Boosting Medical Device Start-ups
Medical Devices Industry is a sunrise sector in India today. The country has depended on imports for way too long. It is time for India to assert and establish a strong base of manufacturing medical devices in the country.
Health Care in India had not taken centre stage for a very long time. It is only now that we are seeing enormous focus on cleanliness, sanitation and basic health care. This is great news for the medical devices industry, which is still in its infancy in India.
The first great news for any organisation looking to make a difference in the medical devices industry is new regulatory framework - the medical devices rules 2017. This is a great step towards building a credible and robust medical devices ecosystem in the country.
Currently in India, there are ample opportunities for any startupwhether it is about starting and building an organisation, which makes devices that have already existed in the market or bringing a completely new and innovative concept; also for an organisation focused on incremental innovation or ones bringing disruptive ideas into the market. India is a crucible for ideas in healthcare innovation. As the scale of problems we have with respect to access to healthcare, cost of health care and quality of healthcare is probably unrivalled in any other part of the world.
Start-ups in medical devices and health care are generally faced with the daunting mountain of capital investment.
Also, for any start-up in medical devices, it is important to ensure patient safety. Therefore the fundamental framework of development is risk elimination. Often, the overall effort required to bring the product to market, taking into consideration all the design frameworks, developing the product and testing is hard to gauge during the ideation stage. Significant overruns end up being a common phenomenon.
Given that this is early days for medical devices industry, finding experienced talent is a challenge. There is of course cross learning that is possible from the well-established pharma or bio tech industry but medical devices industry has their own nuances technically.
A minimum viable product in medical devices is generally expected to be in advanced stage, given the risk oriented nature of their application. Start-up founders tend to underestimate the process orientation, adherence to the quality management system and expectations of the regulators. Many don’t see the pitfalls along the way. These pitfalls sometimes end up being expensive mistakes that are not accounted for in the beginning.
Testing market acceptance with a beta launch is most often not possible given the nature of the devices. Therefore, a thorough market study needs to take place before the product gets too far into the life cycle. Else, the mistakes are likely to be expensive.
Finally, start-up’s that cross all hurdles and make quality products in India face the hurdle of perception. Traditionally, due to lack of regulations, and local ecosystem being small, start-ups do face preconceived notion about quality from physicians, purchase teams and consumers about locally made products. Significant change of perception has to be developed through collaboration, constant communication and confidence building measures.
In conclusion, despite the various hurdles a start-up has to face, the Indian Medical Devices industry does hold a lot of promise. If there is a good idea, it will be unfortunate if the consumers don’t benefit from its outcome. The best practices and international standards have laid out simple framework that ensures success. The leadership needs to have the grit, determination and perseverance to see through a steady state of operations. Having the bird’s view of the world at the same time developing the worm’s view of details on the ground will lead to success.
THE INDIAN MEDICAL DEVICES INDUSTRY DOES HOLD A LOT OF PROMISE. IF THERE IS A GOOD IDEA, IT WILL BE UNFORTUNATE IF THE CONSUMERS DON’T BENEFIT FROM ITS OUTCOME.
Chairman, Blue Neem Medical Devices