16 Dec 14 Innovation in medical devices in India – making it happen
There has been a lot of buzz around low cost innovation in healthcare in India. The Harvard Business Review and McKinsey & Co have studied the innovations in the delivery of health services in the country that have made it possible to offer world class services at a fraction of what it costs in developed countries.
There has also been a fair bit of innovation in the medical devices sector. The Jaipur foot which is now globally known was designed over three decades ago. More recent innovations by established players that are highly quoted include the portable ECG machine by GE and ultra-sound products from Philips. Several start-ups have also emerged – Forus Health, SKL Medtech, Bigtec Labs, Consure Medical and Embrace Innovations among others. The start-ups have attracted a lot of interest from PE and VC investors.
These are positive developments, as affordable healthcare and medical devices are critical for making healthcare available to the masses. The market at the “bottom of the pyramid” is huge and its unmet needs are the biggest drivers for innovation. However, innovators in India have to overcome several hurdles.
First, the regulation is inadequate. The regulator is not accustomed to certifying and licensing medical devices. Since most medical devices have historically been imported from developed countries, the Indian regulator relied on approvals by foreign bodies like the FDA, WHO and European Medicines Agency among others. (Over 70% of medical devices in India are currently imported.) There are no clear guidelines given to the local innovators on what specifications they need to meet. This allows substandard low quality devices to come into the market.
Indian innovators who want to distinguish themselves from the low quality products therefore seek approvals from foreign regulators. This also allows them to export their products to other developed and emerging markets.
The regulator also does not prescribe any continuous education for the medical practitioners, so many of them are not up-to-date with emerging technologies.
Secondly, unlike in many developed markets there is no encouragement given by the government in the form of funding for new technologies. Further, public hospitals which are among the biggest buyers of devices are often not open to purchasing new innovative products. So there is very little support for innovation from the government.
The new Drugs and Cosmetics (Amendment) Bill, 2014, that is expected to be tabled in the parliament hopes to address at least some of the regulatory issues by providing separate standards and regulations for medical devices. (Medical devices are currently covered under a legislation that was really meant for drugs.)
If the Bill is passed (it is expected to be tabled in the current session of the parliament), it will provide an impetus for local innovation and manufacture of medical devices.