ministry of Ayush where more than 2500 devices have been deployed so far.
The company claims its medical device has 98.4% accuracy compared to existing devices used in hospitals.
Dozee is also supported by private and public entities such as the Bill & Melinda Gates Foundation, Qualcomm, BIRAC and the Department of Biotechnology, among others. She applied for three patents for her medical device.
JANITRI’s Agarwal said that getting the right expertise during the development phase is very important for startups, especially those who have made medical devices in the past, and this actually helps entrepreneurs to a great extent. “Otherwise, as a fresher or a young entrepreneur, you could develop a prototype,” he added.
He further said that India has never developed a medical device because we have been importing it from outside and therefore it is very difficult to find the right type of people in the industry to support startups.
